SIST-TS CEN ISO/TS 19256:2017

Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)

ISO/TS 19256:2016 defines the required characteristics for any MPD-system to support use cases in healthcare.
These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases.

Medizinische Informatik - Anforderungen an Arzneimittelverzeichnisse im Gesundheitsbereich (ISO/TS 19256:2016)

Informatique de santé - Exigences pour les systèmes de dictionnaires de produits médicaux pour les soins de santé (ISO/TS 19256:2016)

Zdravstvena informatika - Zahteve za slovarje zdravil v sistemih zdravstvenega varstva (ISO/TS 19256:2016)

Standard ISO/TS 19256:2016 določa zahteve za slovarje zdravil v sistemih zdravstvenega varstva (MPD) za podporo pri uporabi v zdravstvu.
Te značilnosti vključujejo koncepte zdravil, identifikatorje in odnose, ki tvorijo določeno strukturo, ki podpira primere uporabe.

General Information

• Status: Published
• Publication Date: 30-May-2017
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Feb-2017
• Due Date: 16-Apr-2017
• Completion Date: 31-May-2017
• Ref Project: CEN ISO/TS 19256:2017 - Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 19256:2017
01-julij-2017
Zdravstvena informatika - Zahteve za slovarje zdravil v sistemih zdravstvenega
varstva (ISO/TS 19256:2016)
Health informatics - Requirements for medicinal product dictionary systems for health
care (ISO/TS 19256:2016)
Medizinische Informatik - Anforderungen an Arzneimittelverzeichnisse im
Gesundheitsbereich (ISO/TS 19256:2016)
Informatique de santé - Exigences pour les systèmes de dictionnaires de produits
médicaux pour les soins de santé (ISO/TS 19256:2016)
Ta slovenski standard je istoveten z: CEN ISO/TS 19256:2017
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 19256:2017 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 19256:2017


CEN ISO/TS 19256
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

March 2017
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version

Health informatics - Requirements for medicinal product
dictionary systems for health care (ISO/TS 19256:2016)
Informatique de santé - Exigences pour les systèmes de Medizinische Informatik - Anforderungen an
dictionnaires de produits médicaux pour les soins de Arzneimittelverzeichnisse im Gesundheitsbereich
santé (ISO/TS 19256:2016) (ISO/TS 19256:2016)
This Technical Specification (CEN/TS) was approved by CEN on 23 January 2017 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19256:2017 E
worldwide for CEN national Members.

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Contents Page
European foreword . 3

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European foreword
The text of ISO/TS 19256:2016 has been prepared by Technical Committee ISO/TC 215 “Health
informatics” of the International Organization for Standardization (ISO) and has been taken over as CEN
ISO/TS 19256:2017 by 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 [and/or CENELEC] 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 announce 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 19256:2016 has been approved by CEN as CEN ISO/TS 19256:2017 without any
modification.

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SIST-TS CEN ISO/TS 19256:2017
TECHNICAL ISO/TS
SPECIFICATION 19256
First edition
2016-06-01
Health informatics — Requirements
for medicinal product dictionary
systems for health care
Informatique de santé — Exigences pour les systèmes de dictionnaires
de produits médicaux pour les soins de santé
Reference number
ISO/TS 19256:2016(E)
©
ISO 2016

