Implementation Priorities for Integrating the Healthcare Enterprise (IHE)

Medication Management Subcommittee

Prepared by the IHE Strategic Development Medication Management Subcommittee

April 10, 2003

Background

IHE is an initiative that brings together clinicians, information technology professionals and
industry representatives to implement standards for communicating patient information
efficiently throughout the healthcare enterprise and to develop a framework for the
implementation of an electronic health record (EHR).

IHE has defined a multi-dimensional approach to implementing standards-based integration of

information systems throughout the enterprise. The first dimension is vertical integration within
the various departments and units of the enterprise (clinical specialties, emergency department,
laboratory, etc.). In four years of work, the IHE Planning and Technical committees have made
significant progress in defining, testing, demonstrating and implementing a high degree of
vertical integration in the radiology unit. HIMSS and RSNA, sponsors of the IHE initiative to
date, have invited organizations representing other clinical professionals (cardiology, laboratory
medicine, pharmacy and others) to implement the IHE process in their domains.

To extend this work, the IHE Strategic Development Committee formed in November of 2001.
The committee includes leaders in radiology, laboratory medicine, pathology, medical and
nursing informatics, internal medicine, information systems administration, imaging and the
information technology industry.

This committee was charged with validating and addressing the following strategic objectives:
Ø Identify steps in the patient care workflow
Ø Identify and recommend clinical and operational domains
Ø Identify integration needs and barriers (problems/solutions) within and across domains
Ø Identify experts to populate domain specific IHE planning and technical committees.

The second dimension of integration is horizontal: implementing standard methods for the
exchange of relevant information among departments and enterprise-wide information systems.

The Medication Management Subcommittee of the Strategic Development Committee was

formed to: (1) identify key requirements for providing and accessing medication-related
information across departmental boundaries and (2) develop a framework for implement ing an
EHR. By addressing these integration cha llenges, IHE will improve the state of systems
integration and remove barriers to optimal patient care. This white paper documents key
integration needs, barriers, and priorities in the operational domain of medication management.

DRAFT – Medication Management Subcommittee 1 April 10, 2003

Overview

IHE addresses integration needs by identifying the information sharing requirements for clinical
care, selecting the most appropriate standards-based solution for addressing each requirement,
and establishing detailed guidelines for implementing these standards.

Pharmaceutical therapies represent a particularly challenging and promising area for IHE efforts.
Recent work by the Institute of Medicine 1 , the Leapfrog Group 2 , the Institute for Healthcare
Improvement 3 , and several other organizations highlights the potential for care process
improvements and automation assistance in the management of pharmaceutical therapies.
Similarly, recent survey of healthcare information technology vendors 4 identified
pharmacy/medication management as the area of greatest potential improvement if data
standards were more broadly implemented. Laboratory fell a distant second in this survey, with
general practices and emergency rooms tied for third.

Based on the significant advances in patient safety that could be achieved through improved
medication management processes and automation, the IHE launched a subcommittee to address
this area.

Medication Management Subcommittee Charge

The purpose of the Medication Management Subcommittee is to improve decision making and to
streamline workflow across the broad range of patient care activities that span the medication
management process. These activities begin with the contemplation of a pharmaceutical therapy,
which requires both general knowledge concerning the appropriate medications and specific
knowledge concerning the patient. Medication management continues through the
administration, documentation, and monitoring of the selected therapy.

As in other patient care areas, each of these processes can be improved by providing relevant
clinical information:
Ø Whenever and wherever this information is required to support clinical actions
Ø In formats that facilitate clinical decision making and increase patient safety

Accordingly, the Medication Management Subcommittee has identified:

Ø Situations in which the automated exchange of clinical information would be beneficial
Ø The particular data elements of interest, and
Ø The mechanisms for this exchange.

