Journal of Managed Care Pharmacy

volume four.
number six novemberldecember 1998
Journal of Managed Care Pharmacy

Official Journal of the Academy of Managed Care Pharmacy
COMPARATIVE
RESEARCH
. Treatment of
Pharmacist
Patients With ALS:
Implicationsfor the Managed Care
. The
Information Requirements of Health Systems as Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards?
. A Predictive Cost AnalysisModel for EstimatingFormulary Impact of New

Products in Managed Care
FEATURES
. Maximizing Generic Substitution in Managed Care
. State-by-State
Look at Medicaid Retail
Pharmacy Delivery:Trials and Triumphs
'C 0
V E R
(1771)
hardly
IMPRESSIONS
..
Gilbert Stuart (1755-1828)
famous and highly praised works. After being held quietly in private hands, the work called Gentleman Skating was
as a "probable" Thomas Gainsborough seven years after its commission. Although the critics disputed
The Skater
"
r
Looks can be deceiving. For example, The Skater, featured on the cover of this issue of JMCP, shows a courtly 18th-century gentleman skating in a
a great artist, but his portraits the most expert the citizens of were
Newport had seen. The Scottish artist

soon was enjoying an impressive
exhibited
J
'j
peaceful, quiet setting. Who would imagine that such a scene was painted by an often-vulgar prankster with a wild
reputation?
income, and young Stuart was thrilled when Alexander took him on as an apprentice. After studying with Alexander in Newport for several years, Stuart left
Gilbert Stuart played crude practical jokes on his colleagues and students, indu1gedin snuff, and enjoyed liquor. In
1ater years, his face reflected
a
life of
excess. At the same time, however, he
cultured, intelligent man who trave1ed and studied in Europe and was praised by his colleagues and worwas
a
with his mentor in 1770 or 1771 on a tour of the American South, then abroad to Scotland, returning to Newport, then moving to Boston. But he was restless and eventually found his way to London. Stuart spent his early years in Europe destitute, often living on the streets. His work, which had received praise in Newport, seemed shamefully inferior on the sophisticated London art scene. At one point, he actually gave up the idea of being a professional artist.
Stuart's break came when he got an opportunity to study with famed
tis attribution and argued among themselves about the painter's true identity, they agreed unanimously that Gentleman Skating was a standout in a show of
masterpieces. When Stuart was later identified as the artist, the recognition made him famous. After many years in Europe, Stuart eventually returned to New York, a move that led to the artist's place in
shipped by his students. Clearly, Stuart was a man of contradictions. And his works could be just as enigmatic as their creator. They appeared on the surface
serene, peaceful, and attentive to the
American history books. It was here that he was commissioned to paint his most famous subject. Today, the artist's portrait of George Washington hangs in
schools, libraries, and city halls nationwide and has appeared on postage stamps, posters, and adversements. Pharmacists and other health care professionals learn early in their school-
subject. But
closer look at his brush-
work and painting style shows a quick, impatient hand eager to capture the moment, "aware of the luminous possibilities of brushstrokes as applied through the layered glaze technique,"
and indifferent to the subject!
American artist Benjamin West. West "knew that Stuart's hands trembled so
violently because of overtaut nerves; he

recognized his outrageousness was caused by a lack of self confidence; and he treated him, Stuart remembered, like a son."! Although West's portrait style
ing to look beneath the surface and beyond the obvious. They know that the
truth about
patient's condition mayor
The colorful life of Gilbert Stuart began December 3, 1755, in a mill in New England. He was a spoiled child,
pampered by his parents and older sister. He spent his youth in Newport, Rhode Island, in a tobacco shop on the
seafront of the maritime city. Stuart was
may not be what it appears initially. These mysteries, enigmas, and contradictions are part of what makes every minute of our work so interesting.
Joanne Kaldy JMCP Contributing Editor
did not greatly influence Stuart, the young artist matured and grew under West's tutelage. And although he still indulged in vvild sprees, he learned to paint with regularity and self-discipline. He developed a unique style that assimilated the European mode and tradition with American pragmatism. Stuart began to establish a "painterly tradition
remembered as
boy. He also was
capable, self-willed bit of a hooligan and

a
spent time prowling the town with gang of street urchins.

Stuart also exhibited
a
While he enjoyed his wild youth,

strong inte]]ect and artistic leanings. His first artistic studies were with Samuel King, an
instrument maker who had taught himself to produce crude portraits.
of transparent luminosity" that set the scene for the Romantic art movement in I America. It was at West's urging that Stuart agreed to do a full-length portrait of William Grant of Congalton. Inspired
..
Cover Credit
Gilbert Stuart (1755-1828) THE SKATER, oil on

canvas. CopyrightlQ 1998, The National Gallery of
Art, Washington, DC. All rights reserved.
However, Stuart spent only
short
time with King; his head was turned
when Cosmo Alexander came to town. Alexander, an elegant Scotsman, was
when Grant suggested that he and Stuart skip the first sitting for the portrait and go ice skating, the artist began work on what would become one of his most
..
Reference
1. Novak B. American painting of the nineteenth century New York, NY: Harper & Row, Publishers, 1969.
Vol 4, N. 6
November/December 1998
}M{.'P
539
1997-98 BOARD OF DIRECTORS

..pj-esident: Steven G. Avey, M.S.,
RPh., Prospec-
CONTENTS
tive Health, Inc., Sandy,pT .President-Elect: Carey C. Cotterell,
RPh., Kaiser
Perrnanente Medical Care Program, Anaheim, A "Past President: Lowell T. Sterler, RPh., M.BA PCS Health Systems, Inc., Scottsdale, AZ
;pfeasurer: Shawn Burke,
.}~CP
"
Journal 01 Managed Care Pharmacy@
OfflciIIiJo.;'n.oIoI"",-.yolM.l""~CanJ~
RPh., Coventry Health Care, Kansas City, MO Brector: Jean Brown, Pharm.D., PCS Health Systems, Fountain Hills, AZ
Director: Larry Barenbaum, R Ph., Rxlmage,
AMCE,...m,
of Managed Care Pharmacy
Volume 4, Number 6
Wheeling, IL .irector: Bruce Fallik, M.S., RPh., Blue Cross Blue Shield plans of Colorado, New Mexico, and Nevada, Deriver, CO '15i~ector: Cynthia] Pigg, RPh., ClGNA
Healthcare, Glen Allen, VA
EDITORIAL ADVISORY BOARD

Timothy D. Bimer, RPh.,
Health Care, Brookline,
COMPARATIVE RESEARCH
A Predictive Cost Analysis Model for Estimating Formulary Impact of New
MBA,
MA
Harvard Pilgrim
585
Diana I. Brixner, Norvartis Pharmaceuticals
Products in Managed Care

Samuel Hedayati and Peter W!Kleinstiver
Corp., East Hanover, NJ Carey C. Cotterell, RPh., Kaiser Permanente Medical Care Program, Downey, CA
Charles E. Daniels, National Institutes of Health Clinical Center, Bethesada, MD
593
Information Requirements of Health Systems as Drug Purchasers: Does the FDA Have Role in' Setting Evidentiary Standards?
Paul C. Langley
Michael] Dillon, M.S, R.Ph., Foundation for

Managed Care Pharmary, Alexandria, VA Renwyck Elder, R.Ph. MBA, PCS Health Systems, Inc., Scottsdale, AZ
'-,
599
Treatment of Patients with ALS: Implications for the Managed Care

Pharmacist
Anthony Barisano and Jeffrey A. Kramer
Molly Engle, Ph.D., University of Alabama at Birmingham, Birmingham, AL Diane B. Ginsburg, University of Texas, at Austin, College of Pharmacy, Austin, TX
Fritz Hadeler, 3M Pharmaceuticals, St. Paul, Tracy S.,Hunter, Ph.D., NLU College of Pharmacy, Monroe, LA
Robert McCarthy,
MN
&
CONTINUING EDUCATION
Research Methodology: Some Statistical Considerations
Peter
D.
Ph.D, Massachusetts College of Pharmacy &: Allied Health Sciences,
617
Boston, MA Brenda A. Motheral, University of Arizona,

Tuscson, AZ. John E. Ogden, M.S., FA.5.H.P, Department of Veterans Affairs, Washington, DC Lee A. Wanke, M.S.,
Hurd
R.Ph, Immunex
Corporation, Seattle, WA William] Waugh, Pharm.D., Well point Pharmacy Management, Calabasas Hills, CA
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Vol. 4,
No.6
NovemberlDecember 1998
}MlP
541
EDITOR-IN-CHIEF
Louise J. Sargent, M.S., R.Ph.
.
Astra Pharmaceuticals, L.P
St. Paul,
MN 55117
CONTENTS
PUBLISHER
Judith A. Cahill, Executive Director. AMCP Headquarters
MANAGING DIRECTOR
Rebecca Mashaw. Mitchell Petersen, Inc.
.
Editorial Office
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/,'
Journal of Managed Care Pharmacy@
PRODUCTION MANAGER
Sue Partyke
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Mitchell Petersen, lne.
Editorial Office
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PEER REV] EW/ ASSOClATEEDITOR

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Editorial Office
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DEPARTMENTS
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CONTRIBUTING EDITORS
Marlene Z. Bloo~1J.. AMCPROGRESS Perry Cohen A Features Renwyck Elder'" Spotlight
Diane Ginsburg
J.
539 Cover Impressions

The Skater
Gilbert Stuart
Cavcats
Tracy S. Hunter A. Academics Joanne Kaldy ... Cover Impressions Robert McCarthy A Campus
J.
544 Caveats
The Survey Syndrome
Warren Salmon'" International Kenneth W Schafermeyer IJ.. Continuing Education/CE Exam Lee A. Wanke'" Perspectives
567 International
Reform of Japanese Health
Policies Part III
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journal of Managed Care Pharmacy (lSSN 1083-4087) is published bimonthly by the Academy of Managed Care Pharmacy, 100 North Pitt Street, Suite 400, Alexandria, VA 22314; 703/6838416; 800/TAP-AMCP; 703/683-8417 (fax) Annual membership dues are $125 for Active Members and $225 for Associate Members, $20 of which is allocated to a subscription to journal of Managed Care Pharmacy. Periodicals postage pending at Alexandria, VA, and additional
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Microfilm and microfiche editions of journal of Managed Care Pharmacy are available from University Microfilms, 300 N. Zeeb Road, Ann Arbor, MI 48106.jMCP is indexed by International Pharmaceutical Abstracts and Iowa Drug Information Service. Copyright ( 1998, Academy of Managed Care Pharmacy, Ine. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or
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Vol. 4,
No.6
}MCP
Journal of Managed Care Pharmacy.
543
CAVEATS
The Survey Syndrome
You know the feeling: A knot begins
to form in your stomach. Time rushes on. Your coworkers are frantic. Team efforts become more difficult as nerves
justify many of the decisions we make. The outcomes literature still is in its
early years, and there still is much data to be collected. As the field of outcomes
research continues to grow over the next
This is not to say that the accrediting rganizations do not make mistakes in developing standards to which we, as health care providers, must adhere. We should not take a passive role in accepting these faults but assume, instead, a true partnership that creates standards
to which we are proud to be held.
are frayed. Frustration,

a
aggravation~ and
general fear of the unknown are prevalent in the organization.
few years, and as experience grows with it, a more definitive picture of best practice standards will develop.
The cause of the syndrome? A regulatory or accreditation site visit. Health care practitioners resent completing tasks solely to satisfy a regulatory standard. As professionals, we consider everything we do as an exten.
Most health care practitioners don't realize that, to a significant degree, the
accrediting organizations themselves have driven the shift to an outcomes focus. These organizations have shifted from prescriptive standards to standards that allow organizations to find their own best practices, as long as the outcome of the
process of care has been evaluated. Accrediting organizations are striving to expand the outcomes literature by encour-
The next time your organization is scheduled to undergo an accreditation survey, use the experience to showcase
sion of our professionalism. Meeting regulatory standards is considered an intrusion into our professional integrity as
what your organization does really well and look for opportunities to gain insight into processes that you know can be improved. Try approaching the survey with an open mind, anticipation, excitement, and a willingness to exchange experiences. Not only will you
time-consuming task that detracts from our ability to provide highquality care to our patients. Early accreditation o;urveys produced 'these feelwell as
a
ings and the accompanying symptoms. These surveys typically were tied to
aging reporting of outcomes of care and allowing organizations to look within the
industry for benchmark best practices. The value this shift in focus brings
to patient care cannot be overstated. The accreditation process is an extension and
find the survey more tolerable, but you also will likely find that the experience provides some stepping stones for future improvement in the care your organization provides to the' patients it serves.
compliance with stringent standards, Organizations often modified policies to

reflect accreditation standards rather than actual organizational practice. Inor-
dinate amounts of time and energy were devoted to making changes within the
validation of good patient care. Surveyors bring outside expertise and experiences
Charlotte A. Kenreigh, Pharm.D.
Manager
Linda Timm Wagner, Pharm.D. Manager
-both
personal and those gleaned from
organization to meet the regulatory standard. Thesstandards were almost uniformly process- and structure-focused, not outcomes-driven. Currently, health care is shifting to an outcomes focus. As managed care pharmacists, we too use outcomes to
visits to other organizations-that can
be valuable resources to organizations.
When this expertise is combined with that present in each individual organization, the synergy of ideas can result in improvements in performance and outcomes of care for the benefit of patients.
MLC Solutions Galena,OH
544
}MlP
November/December \998
Vol 4, No.6
State-by-State Look at Medicaid Retail Pharmacy Delivery:Trials & Triumphs

As states shift the delivelY
of Medicaid benefits, including retail
pharmacy, to managed care Medicaid insurers, related cost-control
shifts are occurring around the country.
Year
after year, the number of Medicaid enrollees in managed care increases. Between 1992 and
1997, even with the total Medicaid population remaining fairly stable, the number of recipients served through managed Medicaid programs rose from 2.7
million to 13.3 million. Medicaid managed care enrollment increased fourfold, from 9.5% to 40% of eligible recipients.]
Medicaid managed care enrollment can be either voluntary or mandatory. The use of Section 1915b waivers (free-
only the tip of the managed care iceberg. Overall, within the next decade, an estimated 80%-90% of the American population will receive care through an integrated service network that provides primary, specialty, and hospital services. As
result, Medicaid enrollment rates in managed care are likely to continue to increase for at least three reasons: ... States now have the right to mandate
a
Medicaid eligibles into managed care plans.
Mary Ellen McPeak
dom of choice) and Section 1115 waivers (typically, pilot programs of predetermined duration to determine services or
reimbursement requirements for expansion of a state's Medicaid benefits) increases access. As of March 1997, the
... More- health maintenance organizations (HMOs) now can bid for Medicaid contracts because the 75/25 law, which required that managed care plans enroll
a
minimum 25% of commercially
Health Care Financing Administration (HCFA) had granted 114 waivers across
the nation.' Currently, only Alaska and
insured enrollees along with its Medicaid enrollees, has been repealed.
... Some low-income populations now can buy into Medicaid plans, paying a
sliding fee scale.
Wyoming have yet to switch their Medicaid recipients into managed care. At the other end of the spectrum, 31 states have
at least 50% of their Medicaid eligibles in a managed care plan, with Arizona
THE MANAGED MEDICAID PHARMACY BENEFIT

A pharmacy benefit is part of every
and Tennessee providing managed care as their sole source of Medicaid benefits. Although some managed care plans, especially those ne,v to the Medicaid market, have withdrawn from Arizona, Calisey,
,
stte's traditional Medicaid program and, under law, managed care plans must
provide equal coverage to the state's

b.enefit program, even if it exceeds the coverage available to other plan members. For example, some state formula-
fornia, Connecticut, New York, New JerPennsylvania, and other states, blam-
AUe/101
ing inadequate reimbursement rates, 'national enrollment in Medicaid managed

is Senior
ries cover selected over-the-counter
MARY ELLEN McPEAK

Totowa, NJ.
Writerfor Emron,
care programs continues to increase as

states are asked to assume responsibility
drugs, typically nonsteroidal antiinflammatory drugs, cough and cold remedies,
antihistamines, antacids, and vitamins.

Furthermore, most states require no or very low copayments from Medicaid patients. State Medicaid formularies also
for greater numbers of needy patients.
Copyright!9 1998, Academy of Managed Care Pharmacy, Inc. AI/lights reserved.
Although the latest enrollm~nt
statistics
are imposing, they probably represent
546
jMCP
Vol. 4,
No.6
State-by-State Look at Medicaid Retail Pharmacy Delivery: Trials &: Triumphs
rely heavily on generic equivalents, an

aspect that commercial managed care
Figure 1. Changes in Medicaid Spending at Retail Pharmacy LevI
plans welcome. Currently, Medicaid fee-for-service (FFS) reimbursement rates to pharma-
higher than those of third-party insurers.' According to a National

cies are
Pharmaceutical Council survey, most state programs (55%) calculate reim-
71.7%
"-.,.
bursement rates using average wholesale price (AWP) minus 10% or 10.5%.
Alaska, California, Minnesota, Nebraska,
.
iii
II]
EJ
70.0% and greater 60.0

-
69.9%
Ohio, Virginia, and Wyoming have
IIJ 50.0
59.9%
.
higher reimbursement rates, discounting AWP rates by less than 10%. Connecticut, Delaware, Michigan, New HampNew Mexico, Utah, and West Virginia have deeper discounts of 12%shire,
40.0 49.9%
-
30.0
39.9%
Source: Novartis Pharmacy Benefit Report:
IMS Health Retail Method of Payment Report
13%, bringing them closer to the average for commercial third-party payors. Average dispensing fees paid to retail pharmacies for Medicaid prescriptions
also vary
into Detroit and surrounding counties. State-reimbursed pharmacy retail spending is expected to decrease again next
year, however, because Michigan is
The job of cost-effectively administering New York's FFS Medicaid pharmacy benefit program has been daunting. Retail dollars reimbursed grew
have
,
widely In addition, many states range of dispensing fees, with
differentials set according to specific criteria, such as outpatient dispensing versus long-term care dispensing, or brand
versus generic dispensing. The average dispensing fee ranges from $3-$4.50
pushing for its managed mental health plans to add a pharmacy benefit. In Utah, the rate of change in Medicaid
dollars moved down 2.1 %-an impressive achievement, considering that
21.2% from 1996 to 1997, $609 million more than FFS Medicaid in California, the state' with ~hesecond highest Medicaid pharmacy tab.3 In the past, New York carved in pharmacy benefit delivery for Medicaid enrollees diagnosed with HIV/AIDS. During the next few years, the state will be carving in all Medicaid pharmacy delivery This tactic will, for the first time, allow the state to collect statewide Medicaid pharmacy
utilization data via
a
Utah has carved in an FFS Medicaid pharmacy benefit plan. State administrators largely attribute this accomplishment to the state's computerized,
per prescription. Across the board, the cost of a prescription in the United
by $2.80 to an averof $35.89, according to data in the Novart(s Pharmacy BenefitReport: 1998
States rose last year
age
centralized, real-time Medicaid drug utilization program, which contains the name of every Medicaid enrollee in its database. States experiencing less control over their traditional Medicaid retail drug reimbursement levels include Kentucky, New York, and North Carolina. Kentucky
has seen its FFS Medicaid pharmacy
systematic, linked
Facts and Figures.
process-a process that should eventually help New York better control its
FFS Medicaid expenditures.
STATE-LEVEL CHANGES IN PERCENT OF MEDICAID RETAIL PHARMACY DOLLARS

Figure 1 shows the degree of change in FFS Medicaid dollars spent at the retail pharmacy level. Starting on the East Coast, Pennsylvania's share of FFS
In a similar vein, North Carolina experienced an 11.3% increase in FFS

Medicaid pharmacy dollars spent,3 and, at the same time, the state ranked first
in growth (25%) of third-party reimbursed retail prescriptions. North Carolina has been moving Medicaid eligibles in the Charlotte region into managed care Medicaid programs. In addition, it is in the process of developing a disease
spending increase 39%.3 There are at least two reasons for this predicament: 1) the state's goal ,is to introduce managed Medicaid into its counties on an
incremental, region-by-region basis-a tactic Kentucky hopes will avoid some of the implementation/service delivery
Medicaid pharmacy dollars fell 11.6%, largely as a result of the state's first foray into managed Medicaid.3 Its new $11
billion program, Health Choice, is only operational in the state's most populous area-the five-county Philadelphia region.
Moving into the Midwest, data show that Michigan's level of Medicaid pharmacy reimbursement dipped only 1.3% after
the introduction of managed Medicaid
problems incurred by its neighbor, Tennessee, which switched all its traditional
Medicaid enrollees into a managed care program in one fell swoop; and 2) there
has been
a lack of interest in accepting managed care Medicaid members from adequate potential insurers.
management program for Medicaidinsured children with asthma. Other programs have opened access to greater numbers of Medicaid eligibles, some
served by commercial plans and some
under state benefit management (retail reimbursement)

.
Continued on page 551 ~

}M{P
Vol. 4.
No.6
547
State-by-State Look at Medicaid Retail Pharmacy Delivery: Trials &: Triumphs ~

Continued from page 547
Faced with increasing drug costs and

increasing Medicaid enrollment, managed care pharmacists have their cost accountability work cut out for them. This Promethean task is likely to become more
while still important, is a secondary consideration among the many benefits achievable with effectively designed, online, real-time DUR/DUE data systems. Utah's experience with DUR systems
offers
a
100,000 members-75% of whom are children, and 10%-15% of whom are asthmatics-for signs of therapy compliance. Scanning for signs of patient noncompliance, Leslie Lotano-Saba, R.Ph.,
difficult, because most states initially targeted the healthiest members of their
prime example of the health care
Medicaid population-young women and children-for enrollment. Now is the time to provide services for the other Medicaid enrollees-those patients who
account for one-quarter of enrollees but two-thirds of health care expenditures.
enhancements that other states can achieve for their Medicaid enrollees. In Utah, a state with a carved-in FFS pharmacy benefit and an open formulary, currently available drug review and evaluation options include programs that monitor a patient's file for duplicate
therapies, drug-disease contraindications, drug-drug interactions, minimum/maximum dose levels for children and adults, and pregnancy-related con-
M.S., director of pharmacy services, routinely checks for optimal asthma therapy
compliance. Patients identified as possibly noncompliant or not treated optimally,
based on the National Institutes of Health guidelines, are considered candidates for an asthma intervention pro-
NATIONAL SHIFTS EXPANDING OPPORTUNITIES FOR PHARMACISTS AT STATE LEVEL

Shifts in the way the Medicaid phar-
macy benefit is reimbursed are influencing corresponding shifts throughout the health care industry. Both retail and hospital-based pharmacists are affected. No longer viewed as merely product purveyors who simply deliver the salves,
syrups, and syringes from behind a counter, pharmacists are being recog-
traindications. On average, the Medicaid data system processes about 160,000 prescriptions per month, flagging about
gram when their data indicates they: 1) use acute care albuterol inhalers LOO often; 2) do not often receive long-term control therapies; and 3) only infrequently get breakthrough asthma-attack
drugs. The care coordinator provides follow-up with these patients and is likely to refer them to the plan's asthma
30,000, or 19%, for review. Of these, about 1,300, or 4%, of prescription claims are denied based on DUR warnings, according to Duane Parke, R.Ph.,
M.H.A., drug utilization review program manager, Utah Department of Health.
Utah's Medicaid Prospective Drug
DM program.
Mercy has yet to determine savings accrued via fewer asthma-related emergency room and hospital admissions.
Studies demonstrate, however, that patients admitted for an acute exacerbation who go on to enroll in a DM program are three to four times less likely to be readmitted for asthma during the
nized as strategic players in the struggle to maximize pharmacologic benefits and
Utilization Review Program saved the state an estimated $4 million-$5 million

in avoided hospital admissions and physician office visits, according to Ray
minimize adverse events and ineffective

health care expenditures. Pharmacists are earning the right to be financially reimbursed for educational services, as are other health care professionals, especially for services provided in clinical settings.
next three months.
Dell Ashley, its Medicaid pharmacy/ health program director. The state's pharmacists, by doing
their bUR homework, enabled the Utah program to identify and prevent a num-
COGNITIVE SERVICES
Because the pharmacy benefit re-
Emerging fields for pharmacists

include:
... drug utilization review and drug use evaluation programs (DUR/DUE);
... cognitive services; and
ber of narcotic/acetaminophen-combination adverse events, as well as to forecast and avert the phenterminelfenfluramine (phen/fen) disaster before it came onto the national radar screen.
mains a therapeutic linchpin of managed care plans, pharmacists are in an excellent position to demonstrate how their proactive services markedly enhance the
value and reduce the risks associated with pharmaceutical care. The Omnibus
Reconciliation Act of 1990 supports funding of demonstration projects to
evaluate payment for cognitive services, and many cognitive services studies
... disease management programs (DMs).
STRATEGIES FOR MANAGED MEDICAID ENROLLEE PHARMACY BENEFIT PROGRAMS

Data Management for OUR/DUE
Initially, Medicaid administrators viewed DUR programs as a way to identify patients guilty of drug benefit fraud and drug abuse. Today, identifying
Another state making progress in the battle to redirect costs to risk insurers is New jersey. Its Medicaid pharmacy spending dropped by 8.6%, with overall third-party share of prescriptions increasing by 19.6%3 The state has 10
managed care plans providing a pharmacy benefit, including the Mercy Health
around the United States are demonstrating how pharmacist services add to
overall positive health care outcomes,
HMO
Plan of New jersey, a plan managed by Blue, the Medicaid arm of Blue Cross and Blue Shield of New jersey.
although few are reimbursed or recognized. Fiscal redress, however, may be

on the horizon; the U.S. Congress has "expressed interest in reimbursing pharmacists" for reducing provider services that affect Medicaid or Medicare drug
physician and/or patient -oriented abuse,
Since the spring of 1997, Mercy has been revie\ving the pharmacy data of its
Vol. 4,
No.6
}MlP Journal of Managed Care Pharmacy
551

to" rule, under specific circumstances,
Table 1. Community Pharmacist-Provided Cognitive Services

State of Service
Rendered
19 pharmacies!
1 month
Outcome 712 Rx interventions
Estimated Savings
$1.178 million in avoided ER
&: physician office visits/month
Nebraska &: Iowa

:
health care services provided by a nonphysician provider can be billed as if the physician performed them. In incidences
like this, the amount billed is less than physician would charge, and it is suba
Kansas
25 pharmacies/
1 month
294 Rx interventions
$490,836 in avoided hospitalizations, ER &:

physician office visits!month
Texas
4 pharmacies! 2 months
47 Rx interventions
$20,795 in avoided services

or $6.13 returned to health system for each $1 spent on Rxs
mitted to Medicare encoded at the nurse practitioner service rate, according to James Taylor, Pharm.D., of the Department of Pharmacy Practice at the University of Florida at Gainesville. Pharmacist -managed anticoagulant clinics operate under a physician-approved
Arkansas
30 pharmacies/
1 month
421 Rx interventions for Medicaid population
$12,880 in avoided ER &:

physician office visits
protocol. A physician reviews each patient's chart and is available for consultations concerning patients whose warfarin (Coumadin) therapy is difficult to
spending. Canada's subsidized healthcare program, for example, already

reimburses pharmacists for saving the
system money Under that insurance program, pharmacists in at least one province are
asthma, diabetes, and hyperlipidemia.
This process is intended to help individuals identified by their physician as medication noncompliant. To educate Medicaid beneficiaries about their conditions and medications, the disease
control. Numerous studies have demonstrated that these clinics can improve
reimbursed for cognitive services. They

are paid $15 to alter, terminate, or replace a medication in order to prevent
a
anticoagulation control, patient compliance, and clot-related complications. According to the Agency for Health Care Policy and Research, appropriate
use of oral anticoagulants could reduce strokes secondary to atrial fibrillatioI\
drug-related event, and $7 not to dispense a drug they deem harmful under
the circumstances. Additionally, and
management program will require a pharmacist to spend 15-30 minutes privately with each patient. Each recipient will be limited to 12 consultations per year per condition, with a $20 flat fee
per appointment. Ultimately, the program's objective is to reduce the incidence of costly and avoidable hospital admissions and emergency room visits. It is assumed that this DM break-
by
50% and save $600 million annually With the total cost of stroke estimated at $30 billion per year in the United States,
and the estimated mean lifetime cost of an ischemic stroke about $91,000, systematic, pharmacist-managed anticoagu-
more to the point, a recent study demonstrated that pharmacists who are reimbursed for such interventions are more likely to intervene and document their activities. Table i-identifies recent statewide
studiesH that demonstrate the. value of pharmacist intervention in overall health

cost control. Interventions include pre-
through in Mississippi will spread to other states. With that in mind, the National Association of Boards of Pharmacy has called for an industry-wide
coalition to establish a national credentialing system so that all interested pharmacists can provide DM programs
"
lant programs are proving to be less costly and more effective than nonsystematic physician care procedures.
Table 2 demonstrates health care utilization/cost savings achieved through
DM
servicesH'1O
scribing errors, such as wrong drugs or doses, and drug-drug interactions.
CONCLUSION
a few years ago, as Medicaid began to flood into managed patients care waiver programs, states held that
across state lines.
Only
DISEASE MANAGEMENT OPPORTUNITIES

In a benchmark decision by HCFA, Mississippi became the first state in the country to allow pharmacists to bill
Medicaid directly for DM services rendered. Medicaid, however, will not reimburse .state HMOs for this service. This inaugural development allows Medicaid
to reimburse
acist for
a a
Although there are numerous cases of non physician provider DM programs

around the country, so far traditional Medicare is the only government-funded program that pays for nonphysician services under certain circumstances. Within the parameters of specific man-
drug prescription costs should be transferred to the commercial plan that accepted these patients. The pharmacy
benefit was usually managed as a carveout by the plan (i.e., passed on to a
aged care programs, pharmacists participating in such services as anticoagulation clinics have been able to bill Medicare for services provided in those clinics, but the method of billing was indirect.
pharmacy benefit manager). However, the cost of supplying the pharmacy benefit remained difficult to finance under the typical state formulary package. To-
"credentialed" retail pharm-
service beyond drug dispens-
ing. Initial services covered will include four therapeutic areas: anticoagulation,
For example, under an entirely legal pricing scheme known as the "incident
day, states with managed Medicaid experience say that it is essential to
maintain control of the pharmacy benefit

552
}MP
Vol 4, No.6

~ Continued from page 552
...
1.
Table 2. Pharmacist-Staffed Disease Management Programs

State
Arizona
References
Intervention
Anticoagulant
Population
Estimated Savings
81 % reduction in hospitalizations and $154,350 in COStS
Novanis Pharmacy Benefit Repon: ] 998 trends

'
660 palients
& forecasts. Totowa, Nj: Emron, from the lMS Health Retail Method of Payment Repon ] 998: 34.
program
2. Fubini S, Limb S, Morgan SH. 1998 guide to managed care markets. Bethesda, MD: Health
Mid-Atlanlic Region
Anlicoagulant
program
104 patients
49% reduction in ER/ hospi ta lizations-$ 2 00,000

in COStS per 4.5 months
Trends, Inc., 1998: 55. 3. Novartis Pharmacy Benefit Repon: 1998 facts &
figures. Totowa, Nj: Emron; ] 998: 9-11. 4. Fincham j, Hospodka R, Scott D. The true value of pharmacist care. Nat Assoc Retail Druggists j
Maryland
Diabetes program
437 palients
$89,287 comprehensive net

benefit per year
1995(March): 29-31.
j, Hunter j. Documenting the wonh of pharmacist care. Nat Assoc Retail Druggists j 1996(April): 29-32.
5. Fincham
or, at the very least, develop a statewide, seamless link to all Medicaid providers and patients. These states have found
enhanced health and well-being of patients." Twenty years later, this observation has become
6. Dobie RL, Rascati KI.. Documenting the value of pharmacist intervention. Arizona Pharmacist
that it takes an integrated, shared-risk system to deliver cost-effective, highquality patient outcomes across the entire continuum of health care. Ob-
mandate to pharmacists. The opportunities attainable to pharmacists in the new Medicaid systems will be short-lived if drug utilizaa
1994(Sep/Oct): 8-11.
7. McCormack], Reinhardt G, Hastings], McGuin R. Documented value Arkansas study shows phar-
macists who get paid document more interventi9ns. Nat Assoc Retail Druggists] 1996(March):
viously, pharmacists have a clear consulting and administrative role to play

as such programs develop. As long ago as 1975, Dr. John Millis
tion practices and medical benefits cannot be effectively managed. Pharmacists
39-41.
8. Grahl C. Why begin an anticoagulation clinic? Disease State Management, Managed Healthcare:
reported in the Study Commission on Pharmacy, "Delivering pharmaceutical products to the patient is not, or.should not be, an end in'itself. Rather, drug
who seize the opportunity to incorporate their comprehensive skills into the evolving Medicaid care systems will be in the best position to thrive professionally, to establish adequate reimburse-
www.modernmedicine.com/mhc/dsm2sb ]. efficacy and 9. Meszaros I.. Getting a handle on

costs in anticoag therapy. Disease State
preparation and distribution is but a means to an end, the end being the
ment techniques for their contributions, and to move pharmaceutical therapies into their appropriate place within treatment protocols.
Management, Managed Healthcare: www.modernmed icine. com/mhcldsm2 .html. 10. lai LL, Sorkin AI.. Cost benefit analysis of pharmaceutical care in a Medicaid population
(from a budgetary perspective). ] Managed Care Pharm 1998; 4: 303-08.
554
}MCP
November!December 1998
Va\. 4,
No.6
MaximizingGeneric Substitution in Managed Care

Incentives, education, and flexibility combine to create mandatory
substitution programs that work.
With
.
today's health care market under intense pressure to reduce costs, mdependent
practice associations (IPAs) are looking to cut expenses associated with reim-
that comparing MCOs nationally is useful. Reviewing generic substitution rates across the country gives overall direction to the cost ;eduction program. When
this program was considered, the national generic substitution rate was around
bursement for prescription drugs. Priority Health is a National Council on Quality

Assurance (NCQA)-accredited multiproduct managed care organization
39%; it now hovers around 42%. In reviewing national statistics, the benefits manager should look not only
at the overall rate of generic substitution, but also at the specific drugs
(MeO) serving more than 180,000 members in 13 coupties in western Michigan. It has contractual relationships with more than 700 primary care providers, 700 specialists, 16 hospitals, and more than
-involved. Regional and local comparisons can make their analysis meaning-
Edward]. Keating
800 pharmacies in Michigan. More than 2,800 employer groups have selected
.
ful. By reviewing regional and local differences in generic substitution rates, the benefits manager can identify the most
significant obstacles to success in the IPA catchment area. Regardless of the
Priority Health as their plan of choice. After reviewing prescribing patterns of participating physicians and the dispensing records of pharmacists in the
catchment area, Priority Health discovered that many of the prescriptions written could have been filled with less cost-
national trend, different localities will require different strategies based on the attitudes and beliefs of prescribers, pharmacists, and members. In some areas of the country, physicians are more receptive to using generic drugs than in others. In others, pharmacists may have experienced resistance from both prescribers and members, and consequently may be reluctant to substitute generics.
ly generics. It then implemented an

incentive program to maximize use of generic drugs. The potential for savings program like this is significant. The average wholesale price (AWP) per prescription for brand name drugs is estimated to be $53, but only $10 for gener-
in
ic drugs. For every 1 % increase in generic
Members may be hesitant to use generic drugs initially, or resist switching after using a brand-name product.
State and local law also can affect
substitution, Priority Health could save $332,000 annually This article describes this midsized MCOs successful efforts to
AulllOl
improve generic substitution rates using comprehensive program.

is
generic substitution rates. Before 'establishing a program, review existing laws carefully Some states restrict substitution of certain drugs. For example, many
states prohibit generic substitution for
Director oj Pharmaceutical and DME Services, Priority Health, Grand Rapids, MI.
EDWARD J. KEATING, RPH.,
BENCHMARKING: THE BEGINNING

In many areas of pharmacy practice, pharmacy benefits managers (PBMs) find
drugs with narrow th!,Tapeutic indexes, including digoxin, theophylline, and phenytoin. Some prescribers also are
Copyright@1998, Academy oj Managed Care

Pharmacy, Inc All rights reserved.
very reluctant to allow generic substitution of these drugs.

