Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018)

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.

Medizinische Informatik - Anforderungen an die Akte zur Abgaben eines Arzneimittels (ISO/TS 19293:2018)

Informatique de santé - Exigences relatives à un enregistrement de la délivrance d’un médicament (ISO/TS 19293:2018)

Zdravstvena informatika - Zahteve za zapise o izdaji zdravila (ISO/TS 19293:2018)

Ta dokument določa zahteve za zapise o izdaji zdravila. Namenjen je temu, da bo sprejet v podrobnejših, izvedljivih specifikacijah, kot so standardi interoperabilnosti, specifikacije sistema in regulatorni programi.
Ta dokument velja za informacijske sisteme, v katerih je ustvarjen zapis o izdaji zdravila, in za sisteme, ki sprejemajo tovrstne informacije. Ti sistemi so običajno v lekarnah ali drugih zdravstvenih ustanovah. Ta dokument se ne nanaša nujno na trgovine, ki niso lekarne, ali druge nebolnišnične sisteme (npr. blagajne v supermarketih).
Področje uporabe tega dokumenta vključuje dejavnosti v zvezi z izdajo zdravila in vsebino informacij za zajem strukturiranih informacij, ki se ustvarijo pri teh dogodkih.
Te dejavnosti vključujejo dejansko izdajo, preklic ali druge rezultate, ki lahko nastanejo v trenutku načrtovane ali dejanske izdaje. Povedano drugače, zapis o izdaji vsebuje tudi informacije, da je bila izdaja zdravila pričakovana, vendar zdravilo ni bilo izdano.

General Information

Status
Published
Publication Date
08-May-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
09-May-2018
Completion Date
09-May-2018

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 19293:2018
01-julij-2018

Zdravstvena informatika - Zahteve za zapise o izdaji zdravila (ISO/TS 19293:2018)

Health Informatics - Requirements for a record of the dispense of a medicinal product

(ISO/TS 19293:2018)

Medizinische Informatik - Anforderungen an die Akte zur Abgaben eines Arzneimittels

(ISO/TS 19293:2018)

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

médicament (ISO/TS 19293:2018)
Ta slovenski standard je istoveten z: CEN ISO/TS 19293:2018
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 19293:2018 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 19293:2018
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SIST-TS CEN ISO/TS 19293:2018
CEN ISO/TS 19293
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health Informatics - Requirements for a record of the
dispense of a medicinal product (ISO/TS 19293:2018)

Informatique de santé - Exigences relatives à un Medizinische Informatik - Anforderungen an die Akte

enregistrement de la délivrance d'un médicament zur Abgaben eines Arzneimittels (ISO/TS 19293:2018)

(ISO/TS 19293:2018)

This Technical Specification (CEN/TS) was approved by CEN on 19 February 2018 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19293:2018 E

worldwide for CEN national Members.
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CEN ISO/TS 19293:2018 (E)
Contents Page

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

Endorsement notice ..................................................................................................................................................... 3

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SIST-TS CEN ISO/TS 19293:2018
CEN ISO/TS 19293:2018 (E)
European foreword

This document (CEN ISO/TS 19293:2018) 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.

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

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

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

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

Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO/TS 19293:2018 has been approved by CEN as CEN ISO/TS 19293:2018 without any

modification.
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SIST-TS CEN ISO/TS 19293:2018
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/TS 19293:2018(E)
ISO 2018
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SIST-TS CEN ISO/TS 19293:2018
ISO/TS 19293:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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ISO/TS 19293:2018(E)
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

© ISO 2018 – All rights reserved iii
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ISO/TS 19293:2018(E)

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
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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.

© ISO 2018 – All rights reserved v
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ISO/TS 19293:2018(E)
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 actual medication use than a

prescription (even if it also not an unequivocal indication of administration). Therefore, there is a need

to capture the dispensation, as the dispensation either completes the logical chain from prescription

to administration, or provides information for later prescriptions or dispensation, for instance, if

interactions can be anticipated and avoided.

The dispense record should provide information in such a way that it is accurate and reusable; for

example, statistics and other information can be collected across the dispensers for public health

purposes, or for regulatory needs (e.g. controlled substances control).

Additionally, the dispense record is a traceability element. For clinical purposes, it supports recording

the process from prescribing to administration. For supply chain, it allows reconstruction of the supply

chain, for example, in the contexts of recalls or supply chain integrity.

This document defines the information that may be contained in a dispense record, and the applicability

and constraints of such information. It defines a set of conditions that should be verified on detailed

interoperability implementations.

This document also defines requirements for when the dispense record should be issued in the cases

where it is needed. This is not required as a specific moment in a process — which would depend on a

variety of processes and factors — but by providing a common set of activities that are included in a

dispense.

This document addresses the requirements which are to be fulfilled by the systems that record

medicinal product dispensation. It is based on use cases which are chosen from the daily life within the

same jurisdiction, and when the prescription and dispensation have occurred in different jurisdictions.