Situations in which the automated exchange of clinical information would be beneficial

Clinical information relevant to medication management can be used in different situations, for
different purposes, and by different entities (individuals or computer systems ) performing
different roles. For certain activities, the relevant information must be available directly to
clinicians. For example, the prescribing physician must be aware of existing allergies and
underlying medical conditions when he/she is formulating an order. For other activities, this
information must be exchanged among computer systems that perform automated functions (e.g.,
calculate appropriate dosage based on age, height, weight; check for drug- lab interactions).

DRAFT – Medication Management Subcommittee 2 April 10, 2003

 To understand the requirements for clinical data exchange, let us first consider eight steps in the
medication management process:

Step Usually Performed by Focus

1. Order Formulation Physician • Therapeutic appropriateness
− Based on detailed firsthand knowledge of the
patient, what is the best pharmaceutical agent for
the intended purpose?
• Safe medication practice
− Is the dose correct? Is the patient allergic? Are
there other contraindications?
2. Order communication Communication system Efficient, unambiguous transmission of the order details
(paper, fax, computer) to the individual or system that must fill the order
3. Order verification Pharmacist and/or • Safe medication practice
pharmacy information − Is the dose correct? Is the patient allergic? Are
system there other contraindications?
• High level check of therapeutic appropriateness
− Based on documented information about the
patient, is this the best pharmaceutical agent for
the intended purpose?
4. Order translation Pharmacist Faithful conversion of the clinician’s medic ation request
into a filled order (specific brand, tablet size, etc.)
5. Dispensing Pharmacist or automated Dispense appropriate medication, strength, quantity
system
6. Administration Nurse or patient • High level check for safe medication practice
− Reconfirm known allergies
− Reconfirm patient, medication, dose, route, time
• As required, document patient condition (e.g., vital
signs) before and/or after medication administration
• Document administration
7. Patient Monitoring Nurse and physician • For each individual patient: observe for intended
monitoring of individual clinical response
patient; pharmacist • Across all patients: check for indicators of adverse
and/or automated system drug events
to detect possible ADEs
8. Outcomes Quality improvement • Detect nosocomial infections
personnel; hospital • Establish institutional antibiotigrams
epidemiologist • Identify trends of inappropriate medication usage
• Support evidence-based practice

Each of these steps requires the availability of patient-specific clinical information to ensure safe
medication management. In some steps, there is opportunity for computerized assistance (e.g.,
automated checking for threatening drug- lab combinations). Discrete, coded data typically are
required to take advantage of this computer assistance.

In other steps, humans are responsible for the key activities (e.g., determination of medical
appropriateness; administration of oral medications). In these cases, the relevant clinical data
typically need not be coded, though they sho uld be presented in a format that facilitates user
awareness and promotes appropriate action. (Use Case #1, which is presented at the end of this
white paper, addresses a critical data presentation issue.)

DRAFT – Medication Management Subcommittee 3 April 10, 2003

 Recognizing these varied uses of pharmacy-related information leads us to a general principle
guiding the exchange of clinical data to support the medication management process:

Whenever possible, data should be exchanged in discrete, coded format (rather than as text
fields) so that they can be interpreted and manipulated by the receiving system.

Thus, while the Synchronized Patient Views and the Query/Display model proposed by the IHE
IT Infrastructure Subcommittee represent significant steps forward in the communication of
clinical information among disparate systems (computer and human), neither by itself is
adequate to support the patient safety process improvements that are required across medication
management. Improvements in medication management will rely heavily on computer assistance
for dose checking, known contraindications, therapeutic substitutions, monitoring for adverse
drug events, and other safety-enhancing measures that are amenable to automation.

Data elements of interest

For each of these seven steps in the medication management process, let us consider the data
elements of interest, their typical uses, and their likely sources.