.
Vol. 4, No 6
November/December \998
}MlP
557
Maximizing Generic Substitution in Managed Care
BUILDING THE FRAMEWORK

generic substitution campaign are easy to identify; physicians, pharmacists, and members
fair reimbursement for an investment of time, however, pharmacists are less like-
Target audiences for
ly to suggest substitution to physicians

or members. As the liaison between the program, the physician, and the member, pharmacists must be prepared to
advocate for
a substitution program. Pharmacists with good communication
Table 1. Priority Health Generic Incentive Plan

Generic Dispensing
Rate
Less than
Incentive Payment Level
all must be included. Initial acceptance by the physician is crucial to success.
26.00%
$0.00
$0.50 $0.50
$1.25
26.00%-32.99% 33.00%-35.99% 36.00%-37.99%

38.00%-40.99%
41.00%-43.99%
Education and information that addresses the physician should include discussion of the purpose of the program and safeguards that will ensure high-quality clinical outcomes. Priority Health deter-
skills, augmented by a solid understanding of the program's benefits, can help
mined that several areas were of utmost concern to physicians-particular generic brands and their equivalence to
the brand-name product, communica-
generic substitution programs succeed. Involving the pharmacist from the program's inception helped both with poli-
$1.50 $1.75
cy design and consistent communication. Like physicians and pharmacists, members have concerns about generic substitution and must be included in
44.00%-46.99%
47.00% or greater
$2.00 $2.50
tion with members, and communityspecific concerns-and discussed its

specific policies on these issues with prescribers in advance.
Physician education focused on the

program's plan to use only those generic drugs rated "A" by the Food and Drug
the process early. Often, their concerns are less technical and more emotional that those of health care providers.
Generic incentive payment for pharmacies dispensingfewer than 100 prescriptions to Priority Health members in a quarter will remain at
$1.25 extra per generic prescription.
Administration (FDA). Explanation of the rating system for equivalence helped

alleviate concerns about inferior products and bioequivalence. Physicians
Communication with the patient must be clear, direct, professional, and unambiguous. It should be' presented in a
manner that is somewhat redundant, using both oral instructions and written materials, but not condescending. Priority Health designed its member pamphlets and newsletter articles with
the average member in mind. The ques-
brand-name product. Such requests must rely on demonstrable clinical outcomes, rather than the subjective findings of the physician or member. Recognizing that paperwork is the bane of the health care provider's existence is
were particularly concerned about those patients who, for one reason or another, could not use a generic drug. They also
were interested in ensuring that members would be educated about generic
substitution and have appropriate infor-
important; forms should be simple and concise. Justification forms, called

"Dispense as Written" forms by Priority Health, were kept to one page and limit-
tions they addressed ranged from bioequi valence-presented in layman's
terms-to
POLICY
cost.
mation available to them from

"
variety
ed to essential information. In some cases, demonstrable clinical
of sources. Three approaches were used to convey information to physicians. First,

prescribers received direct mailings, including a copy of the formulary. Another
mailing was directed at their office managers (whose support is important to the
success of the
Establishing a firm but flexible polihelps cy everyone understand the criteand ria process for substitution. Therafailures and the ptential for mispeutic adventure are always the greatest concerns. Any policy must address medical necessity exceptions. Physicians and
Figure 1. Generic Substitution Rates

.
1997 Generic Substitution Results Priority Health=4 7.1 % National=41.3%

Generic Substitution Results Priority Health=47.5% National=44%
Generic Substitution Results National=42% Priority Health=48%
.1996 .1995
.
MCO in many matters,
not just generic substitution). Finally, pamphlets addressing member concerns were made available to members at physicians' offices and participating
pharmacies. Newsletter articles were
members want to know in advance that .there are mechanisms to obtain brandname products if generics fail; they need clear, measurable guidelines describing
the exception policy. At
a
1994 Generic Substitution Results National=41 % Priority Health=46%

Generic Substitution Results National=39% Priority Health=41 %
published in the member health journal

as well.
.1993
.
minimum,
these guidelines should include
Once Primary Health addressed physician acceptance, it directed its

efforts at pharmacists, whose influence
is substantial.
a delength of the of the trial, the scription be used to determine measures that will
1992 Generic Substitution Results Priority Health=37% National=39%
success or failure, and the documenta-
Without the incentive of
tion required to request
return to
In 1997, Priority Health identified each percentage point as havinga value of $332,000.00 saved.
558
jMCP
Va\. 4,
No.6
Figure 2. Priority Health Contract Pharmacy Comparison: 1996-1998
;!
Generic
Generic
Bonus
,....
Priority Health
1st Qtr, 98
Volume
% Generic
Index
84.30%
Average
Average
DAW
2.00%
0.5.
24
$/Rx $32.56
311,499
46.80%
'~0~1
.
$0.00
2nd Qtr, 98
,000/;
\
$0.00
$0.00
3rd Qtr, 98 4th Qtr, 98

1st Qtr, 97
$0.00 $0.00
2.00%
2.00%
24 25
25
195,859
191,383
195,378
48.00%
45.60%
84.50%
83.30%
"
$30.34
$32.11
2nd Qtr, 97
Qa);
$0.00 $0.00
....
3rd Qtr, 97
4th Qtr, 97
1st Qtr,
44.90% 46.30%
48.80% 46.90% 45.70% 48.10% 47.50%
82.90%
84.40%
2.00%
2.00%
$33.16
$33.06
220,129
.
$0.00
$0.00
$0.00
25 22
96
191,502
175,381
81.70%
81.80% 82.10% 83.90%
..,
2.00%
2.00%
2.00% 2.00% 1.00%
$26.64
$29.05
2nd Qtr, 96
3rd Qtr, 96
24
24
23 22
176,713 197,039
1,392
$0.00
$29.76
$29.25 $30.22
4th Qtr, 96
1st Qtr, 98
85.50%
['"
;2l.
.
%.
$0.00
$2.50
2nd Qtr, 98

1st Qtr,
97
908
50.00% 48.20% 48.30%
84.20%
"
$2.50
1.00%
22
$28.17
$29.58
2nd Qtr, 97
3rd Qtr, 97
959
1,147
84.80%
83.70%
83.70% 83.50% 84.60%
$2.50
"
1.00%
1.00%
23
22
$2.50
$29.87
$30.02
$28.34
4th Qtr, 97
1st Qtr,
1,260
46.80% 51.10%
48.40%
'."'.:
$2.50
$2.50 2.00%
1.00%
23
20
21
23
96
904
922
2nd Qtr, 96
$2.50
'......
$28.61 $30.35
$29.51
834
45.20% 48.30%
82.30%
85.10%
$2.50
2.00%
966
$2.50
2.00%
22
outcomes are difficult to define. When members experience sleep disturbances, anxiety, or pain, it can be difficult to describe and document problems. In
a firm but consistent policy important, but can be difficult to develop.
guidelines. An acceptable drug list is the foundation for the program. Initially,
Once
drug list is developed, it
this is a tremendous task because of the sheer number of generic products on the
requires constant maintenance to reflect changes in the marketplace. Changes at the FDA have complicated that market.
these cases,
is
MANDATORY SUBSTITUTION
Mandatory substitution programs rely on drug lists so that the prescriber
and the pharmacist have drug selection
market. Many organizations begin by reviewing the Health Care Financing Administration's (HCFA's) generic drug list. This is a comprehensive list of some 800 drugs whose study requires close
attention and an investment of time. But regardless of the source used, the initial list must describe each drug and its
The 1984 Waxman-Hatch Act, which allowed generic versions of drugs approved after 1964 to be processed
under an abbreviated new drug request, as well as internal FDA initiatives to

expedite the drug approval process have helped to fuel exponential growth in the
maximum allowable cost (MAC).
number of new generics. These new generics represent a potential savings
Vol. 4. NO.6
jMCP
559
Figure 3. Priority Health Prescription Cost Differential: 1994-1997

$60.00
Single-Source Brand Generic
~
$50.00
IT] Multi-Source Brand
$40.00
---
$30.00
$20.00
$10.00
$0.00
'<t
'<t
'<t
'<t
1/"\
1/"\
1/"\
1/"\
9,...;
9N
9('i"'j
9'<t
9,...;
9N
9('i"'j
9-
\0
,...;
9-
\0
9N
\0
9('i"'j
\0
9'<t
9,...;
t-
t9N
t9('i"'j
t9'<t
0'
0'
0'
0'
0'
0'
0'
0'
'<t
0'
0'
0'
0'
0'
0'
0'
0'
thtcan be achieved only if the PBM revises its drug list frequently.
During the first few months after
a
some pharmacists have difficulty obtaining them at the low price reflected on the list. However, if changes are not
generic becomes available, the potential
savings ranges from 10%-11 %. In years past, that savings was 30%-50%, but
the potential savings have diminished as
the approval process has accelerated.
made quickly enough, potential savings are lost. MCOs must balance their need for savings with the pharmacist's ability
to comply with the drug list.
Prescription volume baselines for participation must be established. Priority Health established a baseline of 100 prescriptions per quarter per pharmacy, based
....
more on intuition and negotiation than on a formula. Only pharmacies that met
or exceeded this number were included.
.... Payment tiers must be achievable to pharmacists and acceptable to the IPA. Table 1 describes tiers used by Priority
.
Once
from more manufacturers, the potential for savings increase. Drug list changes should be
a
drug
is available
DESIGNING REIMBURSEMENT TIERS

A tiered reimbursement program
made quickly, and the MAC should be adjusted to reflect changes as more generic equivalents for the same product enter the marketplace. Though daunting, this task is
a
provides incentives to participating pharmacists. The pharmacists who will
critical one for PBMs.
be involved are included in setting goals, which are established using data
obtained from reviews of national, regional, and local trends. There are
three criteria:
Health. Pharmacists receive maximum reimbursement if they meet or exceed a generic substitution rate of 47%. The payment schedule changes with every 3% decline in generic substitution. Time frames for adjudication should be manageable and allow for prompt adjustment of the payment rate.
....
Revising the drug list creates potential for conflict. When new generics are added to the drug list very quickly,

560
}MCP
Vol. 4,
No.6

~
Figure 4. Generic Substitution Rate: 1994-1997

50.00%
I_ % GENERIC
49.00%
48.00%
47.00%
46.00%
45.00%
44.00%
43.00%
42.00%
"....
"... "... "...
11"\
11"\
11"\
11"\
9'
......
9'
N
9'
r'1
9'
"...
9'
......
9'
N
9'
r'1
9'
"...
\0
......
9'
CI
\0 9'
N
\0 9'
r'1
\0 9'
"...
I'-
9'
......
9'
N
I'-
I'9'
r'1
I'-
9'
"...
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
plan establishes payment tiers, local pharmacists should be included in the negotiations to ensure that their
Before
a
reimbursement rates very quickly to reflect changes in generic reimburse-
concerns and problems are addressed.
ment rates at each pharmacy. Failure to change the reimbursement rate quickly
causes dissatisfaction among pharmacists who do not receive immediate financial rewards for successful interven-
for pharmacists to examine their own performance in comparison to the IPA's average. The historical information included can be used to track progress
They may provide information about prescriber acceptance, member concerns, or state law that will significantly
change proposed tier structures. Additionally, PBMs must consider seasonal changes in reimbursement rates. Generic substitution rates do vary with seasons, particularly in the case of antibiotics. Figure 1 shows actual generic substitu-
tions. It also adversely affects the IPA when a pharmacy's substitution rate
over the previous three years. Several areas of the report card offer help to the pharmacist who is lo()king for ways to improve. For example:
declines but the reimbursement rate remains high. Because there usually are
... The generic index tells the pharmacist the proportion of prescriptions that
could have been filled with
a
generic
tion rates achieved by pharmacies associatedwith Priority Health; the seasonal

variation is apparent. Reimbursement issues appear simple on the surface, but can be quite complex. Clearly, the PBM should change
multiple steps involved in the payment process, a procedure must be established to ensure that changes are communicated and acted upon expeditiously. Priority Health uses a report -card
format to document information for each pharmacy (see Figure 2). The report card provides enough information
drug that actually were. ... The report card shows the proportion of prescriptions designated "Dispense as Written," indicating how often prescribers eliminate the possibility of substituting generic drugs.
.... A
performance index compares the
562
jMCP
Vol 4, No.6
pharmacy's substitution rate with the average for all pharmacies participating.
The report card provides an element of peer review, and directs the pharmacist's attention to areas of accomplish-
drugs for fiscal years 1994-1997. Nationally, the average cost per prescription has grown at a rate significantly higher than
for savings. Management mechanisms are quite simple, and incentives help
pharmacists become true partners in the
ment as well as areas where improvement is possible. In addition to the report card, participating pharmacies receive a list of drugs by brand name 'tht could have been filled with a generic drug, but were not. The pharmacist can use this information to plan improvements for the next quarter.
expected. The success of this program is demonstrated clearly; as the generic substitution rate has increased, the average
cost per prescription at Priority Health has decreased. Figure 4 describes overall
program. In the future, MCOs and PBMs will develop such programs to address therapeutic substitution and take advantage of opportunities to cut costs while maintaining quality care. We are laying the
generic substitution rates compared to the national average. For the last five years, pharmacies affiliated with Priority Health have consistently exceeded the
framework for new programs now. To

succeed, we will need strong trust relationships with prescribers, participating pharmacists, and members. These relationships must be built on a history of excellent clinical judgement, fulfilled
promises, and accurate communication.
national average for generic substitution. In 1997, this represented savings of

almost $1.8 million to the plan.
RESULTS
Concerted efforts to maximize generic substitution were successful at Priority Health. Figure 3 shows prescription costs for single-source, multisource, and generic
CONCLUSION
Programs designed to encourage generic substitution offer an opportunity
AMCPs J Jth Annual Meeting will offer an exciting line-up of featured speakers,
as well workshops, and topical sessions as the debut of AMCPs Annual Showcase.
-
Don't miss this unique opportunity to discuss your solutions for optimizing the
delivery of cost-efficient and quality-driven pharmaceutical care. Watch your mail for the. Preliminary Announcement. For more information, please call AMCP at
J-800-TAP-AMCP.
~
.
The Academy of Managed Care Pharmacy (AMCP) is approved by the American Council on Pharmaceutical Education (ACPE) as a provider of continuing
pharmaceutical education.
Vol. 4,
No.6
jMCP
563
SPOTLJGHT
Medicaid Waiver Breaks Mississippi New Ground for Pharmacists
Pharmacists, not pharmacies, benefit from
new plan that promotes
pharmaceutical care, credentialing, and pharmacist -physician cooperation.
An
innovative plan in Mississippi that allows pharmacists to be
paid for managing specific disease states could set the stage for major
to counsel their patients and to follow up with them improved therapy outcomes," said Dalton. "The pharmacy school had the strong support of the
changes in the pharmacy profession. The groundbreaking program allows the state to use federal money to reimburse pharmacists for providing counseling and drug therapy management under protocols developed
medical staff." Medicaid believes the pharmaceutical care program put together by the pharmacy school, pharmacy association, and state board of pharmacy will save the program money by keeping patients out
of the urgent care clinics, emergency rooms, and hospitals. Medicaid will give the program an IS-month trial period. Then state
by pharmacists and
physicians.
The well-publicized Medicaid waiver, approved by the Health Care Financing Administration (HCFA) earlier this year, allows Mississippi to pay pharmacistsnot pharmacies-for managing chronic disease in four areas: diabetes, asthma, lipids, and anticoagulation. Mississippi
Medicaid officials will examine outcomes of pharmacists' interventions. "If

Medicaid sees a tremendous savings, reimburserpent to pharmacists might go' up," said Dalton. "If they don't see savings, Medicaid might pull the plug."
Marlene Z. Bloom
is the first state where
HCFA has
allowed reimbursement for pharmaceutical care.
Equally important, this program gives implicit endorsement to the concept of pharmacists managing disease
states and improving patient
About 70% of the Medicaid budget is 'now spent on hospital, emergency care,
and ambulatory services.
"Just as important as the impact on cost is the effect on care," noted Judith
care-con-
cepts that arc: fundamental to the practice of managed care pharmacy.

A key element in
A. Cahill, executive director of the Academy of Managed Care Pharmacy
winning federal
(AMCP). "Pharmacists' intervention will

also improve quality."
support for paying pharmacists was the strong backing of doctors from the University of Mississippi, said S.E. "Bo"
HOW IT WORKS
To be paid for providing disease state management (DSM) services, registered pharmacists must complete a diseasespecific certification program approved
Dalton, R.Ph., executive director of the

Mississippi Pharmacists Association. When the University of Mississippi
Aut/wI
MARLENE Z. BLOOM
Pharmacy.
is
Director of
Medical Center decided to relocate its ambulatory care clinic to an empty shopping mall, the clinic's doctors asked
the medical center also to relocate the clinical pharmacy residents and students
by the Mississippi Board of Pharmacy.

According to the waiver, the state will pay "specially credentialed pharmacists" a flat fee of $20 per encounter to
provide DSM services to Medicaid recipients in the four established areas.
Communications at the Academy
of Managed Care
Copytight@ 1998, Academy of Managed Care

Pharmacy, Inc. All tights reserved.
with whom they had been working. "Doctors said that the extra time taken
by pharmacists and pharmacy students
564
]MlP
Vol. 4,
No.6
Mississippi Medicaid Waiver Breaks New Ground For Pharmacists ~

a
Patients must be referred to
pharma-
... drug therapy review; ... patient treatment plans and clinical practice guidelines; and
cist by a physician, and the state will
pay for no more than 12 encounters per patient per year.

Pharmacists must develop patientspecific protocols jointly with the
patient's physician. These protocols may be based on care plans that pharmacist
knowledge-based exam. Providers of disease state certificate programs are urged to make their programs self-paced and accessible via Internet, video, and other home-study means. Pharmacists
... patient/caregiver education.

All pharmacists who want to provide these services must pass a $25 diseasespecific assessment exam developed by
the National Association of Boards of Pharmacy, (NABP). Those who pass also must sucessfully complete a skillsassessment workshop conducted by faculty authorized by the pharmacy board
must submit claims for reimbursement on HCFA Form 1500 using a new CPT
code, "Preventive Medication
and physician have previously agreed on
must have
for each disease state. Pharmacists also a private counseling area, be
Information. Stevens predicts that NABP eventually will develop an exam to evaluate a
pharmacist's ability to provide pharma-
"
credentialed by the Mississippi pharmacy board, and have a Medicaid personal
provider number.
"Working pharmacists don't need another 10 years of high-level discus-
in conjunction with the University of Mississippi School of Pharmacy

Lucinda Maine, senior vice president for professional and public affairs for the
ceutical care, not just care for specific conditions. "I forecast that NABP eventually will make an exam for pharmaceutical care a prerequisite for all the specific disease states," said Stevens. "But it's an evolving field, and we had to approve the four disease exams quickly"
how this would work in an ideal world," said William L. "Buck" Stevens, executive director of the
sions about
American Pharmaceutical Association
(APM), said APM will work with the

board and the pharmacy school to define the most important skills needed
for each disease and to determine ways
to evaluate pharmacist performance. "Some people think credentialing is
Mississippi Board of Pharmacy "They need something that is reasonable, affordable, and doable. We've set up a system to assure the public and payors
that the pharmacist is knowledgeable
,
THE VALUE OF PHARMACISTS

"In approving this amendment, HCFA has recognized the value of pharmacists' contributions to quality patient care," said Richard Fry, AMCP director
and competent."
portfolio for each patient that includes the physician referral, treatment protocols,
a
Pharmacists also must keep
training, some think it is test of knowledge, and some say it is an assessment of practical skills," said Maine. "Mississippi's credential would encoma
pass all three."
of pharmacy affairs. "The success of the Mississippi program will establish a
pharmacy progress notes, and laboratory data. It also must document:
... patient evaluation;
... compliance assessment;
To ensure maximum pharmacist participation and patient access, the pharmacy board has established a target cost of $150 for each disease state workshop, which includes $25 for each NABP
benchmark for the entire profession, an opportunity pharmacists have long

anticipated," he said. "It is important that all pharmacists and their national associations support this effort."
566
jMCP
Vol. 4,
No.6
INTERNATIONAL
International Movement of Japan's Pharmaceutical Industry:Reform of.
Japanese Health Policies, Part III

There are about 1,550 pharmaceutical
companies in Japan,of which approximate-
skilled in the American pharmaceutical market. Furthermore, a stronger yen in the 1980s lowered some costs of overseas market entry, especially land and labor, making it more attractive for Japanese companies
to establish wholly owned subsidiaries,
ly 450 supply drugs for medical care. J Most of the large companies, such as Takeda,
Fujisawa, and Tanabe, began as traditional
wholesalers, and thus have developedmore
strength in sales promotion than in scientific research2 Japan has a corresponding history of importing foreign products and selling them in the domestic market. Because the Japanese market grew rapidly with the
manufacturing plants, and research facilities in foreign countries. Today, changing

economic conditions are altering manufacturers' strategies yet again.
-,
implementation of national health insurance and was protected by the National Industrial Policy, Japanese pharmaceutical companies did not develop an institutional
capacity to market their products in overseas markets nor did they innovate interna-
This article examines the context of this overseas development, which was the focus
series (published in the MarchiApril1998 issue ofJMCP)J Part III includes a relevant updatefollowing the recent financial turmoil across the Pacific Rim and discusses specific activities of Japanese pharmaceutical firms as they
of Part II of this
Kimiko Chevalier and
]. Warren Salmon
tionally acceptable drugs until the 1980s. At that time, the government was curbing
"
have ventured into overseas markets,
drug prices
to reduce health
expenditures,
and competition with foreign firms for the

domestic market was increasing. Pressures
on Japanese drug companies to develop
including their entlY into the American managed care arena. The contemporary period presents a great deal of
uncertainty as Japanese manufacturers
regroup to
domestic drug products and to market them
adjust to new market conditions
internationally intensified. That historical focus on the domestic
domestically and to continued expansion

overseas.
J. Warren Salmon, Ph.D.
market resulted in a lack of overseas experiences and understanding among the top
management ofJapan's pharmaceutical firms. Foreign language competencies are
essential for overseas drug
International Contributing Editor
marketing activ-
ities because
of the
massive amounts
of
According suo
to
a
rvey conducted
information requiredfor drug approval and marketing and the highdegree of government regulation; U.S. Food and Drug
Au/I101 S
by the Japan Pharmaceutical
Administration regulations have been particularly problematic for Japanese companies. Japanese firms thus have used licens-
Manufacturers Association in March 1993, 41 member firms were engaged in overseas activities: 38 firms in research and development (R&D) and 20 firms in production, with some overlap between the two categories'
Expenses for overseas R&D made up 3.3% of the total R&D budget of 38 firms; six firms spent more than 10% of their R&D funds in overseas research activities5
KlMIKO CHEVALIER, PHARM.D., received her

nurse-midwife training and worked in the Japanese
health care system for several years. She was awarded her Pharm.D. degree in May from the University
ing or joint ventures to introduce their products overseas and have dependedon
the regulatory expertise
ofIllinois at Chicago] WARREN SALMON, PH.D., is Professorof Pharmacy Administration at the University of Illinois at Chicago. He is Contributing
International Editor for ]MCP.
of their
U.S. part-
ners to achieve approvals.
In contrast to their sophisticatedunder-
standing of marketing automobiles, electronics, and now computers in the United
Copyright @ 1998, Academy of Managed Care Pharmacy, Inc. All right reserved.
States, the Japanese are just now becoming
The number of overseas bases has grown rapidly, totaling 245 in March
Vol. 4,
No.6
jMCP
567
International Movement of Japan's Pharmaceutical Industry: Reform of Japanese Health Policies, Part III
Table 1. Overseas Bases of Pharmaceutical Firms as of March 1993 (March 1991

Area Fonn of Base
in parentheses)
N. America
Europe Asia & Oceania Central & S. America Russia & E. Europe Middle East & Africa
Total
Wholly owned subsidiaries

Capital participation
Joint ventures
Branches and offices
36(19)
6(6)
34(16) 8(15)
13(10)
2(2) 2(4) -( -) 1( -)
5(6)
-( -)
-( -) -( -) 1(1)
-( -)
85(47)
8(7) 46(36)
24(11 )
-( -)
24(32)
2(4)
13(1l)
28(30) 83(72)
-( -)
1(1)
24(32)
74(58)
245(189)
20(16) 64(45)
Total
Source:
91(64)
l(l)
1(1)
JAPAN 21st August 1995
1993 compared to 189 in March 1991. Although their presence in Central and South America, Russia and Eastern
Europe, the Middle East, and Africa has been negligible, Japanese companies
have established solid bases in Asia and
already have made an impression around the world. The U.S. Department
of Commerce has stated, "U.S. and European firms appear to be betting
that the top Japanese companies will eventually make the transition to
can give insight into past behaviors of the 10 Japanese firms on the interna-
tional scene and should be useful for assessing future strategies. Table 2
ranks the 10 major Japanese pharma-
Oceania (91 firms), Western Europe (83 firms), and North America (64 firms). Japanese drug companies established 36 wholly owned subsidiaries in North America and 34 in Western Europe, with 20 company branches in North America and 28 in Western
Europe. Asia and Oceania led joint ventures with 46 firms4 (see Table 1). Japanese pharmaceutical companies
world-class competitors."6
Although the information on individual firms spotlighted in the following discussion may be dated or incomplete, it remains one of the few compilations in English documenting their
overseas activity to date. Because current conditions in Japan may be alter-
ceutical companies by overseas sales, and Table 3 offers a timeline of overseas base development for each of the top
10 firms.
TAKEDA CHEMICAL INDUSTRY,

LTD.
Takeda Chemical Industry, Ltd., was founded 215 years ago and ranks at the top of the pharmaceutical enterprise in
ing these strategies individually and/or collectively, the following information
Table 2. Ten Largest Japanese Pharmaceutical Firms (in million yen)

Company
Takeda
ITerm
3
3
Sales
IGrowth
Rate
Operating Profit Growth Rate 67,843

1.6% 0.5% 11.5%
IOrdinary
Profit
IGrowth
2.1
Rate
INet
Profit Growth Rate 7.4%

1.0% 1.8%
574,367
2.3%
1.5%
5.1 %
78,809 83,526
39,809
Sankyo
Yamanouchi Fujisawa
Eisai
401,466
273,048
241,483 240,030 238,176
221 ,819
82,244
56,419
25,036 36,913 23,057 38,166
49,727
10,991
3.9
37,250
28,143
7,474
3
3 3
57,990
24,009
6.6
20.4 12.4
13.7
2.8% 7.0% 3.5% 2.1% 5.3% 0.2%

7.4%
46.0% 12.7% 18.2%

11.2%
25.7%
7.1%
11.1%
36,982
26,192
16,888
11,471
Shionogi
Daiichi
Taisho Tanabe
3
3
41,666 55,602 10,515

19,886
8.7 7.7
27.7
16.8
18,876 27,563
3,122
10.6%
9.9% 8.8% 8.3%
3 3
210,936
183,162 162,588
18.0% 33.1%
Chugai*
12
19,756
131%
7,608
Source: JAPAN 21st August 1995
*Dee. '94 term for Chugai Pharmaceutical only; March '95 term for all other firms.

568
}MlP
Va\. 4,
No.6
International Movement of Japans Pharmaceutical Industry: Reform of Japanese Health Policies, Part III
~
Continued from page 568 Table 3. Overseas Bases by Major Japanese Pharmaceutical Companies
Company
Category*
1
Year
Development of Major Overseas Bases

Strongholds for production and marketing established in Southeast
Candidates of International Drugs

Leuplin (Tx for prostate cancer)
Takepron (proton pump inhibitor)
Takeda
1960
1978
Asian countries.
3 3
by joining with Roussel Uclaf in France. Takeda Pharma GmbH established by joining with Grunenthal GmbH in Germany
Laboratories Takeda established
3.
Takeda Italia Farmaceutici established by joining with Cynamid Italia S.P.A. in Italy
1985
TAP/Pharmaceuticals established by joining with Abbott Laboratories in the U.S.

Takeda Europe R&D Center founded in Frankfurt, Germany.
1988
1994
Tianjin Takeda Pharmaceuticals Co., Ltd., joined with Lisheng Pharmaceutical Factory, Tianjin, China.
"
Takeda has wholly owned subsidiaries and joint companies in 10 countries.
Sankyo
3 3
Sankyo Europe GmbH in Dusseldorf, Germany, established. Sankyo U.S.A. Corp. in New York established.
Mevalatin (antihyperlipidemia drug

Nascal (antidiabetes drug)
Acecol (antihypertensive drug)
3 3 3
2
Uni Sankyo founded in India.

Sino-japanese Synthetic Chemistry, Ltd., established in Taiwan.
Thai Sankyo founded in Thailand.

1990
Capital invested in Luitpold Werk, German pharmaceutical company
1992
Luitpold Pharma GmbH in Munich, Germany, established by fully purchasing Luitpold Werk.
4 4
joint research with University of California in U.S.A. established.
joint research with Medical Research Council in London and

University of Southern California in U.s.A. established.
1994
1995
Beijing office opened.
joint venture founded with Glycomed Inc. & Reagando Co. in U.s.
Yamanouchi Taiwan Co., Ltd., established by joining with Yamanouchi Pharmaceutical Co., Ltd.
Gaster (antiulcer drug)
Yamanouchi
1963
1986 1989
Yamanouchi Ireland Co., Ltd., in Ireland established. japan Shacklee Corp. constituted by purchasing Shacklee
Perdipine (circulation-improving drug)
Hamal (urination-improving drug)

Atack (bronchial dilator)
Corp., U.S.
4
4 4 1
1990
1990 1990 1991
Yamanouchi Research Institute installed at Oxford in England. Korea Yamanouchi Pharmaceutical in Seoul, Korea, established.
Hong Kong office opened.

Royal Gist-Brocades Nv, medical drug division of foods and chemicals company in Netherlands, purchased and renamed Brocades Pharma to Yamanouchi Europe.
Capital invested in Roberts, Inc. in U.S.
2 4 4
1992
1993
1994

Yamanouchi Europe again renamed Yamanouchi Pharma and established sales branched in 12 countries, including France, Germany, and Russia.
1994
Yamanouchi Shenyang Pharmaceutical Co., Ltd., established, building Shenyang First Pharmaceutical Factory in Shenyang, China.
Vol. 4,
Table continued an page 572
NO.6
jMCP
571
International Movement of Japan's PharmaceuLcalIndustry: Reform of Japanese Health Policies, Part III
Table 3. Overseas Bases by Major Japanese Pharmaceutical Companies (continued)

Development of Major Overseas Bases
Fujisawa Pharmaceutical Corp. in U.s. established.
Company
Fujisawa
Category*
I
4
Year
Candidates of ~nternational Drugs
1977
1979
1981
Prograf (immunosuppressant)
Cefamedin (antibiotic)
London office opened.

Fujisawa SmithKline Corp. established as joint venture.
Capital invested in Klinge Pharma GmbH, German pharmaceutical co.
3
2 2 4 4 1 1
1983
1985
1985
Capital invested in Lyphomed Inc., American pharmaceutical co.

Clinical Research Center opened.
1986
1987 1987 1989
Milan office opened.

Fujisawa SmithKline Corp. wholly consolidated.
Fujisawa Holland B.V founded. Maryland Representative Office in
U.S. opened.
4
Lyphomed Ine. totally acquired.

Fujisawa SmithKline Corp. renamed Fujisawa Pharmaceutical Co.
Fujisawa USA, Inc. established by merging with Lyphomed Fujisawa Pharmaceutical company & Maryland Representative Office.
1
1
1989
1990
4 4
1990
1991
Fujisawa Ireland Limited founded. Fujisawa Europe GmbH founded.
Eisai
\988
1989 1992
Eisai America Inc. established.
Eisai Research Institute of Boston in Andover, Massachusetts, in U.S. established. Eisai London Research Laboratories at University College in
Candidates of international drugs are undergoing clinical tests.
London, U.K., established.

4 3 Eisai Corporation in
New jersey founded.
joint venture founded with Sandoz Pharmaceutical in Germany.

Subsidiaries established in U.s.,
Daiichi
u.K., Germany, Taiwan, and Hong Kong.
Tarivid (broad-spectrum antibiotic)
joint ventures founded within France, South Korea, Taiwan, and

Thailand.
Representative offices maintained in U.S., U.K., Germany, Taiwan; and Hong Kong.
Cravit (broad-spectrum antibiotic)

Transamin (antiplasmin agent)
Neuer (gastric mucosal defensive
drug)
1993
1993
Daiichi Research Center at University of California at San

Francisco founded.
3
3
Daiichi Pharmaceutical (Thailand) Limited established.
Joint ventures founded with Shanghai Shin Yi Pharmaceutical Corp. Ltd. and Beijing Pharmaceutical Works NO.4.
1995
Chugai
1989
1992
Gen-probe in U.S., the world's top-class maker of diagnostic biodrugs, purchased.

C61C Research Laboratories established by joining with Choongwae, South Korean pharmaceutical company.
Stocks acquired from Amrad, Australian pharmaceutical company.
Ulcerlmin (Tx for gastritis)

Granocyte (Tx for Leukopenia) Picibanil (anticancer drug)
Sigmart (Tx for angina)

Alfarol (calcium-bone metabolizer)
1993
1994
joint venture founded with Shanghai xim xing Medicine & Drug
Scientific Development Center in China.
Laboratories founded in Korea, Australia, and in San Diego in U.S..
4
4
Chugai Pharmaceutical BioPharmaceuticals Inc. established.
joint venture founded with Rhone-Poulenc in France.
Source:
*Category Number: 1. Wholly owned subsidiaries; 2. Capital participation; 3. Joint ventures; 4. Branches and offices. JAPAN 21st August 1994 & 1995
572
}M(,p
Vol. 4,
No.6
Japan.? Their overseas activity has been
expanding, achieving annual sales of $5.57 billion (574 billion yen) in March
million capitalization.? A pharmaceutical plant was scheduled to be completed in 1996. Takeda now has wholly owned subsidiaries and joint concerns in 10 countries, including China. The
Sankyo is pushing joint research on Alzheimer's disease with the Medical

Research Council in London and the
of 19951 Recently, Takeda has concentrated on reinforcing tripartite research

strongholds covering Japan, the United States, and Europe to construct a global network and establish the foundation of
an international enterprise based on
company believes that the merits of international venture are not in scale but in quality, especially in developing globally acceptable new drugs.
University of Southern California. Additionally, in 1994 Sankyo began working with the University of Alabama on research into rheumatism and malignancies that cause autoimmunization.
With
its purchase of Munich-based
research and development.
In 1978, Takeda established the first French-Japanese joint enterprise, Laboratories Takeda, with Roussel Uclaf. The company soon followed this joint
venture with the formation of Takeda Pharma GmbH in Germany and Takeda
SANKYO COMPANY, LTD.

At the end of March 1995, Sankyo Co., Ltd., reported total sales of $3.9 billion (401 billion yen), including
exports of $301 million (31 billion yen), with a growth rate of 1.5%. Sankyo's ordinary profit totaled 83.5
Luitpold Werk in 1992-now called Luitpold Pharma GmbH-Sankyo

secured footholds for production, marketing, R&D, and the expansion of its international network through
Luitpold's subsidiaries in Europe and North and South America. Sankyo has
offered technical licenses
ltalia Farmaceutici in Italy In 1985, Takeda opened TAP Pharmaceu-ticals as its center in the -United States, achiev-
t~ the Upjohn
ing considerable success with clinical development functions as a joint venture with Abbott Laboratories. In
billion yen, a 3.9% growth rate. Sankyo ranks as the second largest pharmaceuI tical firm in Japan. Sankyo has developed several
remarkable new drugs. Mevalotin, used to treat hyperlipidemia, earns $971 million (100 billion yen) a year in its
domestic market and is sold in 47 Western countries through Bristol-
Co. in the United States for the production and sale of its antibiotics Cefmetazon and Banan. Sankyo's other international activities are managed through Sankyo Europe GmbH in Germany, Sankyo U.S.A. in New York,
February 1988, Takeda Europe R&:D Center was founded in Frankfurt, Germany, as a stronghold for new drug
Uni Sankyo in India, Sino-Japanese

Synthetic Chemistry, Ltd., in Taiwan, and Thai Sankyo in Thailand. Sankyo
development in Europe? Kenkichi Murakami, director of Takeda Chemical Industry, Ltd., has emphasized the importance of developing the R&:D capability to create innovative new drugs.? Takeda has focused on developing innovative drugs in
seven therapeutic areas: dementia, hyper-
now
is
gathering information through
Myers Squibb Company The annual turnover of Mevalotin in the United States alone already has reached $311 million (32 billion yen). Mevalotin works to decrease LDL cholesterol by
inhibiting HMG-CoA reductase and
also to increase
its Beijing office to enable the company to expand its operations in China.
Sankyo moved quickly into the international marketplace; however, it will take time for Sankyo to build international R&:D, production, and sales networks on an integrated basis.
tension, osteoporosis, ulcers, cancer, diabetes, and infectious diseases. Leuplin,
HDL cholesterol8
therapeutic drug for prostate cancer and endometriosis, and Takepron, a

a
Tomonori Miki, executive managing director of Sankyo, has said that the company intends to begin a self-con-
Sankyo will expand overseas markets step by step, with promising new drugs as the core of its marketing strategy
proton pump used for duodenal ulcer and reflux esophagitis, already are marketed in Europe and the United States
and have been very important to the overseas business of Takeda Chemical
trolled marketing system in the United States and begin full-scale sales activities rather than licensing Bristol-Myers
YAMANOUCHI PHARMACEUTICAL COMPANY,

LTD.
In fiscal year 1994, Yamanouchi Pharmaceutical Co., Ltd., achieved total sales of $2.65 million (273 billion yen);
exports accounted for $126 million (12.7 billion yen). Ordinary profits totaled $563 million (57.9 million yen). The sales and profits grew by 5.1 % and
Industry, Ltd. In addition, several new drugs are in application for approval,
with some in clinical trials overseas. Takeda, which markets products such as Cephem antibiotics in China,
established
a joint venture contract with Lisheng Pharmaceutical Factory Tianjin in 1994 to create Tianjin
Squibb Company to sell Mevalotin throughout the world9 Sankyo plans to follow the success of Mevalotin by marketing Noscal for diabetes and Acecol for hypertension in Europe, the United States, and other countries. The company, which conducts its own R&:D, has no research organization abroad because its laboratories in Shinagawa, Tokyo, and its association with Tsukuba Research Laboratories in Kyshu suffice. However,
Takeda Pharmaceutical Co., Ltd., with Takeda contributing 75% of the $19.2
6.6%, respectively The combined organization, including 54 subsidiaries, showed sales of $3.7 million (384 billion yen)
Vol. 4.
No.6
November!December 1998
jMCP
575
and $748 million (77.3 billion yen), up 4.2% and 10.5%, respectivelyl0
Yamanouchi is actively pursuing

business development in North America,
Taiwan Co., Ltd., in 1963, and its Taipei Branch in 1987. The Seoul Office in Korea and the Hong Kong Office were founded in 1990. The
Beijing Office, founded in 1993, has actively maneuvered for technological
establishment and product exports in local pharmaceutical firms. In June
FUJISAWA PHARMACEUTICAL COMPANY, LTD.

Fujisawa Pharmaceutical Co., Ltd., had sales of $2.3 billion (241.4 billion
Europe, and Asia. Consolidated pharmaceutical sales of 336.4 billion yen ($3 billion) in FY96 were up 8%, due in
yen) in 1994 and is ranked fourth among Japanese pharmaceutical companies.1 Consolidated prescription sales
part to contributions from international subsidiaries in Europe and Ireland.11

Yamanouchi was one of the first Japanese pharmaceutical corporations to build plants and laboratories in
Europe. In 1986, the company established its subsidiary, Yamanouchi

has played
1994, Yamanouchi contributed 80% of the 3 billion yen capitalization to build Shenyang First Pharmaceutical Factory, a joint venture with China's Shenyang Pharmaceutical Co.1] The plant began full-scale operation in early 1997 to
produce Gaster and Hamal, a urination-improving agent. This subsidiary
for fiscal year 1996 were 230.2 million yen ($2 billion); drug products represented 86.5%' of total consolidated sales.16 Fujisawa wants to be ranked in
the top 20 enterprises in the world and to firmly establish business in the United States and Europe through self-
Ireland. Its Irish manufacturing plant a vital role in sales and pro-
duction of the circulation-improving agent Perdipine and the antiulcer agent

Gaster, sold in more than 100 countries
with annual sales of $1.2 billion worldwide in 199412 In 1990, the Yamanouchi Research Institute was established at Oxford, where British scientists have been engaged in basic research on cell biology
hopes its first factory will become one of China's top three drug makers within several years14 by marketing Josamycin (an antibiotic), Gaster, Hamal, Perdipine, Atock (for asthma), Bisphonal
(for hyperkalemia), and Elen (for
marketing by the beginning of the 21st century, according to its chairman, Dr. Tomokichiro Fujisawa.17 Fujisawa developed a new immunosuppressant, Prograf (FK506), which began marketing in 1994 after approval in the United States by the Food and Drug Administration (FDA). Prograf
also has been approved in the United
dementia). Construction of another factory is scheduled for early next century. In 1996, Yamanouchi signed licensing agreements with NovoNordisk and
In 1991, Yamanouchi purchased the pharmaceutical division of Royal GistBrocades in the Netherlands as
a
strong-
hold for R&D, drug manufacturing, and sales in Europe. This subsidiary, now called Yamanouchi Pharma, became a head office with sales branches in 12 countries,
Mallinckrodt. Masayoshi Onoda, president of Yamanouchi Pharmaceutical Co., Ltd., said that the aim of the firm is to become a global enterprise, with the highest level of R&D capability in the
Kingdom and Germany for treatment of rejection after liver and kidney transplants. 17 Fujisawa has licensed Cephalosporin antibiotics to various countries in the world; however, Prograf was the first new drug developed and marketed
solely by
play an important role in building

international business. In 1990, Fujisawa USA, Inc., was founded by merging Lyphomed (a
pharmaceutical company acquired in 1989), the joint venture Fujisawa
Pharmaceutical Company, and the company's Maryland Representative Office, which opened in 1987 as a center for
isawa and it Fuj,
is expected to
including France, Germany, and Russia. In addition, a new laboratorywas completed in the Netherlands and a plant in Italy In 1989, Yamanouchi purchased
Shacklee Corporation,
a
world, by the first decades of the 21st century. According to Onoda, the immediate goal of R&D is to "deliver
seven major new products to world market by 2005."15 Yamanouchi be-
San Francisco-
based company that markets enriched foods. Since that purchase, the compa-
Hamal, which was developed in Japan in August 1993 and achieved sales of $146 million (15.2
lieves that
ny has achieved very high sales and profits. In 1992, Yamanouchi purchased a 29% interest in Roberts, Ine., a midsized American pharmaceutical company Yamanouchi USA is engaged in clin-
billion yen), will become the next internationally accepted drug.12 The firm's most emphasized research topics are
dementia senilis, hypertension, cardiac diseases, and diabetes. Onoda also said
that Yamanouchi's management tasks involve not only developing interna-
product development. In Europe, Fujisawa has built a number of strongholds: the London Office in 1979 for collecting informa.
ical development and study, including
tion and surveying, and its Clinical Research Center in 1985 as a develop-
technical joint venture with Tularik Inc. of the United States, which possesses a gene transcription and screening technology
a
advanced research in
tionally acceptable new drugs and the reinforcing of enterprise competitiveness and profitability,
In Southeast Asia, Yamanouchi created the joint venture Yamanouchi
but also maintaining prices of existing drugs and 15 future cost savings.
ment center; the Milan Office in 1986; capital investment in the German pharmaceutical firm Klinge Pharma GmbH; and Fujisawa Holland B.v in 1987 as a
finance business. In addition, Fujisawa
Ireland Limited was established in

576
Journl1l of Managed Care Pharmacy
}MP
Vol. 4,
No.6
~
1990 for ethical drug production and marketing, and in 1991, Fujisawa
,
In Europe and North America, the

Eisai Corporation of North America
enhance exchanges with international researchers. In 1993, Daiichi founded

the Daiichi Research Center at the University of California at San Francisco to conduct basic research on the causes of atherosclerosis. Daiichi conducts research in seven principal areas:
Europe GmbH was founded to supervise stocks in firms of Fujisawa Group
serves as the core of operations. In Southeast Asia, the international
in Europe. Fujisawa's business strategies call for establishing its own bases in the
department of Eisai's main office carries out detailed activities and exchanges
information. Eisai is promoting fundamental and investigative research in a tripolar effort with Japan, the United
States, and Europe and is solidifying its progress toward becoming an interna-
European and U.S. markets through wholly owned, affiliated, or consolidated companies, investment in local
enterprises, or license-based marketing.
antiinfective, anticancer, cardiovascular, central nervous system, gastrointestinal, immunity a1lergy, and contrast media.
The firm seeks to make every effort to develop internationally acceptable

drugs. Its consolidated
tional enterprise.
R&D spending
in fiscal year 1996 was 36.4 billion yen, down 1 % from the previous year.
DAIICHI PHARMACEUTICAL COMPANY, LTD.

