Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
United States
Agency for
International
Development
The Policy, Planning, and Advocacy Division (PPAD) of the DOH has written a
Therapeutics Committee (TC) Manual as a reference for functioning TCs in the Philippines.
The reference is meant to guide the TCs in organizing themselves and in the performance of
their functions. It discusses important tools that TCs can use to analyze and to improve drug
selection and use. Finally, it discusses important issues that TCs are frequently faced with:
drug donations, ethical drug promotions, etc.
Before this manual can be distributed and used by the TCs, it is important to review and to
test it, not only to identify the errors and to judge its usefulness, but also to rectify the errors
and to increase its usefulness.
II Objective
III Methodology
Thus, an alternative testing methodology was used. Comments on the manual were solicited
from three types of sources: a group of local experts, 2 Chairpersons of hospital TCs, and a
MSH consultant. A combination of structured and unstructured methods was utilized. The
hospital TC chairpersons were asked to rate several parameters on a Likert scale:
completeness of coverage of topics, relevance to function of TC, ease of understanding,
format, and length. General comments were also solicited from them. On the other hand,
local experts and the MSH consultant were asked to edit, comment, and recommend
changes to the Manual.
IV Results
In general, the TC Chairpersons gave high scores to the Manual on all parameters.
1
2
The comments and recommendations of the local experts and the MSH consultant resulted
in the following changes to the Manual:
1) division of the Manual into two parts—The main body focuses on the functions,
composition, budget, and reporting system of the TCs. The annex contains the tools for
analyzing drug expenditures and special topics for TCs: drug donations, good prescribing
guidelines, pharmacovigilance, pharmacoeconomics, ethical promotions, and activities to
promote rational drug use.
2) suggestions for additional topics, e.g., pharmacoeconomics
3) addition of report forms to the annex
4) addition of examples to demonstrate concepts
5) correction of conceptual, factual, and grammatical errors
6) formatting changes
V Conclusion
This review of the DOH TC Manual has resulted in improvements in its content and format,
therefore, increasing its usefulness as a reference for TCs.
2
THE
THERAPEUTICS COMMITTEE
MANUAL
TABLE OF CONTENTS
I. PREFACE ...........................................................................................................................................3
II. Introduction and Background........................................................................................................4
III. The Therapeutics Committee.........................................................................................................5
A. Significance of a Therapeutics Committee ...............................................................................5
B. Functions of the Therapeutics Committee ...............................................................................6
1. Organizational Structure within a Health Facility ...............................................................6
2. Organizational Structure Within a Health Agency...............................................................7
3. Model Terms of Reference for Therapeutics Committees....................................................8
4. Activities....................................................................................................................................9
C. Organization of the Therapeutics Committee........................................................................11
1. Membership............................................................................................................................11
2. Frequency of Meetings...........................................................................................................11
3. TC Functions ..........................................................................................................................12
a) Developing an Essential Drugs List.......................................................................................12
b) Adding and Deleting Drugs to the List ..................................................................................12
c) Conducting Drug Utilization Review (DUR) or Medication Utilization Evaluation (MUE) 13
d) Conducting Activities to Promote Rational Drug Use...........................................................14
e) Enforcing Generic Dispensing Policy....................................................................................15
f) Adverse Drug Reaction Monitoring ......................................................................................16
g) Reporting Medication Errors .................................................................................................18
h) Analyzing Drug Costs............................................................................................................19
i) Regulating Drug Representatives ..........................................................................................20
D. Budgeting for Therapeutics Committee Activities ................................................................20
E. Reporting for Therapeutics Committee Activities.................................................................21
F. Sources of Support for TCs .....................................................................................................21
IV. Special Topics ................................................................................................................................22
A. Standard Treatment Guidelines..............................................................................................22
B. Good Prescribing Practices .....................................................................................................23
C. Pharmacovigilance ...................................................................................................................27
1. Reporting Scheme ..................................................................................................................27
2. Definition of drug-reaction relationship codes ....................................................................28
3. Reporting Forms ....................................................................................................................30
4. Causality Assessment .............................................................................................................31
D. Pharmacoeconomics .................................................................................................................32
1. The Cost of a Drug .................................................................................................................32
2. Cost-Evaluation Methods ......................................................................................................33
a) Cost of Illness (COI)..............................................................................................................33
b) Cost Minimization (Cost-identification)................................................................................33
c) Cost-Effectiveness .................................................................................................................34
E. Tools for Analyzing Costs ........................................................................................................34
1. ABC Analysis..........................................................................................................................34
2. Therapeutic Category Analysis.............................................................................................36
3. VEL Analysis ..........................................................................................................................38
F. Ethical Promotions ...................................................................................................................39
G. Guidelines for Drug Donations................................................................................................40
1. WHO Guidelines ....................................................................................................................40
2. Drug Donations in the Philippine Setting ............................................................................42
H. Code of Ethics for a Therapeutics Committee Member........................................................44
V. LIST OF REFERENCES .............................................................................................................46
3 Therapeutics Committee Manual
I. PREFACE
You are what I would consider a privileged reader of this document for this man-
ual attempts to assist in the implementation of the Philippine National Drug Pol-
icy.