Step #1(Order Formulation) and Step #3 (Order Verification)

By their very nature, these two steps require similar clinical data elements. Illustrative examples
include the following:

Data Use Probable Authoritative Data Source

Medication name
(trade and generic)
Age
Gender
Height, Weight
Allergies
Vital signs; fluid intake and
output
Discrete Lab results (e.g.,
potassium; glucose;
creatinine clearance, liver
function; medication levels)
Unambiguous identification of
intended medication
Dose calculation
Contraindication checking
Dose calculation
Contraindication checking
Contraindication checking;
potential dose modification
Dose calculation and/or
modification based on lab
results; contraindication
checking
Formulation: Ordering clinician, based on
selection from medication order catalog,
formulary, pharmacy system, drug
reference system, or personal knowledge
base
Verification: Electronic order entry
system; Pharmacy system; Nursing
system; Clinical data repository
Registration system; Clinical data
repository
Registration system; Clinical data
repository
Nursing documentation system; Clinical
data repository
Pharmacy system; Nursing system;
Clinical data repository
Nursing documentation system; Clinical
data repository
Laboratory system; Clinical data
repository; Nursing documentation
system (bedside testing)

DRAFT – Medication Management Subcommittee 4 April 10, 2003

 Step #1(Order Formulation) and Step #3 (Order Verification) – continued

Data Use Probable Authoritative Data Source

Menstrual history
Microbiology sensitivities
High-information content
text documents (e.g., H&P,
discharge summaries, letters
to referring physicians;
consultation notes)
Diagnoses, problem lists, or
other past medical history
Current medications
Contraindication checking
Therapeutic appropriateness
Check for underlying medical
conditions, relevant past
medical history, response to
previous therapy, known
allergies, etc.
Check for potential
contraindications and/or
previous response to therapies
Drug interaction checking;
avoid therapeutic duplication
Nursing documentation system; Clinical
data repository
Laboratory system; Clinical data
repository
Transcription/Medical Records System;
Clinical data repository
Clinician documentation system (MD or
Nurse); Clinical data repository; Billing
system (ICD codes)
Inpatient medications : Inpatient pharmacy
system; Nursing documentation system
(MAR); Clinical data repository
Outpatient medications : Ambulatory
documentation system (MD or Nurse);
Clinical data repository; Retail pharmacy
system

Step #2(Order Communication) and Step #4 (Order Translation)

These two steps also require similar data (i.e., unambiguous indication of clinician intent).
Common examples appear below:

Data Use Probable Authoritative Data Source

Identification of prescribing
clinician
• Medication name
(trade and generic)
• Dose, frequency, route
Allow order fulfillment Electronic order entry system
Allow proper dispensing, Electronic order entry system; Pharmacy
therapeutic substitution system; Nursing system; Clinical data
repository

Special instructions (e.g., Guide proper administration Electronic order entry system; Pharmacy
hold if pulse < 50) system; Nursing system

DRAFT – Medication Management Subcommittee 5 April 10, 2003

 Step #5(Dispensing)
Data
Patient location
• Medication name
(trade and generic)
• Dose, frequency, route
Step #6 (Administration)
Data
• Administration details
− Trade and generic name
− dose, route, time
− patient ID/name
• Special instructions (e.g.,
hold if pulse < 50)
Allergies
Step #7 (Monitoring)
Data
Laboratory indicators of
adverse drug events (e.g.,
toxic drug levels)
Clinical indicators of ADE
(e.g., rash)
Pharmacy indicators of ADE
(e.g., anti-histamine for
allergic reaction;
antimicrobial for nosocomial
infection)
DRAFT – Medication Management Subcommittee
Use
Determine method and location
of dispensing
Allow proper dispensing,
therapeutic substitution
Use
Allow administration
Contraindication checking
Use
Detect potential medication
problems
Detect potential medication
problems
Detect potential medication
problems
Probable Authoritative Data Source
Inpatient: Admission/Discharge/Transfer
system; Nursing system; Clinical data
repository
Outpatient: Registration system;
Outpatient pharmacy system
Electronic order entry system; Pharmacy
system; Nursing system; Clinical data
repository
Probable Authoritative Data Source
Nursing system (electronic Medication
Administration Record); Electronic order
entry system; Pharmacy system; Clinical
data repository
Pharmacy system; Clinician
documentation system (MD or Nurse);
Clinical data repository
Probable Authoritative Data Source
Laboratory system; Clinical data
repository
Nursing documentation system; Clinical
data repository
Pharmacy system; Order entry system;
Clinical data repository
6 April 10, 2003
 Step #8 (Outcomes)