Daiichi Pharmaceutical Co., Ltd., recorded annual sales of $2.15 billion (221.8 billion yen) and ordinary profits
R&D activities are centralized in the Tokyo R&D Center. Daiichi has developed several internationally acceptable new pharmaceuticals that have been distributed over-
EISAI
Eisai had annual sales amounting to
Tarivid and Cravit, new quinoline-type synthetic broad antibacterial agents; Transamin, an anti plasmin agent; and Neuer, a gastric mucosal
seas, such as
$2.3 billion (240 billion yen)
as of
March 1995 and was ranked fifth in Japan and 32nd among the world's pharmaceutical manufacturing companies.18 Masaji Ohno, a managing director and head of Eisai's R&D department,
of $408 million (41.6 billion yen) as of March 1995. The company's total income and profit increased 2.1 % and
defensive agent for gastric ulcer. Tarivid

is available in
109'markets globally and
has been licensed to Johnson & John-
8.7%, respectively, from the previous fiscal yearl9 In 1995, Daiichi ranked
seventh largest among Japan's pharmaceutical firms. According to President Tadashi Suzuki, Daiichi emphasizes
son in the United States and Hoechst of
Germany Domestic sales of Tarivid totaled $126 million (13.1 billion yen),
while exports totaled $68 million (7.1 billion xen) in 1994. Cravit was developed as a successor to Tarivid and released on the domestic market in December 1993; it achieved sales of $369 million 07.6 billion yen) in 1994. The combined sales of these drugs will sur-
said that the company will try to join the top 20 international firms early in
the 21st century, goal whose success depends on development of new drugs. Eisai has established a tripolar
a
"high technology" and "globalization" to not only strengthen its domestic base, but also to work toward international expansion.'o
research base for R&D: the indepen-
dent Tsukuba Research Laboratories,
Daiichi has subsidiaries in the United States, the United Kingdom,

Germany, Taiwan, and Hong Kong, and joint ventures with local pharmaceutical companies in France, South Korea, Taiwan, and Thailand. The company
pass
which was established in 1982 in Tsukuba Academic New Town as a center for new drugs; Eisai Research Institute of Boston in Andover, Massachusetts, in 1989; and Eisai London Research Laboratories at University Colege in
$534 million (55 billion yen).l9 In 1994, Daiichi's exports accounted
for more than 18.9 billion yen, or 9.1 % of sales. The company wants to raise its
London in 1992. Also, Eisai
America Inc., established in 1988, and London's Eisai Europe Ltd. are conducting basic organic research.
Eisai has not yet introduced outstanding internationally acceptable new drugs, but several candidates are undergoing clinical tests in the United States
maintains representative offices in each subsidiary. Daiichi has emphasized production and sales activities, particularly in Southeast Asia and China. In 1993,
the company set up a joint venture, Daiichi Pharmaceutical Thailand Limited, to strengthen sales in the Southeast Asian market. In 1994, Daiichi began a business venture with
proportion of exports to sales to 20% in the coming years.'o Tarivid and Cravit have already established an international reputation and provide support to the growth of Daiichi's foundation in the international market.
CHUGAIPHARMACEUTICAL COMPANY, LTD.

Chugai Pharmaceutical Co., Ltd., reported total sales in 1994 of $1.58 billion (162 bi1lion yen) and a growth rate of 7.4%. At that time, Chugai
ranked 10th among Japanese pharmaceutical companies21
and Europe. These products include E2020 for the treatment of Alzheimer's disease; E3810 for ulcer; E5531 for the
Shanghai Shin Yi Pharmaceutical Corporation Limited and Beijing

Pharmaceutical Works NO.4 to manufacture Tarivid tablets in China. Daiichi's global R&D strategy aims
to strengthen its research bases and
treatment of septicemia; and E5510 for the prevention of platelets.
578
}MP
Vol 4, No.6
Chugai's primary research areas include malignant tumors (including the relationship of malignancy to viruses and genetics), bone metabolism
(such as osteoporosis), and the cardiovascular system. Research on blood and the immune system also is emphasized.
as
"the Pacific Rim will be seen not only a market in the future, but also as a
treasure trove of resources for R&D," said Osamu Nagayama, president of Chugai Pharmaceutical Co., Ltd21
growth potential as well as improvements in China's health care system. Japan's direct investments in China grew by 78% in 1995, outstripping U.S. investments by 40%22 The key to success in overseas markets is the development of new acceptable drugs. To achieve this goal,
Japanese pharmaceutical companies
Chugai gave Amard marketing rights to G-CSF drugs in 1991 and acquired
some of Amard's stock and marketing rights in Taiwan, Korea, and Japan. According to Nagayama, the Japanese pharmaceutical industry has entered the age of "multi nationalism" and
Chugai focuses on the development of new drugs that act at the genetic level. In 1989, 'Chugai acquired a powerful research center in the United States when it bought Gen-probe,
which has achieved success with DNA

probe diagnostics. Gen-probe has a large share of the diagnostics market
and also has begun to develop several medical products, including G-CSF drugs and
"multiculturalism" by establishing research centers and personnel resources not only in Japan but also in other countries. Chugai believes it must work with other cultures to achieve
must establish advanced research facilities and cooperation of laboratories in joint venture enterprises and universities. Such strategies expedite ne'w drug approval and patent applications and stimulate development projects, while allowing for shared risk." Additionally, Japanese pharmaceut~cal companies must enhance their re-
HIV drugs. In Europe, Chugai markets the G-CSF drug Granocyte for the treatment of leukopenia
French pharmaceutical company. Granocyte already has been marketed in several
international success.
SUMMARY OF OVERSEAS
ACTIVITY
As a strategy for the 21st century, Japanese pharmaceutical companies have been shifting their targets from the domestic market to global markets,
search efficiency and acquire their own specialties. Sankyo's Melavotin and
through Rhone-Poulenc,
Fujisawas Prograf are proof of the potential for new international blockbuster
drugs in coming years. Thus, R&D becomes more important regardless of increasing costs and longer timelines for bringing new products to market.
other European nations. In 1992, Chugai built the C&C

Research Laboratories,
a
joint venture
with Choongwae,
South Korean phar-
maceutical company. Choongwae manages manufacturing and sales of Granocyte; Picibanil, an anticancer drug;
especially North America, Western Europe, and Asia. This shift will affect
R&D, production, and
sales bases.
OUTLOOK FOR THE JAPANESE PHARMACEUTICAL INDUSTRY
calciumbone metabolizer; and Ulcerlmin for gastritis and peptic ulcers. Chugai also
a
Sigmart for angina; Alfarol,
Investment in local production with direct overseas sales remains important for efficiency and cost reduction,
because of preferential taxation and foreign exchange rates. The establishment of wholly owned subsidiaries and man-
Transition of Drug R&D Along With the Aging of Society

Japanese pharmaceutical companies have succeeded in developing antibiotics that have proved extremely effective in the treatment of tuberculosis,
has
a contract for joint exploratory research with the Korean Chemistry
Research Laboratory, which was found-
ed in 1976 to provide the Korean chemical industry with R&D in a wide range of chemical technologies. In ad-
ufacturing plants also is extremely important in future strategies. Yamanouchi and Fujisawa already are constructing manufacturing plants to
dition, in 1993 Chugai provided 61 % of the $5 million start-up capital for a
joint venture in Shanghai to export Chugai products, as well as to import, manufacture, and sell various drugs. Chugai is expanding exploratory
research to the Pacific Rim. The company has begun a joint venture with Amard, an Australian pharmaceutical company founded in 1986. Although
the Pacific Rim has very little of the
produce their own pharmaceuticals. Several companies have begun to acquire local enterprises that offer bases
for overseas development, production, and sales. However, joint venture projects are as actively pursued as mergers and capital participations. Approval of new drugs in Europe is easier to obtain if Japanese companies have joint ventures with European pharmaceutical
companies. Moreover, expanding joint ventures with China, where the population exceeds 1 billion, portends large
pneumonia, and other infectious diseases. In the 1980s, sales of antibiotics were higher than sales of any other
drugs and comprised 27% of Japan's
total drug sales. Since then, Japan has become a leading country for the pro-
duction of antibiotics worldwide. However, the aging of the Japanese
population has increased the incidence of adult, geriatric, and chronic diseases,
rather than infectious and acute ailments. In 1989, the production of
drugs for the circulatory system occupied 14% of Japan's total market, surpassing antibiotics at 13%. Now,
infrastructure needed for
R&D and
relative scarcity of human resources,
Vol. 4,
No.6
}M(P
579
International Movement of japan's Pharmaceutical Industry: Reform of japanese Health Policies, Part III
Table 4. Death Rates in Japan by Five Principal Causes (Rate Per 100,000 population)
Year
I
146.4
Cause 1
Tuberculosis
I
127.1
Cause 2
I
I
93.2
Cause 3
Cause 4
Gaslritis and Emeritis
Cause 5
1950
Cerebrovascular Disease Pneumonia and Bronchitis
82.4
Heart Disease
Malignant Neoplasms 77.4

Senilily
1960
Cerebrovascular Disease
160.7
Malignam Neoplasms 100.4

Pneumonia and Bronchitis 93.2
73.2
Accidemal Dealh
58.0
Senilily
1970
Heart Disease
176.5 1980
87.0
Heart Disease 106.2
42.6
Pneumonia and Bronchitits
38.2
Senilily
139.5 1987

Heart Disease
33.7
Pneumonia and Bronchilis
27.6
Accidental Death
118.3
Heart Disease 175.3
IOU
44.9
Pneumonia and Bronchitis
230
Accidents or Poisonings
1992
Malignam Neoplasms
231.7
117.9
80.2
34.4
Source: International Pharmaceutical Service
patients with diseases associated with aging outnumber those with contagious
diseases
BIOTECHNOLOGY DEVELOPMENT
japan's Ministry of International Trade and Industry (MITI) has encour-
to that of the United States.25 Thus, japan has to improve its own biotech-
by 8:1.23. In 1992, cancer
caused 231,786 deaths in japan; heart disease caused 175,336 deaths; cere-
nical engineering to become a strong contender in the pharmaceutical indus-
try and increase profits.
brovascular disease accounted for 117,908 deaths; and 80,214 died from pneumonia and bronchitis (see Table
aged the development of biotechnology since 1981.24 MITI maintained a strong
4). Cancer became the second most frequent cause of death in 1953 and the leading cause of death in 1981; one out
of every four deaths in Japan now is attributed to cancer. Heart disease surpassed cerebrovascular disease in 1985
to become the second leading killer.
export orientation from the early postwar period but historically lacked involvement with the pharmaceutical industry, whose provenance remained firmly within the Ministry of Health and Welfare (MHW). japanese manufacturers hope that combining molecular
EXPANSION OF PHARMACEUTICAL MARKETING INTO SOUTHEAST ASIA

The pharmaceutical market has expanded by 10% per year worldwide in recent years. The three largest mar-
kets-the United
States, Europe, and
biology and high technology will result

in numerous new drugs and may provide fundamental cures for genetic diseases, cancer, and AIDS, among others. A series of new biodrugs has been developed and is entering extensive
japan-comprise 80% of worldwide

sales. Southeast Asia, together
Cerebrovascular disease also was
increasing, but emphasis on suitable diet and effective drugs has slowed
this trend5
Today, R&D in japan focuses on the treatment of cancer, cardiovascular diseases, cerebrovascular disease, senile
with China, consumes approximately 8% of the world's pharmaceuticals and has become the fourth largest pharmaceutical market6 and the fastest growing.
Asia's newly industrialized coun-
practical stages, including interferon,

insulin, human growth hormone,
tries, such as Singapore, South Korea,
dementia (such as Alzheimer's disease),
and osteoporosis, which are all age related. In addition, fourth-generation antibiotics, which are effective against
drug-resistant bacterium in new forms of tuberculosis and sexually transmitted
diseases, also are important for new
thrombolytic agents, erythropoietin hormone for renal anemia, and the leukocyte proliferation factor G-CSF for the treatment of leukopenia after chemotherapy japan still imports 80% of biotechnology to produce biodrugs. According to Nikkei Biotechnology the market of biodrugs in japan reached sales of 581 billion yen in 1994, similar
Taiwan, and Hong Kong, have become attractive pharmaceutical markets because of high per capita incomes and fairly well-developed health service systems. Traditionally, the most demanded pharmaceuticals in Southeast Asia have
drug development.
been antibiotics. Governments have spent the majority of their funds on
antibiotics, vaccines, vitamins, and

580
]MCP
VoL 4. NO.6
International Movement of japan's Pharmaceutical Industry: Reform of japanese Health Policies,Part III ~
blood products. However, as the area's economies have advanced, the demand for gastrointestinal, respiratory, and contraceptive preparations has increased. Many foreign pharmaceutical firms have
chosen to compete in the markets of Southeast Asia through joint ventures
Asian nations, resistance mounted. With currency devaluations, cheaper foreign imports likely will flood Western markets, to further exacerbate already climbing trade deficits there. A piece of the imposed new framework on Asia would
force sweeping restructuring of basic
"Once, japan invited admiration, which was deserved, if at times exaggerated. Now, however, it invites despair as it fails to escape from the economic stag-
nation of this lost decade, fails to reform its shaky politics and corrupt bureaucracy, and fails as a result to be able to lead
East Asia out of its troubles. At times, that despair has looked itself exaggerat-
and local distributors, because local
firms are more familiar with marketing channels and consumer expectations. A major barrier for foreign competitors in the Southeast Asian market is the
industries, loosening what Safire27 calls the "crony capitalism" of japari's keiretsu,
Koreas chaebol, China's guanxi, and

Suharto's family ties throughout Indonesia.
ed. But not now, for the latest figures show that japan has entered its first
New IMF regulations might break
lack of patent protections. China is one of the worst patent offenders in the
down long-standing cultural barriers to the West and create freer markets for
trade. However, as economies contract in China, Korea, Taiwan, the Philippines, Thailand, Indonesia, Singapore, and
even japan, the richer West will face weaker demand for its exports, at least in the near term 28 japan may be hurt the most because it exports more within
economy-shrinking recession for almost 25 years; and the latest news suggests that no one in authority is capable of doing much about it."30 As international confidence in japan's economy, banks, and state apparatus wanes, its foreign relationships will suffer, most notably
world; generic and pirated drugs constituted 90% of the Chinese market in
19926 Restrictions on distribution also

are very frustrating. Foreign companies must partner with local joint ventures
and cannot cooperate with other foreign

firms or implement their own distribution operations.13 Such regulations make it more difficult for foreign pharmaceutical firms to establish wholly owned subsidiaries in Southeast Asian countries and may make an effective market nearly
with the United States. To recapture confidence, japan may have to yield to greater policy changes demanded by the
Clinton administration. As he struggles
to justify the commitment of billions of dollars to the IMF to prop up the victims
Asia than do America and Europe, particularly when measured by percentage
impossible. Despite these barriers, however, the Southeast Asian pharmaceutical
market holds great promise for japanese

and Western firms.
of japan's GDp, 4.4%. Thus, japanese pharmaceutical manufacturers face new obstacles to overseas markets by the year 2000, and increased challenge by Western companies for the japanese domestic market. Simply put,
japanese pharmaceuticals may be relatively cheaper in the West, but monies
for export purchases, especially in the public health systems of their trading partners, may not be as plentiful across the Asian markets. Western drugs may be more expensive for japanese consumers (or rather the Ministry of Health
&: Welfare), but the barriers to the
of the Asian currency crisis, President Clinton's limited success with fast-track
trade negotiating authority does not
assure speedy worldwide trade liberal-
ization." Fast-track authority would allow the administration to submit trade pacts to Congress for either an up or
THE RECENT PACIFIC RIM CRISIS

The panic in the Asian financial markets this past year shook the global 26 economy. This region's once booming
economies were shaken by
a
down vote without amendments, which greatly strengthens U.S. negotiating

power with trade partners. The ongoing japanese turmoil reaches beyond the potential to cause problems for the world pharmaceutical industry. Some economists fear that if
plummet-
ing stock market and collapsing currency. Given that the world's industries and financial systems are intricately inter-
domestic market may ease to promote more imports.
japan cannot pull itself and its region back together soon, it might drag the
United States and Europe into recession.32 With more and cheaper Asian exports washing onto American shores,
U.S. corporate profits are likely to erode as sales decline throughout Asian
nations. The impact on Wall Street would be certain to abruptly halt consumer spending as prosperous portfolios
fall. Under this scenario, Asian investors
twined, the current growth in U.S. production, employment, and exports is being threatened by this Asian crisis.
Both the United States and Europe now seek greater coordination with japan to
a coherent response to the Asian financial crisis. The course of this policy redirection holds implications for the global pharmaceutical industry.
FINANCIAL TURMOIL IN JAPAN

japan has been said to be the "most consistently misunderstood, misinterpreted country on earth, a place where
nothing
quite as it seems. "29 This description is easy to accept when surveying the turmoil that japan is facing
is ever
mount
In the early months of 1998, as the International Monetary Fund (IMF) began imposing new conditions on the
on its own, beyond the broader crisis across Asia. As The Economist editorialized in March of this year:
would dump their U.S. treasuries to provoke federal intervention, interest rates would rise, monetary and fiscal policy
582
fM{,p
vol. 4, NO.6
interventions in the midst of partisan bickering would further complicate matters, and corporate downsizing would
lead to
has been responsible for deciding policy
market, though they have
much
the end of the longest lasting
for the Japanese pharmaceutical industry, focusing primarily on domestic health affairs; however, the MHW has not been adequately supportive on overseas policies. For example, Southeast Asian countries generally do not recognize Japanese drug approval as equal to
stronger preserice throughout Asia. In the 1980s, Japanese pharmaceutical
peacetime expansion ever for both the United States and the rest of the West. The next year will show whether Japan's leadership can reverse the plunge. Western powers hoped the $75 billion
manufacturers began to establish wholly owned subsidiaries, manufacturing plants, and research facilities in other countries to develop an institutional capacity to sell their products in overseas markets and to innovate internationally acceptable drugs. Domestically,
pressures had intensified because of curbed drug prices intended to reduce
stimulus plan by Ryutaro Hashimoto would reform Japanese society "toward the kind of market capitalism practiced
in the U.S. and Britain."29 (Hashimoto's administration has been replaced.) Such
drug approval in the United States, which results in the automatic approval
of competing products in certain Southeast Asian countries. The Japanese phar-
maceutical industry blames an ineffective MHW for failing to explain Japanese
direction involves a complex undoing of the bureaucratic management of the

a
economy, which outside commentators maintain is responsible for problems in

the Ministry of Finance and the financial
drug approval policy to trading partners. Japanese clinical trials are not readily accepted by regulatory authorities in the
government health expenditures and from competition with foreign pharmaceutical firms. Despite the recent financial crisis, Japanese pharmaceutical manufacturers will regroup and continue their overseas expansion as Japan assures its place as the second largest nation for drug
production.
...
References
With entry barriers lowered, Deutche Bank, Citibank, Merrill Lynch,

sector.
United States or Europe. In Japan, the efficacy of new drugs is compared to that of drugs already used for that indication; if the new drug produces the
same or better results, it is approved. In contrast, FDA marketing approval is based on comparisons of new drugs
and other Western multinationals are eager to gain access to the $11 trillion in savings held by the Japanese. Hashimoto's tax cuts and public spending pro-
grams were designed to stimulate sluggish demand for consumer goods amidst this historically high savings for retirement. Slow growth will force Japanese producers to compete more effectively
abroad. A boomlet of mergers and acqui-
with placebos, while Japanese clinicians tend to resist the use of placebo trials.
As long as such problems persist, Japanese pharmaceutical companies will have
to conduct clinical trials overseas-often through licensing or joint ventures-to
1. Takahashi S. japans pharmaceutical industry contributing to world health. JAPAN 21st 1995(Aug): 24-27. 2. Chevalier K, Salmon jW International movement of JapanS pharmaceutical industry: reform of japanese health policies. Pan I. J Managed Care Pharm 1997; 3(6): 667-74.
deal with regulatory obstacles. The inter-
3. Chevalier K, Salmon jW International movement of Japan's pharmaceutical industry: reform of japanese health policies. Pan II. j Managed Care
(M&A) may follow the American banking M&A feverH Although culturalsitions
ly, market reverses manifest themselves differently in Japan-for instance, mass
national harmonization of regulatory standards will ease these difficulties. At the end of November 1995, the
layoffs do not follow mergers there-its

corporations may align their interests more strongly with stockholders to pursue im-
Third International Conference on Harmonization Convention of medical products in Japan, the United States,
and Europe took place in Yokohama. Progress on unifying standards will
1
Pharm 1998; 4(2): 123-37 4. Coto, T. The globalization of japan's pharmaceutical industry. JAPAN 21st 1 995(Aug): 21-23. 5. Takahashi, S. japan's pharmaceutical industry. JAPAN 21st 1994(Aug): 18-23. 6 Howe, D. The pharmaceutical industry in
southeast Asia.
j Southeast Asia Business
provements in return on investments. Traditionally, growth has been stressed

more than profits. As fast as they come, these economic developments will take
hold in the Japanese pharmaceutical industry and affect their overseas strategies.
speed up approval of new drugs by eliminating unnecessary tests on quality, safety, and effectiveness. Further, the harmonization of patent policies will
INTERNATIONAL HARMONIZATION
International harmonization of pharmaceutical regulations has been a protracted process,33 and Japan has not been in its forefront. Historically, the MHW
improve the R&D environment. The international harmonization of regulations is essential to the globalization of
the Japanese pharmaceutical industry
1992(Winter); 8: 73-97 7. Takahashi, S. japan's leading pharmaceutical enterprise working for a brighter future: interview with Kenkichi Murakami, member of the board, Takeda Chemical Industries, Ltd. JAPAN 21st 1994(Aug): 24-25 8. Sankyo out to develop new medicines after Mevalotin.jAPAN 21st 1994(Aug): 28-29. 9. Sankyo moves quickly into the international marketlace. JAPAN 21st 1994(Aug): 32.
10. Yamanouchi pharmaceutical readies itself for globalization. JAPAN 21st 1995(Aug): 30. 11. Yamanouchi's pharma sales up 8%. SCRIP
CONCLUSION
The Japanese are just now becoming skilled in the American pharmaceutical
2172, Oct 15, 1996: p. 10. 12. japan's drug industry: medicinal madness. The Economist 1993(March): 73. 13 Luo AY, Salmon jW, Lamben B. U.S. pharmaceutical firm prospects within the People's Republic of China. j Managed Care Pharm 1996; 2: 76-82.
14. Yamanouchi completes Chinese factory. SCRIP
Vol 4, No.6
}M{P
583
lnternational Movement of Japan's Pharmaceutical lndustry: Reform of Japanese Health Policies, Part
I11
2242, june 20, 1997: p. 19 IS. Takahashi, S. Delivering seven major new products to the world market by 2005: interview with Masayoshi Onoda, president of Yamanouchi Pharmaceutical Co., Ltd. JAPAN 21st] 994(Aug):
21. Takahashi S Contributing to the health of people throughout the world: interview with Osamu Nagayama, president of Chugai Pharmaceutical Co., Ltd. JAPAN 21st 1994(Aug): 30-31. 22. Koretz G. A marriage made in Asia: Sinojapanese ties worry the U.S. Business Week, jan 29, 1996: 20. 23. Reich MR. Why the japanese don't export more pharmaceuticals: health policy as industrial policy. California Management Review 1990(Winter): 124-50. 24. Spindle B. Merger boom let takes hold in japan. Wall Street journal, April 13, 1998: A18. 25. Biotechnology in japan: alien culture. The Economist, Nov 18, 1995: 79. 26. Variable fallout. The Economist, Nov 29, 1998: 78-80.
27. Sanre W Crony capitalism. New York Times Magazine, Feb 1,1998: 16-18 28. Bremner T, et a!. What to do about Asia.
Business Week,jan. 26,1998: 27-30. 29 Murphy RT. Don't be fooled by japan's big
28-29
16. Fujisawa's drug sales down 7%. SCRIP 2172, Oct IS, ] 996: p 7. 17. Fujisawa Pharmaceutical has high hopes for
the future JAPAN 21st 1994(Aug): 34. 18. Eisais tripolar research system contributes to
bang. Fortune, Dec 29, 1997:214-34. 30. The japan puzzle. The Economist, March 21, 1998: 15. 31. Calmes j, Greenberger, RS. For Clinton, summit is challenge after trade setback. Wall Street
world health. JAPAN 21st 1994(Aug): 33. 19. Daiichi Pharmaceutical ambitious to capture worlds synthetic antibacterial agent market. JAPAN 21st 1995(Aug) 31 20. Daiichi Pharmaceutical Co. Ltd.: enriching the quality of life. JAPAN 21st 1994(Aug): 35.
journal, Nov: 20, 1997: A24 32. Schlesinger jM. Fault lines: behind the U.S. rift with japan. Wall StreeLjournal, April 13, 1998: A2-3 33. Spivey RN, Wertheimer AI, Rucker TD. International pharmaceutical service. New York: Binghamton, 1992.
584
jMCP
Vol. 4,
No.6
A Predictive Cost Analysis Model for Estimating Formulary Impact of New Products in Managed Care
Samuel Hedayati, B. Pharm., Ph.D., and Peter W Kleinstiver, Ph.D.
ABSTRACT: Competition among new pharmaceutical products for unrestricted formulary inclusion continues to
dominate the concerns of managed care decision mak-
generation of nondihydropyridine, T-channel selective

CAs entering a crowded therapeutic area for the treatment of hypertension and angina pectoris. This model
compares the weighted average cost-per-prescription for CAs before and after the formularyinclusion of T-Block. Three key variables of the model-utilization ratios of
ers. These competitive pressures may originate when a
formulary appears to be overcrowded and underfunded

based on what it is expected to deliver-primarily finan-
cial management of an ever-increasing list of new products in addition to day-to-day pharmaceutical needs. For
available strengths, market share for the new product,

and annual CA prescription volume-facilitate preparation of customized financial analyses. Accordingly, the model's simple three-way sensitivity analysis defines
those managers facing the daunting task of improving
quality of pharmaceutical care with finite resources,
appropriate product selection has become a dual consideration involving assessment of the new product's com-
specific' financial scenarios under various conditions of uncertainty. The model also can be used as a post-formulary
utilization management and market share tracking tool.
petitive clinical features and benefits, in tandem with an

assessment of its formulary cost impact.
We present a simple and objective financial model
that, based on historical utilization data, will help predict
Key Words: Calcium antagonist, Drug utilization review, Formulary, Managed care, Pharmacoeconomics, Pharmacy benefits management, Reimbursement
priori an accurate estimate of the cost impact of a new product. We illustrate our financial model with a new cala
cium antagonist(CA), T-Block. T-Block is the first of a new
J Managed Care Pharm 1998: 585-590
In
ed
recent years, health care trends in the u.s. have includa remarkable reduction in patient length of stay, a signi-
ficant contraction in the number of acute care beds, and a patients are treated on an outpatient/ambulatory basis.l Competition among new therapeutic agents for unrestricted formulary access status has intensified, necessitating budgetary processes
that subject new products to greater scrutiny. Managed care organizations that want to maintain the best possible standard of pharmaceutical care must use proactive thinking and planning,
AUTHORS
SAMUEL HEDAYATI,
B.
PHARM, PH.D,
is with the Healthcare Management
Department, Roche Laboratories, Inc., Nutley, Nj, and PETER W KLEINSTIVER, PH.D., is with Katalyst ProfessionalServices, Inc., London, Ontario, Canada.
AUTHOR CORRESPONDENCE: Peter W Kleinstiver, Ph.D., Katalyst Professional Services, Inc., 23 Carriage Hill Crescent, London, ON, Canada, N5X 3W8.
AUTHOR ACKNOWLEDGEMENT: The authors would like
Kleinstiver, A.R. T,
to thank Sandra]. for her assistance with preparation and critical review of the
in making formulary decisions. Upon regulatory approval, pharmaceutical companies may market new drugs. Compared with existing drugs, new agents have been used by significantly fewer patients. Therefore, true cost effectiveness is difficult, if not impossible, to determine until sufficient real-world experience is attained. Nonetheless, pharmacy benefit managers must decide whether to include these new drugs on formulary in advance of such effectiveness data. Typically, in coordination with the pharmacy department, pharmacy and therapeutics (P&T) committees assess both the clinical (safety and efficacy) and financial impacts (cost effectiveness). of a new product before recommending or rejecting
as well as aggressive budgeting,
manuscript.
it for reimbursement. Evaluating the economic outcomes of a formulary candidate may involve a simple comparison of expenditures (cost avoidance) when two drugs have been deemed ther-
CopYlightC91998 Academy of Managed Care Pharmacy, Inc. All rights reserved.
apeutically equivalent.' Formulary decisions also may involve
Vol. 4,
No.6
}MP Journal of Managed Care Pharmacy
585
A Predictive Cost Analysis Model for Estimating Formulary Impact of New Products in Managed Care
Table 1. Required Format for Data Entry
Generic Name Amlodipine
Mfr. Hizer
Trade Name
Norvasc
Strength 2.5mg 5mg

lOmg
Share($) Market Share($YMarket Total Number of % TotaH % Subt Form Prescriptions (Rx) Quantity (units)* AWP($)**
Tab
18,329 262,649
804,403 11,823,617
$981,396
$14,399,801
4.3%
I I
0.635%
Tab Tab
63.3%
32.3%
9.311 %
4.755%
85,114
3,483,317
$7,353,735
Total=$22,734,932
Diltiazem
HMR
Cardizem
30mg
Tab Tab Tab Tab
11,129 9,777
1,122,210
1,003,961
$511,299 $718,187
1.5%
0.331 %
60mg
2.1%
0.7% 0.2%
0.464%
0.166% 0.052%
90mg
120mg
2,404
657
254,855
60,514
$256,534 $79,845
Total=$1,565,865
Quantity=mnnber of units (tablets, capsules, etc.) prescribed/dispensed on those presCtiptions Total A WP($)=total value of prescriptions for those strengths t Market Share($) % Sub=market shw'e as a percentage of total value of each subgroup of CA t Market Share($) % Total=market share as a percentage of total value of all CA preSCIiptions for the entire data
* * *
set
more extensive cost-effectiveness studies3 for compounds that are similar, but not judged to be therapeutically equivalent. However, in the absence of cost-effectiveness data that reOect unrestricted utilization of a newly launched product, some decision makers may resort to a simple comparison of "negotiated" acqui-
addition of a new product to the formulary The model calculates a weighted average cost-per-prescription from utilization data of currently reimbursed products and a price parameter based on Average Wholesale Price (AWP), Wholesale Average
Cost(WAC), or Net
Sales
(including all discounts/rebates). It
sition costs. This method, although convenient, tends to be time consuming and may involve offers and counteroffers (none
then compares this mathematically representative average of the entire data set with its best estimate of the new product's weighted average cost-per-prescription. The weighted average cost-per-prescription for the new product is calculated using an average quantity-per-prescription dispensed for that categoantagonists) and a ry of products (in our example, calcium price parameter based on AWp, WAC, or Net Sales. Finally, to determine the annual cost-impact of the new product, the difference between the weighted average cost-per-prescription before and after the formulary adoption of the new product
of which may be directly comparable) from several parties. It tends to ignore historical patterns of drug utilization that reOect physician prescribing habits and underlying patient demographics, adjunct medication, and the availability of multiple strengths that may be priced differentially In recognition of these limitations, other, more sensitive and convenient techniques of financial impact analysis are slowly emerging, particularly when therapeutic area may be overcrowded; We present a robust, objective, and practical financial model that is designed to assist health care decision makers faced with
a
difficult formulary alternatives. This model calculates (utilizing a weighted average method) a priori the cost impact of a new
product. UsingT-Block as an example, we illustrate that historical drug utilization data (prescriptions, units, average wholesale price), in addition to knowledge of prescribing dynamics,
(using identical AWp, WAC, or Net Sales pricing to compare the new product with established products) is annualized assuming different conditions of uncertainty Specific steps in this cost analysis technique are detailed below.
DATA ENTRY
Table 1 illustrates the required format for data entry of last period CA utilization data for a specified time period.' (All data are automatically annualized.)
can be used to compare the weighted average cost-per-prescription before and after the formulary adoption of a new product.
We also illustrate how
a simple three-way sensitivity analysis generated from the same model can be used to define specific financial goals under conditions of uncertainty, allowing decision ma-
kers to track post-formulary market penetration of
new drug.
Step 1. Calculation of the weighted average cost-per-prescription for each product and for the entire data set.
METHODS
The financial model requires knowledge of historical utilization data for a specified time period, typically a minimum of one continuous financial quarter. It is based on estimation of the weighted average cost-per-prescription before and after the
The weighted average costs-per-prescription for each product separately and for the entire data set are related parameters. The model calculates the weighted average cost-per-prescription for each product by dividing the total AWP($) for each strength of the prduct by the number of prescriptions
(Rx). The model then weights the result by multiplying the respective market share percentage in the subgroup, calculated
by
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dividing total dollars for each strength by the total dollars in that generic subgroup. These results then are summed. The process of calculating the weighted average cost-per-prescription
is repeated for each branded product.
Table 2. Average Quantity-Per-Prescription for Comparable Products

Product
N orvasc
Average Quantity-Per-Prescription
44 44
47
43
Example
For Norvasc, the weighted average cost-per-prescription is equal to the weighted average cost-per-prescription of the 2.5 mg strength plus the weighted average cost-per-prescription of the 5 mg strength plus the weighted average cost-per-prescription of the 10 mg strngth.
=
Cardizem CD
Plendil ER
Procardia XL &: Adalat CC
Calan SR Average for entire dataset
49 44
[$981,396 (Total AWP($)) 18,329 (Number of Rx) x 4.3% (Market Share($) % Sub)] [$14,399,801 (Total AWP($)) -+- 262,649 (Number of
-+-
63.3% (Market Share($) % Sub)] + [$7,353,735 (Total AWP($)) -+85,114 (Number of Rx) x 32.3% (Market Share($) % Sub)]
Rx)
x
=
$64.91
+
duct (by strength), and is weighted by its respective market share based on dollars as a percentage of the total. This is calculated by dividing total dollars for each strength by the total dollars in the entire data set, and then summed. Therefore:
To calculate the weighted average cost-per-prescription for the entire data set, the above process is repeated for each pro-
0.330% (Market Share($) % TtO] [$718,187 (Total AWP($)) + 9,777 (Number of Rx) 0.464% (Market Share($) % TtO] [$256,534 (Total AWP($)) -+- 2,404 (Number of Rx) 0.166% (Market Share($) % TtO] [$79,845 (Total AWP($)) -+- 657 (Number of Rx) x 0.052% (Market Share($) % Ttl)]
$.73
The contribution to the weighted average cost-per-prescription for the entire data set is repeated for all products and then summed. It is unique for each data set and is an important parameter since it will be used as a representative benchmark in the calculation of cost savings or cost increases resulting from the addition of a new, multi-strength product. The weighted average cost-per-prescription for this dataset (excluding T-Block) is $69.86.
Weighted average cost-per-prescription for the entire data

set
=
Average cost-per-prescription for Norvasc

share
+
Total market
x
Average cost-per-prescription for Cardizem

share
+
Total market
Total market
Average cost-per-prescription for Procardia share +
Step 2. Estimation of the weighted average cost-per-prescription for a new product (e.g., T-Block).
Average cost-per-prescription for Calanx Total market share, ete.
The weighted average cost-per-prescription for the new tetralol calcium antagonist (T-Block) is calculated according to the following formula: Weighted average cost-per-prescription of T-Block= Estimated quantity-per-prescription (number of units) of T-Block (2a)
x
Example
For Norvasc, its contribution to the weighted average cost-perprescription for the entire data set is calculated as in the previous example, except that market share as
a a
dollars is substituted for market share as subgroup:

=
percentage of total percentage of the
Blended price of T-Block (2b)
Step 2(a) Estimated quantity-per-prescription of T-Block.

