Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021)

This document specifies the requirements for medication safety alert systems and the topics which are
relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs)
whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;
— requirements for choosing a knowledge base for medication safety alert systems;
— requirements for the proper functionality of CDSSs as related to medication safety alert systems;
— requirements for medication safety alert display;
— requirements for quality measurements to improve the effectiveness of medication safety alerts.
The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.

Medizinische Informatik - Anforderungen an Arzneimittel-Warnmeldungen (ISO/TS 22703:2021)

Dieses Dokument legt die Anforderungen an Arzneimittelsicherheitswarnsysteme und die für Warnsystemanbieter relevanten Themen fest. Dieses Dokument ist für klinische Entscheidungsunter-stützungssysteme (CDSS) anzuwenden, egal ob diese Medizinprodukte sind oder nicht.
Dieses Dokument behandelt Folgendes:
—   Anforderungen an die in Arzneimittelsicherheitswarnungen verwendeten Begriffe;
—   Anforderungen an die Auswahl einer Wissensdatenbank für Arzneimittelsicherheitswarnsysteme;
—   Anforderungen an die korrekte Funktionalität von CDSS in Verbindung mit Arzneimittelsicherheits-warnsystemen;
—   Anforderungen an die Anzeige von Arzneimittelsicherheitswarnungen;
—   Anforderungen an Qualitätsmessungen zur Verbesserung der Effektivität von Arzneimittelsicherheits-warnungen.
Folgendes liegt außerhalb des Anwendungsbereichs dieses Dokuments:
—   die Entwicklung von Inhalten (regelbasierte Wissensbasis) für CDSS;
—   die Entwicklung von Algorithmen für die Erzeugung von Arzneimittelsicherheitswarnungen in CDSS;
—   die Entwicklung von Warnprozessoren für Arzneimittelsicherheitswarnungen in CDSS.

Informatique de santé — Exigences relatives aux alertes de sécurité sur les médicaments (ISO/TS 22703:2021)

Zdravstvena informatika - Zahteve za opozorila o varnosti zdravil (ISO/TS 22703:2021)

General Information

Status
Published
Publication Date
14-Nov-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Nov-2021
Due Date
09-Jan-2022
Completion Date
15-Nov-2021

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SLOVENSKI STANDARD
SIST-TS CEN/ISO TS 22703:2021
01-december-2021
Zdravstvena informatika - Zahteve za opozorila o varnosti zdravil (ISO/TS
22703:2021)

Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021)

Medizinische Informatik - Anforderungen an Arzneimittel-Warnmeldungen (ISO/TS
22703:2021)

Informatique de santé Exigences relatives aux alertes de sécurité sur les médicaments

(ISO/TS 22703:2021)
Ta slovenski standard je istoveten z: CEN ISO/TS 22703:2021
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN/ISO TS 22703:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/ISO TS 22703:2021
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SIST-TS CEN/ISO TS 22703:2021
CEN ISO/TS 22703
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
October 2021
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Requirements for medication safety
alerts (ISO/TS 22703:2021)

Informatique de santé - Exigences relatives aux alertes Medizinische Informatik - Anforderungen an

de sécurité sur les médicaments (ISO/TS 22703:2021) Arzneimittel-Warnmeldungen (ISO/TS 22703:2021)

This Technical Specification (CEN/TS) was approved by CEN on 12 September 2021 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to

submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS

available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in

parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 22703:2021 E

worldwide for CEN national Members.
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SIST-TS CEN/ISO TS 22703:2021
CEN ISO/TS 22703:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST-TS CEN/ISO TS 22703:2021
CEN ISO/TS 22703:2021 (E)
European foreword

This document (CEN ISO/TS 22703:2021) has been prepared by Technical Committee ISO/TC 215

"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national standards

body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO/TS 22703:2021 has been approved by CEN as CEN ISO/TS 22703:2021 without any

modification.
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SIST-TS CEN/ISO TS 22703:2021
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SIST-TS CEN/ISO TS 22703:2021
TECHNICAL ISO/TS
SPECIFICATION 22703
First edition
2021-10
Health informatics — Requirements
for medication safety alerts
Informatique de santé — Exigences relatives aux alertes de sécurité
sur les médicaments
Reference number
ISO/TS 22703:2021(E)
© ISO 2021
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Abbreviated terms ............................................................................................................................................................................................. 5

