Health informatics — Requirements for a record of a dispense of a medicinal product

ISO/TS 19293:2018 specifies requirements for a record of a dispense of a medicinal product. It is intended to be adopted by detailed, implementable specifications, such as interoperability standards, system specifications, and regulatory programs. ISO/TS 19293:2018 applies to information systems in which a dispense of a medicinal product is registered, and the systems that consume such information. These systems are usually in pharmacies or other healthcare institutions. This document does not necessarily apply to non-pharmacy shops or other non-clinical systems (e.g. supermarket cashiers). The scope of ISO/TS 19293:2018 includes the activities relating to the dispensing of a medicinal product and the information content for the capture of structured information produced in those events. These activities include any actual dispense, cancellation or other outcome that may have occurred at the time of planned or actual dispense. In other words, the dispense record also contains information that medication was expected to be dispensed but was not dispensed.

Informatique de santé — Exigences relatives à un enregistrement de la délivrance d’un médicament

General Information

Status
Published
Publication Date
04-Apr-2018
Current Stage
9020 - International Standard under periodical review
Start Date
15-Oct-2024
Completion Date
15-Oct-2024
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TECHNICAL ISO/TS
SPECIFICATION 19293
First edition
2018-04
Health informatics — Requirements
for a record of a dispense of a
medicinal product
Informatique de santé — Exigences relatives à un enregistrement de
la délivrance d’un médicament
Reference number
©
ISO 2018
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Symbols and abbreviated terms. 4
4 Dispense process and dispense event . 4
4.1 General . 4
4.2 Dispense record in diverse dispense processes . 4
4.3 Dispense record information purposes . 5
5 Requirements . 5
5.1 General considerations . 5
5.2 Issuance of the dispense record . 6
5.2.1 General. 6
5.2.2 Dispense record scenarios . 6
5.2.3 Dispense record uniqueness. 6
5.2.4 Dispense process unambiguity . . 7
5.2.5 Dispense record unequivocal identification . 7
5.2.6 Dispense act date/time . 7
5.2.7 Dispense location — Institution/department . 7
5.2.8 Confirmations, authorizations, or advice . 8
5.2.9 Additional information to support the adequate and legal dispensing . 8
5.2.10 Relevant findings elicited during the clinical review . 8
5.2.11 Decision not to dispense . 8
5.3 Prescription-related . 8
5.3.1 General. 8
5.3.2 Link to prescription . 9
5.3.3 Additional prescription linking data . 9
5.3.4 Previous prescription changes/advice . 9
5.3.5 Outcome of clinical review of the prescription. 9
5.4 Dispenser identification .11
5.4.1 Dispensing professional .11
5.4.2 Dispensing organization.11
5.4.3 Automated and semi-automated dispensing systems .11
5.5 Patient identification .11
5.5.1 General.11
5.5.2 Patient identification verification .11
5.6 Dispensed product .12
5.6.1 General.12
5.6.2 Dispensed product type .12
5.6.3 Dispensed physical item .13
5.7 Quantity .14
5.7.1 Dispensed product quantity.14
5.7.2 Retrieved product quantity .14
5.8 Dispense repeat number .14
5.9 Fulfilment notes .14
5.10 Patient instructions .14
5.10.1 General.14
5.10.2 Reimbursement .15
5.10.3 Transport .15
Annex A (informative) Examples of use cases (from NVN-ENV 13607) .16
Annex B (informative) Examples of use cases (other sources) .22
Annex C (informative) Dispensing processes — Examples and variation .28
Annex D (informative) Identifying dispensed products across jurisdictions — Using IDMP
and national identifiers .33
Annex E (informative) Use case-specific constraints of using dispense record .35
Annex F (informative) Informative typical data structures — Elements and vocabularies .36
Bibliography .38
iv © ISO 2018 – All rights reserved

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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Introduction
The record of dispensed medicinal product(s) plays an important role in the patient safety domain.
When a medicinal product has been prescribed, it then has to be dispensed before being administered
to the subject of care. The dispensed product may correspond exactly to what was prescribed, but it
may equally be different for various reasons, such as substitution, unavailability of medicinal product
in the prescribed dosage or route of administration, etc.
There are further situations, when medicinal products are dispensed or supplied without any
prescription. This should also be captured since a non-prescribed medicinal product may have
interactions or other influences with prescribed medicinal products.
When creating a list of a patient’s medication history, prescriptions can provide valuable information,
but the dispensation is sometimes considered a better indicator of the medication taken by a patient
than a prescription, i.e. although neither is information about compliance or administration, the
dispense record is many times considered a more reliable indicator of a
...