As expected, at the time of launch of a new product, little or no utilization data are available for entry into the model. In the absence of such data, the model assumes parameter 2(a) to be equal to the average quantity-per-prescription of other ". products that have a comparable dosing schedule to T-Block, and that T-Block most likely will displace. To accomplish this step, the model calculates an average quantity-per-prescription for Adalat CC, Procardia XL, Norvasc, Cardizem CD, Calan SR and Plendil. In this dataset, the average quantity-per-prescrip-
[$981,396 (Total AWP($))
-+-
18,329 (Number of Rx)

-+-
0.634% (Market Share($) % TtO] [$14,399,801 (Total AWP($)) 262,649 (Number of Rx) x 9.306% (Market Share($) % TtO] [$7,353,735 (Total AWP($)) -+- 85,114 (Number of RX)
4.735% (Market Share($) % TtO] $9.53

x
Example
For Cardizem, its contribution to the weighted average costper-prescription for the entire data set is:
=
tion is 44 (Table 2).
Step 2(b) Blended price of T-Block.
[$511,299 (Total AWP($))
-+-
11,129 (Number of Rx)
If a product
is available in more than one strength,
with
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Table 3. Sensitivity Analyses Showing Formulary Cost Impact of Conditions of Uncertainty

Utilization Ratio of T-Block 50 mg and 100 mg
strengths
New Product as Each Parameter Is Varied to Examine

No Change in Total Number of Prescriptions
$0
T-Block Market Share (prescriptions)
Decrease in Prescriptions
Increase in Prescriptions
-15%
$0
-10%
$0
-5%
$0 -$1,325,681
5%
$0
10%
$0
15%
$0
90%:10%
0%
5% 10%
15%
-$1,186,136
-$2,372,272 -$3,558,408
$0
-$1,255,909 -$2,511,818
-$3,767,726
$0
-$1,395,454
-$1,465,227
-$2,930,454 -$4,395,681
$0
-$1,535,000
-$3,069,999
-$4,604,999
$0
-$1,604,772
-$3,209,545
-$2,651,363
-$2,790,908 -$4,186,363
$0
-$3,977,044
$0
-$4,814,317
$0
80%:20%
0%
5%
-$776,305
-$1,552,610
-$821,970
-$867,635 -$1,735,270 -$2,602,905

$0
-$913,300
-$1,826,600
-$958,965
-$1,004,630
-$1,050,295
10%
15%
-$1,643,940
-$2,465,910
$0
-$1,917,930
-$2,876,895
$0
-$2,009,260
-$3,013,890
$0
-$2,100,590
-$3,150,885
$0
-$2,328,915
$0
-$2,739,900
$0
70%:30%
0%
5%
-$367,506 -$735,012
-$389,124
-$778,248
-$410,742
-$432,360 -$864,720
-$1,297,080
-$453,978
-$907,956 -$1,361,934
-$475,596 -$951,192
-$497,214
-$994,428
-$1,491,642
10%
15%
-$821,484 -$1,232,226
-$1,102,518
-$1,167,372
-$1,426,788
each strength priced differently and utilized/prescribed differentially, a blended price is calculated. In this illustration, the
set
x
two T-Block strengths (50 mg and 100 mg) are differentially priced; it is assumed that 90% of prescriptions will be for the low dose (a weight of 0.9) and 10% for the high dose (a weight of 0.1). For this analysis, AWPs of $ 1.24/tablet and
[weighted average cost-per-prescription for entire data (Y)] [T-Block prescription volume (Z)]
$2.14/tablet have been used for the 50 mg and 100 mg TBlock strengths, respectively. Thus,
Blended price
Parameters (W) and (Y) have been described previously. Parameter (Z), anticipated prescription volume for the new product, is derived using this formula:
$1.24 (unit price/50 mg)] $2.14 (unit price/lOO mg)] $58.52

=
[0.9
[(0.1
T-Block prescription volme (Z) [total volume of CA prescriptions (annualized) change in CA prescription volume]
=
:t
T-Block prescription market share (%)
Therefore, assuming a 90%:10% utilization ratio, the weighted average cost-per-prescription for T-Block:
Through the sensitivity analyses one can observe the costimpacts, assuming changes in prescription volumes (e.g., from
-15% to +15%) or, for
44 (estimated quantity-per-prescription) price of T-Block) $1.33

=
$1.33 (blended
a fixed volume of prescriptions, observe the cost-impact of different T-Block market shares (e.g., 5%, 10%, or 15%). If cost-impact ($) is a negative number (when W<Y) this
.
Obviously the 90%: 10% utilization ratio can vary; the model allows for this through sensitivity analyses.
Step 3. Determination of the cost-impact of T-Block.

To p~edict the cost-impact of T-Block, the model compares the weighted average cost-per-prescription for the entire data set with and without T-Block. The relevant formula is shown below:
signals a cost savings; the model predicts a net decrease in total cost through addition of a new product to the existing formulary mix. Conversely, if cost-impact ($) is a positive number (when W>Y) the model predicts a net increase in total
costs if
a
new product
is
added to existing formulary mix.
SENSITIVITY ANALYSES
Simple sensitivity analyses are a central component of this predictive technique, enabling the user to observe a new product's cost-impact under various conditions of uncertainty.
T-Block cost-impact ($)

=
[weighted average cost-per-prescription for T-block (W)]
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Impact of New Products in Managed Care
Uncertainty may exist in terms of three key variables: growth (positive or negative) in the total number of prescriptions for the therapeutic category of interest; the prescription market share acquired by the new product; and the utilization ratio of its various strengths, if they are priced differently.
Table 3 presents the results of a three-way sensitivity analysis, where the impact of changing the magnitude of the three variables in the model, either alone or in combination,
was tested. In our example, the individual and combined effects of changes in total number of CA prescriptions (from -15% to
Assumptions of the model

The three assumptions of the model are that:
... product mix, as shown by historical utilization data, will remain uncha:nged during the evaluation period; ... pattern of utilization, implicit in the dataset, will continue to apply to the specified period; and prices will not change significantly throughout the evalua...
tion period.
+15%, in 5% increments), changes in T-Block prescription market share (at 5%, 10%, or 15%), and changes in utilization ratios of the 50 mg and 100 mg strengths (90%:10%, 80%:20%, and 70%:30%) are displayed in Table 3.
DISCUSSION
Projecting the costs of drug expenditures is a blend of science and art. As drug expenditures continue to grow disproportionately to the number of lives covered, it may be helpful to know a plioli the expected financial implication of adopting a
These assumptions are straightforward and correspond well with the model's simplicity and transparency. Independent tests of robustness based on utilization data from several health care jurisdictions (private and public) have
shown that this model is robust and that, as one would expect, the financial impact of a new product actually differs from one institution to another.
new product on formulary. In the absence of cost-effectiveness data, other simple finanCial modeling techniques can assist with the formulary decision process to include a new product.
as a paragon, particularly when the therapeutic area of interest may be crowded with several variants of existing products, but where there still is room for new
Our model may serve
RESULTS
The data set presented here was obtained from a leading pharmacy benefit management company in the United States. The weighted average cost-per-prescription for the entire
data set was $69.86. The average quantity-per-prescription for
products to fill unmet medical needs. Central to our models underlying concept is the calculation of a weighted average cost-per-prescription before and after new product adoption, based on real-world historical utilization data. A weighted, rather than an arithmetic, average better reflects the mix of different products and different available strengths, which in most instances are differentially priced. The weighting factor in the adjustment of the mean is a product's or a strength's market share ($) expressed as a pro-
comparable products in the dataset was 44, 44, 47, 43, and 49 for Norvasc, Cardizem CD, Plendil ER, Procardia XL and Adalat CC and Calan SR, respectively, resulting in an average quantity-per-prescription for the entire dataset of 44. Table 4 depicts the weighted average cost-per-prescription
for
new product (T-Block) assuming different utilization ratios of two strengths (50 mg and 100 mg). These weighted
a
portion of total expenditures for the entire data set. As the mix of products, strengths, and their relative market shares change from one facility to another, so does the weighted average
cost-per-prescription and the estimate of savings or cost increases resulting from the inclusion of a new product. Therefore, the model's weighted average concept applied to historical utilization data from a specific facility enables prepa-
average costs are $58.37, $62.34, and $66.30 for utilization ratios of 90%: 10%, 80%:20% and 70%:30%, respectively. The
corresponding estimates of savings by adopting the new product at these three assumed utilization ratios were -$1,395,454, -$913,300, and -$432,360, respectively (see Table 5).4 (By convention, negative numbers represent cost savings and positive
ration of an exclusive cost-impact analysis. These attributes fortify the model's analytic sensitivity to variations in the mix
of products from one facility to another, as well as to variations in geographic locations throughout the country. In our example, the weighted average-cost-per-prescription
for the entire calcium antagonist data set was $69.86 before the adoption of T-Block. The average quantity of product-perprescription was 44. Assuming a blended price of the 50 mg
numbers indicate cost increases.)
Table 4. Estimates of the Average Cost-Per-Prescription for T-Block at Different Utilization Ratios of 50 mg and 100 mg
Strengths
Utilization Ratio of T-Block Strengths (50 mg and 100 mg) 90%:10%
Weighted Average Cost-Per-Prescription
$58.37
and 100 mg tablets, the weighted average cost-per- T-Block prescription was estimated to be $58.37, $62.34, or $66.30, respectively, based on varying the utilization ratio of 50 mg and 100 mg strengths. Therefore, the model predicts that inclusion of T-Block will reduce the yearly cost of purchasing calcium antagonists. The reduction in costs arises from three potential sources: 1) partial displacement of one or more costly
80%:20%
70%:30%
$62.34
$66.30
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S89
Table 5. Cost Impact of T-Block Following Formulary Acceptance at Different Utilization Ratios of 50 mg and 100 mg Strengths*
Savings (-) or Cost Increases (+)
Accordingly, cost impact estimates vary in such scenarios and the scope of results will vary from customer to customertherefore symbolizing the essence of a customized financial
report.
Utilization Ratio of I-Block Strengths (50 mg and 100 mg)
Per Year by Adding New

Product on Formulary
CONCLUSION
Methods and models must be developed to predict the financial impact of new products on restricted formularies, even without extensive cost-effectiveness data. We present a robust, objective, and practical financial model that can be
applied not only to calcium antagonists but also to any crowded therapeutic area requiring frequent formulary decisions resulting from the market entry of new compounds. In the development of this predictive cost-impact model, we have
90%:10%
80%:20% 70%:30%
*
-$1,395,454
-$913,300
-$432,360
Assuming 5% market share by end
offirst year and no change in total
number of prescriptions for calcium antagonists
products or formulations predominant in the data set; 2) partial displacement of existing price-equivalent products now
being utilized at the high end of their recommended daily dose range; and 3) partial displacement of existing and lessexpensive products now utilized at multiples higher than their
shown that simple and easily obtained drug utilization data (number of prescriptions, number of units, and average wholesale price) can be analyzed to determine the cost impact
a
recommended daily doses. The results also demonstrate that the magnitude of T-Block savings will decrease (from -$1,395,454 to -$432,360) as the assumed reliance on the 100 mg dosage formulation increases from 10% to 30% with time.
Although sales figures and market shares have been expressed in terms of Average Wholesale Prices (which are public knowledge), other price parameters (e.g., Wholesale Average Cost, Net Sales after rebates/discounts) can be used in the model. It is obvious that the more closely the price para-
priori of the introduction of

Trademarks
new compound on formulary.
...
1. Adalat
and Adalat CC are registered trademarks of Bayer Aktiengesellschafl. Calan SR are registered trademarks of G.D. Searle &: Co. Calan and 2. SR are registered trademarks of Syntex (U.S.A.) Ine 3. Cardene and Cardene registered trademarks of 4. Cardizem, Cardizem SR, and Cardizem CD are Carderm Capital L.P
5. Dilacor XR is
a
registered trademark of Rhone-Poulenc Rorer
Pharmaceuticals
Ine
meter reflects actual transactional prices, the more accurately the model will estimate the new product's cost impact. As one extrapolates into the future with any given model,
less and less
6. Dynacirc is a registered trademark of Sandoz pharmaceuticals Corporation. 7 Isoptin and Isoptin SR are registered trademarks of Knoll Aktiengesellschafl.
certainty can be attached to the accuracy of costimpact projections determined by that model. For this reason, our financial model automatically annualized savings based on a single quarter. In doing so, it assumed there was no seasonality in the pattern of consumption of calcium antagonists. This assumption is reasonable as there is no evidence of sea-
Aktiengesellschafl. 8. Nimotop is a registered trademark of Bayer 9. Norvasc is a registered trademark of Pfizer Ine 10. Plendil and plendil ER are registered trademarks of Astra Aktiebolag. 11. Pro cardia and Procardia XL are registered trademarks of Pfizer Inc. 12. Vascor is a registered trademark of Johnson &: Johnson.
13. Verelan is
a
registered trademark of the Elan Corporation.
...
References
sonal utilization of this therapeutic class, and annualizing the cost impact is consistent with managed care decision makers'
desire to confine projections to one fiscal period. Where seasonality is a well-documented feature, as in oral and parenteral antibiotics in the treatment of community-acquired pneumonia, necessary adjustments need be introduced in the annualization of cost impact reflecting one quarter only.
1. Mehl B, SantellJP Projecting future drug expenditures-1997. AmJ Health-Syst Pharm 1997; 54: 153-61.
formulary 2. Bowman GK, Moleski R, Mangi Rj. Measuring the impact of a decision: Conversion to one quinolone agent Formulary 1996; 31: 906-14. 3. Gustin G, White WB, Taylor S, Daragjati, C. Clinical outcome of a mandatory formulary switch for dihydropyridine calcium channel blocker therapy at a veteran's administration medical center. Am J Hypertension 1996; 9: 312-16. 4. Summers KH, Szeinbach SL. Formularies: The role of pharmacy-and-therapeutics (P&:T) committees. Clinical Therapeutics 1993; 15: 433-41.
Other than periodic price adjustments, there are three obvious sources of variability in the model. These are the utilization ratio of differentially priced strengths or formulations of a
new product, year-end market shares attained by that new product, and total volume of prescriptions written for the therapeutic class. Uncertainty in terms of validity of the cost impact estimates arising frbm changes in magnitude of these three key variables is examined through the technique of simple sensitivity analysis. Within the limits of the model, the three-way sensitivity grid is really a summary statement showing typical
financial scenarios that introducing
a
new product may pose.
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Vol. 4,
No.6
Information Requirements of Health Systems as Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards?
Paul C. Langley
ABSTRACT: The objective of this article is to consider the information needs of drug purchasers; whether the Food and Drug Administration (FDA) should have
information. The author concludes that the FDA should not attempt to micro-
manage information flow in promotion and marketing campaigns, but should

consider the Federal Trade Commission approach to deceptive advertising with
regulating information on the characteristics and cost-outcomes impact of new pharmaceutical products to health care purchasers; and the requirements in the new FDA Modernization Act of 1997 for "competent and reliable scientific
a role in
possible inputs in gray areas from an expert panel.

KEYWORDS: FDA, Regulation, Economic information, Pharmacoeconomics
evidence.
"
Market-mediated advertising claims are compared to regulated market

claims and the role of the market in potentially limiting the flow of deceptive
The
purpose of this paper is to consider whether the Food and Drug Administration (FDA) plays a legitimate and useful role in regulating the promotional and
marketing activities of pharmaceutical manufacturers by establishing evidentiary standards for pharmacoeconomic evaluations that focus on managed care and other health systems as drug purchasers. In late 1997, the U.S. Congress passed the FDA Modernization Act of 1997, which has given this issue new importance. Section 114 of this act (entitled Health Care Economic Infor-
mation) amends the previous 1992 legislation by adding to Section 502(a) (21 USe. 352(a)) the statement, "Health care economic information provided to a formulary committee, or
other similar entity, in the course of the committee carrying out its responsibilities for the selection of drugs.. .shall not be considered to be false or misleading. .if the information
.
directly relates to an indication approved.. .and is based on competent and reliable scientific evidence." Two issues are involved here: 1) should the FDA be involved in the regulation of health care economic information (as defined by the legislationl); and 2) if we believe the FDA should be involved, what should its responsibilities be? Some
would argue that the FDA does have
a role, but only to the extent that it operates, as does the Federal Trade Commission (FTC), to "defer deceptive claims that harm consumers (the
users of such information) but not to interfere unnecessarily with the dissemination of truthful, nondeceptive informa.
AUTHOR
PAUL C. LANGLEY, PH.D.. is Professor, Department of Pharmacy Practice, School ofPharmacy, University of Colorado Health Sciences Center, Denver, CO.
role would require the FDA to eschew attempts to micromanage pharmacoeconomic studies by attempting to control the flow of information and by setting standards for
tion.'" Such
a
Copyright@ 1998 Academy of Managed Care Pharmacy, Inc. All rights reserved.
marketing and promotion that may do more harm than good. The FDAS role must recognize the power of the marketplace to police the activities of pharmaceutical manufacturers.
Vol. 4,
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Information Requirements of Health Systems as Drug Purchasers: Does the FDA Have
Role in Setting Evidentiary Standards?
The reasoning underlying this position holds that the market for pharmaceutical products is highly competitive. As a result,
strong presumption that we can rely on market forces to ensure that the types of studies that pharmaceutical manufacturers undertake, and the claims they make for particular there is
a
A to drug B; in many cases, the analysis is based directly on clinical trial resul~s. This focus is most clearly expressed in the revised November 1995 Australian Guidelines, in which all
submissions are required to provide evaluation based on trial results.6
preliminary economic
products, will meet the professional standards found in the eco-
nomic evaluation literature and, in consequence, are unlikely to be deceptive. Whereas advertising can be deceptive, legal requirements imposed on advertising have the potential to discourage truthful claims about the economic aspects of pharmaceutical products. However, as is pointed out below, a highly competitive environment for drug manufacturers in specific disease or therapy areas is likely to be equally, if not more, effective. Advertising has the potential to encourage competition, to
facilitate the acceptance of new products, and to ensure that
The FDA also embraces this traditional perspective. Consider the statement that "effectiveness elements of costeffectiveness claims must be based on adequate and well controlled studies.'" Although this might be interpreted as an FDA
endorsement of naturalistic randomized-controlled trials (in using the term "effectiveness" rather than "efficacious"), in pro-
consumers of health care make effective choices. Relying on
market forces to drive evidentiary standards is more likely to ensure that such studies meet the information needs of drug
purchasers. As far as the FDA is concerned, one principal concern lies in defining the informational needs of drug purchasers. Should
the FDA take these into account?
motion and marketing terms it means that the pharmaceutical manufacturers should base any claims for cost -effectiveness on the traditional randomized-controlled trial or on models that extrapolate from those trials. The status of attempts to model drug impacts with data drawn from a variety of data sources, or to use retrospective analyses as the basis for promotional
and marketing claims, is unknown. Indeed, it is important to point out that in FDA legislation and regulation the terms efficacy and effectiveness are used interchangeably.
What information does the
FDA consider appropriate for formulary decisions? Until the FDA articulates its position, it is difficult to see how we can square the emphasis the FDA places on experimentally based
evidence with the perceived information needs of managed care systems and other drug purchasers. However, to be fair, few, if
any, of those working in the area of health care evaluations
The essence of the systems approach is to recognize that any evaluation of the potential or projected impact of a new therapy must take into account the treating environment, the impact of introducing that therapy on the distribution of
patients among therapy options, and the consequences of these factors on the costs of delivering therapy to that treating
seem to have considered these information needs and how
manufacturers might address them in their choice of study design and analytical perspective. This is all the more surprising when we consider the attention that pharmacoeconomics literature gives to the role of guidelines in formulary submissions' and to the promotion of reference standards.4 Although manda-
population and on their outcomes profile. The systems approach, which takes explicit account of the information needs of drug purchasers, is the perspective found in guidelines documents published by managed care in the United StatesB,9 These guidelines, which follow closely a template pro-
posed by Langley and Sullivan, ask pharmaceutical manufacturers to report on: I) the safety, efficacy, and effectiveness of their product relative to existing medications; and 2) a pharmacoeconomic evaluation, involving outcomes modeling, which includes an assessment of the impact of the new product on the outcomes profile of the treating population, across all options in a disease or therapy area, and on the direct costs of treatment within that therapy area.10
.
tory submission guidelines are found in only a few countries with national health care systems, such as Australia, Canada, and Switzerland, in the United States, managed care has taken
the initiative in developing submission guidelines.5Unfortunately, at this time, few seem to be aware of the existence of these guidelines and the perspective they give on the informa-
In the Regence Washington Health guidelines, manufacturers are asked to consider two scenarios: first, an evaluation of the current costs of providing treatment in that therapy area;
tion needs of managed care in formulary decision making.
TRADITIONAL VERSUS SYSTEMS PERSPECTIVES IN ECONOMIC EVALUATIONS

One of the more puzzling and unfortunate features of pharmacoeconomic analysis is the extent to which many, if not most, of those working in the area are wedded to what may be described as the traditional evaluation paradigm. The hallmark of the traditional paradigm is the assumption that the information needs of health care purchasers can be met by the estimation of cost-outcomes ratios. These ratios typically are grounded in a simple decision-model framework that compares drug
and, second, an estimate of the impact of introducing the new product once "a new equilibrium of resource utilization and outcomes has been established." The guidelines note that the
latter scenario requires estimates of patterns and rates of drug substitution and the redistribution of patients between treatment pathways. The characteristics of the treating population
are taken into account. The impact of introducing a new drug into a treatment area also can take account of budget con-
straints, as well as of health care intervention programs that may be in place or may be suggested to optimize the effectiveness of the particular drug or therapy.
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Of course, when a health system has guidelines in place, the issue is not one of promotion and marketing, because the
pharmaceutical manufacturer is responding to a request for information to support a formulary decision. However, our concern lies with the status of promotion and marketing activities by pharmaceutical manufacturers that may attempt to use
systems-based evaluation modeling framework to explore the impact of introducing a new product for a representative
a
on income and employment outcomes. There seems no reason why these techniques could not be applied to issues of retrospective drug impact assessment, forming the basis for marketing and promotion activities.
managed care purchaser, or to report on modeling exercises undertaken for specific purchasers or health systems.
Clearly, the systems perspective and its information requirements represent a major shift in analytical focus, one that is far removed from the traditional, clinically based evaluation paradigm. Not only are the information needs of the systems approach more demanding, but also the need to model
The systems perspective also may be contrasted to what may be described as the component approach to cost containment. Under this approach, the accounting and reporting framework within health systems is compartmentalized, with budgetary targets set for often arbitrarily defined cost centers.
These cost centers may cut across disease or therapy area boundaries and bear no resemblance to any meaningful activity-accounting framework that encompasses both pharmacy
systems
and medical costs in disease or treatment areas. In many health a major cost center is the formulary, where targets and
therapy or disease area creates a major challenge for pharmaceutical manufacturers and for those evaluating a systems-based model or an actual formulary submission. One way of differentiating the tradithe net cost and outcomes impact within
a
criteria for drug selection reflect only drug costs. The possible adverse impact of drug restrictions on nondrug health care costs
and the possibility that overall health care delivery costs may increase following restrictions on drug purchases are not taken
tional and systems perspectives in an advertising context is to see the traditional approach as supporting efficacy claims and
the systems approach as focused on effectiveness claims-that is, claims based on the anticipated impact of a product in a
into account. There appears to be ample evidence to support this latter proposition--evidence that is either ignored or not
seen as relevant by financial managers.ll
real-world treating environment. We can conceive of traditional approaches that extrapolate from clinical trials and attempt
Indeed, the so-called restricted versus open formulary debate may be seen as a variant of the component management argument. In its most widely publicized version, this debate
focuses on an observed negative statistical association between
modeling framework, modifications of clinical endpoints and cost estimates to reflect actual treating
to include,
a
within
the openness of
formulary and the utilization of ambulatory
care visits, hospital admissions, and prescription drugs.l2
environments (e.g., compliance and discontinuation behavior). However, the challenge facing health care evaluations is to translate clinical findings into claims that reflect the characteristics of the treating population, their behavior, and the organizational framework within which health care is delivered. If, for example, the manufacturer believes that compliance behavior and the nature of contracts between health systems and health care providers will significantly modify trial-based claims
for clinical efficacy, then these points should be made explicit to potential drug purchasers. It seems pointless and deceiving
Although the link between the openness of a formulary and the costs of health care delivery is never fully articulated (the argument being essentially observational), a number of commentators have interpreted these findings as supporting the case
for an open formulary in which there is (apparently) no need for a prior pharmacoeconomic evaluation of drug therapies, because all products are immediately admitted. Such a posi-
tion has an obvious appeal to pharmaceutical manufacturers, although it overlooks the role of formularies in health systems and their potential contribution to the delivery of health care.
Needless to say, this is a highly dubious argument and one many commentators believe is built on a flimsy methodological and empirical base.13 One key issue is how we define and
under the carpet by setting regulatory standards that exclude attempts to evaluate the impact of these factors simply because the regulatory agency considers
to sweep these issues
that such evaluations fail to meet standards for scientific rigor. This emphasis on a systems perspective does not mean that
claims for particular products might not be based on other analytical frameworks. There are, for example, a number of
nonexperimental approaches to drug impact assessment that might form the basis for marketing and promotion claims. Retrospective studies using claims databases might be commissioned to evaluate cost savings associated with drug interchanges or the impact of particular patterns of compliance behavior on claims for cost-effectiveness. Indeed, considerable resources have been allocated by economists to resolving (or
interpret, in quantitative terms, an index of the degree of openness of a formulary After all, the absence of particular drug products from a formulary may be due to either an a priori exclusion based on acquisition cost considerations or to an ex post facto exclusion decision following a systematic clinical and economic evaluation of therapy options. A more serious concern lies in the potential for regulatory
authorities arbitrarily to restrict the flow of information to health care decision makers, or (possibly inadvertently) to countenance evidentiary standards that conflict with the information needs of those purchasers. Both these scenarios could
have an adverse impact on the cost effectiveness of health care delivery. It does not automatically follow that health care
understanding) the technical issues associated with generating unbiased estimates of the impact of social programs
at least
Vol. 4.
NO.6
jMCP
595
systems simply will subscribe to component-cost management in drug evaluations and formulary listing in the absence of this
information; however, it could mean that the type of information that manufacturers are allowed to provide is inappropriate for that treating environment. Regulation must not stand in the way of meeting the information requirements of purchasers; the market must be allowed to respond to those needs.
groups, apply with equal force to attempts to evaluate the impact of new and existing drug therapies on treating populations.l? Clinical trials ignore the context within which programs
or therapies are to be delivered, the divergent characteristics of treating populations, and the distribution of outcomes and strategies open for patient management; they must be seen only
a first step in therapy evaluation. Nonexperimental retrospective drug evaluation designs, which might utilize claims databases, present major challenges but may be equally impor-
as
CLINICAL TRIALS AND EVIDENTIARY REQUIREMENTS

For those coming from a clinical background, the randomized-controlled trial is typically seen as the evidentiary gold standard in claims for drug efficacy and safety. Pharmacoeconomic evaluations, which usually involve piggy-backing
resource utilization and outcomes measures onto an established
tant in the promotional and marketing activities undertaken
by pharmaceutical manufacturers. In short, from the perspective of a managed care group, the evidence provided by clinical trials may be (and typically is) of
limited utility. Unless trial results can be translated to a particular treatment setting or at least factored into an impact assessment model, claims for the superiority of one drug over another based on a particular trial protocol are likely to be ignored. Such
claims accepted at their face value may mislead an uncritical formulary committee as to their impact in a disease or therapy area.
clinical protocol, are judged on this standard. External validity, which in this context meets the information needs of drug purchasers, takes a back seat. This is not to deny that a num-
ber of commentators have argued for naturalistic trials as a basis for greater external validity and as a counterweight to
14 modeling, which many continue to view with suspicion. However, as these approaches still accept the traditional evaluative framework, they go only a small part of the way toward 15 meeting the information needs of drug purchasers. Clinical trials are coming under increasing scrutiny. Although
SUBSTANTIATION AND VERIFICATION

The question of translating clinical results into practice settings raises further issues of substantiation and verification. The term "substantiation" can be considered from two perspectives: 1) as a legal or regulatory requirement; and 2) as a
procedure for evaluating experimentally and nonexperimentally based claims. The new act takes a legal or regulatory perspective on substantiation. In evaluating health care information,
they typically are defended for their ability to "eliminate the potential for selection bias to affect mean-impact estimates," Heckman and Smith conclude that "the existing literature overstates many of the other arguments in their favor."'6 The authors identify five principal criticisms of social experiments: the failure to provide answers to many questions of interest to policy
makers; the failure to provide useful information on the distributional impact of programs; the presence of randomization bias; the presence of institutional limitations on social experiments; and the presence of substitution bias. Although not all
the FDA will accept information provided as part of a promotional or marketing activity if it is based on competent and reliable scientific evidence. The FTC, in invited comments, has been at pains to discourage the FDA from putting advertised
regulatory straitjacket. It argues, first and foremost, that the types of economic claims that are likely to be made cover a wide range. They would include claims based on both
claims into
a
of these criticisms apply with equal strength to clinical trials, the authors argue that "there is a sizable divergence between the theoretical capabilities of experiments based on random assignment and the practical results of such evaluations." More important-and this is a key point to note-Heckman and Snth argue that many who advocate the experimental approach to program evaluation "ignore promising developments in the theory and practice of nonexperimental evaluations." The authors also consider the contribution of "self-contained black-box experimental evaluations" to the general body of social science knowledge. They maintain that such evaluations "pose a serious threat to the accumulation of knowledge
about the behavior of persons and institutions." Indeed, because "they are not conducted within a behaviorally coherent frame-
experimental and nonexperimental study designs, as well as those based on the modeling of disease interventions for target populations. It should be emphasized that substantiation also
is possible
when a drug manufacturer takes a system perspec-. tive to predict the impact of a particular new product on the costs and outcomes within a representative' treating environ-
ment, or on an environment modeled to allow such cost and impact predictions for alternative treating scenarios. If a pharmaceutical manufacturer can substantiate the choice of assumptions, including key parameter values, then there seems to be no reason why claims cannot be based on such an approach. Cost-effectiveness claims that pharmaceutical manufacturers make for their products should be verifiable-that is, manufacturers should couch their claims so that predictions about the impact of the drug in a given treating environment can be empirically assessed. In the United States it is clearly possible,
work of analysis, the evidence from experiments does not accumulate." These are important criticisms which, although levied in an evaluation of training programs for disadvantaged
given the availability of pharmacy and medical claims data, to
596 Journal of Managed Care. Pharmacy
jMCP
Vol. 4,
No.6
evaluate claims about the rate of market penetration of a drug, patient switching patterns, and the cost implications of introducing a new product. Unfortunately, traditional trial-based
false claim.. .benefts of
truthful claim" and the degree of sub-
stantiation that experts in the field might consider reasonable. In the case of pharmacoeconomic evaluations and claims
economic evaluations or evaluations based on extrapolations from clinical trials, with their focus on cost-outcomes ratios as
decision variables, cannot generate testable predictions. If a pharmaceutical manufacturer bases promotion and marketing activities on such models, there is no way to substantiate the
made for pharmaceutical products, there is not only a wide range of claims that can be made (which may be based on a "selective" use of the scientific evidence), but the claims made
can vary in terms of data sources, study design (where clinical trials are one option), analysis techniques target audience, and organizational or institutional context of the analysis. Any
veracity of these claims. This is not a question of misleading or incomplete information, but reflects the fact that traditional
pharmacoeconomic evaluation has its roots in experimental, randomized-controlled trials rather than in the nonexperimental design of mainstream economics, and attempts to model and predict the impact of new drug therapies in given treating
environments. Systems models, however, have the potential to generate testable predictions. Because these models focus on the impact of introducing a new product on the costs and outcomes for a defined population in a given treatment environment, predictions about the magnitude of this impact can be made and such
attempt to set standards for deceptive advertising not only must take this diversity into account (e.g., evaluative ability of the target audience), but also must ensure that substantiation rules do not stifle the flow of useful information. Claims based on
randomized clinical trials may be judged deceptive if such factors as biases inherent in clinical trials, compliance behavior, and misdiagnoses by physicians are not taken into account. The fact that information is incomplete does not mean that the claim made is necessarily deceptive, although a deliberate
attempt to suppress critical information would be construed as such. As Ippolito points out, three features of the marketplace are important in considering inco~plete information: compeIS tition, background information, and consumers. In competitive markets, a marketing claim that emphasizes one aspect of a product is likely to be countered by competitors if it is successful in switching sales. Also, purchasers of a product do not
claims verified by monitoripg medical and pharmacy claims (where the latter, it is hoped, would include clinical markers).
PROMOTION, MARKETING, AND INDICATION

The FDA will draw the line at allowing pharmaceutical manufacturers to make claims for the off-label use of a product. This places the prospective purchaser of a drug in a difficult situation. Although there are, quite clearly, concerns about
claims for off-label use-situations in which a drug has not met FDA requirements for safety and efficacy-there is equally clear evidence that many drugs have substantial potential for
off-label uses. Prospective purchasers need to know about these patterns of off-label use, which have direct implications for budget impacts and patient outcomes. Purchasers also need
rely simply on advertised claims. There is a range of other data sources that can be drawn on in making a purchasing decision.
Finally, consumers (which would include both prospective patients and medical practitioners) are well aware that adver-
tising is likely to emphasize the positive features of a product and thus will make appropriate allowances. Indeed, in the case of medical practitioners, we have an expert purchasing group
well qualified to make a clinical evaluation, but possibly less well placed to make a pharmacoeconomic one. However, we
know what prospective applications the manufacturer will make for expanding indications for a drug. T~ere seems to be
to
should not overlook pharmacy and therapeutics committees, which, as agents for health systems and medical practitioners, also have a key role in evaluating claims for particular products.
no reason why drug manufacturers could not disseminate such information as part of their marketing activities. But because manufacturers are unlikely to do this, it is up to the drug
In short, the competitive nature of the health care market

is probably the single most important reason for believing
purchaser, as part of formulary submission guidelines, to request such information and factor it into purchasing decisions.
that, even without FDA or FTC regulation, the amount of deceptive advertising is likely to be minimal. Companies that believe their competitors are guilty of deception are likely to
DECEPTION, INCOMPLETE INFORMATION, AND MARKET COMPETITION

For the FTC, a claim for a product is considered to be deceptive "if it contains a material representation or omission of fact that is likely to mislead consumers acting reasonably
under the circumstances." This is typically considered from the perspective of the audience. Whether or not a particular claim
considered deceptive involves consideration of a number of factors "relevant to the benefits and costs of substantiating a particular claim... [including] type of claim.. consequences of a
is
.
respond rapidly, whereas companies that feel they are losing market share because they are not meeting the information
needs of purchasers will adjust their promotion and marketing activities. Although whistle-blowing is, presumably, not to be
FDA or
encouraged, it is clear that complaints would be made to the a nominated adjudicator if it were felt that competitors were engaged in deceptive practices.
CONCLUSIONS
We face an interesting dilemma in any attempt to regulate the form and content of pharmacoeconomic evaluations. If the
Vol. 4, NO.6
jMCP
597
FDA enshrines traditional trial-based pharmacoeconomic evalonly form of evaluation capable of meeting the criteria of competent and reliable scientific evidence within a given indication, the information needs of drug purchasers are unlikely to be met. uation
as the
If the FDA takes the view that the phrase "competent and reliable scientific evidence" must be interpreted as evidence based on randomized-controlled experiments, then we are back to square one. If the FDA takes a more eclectic position and refers to accepted standards of professional practice within
the appropriate discipline, in this case health care economics, then we can look forward to entering a more information-rich environment-and one that will present some interesting challenges not only to pharmaceutical manufacturers but also to
As has been argued, the use of the word "scientific" would appear at face value to be redundant. If competent and reliable evidence would reasonably be judged acceptable by an independent observer in the appropriate field, then there is no need to debate the scientific nature of that evidence. Although the
multidisciplinary nature of health care evaluations will admit to some disputation regarding the standards accepted by those from different disciplines, there seems to be sufficient consensus. The FDA has argued that all "effectiveness elements of costeffectiveness claims must be based on adequate and well-controlled studies." This is not a position to which the majority of health economists would subscribe. Unless we resolve this issue and admit a wider range of studies-studies that take explicit account of the information needs of health care pura bleak future in the provision of useful and truthful information to health care purchasers. It is difficult to see how a regulatory body can set standards that differ-
health economists and health care purchasers. Unless a more eclectic regulatory position is taken, it is most unlikely that the discipline of pharmacoeconomics will become anything more
than an exercise in generating clinical trial-based cost-outcomes ratios.
...
References
1. U.S. FDA Modernization Act 1997, Section 114. 2. Public hearings before the Department of Health and Human Services, Food and Drug Administration. Washington, DC: Federal Trade Commission,
chasers-then we face
Bureaus of Consumer Protection and Economics; January 16, 1996, Docket
entiate between traditional and systems perspectives, study designs, techniques, and analyses used to support promotional
No. 95N-0228: 5. 3. Langley Pc. Pharmacoeconomics: achieving gold standards. London: Financial Times Health Care Publications, 1997.
4. Gold MR, et al. Cost-effectiveness in health and medicine. New York:
Oxford University Press, 1997.

5. Langley PC, Martin RE. Managed care guidelines for the economic evaluation of pharmaceuticals. Am] Managed Care 1997; 3: 733-41. 6. Langley Pc. The November 1995 revised Australian guidelines for the economic evaluation of pharmaceuticals. PharmacoEconomics 1996; 9: 341-52.
and marketing activities, and those that would be disallowed. Of course, the FDA might attempt to enlist the contribution of
health economists and convene an expert committee of leading health economists to advise on a set of standards. There is a precedent for this in the expert committee convened by the
National Oceanic and Atmospheric Administration to report 19 on willingness-to-pay techniques. However, given the nature analyses and range of economic that can be applied to pharmaceutical evaluations (where willingness-to-pay evaluations are only one type), it seems doubtful that a set of standards
can support such
a
7.60 Federal Register 41,892; August 14, 1995. 8. Langley PC, Martin RE. Guidelines for formulary submissions. Rancho Cordova, CA: Foundation Health and Integrated Pharmaceutical Services,
October 1996. 9. Regence Washington Health Pharmacy Services. Guidelines for the submission of clinical and economic data supporting formulary consideration. Seattle: Regence Washington Health, 1997. 10. Langley PC, Sullivan SD. Pharmacoeconomic evaluations: guidelines for drug purchasers.] Managed Care Pharm, 1996; 2(6): 671-77. 11. Soumerai SB, et al. Effects of limiting Medicaid drug-reimbursement benefits on the use of psychotropic agents and acute mental health services by patients with schizophrenia. New England] Medicine 1994; 49: 2207-10.
12. Horn SD, et al. Intended and unintended consequences of HMO cost-containment strategies: results from the managed care outcomes project. Am] Managed Care 1996; 2(3): 253-64.
differentiation-not to mention the legal
interpretations that may be placed upon them. The only practical options open to the FDA, if it wishes to introduce such standards, are either to insist on a narrowly defined set of standards (e.g., evaluations must be experimentally based and report only on the outcomes of randomized pharmacoeconomic trials) or to establish a pharmacoeconomic review committee
that makes recommendations on proposed and completed economic evaluations that manufacturers and others may wish to
use as part of a promotion and marketing strategy. To an economist, this is clearly a second-best solution.
13. Vaczek D. Formularies:
debate flares. Pharmacy Times 19960uly): 53-
54.
14. Drummond MF, Spilker B, ed. The future of pharmacoeconomics in quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-
If
our ultimate objective is to ensure that pharmaceutical manufacturers are not discouraged from producing pharmacoeco-
Raven, 1996. 15. Langley Pc. The future of pharmacoeconomics: Therapeutics 1997; 19(1): 762-69.
comment. Clinical
nomic studies that meet the needs of drug purchasers in varied treating environments, then the FTC approach might appear the most appropriate. It still could involve an expert committee to review studies that are considered to be deceptive, but it would not be involved in policing initial proposals for pharmacoeconomic studies or reviewing those undertaken for promotion and marketing by pharmaceutical manufacturers.
16. Heckman ]], Smith]A. Assessing the case for social experiments. ] Economic Perspectives 1995; 9(2): 85-110. 17. Friedlander D, et al. Evaluating government training programs for the economically disadvantaged.] Economic Literature 1997; 35(4): 1809-55. 18. Ippolito P. Issues in regulating economic claims in health-care markets.
Conference Paper, Policy Issues in Pharmaceutical Cost-Effectiveness Research, American Enterprise Institute, Washington, DC; Nov 1996. 19. Portney PR. The contingent valuation debate: why economists should care. ] Economic Perspectives 1994; 8(4): 3-18.
598
jMCP
Vol. 4,
No.6
Treatment of Patients with ALS: Implications for the Managed Care Pharmacist
Anthony Barisano and]effrey A. Kramer
ABSTRACT: The objective of this study was to present a in the manperspective for the management of patients aged care environment with amyotrophic lateral sclerosis
like that of patients with cancer, would enhance their quality of life and life expectancy.Treatment should be ini-
tiated early in the course of ALS, perhaps even before the
(ALS)parallel to that
for patients with neoplasms, high-
diagnosis is definitive. Prolonging survival during the
lightingthe potentialcontributions of the pharmacist.