We hope each member of the Therapeutics Committee considers the value of us-
ing health economics in making these decisions. We are putting our confidence
and trust in you, the implementers of a functional Hospital Therapeutics Commit-
tee, and relying on you to help introduce creative and sound committee decisions
based on scientific evidence and tempered with the art of clinical practice in the
service of our people.
In every hospital, medicines are critical to the delivery of service. However, the
availability of medicines in the hospital depends not only on good supplies but
also on efficient use through rational prescribing and dispensing practices. Several
approaches have been tried to improve the management and use of drugs in vari-
ous health settings. In a hospital setting, Therapeutics Committees (TCs) are
thought to be effective in ensuring that medicines are used in a safe, appropriate,
and cost-effective manner.
When the Generics Act was passed in 1988, the establishment of therapeutics com-
mittees in all field offices, hospitals, and medical centers nationwide was a strategy to
implement the law and the national drug policy. These committees play a vital role in
rational drug use, an important pillar of the national drug policy. Its main responsi-
bility is to develop and maintain in their respective organizational set-up an essential
drugs list, which serves as the basis for the procurement program.
The National Drug Policy is a policy and program of the national government to ensure that safe and ef-
fective drugs are made available to all Filipinos at any time and place and at a reasonable and affordable
cost. The DOH recognizes the fact that drugs and medicines are a vital component of health care.
Given the low level of income of the vast majority of the Philippine population, the cost of pharmaceuticals
is a major, if not dominant factor, in the overall cost of health care. Furthermore, the constitution recog-
nizes the citizen’s right to health and mandates the government to address the issue of assuring the avail-
ability of necessary drugs and medicines.
The Therapeutics Committee (TC), is an advisory group that serves as an organizational line of commu-
nication between the medical staff, the pharmacy staff, and other technical personnel. Therapeutics com-
mittees shall be organized in all government health facilities as stipulated in AO 51 s 1988 (Implement-
ing guidelines for DOH compliance to the Generics Act).
The therapeutics committees shall perform advisory and educational functions and shall be composed of
the heads of the major clinical departments, the chief pharmacist, the chief nurse, and the administrative
officer.
5 Therapeutics Committee Manual
Based on the World Health Organization (WHO) report, 90% of all ailments can
be cured by about 250 essential drugs. In 1987, there were 12,000 different drug
products, some of dubious quality, in the Philippine pharmaceutical market; in
spite of this, the Philippines was still classified as a country where less than 30%
of the population had regular access to essential drugs. Moreover, most Filipinos
lack access to the medicines they need, while consuming unnecessary and ineffec-
tive preparations.
Faced with ever-increasing costs and a capped budget, hospitals must find ways to
continue to offer effective but affordable care. These spiraling costs have been at-
tributed to unregulated prices, unethical promotions, poor procurement proce-
dures, and inefficient distribution mechanisms. Moreover, drugs are often pre-
scribed, dispensed, and used inefficiently. When choosing between drugs, clini-
cians often consider only efficacy and are not aware of the most cost-effective
treatment regimen. On their part, dispensers often sell without the required pre-
scription. All these contribute to irrational drug use.
Apart from cost, the inefficient use of medicines also affects the safety and quality
of therapeutic care. This is reflected in the WHO definition of the quality use of
medicines:
When drug use is not in accordance with this definition, it is often associated with
undesirable health and/or economic outcomes. An adverse drug reaction is one
such undesirable and often preventable outcome. Inappropriate use of antibiotics
also leads to the increased frequency and spread of resistant microorganisms. The
inability to treat common infections with the antibiotic of choice can be costly or
even disastrous.
