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
General Information
Relations
Buy Standard
Standards Content (Sample)
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
---------------------- Page: 1 ----------------------
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
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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.
iv
© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
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.
v
© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
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).
vi
© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
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/
1
© ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
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]
2
© ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
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.
3
© ISO 2021 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/TS 22703:2021(E)
[SOURCE: ASHP Guidelines on Medication-Use Evaluation, available at https:// www .ashp .org/ -/ media/
assets/ pharmacy -informaticist/ docs/ sopit -formulary -guideline -medication -use -evalutation .ashx ?la =
en]
3.15
medicinal product
substance or combination of substances that may be administered to human beings (or animals) for
treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or
modify physiological functions
[SOURCE: ISO 11615:2017, 3.1.50, modified]
3.16
monograph
written, unbiased evaluation of a specific medication
Note 1 to entry: Such a document includes the drug name, therapeutic class, pharmacology, indications for use,
summary of clinical trials, pharmacokinetics/dynamics, adverse effects, drug interactions, dosage regimens and
cost.
[SOURCE: ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System,
available at https:// www .ashp .org/ -/ media/ assets/ policy -guidelines/ docs/ guidelines/ gdl -pharmacy
-therapeutics -committee -formulary -system .ashx]
3.17
overutilization
use of a drug in a quantity, strength or duration that is greater than necessary to achieve a desired
therapeutic goal or that puts the recipient at risk of a clinically significant undesirable effect, or both
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
3.18
pharmacy electronic health record
PEHR
logical representation of information regarding or relevant to the health of a subject of care in
pharmacies in community or organized healthcare organizations
[SOURCE: Pharmacy Health Information Technology Collaborative HL7 EHR-System for a Pharmacist/
Pharmacy Electronic Health Record Implementation Guide for Community Practice, available at https://
www .hl7 .org/ documentcenter/ public/ standards/ informative/ 13 -294 _HITSbook _HL7 _Web .pdf]
3.19
predetermined standard
criteria and standard that has been established in accordance with the requirements of a drug use
review programme
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
3.20
prescribing
creating a prescription
[SOURCE: ISO/TS 19256:2016, 3.33]
4
© ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/TS 22703:2021(E)
3.21
prescription
direction created by an authorized healthcare person to instruct a dispensing agent regarding the
preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of
care
Note 1 to entry: The term “prescription” alone should be avoided as it is colloquially used at random for the
following terms: new prescription message, prescription set and prescription item. Further, it is also used to
describe a prescription form. The use of the terms prescription set, prescription item and new prescription
message where appropriate is recommended.
[SOURCE: ISO/TS 19256:2016, 3.34]
3.22
screening
process of inspecting data for errors and correcting them prior to doing data analysis
Note 1 to entry: The screening can involve checking raw data, identifying outliers and dealing with missing data.
[SOURCE: Business Dictionary, WebFinance Inc.]
3.23
substance
matter of defined composition that has discrete existence, whose origin may be biological, mineral or
chemical
[SOURCE: ISO 11238:2018, 3.84, modified]
3.24
underutilization
use of a drug by a beneficiary [recipient] in insufficient quantity, strength or duration to achieve a
desired therapeutic goal or that puts the recipient at risk of a clinically significant undesired effect, or
both
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
4 Abbreviated terms
CPOE computerized physician order entry
DDI drug–drug interaction
IDMP identification of medicinal products
MPD medicinal product dictionary
ORCA operational classification
PBM pharmacy benefit manager
5 Requirements
5.1 General
This document applies to medication safety alerts which will be prospectively presented to healthcare
providers at the point of care during medication use processes in clinical settings where a digitized
health information system is operational to manage medication therapy for patient care.
5
© ISO 2021 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/TS 22703:2021(E)
The prospective safety alerts are displayed on visually verifiable devices before medication is
prescribed, dispensed or administered to the patients, whereas the retrospective alerts occur after the
patient has received the medication.
Since the ultimate goal of medication safety alerts is to prevent adv
...