This article presents
a
brief overview of ALS and illus-
early stages of the disease allows the patient to remain independent and productive, establishing riluzole as a
cost -effective therapy for ALS. Pharmacists can positive-
trates a therapeutic parallel to the management of
patients with cancer. Physiciansoften are reluctant to prescribe riluzole because it is not a cure for ALS. Oncologists, however, commonly initiate antineoplastic regimens with limited efficacy in their patients because
such action allows the patient hope for alleviation of
ly impact the pharmacologicmanagement of ALS. Early

access to a multidisciplinary team to confirm the diagno-
sis, initiate treatment, and manage the symptoms of ALS

can reduce both complications and costs.
KEY WORDS: Amyotrophic lateral

ment, Riluzole
symptoms and an extended life expectancy. A similar approach to treating patients with ALS presents professional opportunities for the managed care pharmacist.
sclerosis
(ALS),
Oncology,Managed care pharmacist, Disease manage-
Such management of patients with ALS, if approached
Amyotrophic
lateral sclerosis (AlS) is a progressive neurode generative disease characterized by muscle weakness, wasting, spasticity, and weight loss that results in
I death in 50% of patients within three years. The estimated incidence for AlS ranges from 0.4-1.8 per 100,000 people per year worldwide,2 and the prevalence ranges from 4-6 per
100,0003 AlS is more common in men than in women until when the rate becomes the same for both sexes. Average age of onset is in the mid-50s, but AlS can occur at
age 70,
any time after the teen years.' ALS occurs in two forms: classic, which comprises more than 90% of AlS cases, and familial, which comprises 5%- 10% of
~.
cases' Patients initially present with symptoms in an arm (40%60%), such as weakness or difficulty performing delicate tasks,
or in a leg (20%), such as tripping or foot dragging.s Approximately 20%-25% of AlS patients present with bulbar symptoms, such as dysarthria, dysphagia, and sialorrhea6 The initial stimulus for the development of AlS and the duration of the preclinical stage are not known. Electrophysi
AUTHORS
ological studies have shown the presence of denervation and reinnervation at the time of first clinical presentation, which
suggests an ongoing occult process.
ANTHONY BARISANO, PHARMD., is Director of Pharmacy, Vytra Healthcare, Melville, NY; JEFFREY A KRAMER, PHARMD., is Medical Director, Applied
Clinical Communications, Inc., Parsippany, N].
long before overt clinical
deficits are apparent, some patients experience subtle clinical
AUTHOR CORRESPONDENCE: Anthony Barisano, Pharm.D., Vytra Healthcare, Corporate Center, 395 North Service Road, Melville, NY 11747.
Copyright@1998 Academy of Managed Care Pharmacy, Inc. All rights reserved.
features, including cramps, fasciculation, and exercise intolerance. Some patients with bulbar disease report intermittent hoarseness or other speech impediments. In many cases, however, patients report excellent motor function until the time of their first clinical deficit. 7
VoL
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No.6
}MlP
Journal of Managed Care
Pharma~y 599
PATHOGENESIS OF ALS
There are currently four major hypotheses on the pathogenesis of ALS: glutamate-induced excitotoxicity, autoimmunity, deficiency
for monitoring purposes. A Kaplan-Meier curve, commonly used to depict the survival benefit of antineoplastic drug regi-
mens, illustrates the survival benefit of riluzole compared with placebo (see Figure 1).22 This type of analysis is useful because
data from all study patients are included regardless of survival outcome; results are not skewed by the omission of data for
induced by free radicals" Glutamate
of neuronal growth factors, and oxidative stress is the principal excitatory
neurotransmitter in the brain, and the accumulation of glutamate in a synapse is an important factor in the development of neuronal damage in ALS9.IO The autoimmune theory is based
on the identification of antibodies to calcium channels in a large percentage of patients with ALS, as well as to the neuronal ganglioside GMI in others".11.12 An insufficiency of neurotrophic growth factors, including ciliary (CNTF), brainderived (BDNF), and insulin-like (IGF-I) neurotrophic growth factors, also has been implicated in motor neuron degeneration.".13 Recent studies have shown mutations in the gene for superoxide dismutase in some cases of familial ALS,14 and
specific patients. Despite the shortcomings of existing drug therapies for some cancers, disease specialists commonly prescribe these
regimens for their patients because treatment provides the patient with hope, not for a cure but for a longer life and relief from symptoms of the disease. Many oncologists realize that initiating a treatment plan inspires hope by giving the patient a
sense of control over the diseaseH A similar benefit is gained when using riluzole in ALS. For example, palliative care is used to treat multiple myeloma. Like ALS, this form of cancer is relatively rare and usually
there also is growing evidence that oxidative stress is important in the initiation of sporadic ALS. 15
Each of these hypotheses is the basis for active research on new therapies to better manage, and ultimately control, the 16 symptoms of ALS. For example, riluzole, the only FDAapproved medication for ALS, is an antiglutamate agent that
17 protects against glutamate excitotoxicity Gabapentin, another anti glutamate agent available for use as an anticonvulsant, has
18 been tested with disappointing results in ALS. Several neurotrophic factors, including IGF-l (mecasermin), have been
results in patient mortality" Treatment for multiple myeloma, in the form of antineoplastic chemotherapy and radiation, is not initiated to achieve a cure but to improve the patient's quality of life by controlling bone pain, fractures, hypercal-
cemia, and renal failure." Significantly, survival can be prolonged by two years in treated patients as compared to
untreated patients." Until riluzole was shown to significantly increase survival
studied as therapies for ALS, alone and in combination with

each other and with riluzolel9 Unfortunately, neurotrophic
Figure 1. Kaplan-Meier Survival Curves for Riluzole Compared with Placebo in Patients with ALS (n=478)22
growth factor trials have not conclusively proven that any member of this class of agents is beneficial when used alone8.2o controlled, randomized clinical trial, riluzole slowed the progression of ALS and improved the survival of patients.21 The survival benefit was confirmed in a second dose-ranging
a
1.0
In
0.9
Riluzole 100 mg/day (n=236)
study" Even with riluzole and nonpharmacologic therapies to control the symptoms of ALS,23 however, the long-term prognosis for ALS patients is poor. Use of a wheelchair or feeding
tube often is necessary, and ventilatory assistance usually is required to sustain survival. As described above, approximately half of ALSpatients die within three years of the onset of
the disease, mainly as
a
I result of respiratory failure.
E
:.8
~
01
0.8
0 ... Ilo
0.7
-; ;>
'E
::s
0.6
Placebo
<J)
PARALLEL BETWEEN CANCER AND ALS

0.5
Several characteristics of ALS, from the grim prognosis to
(n=242)
the emphasis on extending survival time and improving quality of life rather than curing the disease, are similar to those of
0.4
various cancers. This parallel suggests that patients with cancer and patients with ALS can be managed similarly and that practitioners treating patients with ALS might benefit from the experience of hematologists and onc~logists. Most of the drugs used to treat cancer ar tested in clinical trials that use survival as a primary endpoint, because surrogate markers for incurable chronic conditions are suboptimal
0.1
J
0
3 6 9
12 Months
15
18
21
Adapted with permission,
600
Journ'al of Managed Care Pharmacy
jMCP
Vol. 4,
No.6
the only pharmacological interventions available for ALS were for symptom relief. Many neurologists, with patients however, remain reluctant to prescribe this drug for their ALS patients. This reluctance may be attributed to a concern that the patient will develop unrealistic expectations. Experience in
ALS,21.22
Table L El Escoiial Criteria for the Diagnosis of ALS: Lower Motor Neuron and Upper Motor Neuron Signs in
Four Regions27
Lower Motor Neuron (LMN)
jaw, face, palate, tongue, larynx
with patients with cancer has shown, however, that providing a drug, even one with limited efficacy, usually does not engender false expectations but rather helps the patient cope with the reality of the disease.'6 One study found that the psychological status of 'patients with ALS is strongly related to outcome;27 patients with a good psychological status had a lower risk of dying and a longer survival time than did those with psychological distress. Prescribing riluzole may, therefore, have an effect beyond its physiological one: the psychological status
of the patient may be improved, having effect on the patient's physical health.
a
Region
Upper Motor Neuron (UMN)*

clonic jaw, gag reflex, forced yawning, pathologic deep ten-
Bulbar
don reflexes, spastic tone
Cervical
neck, hand, arm,
diaphragm
clonic deep tendon reflexes, pathologic deep tendon reflexes, spastic tone
Thoracic
back, abdomen
loss of superficial abdominal
further beneficial
Lumbosacral
back, abdomen, leg, foot
reflexes, pathologic deep tendon reflexes, spastic tone
INITIATION OF PHARMACOLOGIC THERAPY

Several other agents are currently under investigation for the treatment of ALS, but as noted above, riluzole is the only one that has been shown to extend survival of ALS patients.']..'2 As more drugs are tested, they must be compared with each
clonic deep tendon reflexes, extensor plantar response,
pathologic deep tendon reflexes, spastic tone
*LMN signs-Weakness, atrophy, Jasciculations *UMN signs-Pathologic spread oj reflexes, clonus Adapted with permission.
other and with riluzole.19 To ensure that clinical trials involving patients with ALS are rigorous and standardized, the World Federation of Neurology Subcommittee of Motor
Neuron Disease issued the El Escorial diagnostic criteria (see

Table 1).28 The El Escorial criteria also can be used by physicians to help with the diagnosis of ALS in difficult cases29
nausea, vomiting, and perioral paresthesia were found to be dose related. Laboratory tests in which changes were most commonly
reported included certain liver function tests. Serum alanine aminotransferase (ALT) levels greater than three times the upper limit of normal were reported in 6.5% of patients treated with 100 mg/day of riluzole (the recommended dose) as compared with 1.7% of placebo-treated patients..'1.22 Aspartate aminotransferase (AST) levels were elevated in 14.3% of patients receiving 100 mg/day of riluzole and 3.8% of placebo-treated patients21 Spontaneous reversal of aminotransferase levels despite
Riluzole is most effective in the early stages of AL90 and should be offered to all patients as early as possible in the disease process to prolong the early, less severe stage of the disease in
which the patient has greater capacity to maintain the activities of daily living. Some ALS experts recommend intro-
ducing riluzole even before a definitive diagnosis has been made; this strategy diminishes the risk of missing the opportu-
nity for the most effective treatment'l If pharmacologic treatment has not begun before a diagnosis of ALS is made, it should be initiated quickly thereafter to maximize survival benefits. The physician should discuss with the patient the
results of the clinical trials, expected side effects, and cost before prescribing riluzole.31
continued therapy was reported,'.' and in most other cases decrease to twice the upper limit of normal or to baseline
occurred within two months after riluzole was withdravm.'1.2.' Because riluzole is extensively metabolized and subse-
quently excreted in the urine,3.' functional hepatic or renal impairment will reduce the clearance of riluzole and may make side effects more pronounced or more likely to occur.
ADVERSE EVENTS
Some neurologists are comfortable prescribing riluzole before the diagnosis is confirmed because of its favorable adverse event profile31 A total of 794 patients received riluzole
RILUZOLEINTERACTIONS
There are several key variables that pharmacists should
monitor in patients receiving riluzole. Riluzole is metabolized through cytochrome p450-dependent glucuronidation and hydroxylation, primarily via isoenzyme CYP lA2.3.' Lower activity of this isoenzyme in women may lead to higher serum levels of riluzole. Pharmacists also should consider the drugs administered concomitantly with riluzole. Combination therapy with compounds that inhibit CYP lA2 (e.g., caffeine, theophylline,
(50, 100, or 200 mg/day) in phase ll/Ill studies. The most commonly reported adverse events were asthenia (18% vs. 12% for patients receiving placebo), nausea (16% vs. 11 %),
lung function decrease (13% vs. 10%), and dizziness (7% vs. 3%)32 The occurrence rates of asthenia, somnolence, vertigo,
Vol. 4,
No.6
jMCP
601
quinolones, and amitriptyline) or induce the activity of the cytochrome system (e.g., rifampin and barbiturates) may result
symptoms management, and pharmacologic treatment. In addition, a database of ALS outcomes, called the ALS CARE (clinical assessment, research, and education) Project, was developed with the goals of identifying opportunities to
in significant changes in riluzole serum levels.32 Administration of riluzole with a high-fat meal decreases absorption of the medication, reducing peak blood levels by approximately 45% and the area under the time-concentration
curve by 20%32 Pharmacists can be instrumental in ensuring that monitoring is appropriate and can help in the management of any difficulties that patients encounter with riluzole therapy
improve the quality of care for ALS patients; describing diagnostic and treatment strategies and patient outcomes; providing ALS centers with data-to evaluate and improve their practices; publishing objective data on temporal trends and regional differences in the care of patients with ALS; and developing hypotheses for future clinical trials.3s
IMPLICATIONS FOR MANAGED CARE

Several factors in the care of patients with ALS have particular relevance for managed care. Use of El Escorial criteria will
diagnosis, minimizing Expenditures costly of $10,000unnecessary and testing. $20,000 have been documented during the initial phase of diagnosis as a result of the physician's desire to identify a dis-
assist in accurate and efficient early
Another important factor in the management of patients with ALS is that, for patients with cancer, care is optimized through a multidisciplinary approach23 A patient with ALS may need the services of a nutritionist, speech therapist, and respitherapist.23.39.4o Many patients will initially deny that they ratory have a terminal disease; once they have accepted this fact, they
may become depressed. Depression often can be treated with psychological support from the physician but may require referral to a psychiatrist and treatment with antidepressants.23 Patients who have remained at home should be visited periodically by home care personnel to review family and psychosocial
which would eliminate the need for discussing the dire prognosis.33 Unpublished data show, not unexpectedly, that the cost of ALS is related to the severity of
ease other than ALS,
the disease, with the terminal state of illness resulting in an annualized expenditure of nearly $80,000 in direct costs and
lost income.34 Educational efforts to accelerate the diagnosis of ALS for the dual purposes of relieving uncertainty and initiating early treatment should encompass both primary care and specialty staff, in view of evidence that a diagnosis of ALS continues to be one of exclusion, even for many neurologists.33 As discussed above, riluzole is most effective when therapy
problems, imminent crisis situations, and the need for equipment or community services. Each of these health care professionals is an important member of a team providing a continuum of compassionate care to the patient with ALS. Early access to
these specialists
who help manage the symptoms of ALS can re-
duce complications and therefore reduce overall health care costs.23
during the early stages of the disease,3o and it may even be prudent to begin therapy before a definitive diagnosis has been made3l Riluzole is not inexpensive, and physicians
is started
may hesitate to prescribe a costly agent before a patient is experiencing severe symptoms. An oncologist would not hesitate to prescribe an expensive drug, however, as soon as a tumor was detected, knowing that earlier intervention results in improved long-term outcome for patients. Riluzole should be viewed similarly, because early treatment supports a higher level of independent function by the patient before the loss of motor neurons is widespread 30 Use of recently published guidelines for the use of riluzole will help determine which
patients are likely to benefit from therapy with this medicine3s Results of a recent pharmacoeconomic study showed that riluzole use is cost effective: hospitalization was delayed in
in the 2);37 ALS (see Table pharmacist of the case course an can contribute significantly to the multidisciplinary team's care of the patient by monitoring response to and tolerance of each prescribed medicine and making suggestions for appropriate modifications. As ALS progresses and muscle wasting becomes
more serious, muscle mass and total body weight are reduced:o so a reduction in the dosage of many drugs may be required to avoid drug toxicity For instance, insulin requirements change as muscle mass and physical activity diminish. Diabetic patients with ALS often have a declining energy need but continue the same energy intake, thereby increasing insulin requirements. When meal schedules and the composition of meals alter as ALS progresses, other changes in insulin dosage may be required. Most diabetic patient? have been taught to take early morning and late afternoon insulin injections, planned to coincide with peaks in glucose production. If
patients with ALS are being tube-fed by continuous infusion, insulin should be administered at regularly spaced intervals. Regimens used to control cardiovascular problems such as hypertension and heart disease also may have to be altered in patients with ALS. Clinicians may note a decline in blood pressure in hypertensive patients as they approach the terminal stage of the disease. There are several possible explanations for this phenomenon, including decreased salt intake and improved medication compliance. Doses of antihypertensive
A variety of pharmacologic agents may be used
riluzole-treated patients, though the savings were offset by additional services required during the extended survival period. The authors concluded that increases in both longevity
and productivity resulting from riluzole therapy provide societal benefits that outweigh the increase in expenditures36 Two important aids in making trea~ment decisions are the
ALS Standard of Care Consensus on Diagnosis and ManageALS37 and the riluzole usage guidelines mentioned ment of previously3S These documents were created to assist ALS health
care providers with recommendations for diagnostic criteria,
medicines may need to be reduced.
602
jMCP
Vol. 4,
No.6
Table 2. Pharmacologic Interventions for Symptomatic ALS"

Symptom
Cramping
Spasticity
Assessment
Sleep disturbances Unusual as
Treatment
Quinine, phenytoin, diazepam
Baclofen
with an ethics committee or consultant. The provision of riluzoie, palliative medications, and supportive care, combined
with the ethical issues of mechanical ventilation and end-oflife planning, are aspects of ALS treatment to which the pharmacist and the other members of the team apply their knowledge and experience to improve patient outcomes and quality
of life. Although chronic conditions such as ALS, infection with human immunodeficiency virus, and certain neoplasms are
incurable today, they are nonetheless treatable. Providing comprehensive care to patients with such diseases is vital to the growth of the profession of pharmacy. Presently, most pharmacists are unfamiliar with ALS; yet if patients with the disease
are not well managed, health care costs will increase without
major
problem
Pain
Salivation
Sleep disturbances
Analgesics (including opiates)

Atropine, amitriptyline
Antidepressants,
Laryngospasm,
coughing
Depression/insomnia
Sleep disturbances
Leg movements, myoclonus, apnea
Results of decreased
anxiolytics
Sleep disturbance
Infections
Clonazepam, Sinemet CR
Antimicrobials, vaccines (e.g., prophylactic influenza,
bronchial secretions
pneumococcal)
Adapted with permission.
Intolerance to new medications also may be a problem in patients with ALS. Tolerance is an important aspect of riluzole therapy because the initial gastrointestinal side effects may dis,
providing the patient an improved quality of life. Recent publications have documented the financial value of pharmacist involvement;42.43 reimbursement for cognitive health care professional services in global disease management inevitably will be justified by intermedite and long-term savings. Participation in the optimal management of patients with ALS by encouraging early riluzole therapy and applying other pharmacotherapeutic principles is an example of how pharmacists can be proactive, aggressive, and clinically
adept in meet-
ing these challenges.

References
courage patient compliance.32 These problems are managed by some ALS specialists by initially titrating riluzole, starting once daily with food, increasing to twice daily with food, and final-
...
1.
Although the preceding procedure is not published, the pharmacist can recommend it as a practical method to improve tolerance during the initial stage of riluzole therapy. The prescription of riluzole fosters optimism in patients with ALS. This hope for both alleviation of symptoms and extension of life has been shown to improve the patient's quality of life, not only in oncology, but also in ALS.27 Rationing of health care resources should not be a factor in the physician's prescribing decisions. As in oncology practice, such choices
as recommended.32
ly administering without food
ic lateral sclerosis. Mayo
Mulder DW, Howard FM Jr. Patient resistance and prognosis in amyotrophClin Proc 1976; 51: 537-41.
2. Juergens SM, Kurland LT. Epidemiology: In: Mulder DW, ed. The diagnosis and treatment of amyotrophic lateral sclerosis. Boston: Houghton Mifflin,
1980: 35-51.
3. Kurtzke JE Epidemiology of amyotrophic lateral sclerosis. In: Rowland Lp, ed. Human motor neuron diseases. New York: Raven, 1982: 281-302.
4. Mitsumoto H. Diagnosis and progression of ALS. Neurology 1997; 48
(Suppl 4): 52-8.

5. Tyler HR, Shefner]. Amyotrophic lateral sclerosis. In: Vinken PJ, Bruyn GW, Klawans HL, eds. Diseases of the motor system. New York: Elsevier
Science Publishing, 1991: 169-215.
6. Mitsumoto
should not be made on an individual basis but should instead be made at the level of organizational guidelines.4l As the physical condition of the patient deteriorates, critical decisions about life support systems must be made. These
H. Classification and clinical features of amyotrophic lateral
sclerosis. In: Mitsumoto
H, Norris FH,
eds. Amyotrophic lateral sclerosis:
comprehensive guide to management. New York: Demos Publications, 1994:
decisions should not be made at the last minute. The team is obligated to discuss life support issues with the patient and to
1-19. 7. Eisen A. Amyotrophic lateral sclerosis is Nerve 1995; 18: 741-52.
multifactorial disease. Muscle
8. Jerusalem F, Pohl C, Karitzky J, Ries E ALS. Neurology 1996; 47(Suppl 4):
5218-20.
9. RothsteinJD. Excitotoxicity hypothesis. Neurology 1996; 47(SuppI2): 519-26. 10. Leigh PN, Meldrum BS. Excitotoxicity in ALS. Neurology 1996; 47(Suppl
fully inform the patient and the family of the consequences of choosing a life support system. This discussion should include
the financial considerations, such as what will be provided the patient's health care coverage.37
by
4): 5221-27. 11. Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci 1993; 118: 169-74. 12. Kornberg AJ, Pestronk A, Bieser K, et al. The clinical correlates of hightiter IgG anti-GMI antibodies. Ann Neuro11994; 35: 234-37. 13. Martin JE. Neurotrophic factors and neurodegeneration. In: Leigh PN,
Swash M, eds. Motor neuron disease. New York: Springer-Verlag, 1995: 241-58. 14. Rosen DR, Siddique T, Patterson D, et al. Mutations in the Cu/Zn superoxide dismutase gene are associated with familial amyotrophic lateral sclerosis. Nature 1993; 362: 59-62.
CONCLUSION
A multidisciplinary team, whether treating patients with ALS or neoplasm, often will be confronted with difficult ethical dilemmas and may be helped
by discussing these
issues
Vol. 4,
No.6
jMCP
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15. Bergeron C. Oxidative stress: its role in the pathogenesis of amyotrophic lateral sclerosis. J Neurol Sci 1995; 129(Suppl): 81-84. 16. Miller RG, Sufit R. New approaches to the treatment of ALS. Neurology
29. Belsh JM. Definition of terms, classification, and diagnostic criteria of ALS. In: Belsh JM, Schiffman PL, eds. Amyotrophic lateral sclerosis: diagnosis and management. Armonk, NY: Futura Publishing, 1996: 25-45. 30. Riviere M, Meininger
V, Zeisser P,
1997; 48(SuppI4): S28-32.

17. Bryson HM, Fulton B, Benfield P Riluzole. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in amy-
Munsat
TL An
analysis of extended sur-
vival in amyotrophic lateral sclerosis patients treated with riluzole. Arch Neuro11998; 55: 526-28.
otrophic lateral sclerosis. Drug Eva11996; 52: 549-63. 18. Miller RG, Moore D, Young LA, et al. Placebo-controlled trial of gabapentin in patients with amyotrophic lateral sclerosis. Neurology 1996; 47:
31. Mitsumoto H. Riluzole-what is its impact in our treatment and understanding of amyotrophic lateral sclerosis? Ann Pharmacother 1997; 31: 77981.
1383-88.
19 Mitsumoto H, Olney RK. Drug combination treatment in patients with ALS: current status and future directions. Neurology 1996; 47(Suppl 2): S103-
32. Wokke]. Riluzole. Lancet 1996; 348: 795-99. 33. Klein LM, Forshew DA. The economic impact of ALS. Neurology 1996;
47(SuppI2): S126-29.
34. Data on file, Rhne-Poulenc Rorer, Collegeville, PA, 1996. 35. Quality Standards Subcommittee of the American Academy of Neurology
Practice advisory on the treatment of amyotrophic lateral sclerosis with riluzole: report of the Quality Standards Subcommittee of the American
07.
20. Myotrophin T-IND expanded to a total of 450 patients; advisory committee does not find arguments for fundamental effect on ALS progression compelling. FDC Reports, The Pink Sheet, May 12, 1997; 59: 7-8.
21. Bensimon G, Lacomblez L, Meininger V, et al. A controlled trial of riluzole in amyotrophic lateral sclerosis. N Engl J Med 1994; 330: 585-91. 22. Lacomblez L, Bensimon G, Leigh PN, et al. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Lancet 1996; 347: 1425-31. 23. Suft R. Symptomatic treatment of ALS. Neurology 1997; 48(Suppl 2):
Academy of Neurology Neurology 1997; 49: 657-59. 36. Ginsberg GM, Lev B. Cost-benefit analysis of riluzole for the treatment of amyotrophic lateral sclerosis. Pharmacoeconomics 1997; 12(S); 578-84.
37. Miller RG, Sufit R, Mitsumoto H, Gelinas D(Brooks BR. ALS standard of care consensus. Neurology 1997; 48(SuppI4): S33-37. 38. Anderson FAJr, Miller RG, Appel S, et al. ALS CARE: a resource for measuring and improving ALS outcomes. Neurology 1996; 47(Suppl 2): S1I3-16. 39. Chan Cw, Sinaki M. Rehabilitation management of the ALS patient. In: Belsh JM, Schiffman PL, eds. Amyotrophic lateral sclerosis: diagnosis and management for the clinician. Armonk, NY: Futura Publishing, 1996: 315-31. 40. Kasarkis EJ, Neville HE. Management of ALS: nutritional care. Neurology
SI5-22.
24. Delvecchio Good MJ, Good BJ, Schaffer C, Lind SE. American oncology and the discourse on hope. Cult Med Psychiatry 1990; 14: 59-79.
25. Salmon SE, Cassady JR. Plasma cell neoplasms. In: DeVita VT Jr, Hellman S, Rosenberg S, eds. Cancer: principles and practice of oncology, 5th ed., vol. 2. Philadelphia: Lippincott-Raven, 1997: 2344-87. 26. Kodish E, Post SG. Oncology and hope. J Clin Onco11995; 13: 1817-22. 27. McDonald ER, Wiedenfeld SA, Hillel A, Carpenter CL, Walter RA. Survival in amyotrophic lateral sclerosis: the role of psychological factors. Arch Neurol
1994; 51: 17-23.
28. Subcommittee on Motor Neuron Diseases!Amyotrophic Lateral Sclerosis of The \Vorld Federation of Neurology Research Group on Neuromuscular Diseases El Escorial Clinical Limits of Amyotrophic Lateral Sclerosis Workshop
Contributors. EI Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis. J Neurol Sci 1994; 124(Suppl): 96-107.
1996; 47(SuppI2): S1I8-20. 41. Kodish E, Singer PA, Siegler M. Ethical issues. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer. Principles and practice of oncology 5th ed., vol. 2. Philadelphia: Lippincott-Raven, 1997: 2973-82. 42. Bootman JL, Harrison DL, Cox E. The health care cost of drug-related morbidity and mortality in nursing facilities. Arch Intern Med 1997; 157:
2089-96.
43. Dalzell MD. Having pharmacists review drug regimens could save billions. Managed Care 1997; 6: 20F-20H.
604
}MCP
Vol. 4, NO.6
CAMPUS
Pharmacy InternshipOffers Real-World Exposureto Managed Care Pharmacy Practice
Education for managed care pharmacy

has been evolving over the past few years
ceutical industry, and organization management. It allowed for improvement of

practical skills needed in real-world settings, while providing an understanding
selection and administration of drug therapies. The intern participated in

assessments, attended nurse case management meetings, and participated in visits to patients.
throughout the United States. Clerkships, externships, rotaons, and residencies in managed care are becoming more common as traditional pharmacy curricula integrate many of the principles and
practices of managed care. Nevertheless,
students still must seek to broaden their
of the role of pharmacy in managed care. Activities included writing and editing academic detailing articles, clinical case management, drug utilization
The intern then was challenged to coordinate a Senior Plus Orientation

Program, including a brown-bag medication review. The intern worked with the HAP Marketing Department and the new member specialist for Medicare
Risk/Senior Plus to discourage member disenrollment by informing members of their rights and privileges within the
experience through jobs, summer internships, or volunteer work to gain the

skills they need to
management, quality improvement, pharmacy benefit redesign, formulary management, provider reimbursement, network management, and claims processing. Marketing and business strategies are emphasized, as is the importance of technology within health care.
work within this
practice discipline.
Gaining experience in this nontraditional setting remains difficult for many
students, but thanks to networking opportunities within the Academy of Managed Care Pharmacy (AMCP), some students are gaining invaluable additional education. This article describes one such opportunity: a summer internship
PROJECT PARTICIPATION: HAP SENIOR PLUS

As the role of managed care in health care delivery grows, HAP progresses toward a more integrated system of
health care plan. The brown-bag medication review was included to further discourage disenrollment and encourage
pharmacist participation in alleviating polypharmacy within the health care
plan.
with Health Alliance Plan in Detroit, Michigan.
HAP DAILY OPERATIONS

Throughout the internship, the intern
was exposed to the daily operations of the MCO. The preceptor challenged the
HEALTH ALLIANCE PLAN INTERNSHIP

Health Alliance Plan (HAP), a mixedmodel health maintenance organization
with 530,000 members, initiated a sixweek, intensive summer internship that gives a student experience in an integrated health care system, stressing the importance in that setting of written and interpersonal communication skills and
self-motivated learning. Thanks to a very diligent and dedicated preceptor, Suzanne Rivkin, Pharm.D., manager of pharmacy quality improve-
health care, developing programs that integrate various practice disciplines. To gain experience in this setting, the student participated in a project combining
clinical pharmacy and business management, observing interprofessional relations and some resulting obstacles.
student with activities related to clinical services, formulary management, and

disease state management. The intern
HAP reently introduced Senior
assisted with writing and editing for aca-
Plus-a pharmacy benefit rider for

Medicare participants 65 years of age and older. This population typically has a high rate of medication utilization.
Historically, nurses have managed the health of this population, monitoring
demic detailing materials, thus learning
more about population-based pharmacotherapeutics and about the importance of detailing materials in educating physicians.
patient care and drug utilization. Today, physicians, pharmacists, and nurses are
The intern further learned about the financial aspects of formulary design and the need for cost analyses during
drug selection, with emphasis on the
importance of pharmacotherapeutic and pharmacoeconomic measures within for-
ment with HAP, and to funding from Abbott Laboratories, the internship offered an unparalleled learning experience for the student.
working together to manage this care. The HAP Managed Care Services and
.
The internship provided insight into

the principles and practices of managed care through exposure to care organization
a
HAP Pharmacy Services departments implemented a case management program to improve outcomes for the Senior Plus population. This program shows promise in merging differing levels of knowledge, views, and responsibilities in various disciplines in the
mulary and disease management. The experience also offered insight into the
marketing strategies that various pharmaceutical companies employ to
encourage formulary inclusion of their products. Participation in meetings and
large managed
(MCO), the pharma-
Vol. 4,
No.6
jMCP
605
Pharmacy Internship Offers Real-World Exposure to Managed Care Pharmacy Practice
staff discussions provided information
about an MCO's formulary management and business strategies. In addition, the intern was exposed to
PURSUIT OF KNOWLEDGE AND EXPERIENCE

The real world of business, marketing, and managed care pharmacy enabled the student to experience the breadth of managed care activities, making the
forces that direct health care and the
medical information and the role of pharmacy benefit management companies (PBMs) in delivering quality pharmaceutical services. The internship introduced the student to the concept of online pharmacy claims processing and claims adjudication, linking payors directly to pharmacy providers. The intern learned how PBMs provide an
profession. Our primary responsibility must be to advocate for patients while preparing for enhanced administrative and clinical roles. As future managed
care pharmacists, students should be social activists, gaining
a
population-
internship very worthwhile. It cannot be stressed enough that more than a basic understanding of the principles and
practices of managed care pharmacy develops through self-motivated learning
based health perspective for implement-
ing better systems of pharmaceutical

care.
The HAP internship offers knowledge

and experience to build on and to fill the gaps in a traditional pharmacy curriculum. It emphasizes an integrated
integrated financing and delivery network with real-time responses of the formulary, prior authorization requirements, and disease treatment guidelines
and reviewing primary and secondary scientific literature sources, including such basic reading as the Foundation of Managed Care Pharmacy's book, The Pharmacist Guide: The Principles and
Practices of Managed Care Pharmacy. To increase the student's insight and confi-
within the health plan, and how PBMs use drug utilization review to detect duplicate therapies, patient allergies, and
potential drug interactions. The internship provided exposure to groundbreaking initiative of formulary
a
health care system philosophy and population-based health perspective to provide the tools and skills necessary to progress in the ever-evolving profession of pharmacy As managed care continues
to be the guiding force within health
care delivery, it offers numerous opportunities for pharmacists.
dence in managed care pharmacy, continuing education is a necessity, coupled
with an internship experience.
management-electronic prescribing. This pilot program may lead to increased formulary compliance, simplified pharmacy administration, fewer dispensing
errors, and, ultimately, increased patient
satisfaction.
SEEK TO GAIN KNOWLEDGE AND EXPERIENCE

A student interested in the principles
and practices of managed care pharmacy must seek an understanding of all the
James R. Bataoel, Pharm.D. Candidate University of Illinois at Chicago
College of Pharmacy
606
jMCP
Vol. 4,
No.6
AMCPROGRESS
AMCP JOINS SCRIPT COALITION TO INVESTIGATE MEDICATION PROBLEMS
The Academy joined
a
Once the coalition decides the quality measurements, the technical expert panels will convene to help evaluate the
performance measures. These measures will involve three levels of complexity: those for plans and group practices that
committees how effective the drug is in a particular disease state, nor does it evaluate the impact on budgets and disease outcomes," said Langley. "Much of
two-year, fed-
eral/private coalition of government agencies, pharmacy associations, and
this is due to the restrictions placed on manufacturers by the FDA on the kinds
health care groups established to develop quality measures related to appropriate medication use. Called SCRIPT (Study of Clinically Relevant Indicators for Pharmacologic
.
have pharmacy databases only; those for plans and groups that have pharmacy and other (e.g., clinical laboratory, encounter) databases; and a third that requires medical record reviews. The goal is to produce a core set of test per-
of information they may share about their drugs." AMCP's Professional Practice
Committee reviewed Langley's proposal and, after lengthy discussion, agreed that such guidelines would be extremely
valuable to MCOs and pharmacy benefit
Therapy), the organization plans to develop and test a core of performance

measures for medication management in both managed care and fee-for-service settings that can be implemented by
formance measures on medication use at several levels of the health care system.
A manual
will be produced containing
measures and specifications.
management companies. Pharmaceutical manufacturers potentially could use these guidelines to prepare clinical and pharmacoeconomic information in a format that meets the needs of managed care. For example, the guidelines would
request:
payors, purchasers, regulators, accreditors, and health care systems. Morbidity

and mortality associated with medication use is a significant public health
In addition to AMCp, members of the coalition include the American Health

Quality Association, the American Medical Association, the American Pharmaceu-
problem, causing more than 120,000 deaths per year and costing an estimated $20-$60 billion annually. The goal is to enhance overall patient
care, improve prescribing practices, and
tical Association, the American Society of Health-System Pharmacists, the Health
Care Financing Administration, the Joint Commission on Accreditation of Healthcare Organizations, and. the National
... data on baseline utilization, cost, and impact on disease management; ... basic informational and analytical
data; and
reduce medication-induced mortality and morbidity. "Managed care pharmacists are leading the profession in developing measures to evaluate health care processes and outcomes," said AMCP
Committee for Quality Assurance. A project overview is available on AMCP's Web site, www.amcp.org or
through the Fax-on-Demand service, 800/964-9648, #1208 (quality issues).
... an outline of educational and training information to support formulary implementation. Langley is developing the guidelines,
to be evaluated by an expert review panel of AMCP members, industry representatives, and pharmacoeconomic and formulary decision makers.
Executive Director Judith A. Cahill. She noted AMCP's leadership in establishing
Council-a group of nine pharmacy associations established in 1996 to focus on quality measures. The Academy also published the
the Pharmacy Quality
AMCP APPROVES DRAFTING OF GUIDELINES FOR FORMULARY SUBMISSIONS

AMCP's Board of Directors has a proposal to develop a set of guidelines generic on pharmacoeconomapproved
ic data that manufacturers could use in
AMCP BOARD APPROVES ANNUAL EXHIBIT PROGRAM

In an attempt to more fully expose members to important new products and services for managed care pharmacy, AMCP's Board of Directors has voted to
include an exhibit program for the Aademy's 1999 Annual Meeting, April 29-May 2, 1999, in Minneapolis. This
decision builds on the success of the New Product Showcase launched at the 1998 Annual Meeting in Philadelphia.
"A large majority of our members strongly favored the New Product
Catalog of Pharmacy Quality Indicators in 1997. The SCRIPT coalition had its first
meeting in July. Three groups will be involved in the project: the coalition, the steering committee, and the technical
submitting drugs to include in managed

care formularies.
expert panels. The coalition will provide leadership for the project, while the steering committee will provide over-
The proposal, presented to the board by Paul Langley, Ph.D., professor at the
University of Colorado School of Pharmacy, would identify the core informational and analytical requirements of managed care organizations (MCOs) and
as standard by which manufacturers could develop formulary submissions.
sight and management. The technical expert panels and the coalition will develop or select evidence-based performance measures. The Health Care Financing Administration will provide the initial funding.
would serve
Showcase," said Steven G. Avey, AMCP president. "The next logical step is to expand this educational process, to allow two-way communication on all
'The information made available by manufacturers does not tell formulary
Vol. 4.
No.6
jMCP
607
AMCPROGRESS
important pharmaceutical products and. services in the managed care marketplace."

This new exhibit program, AMCP's Annual Showcase, will be available only at the Academy's Annual Meetings, held
each spring. The Educational Conferences, held each fall, will feature AMCP's
STERN NAMED NEW JMCP EDITOR-IN-CHIEF

Craig S. Stern, Pharm.D., M.B.A., president of ProPharma Pharmaceutical
Consultants, Inc., has been selected as the new editor-in-chief of the journal of Managed Care Pharmacy, effective April
of directors, was effective September 1, 1998. FMCp, a nonprofit charitable trust, was established in 1990 to support
research in managed care pharmacy, to
promote the development of continuing education for AMCP members, and to solicit gifts and grants to underwrite research on managed care pharmacy
practice. "It is vital to support educational
traditional Managed Care Industry Forum, educational discussions that do

not allow exhibits of products.
AMCP COOPERATES ON AUTOMATION WHITE PAPER

A two-year collaboration among
1999. He replaces Louise Sargent, R.Ph., M.S., who has been the editor-in-chief sincejMCP was started in 1995. The Academy's Board of Directors selected Stern at its September 1998 meeting,
following a recommendation by a fourmember task force comprising three members of the jMCP Editorial Advisory Board and AMCP Executive Director Judith A. Cahill.
"It is a pleasure and an honor to be taking over from Louise Sargent, who has done such an excellent job in starting the journal," said Stern. "I will try to carry on with her excellent work." Stern has been a member of AMCP since 1990 and has been active in the
programs that show how managed care pharmacy contributes to improving patient care," Dillon said. "It also is
pharmacy associations, representatives of state boards of pharmacy, and representatives from the pharmacy automation
imperative to underwrite research in managed care practice. Therefore, it is important that the foundation solicit funds to achieve these important goals." Dillon was president of AMCP from
industry has produced a white paper on automation in pharmacy The paper describes the state of automation in pharmacy today; barriers to its use; and quality, safety, manpower, and professional issues surrounding the use of automated technologies.
1993 to 1994 and serves on the editorial advisory board of the journal of Managed
Care Pharmacy.
The paper is intended to "assist in understanding how automated drug dis-
tribution technology may effect the quality and efficiency of the delivery of
drugs." It addresses automation in all pharmacy practice sites, but is limited to
Academy for several years, serving as chair of the Professional Practice Committee and the Strategic Marketing
and Development Committee. A licensed pharmacist in California and
From 1997 to 1998 Dillon was acting director of pharmacy services for Kaiser Permanente Northeast Division, Latham, New York. He served as director of pharmacy operations for Community Health Plan in Latham from 1988 to 1997, where he oversaw pharmacies dispensing 2.5 million prescriptions annually In addition, he has been responsible for the operations of 26 health center-based pharmacies,
automated equipment used for storage, packaging, dispensing, and distribution

of medication. It does not address automated compounding, drug delivery systems such as infusion pumps, or issues surrounding electronic data transfer.
Nevada, his firm consults with HMOs, physician groups, third-party payors,
and multihospital corporations. He also teaches at the University of Southern California School of Pharmacy and other
universities. Stern is a coauthor of AMCP's Experiential Learning Manual and has served as a peer reviewer for several pharmacy publications.
mail-order prescription program, oncology pharmacy services, and a network of more thaI).
a
3,200 community pharmacies.