With scarce resources and an increasing demand for quality care, how can hospi-
tals ensure that available resources are used efficiently for effective and afford-
Therapeutics Committee Manual 6
able treatments? The hospitals must develop and implement strategies for selec-
tion and quality use of medicines. This cannot happen without doctors, pharma-
cists, nurses, and financial managers coming into partnership to negotiate the best
balance between cost and quality.
The therapeutics committee should have its own terms of reference which spell
out the committee’s place in the organizational structure of the agency, its goals,
objectives, scope of authority, and responsibilities.
CHAIRMAN
Pharmacologist Secretary
REGULAR EX-OFFICIO
Dept. Heads/
Program Pharmacist Chief Nurse NDP Consumer
Coordinators or Food or Compliance
and Drug Regional Officer
Regulation Nurse
Surgery Officers
(FDROs)
Ob-Gyne
Administration
(Administrative PHIC
Medicine
Officer)
Pediatrics
7 Therapeutics Committee Manual
Pharmacy/FDROs
Therapeutics Committee Manual 8
The committee shall be responsible for defining its own specific objectives on an
annual basis or as the need arises. Each committee can do this by reviewing the
following objectives and choosing what they want to work on. It will be helpful
for the committee to draw up an annual strategic plan of action.
4. Activities
To meet these objectives, the committee must plan and carry out certain activities
that may include:
• Drawing up and circulating criteria for selecting drugs for the hospital essen-
tial drugs list. Clinical efficacy and cost of therapy are two key criteria, but
others may be considered.
• Appointing individual members within or outside the committee to develop
standard treatment guidelines.
• Developing protocols and defining level of use for particular items such as
blood, antibiotics, and high-cost drugs.
• Presenting drug consumption and cost information by ward or by consultant
monthly or quarterly.
• Designing interventions (educational, managerial, or regulatory) to correct
specific drug use problem.
• Evaluating the impact of interventions.
Therapeutics Committee Manual 10
Standards
Assessment
Intervention/Strategy
Quantities assessment of performance
! Targeted intervention to improve ! Drug utilization studies of adherence to
practice STG
! Education of prescriber, dis- ! Availability of essential drugs: %EDL use
penser and other health workers ! Indicators for monitoring RDU
! Course and training ! AMR surveillance
! Create drug information unit ! ADR monitoring
! Pharmaceutical promotion monitoring
! Estimated drug requirements & consump-
tion
! Cost-benefit analysis
Diagnosis
Qualitative assessment
! Logistics and resources
! Patient/consumer factor
! Health providers
! Pharmaceutical industry influence
! Access of information
11 Therapeutics Committee Manual
1. Membership
2. Frequency of Meetings
The committee should meet regularly, at least monthly, with each meeting not ex-
ceeding one hour and a half.
• Items of agenda, any background material, and minutes of the previous meet-
ing are circulated in sufficient time for members to prepare for the meeting.
• All proceedings of the meeting are recorded accurately, showing the matters
discussed, the decisions taken, the persons responsible for acting on the deci-
sions, and the time frame for implementing the decisions.
• Decisions of the committee are followed up in-between meetings.
3. TC Functions
Since it is neither possible nor desirable for the TC to do everything, it must pri-
oritize the activities in which to invest time and human resources.
Selecting essential drugs for the hospital shall be the first major activity for the
committee. This can be divided into two manageable parts such as in-patient and
outpatient lists. The in-patient can be further divided into separate stocks for the
surgical, medical, pediatric, emergency, and maternity wards.
The committee shall develop guidelines for the management and periodic review
of the list to ensure availability of a range of medicines sufficient to cover condi-
tions treated at the hospital while at the same time avoiding duplication. These
should include procedures for adding a new drug to the list or simply obtaining a
non-listed drug either to initiate or continue therapy in the hospital. To add drugs
to the list, all applications must be accomplished on the official application form
and endorsed by the respective department head.
It would be advisable for the committee to have two sets of criteria. One set of
criteria would be for consideration of new treatments for conditions that are not
amenable to existing drug therapy or treatments, representing major improve-
ments in survival and quality of life and another set for treatments representing
minor improvements in therapy compared to existing listed drugs. For new treat-
ments or major improvements, the committee shall consider the following factors:
• The efficacy and safety of the drug. Whether the hospital has the necessary
clinical expertise to use the drug and what role specialists should play to
regulate therapy.