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COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Abbreviated terms . 9
5 Boundary between MPD-systems and IDMP, ancillary information to build an MPD-
system and local implementation. 9
5.1 Boundary between MPD-systems and IDMP . 9
5.2 Boundary between MPD-systems and ancillary information to build an MPD-system . 9
5.3 Boundary between MPD-systems and local implementation . 9
5.4 Content of the MPD-systems in terms of product coverage .10
5.5 Definition of Medicinal Product Dictionary MPD-systems .10
5.6 Benefits of the Technical Specification .10
5.7 Target users for the Technical Specification .10
6 Positioning of Medicinal Product Dictionary Systems for Healthcare .11
6.1 Base materials for MPD-systems .11
6.1.1 Relation with ISO IDMP standards .12
6.1.2 Relation with health/clinical/pharmacy information systems, decision
support, EHR and dose instructions .13
6.1.3 Relation with EHR-S FM .14
6.2 Use cases for requirements for an MPD-system .14
6.2.1 Prescribing use case . .15
6.2.2 Dispensing use case . .15
6.2.3 Administration use case .15
6.2.4 Recording medication history use case .15
6.2.5 Reconciling medication list use case .15
6.2.6 Ordering and supply chain (logistics) use case .16
6.2.7 Analysis, statistics, and pharmacoepidemiology use case .16
6.2.8 Electronic data exchange of medicinal product information between
healthcare systems and/or related systems, i.e. reporting use case .16
6.2.9 Reimbursement use case .16
6.2.10 Clinical research use case .16
6.2.11 Tracking and tracing for patient and public safety use case .17
6.2.12 Pharmacovigilance use case.17
6.2.13 Patient safety through linking personal data with the decision support
system on medicinal products use case .18
6.2.14 Migration use case .18
7 The Functional Requirements for MPD-systems .18
7.1 Introduction .18
7.2 Goal of an MPD system .19
7.3 Normative content .19
7.3.1 Content of regulated medicinal products .19
7.3.2 Prescription .23
7.3.3 Dispensing .23
7.3.4 Administration .24
7.3.5 Recording and reconciliation .24
7.3.6 Order and supply chain and logistics .25
7.3.7 Analysis, statistics, pharmacoepidemiology, and clinical research .25
7.3.8 Ensuring patient safety through linking personal data with the decision
support system on medicinal products .27
7.3.9 Interaction with reimbursement systems .27
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7.3.10 Interaction of MPD-systems with pharmacovigilance systems .27
7.3.11 Data exchange and technical functions .28
7.4 Governance .29
7.5 Maintenance .30
7.5.1 Regular maintenance processes of the MPD-system .30
7.5.2 Interaction with regulatory information .31
7.6 Localization .32
Annex A (informative) IDMP series in context, serving this Technical Specification.33
Bibliography .35
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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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
© ISO 2016 – All rights reserved v

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Introduction
This introduction contains the following topics:
a) What is a Medicinal Product Dictionary system?
b) What are the use cases and who are the stakeholders?
c) What are the benefits for the different stakeholders?
d) What are the core functional requirements for an MPD-system for healthcare?
The main target audience is the developers and service providers of MPD-systems, and those who
contract such developers and service providers.
The goal of MPD Systems is to offer various parties in healthcare a complete overview of available
medicinal products in such a way the (elements of the) concepts and the descriptions and medicinal
product identifiers can be used in a variety of other healthcare information systems. The principle for
this Technical Specification is that the global unique IDs of IDMP (Identification of Medicinal Products)
shall be maintained in any MPD-system.
Medicinal products play an important role in healthcare. There are many (thousands of) medicinal
products and each medicinal product has many characteristics (attributes), both defining and non-
defining. The development and use of medicinal products is highly regulated; currently the way to
define information about them is guided by the ISO IDMP standards. Furthermore, many healthcare
providers, institutions and enterprises are involved in the use of medicinal products. Each of these
actors uses information systems in which information on medicinal products is stored and exchanged.
These information systems need an MPD-system to accurately and consistently identify medication
concepts in the form(s) that fulfill their use cases.
An MPD-system establishes a consistent representation of medication concepts (set of identifiers) at
various levels of detail and with meaningful relationships between the concepts, in order to support
parts of several processes in healthcare in which medication plays a role. This Technical Specification
describes a Medicinal Product Dictionary system in that way, that the concepts, identifiers and the
relationships form a kind of structure that supports the use cases; together with the description of how
this structure supports the use cases and what is needed for that. The MPD-system is further described
from within an architecture in which it is connected to other parts of healthcare information systems.
Cultural differences in the practice and delivery of care and national legislation require electronic MPD-
systems that meet specific local, regional or national needs. Each MPD-system is designed to support
a particular set of use cases, which helps to determine the functional requirements which must be met
by such systems. These functional requirements will then, in turn, determine the specific collection
of ‘medication abstractions’ which must be identified, defined and related to each other within the
MPD-system. Each ‘medicinal product’ in the MPD-system is described in terms of a specific subset
of all possible defining and non-defining information elements, which together enable it to support
one or more specific use case(s). The concepts are formally defined in terms of their characteristics
and relationships with other concepts according to the ISO IDMP Standards, in particular ISO 11615,
ISO 11616 and ISO 11238. Relationships between each of these medicinal product entries give the MPD-
system the potential to support interoperability between use cases, processes, information systems,
organizations and jurisdictions.
The anticipated stakeholders of this Technical Specification include healthcare providers that have
responsibilities in selecting appropriate MPD-systems, software vendors, governments, pharmaceutical
companies, wholesalers, payers, drugs regulatory authorities, and patients / patients’ organizations.
In general, this Technical Specification supports the following business goals:
• It provides information to MPD-system developers, to help them design MPD-systems which are
better able to meet the ISO IDMP standards and the needs of multiple use cases;
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• It facilitates accuracy and consistency of the use of concepts and terms according to the ISO IDMP
standards in the MPD-systems;
• It increases the potential for consistency between MPD-systems around the world;
• It reduces redundancy of data collection and governance;
• It provides the foundations for future international standards, which help to enable interoperability
between medication use cases, information systems, and jurisdictions involved in cross-border
healthcare;
• It might reduce the cost of developing and maintaining medicinal product dictionaries systems.
The Technical Specification is partly based on the following terminologies / databases:
- The Australian Medicinal Terminology (AMT);
- NHS dictionary of medicines and devices (DM+D);
- Singapore Drug Database;
- SNOMED CT;
- Dutch G-Standaard from Z-Index (and Pharmabase from Healthbase) (NEN 7507);
- ISO/TR 22790, Health informatics — Functional characteristics of prescriber support systems.
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SIST-TS CEN ISO/TS 19256:2017
TECHNICAL SPECIFICATION ISO/TS 19256:2016(E)
Health informatics — Requirements for medicinal product
dictionary systems for health care
1 Scope
This Technical Specification defines the required characteristics for any MPD-system to support use
cases in healthcare.
These characteristics include the medication concepts, identifiers and relationships to form a kind of
structure that supports the use cases.
In order to support the use cases, an MPD-system needs to:
• be comprehensive and exhaustive as far as possible – unless all medicinal products that are in
scope are included, other systems cannot fully rely on the MPD-system to supply the necessary
information, and some amount of duplicated registration of information will still be necessary;
• contain the information in a consistent and appropriate structure according to the ISO IDMP
Standards (as described in this Technical Specification) and with an appropriate level of detail.
Outside the scope of this Technical Specification are:
• the functionality of health, clinical and/or pharmacy systems;
• the other kinds of content of health, clinical or pharmacy systems that are needed to support the
whole process of healthcare providers, like:
o the wide range of knowledge about medicines, which would be handled in drug knowledge
databases and decision support systems,
o the medication record,
o the dose instructions;
• in terms of products:
o traditional Chinese medicines,
o medical devices, such as for medication administration [this Technical Specification focuses on
administration devices that are intended for correct administration of the medicinal product
only (see ISO 11615)],
NOTE An administration device can be an integral part of an immediate container or a closure.
o veterinary medicines.
The purpose of this Technical Specification is to provide a set of functional requirements for systems
handling details about medicinal products and the relationships between them for the purpose of
supporting healthcare.
© ISO 2016 – All rights reserved 1