Dillon is an adjunct faculty member of the Albany College of Pharmacy and serves on the editorial advisory board of the Novartis Pharmacy Benefit Report.
The entire paper is in the March 1998

issue of Consultant Pharmacist, published
by the American Society of Consultant

Pharmacists, the lead pharmacy organization involved in the project. In addition
to AMCp, other organizations that worked on the automation paper are the American Pharmaceutical Association, the American Society of Health-System Pharmacists, the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the Pharmaceuti-
DillON NAMED FOUNDATION

DIRECTOR
Michael]. Dillon, M.s., R.Ph., a pharmacist with 19 years experience in managed care and former president of the Foundation for Managed Care
Pharmacy (FMCP), has been named the Foundation's first executive. The ap-
cal Care Management Association.
pointment, made by the FMCP's board
608
}MP
Vo1.
4, No.6
CONTINUING EDUCATION
Peter D. Hurd
ABSTRACT:This article is ttie third in a series of three designed

to help managed care pharmacists design and
.
statistical concepts will benefit the pharmacist practicingin a
interpret
managed care environment.
research studies. The objective of this article is to provide a
general introduction to the use of statistics in research articles. In the changing health care industry, an overview of basic
Key Words: Statistics,Variation, Significance,Statistical tests

J Managed Care Pharm 1998: 617-621.
This
article is the third in
series of articles about
research methodology!) written for those who are relatively unfamiliar with statistics and research in managed care. It is designed to provide a broad overview of statisa textbook or but the course on statistics, it can provide some of tools needed to understand and use research articles while avoiding some of the common misinterpretations of research findings.
tical issues. This article cannot serve the place of
Those who have not read the previous two articles in the series can benefit from this article alone, but reading all three
in sequence would be the best approach.
VARIATION
One of the central concepts in statistics is variation. When comparing two groups-for instance, one group that has received a placebo and another that has received an active drug-the responses of the individuals in each group will show variations. Some variation will be due to the difference between the placebo and the drug; but additional variation
...
AUTHOR
will be due to the differences between the people receiving the placebo (perhaps taller, or older, or sicker, or less liverimpaired) when compared to those who received the active drug. How can we tell if the difference between the two
groups is due to the effect of the drug or to the effects of the variation in the people assigned to the two groups?
PETER D. HURD,' PH.D., is Professor and Director of the Division of Administrative Sciences and Liberal Arts at the St. Louis College of Pharmacy, St.
Louis, MO.
CLINICAL AND STATISTICAL SIGNIFICANCE

St. Louis
AUTHOR CORRESPONDENCE: Peter D. Hurd, Ph.D.,

Pharmacy, 4588 Parkview Place, St. Louis, MO, 63110.
College of
Statistics provide one of many ways to detect differences between groups. Sometimes the variation in responses of one
ACKNOWLEDGEMENTS: The author would like
to thank Brenda R. Motheral,
R.Ph., Ph.D., Assistant Professorat the University of Arizona College of Pharmacy, and Kenneth W Schafermeyer,Ph.D., Associate Professorand Director of Graduate
sion
group is so great in comparison to the other group that the difference obviously exists even without calculating the statistics. For example, assume that advertising begins for a drug
Studies at the St. Louis College of Pharmacy for their comments on an earlier verof the manuscript.
IK:I
~
CE CREDIT: This is article number 233-000-98-006-H04 in AMCP's continuing education program. It affords 1.0 hours (0.01 CEU) of credit. Learning objectives and test questions follow on page 622.
information SOO-number. Immediately after the advertising begins, calls increase from two per day to more than 80 per day. Statistics are unnecessary to reveal things already known,
such as that the advertising has been successful; the increase in calls is significant; and more people will be needed on the
Vol. 4,
No.6
}M(P
617
phones. At other times, only one case can detect a difference. For example, if a patient's cancer therapy is so expensive that the drug budget for the year is spent, it's clear that this year's
statistical difference is attributable to
mistake, is called
Type I
drug budget will be significantly higher than the previous year's. Sometimes, however, the variation between groups is not clearly different from the variation that exists within each of the groups. Statistical significance provides an additional
means of asserting that the variation between situation one and situation two is great enough to conclude that they are different. To do this, we rely on the fact that our world has certain patterns of variation. For example; consider coin tosses. We expect that heads will appear half the time and tails the other half with an unbiased coin, and we can extrapolate that expectation to the results of tossing the same coin a number of times or tossing a lot of coins all at once. If, over the long run,
II (Type Two) error occurs when the researcher concludes that there was no difference when in fact a difference actually existed. A Type I error can be com(or Type One) error. A Type pared to
tect
a
diagnostic test that gave

a
false positive result and
Type II error to
false negative, in
which the test failed to de-
problem that the patient really had. So statistical conclu-
sions can be made in error, just like other types of conclusions. Another caution: Because of the nature of statistics, differences that arepatistically significant may have less value in
terms of clinical significance. Although the same difference would be expected again from a statistical standpoint, one also should ask if this difference is meaningful or important.
THE NUMBER OF SUBJECTS AND SIGNIFICANCE

The discussion of statistical significance raises an issue about the number of subjects, patients, clients, or members in a research design. Which is better: a large number of subjects subjects, a researcher or just a few subjects? With just a few would be unable to detect rare side effects of a drug. With a large number of subjects, research could be wasting funds if it found a significant difference with the first 15 patients in a subjects through group, but continued to run hundreds more The the study only to find the same difference. answer, of depends subjects on the situation course, is that the number of
and the research question that one is attempting to answer. As a general rule, the more subjects used in a research project, the easier it is to find a statistically significant difference.
the results of tossing the coin vary too much from 50/50, then the coin probably is biased. Statistics sets the rules for what is
"too" different. A similar example would be the normal distri-
bution, or the bell-shaped curve. Some things in nature show a variation that resembles this curve; some faculty members feel that performance on a test should fit this distribution. Again, statistics sets the rules to help a researcher determine if the distribution of scores from one group (the active drug group) is different enough from the distribution of scores from another group (the placebo group) to conclude that this much
variation would not be expected if the two groups were responding in the same way What does it mean to say that a difference is statistically significant? In very general terms, this means that the findings are unusual enough that one could not reasonably expect that the difference is due to chance or expected differences between groups that result from random variation, measurement error, and less-than-perfect research design. The amount
of variation between the two groups usually would not be observed if both groups really represented the same underlying distribution of responses.
This does, however, raise the issue of statistical versus clinical significance. For example, a study might find a compliance rate of 77% among patients taking a drug once a day, whereas the compliance rate of patients taking the same dose twice a
75%. With a large number of subjects, this difference could be deemed statistically significant. Yet this difference
day
is
nutshell, the researcher is saying that if the study were repeated, there is a strong likelihood that the findings would be the same; the difference would be found again. This brings us to something called the p-value, most often
In
may have little, if any, clinical meaning. Nonresponse bias is another problem associated with the In number of subjects and the interpretation of significance. talking a is this case, we usually are about survey that
answered by a percentage of those who have received the survey As a general rule, response rates greater tan 50% are less likely to show response bias than those with response rates of less than 50%. The logic is very straightforward: If less than half the people respond, then it is possible that they feel total-
research article, expressed as p=0.05 or p<0.05. Think of "p" as representing "probability" This means that the
seen in
a
researcher, using some statistical test, has determined that the chance of random variation causing these differences is less
than five in 100. By tradition, when random variation is this unlikely to have caused a difference (p<0.05), that difference is considered statistically significant.
Statistical differences have
a
margin for
error-a
fact that
ly different from those who did respond. If more than half respond, the study is at least dealing with a majority of the possible responses. If the survey design encourages some to
respond and others not to respond (for example, only those who have a problem with a service tended to respond), then
a wider-ranging higher percentage of response would not suP-. survey with a port. Studies with a low response rate should be treated with
may be troubling to some. Two types of errors have special importance. There is a chance that a re2earcher may conclude
that two groups are different, when in fact if the study were repeated, the results would show that the groups are not really different. In statistics, the risk that this will happen five times
the researcher could draw conclusions that
in 100 (p<0.05) is acceptable. This type of error, in which
considerable caution.
618
jMCP
Vol. 4,
No.6
Studies with a low response rate often will attempt to rule out biases by an examination of their data. For instance, data from early responders will be compared to the responses of the last individuals who reply to a survey: When the responses
are similar, there is less chance for bias. For example, a study of pharmacies in the United States could show that, despite a
first, second, third, and fourth should not imply that number
two is twice as good as number four. But two has been judged more favorably than four, and this difference is presented as if it is meaningful. This is an ordinal use of numbers because the
low response rate, the percentage of busy stores that returned the questionnaire early was similar to the percentage that
returned the survey late. In a survey that showed the later responders tended to be the busier stores, one might suspect a potential bias based on how many prescriptions were filled per week. When the potentially biased study demonstrates significant differences between groups, this tendency for the busiest stores to be underrepresented needs to be considered in the
numbers' order has meaning. Sometimes the numbers' intervals have a very real meaning. A temperature of 50 degrees Fahrenheit is in fact 10 units less than a temperature of 60 degrees. In this case, though, a
O-degree temperature does not imply the absence of any temperature. The use of numbers when the interval is assumed to be equal across the scale, but zero does not mean the absence of the property, is called interval data. Often the data has a zero that means absence of a condi-
interpretation of the data. Another way to examine the potential for bias in a survey with a lower response rate would be to compare the demographics of those who responded to the demographics of the
entire population. In a national survey of patients in a particular managed care plan, a researcher could compare the geographic distribution, ages, gender mix, and health problems to
tion-no heart rate, zero on a test, or zero money in the checkbook. This use of numbers is called ratio data. In managed care, this is often the type of data analyzed: number of medications, number of side effects, cost of the procedure, and so on.
Statistics have been devised for all four types of data. Usually nominal and ordinal data are analyzed by nonparametric statistics (e.g., chi square is one of the most familiar
that of the total care plan. When the respondents' characteristics are similar to those of the total population, there is less chance that these factors will bias the results. When studying patients who have one or more diseases,
.
nonparametric tests), and interval/ratio data usually are analyzed with parametric statistics (e.g., t-test, analysis of variance, regression).
researchers must consider the availability of appropriate participants. One of the classic problems encountered in clinical research is a study design that requires more patients than the clinic normally would see during the time allotted for the study: One way to examine this problem is to study the history of the
The mean (the sum of the numbers divided by the number of the data points) helps illustrate this. Will the mean make sense with nominal data? No. Why would anyone ever add up the numbers on the team's roster and then divide by the number of players? This would not provide useful information. Similarly, would it make sense to add up the rankings of the different hospitals in each state to come up with an "average"
rank? Well, this is done, but ordinal data's lack of equal intervals makes these numbers difficult to interpret. The median response (the response in the middle of the responses after they
patient population and make a very conservative estimate of the availability of appropriate participants, remembering to
apply the exclusion criteria planned for the study to determine the number of subjects for the project. Studies that are unable to enroll enough subjects may lack the statistical power to find
a
difference when one exists (a Type II error). For example,
studies that report that two medications showed no treatment differences but rely on very small samples (perhaps about 10 patients per treatment) simply may have failed to detect a more subtle difference because of the limited number of subjects~
have been put in order) or the modal response (the response used most often) would be more appropriate for ordinal data. In the following sequence, what is the modal response? The median response?
PARAMETRIC AND NON PARAMETRIC STATISTICAL TESTS

As described in the first article of this series, numbers are used in many different ways. Sometimes numbers are used as a shorthand name: group 1 and group 2, or baseball players' numbers on their uniforms. The baseball player using "16" is
The modal response would be 1; the median response would be 1.5 (halfway between 1 and 2, because there are an even number of responses); and the mean would be 14/6 (which is 2.33 if one compares the three measures). Each of
these has
a
1,1,1,2,4,5
use, but the mean response is most commonly
reported. The use of the median can help when outliers might distort the interpretation of the mean of a set of numbers. The housing market is a good example. Although the mean price of a
house in
a
community is useful information,
few very expen-
not half as good as the player using number "32"; these are just identifiers. This use of numbers is called "nominal"
because there is little mathematical meaning to the numbers,
sive houses will distort this number so that it is much higher than the price most people would pay for homes in that area.
Consequently, the median response often is used in local hous-
just
categorization. In other instances, a number signifies a particular order, but nothing else. Ranking the best hospitals in the country as
ing reports.
Much as the mean is most appropriate for interval and ratio data, two measures of variation also are based on equal
Vol. 4.
NO.6
jMCP
619
intervals between numbers: variance and standard deviation. Variance refers to the amount of variation around the mean of the data being analyzed. As a general rule, a larger variance
Is the following
positive or negative correlation? The

a
faster the car goes, the poorer the gas mileage. Correlating the
faster speed with fewer miles per gallon gives
negative corre-
would indicate more variation in the data. Conversely, if everyone chose the same response, then there would be no
variance in the responses.
lation. Sometimes, however, one could associate the faster speed with more use of gas, a positive correlation. So, it depends on what is being measured and how the data are
reported.
Here is an illustration of the importance of considering both mean and variance rather than only the mean. It is possible on a survey to have a mean of 3 on a 5-point scale 0-2-3-4-5) with no variance-everyone chose 3. If half the
respondents chose 1 and the' other half chose 5, then the mean would still be 3, but the variance would be quite large, such as the difference between
a
.
The correlation of two variables does not necessarily mean that one is the cause of another. Correlation does not equal cause. For example, one might find that the sale of ice cream
increases with the number of drownings. Does the ice cream cause the drownings? Probably not. Both are associated with
barbell and
rolling pin.
xxx __u__ xxx
--- xxxxxx ---
Based on this example, it should be clear that both mean and variance are important in the analysis of this type of data. Technically, standard deviation is the square root of the
another variable-warm weather. People eat more ice cream and participate in more water sports in hotter weather. Avoid the error of assuming cause when all that has been demonstrated is correlation. A number of statistical tests are related to correlation. For example, regression is an attempt to fit a line through a distri-
variance. From a more practical standpoint, the standard deviation is easier to compare with other standard deviations and is usually presented in research articles. Without getting very
specific, the variance is computed by squaring numbers, whereas the standard deviation is more applicable to the particular measuring scale that was used. (The term "standard error" is not the same and may be smaller than the standard
bution of data. That line would be similar to a representation of the correlation between the two variables. Multiple regression is an elaboration of simple regression, using a number of variables to discover the best combination of variables to predict the targeted variable. Factor analysis also is based on
association between variables. In this case, the statistical procedure is looking for various factors that seem to be related.
deviation.)
CORRELATIONS
The association between two variables sometimes is analyzed using correlations. Some tests for correlation are parametric (e.g., Pearson product moment correlation coefficient), and some correlation tests have been designed for ordinal data
(e.g., Spearman rank correlation). The fundamental question being asked has to do with the relationship between the observations. For example, as age increases does drug use
a statistical way to decide if the relationship between observations could be the result of chance or if there is some pattern that could not be expected
Although factor analysis and multiple regression are complicated statistics that rely on computers for calculation, each tries to determine the association between different variables
that the researcher is studying.
DIFFERENCES BETWEEN GROUPS

Sometimes a researcher wants to determine whether one group is different from another. For example, have subjects taking the active drug responded better than those in the placebo group? There are statistical tests to help answer this
increase? Correlations provide
if the two observations were unrelated. As mentioned above,

the more subjects in the analysis, the easier it is to find statistically significant correlations, but they may be of little clinical interest.
question; some are parametric and others are for nonparametric data. This section will concentrate on two parametric tests: the I.-test and the analysis of variance (ANOVA). The I.-test is designed to detect statistically significant differences between two groups. For this test to work, it assumes that there are no systematic biases between the groups, a cir-
Correlations can be either positive or negative. Positive correlations mean that a larger response on one variable is
a larger response on the second variable. In pharmacy, for example, the mQre medications a patient is taking, the more side effects the patient is likely to experience. This would be a positive correlation between the number of
cumstance often accomplished by random assignment to conditions and good data collection techniques. Of course, in the
case of clinical trials, there is one intentional difference be-
associated with
tween the groups: half received the placebo and half received the active drug. To analyze the data the researcher needs each subject's results and to know if they received placebo or active
drug. This information is entered into the computer, and a I.-value is generated. A larger I.-value is more likely to have
a
medications and the number of side effects. A negative correlation means that a higher score on one variable is associated
with
lower score on the second variable-for example, usually the more medications individuals are taking, the poorer their health would be.
a
p-value that is less than 0.05. When the I.-value is large enough to have a p-value less than 0.05, the researcher will conclude that the difference is statistically significant. In our
620
jMCP
Va\. 4,
No.6
terms, that indicates that the variation between the two groups was too great to happen by chance (at least 95 times out of 100, anyway). We feel confident saying that the groups have significantly different values for the dependent variable being
measured. Sometimes the difference between two groups is based on a study design that uses the same individual or matched individ.
QUALITATIVE DATA
Because this article deals with numbers and statistics, little has been said about the value of qualitative data. Qualitative
data can range from the question at the end of a survey that asks for any comments that the individual would like to provide, all the way to an elaborate collection of stories and anecdotes as a part of a sociological analysis of a company. Qualitative information can be extremely powerful; one story
uals-for example, before and after taking a medication. This is a special case of the t-test because the two groups are not
independent. The Hest is modified statistically to account for this expected change in variation and reports a matched, paired, or dependent t-test value. Again, the larger the t-value, the more likely the researcher will be able to say that the pvalue is less than 0.05, and the groups apper to be different. This use of the words "independent" and "dependent" refers to the subjects analyzed with the t-test. These words
different way when referring to dependent and independent variables. As described in the first article in this sequence, dependent variables are those variables that one
have been used in
a
of a' patient helped by a staff member can carry much more impact than an analysis of patient satisfaction that shows a significant increase from the previous year.
CONCLUSIONS
Perhaps the most important message in the use of statistics is to plan statistical analysis at the very start of the study
design. Perhaps the researcher should determine the type of analysis that will be done, or consult with a statistics expert before collecting the data. After data collection has started, it
trying to explain. In a clinical trial, the dependent variable would be the patient's response to either the treatment or placebo medication. The independent variables are those
is
manipulated by the experimenter (e.g., random assignment to receive drug or placebo) or expected to affect the dependent
variable (e.g., in the ice cream and drownings example, the ice cream was presented as the independent variable). The use of. the term "independent variable" is slightly different for experi-
can be expensive or impossible to repair faulty design. The first article in this series discussed the development of hypotheses. Hypotheses have a direct link with the statistical
analysis of a project. Being clear and precise about both will greatly aid the researcher as the project develops. Both should
be formalized before the project moves to the data collection stage. The second article discussed research methodology. The
ments (drug/placebo) and for correlations (drownings and ice cream) as illustrated above. Considering the context in which the term is used will help clarify what the researcher is
describing.
planning of the statistical analysis should be integrated with the design of the research project. The sequential nature of these articles does not necessarily imply an order of events that must take place in the implementation of a research project.
The t-test is limited to two groups, whereas ANOYA is designed to handle more complicated research designs. For
researcher would use ANOYA to determine if any of three conditions differs from the others, as when comparing
example,
low dose, higher dose, and highest dose of a drug. Other ANOYA will handle factorial designs, such as a 2x2 experiment in which patients are randomly assigned to one of four conditions-receiving low or high doses of a drug and
a
types of
Numbers need to be interpreted in the context of the patients that they represent. The numbers are abstractions of real people, suffering real pain and providing real answers. A good researcher tries to use the numbers to summarize the responses of a group of people, while remembering that a very
real heartbeat is associated with each of the responses.
References
low or high levels of follow-up. This results in four cells: lowllow, low/high, highllow, and high/high. ANOYA also will be able to handle more complicated factorial designs (e.g., 2x3x2). Again, the independence of subjects in each cell is
assumed, usually through randomization. Collecting data from subjects in a pre/posHest design requires a modification of the
statistical test to account for this fact.
....
1. Motheral BR. Research methodology: hypotheses, measurement, reliability, and validity.] Managed Care Pharm 1998: 4: 382-94. 2. Schafermeyer KW, Hurd PD. Research methodology: designing a research
study.] Managed Care Pharm 1998; 5: 504-14.
an overview. It is hoped that
This very brief description of these tests is meant only as a general understanding of the
terms and the concepts will establish a foundation for further study and will assist the reader in the literature that uses these approaches.
Vol. 4,
No.6
}MlP
621
CE
Research Methodology: Some Statistical Consideration
EXAM
7.lf
the variance of
a
Upon completion of this article, the successful participant should be able to:
1. explain the term "statistical signifi"
3. When the research article reports p<0.05, this would usually mean
sample was four,
cance. 2. discuss the impact of the number of
t-value. a. small b. insignificant

c.
a_
which number would be larger?

a. Variance
b. Standard deviation
8. When two variables are correlated, then one can be said, statistically, to
-
large
1 error
subjects on statistics. 3. differentiate between parametric and

non parametric tests.
4. discuss the importance of mean and variance in data analysis.
5. differentiate correlation and causa-
4.A Type
a.
would be:
cause the other.

a. True
reporting no difference when one

existed.
a
b. False
b. reporting
difference when one did

9. When two means from two questions on a survey are about the same: a. the standard deviation of the scores
NOT
exist.
tion.
SELF-ASSESSMENT
QUESTIONS
1. Statistical tests are:
a. either parametric or nonparametric. b. only parametric.
c. using too large of a sample size. d. running a parametric statistic inappropriately
will be the same. b. the distribution of the scores will be

different.
c. the standard
t-test with a sample size of 10 to report that two medications were equally effective could be a:
5. Using
a
deviation of the scores
c.
only nonparametrie.
1 error. a. Type
might help understand the results. d. the data cannot be analyzed with
statistics.
d. neither parametric
nor nonpara-
b. Type
11
error.
metric.
2. When the research article reports p<0.05, this usually refers to a:
a.
e. correlation.
d. significant difference.
lack of difference between two or
more groups. b. statistically significant difference. c. clinical difference that may have little statistical significance. d.small sample size.
6.A larger sample size cant difference compared to sample size.

_
a a
signifi-
10. To test for significant differences between three groups, the best choice a. correlation. b. t -test. c. analysis of variance.
is:
smaller
makes it harder to show b. has no effect on showing

a.
c. makes it easier to show
II
oc~o",og 00 '"&' 617 of <h" ";0'" ]Mep This article qualifies for 1 hours of continuing pharmaceutical education (0.10 CED). The Academy of Managed Care Pharmacy is approved by of continuing pharmaceutical education. This is program number 233-000-98the American Council on Pharmaceutical Education as a pr~vider offerings. @ 006-H04 in AMCP's educational
S'dW of mid,
622 Journal'of Managed Care Pharmacy
jMCP
Vol. 4, NO.6
CEEXAM
DEMOGRAPHIC INFORMATION
(not for scoring)
11. In what type of setting do you work (leave blank if none of the responses
13. How many minutes did it take you to complete this program, including the
quiz (fill in on answer sheet)?

14. Did this program provide insights relevant or practical for you or your work?
a. Yes.
below applies)?
a.HMO.
b.PPO. e. Indemnity insurance. d. Pharmacy benefits management.
e. Other.
b. No.
15. Please rate the quality of this CE
article.
a. Excellent.
12. Did this program achieve its educational objectives?

a. Yes.
b. Good.
c. Fair.
d. Poor.
b. No.
INSTRUCTIONS
This quiz affords 1 hours (0.10 CEU) of continuing pharmaceutical education in all states that recognize the American Council on Pharmaceutical Education. To receive credit, you must score at least 70% of your quiz answers correctly To record an answer, darken the appropriate block below. Mail your completed answer sheet to: Academy of Managed Care Pharmacy, lOON. Pitt Street, Suite 400, Alexandria, VA 22314. Assuming a score of 70% or more, a certificate of achievement will be mailed to you within 30 days. If you fail to achieve 70% on your first try, you will be allowed only one retake. The ACPE
Provider Number for this lesson is 233-000-98-006-H04. This offer of continuing education credits expires October 31, 1999.
2. 0
1.0000 0 0 0
0
0 0 0
ABC
ABC
7.0 8.0
6.000 0
0
12. 0 Yes
1l.OA DB
OCODOE
ONo
3.000 4. 0 0 0
5. 0
13. Minutes
9. 0 10. 0
0
0
0
0
14. DYes 15. 0 A 0 B
ONo
DC OD
Participant Identification: Please type or print

Social Security #
For Identification Purposes Only
Date
Name
Last
Work Phone
First
Middle
Company
Address
Street (with Apt. No.) or PO. Box
City
State
Zip
State and Lie. No.

State
No.
Member Type:
Active Student
Supporting Associate Nonmember
Signature
Vol. 4.
No.6
jMCP
623
Annual Index
Index to Volume 4, Numbers 1-6. The index to Volume 4 is comprised of two parts:
an author index and a subjectindex.
Boland, Beth. The Evolution of Best-in-Class

Pharmacy Management Techniques. 1998; 4:
Desselle, Shane, et al. The Importance of

Communication Skills for the Managed Care
Pharmacist.
Issue
January/February March/April
Pages
1-96 97-236
237-358
366. Featu re. Bramlet, Dean A., et al. A Comparison of Hypercholesterolemia Management in the
Secondary Prevention of Coronary Heart
Disease by PayorTypes: Fee-For-Service,
1998; 4: 102. Perspectives.
Dickson, W. Michael. see Kozma, Chris M., et al. 1998; 4: 205. Comparative Research.
Dole, Ernest J. see Gupchup, Gireesh V., et al. 1998; 4: 495. Comparative Research.
May/June
July/Augst
September/October
November/December
Medicare, and Managed Care Organizations.
359-446 447-538 539-640
1998; 4: 483. Comparative Research.
Breault, Diane. Health Care Communications Agencies Respondto Managed Care. 1998; 4:
9. Feature.
Edgell, Eric T. see Summers, Kent 1998; 4: 42. Review.
H., et al.
AUTHOR INDEX
Anderson, Robert J., et al. The Efficacy and Safety of Anorexiant Medication in the Treatment of Obesity: Implications for Managed
Brixner, Diana. see Wilson, Marcus, et al. 1998;

4: 194. Descriptive Report.
Eicher, Jessica. see Wilson, Marcus, et 1998; 4: 194. Descriptive Report.
al.
Ettinger, Bruce, et al. Alendronate Use Among

812 Women: Prevalence of Gastrointestinal
Complaints, Noncompliance with Patient
Instructions, and Discontinuation. 1998; 4: 488.
Brunner, Lane J. The NTI Debate. 1998; 4:

289. Caveats.
Care Formularies. 1998; 4: 422. Descriptive

Report.
Comparative Research.
Carter, Barry L. see Grier, Dana, et al. 1998; 4:
478. Campus.
Chan, Julia. see Ettinger, Bruce, et Badger, Bruce.

478. Campus.
see Grier, Dana, et al. 1998; 4:
al.
1998; 4:
488. Comparative Research.
Fallik, Bruce B. Integration:The Future of Pharmacy. 1998; 4: 452. Perspectives.

and Felkey, Bill G., et al. Technology Automation Update. 1998; 4: 345. Continuing
Education.
Chevalier, Kimiko. see Salmon,

al.
J. Warren, et
Bailey, Michael, et al. Innovative Drug

Formulary Management Through ComputerAssisted Protocols. 1998; 4: 246. Feature.
1998; 4: 123. International.
Chevalier, Kimiko, et al. International

Movement of Japan's Pharmaceutical Industry:
Reform of Japanese Health Policies, Part III.
Ferro, Karen. see Bailey, Michael, et al. 1998;

4: 246. Feature. Forsstrom, Kristi. see Anderson, Robert J., et al. 1998; 4: 422. Descriptive Report.
Bair, Teri L. see Ginsburg,Diane

4: 193. Caveats.
B.,
et al. 1998;
1998; 4: 567. International.
Baran, Robert W. Room in Brooklyn; Edward Hopper.1998; 4: 1. Cover Impressions.
Clark, David
C.
Medicare and Managed Care:
EmergingPartnerships. 1998; 4: 105. Feature. Connolly, Nancy. see Ettinger, Bruce, et 1998; 4: 488. Comparative Research.
al.
Barisano, Anthony, et al. Treatment of

for the Patients with ALS: Implications
Managed Care Pharmacist. 1998; 4: 599.

Craig, Robert
P. The Patient as a Partner in
Gericke, Kristin R., et al. Formulary Management by an On-Site School of

Pharmacy Faculty Member in
a
Prescribing: Direct-to-Consumer Advertising.
Medicaid
Barrington, Monica. ChangingPractices in

Home Inodilator Infusion Therapy for Advanced
1998; 4: 15. Feature.
Managed Care Organization. 1998; 4: 407.
Congestive Heart Failure. 1998; 4: 73.

Crawley, Joseph A. see Keyser, Mary S., 1998; 4: 64. ComparativeResearch. Crawley, Joseph A. see Keyser, Mary 1998; 4: 336. ComparativeResearch.
S.,
et al.
Ginsburg, Diane B. see Beardsley, Bob et al. 1998; 4: 78. Caveats. Ginsburg, Diane
B. Pharmacy: Over- or Under-
et al.
Bataoel, James R. Pharmacy Internship Offers Real-World Exposureto Managed Care

Pharmacy Practice. 1998; 4: 605. Campus.
Where Beardsley,Bob, et al. Counseling:
Does the Profession Stand? 1998; 4: 78. Caveats.
Regulated?1998; 4: 193. Caveats.
Crischilles, Elizabeth A. see Phillips, Charles R., et al. 1998; 4: 183. Comparative Research.
Goldberg, GeorgeA. see Keyser, Mary S., et 'Research. 1998; 4: 64~ Comparative Goldberg, George A. see Keyser, Mary S., et
1998; 4: 336. Comparative Research. Graden, Suzanne E., et al. Performance
Reporting for Managed Care Prescription
al.
al.
Bjornson, Darrel C. see Phillips,Charles

I"
R., et
Dedhiya, Seema D. see Salmon, al. 1998; 4: 23. Feature.
J. Warren, et
'I 'I
I'
'I
al. 1998; 4: 183. Comparative Research.
Desselle, Shane, et al. The Evolution of

Pharmaceutical Care into Managed Care
Environments. 1998; 4: 55. Continuing
Education.
to Bloom, Marlene Z. ConnectingPhysicians Pharmacies-and Patients. 1998; 4: 473.
Programs. 1998; 4: 160. ContinuingEducation.
Graden, Suzanne E., et al. Performance

Reporting for Managed Care Prescription
Programs. 1998; 4: 171. CE Exam.
Spotlight.
;Ji
Bloom, Marlene Z. MississippiMedicaid

Waiver Breaks New Ground for Pharmacists.
Desselle, Shane, et al. The Evolution of Pharmaceutical Care into Managed Care Environments.
1998; 4: 564. Spotlight.
(Desselle, Shane, et al.) 1998; 4: 61. CE Exam.
Grapes, Z. Tom. ExpandingPharmacy Students' Understanding of Managed Care.

1998; 4: 223. Campus.
624
jMCP
Vol. 4,
No.6
Annual Index
Grier, Dana, et al. The University of Colorado School of Pharmacy and the University of
Colorado Health Plan Forge a PBM Partnership.
Kaldy, Joanne. Flowers and Birds; Sesshu Toyo. 1998; 4: 97. Cover Impressions. Kaldy, Joanne. Kindred Spirits;Asher
B.
Lin, Swu-Jane. see Salmon, J. Warren, et al.
1998; 4: 80. Campus.

Lin, Swu-Jane. Developing Disease State
1998; 4: 478. Campus. Gupchup, Gireesh V., et al. Burnout in Sample of HMO Pharmacists Usingthe
Durand. 1998; 4: 237. Cover Impressions.

a
Management in the United Kingdom: An Obviously American ConjectureFinds Export

OpportunitiesAbroad. 1998; 4: 275.
International.
Kaldy, Joanne. Springtime; Claude Monet.

1998; 4: 359. Cover Impressions.
Maslach Burnout Inventory. 1998; 4: 495.
Kaldy, Joanne. Several Circles; Wassily

Kandinsky. 1998; 4: 447. Cover Impressions.
Kaldy,Joanne. The Skater,

Hamilton, William R., et al. A Studyon the
Characteristics of PrescriptionTransmittal
Processes and the Effect of Patient Prescription
Gilbert Stuart.
Lively, Buford T. see Gupchup,Gireesh V., et al. 1998; 4: 495. ComparativeResearch.
1998; 4: 539. Cover Impressions. Kalmanowicz, Jeffrey. see Wilson, Marcus, et

al.
Louie, Clifton. see Gericke, Kristin R., et 1998; 4: 407. ComparativeResearch.
al.
1998; 4: 194. Descriptive Report.

F. see Bramlet, Dean A., et al.
Kaul, Alan
1998;
MacKinnon III, George E. Cooperative Learning in a Required Outcomes Assessment
Course. 1998; 4: 432. Campus. Malone, Daniel. see Grier, Dana, et al. 1998; 4:
Reminder System on Patient Compliance.
4: 483. Comparative Research.
Hargis, Jo Ellen. Biotechnology as

Specialty. 1998; 4: 465. Feature.
Pharm~cy
Keating, Edward J. Maximizing Generic Substitution in Managed Care. 1998; 4: 557.

Featu re.
Hauser, Robert. Patient Protection: Will

Pharmacoeconomics Complement or Conflict?
Kenreigh, Charlotte A., et al. The Survey

Syndrome. 1998; 4: 544. Caveats.
478. Campus.
1998; 4: 381. Caveats. Hedayati, Samuel, et al. A Predictive Cost AnalysisModel for Estimating Formulary
Keyser, Mary S., et al. Gastroesophageal

Reflux Disease in
a
McPeak, Mary Ellen. State-by-State Look at Medicaid Retail Pharmacy Delivery:Trials &
Triumphs. 1998; 4: 546. Minor, Paul A., et al. If It Is Worth Doing, It Is Worth DoingWell.. Then Proven. 1998; 4: 359.
.
Managed Care Setting:
Professional, Facility, and Pharmacy Charges.
Impact of New Products in Managed Care.

1998; 4: 584. Comparative Research. Hessen, Jody. Oncology Drugs and Managed
Care. 1998; 4: 374. Feature. Hetler, Tamara A. see Hamilton, William R., et al. 1998; 4: 174. Comparative Research.
1998; 4: 64. ComparativeResearch. Keyser, Mary S., et al. Gastroesophageal

Reflux Disease in
a
Caveats.
Managed Care Setting:
Motheral, Brenda R.
Research Methodology:
Charges by Place and Type of Service. 1998; 4: 336. Comparative Research.
Hypotheses, Measurement, Reliability,and

Validity. 1998; 4: 382. ContinuingEducation.
Kleinstiver, Peter W. see Hedayati, Samuel, et

al.
Holubiak, Myron. Local Area Market Dynamics.

1998; 4: 115. Feature. Hopkins, Ursula K. see Hamilton, William R., et al. 1998; 4: 174. Comparative Research.
Mullenix, TimothyA. see Kozma, Chris M., et al. 1998; 4: 205. Comparative Research.
Kozma, Chris M., et al. DefiningStrategiesfor Peptic Ulcer Treatment: A Helicobacter pylori
Economic Cost Model. 1998; 4: 205.
Nee, Chris. Academic Detailing and HMG CoA

Agents. 1998; 4: 94. Feedback.
Hsiao, L. Daphne. see Bramlet, Dean A., et 1998; 4: 483. Comparative Research.
Hunter, Tracy S., see Desselle, Shane, et al. 1998; 4: 55. ContinuingEducation.
al.
Kramer, Jeffrey A. see Barisano, Anthony, et al. 1998; 4: 599. Comparative Research. Kucukarslan, Suzan N., et al. ResponseOriented Patient Evaluation Survey (ROPES): An Administrator's Tool for Identifying
Hurd, Peter D. see Shalita, Eric A., et al. 1998; 4: 413. ComparativeResearch. Hurd, Peter
D. see Schafermeyer, Kenneth W.
Parker, Dianne A. Kane. AdvancingOutcomes Research in Managed Care Pharmacy:A Call to

Action. 1998; 4: 257. Feature.
Opportunitiesfor Service Quality Improvement.
1998; 4: 504. ContinuingEducation. Hurd, Peter D. Research Methodology:Some

Statistical Considerations. 1998; 4: 617.
Pathak, Dev S. see Kucukarslan, Suzan N., et al. 1998; 4: 311. Comparative Research.
Patwell, John. see Wilson, Marcus, et al. 1998;
4: 194. DescriptiveReport.
Continuing Education.
Lai, L. Leanne, et al. Cost Benefit Analysis of

Pharmaceutical Care in a Medicaid
Pedersen, CraigA. Managed Care Pharmacy

at CreightonUniversity. 1998; 4: 324. Campus.
Hylan, Timothy R.
see Summers, Kent H., et al.
1998; 4: 42. Review.
Population-From a BudgetaryPerspective.
Phillips, Charles R., et al. The Pharmacist's

Assessment of Second Generation On-Line
1998; 4: 303. Comparative Research. Langley, Paul. The Information Requirements
Prospective Drug Utilization Review. 1998; 4:

183. Comparative Research. Poi konen, John. see Felkey, Bill G., et al. 1998;
4: 345. Continuing Education.
James, John D. see Shalita, Eric A., et 1998; 4: 413. Comparative Research.
al.
of Health Systems as Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary
Standards? 1998; 4: 593. Comparative
Kaldy,Joanne.
Ever.
Writers are More Welcome than
Research.
1998; 4: 6. Perspectives.
Larson, Lon L. see Phillips, Charles R., et al. 1998; 4: 183. Comparative Research.
Pressman, Alice. see Ettinger, Bruce, et al. 1998; 4: 488. ComparativeResearch.
Vol. 4, NO.6
jMCP
625
Annual Index
Reeder, C.E. see Kozma, Chris M., et
al.
1998;
Stoukides, CherylA. see Bramlet, Dean A., et

al.
AMCP conventions
AMCP Board Approves Annual Exhibit Program.
Richards, Warren. Pharmacy: LookingBack to

See the Future. 1998; 4: 454. Feature.
Summers, Kent H., et al. The Use of Economic Models in Managed Care Pharmacy
Decisions. 1998; 4: 42. Review.
1998; 4: 607. AMCP's 10th Annual Meeting Preliminary

Program. 1998; 4: 139. AMCP's 1998 Educational Conference
Salmon, J. Warren, et al. First Managed Care Pharmacy Course at the University of Illinois at
Chicago. 1998; 4: 80. Campus.
Summers, Kent. see Kucukarslan, Suzan al. 1998; 4: 311. Comparative Research.
N., et
Preliminary Program. 1998; 4: 395.
AMCP Reports
Tullio, Carl J. see Shalita, Eric A., et al. 1998;
Salmon, J. Warren, et al. The Vital Role of Pharmay Benefit Management Firms in Health
Services Research. 1998; 4: 23. Feature.
Managed Care Pharmacy Residency Programs. 1998; 4: 518.
AMCProgress
AMCP Approves Drafting of Guid~lines for
Salmon, J. Warren, et al. International

Movement of Japanese Pharmaceutical
Wanke, Lee A. Adverse Drug Events: A Plea for

Reporting and New Rules to Ease the Burden.
Industry:Reform of Japanese Health Policy,
1998; 4: 123. International. Salmon, J. Warren. see Chevalier, Kimiko, et

Part II.
1998; 4: 364. Perspectives. Wagner, Linda Timm. see Kenreigh, Charlotte A., et al. 1998; 4: 544. Caveats.
Weber, Mary
P. A Cost-Effective
Formulary Submissions. 1998; 4: 607. AMCP Approves Position Statement on Patient Confidentiality. 1998; 4: 534.
1998; 4: 567. International. Sardinha, Carol. Electronic Prescribing: The

al.
1998; 4: 607. AMCP Cooperateson Automation White Paper.

