ISO/TS 19256:2016
(Main)Health informatics — Requirements for medicinal product dictionary systems for health care
Health informatics — Requirements for medicinal product dictionary systems for health care
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.
Informatique de santé — Exigences pour les systèmes de dictionnaires de produits médicaux pour les soins de santé
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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
---------------------- Page: 1 ----------------------
ISO/TS 19256:2016(E)
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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 19256:2016(E)
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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ISO/TS 19256:2016(E)
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
iv © ISO 2016 – All rights reserved
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ISO/TS 19256:2016(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 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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ISO/TS 19256:2016(E)
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;
vi © ISO 2016 – All rights reserved
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ISO/TS 19256:2016(E)
• 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.
© ISO 2016 – All rights reserved vii
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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.
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ISO/TS 19256:2016(E)
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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ISO/TS 19256:2016(E)
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 filling/dispensing prescriptions
Note 1 to entry: The dispenser is usually a pharmacist but can be other individuals according to local jurisdiction.
[SOURCE: ISO 21549-7:—, 3.5, modified]
3.12
dose form
pharmaceutical dose form
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ISO/TS 19256:2016(E)
physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s)
that are intended to be delivered to the patient
Note 1 to entry: Pharmaceutical dose form can refer to the administered dose form or the packaged dose form,
depending on the product it is describing.
[SOURCE: ISO 11616:2012, 3.1.10]
3.13
Electronic Health Record
EHR
logical representation of information regarding or relevant to the health of a subject of care
[SOURCE: ISO 18308:2011, 3.20, modified]
3.14
entity
concrete or abstract thing of interest, including associations among things
[SOURCE: ISO/IEC 2382:2015, 2120770]
3.15
identifiers
sequence of characters, capable of uniquely identifying that with which it is associated, within a
specified context
[SOURCE: ISO/IEC 11179-1:2015, 3.1.3, modified]
3.16
immediate container
immediate packaging in which a manufactured item or pharmaceutical product is contained and with
which it is in direct contact
EXAMPLE Ampoule, vial, prefilled syringe, bottle, blister.
Note 1 to entry: An immediate container can be fitted with or have integrated into it an administration device
and/or closure.
Note 2 to entry: A pharmaceutical dose form can fulfill the role of an immediate container, e.g. a capsule
containing a powder for inhalation; the capsule in this case is not a container.
Note 3 to entry: An alternative, compatible definition of immediate container (“immediate packaging”) is given
in Directive 92/27/EEC.
3.17
Investigational Medicinal Product
pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical
trial, including products already with a marketing authorization but used or assembled (formulated or
packaged) in a way different from the authorized form, used for an unauthorized indication, or used to
gain further information about the authorized form
[SOURCE: ISO 11615:2012, 3.1.28]
3.18
Investigational Medicinal Product Identifier
unique identifier allocated to an Investigational Medicinal Product supplementary to any existing
identifier as ascribed by a Medicines Regulatory Agency in a jurisdiction or a sponsor of a clinical trial
Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the
unique identification of medicinal products worldwide.
[SOURCE: ISO 11615:2012, 3.1.31]
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ISO/TS 19256:2016(E)
3.19
knowledge database
system in which knowledge on a specific topic is specified as set of declarative statements, hierarchical
organization of such statements, and relationships between declarative statements, which serves as
the underpinning of decision support systems
3.20
marketing authorization holder
organization that holds the authorization for marketing a medicinal product in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.41]
3.21
marketing authorization number
identifier assigned by a Medicines Regulatory Agency to a medicinal product
[SOURCE: ISO 11615:2012, 3.1.42]
3.22
medication concepts
formally defined medicinal products in terms of their characteristics and relationships with other
concepts
3.23
medication history
record keeping of the specificities of the prescribed/dispensed/OTC medicinal product (identification,
brand, type, form, quantity, dosage, etc.); this record contains the medication still in use as well as the
medication no longer in use
[SOURCE: IHE Pharmacy - Technical Framework Specification, modified]
3.24
medicinal product
any 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
Note 1 to entry: A medicinal product can contain one or more manufactured items and one or more pharmaceutical
products.
Note 2 to entry: In certain jurisdictions a medicinal product can also be defined as any substance or combination
of substances which might be used to make a medical diagnosis.
Note 3 to entry: Medicinal Product MPID XXXX87456 Slaapdiep tablet / Slaapdiep20 mg tablets National – has a
name dedicated to a specific jurisdiction. (the code number is just an illustration, not a real identifier).
[SOURCE: ISO 11615:2012, 3.1.49, modified]
3.25
Medicinal Product Dictionary System
system that is specifically designed to support the prescription, dispensing and administration of
medications in healthcare based on an accurate listing, description and identification of medicinal
products
3.26
Medicinal Product Identifier
unique identifier allocated to a medicinal product supplementary to any existing authorization number
as ascribed by a Medicines Regulatory Agency in a jurisdiction
Note 1 to entry: This is for indexing purposes
...
