ISO/TS 22703:2021
(Main)Health informatics — Requirements for medication safety alerts
Health informatics — Requirements for medication safety alerts
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.
Informatique de santé — Exigences relatives aux alertes de sécurité sur les médicaments
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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 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
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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
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.
iv
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
...
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 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
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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
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.
iv
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
...
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