TECHNICAL ISO/TS
SPECIFICATION 19293
First edition
2018-04
Health informatics — Requirements
for a record of a dispense of a
medicinal product
Informatique de santé — Exigences relatives à un enregistrement de
la délivrance d’un médicament
Reference number
©
ISO 2018
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Symbols and abbreviated terms. 4
4 Dispense process and dispense event . 4
4.1 General . 4
4.2 Dispense record in diverse dispense processes . 4
4.3 Dispense record information purposes . 5
5 Requirements . 5
5.1 General considerations . 5
5.2 Issuance of the dispense record . 6
5.2.1 General. 6
5.2.2 Dispense record scenarios . 6
5.2.3 Dispense record uniqueness. 6
5.2.4 Dispense process unambiguity . . 7
5.2.5 Dispense record unequivocal identification . 7
5.2.6 Dispense act date/time . 7
5.2.7 Dispense location — Institution/department . 7
5.2.8 Confirmations, authorizations, or advice . 8
5.2.9 Additional information to support the adequate and legal dispensing . 8
5.2.10 Relevant findings elicited during the clinical review . 8
5.2.11 Decision not to dispense . 8
5.3 Prescription-related . 8
5.3.1 General. 8
5.3.2 Link to prescription . 9
5.3.3 Additional prescription linking data . 9
5.3.4 Previous prescription changes/advice . 9
5.3.5 Outcome of clinical review of the prescription. 9
5.4 Dispenser identification .11
5.4.1 Dispensing professional .11
5.4.2 Dispensing organization.11
5.4.3 Automated and semi-automated dispensing systems .11
5.5 Patient identification .11
5.5.1 General.11
5.5.2 Patient identification verification .11
5.6 Dispensed product .12
5.6.1 General.12
5.6.2 Dispensed product type .12
5.6.3 Dispensed physical item .13
5.7 Quantity .14
5.7.1 Dispensed product quantity.14
5.7.2 Retrieved product quantity .14
5.8 Dispense repeat number .14
5.9 Fulfilment notes .14
5.10 Patient instructions .14
5.10.1 General.14
5.10.2 Reimbursement .15
5.10.3 Transport .15
Annex A (informative) Examples of use cases (from NVN-ENV 13607) .16
Annex B (informative) Examples of use cases (other sources) .22
Annex C (informative) Dispensing processes — Examples and variation .28
Annex D (informative) Identifying dispensed products across jurisdictions — Using IDMP
and national identifiers .33
Annex E (informative) Use case-specific constraints of using dispense record .35
Annex F (informative) Informative typical data structures — Elements and vocabularies .36
Bibliography .38
iv © ISO 2018 – All rights reserved

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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Introduction
The record of dispensed medicinal product(s) plays an important role in the patient safety domain.
When a medicinal product has been prescribed, it then has to be dispensed before being administered
to the subject of care. The dispensed product may correspond exactly to what was prescribed, but it
may equally be different for various reasons, such as substitution, unavailability of medicinal product
in the prescribed dosage or route of administration, etc.
There are further situations, when medicinal products are dispensed or supplied without any
prescription. This should also be captured since a non-prescribed medicinal product may have
interactions or other influences with prescribed medicinal products.
When creating a list of a patient’s medication history, prescriptions can provide valuable information,
but the dispensation is sometimes considered a better indicator of the medication taken by a patient
than a prescription, i.e. although neither is information about compliance or administration, the
dispense record is many times considered a more reliable indicator of a
...

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