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2 Normative references
The following referenced documents are indispensable for the application 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 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated pharmaceutical product information
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated information on substances
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 11240, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of units of measurement
ISO/TS 16791, Health informatics — Requirements for international machine-readable coding of medicinal
product package identifiers
ISO 17523, Health informatics — Requirements for electronic prescriptions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
administration
act of (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
3.2
administration method
general method by which a pharmaceutical product is intended to be administered to the patient
EXAMPLE Application, inhalation, injection.
Note 1 to entry: The administration method is a general term that is used to group related pharmaceutical dose
form concepts, and is not intended to describe a precise method or route of administration.
[SOURCE: ISO 11239:2012, 3.1.3]
3.3
administration device
equipment intended for correct administration of the Medicinal Product
EXAMPLE Applicator, needle, oral syringe.
Note 1 to entry: An administration device can be an integral part of an immediate container or a closure.
[SOURCE: ISO 11239:2012, 3.1.2, modified]
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3.4
attribute
characteristic of an object or entity
Note 1 to entry: In the context of this Technical Specification: a specific characteristic of a data element.
[SOURCE: ISO/IEC 11179-1:2015, 3.1.1, modified]
3.5
authorized product
medicinal product that has a marketing authorization
3.6
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087-1:2000, 3.2.1, modified]
3.7
context
related conditions and situations that provide a useful understanding and meaning of a subject
[SOURCE: ISO/TR 17119:2005, 2.4]
3.8
data
reinterpretable representation of information in a formalized manner suitable for communication,
interpretation or processing
[SOURCE: ISO/IEC 2382:2015, 2121272, modified]
3.9
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: IHE Pharmacy - Technical Framework Specification]
3.10
dispense record
record of dispensed medicinal product and dispense process
Note 1 to entry: Dispensed medicinal product includes the actual product dispensed identifiers, brand, type, form,
quantity etc. Dispense process record includes details of the delivery method, date and recipient (where this is
not the subject of care) and the dispenser. The ability to record a comment where assessments of prescriptions
are undertaken might also be part of this record.
3.11
dispenser
healthcare professional responsible for f
...