• An estimation of the cost (and potential savings) to the hospital should the
drug be introduced. These should include costs of the drug itself, hospitaliza-
tion, and investigation.
• The availability of the drug on the market.
13 Therapeutics Committee Manual
Apart from additions to the list, the committee will also need to consider requests
for non-listed drugs to cover special circumstances such as non-response or con-
traindications to available drugs. Doctors may also request a non-listed drug to
continue therapy for a patient who had been stabilized on a non-listed drug before
admission to the hospital where changing to another drug is considered detrimen-
tal. The pharmacy must keep a register of all non-listed drug requests for which
the drug was requested. When compiled at the end of the year, this information
helps the committee decide whether or not to add the drug onto the list.
Assessing drug utilization is an important function of the DTC and this system
should be set up in the health facility. The following are the steps in instituting
DUR/MUEs:
• Step 1. Establish responsibility for the DUR/MUE process. This is usually the
therapeutics committee but may be allocated to a sub-committee.
• Step 2. Establish the Scope for each Study. A DUR/MUE study may focus on
a drug or a condition. Selecting which condition or drug to study may be diffi-
cult but making a matrix may be of help in making a choice.
• Step 3. Establish Criteria or Indicators for how the drugs should be used or
how the condition should be treated. The criteria would usually define which
patients should and should not receive the drug. Other criteria might depend
on laboratory findings. Whatever the criteria selected, it must be easy to
measure and it must be agreed upon.
• Step 4. Collect and organize data. Data collection forms can be developed
which are simple tally sheets, observational checklist, or simple question-
naires. Only a few items of data should be collected for each DUR/MUE
study. Sources of data are mostly patient’s case notes but they may be obser-
vational checklists, dispensing records, laboratory reports or dispensing regis-
ters. Collect only data directly related to the problem being studied.
• Step 5. Analyze the data.
• Step 6. Develop conclusions.
• Step 7. Make recommendations.
• Step 8. Take action.
• Step 9. Follow up.
All healthcare professionals need constant updating of their skills and knowledge.
It is impossible for the physicians or pharmacist to keep abreast with constant
15 Therapeutics Committee Manual
changes in the pharmaceutical field without intensive efforts by the individual and
the health facility to provide continuing education.
The strategies to improve drug use fall into three main categories:
• Educational
• Managerial
• Regulatory
Each main category can be done in several ways. Among these are:
It is important that the committee should define clearly the target groups for these
activities and what key messages should be transferred. Target groups would in-
clude the prescribers, nurses, pharmacists, patients, opinion leaders, etc. It is
equally necessary to evaluate the impact of these interventions regularly to be able
to revise, improve or fill in gaps in its implementation.
For example, the committee may stipulate that the pharmacy may
supply the generic equivalent of any drug ordered, unless the pre-
scriber has specifically endorsed on the prescription that there shall
be no substitution for the specified brand product because the drug
has bioequivalence problems. When a generic equivalent is dis-
pensed, the patient must be informed.
One important criterion in the selection of drugs for the formulary is that of
safety. This requires close attention to established information on the drug as well
as current post-marketing surveillance of the drug’s safety record. Drugs are
known to be two-edged swords. They can either heal (therapeutic effects) or harm
(side effects) the patient.
Adverse drug reaction has been defined as “any response to a drug which is nox-
ious and unintended and which occurs at doses used in man for prophylaxis, diag-
nosis or therapy. These may result from effects of the drugs, of the illness, or their
interactions with each other. Causality between the clinical event and the drug
may not always be present, although with a reaction (ADR), causality is more
definite.
17 Therapeutics Committee Manual
Counterfeit medicines are also responsible for some ADRs and can thus com-
promise a patient’s welfare. In addition to failure of efficacy, counterfeit medi-
cines can be associated with all the above-mentioned types of ADR (A, B, C, D,
E) due to the presence of (or adulteration with) various active or toxic ingredients.
Setting up an ADR unit in the health facility can be initiated by the Therapeutic
Committee. A program coordinator is chosen who is willing to provide training
for the health staff and to communicate regularly with the ADRMP (based in
BFAD) by sending in completed ADR forms for collation and analysis.