TECHNICAL ISO/TS
SPECIFICATION 22703
First edition
Health informatics — Requirements
for medication safety alerts
Informatique de santé — Exigences relatives aux alertes de sécurité
sur les médicaments
PROOF/ÉPREUVE
Reference number
ISO/TS 22703:2021(E)
©
ISO 2021
---------------------- Page: 1 ----------------------
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
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
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 Monit oring 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
© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
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.
iv PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
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 PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
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).
vi PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
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 PROOF/ÉPREUVE 1
---------------------- Page: 7 ----------------------
ISO/TS 22703:2021(E)
3.1
administration
(self-) administering a (prescribed) medicinal product to the patient, using an administration 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]
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]
2 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
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 rights reserved PROOF/ÉPREUVE 3
---------------------- Page: 9 ----------------------
ISO/TS 22703:2021(E)
[SOURCE: ASHP Guidelines on Medication-Use Evaluation, available at https:// www .ashp .org/ -/ media/
assets/ pharmacy -informaticist/ docs/ sopit -formulary -guideline -medication -use -evalutation .ashx ?la =
en]
3.15
medicinal product
substance or combination of substances that may be administered to human beings (or animals) for
treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or
modify physiological functions
[SOURCE: ISO 11615:2017, 3.1.50, modified]
3.16
monograph
written, unbiased evaluation of a specific medication
Note 1 to entry: Such a document includes the drug name, therapeutic class, pharmacology, indications for use,
summary of clinical trials, pharmacokinetics/dynamics, adverse effects, drug interactions, dosage regimens and
cost.
[SOURCE: ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System,
available at https:// www .ashp .org/ -/ media/ assets/ policy -guidelines/ docs/ guidelines/ gdl -pharmacy
-therapeutics -committee -formulary -system .ashx]
3.17
overutilization
use of a drug in a quantity, strength or duration that is greater than necessary to achieve a desired
therapeutic goal or that puts the recipient at risk of a clinically significant undesirable effect, or both
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
3.18
pharmacy electronic health record
PEHR
logical representation of information regarding or relevant to the health of a subject of care in
pharmacies in community or organized healthcare organizations
[SOURCE: Pharmacy Health Information Technology Collaborative HL7 EHR-System for a Pharmacist/
Pharmacy Electronic Health Record Implementation Guide for Community Practice, available at https://
www .hl7 .org/ documentcenter/ public/ standards/ informative/ 13 -294 _HITSbook _HL7 _Web .pdf]
3.19
predetermined standard
criteria and standard that has been established in accordance with the requirements of a drug use
review programme
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
3.20
prescribing
creating a prescription
[SOURCE: ISO/TS 19256:2016, 3.33]
4 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/TS 22703:2021(E)
3.21
prescription
direction created by an authorized healthcare person to instruct a dispensing agent regarding the
preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of
care
Note 1 to entry: The term “prescription” alone should be avoided as it is colloquially used at random for the
following terms: new prescription message, prescription set and prescription item. Further, it is also used to
describe a prescription form. The use of the terms prescription set, prescription item and new prescription
message where appropriate is recommended.
[SOURCE: ISO/TS 19256:2016, 3.34]
3.22
screening
process of inspecting data for errors and correcting them prior to doing data analysis
Note 1 to entry: The screening can involve checking raw data, identifying outliers and dealing with missing data.
[SOURCE: Business Dictionary, WebFinance Inc.]
3.23
substance
matter of defined composition that has discrete existence, whose origin may be biological, mineral or
chemical
[SOURCE: ISO 11238:2018, 3.84, modified]
3.24
underutilization
use of a drug by a beneficiary [recipient] in insufficient quantity, strength or duration to achieve a
desired therapeutic goal or that puts the recipient at risk of a clinically significant undesired effect, or
both
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
4 Abbreviated terms
CPOE computerized physician order entry
DDI drug–drug interaction
IDMP identification of medicinal products
MPD medicinal product dictionary
ORCA operational classification
PBM pharmacy benefit manager
5 Requirements
5.1 General
This document applies to medication safety alerts which will be prospectively presented to healthcare
providers at the point of care during medication use processes in clinical settings where a digitized
health information system is operational to manage medication therapy for patient care.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 5
---------------------- Page: 11 ----------------------
ISO/TS 22703:2021(E)
The prospective safety alerts are displayed on visually verifiable devices before medication is
prescribed, dispensed or administered to the patients, whereas the retrospective alerts o
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.