1998; 4: 607. AMCP Issues Position Statement on Therapeutic
Interchange. 1998; 4: 87. AMCP Joins "SCRIPT" Coalition to Investigate
Medication Problems. 1998; 4: 607. AMCP Office Move Complete. 1998; 4: 353. AMCP OpposesFDA Draft Guidance on Health
Promotion. 1998; 4: 436. AMCP Publishes Catalog of Quality Pharmacy
Indicators. 1998; 4: 87. AMCP to Collaborate with CDC. 1998; 4: 226. AMCP Voices Concern Over Proposed Federal
Rules.
Analysis of
Next Revolution in Pharmacy?1998; 4: 35.
AppetiteSuppressantsfor Obesity Treatment in

a
Spotlight.
Managed Care Organization.1998; 4: 293.

al.
Schafermeyer, Kenneth W. see Graden, Suzanne E., et al. 1998~4: 160. Continuing
Education.
White, Jennifer. see Minor, Paul A., et

4: 359. Caveats.
1998;
Schafermeyer, Kenneth W., et al. Research

Methodology:Designing a Research Study. 1998; 4: 504. ContinuingEducation.
Wilson, Marcus, et al. The Clinical and

Economic Implications of Drug Utilization
Patterns in the Treatment of Hypertension with
Schein, Jeffrey. see Ettinger, Bruce, et 1998; 4: 488. Comparative Research.
al.
ACE Inhibitors and Calcium Channel Blockers

in a Managed Care Setting. 1998; 4: 194.
Schwartz, Arnold and Marie. see Desselle, Shane, et al. 1998; 4: 102. Perspectives.
DescriptiveReport.
Wuller, Cynthia A. see Shalita, Eric A., et al. 1998; 4: 413. Comparative Research.
1998; 4: 353.
Shalita, Eric A., et al. PhysicianAttitudes

Toward Pharmacist-Run Anticoagulation Clinics
Academy Decries Proposal to End Need for Pharmacists. 1998; 4: 534.

Board Approves Supplementsto JMCP. 1998; 4:
in Department of Defense Health Services
226.
Region5. 1998; 4: 413. Comparative

Research.
Zimmerman, Allan. Successful Disease

Management Programs For Health And Welfare
al.
EliminatingPharmacists for Medicare/Medicaid? 1998; 4: 353.

HCFA Proposes Standards for Electronic
Transmission. 1998; 4: 436.
Shaw, Michele M. see Keyser, Mary S., et

Fund Union Groups. 1998; 4: 268. Feature.
New Brochure HighlightsDisease State

al.
Shaw, Michele M. see Keyser, Mary S., et

SUBJECT INDEX
ACE inhibitor
The Clinical and Economic Implications of Drug
Management. 1998; 4: 226.

Two New ResidencyActivities Approved. 1998; 4: 226.
Shoheiber, Omar. see Wilson, Marcus, et 1998; 4: 194. Descriptive Report.

Silver, Paula. see Ettinger, Bruce, et 4: 488. Comparative Research.
al.
al.
1998;
V., et
Singhal, Puneet K. see Gupchup, Gireesh al. 1998; 4: 495. ComparativeResearch.

Sorkin, Alan A. see Lai,
L.
Utilization Patterns in the Treatment of Hypertension with ACE Inhibitors and Calcium
Channel Blockers in a Managed Care Setting.
Abstracts, Articles Alendronate Use Among 812 Women: Prevalence of Gastrointestinal Complaints, Noncompliance
with Patient Instructions, and Discontinuation.
(Wilson, Marcus, et al.) 1998; 4: 194.
(Ettinger, Bruce, et al.) 1998; 4: 488.

Burnout in a Sample of HMO Pharmacists Using
Leanne, et al. 1998;
4: 303. ComparativeResearch.
Sorofman, Bernard A. see Phillips, Charles R., et al. 1998; 4: 183. Comparative Research.
ACG case-mix adjustment Cost Benefit Analysisof Pharmaceutical Care in

a
the Maslach Burnout Inventory. (Gupchup, Gireesh V., et al.) 1998; 4: 495.
Strand, Linda M. Managing Drug Therapy

Decisions: Pay Me Now or Pay Me Later. 1998;
Medicaid Population-From a Budgetary Perspective. (Lai, L. Leanne, et al.) 1998; 4:
303.
ChangingPractices in Home Inodilator Infusion Therapy for Advanced CongestiveHeart Failure. (Barrington, Monica.) 1998; 4: 73.
4: 242. Perspectives.
ALS, see Amyotrophic lateral sclerosis
626
jMCP
Vol. 4.
No.6
Annual Index
Clinical and Economic Implications of Drug
Utilization Patterns in the Treatment of Hypertensionwith ACE Inhibitors and Calcium Channel Blockers in a Managed Care Setting,
Research Methodology:Hypotheses,
Academy of Managed Care Pharmacy AMCP Approves Drafting of Guidelines for

Formulary Submissions. 1998; 4: 607:
Measurement, Reliability, and Validity.
(Motheral, Brenda R.) 1998; 4: 382. Research Methodology:Some Statistical

Considerations. (Hurd, Peter D.) 1998; 4: 617. Response-Oriented Patient Evaluation Survey
AMCP Approves Position Statement on Patient
The. (Wilson, Marcus, et al.) 1998; 4: 194. A Comparison of Hypercholesterolemia
Confidentiality. 1998; 4: 534. AMCP Board Approves Annual Exhibit Program.
Management in the Secondary Prevention of

Coronary Heart Disease by Payor Types: Fee-
An Administrator's Tool for Identifying (ROPES):
For-Service, Medicare, and Managed Care
Opportunities for Service Quality Improvement. (Kucukarslan,Suzan N., et al.) 1998; 4: 311.
1998; 4: 607. AMCP Cooperates on Automation White Paper.

1998; 4: 607.AMCP Issues Position Statement Therapeutic Interchange. 1998; 4: 87. AMCP Joins "SCRIPT" Coalition to Investigate
on
Organizations.(Bramlet, Dean A., et al.) 1998; 4: 483.A Cost-Eff!)ctive Analysis of Appetite
A Studyon the Characteristics of Prescription

Transmittal Processes and the Effect of Patient
Suppressantsfor Obesity Treatment in
PrescriptionReminder System on Patient

Compliance. (Hamilton,William R., et al.) 1998; 4: 174.
and Automation Update. (Felkey,Bill Technology et al.) 1998; 4: 345. G., Treatment of Patients with ALS: Implicationsfor
Medication Problems. 1998; 4: 607.
Managed Care Organization. (Weber, Mary P.) 1998; 4: 293.

Cost Benefit Analysisof Pharmaceutical Care in
a
AMCP Management Development Program.
Medicaid Population-From a Budgetary
Perspective. (Lai, L. Leanne, et al.) 1998; 4: 303. Defining Strategies for Peptic Ulcer Treatment: A
Helicobacter pylori Economic Cost Model.
1998; 4: 308, 371. AMCP Office Move Complete.1998; 4: 353. AMCP Opposes FDA Draft Guidance on Health Promotion. 1998; 4: 436.
AMCP to Collaborate with CDC. 1998; 4: 226. AMCP Voices Concern Over Proposed Federal
Rules.
the Managed Care Pharmacist. (Barisano,
Anthony, et al.) 1998; 4: 599. Use of Economic Models in Managed Care Pharmacy Decisions, The. (Summers, Kent H., et al.) 1998; 4: 42.
1998; 4: 353.AMCP Publishes Catalogof
(Kozma, Chris M., et al.) 1998; 4: 205. Efficacy and Safety of Anorexiant Medication in
the Treatment of Obesity: Implicationsfor
Quality Pharmacy Indicators. 1998; 4: 87. AMCP's 10th Annual Meeting Preliminary
Program. 1998; 4: 139.
AMCP's 1998 Educational Conference
Managed Care Formularies, The. (Anderson, Robert J., et al.) 1998; 4: 422..
Evolution of Pharmaceutical Care into Managed Care Environments, The. (Desselle, Shane, et
Abstracts, poster sessions Comparisonof SF-12 and SF-36 as Generic

Health-Related Quality-of-Life Measures in
Patients with Osteoarthritis. 1998; 4: 527. Comprehensive Review of Managed Care Formularies in the United States. 1998; 4: 528. CYP3A4: Undetermined Impact on 1.1 Million
al.) 1998; 4: 55. Formulary Management by an On-Site School of
Preliminary Program. 1998; 4: 395. Academy Decries Proposal to End Need for Pharmacists. 1998; 4: 534. Board Approves Supplementsto JMCP. 1998; 4: 226. ConnectingPhysiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473. Eliminating Pharmacists for Medicare/Medicaid?
Pharmacy Faculty Member in a Medicaid Managed Care Organization.(Gericke, Kristin R., et al.) 1998; 4: 407.
Gastroesophageal Reflux Disease in
a
Health Plan Members in Minnesota. 1998; 4:
Managed
Care Setting: Professional, Facility, and
531. Dihydropyridine Conversion: Was it a Good Decision? 1998; 4: 527.

Effect of a Closed Formulary on Pharmaceutical
1998; 4: 353. Expanding Pharmacy Students' Understandingof Managed Care. (Grapes,Z. Tom.) 1998; 4: 223.
HCFA Proposes Standards for Electronic
Pharmacy Charges. (Keyser,Mary S., et al.) 1998; 4: 64. Gastroesophageal Reflux Disease in a Managed
Care Setting: Charges by Place and Type of
Service. (Keyser, Mary S., et al.) 1998; 4:
Utilization, Expenditures,and Treatment

Continuation, The. 1998; 4: 528.
Patterns and Costs of Pharmaceutical Care
Managed Care Pharmacy ResidencyPrograms.

1998; 4: 518. MississippiMedicaid Waiver Breaks New Ground for Pharmacists. (Bloom,Marlene Z.) 1998; 4: 564.
New Brochure HighlightsDisease State Management. 1998; 4: 226.
Among Newly Treated Gastroesophageal Reflux

Patients: H2 Blockers (GERD Compared to Proton Pump Inhibitors. 1998; 4:
Disease
336.lnformation Requirements of Health Systems as Drug Purchasers: Does the FDA

Have a Role in Setting Evidentiary Standards?
531.Quality Improvement Initiatives in
(Langley, Paul C.) 1998; 4: 593. Performance Reporting for Managed Care PrescriptionPrograms. (Graden, Suzanne E., et
al.) 1998; 4: 160.
Pharmacist's Assessment of Second Generation
Managed Care Pharmacy Residency Program. 1998; 4: 527. Antihypertensive Reasons Given for Discontinuing
Medications. 1998; 4: 530. Research Experience and Interests of Managed
Care Organizations. 1998; 4: 530.
Pharmacy Internship Offers Real-World Exposure to Managed Care Pharmacy Practice. (Bataoel,
James R.) 1998; 4: 605.
Two New ResidencyActivities Approved. 1998; 4:
On-Line Prospective Drug Utilization Review, The. (Phillips, Charles R., et al.) 1998; 4: 183.
Validation of a Primary Open-angle Glaucoma
226.
PhysicianAttitudes Toward Pharmacist-Run Clinics in Department of Anticoagulation

Defense Health Services Region 5. (Shalita, Eric A., et al.) 1998; 4: 413.
CostingModel: Second-line Latanoprost vs. Dorzolamide vs. Brimonidine, Monotherapy,and in Combination with Beta-adrenergic Blockers.
1998; 4: 530.
Unmet Needs in Managed Care for Six Prominent
Diseases. 1998; 4: 528.
Accreditation
The Survey Syndrome. (Kenreigh,Charlotte A., et al.) 1998; 4: 544.
A Predictive Cost AnalysisModel for Estimating

Formulary Impact of New Products in Managed
Care. (Hedayati,Samuel, et al.) 1998; 4:
Adjudication
The Pharmacist's Assessment of Second Generation On-Line Prospective Drug Utilization Review. (Phillips, Charles R., et al.) 1998; 4:
584.Research Methodology:Designinga
Research Study. (Schafermeyer, Kenneth w., et al.) 1998; 4: 504.
Academic publishing
Writers Are More Welcome Than Ever. (Kaldy,
Joanne.) 1998; 4: 6.
183.
Vol 4, NO.6
}MlP
627
Annual Index
Adverse drug events
Adverse Drug Events: A Plea for Reporting and New Rules to Ease the Burden. (Wanke, Lee A.)
Argus Health Systems Inc.

Innovative Drug Formulary Management Through
Performance Reportingfor Managed Care PrescriptionPrograms. 1998; 4: 171.

Research Methodology:Designinga Research
1998; 4: 364.
Alendronate Use Among 812 Women: Prevalence
Computer-Assisted Protocols. (Bailey,Mihael, et al.) 1998; 4: 246. Asthma

Technologyand Automation Update. (Felkey, Bill G., et al.) 1998; 4: 345.
Study. 1998; 4: 515.

of Gastrointestinal Complaints,Noncompliance
Measurement, Reliability, and Validity. 1998; 4:
389"
Some Statistical Research Methodology: Considerations. 1998; 4: 622. Technologyand Automation Update. 1998; 4:
(Ettinger,Bruce, et al.) 1998; 4: 488. Treatment of Patients with ALS: Implicationsfor

Anthony,et al.) 1998; 4: 599.
Advertising
Health Care Communications Agencies Respond
to Managed Care. (Breault, Diane.) 1998; 4: 9. Patient as a Partner in Prescribing: Direct-to-
Automation AMCP Cooperates on Automation White Paper. 1998; 4: 607. Connecting Physiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473. Technologyand Automation Update. (Felkey,
Bill
351.
Calcium antagonist
Predictive Cost AnalysisModel for Estimating
et al.) 1998; 4: 345. G.,
Care.
Formulary Impact of New Products in Managed (Hedayati,Samuel, et al.) 1998; 4: 584.
Consumer Advertising, The. (Craig,Robert P.)
1998; 4: 15. Alendronate

Barriers
Evolution of Pharmaceutical Care into Managed Care Environments, The. (Desselle, Shane, et
Calcium channel blockers Clinical and Economic Implicationsof Drug

Channel Blockers in
a
of Gastrointestinal Complaints,Noncompliance
al.) 1998; 4: 55.

Performance Reportingfor Managed Care
PrescriptionPrograms. (Graden, Suzanne

al.) 1998; 4: 160.
E., et
The. (Wilson, Marcus, et al.)
Managed Care Setting, 1998; 4: 194.
Campus
Cooperative Learning in a RequiredOutcomes Assessment Course. (MacKinnon III, George E.)
Amyotrophic lateral sclerosis

Treatment of Patients with ALS: Implicationsfor
Pharmacy: LookingBack to See the Future. (Richards,Warren.) 1998; 4: 454. and Automation Update. (Felkey,Bill Technology
G., et al.)
Anthony, et al.) 1998; 4: 599.
1998; 4: 345.
Anorexiants
Cost-Effective Analysis of Appetite Suppressants
for ObesityTreatment in a Managed Care
Biotechnology
Biotechnologyas a Pharmacy Specialty. (Hargis, Jo Ellen.) 1998; 4: 465. International Movement of Japan's
Pharmaceutical Industry: Reform of Japanese Health Policies, Part III. (Chevalier,Kimiko, et
1998; 4: 432. ExpandingPharmacy Students' Understandingof Managed Care. (Grapes, Z. Tom.) 1998; 4: 223.
First Managed Care Pharmacy Course at the
University of Illinois at Chicago. (Salmon, J.

Warren, et al.) 1998; 4: 80. Managed Care Pharmacy at CreightonUniversity.
Organization.(Weber, Mary P.) 1998; 4: 293. Efficacy and Safety of Anorexiant Medication in
Managed Care Formularies, The. (Anderson, Robert J., et al.) 1998; 4: 422.
al.) 1998; 4: 567.
Bisphosphonates
of Gastrointestinal Complaints, Noncompliance
(Pederson, Craig A.) 1998; 4: 324. Pharmacy Internship Offers Real-World Exposure to Managed Care Pharmacy Practice. (Bataoel, James R.) 1998; 4: 605. University of Colorado School of Pharmacy and
the University of Colorado Health Plan Forge a
Anticoagulation clinic
Attitudes Toward Pharmacist-Run Physician
Clinics in Department of Anticoagulation Defense Health Services Region 5. (Shalita,

Eric A., et al.) 1998; 4: 413.
PBM Partnership,The. (Grier,Dana, et al.)
1998; 4: 478.
Cancer OncologyDrugs and Managed Care. (Hessen, Jody.) 1998; 4: 374. Treatment of Patients withALS: Implicationsfor
Blue Cross Blue Shield

Evolution of Best-in-Class Pharmacy
Antineoplastics
Oncology Drugs and Managed Care. (Hessen, Jody.) 1998; 4: 374. for Treatment of Patients with ALS: Implications
Management Techniques,The. (Boland,Beth.)

1998; 4: 366.
Burnout
Anthony, et al.) 1998; 4: 599. Case management and Automation Update. (Felkey,Bill Technology G., et al.) 1998; 4: 345.
Anthony,et al.) 1998; 4: 599.
the Maslach Burnout Inventory. (Gupchup,

Gireesh V., et al.) 1998; 4: 495.
Appetite suppressants
Cost-Effective Analysisof Appetite Suppressants
Organization.(Weber, Mary P.) 1998; 4: 293.
CDC, see Centers for Disease Control
CE Exam
Evolution of Pharmaceutical Care into Managed
Caveats Counseling:Where Does The Profession Stand? (Beardsley,Bob, et al.) 1998; 4: 78.
If It Is Worth Doing, It Is Worth DoingWell. Then.Proven. (Minor, Paul A., et al.) 1998; 4:
. .
Care Environments, The. 1998; 4: 61.
359.
628
jMCP
Vol. 4.
No.6
Annual Index
NTI Debate, The. (Brunner, Lane J.) 1998; 4: 289.
Comparison of Hypercholesterolemia
Pharmacy:Over- or Under-Regulated? (Ginsburg,Diane B., et al.) 1998; 4: 193.

Patient Protection: Will Pharmacoeconomics
Management in the Secondary Prevention of

Coronary Heart Disease by Payor Types: FeeFor-Service, Medicare, and Managed Care
Consumers Advancing Outcomes Research in Managed Care

Pharmacy: A Call to Action. (Parker, Dianne A. Kane.) 1998; 4: 257.
Health Care Communications AgenciesRespond
to Managed Care. (Breault, Diane.) 1998; 4: 9.
Complementor Conflict? (Hauser, Robert.) 1998; 4: 381.

Survey Syndrome, The. (Kenreigh,Charlotte A., et al.) 1998; 4: 544.
Organizations.(Bramlet, Dean A., et al.) 1998;

4: 483.
Cost Benefit Analysisof Pharmaceutical Care in a

Patient as a Partner in Prescribing: Direct-toConsumer Advertising, The. (Craig, Robert P.)
Centers for Disease Control

AMCP to Collaborate with CDC. 1998; 4: 226.
.
.
1998; 4: 15.
303.
Cost-Effective Analysis of
Appetite Suppressants
Continuing Education
Care Environments, The. (Desselle, Shane, et
Cholesterol management
Comparisonof Hypercholesterolemia Management in the Secondary Prevention of

Coronary Heart Disease
Organization. (Weber, Mary P.) 1998; 4: 293. Defining Strategies for Peptic Ulcer Treatment: A
al.) 1998; 4: 55.

Performance Reportingfor
Managed Care
by Payor Types: Fee-
Organizations. (Bramlet, Dean A., et al.) 1998;

4: 483.
M., et al.) 1998; 4: 205. Formulary Management by an On-Site School of Pharmacy F1:!cultyMember in a Medicaid
(Kozma, Chris
Prescription Programs. (Graden, Suzanne E., et al.) 1998; 4: 160.

Research Methodology:Designing a Research
Technologyand Automation Update. (Felkey,Bill G., et al.) 1998; 4: 345.
Managed Care Organization. (Gericke, Kristin R., et al.) 1998; 4: 407. Gastroesophageal Reflux Disease in a Managed
Care Setting: Charges by Place and Type of
Service. (Keyser, Mary S., et al.) 1998; 4: 336.
Chugai Pharmaceutical Co., ltd.

International Movement of Japan's
Study. (Schafermeyer, Kenneth w., et al.) 1998; 4: 504. Research Methodology:Hypotheses, Measurement, Reliability, and Validity.
(Motheral, Brenda R.) 1998; 4: 382.

Research Methodology:Some Statistical
Pharmaceutical Industry: Reform of Japanese
Reflux Gastroesophagal
Disease in a Managed
Health Policies, Part III. (Chevalier,Kimiko, et al.) 1998; 4: 567.
Pharmacy Charges. (Keyser, Mary S., et al.) 1998; 4: 64.

Information Requirements of Health Systems as
Considerations. (Hurd, Peter D.) 1998; 4: 617. Technologyand Automation Update. (Felkey, Bill G., et al.) 1998; 4: 345.
Colleges of pharmacy
Cooperative Learning in
a
RequiredOutcomes
Drug Purchasers: Does the FDA Have
Role in
Cooperative learning
Cooperative Learning in 1998; 4: 432.
a
Assessment Course. (MacKinnonIII, GeorgeE.)
1998; 4: 432.
Setting EvidentiaryStandards? (Langley,Paul C.) 1998; 4: 593.

On-Line Prospective Drug Utilization Review,
Required Outcomes
Assessment Course. (MacKinnonIII, GeorgeE.)
University of Illinois at
Chicago. (Salmon, J.
Warren, et al.) 1998; 4: 80. Managed Care Pharmacy at CreightonUniversity.
The. (Phillips, Charles R., et al.) 1998; 4: 183. PhysicianAttitudes Toward Pharmacist-Run
Coronary heart disease Comparison of Hypercholesterolemia Management in the SecondaryPrevention of

Coronary Heart Disease by Payor Types: Fee.
(Pederson, CraigA.) 1998; 4: 324. University of Colorado School of Pharmacy and

PBM Partnership, The. (Grier, Dana, et al.)
AnticoagulationClinics in Department of Defense Health Services Region 5. (Shalita, Eric et al.) 1998; 4: 413. A.,
Predictive Cost Analysis Model for Estimating
Organizations.(Bramlet, DeanA., et al.) 1998;

4: 483.
1998; 4: 478.
Communications
Health Care Communications Agencies Respond to Managed Care. (Breault, Diane;) 1998; 4: 9. Importance of Communication Skills for the
Formulary Impact of New Products in Managed Care. (Hedayati,Samuel, et al.) 1998; 4: 584. Response-Oriented Patient Evaluation Survey
(ROPES): An Administrator's Tool for Identifying

Opportunitiesfor Service Quality Improvement. (Kucukarslan,Suzan N., et al.) 1998; 4: 311.
Cost benefit analysis Cost Benefit Analysis of Pharmaceutical Care in Medicaid Population-From a Budgetary Perspective. (Lai, L. Leanne, et al.) 1998; 4:
303.
Managed Care Pharmacist, The. (Desselle, ShaneJ 1998;4:102.
Study on the Characteristics of Prescription

Comparative Research
Prescription Reminder System on Patient
with Patient Instructions, and Discontinuation. (Ettinger, Bruce, et al.) 1998; 4: 488.
Compliance. (Hamilton,William R., et al.) 1998; 4: 174. Treatment of Patients with ALS: Implicationsfor
Cost effectiveness Cost-Effective Analysisof Appetite Suppressants for ObesityTreatment in a Managed Care Organization. (Weber, Mary P.) 1998; 4: 293.
Formulary Management by an On-Site School of PharmacyFaculty Member in a Medicaid
Managed Care Organization. (Gericke, Kristin R., et al.) 1998; 4: 407. Predictive Cost Analysis Model for Estimating
Anthony, et al.) 1998; 4: 599.
the Maslach Burnout Inventory. (Gupchup, Gireesh V., et al.) 1998; 4: 495. Practices in Home Inodilator Infusion Changing
Congestive heart failure

ChangingPractices in Home Inodilator Infusion Therapyfor Advanced CongestiveHeart Failure.
(Barrington, Monica.) 1998; 4: 73.
Formulary Impact of New Products in Managed Care. (Hedayati,Samuel, et al.) 1998; 4: 584.
Therapy for Advanced Congestive Heart Failure. (Barrington, Monica.) 1998; 4: 73.
Vol 4, NO.6
jMCP
629
Annual Index
Costs
DefiningStrategiesfor Peptic Ulcer Treatment: A
Helicobacter pyloriEconomic Cost Model.
Efficacy and Safety of Anorexiant Medication in

the Treatment of Obesity: Implications for
1998; 4: 478.
(Kozma, Chris M., et al.) 1998; 4: 205. Evolution of Best-in-Class Pharmacy
Managed Care Formularies, The. (Anderson, Robert J., et al.) 1998; 4: 422. Detailing, academic
Academic Detailing and HMG CoA Agents. (Nee,
ManagementTechniques,The. (Boland, Beth.) 1998; 4: 366.

Formulary Management by an On-Site School of
Daiichi Pharmaceutical Co., Ltd. International Movement of Japan's

Pharmaceutical Industry:Reform of Japanese
Chr,is.)1998; 4: 94.
Pharmacy Faculty Member in a Medicaid Managed Care Organization. (Gericke, Kristin

R., et al.) 1998; 4: 407. Gastroesophageal Reflux Disease in
a
Health Policies, Part
III.
(Chevalier,Kimiko, et
al.) 1998; 4: 567.
Dexfenfluramine
Cost -Effective Analysis of Appetite Suppressants for ObesityTreatment in a Managed Care
Managed
Care Setting: Charges by Place and Type of Service. (Keyser,Mary S., et al.) 1998; 4: 336.
Data collection Vital Role of Pharmacy Benefit Management

Firms in Health Services Research, The.
Organization, (Weber, Mary P.) 1998; 4: 293. Efficacy and Safety of Anorexiant Medication in
Managed
(Salmon, J. Warren, et al.) 1998; 4: 23. Decision making

Advancing Outcomes Research in Managed Care
Pharmacy Charges. (Keyser,Mary S., et al.)

1998; 4: 64. Innovative Drug Formulary Management Through Computer-Assisted Protocols. (Bailey, Michael, et al.) 1998; 4: 246.
Pharmacy: A Call to Action. (Parker, Dianne A.
Kane.) 1998; 4: 257.

Health Care Communications Agencies Respond to Managed Car~. (Breault, Diane.) 1998; 4: 9. Information Requirements of Health Systems as
Diabetes Technologyand Automation Update. (Felkey, Bill G., et al.) 1998; 4: 345.
Disease state management Defining Strategiesfor Peptic Ulcer Treatment:
Managing DrugTherapy Decisions: Pay Me Now or Pay Me Later. (Strand, Linda M.) 1998; 4:
242. Pharmacy:LookingBack to See the Future.
Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards? (Langley,Paul
C.) 1998; 4: 593.
Local Area Market Dynamics. (Holubiak,Myron.)
(Richards,Warren.) 1998; 4: 454. State-by-State Look at Medicaid Retail

Pharmacy Delivery: Trials & Triumphs.
(Kozma, Chris M., et al.).1 998; 4: 205. Developing Disease State Management in the
United Kingdom:An Obviously American
(McPeak, Mary Ellen.) 1998; 4: 546.
1998; 4: 115. Managing Drug Therapy Decisions: Pay Me Now or Pay Me Later. (Strand, LindaM.) 1998; 4:
242. OncologyDrugs and Managed Care. (Hessen,
Conjecture Finds Export OpportunitiesAbroad.

(Lin, Swu-Jane.) 1998; 4: 275. Evolution of Best-in-Class Pharmacy
Cover Impressions
Flowers and Birds. (Kaldy,Joanne.) 1998; 4: 97.
Management Techniques, The. (Boland, Beth.)
Kindred Spirits. (Kaldy,Joanne.) 1998; 4: 237. Room in Brooklyn. (Baran, Robert W.) 1998; 4: 1. Several Circles. (Kaldy,Joanne.) 1998; 4: 447. The Skater. (Kaldy,Joanne.) 1998; 4: 539. Springtime. (Kaldy,Joanne.) 1998; 4: 359.
Jody.) 1998; 4: 374. Predictive Cost Analysis Model for Estimating

Care. (Hedayati, Samuel, et
1998; 4: 366.
New Brochure Highlights Disease State
.
Management. 1998; 4: 226.
al:)1998;
4: 584.
Designing a Research Research Me~hodology: Study. (Schafermeyer,Kenneth W., et al.) 1998; 4: 504. Use of Economic Models in Managed Care Pharmacy Decisions, The. (Summers, Kent H., et al.) 1998; 4: 42. Decision tables Cooperative Learning in a Required Outcomes Assessment Course. (MacKinnonIII, GeorgeE.)
OncologyDrugs and Managed Care. (Hessen, Jody.) 1998; 4: 374. MississippiMedicaid Waiver Breaks New Ground for Pharmacies. (Bloom, Marlene Z.) 1998; 4:
564. State-by-State Look at Medicaid Retail
Credentialing
If it Is Worth Doing, It Is Worth DoingWell. Then .. Proven. (Minor, Paul A., et al.) 1998; 4: 359.
Curriculum
AMCP's 1998 Educational Conference. 1998; 4:
.
Pharmacy Delivery: Trials & Triumphs, (McPeak, Mary Ellen.) 1998; 4: 546.
Successful Disease Management Programs For Health And Welfre Fund Union Groups.
395.
Pharmacy:A Call to Action. (Parker, Dianne A. Kane.) 1998; 4: 257.

Learning in a RequiredOutcomes Cooperative Assessment Course. (MacKinnon III, George E.)
1998; 4: 432.
(Zimmerman, Allan.) 1998; 4: 268. Treatment of Patients withALS: Implicationsfor

1998; 4: 432. ExpandingPharmacy Students' Understandingof Managed Care. (Grapes,Z. Tom.) 1998; 4: 223. First Managed Care Pharmacy Course at the University of Illinois at Chicago. (Salmon, J. Warren, et al.) 1998; 4: 80. Managed Care Pharmacy at Creighton University. (Pederson,CraigA.) 1998; 4: 324. University of Colorado School of Pharmacy and
Decision trees Cooperative Learning in a Required Outcomes Assessment Course. (MacKinnonIII, George E.)
.
Anthony, et al.) 1998; 4: 599.
Documentation
1998; 4: 432.
Descriptive Reports
.

Utilization Patterns in the Treatment of
al.) 1998; 4: 55. Performance Reporting for Managed Care
Prescription Programs. (Graden, Suzanne E., et

al.) 1998; 4: 160.
Hypertension with ACE Inhibitors and Calcium

Channel Blockers in a Managed Care Setting,
The. (Wilson, Marcus, et al.) 1998; 4: 194.
630
}MP
VoL 4,
No.6
Annual Index
Drug misadventuring
The Vital Role of Pharmacy Benefit Management
Firms in Health Services Research. (Salmon, J.
Dyspepsia DefiningStrategiesfor Peptic Ulcer Treatment: A


al.) 1998; 4: 55.
Warren, et al.) 1998; 4: 23.
(Kozma, Chris M., et al.) 1998; 4: 205.
Drug safety
ExpandingPharmacy Students' Understandingof Managed Care. (Grapes, Z. Tom.) 1998; 4: 223. First Managed Care Pharmacy Course at the
University of Illinois at Chicago. (Salmon, J.
Warren, et al.) 1998; 4: 80. Managed Care Pharmacy at Creighton University.
Economic models
(Ettinger, Bruce, et al.) 1998; 4: 488. Efficacy and Safety of Anorexiant Medication in
the Treatment of

Channel Blockers in a Managed Care Setting, The. (Wilson, Marcus, et al.) 1998; 4: 194. Use of Economic Models in Managed Care
besity: Implicationsfor
(Pederson,CraigA.) 1998; 4: 324. Managed Care Pharmacy Residency Programs. 1998; 4: 518.
Performance Reporting for Managed Care
Drugs, biotech Biotechnology as a Pharmacy Specialty. (Hargis, Jo Ellen.) 1998; 4: 465.
Pharmacy Decisions, The. (Summers, Kent H., et al.) 1998; 4: 42.
Prescription Programs. (Graden,Suzanne E., et al.) 1998; 4: 160. Pharmacy Internship Offers Real-World Exposure to Managed Care Pharmacy Practice. (Bataoel,
James R.) 1998; 4: 605.
Research Methodology: Designinga Research
Economics
Drug therapy/use
AMCP Joins "SCRIPT" Coalition to Investigate
Medication Problems. 1998; 4: 607.
Adverse Drug Events: A Plea for Reporting?nd

The. (Wilson, Marcus, et al.) 1998; 4: 194. DefiningStrategies for Peptic Ulcer Treatment: A Helicobacter pylori Economic Cost Model. (Kozma, Chris M., et al.) 1998; 4: 205.
New Rules to Ease the Burden. (Wanke, Lee A.)
1998; 4: 364.
Study. (Schafermeyer,Kenneth w., et al.) 1998; 4: 504. Research Methodology: Hypotheses, Measurement,Reliability, and Validity. (Motheral, Brenda R.) 1998; 4: 382.
Research Methodology: Some Statistical
Considerations. (Hurd, Peter D.) 1998; 4: 617. Technologyand Automation Update. (Felkey, Bill G., et al.) 1998; 4: 345.

Gastroesophageal Reflux Disease in a Managed Care Setting: Charges by Place and Type of
Service. (Keyser,Mary S., et al.) 1998; 4: 336.
Managed
Two New Residency Activities Approved. 1998; 4:

a
226.
Pharmacy Charges. (Keyser, Mary S., et al.) 1998; 4: 64.

University of Colorado School of Pharmacy and

303.
PBM Partnership, The. (Grier,Dana, et al.)
for ObesityTreatment in a M~nagedCare
Drug Purchasers: Does the FDA Have a Role in Setting EvidentiaryStandards? (Langley,Paul
C.) 1998; 4: 593.
International Movement of Japanese
1998; 4: 478.
Electronic communication
Electronic Prescribing: The Next Revolution in
Organization. (Weber, Mary P.) 1998; 4: 293.Electronic Prescribing:The Next Revolution

in Pharmacy? (Sardinha, CaroL) 1998; 4: 35. Local Area Market Dynamics. (Holubiak, Myron.)
Pharmaceutical Industry: Reform of Japanese Health Policy, Part II. (Salmon, J. Warren, et al.)
Pharmacy?(Sardinha,CaroL) 1998; 4: 35.

Connecting Physiciansto Pharmaciesand
Patients. 1998; 4: 473. HCFAProposes Standards for Electronic
1998; 4: 115. ManagingDrug TherapyDecisions: Pay Me Now or Pay Me Later. (Strand, Linda M.) 1998; 4: 242. NTI Debate, The. (Brunner, Lane J.) 1998; 4: 289.
OncologyDrugs and Managed Care. (Hessen, Jody.) 1998; 4: 374.
1998; 4: 123.
Education
1998; 4: 607. AMCP Management Development Program. 1998; 4: 308, 371. AMCP's 1998 Educational Conference. 1998; 4:
Computer-Assisted Protocols. (Bailey,Michael,

et al.) 1998; 4: 246.
Pharmacist's Assessment of Second Generation On-Line Prospective Drug Utilization Review. (Phillips, Charles R., et al.) 1998; 4: 183. Technologyand Automation Update. (Felkey, Bill
G., et al.) 1998; 4: 345. University of Colorado School of Pharmacy and
Drug utilization review

158,178,326,395,521.
Advancing Outcomes Research in Managed Care Pharmacy: A Call to Action. (Parker, Dianne A. Kane.) 1998; 4: 257.
Computer-AssistedProtocols. (Bailey,Michael, et al.) 1998; 4: 246.

On-Line Prospective Drug Utilization Review, The. (Phillips, Charles R., et al.) 1998; 4: 183.
CooperativeLearning in 1998; 4: 432.
Required Outcomes
the University of Colorado Health Plan Forge a PBM Partnership, The. (Grier, Dana, et al.)
Assessment Course. (MacKinnon III, George E.)

1998; 4: 478.
Electronic prescribing ConnectingPhysicians to Pharmacies-and
Patients. (Bloom, Marlene Z.) 1998; 4: 473.
Formulary Impact of New Products in Managed (Hedayati,Samuel, et al.) 1998; 4: 584. State-by-State Look at Medicaid Retail
Care.
1998; 4: 366.
Pharmacy Delivery:Trials & Triumphs.
Vol. 4,
No.6
jMCP
631
Annual Index
Pharmacy?(Sardinha,Carol.) 1998; 4: 35. and Automation Update. (Felkey,Bill Technology

G., et al.)
Fee-for-service Comparison of Hypercholesterolemia Management in the Secondary Prevention of

Coronary Heart Disease by Payor Types:.FeeFor-Service, Medicare, and Managed Care
FormularyManagement by an On-Site School of

Pharmacy Faculty Member in a Medicaid Managed Care Organization.(Gericke, Kristin R., et al.) 1998; 4: 407.
1998; 4: 345.
FDA, see Food and Drug Administration

FTC, see Federal Trade Commission
Organizations.(Bramlet, Dean A., et al.) 1998; 4: 483.
Computer-AssistedProtocols. (Bailey,Michael, et al.) 1998; 4: 246.

Fenfluramine
Features Outcomes Research in Managed Care Advancing Pharmacy:A Call to Action. (Parker, Dianne A. Kane.) 1998; 4: 257.
Biotechnology as
a
Formulary Impact of New Products in Managed Care. (Hedayati, Samuel, et al.) 1998; 4: 584. State-by-State Look at Medicaid Retail
Organization. (Weber, Mary P.) 1998; 4: 293. Efficacy and Safety of Anorexiant Medication in
Pharmacy Delivery:Trials & Triumphs. (McPeak, Mary Ellen.) 1998; 4: 546. Use of Economic Models in Managed Care
Pharmacy Decisions, The. (Summers, Kent H.,
et al.) 1998; 4: 42.
Pharmacy Specialty. (Hargis,
Managed Care Formularies, The. (Anderson,

Robert J.,
Jo Ellen.) 1998; 4: 465.
t al.) 1998;
4: 422.
Fluoxetine
Cost-Effective Analysisof Appetite Suppressants
Fosamax
Alendronate Use Among 812 Women: Prevalence of Gastrointestinal Complaints,Noncompliance
1998; 4: 366.
to Managed Care. (Breault, Diane.) 1998; 4: 9. Innovative Drug Formulary Management Through

Foundation of Managed Care Pharmacy
Computer-AssistedProtocols. (Bailey,Michael,
et al.) 1998; 4: 246.
Managed Care Formularies, The. (Anderson, Robert J., et al.) 1998; 4: 422. Food and Drug Administration Information Requirements of Health Systems as
Drug Purchasers: Does the FDA Have a Role in Setting EvidentiaryStandards? (Langley,Paul C.) 1998; 4: 593.
NTI Debate, The. (Brunner, Lane J) 1998; 4: 289. Patient as a Partner in Prescribing:Direct-toConsumer Advertising, The. (Craig, Robert P.)
University of Illinois at Chicago. (Salmon, J

Warren, et al.) 1998; 4: 80. Campus.
1998; 4: 115. MaximizingGeneric Substitution in Managed Care. (Keating, Edward J.) 1998; 4: 557.
Medicare and Managed Care: Emerging
Funding, capitated
Developing Disease State Management in the United Kingdom:An Obviously American
Conjecture Finds Export OpportunitiesAbroad. (Un, Swu-Jane.) 1998; 4: 275.
Partnerships. (Clark, David C.) 1998; 4: 105. OncologyDrugs and Managed Care. (Hessel],
Jody.) 1998; 4: 374.