Data Use Probable Authoritative Data Source

• Medication name Identification of pharmaceutical Electronic order entry system; Pharmacy
(trade and generic) therapy system; Clinical data repository
Outcome measures (e.g., Detect potential medication Hospital epidemiology database;
successful treatment of problems Infectious Disease database; Hospital
infection; length of stay) decision support system; Case
management system; Utilization review
system

Mechanisms for information exchange

IHE-supported exchange of clinical information to coordinate pharmaceutical therapies will use

existing data standards and controlled vocabularies. According to a recent survey of healthcare
information technology vendors 4 , these standards (ordered by current frequency of use) include:

Standard Focus
HL7 5 Syntax and semantics of clinical data exchange
ICD 6 Diagnoses
CPT 7 Procedures
SNOMED 8 Broad range of clinical findings and terminology
DICOM 9 Radiology
ASTM International10 Medical devices
LOINC 11 Laboratory and other clinical observations
NCPDP 12 Retail pharmacy

The IHE Strategic Development Committee recently has established a formal liaison relationship
with HL7, which is the most common standard for exchange of clinical data among clinical
information systems in U.S. hospitals. Significant variability exists across the thousands of HL7
implementations supporting pharmacy data exchange, however, due to local variations in
implementation of the HL7 data segments.

Given the large installed user base, HL7 appears to be the appropriate foundational data
interchange standard upon which to build the IHE Pharmacy Integration Profile. Additional
analysis will be required to determine the appropriate roles for the many other available data
standards, including tho se listed above. While several of these standards have a clearly defined
area of focus (e.g., ICD for diagnoses; LOINC for laboratory tests), there is considerable overlap
among them (e.g., SNOMED strives to index the entire medical record). The Medication
Management Subcommittee must investigate the opportunities and requirements for
incorporating the various standards in the IHE Pharmacy Integration Profile.

Use Cases for the Pharmacy Integration Profile

The Medication Management Subcommittee recommends the following three Use Cases as the
initial areas of emphasis for the IHE Pharmacy Integration Profile.

DRAFT – Medication Management Subcommittee 7 April 10, 2003

Use Case #1: Presentation of Medication Names

Recommendations concerning naming convention for data input and display:

Ø Data entry, display, and representation of medications must include both trade and generic
names
Ø Documentation of current medications upon presentation to any entrance point in the health
care system must support the ability to enter either trade or generic name for all
medications
• Examples: Inderal (generic = propranolol); Claritin (generic = loratidine)
• User will decide whether trade or generic name is entered
• Use of abbreviations or short aliases is allowable to facilitate the electronic search
for medication names (e.g., user entry of “prop” retrieves all medications beginning
with these four letters, including “propranolol). Subsequent use of abbreviations for
display of medications is prohibited (i.e., once specified, each medication name will
be displayed without abbreviation)
• Once specified, subsequent displays always will list trade name first, then generic
name
Ø Aside from abbreviations that may be used to speed the electronic search for medication
names , displa y of all medications will include both trade and generic names in all
situations, including:
• Order formulation and verification (physician)
• Medication review (nurse, pharmacist)
• Medication Administration Record (nurse)
• Medication administration (dispensing devices; bar code itself; bar code reader
display; any other point of care documentation device)
• Any information given to patient or family
• Medication labels
• Drug monographs
• Patient educational materials
Ø Medication display always will list trade name first, then generic name

Systems :
Ø Systems adopting this standard presentation of medication names include:
• Order entry
• Clinical documentation, including MAR
• Pharmacy
• Medication dispensing and bar coding
• Data repository
• Clinical decision support (e.g., clinical alerts and warnings)
• Patient education