What to report:
• Death
• Danger to life
• Admission to hospital
• Prolongation of hospitalization
• Absence from productive activity
• Increased investigational or treatment costs
• Birth Defects
Therapeutics Committee Manual 18
The Therapeutics Committee should encourage all health workers to bring to its
attention any cases of suspected therapeutic failure, any adverse effect of chang-
ing between brand and generic products, adverse effects of herbal and traditional
medicines and adverse reactions to vaccines. Suspicion is enough to report ad-
verse effect of reaction.
Reaction Details:
• What happened?
• When?
• What was done?
• What was the outcome?
Drug Details:
• Suspected agent (brand names)
• What other drugs are involved
• Batch and Lot number of the medication
Reporter:
• Who?
The monitoring and reporting of adverse drug reactions (ADRs) is important. This
is because “reporting of a seemingly insignificant or common adverse reaction or
side effect may help pinpoint a more widespread prescribing problem”. Apart
from being a health hazard, ADR may contribute to increased health care costs if
serious enough to require treatment. It is important to encourage ADR monitoring
and reporting especially of new medicines whose safety has only been evaluated
in pre-marketing clinical trials. ADR monitoring and reporting is an important as-
pect of post-marketing surveillance which contributes to better understanding of
the drug’s safety and effectiveness in the real world of practice as opposed to pre-
market clinical trials which are conducted in a highly-selected small population.
Having a pharmacist or nurse or another doctor review the prescription before the
drugs are administered can prevent some of these errors. If an error occurs in the
administration or application of medication, the proper official should be in-
formed immediately. Medication errors should not be discussed with the patient.
A detailed account of the error, whether of omission or commission should be
prepared with a duplicate copy and forwarded to the proper official. All errors
should be compiled and a report presented to the full TC monthly.
There are several analytical tools which can be utilized to quantify costs and to
identify areas where costs can be reduced; the information garnered can be used
to design and monitor interventions to control costs. These tools include:
• VEN analysis
• ABC analysis
• Therapeutic category analysis
• Price comparison analysis
• Total variable cost analysis
• Lead-time and payment-time analysis
• Expiry date analysis
• Hidden cost analysis
For this manual, the tools discussed are limited only to the first three.
The tools are discussed in more detail on “Managing Drug Supply” (MDS) 2nd
Edition, Chapter 41, pages 633-642.
Therapeutics Committee Manual 20
“In order to avoid any bias in the selection of drugs and supplies, TC members
are not allowed to hold any business relations with any pharmaceutical com-
pany (manufacturer or distributor).”
• Staff time costs are to cover a small sitting allowance for members who are
not employed by the agency such as private practitioners and consumer repre-
sentatives.
• Meeting costs must cover food served during meetings, secretarial services,
duplication of minutes and any other background reading materials.
• Data collection for DUR/MUE is often very involving and may have to be
done by staff outside the normal working hours. It is best to fix a payment rate
per record collected or reviewed rather than time taken.
Reporting costs should cover production and dissemination of all reports by the
TC quarterly and annually.
The TC should report on its activities to the Agency executive, the district and
provincial health executives, the Policy, Planning and Advocacy Division (PPAD)
of BFAD every 20th day of January and December (AO No. 107 s 2000). To ac-
complish this task, it may be better to submit quarterly reports and then compile
these to make semi-annual reports. Publications of reports make information dis-
semination to other TCs useful.
Local manuals are needed in every health system because of differing decisions
about drug choices and the patterns of illness within a country. Disease oriented
manuals are called standard treatment guidelines (STGs), treatment protocols, or
prescribing policies.
The selection of drugs to be included on the essential drug list is based on preva-
lent pattern of illness and the standard treatments decided upon to treat these con-
ditions. Training, drug supply, assessment, and quality evaluation are based on
these standard treatments.
Standard treatments list the preferred drug and non-drug treatments for common
health problems experienced by people in a specific health system. Information
would include the name, dosage form, strength, average dose (pediatric and
adult), number of doses per day, and duration of treatment.
Advantages that can be achieved through the use of standard treatments include:
• Describe appropriate care based on the best available scientific evidence and
broad consensus.
• Reduce inappropriate variation on practice.
• Provide a more rational basis for referral.
• Provide a focus for continuing medical education.
• Promote the efficient use of health care resources.
• Act as a focus of quality control, including audit.
• Highlight the shortcomings of existing literature and suggest appropriate fu-
ture research.
The use of standard treatment guidelines is a strategy to promote rational drug use
and is now a basis for the reimbursement of drugs with the Philippine Health Care
Insurance (PHIC Memo Cir. No. 09-1999).