5 Requirements .......................................................................................................................................................................................................... 5

5.1 General ........................................................................................................................................................................................................... 5

5.2 Potential medication problem types for medication safety alerts........................................................... 7

5.2.1 General ........................................................................................................................................................................................ 7

5.2.2 Selection of potential medication problem types ................................................................................. 7

5.2.3 Other potential medication problem types ............................................................................................. 10

5.2.4 Predetermined standards for potential medication problem types ................................. 10

5.3 Data sources of potential medication problem types and predetermined standards ........ 11

5.3.1 Evidence-based resources ...................................................................................................................................... 11

5.3.2 Other resources ................................................................................................................................................................ 11

5.3.3 Patient data sources .....................................................................................................................................................12

5.4 Alert processor ....................................................................................................................................................................................12

5.5 Alerting guidelines (methods) ............................................................................................................................................... 14

5.5.1 General ..................................................................................................................................................................................... 14

5.5.2 Severity or safety risk grading ........................................................................................................................... 14

5.5.3 Alert schema ........................................................................................................................................... ............................. 16

5.5.4 Display of medication safety alert ................................................................................................................... 16

5.5.5 Alert receivers ................................................................................................................................................................... 17

5.5.6 Alert timings ....................................................................................................................................................................... 18

5.5.7 Alert interventions ........................................................................................................................................................ 18

5.5.8 Audit trail ............................................................................................................................................................................... 18

5.6 Interfaces and relations ............................................................................................................................................................... 19

5.6.1 General ..................................................................................................................................................................................... 19

5.6.2 Clinical information system .................................................................................................................................. 19

5.6.3 Pharmacy information system ........................................................................................................................... 20

5.6.4 Relation to international standards ............................................................................................................... 21

6 Other recommendations ..........................................................................................................................................................................21

6.1 General ........................................................................................................................................................................................................ 21

6.2 Pre-development steps ................................................................................................................................................................. 22

6.3 Development steps ........................................................................................................................................................................... 22

6.4 Implementation step ...................................................................................................................................................................... 23

6.5 M onitoring and management of the system .............................................................................................................. 23

Annex A (informative) Example of definition and requirement of predetermined standards .........24

Annex B (informative) A flexibility configuration setting screen shot of a CDSS system (a

case in Korea) .......................................................................................................................................................................................................25

Annex C (informative) Recommendations for DDI alert display ........................................................................................27

Annex D (informative) An alert display screen shot of a CDSS system (a case in Korea) .........................31

Bibliography .............................................................................................................................................................................................................................33

iii
© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health

informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)
Introduction

To improve the quality and safety of patient care in digital work-flow environments, computer assisted

clinical decision support systems (CDSSs) have been emphasized and implemented in healthcare

organizations and pharmacies, especially focusing on medication safety.

CDSSs for medication safety have been developed and used in many countries as an essential

component for decision support for clinicians in prescribing, dispensing and administering medication

in connection with an electronic health record (EHR), computerized physician order entry (CPOE)

system or pharmacy electronic health record (PEHR) and digitized knowledge bases.

Depending on the availability of knowledge bases and functionalities, CDSS can be classified into four

[12]
types :

Type 1 CDSS: provides categorized information that requires further processing and analysis by

users before a decision can be made. This type of decision support includes direct access to relevant

information, such as web-based access to current rules for travel inoculation.

Type 2 CDSS: presents the clinician with trends of a patient’s changing clinical status and alerts

clinicians to out-of-range assessment results and intervention strategies. Clinicians are prompted to

review information related to the alerts before arriving at a clinical decision.

Type 3 CDSS: uses deductive inference engines to operate on a specific knowledge base and automatically

generate diagnostic or intervention recommendations based on changing patient clinical condition, with

the knowledge and inference engines stored in the knowledge base. These systems include systems that

consider the disease and medication of the patient and whether these have contraindications for new

medication. These systems require computer-readable rules and an underlying computer EHR system

that is also computer processable. They also require computerized terminological representation of

clinical concepts.