This document relies on the assumption that prescription and dispensation are supported by medicinal

product dictionaries that ensure interoperability.

One key aspect in this document is that the notion of dispense can vary according to context (hospital

versus community), jurisdiction, and other factors. The uses of the dispense record can also vary. These

variations can have a strong impact on the definition of dispense.

For example, the process of dispensing a medication varies considerably between hospital and

community settings, and even inside a hospital. Another example is if the dispense record is used

mostly for operational concerns (reimbursement), the relevant dispense information is obtained

when the medication is retrieved for that patient. But if the dispense record is supposed to support

clinical systems, it may be better to capture information until the medication is delivered to the patient

or handed to a next of kin and thus presumed to be delivered to the patient. It is important that the

medication dispense record contains sufficient information to support these different and variable uses.

Another example of process variability is how a dispense record can be a consequence of an electronic

prescription. However, in some cases, there are dispenses without a prescription. The scope of this

document considers dispensing with or without the existence of a prescription.
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ISO/TS 19293:2018(E)

There is an increasing number of scenarios for electronic capture of dispensing information and an

increasing need to exchange this information in electronic health information systems, in particular,

for purposes of clinical care, decision support, claiming and reimbursement, research, statistics,

regulation, as well as for product integrity.

This document is, thus, not about the processes but the information content. This document does not

impose any activity to be part of the dispense process, but informs what information may be captured

from each activity.

Other uses for this information are identified, not for exhaustively listing them — which would be

limiting and impractical — but to ensure that the scope of this document covers the expected scenarios

and uses.

In this way, the information in a dispense record can be correctly recorded and used in any of the

contexts of dispense, ensuring the global applicability of this document.
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SIST-TS CEN ISO/TS 19293:2018
TECHNICAL SPECIFICATION ISO/TS 19293:2018(E)
Health informatics — Requirements for a record of a
dispense of a medicinal product
1 Scope

This document 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.

This document 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 this document 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.
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 11239, Health informatics — Identification of medicinal products — Data elements and structures for

the unique identification and exchange of regulated information on pharmaceutical dose forms, units of

presentation, routes of administration and packaging
ISO 17523, Health informatics — Requirements for electronic prescriptions

ISO/TS 19256, Health informatics — Requirements for medicinal product dictionary systems for health care

3 Terms, definitions and abbreviated terms
3.1 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 https: //www .electropedia .org/
© ISO 2018 – All rights reserved 1
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ISO/TS 19293:2018(E)
3.1.1
dispense, noun

series of events and activities that have the purpose of giving a medicinal product to a patient, whether

or not as part of a planned treatment, or to be used in procedures such as anaesthesia or imaging, where

the key activity is the act or effect of assigning a product to a patient

Note 1 to entry: Typically, a dispense is done at a community pharmacy when the product is provided to a patient,

but also in care settings, where the product is either dispensed for a specific patient by a pharmacy, or picked for

the patient from the ward stock, after being distributed by a pharmacy.
3.1.2
dispense event

time or event when a dispense is considered complete (which can vary across processes, jurisdictions,

settings)
3.1.3
dispensing process

sequence of activities leading up to the dispense event, i.e. the activities done by the dispenser before

the dispense is complete
3.1.4
dispense record
data set that identifies and describes the dispense activity/activities

Note 1 to entry: The above definitions enhance the definition of "dispensing" in ISO TS 17523 (where "dispensing"

is the set of activities originating from a prescription until the actual delivery of the product to the patients). First,

the present definition of dispense also includes the cases where a dispense is not a consequence of an existing

prescription. Second, this definition of dispense also separates the actual dispense from the pharmaceutical

review, validation or advice that is usually associated with the dispenser and many times done immediately

prior to the dispense. Furthermore, actions upstream or downstream of this dispensing act are considered

distribution and are not related to a specific patient, so they are not part of the definition of dispense. Example of

upstream actions are bulk supply and inventory management. Examples of downstream actions are transport of

a dispensed medication to the place of consumption, or shipment to the patient, etc.

3.1.5
dosage

intended or actual amount of medicinal product to be taken by the patient, including the dose form,

route of administration as intended to be applied to be used in the patient’s treatment

3.1.6
dispense record system
system of record of dispense

information system that collects the information about the dispense activity and provides the

information contained in the dispense record
3.1.7
medicinal product

any substance or combination of substances that may be administered to human beings (or animals) for

treating or preventing diseases, with the view of making a medical diagnosis or to restore, correct or

modify physiological functions
3.1.8
encoding

detailing a (medication) order from implicit or less specific information into more specific or

detailed information

EXAMPLE 1 “1 tablet bid” can be encoded into detailed times: “one tablet at 8:00 and one tablet at 20:00”.

EXAMPLE 2 “Paracetamol 500 mg”
...

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