CEN ISO/TS 19293:2018
(Main)Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018)
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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
Endorsement notice . 3
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.
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
ISO/TS 19293:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2018 – All rights reserved
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 .
...
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