Rationale :
Ø Reduce potential for medication error through consistent naming of medications:
• Avoid confusion concerning a patient’s current medications (e.g., due to lack of
familiarity with trade and/or generic name)
• Establish a standard methodology for data entry and data review of medication
names, thus making the process more predictable and less distracting

DRAFT – Medication Management Subcommittee 8 April 10, 2003

 • Reduce variability (e.g., simplify training requirements; facilitate personnel working
across facilities; improve communications across disciplines, such as physician and
nurse; facilitate data exchange across vendor applications)
• Facilitate quicker and easier recognition by clinicians
Ø Facilitate data exchange across vendor applications (i.e., interfacing to allow inter-
operability)
Ø Establish a standard representation for medication names (no uniform standard currently
exists)

Note: The Medication Management Subcommittee also recognizes the critical importance of
dosage form, route, frequency, and duration of therapy. We recommend that standard formats be
established for these as well, once the IHE Pharmacy Integration Profile establishes the standard
naming convention (trade name followed by generic name, without abbreviations). Consistent
use of the standard naming convention – throughout the entire medication management process –
is of more immediate importance.

Use Case #2: Allergies

Recommendations :
Ø For each patient, there will exist a single profile for allergies.
Ø Any system that supports documentation of allergies will contribute to this single profile.
Ø Any system that relies on allergy information (e.g., for clinical decision support) must be
able to retrieve up-to-the-minute information concerning patient allergies.
Ø There will exist a standard vocabulary for allergy documentation. This vocabulary will
include:
• Agent (allergen)
• Allergic reaction
• Informant
• Recorder
Ø At least Agent (allergen) and Allergic Reaction must be coded (not free text). This will
allow automated processing for clinical decision support and outcomes monitoring.

Systems :
Ø Systems complying with this standard for the capture and display of allergy information
include:
• Admission/discharge/transfer and registration
• Scheduling
• Order entry
• Clinical documentation (any that document allergy information)
• Pharmacy
• Medication dispensing and bar coding
• Data repository
• Clinical decision support (e.g., clinical alerts; warnings; rules)
• Radiology

DRAFT – Medication Management Subcommittee 9 April 10, 2003

Rationale :
Ø Reduce potential for medication errors and Adverse Drug Events (ADEs) through standard
documentation of allergies:
• Facilitate capture of allergy information
• Facilitate a standard methodology for documentation and review of allergies, which
will support good practice (i.e., the review and documentation of allergies before all
medication ordering, dispensing, and administration)
• Reduce variability (e.g., simplify training requirements; facilitate personnel working
across facilities; improve communications across disciplines, such as MD and RN;
facilitate data exchange across vendor applications)
• Support automated clinical decision support (e.g., alerts and warnings), which
requires coded allergy information
Ø Facilitate data exchange across vendor applications (i.e., interfacing to allow inter-
operability)
Ø Establish a standard representation for documenting allergies and allergic reactions (no
uniform standard currently exists)
Ø Improve our ability to quantify, track, and monitor the frequency and impact of allergic
reactions
Ø Facilitate compliance with regulatory standards (e.g., JCAHO)

Use Case #3: Other data elements for safe medication management

Recommendations :
Ø The following data elements will be coded and presented in a standard format:
• Height
• Weight
• Date of birth
• Gender
• Last menstrual period

These elements are critical for clinical decision support at the time of ordering, dispensing,
and administration. Examples of automated clinical decision support include:
• Dose range recommendation and checking
• Pregnancy contraindications
Ø Establish a standard unit of measure for height and weight (metric vs. English)
Ø Establish a standard for expressing dates such as Last Menstrual Period (e.g., date vs.
elapsed time)
Ø Establish a standard format for expressing dates (e.g. mm/dd/yy vs. month day, year)