Type 4 CDSS: uses more complex knowledge management and inference models than the other three

decision support types. These systems include case management reasoning, neural networks and

statistical discrimination analysis to perform outcome or prognostic predictions. Such systems possess

self-learning capabilities and use fuzzy set formalism and similarity measures or confidence level

computation as mechanisms to deal intelligently and accurately with uncertainty.

Among the four types of CDSS, type 3 has been focused on developing CDSS for medication safety alerts

in the countries where EHRs are in use, though type 4 is available in some countries.

Since the primary purpose of a medication CDSS implementation is the prevention of potential harmful

effects of medication or errors, all types of CDSS have been designed to have the functionality of alerting

or warning clinicians in a prospectively actionable fashion for all settings.

However, the desired outcome of prevention of harmful drug therapy with the use of CDSS for

medication safety has not been clearly defined. This can be attributed to factors such as poor and varied

stratification (mainly due to lack of clear consensus on terminology and rules) of safety risk warnings

or alerts. In addition, alert fatigue (the result of frequent alerts to clinicians which are not clinically

significant or tailored to speciality interests) is known to be one of the major factors contributing to

alert overrides, which can result in serious clinical consequences.

Unclear content and verbose language in medication safety alerts can also be barriers to clear

communication with clinicians of the clinical significance of potential safety risks.

In addition, since the alerts are linked to the embedded CDSS knowledge base through specifically

designed algorithms, the differences between algorithms to produce alerts, even though they are based

on the same knowledge base, can be another inhibiting factor in getting uniform and maximal benefit

from safety alert systems operating on the same patient population with the same clinical condition or

situation.
© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)

In the USA, a number of EHR and CPOE vendors, as well as several drug knowledge bases, are in use

with wide differences in content, alert types and displays. Medication safety alerts in computerized

information systems have typically been developed for pharmacy software, often in connection with

pharmacy benefit management, the requirement for a prospective drug utilization review (DUR)

programme for outpatients using a prescription filling service in community pharmacies, or both. For

prospective DUR programmes, the potential medication problem types for medication safety alerts

were defined by federal regulation and have been used for developing CDSS for pharmacy practitioners

and CPOE by system vendors.

In the Republic of Korea, a number of drug knowledge bases (in the form of CDSS) with the functionality

of safety alerts which are developed by system vendors and pharmacy benefit managers of national

health insurance bodies are in use, mostly benchmarking the prospective DUR programme in the USA.

However, they are not detailed enough to meet individual use cases and thus healthcare organizations

resort to commercial vendors for more in-depth and user-friendly coverage of medication alert content.

In other countries, various types or methods for providing medication safety alerts in connection

with digitized knowledge bases have been developed and implemented in digitized health information

systems. However, there are no internationally or regionally standardized requirements for improving

patient safety by alerting healthcare professionals to potential safety risks.

Given the wide variability of medication safety alert content and implementation approaches across

different system vendors and drug knowledge bases, there is a need for medication alert standardization

both nationally and internationally.

Stakeholders can use this document for developing common and structured medication safety alert

systems to improve patient safety.

The actors included in the scope of this document include, but are not limited to:

— healthcare organisations which deploy EHR or PEHR systems incorporating medication safety

alerts;

— vendors and implementors of systems with medication safety alerts or those who provide

information for the alerts, such as:
— CDSSs
— EHRs
— pharmacy systems
— clinical information systems

— practice management systems (EHR-like systems for individual or small-group settings).

© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
TECHNICAL SPECIFICATION ISO/TS 22703:2021(E)
Health informatics — Requirements for medication safety
alerts
1 Scope

This document specifies the requirements for medication safety alert systems and the topics which are

relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs)

whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;

— requirements for choosing a knowledge base for medication safety alert systems;

— requirements for the proper functionality of CDSSs as related to medication safety alert systems;

— requirements for medication safety alert display;

— requirements for quality measurements to improve the effectiveness of medication safety alerts.