23 Therapeutics Committee Manual
Diagnosis (Health
Rx Problems) Rx
Treatment Rx
Drug
Supply
Adherence
(Compliance) Rx
Clinical Outcome
At the start of clinical training, most medical students find that they do not have a
very clear idea of how to prescribe a drug for their patients or what information
they need to provide. This is because their earlier pharmacology training has con-
centrated more on theory than on practice. In many medical schools, methods of
teaching pharmacology and therapeutics have not changed, despite great progress
in pharmacotherapeutic approaches to disease. Teaching often remains character-
ized by transferring knowledge about drugs, rather than training students to treat
patients in a rational way. Clinical training for undergraduate students often fo-
cuses on diagnostic rather than therapeutic skills. Sometimes students are only
expected to copy the prescribing behavior of their clinical teachers, or existing
standard treatment guidelines, without explanations as to why certain treatments
are chosen. Some students may think that they will improve their prescribing
Therapeutics Committee Manual 24
skills after finishing medical school, but research shows that despite gains in gen-
eral experience, prescribing skills do not improve much after graduation.
The Generics Acts of 1988 (RA 6675) orders that all prescriptions be written in
generics and that drugs prescribed are those listed in the Philippine National Drug
Formulary (PNDF). It is imperative therefore, that Filipino medical practitioners
have a good grasp and understanding of RA 6675 and the implementing rules and
guidelines issued by the Department of Health.
P-drugs refer to those drugs that a prescriber has chosen to use regularly, with
which he has become familiar, and are the prescriber’s priority choice for given
indications.
25 Therapeutics Committee Manual
• Through developing your P-drugs, you will learn how to handle pharmacol-
ogical concepts and data. It enables you to determine its pharmacological
value and to evaluate conflicting information from various sources.
• Learn alternatives when your P-drug is not available or has adverse reactions
or contraindications.
• The latest or the most expensive drug is not necessarily the best, the safest, or
the most cost-effective.
??
?
Rational
Drug
? Generic
?
? Branded
C. Pharmacovigilance
1. Reporting Scheme
Reports of suspected adverse drug reactions are best made by using the prescribed
reporting form and sent to the Adverse Drug Reaction Monitoring Unit in BFAD,
Alabang, Muntinlupa, Telephone No. 807-8517.
Therapeutics Committee Manual 28
Note: submission of this report does not constitute an admission that the drug caused the adverse reaction. Identities of the
reporter, institution and patient will remain confidential. Please mark all appropriate items.
Treatment of reaction/s:
Outcome
Recovered Date: _____/______/ 200___
Not yet recovered
Unknown
Died Date: _____/______/ 200___
Resulted in prolonged hospitalization? No Yes
Sequelae? No Yes Please describe:
Comments:
Allergies
Previous exposure/reaction to suspect drugs
Pregnancy with LMP
Relevant history
Others
Name of reporter Signature Date reported: _____/______/ 200___
4. Causality Assessment
Report of an ADE
Yes No
Yes No
CERTAIN PROBABLY/LIKELY
Therapeutics Committee Manual 32
D. Pharmacoeconomics
The careful evaluation of new drugs before inclusion in the formulary must in-
volve efficacy, safety, quality, and cost. Cost is an important consideration in the
evaluation of new drugs. The therapeutics committee must know how evaluate the
cost of a drug; this includes not only its procurement cost, but also the cost impact
on the entire healthcare system, especially on the patient. Pharmacoeconomics
refer to the description and analysis of the costs of drug therapy to healthcare sys-
tems and society.
There are three types of cost associated with drug in a health facility: direct, indi-
rect and intangible. These three cost when taken collectively will give the most
comprehensive assessment of actual drug cost.
• Direct Costs
• Acquisition cost of the drug or drug price
• Supply management costs
• Supply personnel salary
• Storage facilities, including warehouse, freezer, refrigerator
• Professional Services Costs
• Pharmacist salary- manage, prepare, dispense, etc.