Systems :
Ø Systems complying with this standard capture and display of patient information include:
• Admission/discharge/transfer and registration
• Scheduling
• Clinical documentation (any that record these data elements)
• Pharmacy
• Data repository
• Clinical decision support (e.g., clinical alerts; warnings; rules)
• Radiology
DRAFT – Medication Management Subcommittee 10 April 10, 2003
 • Cardiology
• Other

Rationale :
Ø Reduce potential for medication errors and Adverse Drug Events (ADEs) through standard
data capture and display of these elements, which enables:
• Facilitation of a standard me thodology for data entry and data review, which will
support good practice (i.e., the automated checking of appropriate dose range and
pregnancy contraindications whenever medications are ordered, dispensed, or
administered)
• Reduction of variability (e.g., simplify training requirements; facilitate personnel
working across facilities; improve communications across disciplines, such as MD
and RN; facilitate data exchange across vendor applications)
• Support of automated clinical decision support (e.g., alerts and warnings), which
requires coded allergy information
Ø Facilitate data exchange across vendor applications (i.e., interfacing to allow inter-
operability)
Ø Establish a standard representation for these data elements (no uniform standard currently
exists)
Ø Facilitate compliance with regulatory standards (e.g., JCAHO)

Discussion:

The use of information technology to enhance patient safety has become a priority for healthcare.
The Centers for Medicare and Medicaid Services has announced a new rule calling on hospitals
to develop and implement quality improvement programs, a move intended to encourage a
reduction in medical errors. Under the final rule, which was published in the Federal Register on
January 24, hospitals must implement a quality assessment and performance improvement
program that identifies patient safety issues and reduces medical errors. The Institute of
Medicine (IOM) has identified medication management as one of 20 priority areas for
transforming healthcare. The IOM also collaborated with HL7 on a patient safety demonstration
featuring medication management at HIMSS 2003 Annual Conference and Exhibition. At the
state level, a 2000 California law requires hospitals to implement formal plans, including new
technologies, to eliminate or substantially reduce medication-related errors by Jan. 1, 2005.
HIMSS is actively advocating the use of applications and technologies such as Computerized
Practitioner Order Entry and Bar coding.

Standardization and interoperability in the area of medication management will have a real and
immediate impact on enabling clinicians to provide optimal patient care. This white paper
describes priority areas for applying the IHE process to enable automated exchange of clinical
information necessary for safe and efficient medication management. Data elements needed to
support the seven steps of the medication management process and relevant data standards are
identified. Use cases are delineated that address areas of emphasis and standardization including
presentation of medication name, allergies, and other key data elements. This important
functionality will go far to provide the needed interoperability of systems, enhance the ability to
deliver optimal patient care, and further develop a framework for the implementation of an
electronic health record (EHR).

DRAFT – Medication Management Subcommittee 11 April 10, 2003

References:

1. Institute of Medicine. To Err is Human, Building a Safer Health System. National

Academy Press. Washington DC, 1999.

2. The Leapfrog Group. Factsheet: Computer Physician Order Entry.

http://www.leapfroggroup.org/FactSheets/CPOE_FactSheet.pdf.

3. Institute for Healthcare Improvement. Would You Prefer Your Medications Safe or
Scrambled? http://www.ihi.org/idealized/idms/ci0401idms.asp.

4. HIMSS. Statement on Data Standards Initiatives for the Committee on Patient Safety Data
Standards Committee, Institute of Medicine, November 25, 2003. http:// www.himss.org

5. http://www.hl7.org

6. http://www.who.int/whosis/icd10

7. http://www.ama-assn.org/ama/pub/category/3113.html

8. http://www.snomed.org

9. http://medical.nema.org

10. http://www.astm.org

11. http://www.loinc.org

12. http://www.ncpdp.org

i
HIMSS (2003). Statement on Data Standards Initiatives for the Committee on Patient Safety Data Standards
Committee, Institute of Medicine, November 25,2003 http:// www.himss.org

DRAFT – Medication Management Subcommittee 12 April 10, 2003