The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO/TS 22756, Health informatics — Requirements for a knowledge base for clinical decision support

systems to be used in medication related processes
ISO 27789, Health informatics — Audit trails for electronic health records
IEC 82304-1, Health software — Part 1: General requirements for product safety
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)
3.1
administration

(self-) administering a (prescribed) medicinal product to the patient, using a specified method, and via

a defined route, and recording that the act has actually happened at a particular date and time

[SOURCE: ISO/TS 19256:2016, 3.1, modified]
3.2
clinical decision support
CDS
software system that assists healthcare providers in making medical decisions

Note 1 to entry: These types of systems typically require input of patient-specific clinical variables and as a result

provide patient-specific recommendations.
[SOURCE: ISO/TR 14639-2:2014, 2.8, modified]
3.3
clinical decision support system
CDSS

software that is designed to be a direct aid to clinical decision-making, in which the characteristics of

an individual patient are matched to a computerized clinical knowledge base

Note 1 to entry: Patient-specific assessments or recommendations are then presented to the clinician or the

patient to aid in the process of making evidence-based clinical decisions
[SOURCE: ISO/TS 22756:2020, 3.2, modified]
3.4
dispensing

process by which an individual healthcare provider takes in a prescription, assesses that prescription,

selects the prescribed medicinal product and delivers that medicinal product to the subject of care

or their representative

Note 1 to entry: In most cases, but not necessarily always, the individual healthcare provider concerned will be a

Pharmacist.
[SOURCE: ISO/TS 19256:2016, 3.9]
3.5
dispenser

specialization of a healthcare professional which is a representation of an individual professionally

responsible for filling/dispensing the prescription

Note 1 to entry: The dispenser is usually a pharmacist but can be other individuals according to local jurisdiction.

[SOURCE: ISO 21549-7:2016, 3.5, modified]
3.6
drug (pharmacy) and therapeutics committee
DTC
forum to bring together all stakeholders involved in decisions about drug use

Note 1 to entry: The described forum can exist at any level within the health-care system – at district level

(overseeing primary health-care facilities), in hospitals, or at the national level.

[SOURCE: Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]

© ISO 2021 – All rights reserved
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SIST-TS CEN/ISO TS 22703:2021
ISO/TS 22703:2021(E)
3.7
drug utilization review
DUR

authorized, structured, ongoing review of healthcare provider prescribing, pharmacist dispensing and

patient use of medication
[SOURCE: Academy of Managed Care Pharmacy – Managed Care Glossary]
3.8
electronic health record
EHR

logical representation of information regarding or relevant to the health of a subject of care

[SOURCE: ISO/TS 13972:2015, 2.24]
3.9
formulary list
list of medicines approved for use in a specific health-care setting

[SOURCE: Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]

3.10
formulary system

principles, criteria, procedures and resources for developing, updating and promoting the formulary

(essential medicines) list

[SOURCE: Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]

3.11
knowledge database

system in which knowledge on a specific topic is specified as a set of declarative statements, hierarchical

organization of such statements, and relationships between declarative statements, which serves as

the underpinning of decision support systems
[SOURCE: ISO/TS 19256:2016, 3.19]
3.12
medication history

record keeping of the specificities of the prescribed/dispensed/OTC medicinal product (e.g.

identification, brand, type, form, quantity, dosage)

Note 1 to entry: this record contains the medication still in use as well as the medication no longer in use.

[SOURCE: ISO/TS 19256:2016, 3.23, modified]
3.13
medication safety
freedom from preventable harm with medication use

[SOURCE: ISMP Canada, 2007, available at https:// www .ismp -canada .org/ definitions .htm #: ~: text =

Medication %20Safety %3A ,did %20not %20reach %20the %20patient]
3.14
medication use evaluation

performance improvement method that focuses on evaluating and improving medication use processes

with the goal of optimal patient outcomes

Note 1 to entry: medication use evaluation may be applied to a medication or therapeutic class, disease state or

condition, a medication-use process (prescribing, preparing and dispensing, administering and monitoring) or

specific outcomes.
© ISO 2021 – All r
...

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