Patient as a Partner in Prescribing:Direct-toConsumer Advertising, The. (Craig, Robert P.)
Fujisawa Pharmaceutical Co., Ltd.

1998; 4: 15. Pharmacy: LookingBack to See the Future. (Richards,Warren.) 1998; 4: 454. Successful Disease Management Programs For
Health And Welfare Fund Union Groups.
1998; 4: 15. Food and Drug Administration draft guidance

AMCP Opposes FDA Draft Guidance on Health
Promotion. 1998; 4: 436. AMCP Voices Concern Over Proposed Federal Rules. 1998; 4: 353.
Pharmaceutical Industry: Reform of Japanese Health Policies, Part

III.
(Chevalier, Kimiko, et
al.) 1998; 4: 567.
(Zimmerman,Allan.) 1998; 4: 268. Vital Role of Pharmacy Benefit Management

Future
The Next Revolution in Electronic Prescribing:
Patient as
a Partner
in Prescribing:Direct-to-
Consumer Advertising, The. (Craig, Robert P.)
(Salmon,J. Warren, et al.) 1998; 4: 23.

Federal Trade Commission
1998; 4: 15.
Pharmacy? (Sardinha,Carol.) 1998; 4: 35. Integration:The Future of Pharmacy. (Fallik,

Bruce B.) 1998; 4: 452.
Foreign competition
Performance Reporting for Managed Care
PrescriptionPrograms. (Graden,Suzanne
al.) 1998; 4: 160. Pharmacy: LookingBack to See the Future. (Richards, Warren.) 1998; 4: 454.
E., et
1998; 4: 15. Information Requirementsof Health Systems as

Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards? (Langley,Paul
C.) 1998; 4: 593.
Health Policy,Part
II.
(Salmon, J. Warren, et al.)
1998; 4: 123.
Formulary
AMCP Approves Drafting of Guidelines for
Formulary Submissions. 1998; 4: 607. Advancing Outcomes Research in Managed Care
Gastritis
DefiningStrategies for Peptic Ulcer Treatment: A

Feedback
Academic Detailing and HMG CoA Agents. (Nee,
Chris.)1998; 4: 94.
Pharmacy: A Call to Action. (Parker, Dianne A. Kane.) 1998; 4: 257.

Gastroesophageal Reflux Disease

a
Managed
Managed Care Formularies, The. (Anderson, Robert J, et al.) 1998; 4: 422.
Care Setting: Chargesby Place and Type of
Service. (Keyser, Mary S., et al.) 1998; 4: 336.
632
jMCP
Vol. 4,
No.6
Annual Index
a
Managed
Health care, private DevelopingDisease State Management in the

Hypertension
Clinical and Economic Implicationsof Drug
Channel Blockers in a Managed Care Setting, The. (Wilson, Marcus, et al.) 1998; 4: 194.
Pharmacy Charges. (Keyser, Mary S., et al.) 1998; 4: 64. General practitioner
Conjecture Finds Export OpportunitiesAbroad.
(Un, Swu-Jane.) 1998; 4: 275.
DevelopingDisease State Management in the United Kingdom:An Obviously American Conjecture Finds Export Opportunities Abroad. (Un, Swu-Jane.) 1998; 4: 275.
Generic drugs
Health care reform Pharmacy: LookingBack to See the Future. (Richards,Warren.) 1998; 4: 454.
Health care research Vital Role of Pharmacy Benefit Management
Firms in Health Services Research, The. (Salmon, J. Warren, et al.) 1998; 4: 23.
Technology and Automation Update. (Felkey,Bill G., et al.) 1998; 4: 345.
Hypotheses
Maximizing Generic Substitution in Managed Care. (Keating, Edward J.) 1998; 4: 557. NTI Debate, The. (Brunner, Lane J.) 1998; 4: 289.
GERD, see Gastroesophageal Reflux Disease
(Motheral, Brenda R.) 1998; 4: 382. Independent practice associations

Maximizing Generic Substitution in Managed
Care. (Keating, Edward J.) 1998; 4: 557.
Health Plan of the Redwoods

.
Guidelines
AMCP Approves Drafting of Guidelines for Formulary Submissions. 1998; 4: 607. AMCP Voices Concern Over Proposed Federal Rules. 1998; 4: 353.
Adverse Drug Events: A Plea for Reporting and
Computer-Assisted Protocols. (Bailey, Michael, et al.) 1998; 4: 246.
Health Plans and Employment Data Information Set

AMCP Publishes Catalogof Quality Pharmacy
Indicators. 1998; 4: 87. Medicare and Managed Care: Emerging
Informatics ConnectingPhysicians to Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473.

Technologyand Automation Update. (Felkey,Bill G., et al.) 1998; 4: 345.
Infusion therapy
New Rules to Ease the Burden. (Wanke, Lee A.)
1998; 4: 364.
Partnerships. (Clark, David C.) 1998; 4: 105. Vital Role of Pharmacy Benefit Management
HCFA, see Health Care Financing

Administration
ChangingPractices in Home Inodilator Infusion Therapy for Advanced Congestive Heart Failure.
(Barrington,Monica.) 1998; 4: 73.
Inodilator infusion therapy
Practices in Home Inodilator Infusion Changing
(Salmon, J. Warren, et al.) 1998; 4: 23.

Health policy, foreign
International Movement of Japanese Pharmaceutical Industry: Reform of Japanese
HEDlS, see Health Plans and Employment
Data Information Set

Health Alliance Plan Electronic Prescribing:The Next Revolution in Pharmacy? (Sardinha,Carol.) 1998; 4: 35. Pharmacy Internship Offers Real-World Exposure
to Managed Care Pharmacy Practice. (Bataoel,
Therapy for Advanced Congestive Heart Failure.
Health Policy,Part
II.
(Barrington,Monica.) 1998; 4: 73. Integrated health care delivery systems Pharmacy: Looking Back to See the Future. (Richards,Warren.) 1998; 4: 454. International DevelopingDisease State Management in the United Kingdom:An ObviouslyAmerican Conjecture Finds Export OpportunitiesAbroad.
(Un, Swu-Jane.) 1998; 4: 275.
Focus on International. 1998; 4: 88. International Movement of Japanese
1998; 4: 123.

Health Policies, Part III. (Chevalier, Kimiko, et
James R.) 1998; 4: 605.
al.) 1998; 4: 567.
Health and welfare fund union groups Successful Disease Management Programs For
Helicobacter pylori DefiningStrategiesfor Peptic Ulcer Treatment: A

(Zimmerman, Allan.) 1998; 4: 268.
Health care Pharmacy: LookingBack to See the Future. (Richards,Warren.) 1998; 4: 454. Health care market
HMG CoA Academic Detailingand HMG CoA Agents. (Nee, Chris.) 1998; 4: 94.
Health POlicy,Part
II.
1998; 4: 123.
Hypercholesterolemia
Comparison of Hypercholesterolemia Management in the Secondary Prevention of
Coronary Heart Disease by PayorTypes:FeeFor-Service, Medicare, and Managed Care
III.
al.) 1998; 4: 567.
Health POlicy,Part II. (Salmon, J. Warren, et al.)
1998; 4: 123.
Local Area Market Dynamics. (Holubiak, Myron.)'
Organizations. (Bramlet, Dean A., et al.) 1998;

4: 483.
Japan
International Movement of Japanese Pharmaceutical Industry: Reform of Japanese Health Policy,Part II. (Salmon,J. Warren, et al.)
1998; 4: 115.
Health Care Financing Administration Medicare and Managed Care: Emerging
Partnerships. (Clark, David C.) 1998; 4: 105.
1998; 4: 123.
VoL 4.
No.6
}MCfl.
633
Annual Index
International Movement of Japan's Pharmaceutical Industry: Reform of Japanese
Health Policies, Part III. (Chevalier,Kimiko, et

al.) 1998; 4: 567.
OncologyDrugs and Managed Care. (Hessen, Jody.) 1998; 4: 374. Performance Reportingfor Managed Care
PrescriptionPrograms. (Graden, Suzanne E., et al.) 1998; 4: 160. Predictive Cost AnalysisModel for Estimating
Formulary Impact of New Products in Managed Care. (Hedayati,Samuel, et al.) 1998; 4: 584. Response-Oriented Patient Evaluation Survey
Medicaid
AMCP Voices Concern Over Proposed Federal
Rules. 1998; 4: 353. Cost Benefit Analysis of Pharmaceutical Care in
a
Medicaid Population-From a Budgetary Perspective.(Lai, L. Leanne, et al.) 1998; 4:
Law.
Maximizing Generic Substitution in Managed Care. (Keating, Edward J) 1998; 4: 557.

Pharmacy: Over- or Under-Regulated?(Ginsburg, Diane B., et al.) 1998; 4: 193.
303. Eliminating Pharmacists for Medicare/Medicaid?
Legislation
NTI Debate, The. (Brunner, Lane J) 1998; 4: 289.
Opportunitiesfor Service Quality Improvement. (Kucukarslan,Suzan N., et al.) 1998; 4: 311.

State-by-State Look at Medicaid Retail Pharmacy Delivery: Trials & Triumphs.
1998; 4: 353. Formulary Management by an On-Site School of Pharmacy Faculty Member in a Medicaid
Managed Care Organization.(Gericke, Kristin R, et al.) 1998; 4: 407.
If It Is Worth Doing, It Is Worth DoingWelL.. Then Proven. (Minor, Paul A., et al.) 1998; 4:
MCOs, see Managed Care Organizations Managed care

Clinical and Economic Implicationsof Drug
Managed care organizations

359.
for Obesity Treatment in a Managed Care
Utilization Patterns in the Treatment of Hypertension with ACE Inhibitors and Calcium Channel Blockers in a Managed Care Setting,
Organization. (Weber, Mary P.) 1998; 4: 293. Formulary Management by an On-Site School of PharmacyFaculty Member in a Medicaid Managed Care Organization. (Gericke, Kristin R, et al.) 1998; 4: 407.
Partnerships. (Clark, David C.) 1998; 4: 105. MississippiMedicaid Waiver Breaks New Ground for Pharmacies. (Bloom, Marlene Z.) 1998; 4:
564.

On-Line Prospective Drug Utilization Review, The. (Phillips, Charles R., et al.) 1998; 4: 183. State-by-State Look at Medicaid Retail
Organizations. (Bramlet, Dean A., et al.) 1998; 4: 483. Efficacy and Safety of Anorexiant Medication in
Marketing
Advancing Outcomes Research in Managed Care Pharmacy:A Call to Action. (Parker,Dianne A.
Kane.) 1998; 4: 257. Health Care Communications Agencies Respond
to Managed Care. (Breault, Diane.) 1998; 4: 9. Information Requirements of Health Systems as
Medicare
Comparison of Hypercholesterolemia Management in the Secondary Prevention of
Managed Care Formularies, The. (Anderson, Robert J, et al.) 1998; 4: 422. Evolution of Pharmaceutical Care into Managed
Drug Purchasers: Does the FDA Have

C.) 1998; 4: 593.
a Role in
al.) 1998; 4: 55. First Managed Care Pharmacy Course at the
Setting EvidentiaryStandards? (Langley, Paul

Organizations. (Bramlet, Dean A., et al.) 1998; 4: 483. EliminatingPharmacists for Medicare/Medicaid?
1998; 4: 353.
Universityof Illinois at Chicago. (Salmon, J Warren, et al.) 1998; 4: 80. Campus. FormularyManagement by an On-Site School of Pharmacy Faculty Member in a Medicaid
1998; 4: 15.
Military
Markov models
Use of Economic Models in Managed Care
ManagedCare Organization.(Gericke, Kristin R, et al.) 1998; 4: 407. GastroesophagealReflux Disease in a Managed

Care Setting: Chargesby Place and Type of
Service. (Keyser,Mary S., et al.) 1998; 4: 336.
PhysicianAttitudes Toward Pharmacist-Run Clinics in Department of Anticoagulation


et al.) 1998; 4: 42.
Maslach Burnout Inventory

Reflux Disease in Gastroesophageal
Managed

Gireesh V., et al.) 1998; 4: 495.
Milrinone ChangingPractices in Home Inodilator Infusion Therapy for Advanced CongestiveHeart

Failure. (Barrington, Monica.) 1998; 4: 73. NCPDP,see National Council for Prescription
Pharmacy Charges. (Keyser, Mary S., et al.)
1998; 4:64.
.
Media
Media. 1998; 4: 85, 228
Drug Programs
to Managed Care. (Breault, Diane.) 1998; 4: 9. Managed Care Pharmacyat CreightonUniversity.
Medial treatment facilities

PhysicianAttitudes Toward Pharmacist-Run AnticoagulationClinics in Department of
(pederson, CraigA.) 1998; 4: 324.
MaximizingGeneric Substitution in Managed Care. (Keating, Edward J.) 1998; 4: 557.

Narrow therapeutic index NTI Debate, The. (Brunner,Lane J.) 1998; 4: 289.
634
Journal of Managed Care Pharmacy.
jMCP
Vol 4, No.6
Annual Index
National Association of Boards of
Osteoporosis
Pharmacy
MississippiMedicaid Waiver Breaks New Ground for Pharmacies. (Bloom, Marlene Z.) 1998; 4:
564. National Council for PrescriptionDrug Programs
Management Techniques, The. (Boland,Beth.) 1998; 4: 366.

to Managed Care. (Breault, Diane.) 1998; 4: 9. MississippiMedicaid Waiver Breaks New Ground
Outcomes
Cooperative Learning in
a
Pharmacy? (Sardinha, CaroL) 1998; 4: 35.

National Health Service of Great Britain
Required Outcomes
for Pharmacies. (Bloom, Marlene Z.) 1998; 4:
Assessment Course. (MacKinnon III, George E.)
DevelopingDisease State Management in the

ConjectureFinds Export OpportunitiesAbroad. (Lin, Swu-Jane.) 1998; 4: 275. National PrescriptionAdministrators

Successful Disease Management Programs For
1998; 4: 432. Developing Disease State Management in the United Kingdom: An Obviously American Conjecture Finds Export OpportunitiesAbroad.
(Lin, Swu-Jane.) 1998; 4: 275. Bill Technology and Automation Update. (Felkey,
G., et
564. Patient Protection: Will Pharmacoeconomics
Complementor Conflict? (Hauser, Robert.) 1998; 4: 381.

On-Line Prospective Drug Utilization Review,

The. (Phillips,Charles R., et al.)
1998; 4: 183.
aL) 1998; 4: 345.
Outcomes research
Advancing Outcomes Research in Managed Care Pharmacy:A Call to Action. (Parker, Dianne A.
Anthony,et aL) 1998; 4: 599. Patient compliance

Alendronate Use Among 812 Women: Prevalence of Gastrointestinal Complaints, Noncompliance with Patient Instructions, and Discontinuation.
Neoplasm
Anthony, et aL) 1998; 4: 599.
Kane.) 1998; 4: 257. Managed Care Pharmacy at CreightonUniversity. (Pederson,CraigA.) 1998; 4: 324.
Pharmacy Decisions,The. (Summers, Kent H.,
(Ettinger, Bruce, et al.) 1998; 4: 488. Study on the Characteristics of Prescription

Obesity
Cost-Effective Analysis of Appetite Suppressants for ObesityTreatment in a Managed Care
et al.) 1998; 4: 42. Vital Role of Pharmacy Benefit Management Firms in Health Services Research, The.

Compliance. (Hamilton, William
4: 174.
R.,
et
aL) 1998;
(Salmon, J. Warren, et aL) 1998; 4: 23.
P&T, see Pharmacy & Therapeutic

Committees
Technologyand Automation Update. (Felkey, Bill G., et aL) 1998; 4: 345. Patient confidentiality
AMCP Approves Position Statement on Patient Confidentiality.1998; 4: 534.
Managed Care Formularies, The. (Anderson, Robert J., et aL) 1998; 4: 422.
Omnibus Budget Reconciliation Act
PCS Health Systems

University of Colorado School of Pharmacy and the Universityof Colorado Health Plan Forge a
Pharmacy: LookingBack to See the Future. (Richards,Warren.) 1998; 4: 454. State-by-State Look at Medicaid Retail
PBM Partnership, The. (Grier, Dana, et aL)
Patient satisfaction
Response-Oriented Patient Evaluation Survey
1998; 4: 478.

(ROPES): An Administrator's Tool for Identifying

Opportunitiesfor Service Quality Improvement. (Kucukarslan, Suzan N., et aL) 1998; 4: 311.
Oncology
OncologyDrugs and Managed Care. (Hessen, Jody.) 1998; 4: 374.
Treatment of Patients with ALS: Implications for
Partnerships
ConnectingPhysiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473. Medicare and Managed Care: Emerging
Medicaid Waiver Breaks New Ground Mississippi for Pharmacies. (Bloom, Marlene Z.) 1998; 4:
Peptic ulcer
DefiningStrategies for Peptic Ulcer Treatment: A
(Kozma, Chris M., et aL) 1998; 4: 205.
Anthony,et al.) 1998; 4: 599. Order entry
Technology and Automation Update. (Felkey,Bill G., et aL) 1998; 4: 345. Orlistat
Efficacy and Safety of Anorexiant Medication in the Treatment of Obesity: Implications for
564. University of Colorado School of Pharmacy and the University of Colorado Health Plan Forge a
PBM Partnership, The. (Grier, Dana, et aL) 1998;
4: 478.
Performance Response-Oriented Patient Evaluation Survey (ROPES): An Administrator's Tool for Identifying Opportunitiesfor Service Quality Improvement.
(Kucukarslan, Suzan N., et al.) 1998; 4: 311.
PrescriptionPrograms. (Graden, Suzanne E., et Patient care AMCP Joins "SCRIPT" Coalition to Investigate Medication Problems. 1998; 4: 607.
al.) 1998; 4: 160.
Managed Care Formularies, The. (Anderson,

Robert J., et aL) 1998; 4: 422.
Perspectives
Adverse Drug Events: A Plea for Reportingand
ConnectingPhysiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473.
New Rules to Ease the Burden. (Wanke, Lee A.) 1998; 4: 364.
Vol. 4,
No.6
jMCP
635
Annual Index
Importance of Communication Skills for the
Pharmacoeconomics
AMCP Approves Drafting of Guidelines for
Managed Care Pharmacist, The. (Desselle,
Shane.) 1998; 4: 102. Integration:The Future of Pharmacy. (Fallik, Bruce B.) 1998; 4: 452.
1998; 4: 366. Health Care Communications Agencies Respond

to Managed Care. (Breault, Diane.) 1998; 4: 9. International Movement of Japanese
FormularySubmissions. 1998; 4: 607. Advancing Outcomes Research in Managed Care

Managing Drug Therapy Decisions: Pay Me Now or Pay Me Later. (Strand, Linda M.) 1998; 4:
242.
Writers Are More Welcome Than Ever. (Kaldy,
Health Policy,Part II. (Salmon, J. Warren, et al.)
Kane.) 1998; 4: 257. Cooperative Learning in a Required Outcomes Assessment Course. (MacKinnon III, George E.)
1998; 4: 123.
1998; 4: 432.
Cost-Effective Analysis of
Joanne.) 1998; 4: 6.
AppetiteSuppressants
for Obesity Treatment in a Managed Care
Pharmaceutical care
AMCP Publishes Catalog of Quality Pharmacy
Indicators.
Health Policies, Part III. (Chevalier,Kimiko, et
Organization. (Weber, Mary P.) 1998; 4: 293.

al.) 1998; 4: 567.

1998; 4: 87.
Academy Decries Proposal to End Need for Pharmacists. 1998; 4: 534.

a
Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards? (Langley,Paul C.) 1998; 4: 593.
Patient Protection: Will Pharmacoeconomics
1998; 4: 15.
Medicaid Population-From a
Budgetary
(Lai, L. Leanne, et al.) 1998; 4:
Perspective.

Vital Role of Pharmacy Benefit Management
Complement or Conflict? (Hauser, Robert.)
303. Evolution of Pharmaceutical Care into Managed

Care Environments, The. (Desselle, Shane, et al.) 1998; 4: 55. Managing DrugTherapy Decisions: Pay Me Now or Pay Me Later. (Strand, Linda M.) 1998; 4:
1998; 4: 381. Predictive Cost Analysis Model for Estimating

Formulary Impact of New Products in Managed Care. (Hedayati,Samuel, et al.) 1998; 4: 584.
University of Colorado School of Pharmacy and
(Salmon,J. Warren, et al.) 1998; 4: 23.

Pharmacist counseling
Counseling:Where Does The Profession Stand? (Beardsley, Bob, et al.) 1998; 4: 78.
Medicaid Waiver Breaks New Ground Mississippi for Pharmacies. (Bloom, Marlne Z.) 1998; 4:
242. Medicaid Waiver Breaks New Ground Mississippi

1998; 4: 478.

et al.) 1998; 4: 42.
564.
Performance Reporting for Managed Care PrescriptionPrograms. (Graden, Suzanne E., et al.) 1998; 4: 160.
564. State-by-State Look at Medicaid Retail Pharmacy Delivery: Trials & Triumphs.
Pharmacology
OncologyDrugs and Managed Care. (Hessen, Jody.) 1998; 4: 374. Treatment of Patients with ALS: Implicationsfor
PhysicianAttitudes Toward Pharmacist-Run AnticoagulationClinics in Department of Defense Health Services Region5. (Shalita,
Eric A., et al.) 1998; 4: 413. Predictive Cost AnalysisModel for Estimating
(McPeak, Mary Ellen.) 1998; 4: 546. University of Colorado School of Pharmacy and the University of Colorado Health Plan Forge a
1998; 4: 478.
Anthony, et al.) 1998; 4: 599.
Formulary Impact of New
Products in Managed
Pharmacist intervention
State-by-State Look at Medicaid Retail
Pharmacy
Care. (Hedayati, Samuel, et al.) 1998; 4: 584. State-by-State Look at Medicaid Retail
(McPeak,Mary Ellen.) 1998; 4: 546. Pharmaceutical firms, foreign International Movement of Japanese
(McPeak, Mary Ellen.) 1998; 4: 546. Studyon the Characteristics of Prescription

Pharmacy: A Call to Action. (Parker, Dianne A. Kane.) 1998; 4: 257. Biotechnology as a Pharmacy Specialty. (Hargis,
Jo Ellen.) 1998; 4: 465. Connecting Physiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473.
PrescriptionReminder System on Patient Compliance. (Hamilton, William R., et al.) 1998;

4: 174.
Health
Policy, Part
II.
1998; 4: 123.
Pharmaceutical manufacturers AdvancingOutcomes Research in Managed Care
Pharmacist roles PhysicianAttitudes Toward Pharmacist-Run AnticoagulationClinics in Department of Defense Health Services Region5. (Shalita,
Eric A., et al.) 1998; 4: 413. for Treatment of Patients with ALS: Implications the Managed Care Pharmacist. (Barisano,
EliminatingPharmacists for Medicare/Medicaid? 1998; 4: 353. Integration:The Future of Pharmacy. (Fallik,

Bruce B.) 1998; 4: 452. Managed Care Pharmacy at CreightonUniversity. (Pederson,CraigA.) 1998; 4: 324.
Kane.) 1998; 4: 257. DevelopingDisease State Management in the American An Obviously United Kingdom:

Pharmacist's Assessment of Second Generation On-Line Prospective Drug Utilization Review,
The. (Phillips, Charles R., et al.) 1998; 4: 183. Pharmacy: LookingBack to See the Future.
ConjectureFinds Export Opportunities Abroad. (Lin, Swu-Jane.) 1998; 4: 275.
Anthony, et al.) 1998; 4: 599. State-by-State Look at Medicaid Retail

(Richards,Warren.) 1998; 4: 454.
636
jMCP
Vol. 4.
No.6
Annual Index
Response-Oriented Patient Evaluation Survey
Pharmacy regulation
Practice standards, guidelines

AdvancingOutcomes Research in Managed Care Pharmacy:A Call to Action. (Parker,Dianne A.
(ROPES): An Administrator's Tool for Identifying Opportunitiesfor Service Quality Improvement. (Kucukarslan, Suzan N., et al.) 1998; 4: 311. Pharmacy administration
Pharmacy reimbursement
If It Is Worth Doing, It Is Worth Doing Well...
Then Proven. (Minor, Paul al.) 1998; 4: A., et
Kane.) 1998; 4: 257.

359.
University of Illinois at Chicago. (Salmon, J Warren, et al.) 1998; 4: 80.
MaximizingGeneric Substitution in Managed Care. (Keating, Edward J.) 1998; 4: 557. MississippiMedicaid Waiver Breaks New Ground
Care Environments, The. (Desselle, Shane, et al.) 1998; 4: 55. Performance Reportingfor Managed Care
Prescription Programs. (Graden, Suzanne E., et

al.) 1998; 4: 160.
Pharmacy and therapeutic committees

to Managed Care. (Breault, Diane.) 1998; 4: 9. Use of Economic Models in Managed Care
Prescribing
DevelopingDisease State Management in the United Kingdom: An Obviously American ConjectureFinds Export Opportunities Abroad.
(Lin, Swu-Jane.) 1998; 4: 275. Electronic Prescribing: The Next Revolution in
564.
Pharmacy Decisions,The. (Summers, Kent H., et al.) 1998; 4: 42.
FormularyImpact of New Products in Managed Care. (Hedayati, Samuel, et al.) 1998; 4: 584. State-by-State Look at Medicaid Retail
Pharmacy Delivery: Trials & Triumphs. (McPeak, Mary Ellen.) 1998; 4: 546.
Pharmacy benefit management

AMCP Voices Concern Over Proposed Federal
Rules. 1998; 4: 353. ConnectingPhysicians to Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473. Evolution of Best-in-Class Pharmacy Management Techniques,The. (Boland,Beth.) 1998; 4: 366.
Pharmacy? (Sardinha, Carol.) 1998; 4: 35. Health Care Communications AgenciesRespond

to Managed Care. (Breault,Diane.) 1998; 4: 9. Local Area Market Dynamics. (Holubiak,Myron.)
Phentermine Cost-Effective Analysisof AppetiteSuppressants for Obesity Treatment in a Managed Care

1998; 4: 115.
Maximizing Generic Substitution in Managed Care. (Keating, Edward J.) 1998; 4: 557.
Formulary Management by an On-Site School of Pharmacy Faculty Member in a Medicaid Managed Care Organization. (Gericke, Kristin
R., et al.)
Managed Care Formularies, The. (Anderson, Robert J, et al.) 1998; 4: 422.
1998; 4: 15.
Prescription claims
1998; 4: 407.
Physicians
ConnectingPhysiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473.
PrescriptionPrograms. (Graden, Suzanne

al.) 1998; 4: 160.
E., et
Computer-AssistedProtocols. (Bailey,Michael,
et al.) 1998; 4: 246. Maximizing Generic Substitution in Managed
Care. (Keating,Edward J) 1998; 4: 557. Predictive Cost Analysis Model for Estimating
Management Techniques, The. (Boland, Beth.) 1998; 4: 366.

to Managed Care. (Breault, Diane.) 1998; 4: Attitudes Toward Pharmacist-Run Physician AnticoagulationClinics in Department of
9.
On-Line Prospective Drug Utilization Review, The. (Phillips,Charles R., et al.) 1998; 4: 183. Study on the Characteristics of Prescription
Formulary Impact of New Products in Managed Care. (Hedayati, Samuel, et al.) 1998; 4: 584. State-by-State Look at Medicaid Retail
PrescriptionReminder Systemon Patient

Compliance. (Hamilton, William R., et al.) 1998; 4: 174.
PharmacyDelivery:Trials & Triumphs. (McPeak, Mary Ellen.) 1998; 4: 546.

Physician prescribing patterns

Prescription reminder systems Studyon the Characteristics of Prescription

(Zimmerman, Allan.) 1998; 4: 268. Universityof Colorado School of Pharmacy and

the University of Colorado Health Plan Forge a PBM Partnership, The. (Grier, Dana, et al.)
1998; 4: 115.

Compliance.(Hamilton,William R., et al.) 1998;
4: 174.
Physician report cards

1998; 4: 478. Vital Role'of Pharmacy Benefit Management Firms in Health Services Research, The.
(Salmon, J Warren, et al.) 1998; 4: 23.
Management Techniques,The. (Boland, Beth.) 1998; 4: 366.
Prescription transmittal Studyon the Characteristics of Prescription

Pipeline
Pipeline. 1998; 4: 82, 179, 321, 420.

Compliance. (Hamilton, William R., et al.) 1998;
4: 174.
Pharmacy performance
Indicators. 1998; 4: 87. Performance Reportingfor Managed Care
POlicy
PrescriptionPrograms. (Graden, Suzanne al.) 1998; 4: 160.
E., et
Pharmaceutical Industry:Reform of Japanese Health Policy,Part II. (Salmon, J Warren, et al.)
President's Task Force on National Health
Care Reform
Pharmacy: LookingBack to See the Future. (Richards,Warren.) 1998; 4: 454.
1998; 4: 123.
Vol. 4,
NO.6
jMCP
637
Annual Index
Priority Health
Maximizing Generic Substitution in Managed Care. (Keating,Edward J.) 1998; 4: 557.
Reminder systems Study on the Characteristics of Prescription Transmittal Processes and the Effect of Patient
Prescription Reminder System on Patient Compliance. (Hamilton,William R., et al.) 1998;
4: 174.
Prescription Programs. (Graden, Suzanne

al.) 1998; 4: 160.
E., et
Profiling
Burnout in a Sample of HMO Pharmacists Using the Maslach Burnout Inventory. (Gupchup, Gireesh V., et al.) 1998; 4: 495. Performance Reporting for Managed Care PrescriptionPrograms. (Graden, Suzanne E., et
.
Riluzole
Reporting
Adverse Drug Events: A Plea for Reporting and New Rules to Ease the Burden. (Wanke, Lee A.)
Anthony, et al.) 1998; 4: 599.
Risk assessment
al.) 1998; 4: 160.
1998; 4: 364. Research

Importance of Communication Skills for the
Health And Welfare Fund UnipnGroups.
Prozac Efficacy and Safety of Anorexiant Medication in

(Zimmerman, Allan.) 1998; .4: 268.
Managed Care Pharmacist, The. (Desselle, ShaneJ 1998; 4: 102.

International Movement of Japanese Pharmaceutical Industry: Reform of Japanese
SCRIPT
AMCP Joins "SCRIPT" Coalition to Investigate
Medication Problems. 1998; 4: 607. Electronic Prescribing:The Next Revolution in
Public health
AMCP to Collaborate with CDC. 1998; 4: 226.
Health Policy, Part II. (Salmon, J. Warren, et al.)
1998; 4: 123.
Pharmacy?(Sardinha,Carol.) 1998; 4: 35:
Sampling
Research Methodology:Designinga Research
Qualitative data Research Methodology:Some Statistical Considerations. (Hurd, Peter D.) 1998; 4: 617.
III.
al.) 1998; 4: 567. Use of Economic Models in Managed Care
Study. (Schafermeyer, Kenneth w., et al.) 1998; 4: 504.
Quality of care
Indicators. 1998; 4: 87.

Vital Role of Pharmacy Benefit Management
Sankyo Co., Ltd.

International Movement of Japan's Pharmaceutical Industry: Reform of Japanese
Quality of life
Changing Practices in Home Inodilator Infusion Therapy for Advanced CongestiveHeart
Failure. (Barrington,Monica.) 1998; 4: 73. Treatment of Patients with ALS: Implications for
(Salmon, J. Warren, et al.) 1998; 4: 23.
Health Policies, Part III. (Chevalier,Kimiko, et al.) 1998; 4: 567.
Research methodology Designinga Research Research Methodology: Study. (Schafermeyer, Kenneth w., et al.) 1998;
4: 504.
Sensitivity analysis
Cost Benefit Analysis of Pharmaceutical Care in
a
Medicaid Population-From a Budgetary
Perspective. (Lai, L. Leanne, et al.) 1998; 4: 303.

Anthony, et al.) 1998; 4: 599.
Regulation
Academy Decries Proposal to End Need for
Pharmacists. 1998; 4: 534. Information Requirements of Health Systems as

Research Methodology:Some Statistical Considerations. (Hurd, Peter D.) 1998; 4: 617.
Restrictions
Formulary Impact of New Products in Managed Care. (Hedayati, Samuel, et al.) 1998; 4: 584. Service quality Response-OrientedPatient Evaluation Survey
Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards? (Langley, Paul C.) 1998; 4: 593. Patient as a Partner in Prescribing:Direct-toConsumer Advertising, The. (Craig, Robert P.)

Coronary Heart Disease by Payor Types: FeeFor-Service, Medicare, and Managed Care Organizations. (Bramlet, Dean A., et al.) 1998; 4: 483.
for Service Quality Improvement. Opportunities (Kucukarslan, Suzan N., et al.) 1998; 4: 311.
Sibutramine
.
1998; 4: 15.

Review
Reliability
Research Methodology: Hypotheses,

et al.) 1998; 4: 42.
Significance
Some Statistical Research Methodology:
Considerations. (Hurd, Peter D.) 1998; 4: 617.
and Validity. Measurement, Reliability,
Reward systems
Specialty pharmacy
Biotechnologyas a Pharmacy Specialty. (Hargis, Jo Ellen.) 1998; 4: 465.
al.) 1998; 4: 55.
638
jMCP
Vol 4, No.6
Annual Index
Spotlight
ConnectingPhysiciansto Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473. Electronic Prescribing: The Next Revolution in
Pharmacy? (Sardinha,CaroL) 1998; 4: 35. MississippiMedicaid Waiver Breaks New Ground
Telepharmacy
Variation
Research Methodology: Some Statistical. Considerations. (Hurd,Peter D.) 1998; 4: 617.
Pharmacy? (Sardinha, CaroL) 1998; 4: 35. The PlymouthGroup

Local Area Market Dynamics. (Holubiak, Myron.)
1998; 4: 115.
564.
Therapeutic conversion
Waxman-Hatch Act Maximizing Generic Substitutionin Managed Care. (Keating,Edward J.) 1998; 4: 557.
Standards
Connecting Physici;:ms to Pharmacies-and Patients. (Bloom, Marlene Z.) 1998; 4: 473. HCFA Proposes Standards for Electronic
Weight loss
Cost-Effective Analysis of AppetiteSuppressants
Therapeutic interchange
AMCP Issues Position Statement on Therapeutic
for ObesityTreatment in a
Managed Care
1998; 4: 436. Information Requirements of Health Systems as Drug Purchasers: Does the FDA Have a Role in Setting EvidentiaryStandards? (Langley,Paul C.) 1998; 4: 593. Technologyand Automation Update. (FeIkey, Bill G., et al.) 1998; 4: 345.
Transmission.
Interchange.1998; 4: 87. Importance of Communication Skills for the

Managed Care Pharmacist, The. (Desselle, Shane.) 1998; 4: 102. Trends
Trends. 1998; 4:
the Treatment of Obesity:Implications for
31,235,344,435.
Xenical
The Efficacy and Safety of Anorexiant Medication
Statistics
Research Methodology: Some Statistical
Considerations. (Hurd, Peter D.) 1998; 4: 617.
in the Treatment of Obesity: Implications for
Step therapy
Computer-AssistedProtocols. (Bailey, Michael,

et al.) 1998; 4: 246.
Ulcer DefiningStrategiesfor PepticUlcer Treatment: A Helicobacter pylori Economic Cost Model. (Kozma, Chris M., et al.) 1998; 4: 205. Unclaimed prescriptions A Study on the Characteristics of Prescription
Managed Care Formularies. (Anderson,Robert

J., et al.) 1998; 4: 422.
Yamanouchi Pharmaceutical Co. Ltd.

International Movement of Japan's Pharmaceutical Industry:Reform of Japanese
Stress management
Health Policies,Part
al.) 1998; 4: 567.
III.
(Chevalier, Kimiko, et
Prescription Reminder System on Patient Compliance. (Hamilton,William R., et al.) 1998;

4: 174.
Gireesh V., et al.) 1998; 4: 495.
T-Block
A Predictive Cost Analysis Model for Estimating
United Kingdom
DevelopingDisease State Management in the United Kingdom:An Obviously American ConjectureFinds Export OpportunitiesAbroad.
(Un, Swu-Jane.) 1998; 4: 275.

Care. (Hedayati, Samuel, et al.) 1998; 4: 584.
Takida Chemical Industry ltd.

Pharmaceutical Industry:Reform of Japanese Health Policies, Part III. (Chevalier,Kimiko, et
Validity
Research Methodology: Hypotheses,
al.) 1998; 4: 567.
Measurement, Reliability,and Validity. (Motheral, Brenda R.) 1998; 4: 382.
Vol. 4.
No.6
}M(P Journal of Managed Care Pharmacy
639
EVENTS
National Council for Prescription Drug Programs 22nd Annual Membership Conference
....
Education, Centerfor Continuing Professional 677 Huntington Avenue, IL-23, Dept. C,

Boston,
MA 02115-6096; 617/432-1171.
Scottsdale, AZ
February 28-March 3, 1999 Contact: NCPDp, 4201 N. 24th Street, Suite 365, Phoenix, AZ 85016; 602/957-9105.
Upcoming conventions, conferences, symposia, and workshops of interest to managed care pharmacists are listed in JMCP's Events column. Listings are placed on
space-available basis. Send notices to: Managing Editor, Mitchell Petersen, 1775
Jamieson Avenue, Suite 210, Alexandria, VA
American Association of Colleges of Pharmacy Interim Meeting February 24 March 2, 1999

....
-
Washington,DC
Contact: AACp,
22314.
1426 Prince Street, Alexan-
dria, VA 22314; 703/739-2330.

....
Cost-Effectiveness Analysis for Med-
ical Technologies and Pharmaceuticals June 1-4, 1999
... American Association of Health Plans Third Annual Summit on International Managed Care Trends
Dember 9-12,1998 Miami, FL
Contact: Harvard School ofPublic Health, Education, Center for Continuing Professional
Boston,
677 Huntington Avenue, LL-23, Dept. C, MA 02115-6096; 617/432-1171.
AAHP Conference Office, 1129 20th Street, NV, Suite 600, Washington,DC 20036Conta:
3421; 202/778-3269.
.... Measurement, Design, and Analysis Methods for Health Outcomes Research June 15-18,1999
Contact: Harvard School
of Public Health,
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. . . .
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.Inside Back Cover, Back Cover

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.Pharmacy Affairs.
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}MlP
Vol 4. NO.6

Journal of Managed Care Pharmacy

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Journal of Managed Care Pharmacy

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volume four.

number six novemberldecember 1998