• Nursing salary - to administer
• Physician- to manage and prescribe
• Supplies to administer drug
• Equipment for administration - syringes, gauze, IV sets
33 Therapeutics Committee Manual
• Indirect Cost
• Cost of illness to the patient
• Lost time from work
• Intangible Cost
• Quality of life
2. Cost-Evaluation Methods
This is defined as the cost involved in treating a particular disease without provid-
ing a particular relationship to any type of medical therapy or drug treatment. This
is descriptive analysis and does not provide information as to the appropriateness
of therapy. This type of analysis will answer the following questions:
c) Cost-Effectiveness
This analysis is utilized when it is necessary to measure both costs and benefits of
the drugs as measured in health care improvements and outcomes from the use of
the drug. The effectiveness component of this evaluation is determined by one
measurable outcome. Some examples of measurable outcomes or health care im-
provements for specific conditions are as follows:
A cost-effective ratio is calculated based on the cost of the drug and the targeted
medical endpoint. The numerator will be the cost in monetary units and the de-
nominator will be the effectiveness expressed in the measurement of reportable
units.
1. ABC Analysis
An ABC analysis examines the annual consumption of drugs and expenditures for
procurement. It can:
• Reveal high usage items for which there are lower-cost alternatives on the list
or available on the market.
• Identify purchases for items not on the hospital essential drugs list.
• List items consumed or purchased and enter the unit cost of each item. To ac-
count for changes in price over time, calculate the average unit cost.
• Enter the number of units purchased or consumed.
• Calculate the value of consumption by multiplying the unit cost by the number
of units consumed for each item. The total value of consumption is the sum of
item values.
• Calculate the percentage of total value for each item by dividing the value of
each item by the total value. Express the percentage to two decimal places.
35 Therapeutics Committee Manual
This method makes a review of the volume of use and the value of various thera-
peutic categories and subcategories of drugs.
Building on the ABC analysis, it sorts out the therapeutic categories (based on
cumulative volume and value of the individual drugs in those categories) this
technique can:
• Help the committee choose the most cost-effective drugs within a therapeutic
class and to choose alternatives for therapeutic substitution.
• Indicate potential appropriate use if used together with information on the
morbidity pattern.
• Identify drugs that are overused or whose consumption is unaccounted for by
the number of cases of a particular disease for example, rifampicin and tuber-
culosis.
• Do the first three steps of ABC analysis to produce a list of all items by vol-
ume and value of consumption.
• Assign a therapeutic category to each drug using the WHO Model List of Es-
sential Drugs.
• Rearrange the list into therapeutic categories and sum the percentage value of
items in each category.
3. VEL Analysis
This method is ideal in setting priorities for selection, procurement, and use based
on the potential health impact of each drug.
• V: vital drugs are potentially lifesaving, have significant withdrawal side ef-
fects (making regular supply mandatory), or are crucial to providing basic
health services,
• E: essential drugs are effective against less severe but nevertheless significant
forms of illness but are not absolutely vital to providing basic health care,
• L: less-essential drugs are used for minor or self-limited illnesses, are of ques-
tionable efficacy, or have a comparatively high cost for a marginal therapeutic
advantage. Drugs identified to be non-essential shall be deleted from the for-
mulary.
Drug Action Prevention of disease; Cure of disease; pre- Relief and/or mitiga-
cure of disease; pre- vention or treatment tion of self limited
vention of complica- of complication disease; palliative
tion treatment of minor
symptoms/
Complications
Cost
- Average cost of single course of Low Moderate High
therapy (acute therapy)
-Average yearly cost of therapy Low Moderate High
(chronic therapy)
Source: Primary Medical Care Drugs Handbook (PNDP1997)
F. Ethical Promotions
It is an undeniable fact that both doctors and the pharmaceutical industry have a
common goal in the treatment of disease. Medical representatives will always be a
source of information with regards to the latest development in the field of phar-
maceuticals. Doctors, on the other hand, must see to it that the information given
is based on scientific evidence to ensure product safety and efficacy. Therapeutics
committee members must operate in a manner that insures transparency and
avoids conflicts of interest with drug manufacturers and distributors. A strict eth-
ics policy must be provided and rigorously enforced to maintain objectivity and
credibility. The doctor-industry relationship must be kept on a strictly profes-
sional level to encourage the flow of unbiased information about the drug prod-
ucts being promoted.
Some doctors assume that they are immune from skilled advertising techniques.
While physicians are trained to make rational decisions, they may be no more re-
sistant than other community members to expertly designed promotions, which
are created to appeal to emotions and to tap into personal values and biases.
defrayed by the funds provided by industry; the cost of travel and attending such a
meeting is met by physicians because of its value to their continuing education.