TECHNICAL ISO/TS
SPECIFICATION 19256
First edition
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
PROOF/ÉPREUVE
Reference number
ISO/TS 19256:2016(E)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO/TS 19256:2016(E)
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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii PROOF/ÉPREUVE © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 19256:2016(E)
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 .10
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 .11
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 .13
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 .15
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 .17
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 .18
7.3 Normative content .19
7.3.1 Content of regulated medicinal products .19
7.3.2 Prescription .22
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 .26
7.3.9 Interaction with reimbursement systems .27
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ISO/TS 19256:2016(E)
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 .31
Annex A (informative) IDMP series in context, serving this Technical Specification.32
Bibliography .34
iv PROOF/ÉPREUVE © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 19256:2016(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 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 PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
ISO/TS 19256:2016(E)
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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ISO/TS 19256:2016(E)
• 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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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.
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ISO/TS 19256:2016(E)
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
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]
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
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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 filling / dispensing prescriptions
Note 1 to entry: The dispenser is usually a pharmacist but can be other individuals according to local jurisdiction.
[SOURCE: ISO 21549-7:—, 3.5, modified]
3.12
dose form
pharmaceutical dose form
physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s)
that are intended to be delivered to the patient
Note 1 to entry: Pharmaceutical dose form can refer to the administered dose form or the packaged dose form,
depending on the product it is describing.
[SOURCE: ISO 11616:2012, 3.1.10]
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ISO/TS 19256:2016(E)
3.13
Electronic Health Record
EHR
logical representation of information regarding or relevant to the health of a subject of care
[SOURCE: ISO 18308:2011, 3.20, modified]
3.14
entity
concrete or abstract thing of interest, including associations among things
[SOURCE: ISO/IEC 2382:2015, 2120770]
3.15
identifiers
sequence of characters, capable of uniquely identifying that with which it is associated, within a
specified context
[SOURCE: ISO/IEC 11179-1:2015, 3.1.3, modified]
3.16
immediate container
immediate packaging in which a manufactured item or pharmaceutical product is contained and with
which it is in direct contact
EXAMPLE Ampoule, vial, prefilled syringe, bottle, blister.
Note 1 to entry: An immediate container can be fitted with or have integrated into it an administration device
and/or closure.
Note 2 to entry: A pharmaceutical dose form can fulfill the role of an immediate container, e.g. a capsule
containing a powder for inhalation; the capsule in this case is not a container.
Note 3 to entry: An alternative, compatible definition of immediate container (“immediate packaging”) is given
in Directive 92/27/EEC.
[SOURCE: ENV 12610:1997]
3.17
Investigational Medicinal Product
pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical
trial, including products already with a marketing authorization but used or assembled (formulated or
packaged) in a way different from the authorized form, used for an unauthorized indication, or used to
gain further information about the authorized form
[SOURCE: ISO 11615:2012, 3.1.28]
3.18
Investigational Medicinal Product Identifier
unique identifier allocated to an Investigational Medicinal Product supplementary to any existing
identifier as ascribed by a Medicines Regulatory Agency in a jurisdiction or a sponsor of a clinical trial
Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the
unique identification of medicinal products worldwide.
[SOURCE: ISO 11615:2012, 3.1.31]
3.19
knowledge database
system in which knowledge on a specific topic is specified as set of declarative statements, hierarchical
organization of such statements, and relationships between declarative statements, which serves as
the underpinning of decision support systems
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3.20
marketing authorization holder
organization that holds the authorization for marketing a medicinal product in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.41]
3.21
marketing authorization number
identifier assigned by a Medicines Regulatory Agency to a medicinal product
[SOURCE: ISO 11615:2012, 3.1.42]
3.22
medication concepts
formally defined medicinal products in terms of their characteristics and relationships with other
concepts
3.23
medication history
record keeping of the specificities of the prescribed/dispensed/OTC medicinal product (identification,
brand, type, form, quantity, dosage, etc.); this record contains the medication still in use as well as the
medication no longer in use
[SOURCE: IHE Pharmacy - Technical Framework Specification, updated April 22nd, 2014, modified]
3.24
medicinal product
any 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
Note 1 to entry: A medicinal product can contain one or more manufactured items and one or more pharmaceutical
products.
Note 2 to entry: In certain jurisdictions a medicinal product can also be defined as any substance or combination
of substances which might be used to make a medical diagnosis.
Note 3 to entry: Medicinal Product MPID XXXX87456 Slaapdiep tablet / Slaapdiep20 mg tablets National – has a
name dedicated to a specific jurisdiction. (the code number is just an illustration, not a real identifier).
[SOURCE: ISO 11615:2012, 3.1.49, modified]
3.25
Medicinal Product Dictionary System
system that is specifically designed to support the prescription, dispensing and administration of
medications in healthcare based on an accurate listing, description and identification of medicinal
products
3.26
Medicinal Product Identifier
unique identifier allocated to a medicinal product supplementary to any existing authorization number
as ascribed by a Medicines Regulatory Agency in a jurisdiction
Note 1 to entry: This is for indexing purposes and to contribute to improved patient safety by allowing for the
unique identification of medicinal products worldwide.
[SOURCE: ISO 11615:2012, 3.1.50]
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ISO/TS 19256:2016(E)
3.27
Medicinal Product Package Identifier
unique identifier allocated to a packaged medicinal product supplementary to any existing authorization
number as ascribed b
...
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