A policy must be set that will regulate the interaction between hospital staff and
the industry. The Therapeutics Committee should promote the guiding principles
that “All promotion-making claims concerning medicinal drugs should be reli-
able, accurate, truthful, informative, balanced, up-to-date, capable of substantia-
tion, and in good taste.”
1. WHO Guidelines
In 1996, the World Health Organization (WHO) developed a set of guidelines re-
garding Drug Donations that reflect a consensus between the major international
agencies active in humanitarian relief. They are not an international regulation,
but are intended to serve as a basis for national or institutional guidelines, to be
reviewed, adapted and implemented by governments and organizations dealing
with drug donations.
There are several benefits that can be derived from the Guidelines and are as fol-
lows:
• Provides a framework for improved drug donation practices and procedures.
• Serves as a support to a country’s national drug policy
• Requests for donations are more carefully solicited and formulated in keeping
with the Guidelines.
• Helps to ensure the quality of donations.
However, certain problems that can arise from drug donation are:
• Irrelevance to the existing emergency situation.
• Not appropriate for the prevailing disease pattern and level of care that is
available in the community
• The quality of the drug may not always comply with standards in the donor
country.
41 Therapeutics Committee Manual
• The drugs may have a high-declared value. Import taxes and overheads for
storage and distribution may be unnecessarily high and the inflated value of
the donation may be deducted from the government drug budget.
• Drugs may be donated in wrong quantities, and some stock may have to be
destroyed.
• Stockpiling of unused drugs can encourage pilfering and black market sales.
Probably, the most important underlying factor for these problems is the common
but mistaken belief that in an acute emergency any type of drug is better than
none at all. Moreover, there is usually a general lack of communication between
donor and the recipient.
The following articles (a-l) of the Guidelines rests on the four core principles (A-
D) stated above and are distributed into four (4) main categories:
• Selection of Drugs
• Quality and assurance
• Presentation, packaging and labeling
• Information and management
Selection of Drugs
• Must be based on an expressed need and is relevant to the disease pattern in
the recipient country.
• Donated drug or their generic equivalence should be approved for use in the
recipient country.
• The presentation, strength and formulation of donated drugs should, as much
as possible, be similar to those commonly used in the recipient country.
• All donated drugs; should be obtained from a reliable source and must comply
with quality standards in both donor and recipient country.
• Drugs given to health professionals as free samples or issued to patients
should never be included in the donation.
• Drugs should have a remaining shelf life of at least one (1) year.
Donated drugs are classified under accelerated registration wherein, only a test of
the potency range of the active ingredients (as per label claim) is being conducted
by the BFAD laboratory section.
The following government and private institutions are recognized to deal with
drug donations and are required to secure accreditation from the Department of
Social Welfare and Development (DSWD).
43 Therapeutics Committee Manual
• Foundations
• Medical Missions
• Religious Missions
• Professional Groups
• Non-Governmental Organizations (NGOs)
• Political-based Organizations
Documentary Requirements:
• Accreditation letter from DSWD
• Letter or Pledge of donation from group (s)
• Letter of Acceptance from Recipient
• SEC Papers (Optional)
• Letter of Exemption from the Department of Finance
• Letter from the Department of Health (DOH) Foreign Assistance & Coordina-
tion Services (FACS) for endorsement to BFAD.
• List of Drug donations and quantity indicating on the label the following in-
formation printed on the label and shall be in English or with English transla-
tion.
• Formulation
• Generic Name/brand name, if any
• Dosage forms/strength
• Batch & lot number
• Expiry date. Drugs should have a shelf-life of at least six (6) months after the
estimated arrival in the country of destination.
• Storage condition.
• Name and address of the manufacturer/distributor
• Bill of Lading/ Airway bill
• Plan of Action indicating where donated drugs are intended.
Section 1
Section 2
Members of the Therapeutics Committee shall abstain from seeking any form of
personal sponsorship or receive any compensation, whether in cash or in kind,
from any drug company.
Section 3
Section 4
Section 5
Members shall sign a “Declaration of Interest” that will bind them to the working
principles and ethics of this committee.
45 Therapeutics Committee Manual
FLOWCHART:
Therapeutics Committee Manual 46
V. LIST OF REFERENCES
“Tackle every task that comes along, and if you fear GOD, you can expect his blessing.”
“Let love and faithfulness never leave you; bind them around your neck, write them on the tablet of
your heart. Then you will win favor and a good name in the sight of God and man.”