ISO/TS 19256:2016

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 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

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
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

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.
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

• 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.
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.
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]
2 © ISO 2016 – All rights reserved

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
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]
4 © ISO 2016 – All rights reserved

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 and to contribute to improved patient safety by allowing for the
unique identification of medicinal products worldwide.
[SOURCE: ISO 11615:2012, 3.1.50]
3.27
Medicinal Product Package Identifier
unique identifier allocated to a packaged 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 improving patient safety by allowing for the
unique identification of medicinal products worldwide.
[SOURCE: ISO 11615:2012, 3.1.52]
3.28
packaged medicinal product
medicinal product in a container being part of a package, representing the entirety that has been
packaged for sale or supply
[SOURCE: ISO 11615:2012, 3.1.57]
3.29
off label use
use of a medicine for an unapproved indication or in an unapproved age group, or in a unapproved
dosage or in an unapproved route of administration
3.30
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form authorized for
administration by a regulatory authority, and as represented with any corresponding regulated
product information
Note 1 to entry: A medicinal product can contain one or more pharmaceutical products.
Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However,
there are instances where the manufactured item undergoes a transformation before being administered to the
patient (as the pharmaceutical product) and the two are not equal.
Note 3 to entry: For example: Pharmaceutical Product PhPID: L4M456897456123 Sweetopam 20mg tablet (the
code number is just an illustration, not a real identifier).
[SOURCE: ISO 11616:2012, 3.1.19, modified]
3.31
pharmaceutical product identifier
globally unique identifier assigned to the pharmaceutical product(s)
[SOURCE: ISO 11616:2012, 3.1.22]
3.32
pharmacovigilance
process and science of monitoring the safety of medicines and taking action to reduce the risks and
increase the benefits of medicines
[SOURCE: ISO 11615:2012, 3.1.59, modified]
3.33
prescribing
process of creating a prescription
6 © ISO 2016 – All rights reserved

3.34
prescription
direction created by an authorized healthcare person, to instruct a dispensing agent regarding the
preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care
Note 1 to entry: The term “prescription” alone is best avoided as it is colloquially used at random for the following
terms: new prescription message, prescription set and prescription item. Further, it is also used to describe a
prescription form. The use of the terms prescription set, prescription item and new prescription message where
appropriate is recommended.
3.35
prescription product
abstract level of a medicinal product that contains the elements for prescribing a medicine at a generic
level, which are necessary to dispense the appropriate medicine
EXAMPLE Salbutamol aerosol 100 µg/dose 200 doses volumatic. The addition ‘volumatic’ is not included in
the pharmaceutical product, but is necessary in the description of the prescribed medicine to express that the
product with the ‘volumatic’ (and not e.g. the autohaler) is meant.
Note 1 to entry: The level of abstraction needed for generic prescription can vary between the healthcare settings
3.36
quality
degree to which all the properties and characteristics of a product, process or service satisfy the
requirements which ensue from the purpose for which that product, process or service is to be used
[SOURCE: ISO 9000:2015, 3.6.2, modified]
3.37
reference strength
substance(s) and/or specified substance(s) used as a reference to form the basis of strength of an
investigational or authorized medicinal product
Note 1 to entry: The reference strength refers to the strengths of the base, in case the strength of the substance is
expressed as the salt or water for hydration.
[SOURCE: ISO 11616:2012, 3.1.26]
3.38
route of administration
path by which the pharmaceutical product is taken into or makes contact with the body
EXAMPLE Oral, intravenous, oromucosal, ocular.
[SOURCE: ISO 11615:2012, 3.1.73]
3.39
safety
freedom from unacceptable risk of harm
[SOURCE: ISO/IEC Guide 51, 3.14, modified]
3.40
strength
quantitative composition
amount of substance or specified substance expressed quantitatively per dosage unit, per unit of mass
or volume, according to the dosage form
Note 1 to entry: It is necessary for the quantitative composition of the substance(s)/specified substance
descriptions of the finished authorized/investigational medicinal products, depending on the pharmaceutical
form concerned, to specify the mass, or the number of units of biological activity, either per dosage unit or per
unit of mass or volume, of each substance/specified substance.
Note 2 to entry: Substances/specified substance descriptions present in the form of compounds or derivatives
are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active
entity, or entities, of the molecule.
[SOURCE: ISO 11616:2012, 3.1.29]
3.41
substance
any matter of defined composition that has discrete existence, whose origin may be biological, mineral
or chemical
Note 1 to entry: Substances can be single substances, mixture substances or one of a group of specified substances.
Single substances are defined using a minimally sufficient set of data elements divided into five types: chemical,
protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases
or mixtures of related compounds that are either isolated or synthesized together. Pharmacopeial terminology
and defining characteristics will be used when available and appropriate. Defining elements are dependent on
the type of substance.
Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other
substance. Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e.
isomeric mixtures) or naturally occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite
molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which
the chemical structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free
bases and mixtures of related compounds that are either isolated or synthesized together.
[SOURCE: ISO 11238:2012, 2.1.58]
3.42
term
designation of a defined concept in a special language by a linguistic expression
[SOURCE: ISO 1087-1:2000, 3.4.3, modified]
3.43
terminological system
ordered collection of concepts, in which each concept is expressed by terms, words or expressions
[SOURCE: ISO/IEC 11179-1:2015, 3.2.25, modified]
3.44
unit of measurement
real scalar quantity, defined and adopted by convention, with which any other quantity of the same
kind can be compared in order to express the ratio of the two quantities as a number
Note 1 to entry: Depending on the nature of the reference scale, the unit of measurement expression may stand
either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily
defined unit of measurement, which might refer to a certain reference material, a standard measurement
procedure, a material measure or even to a combination of those.
[SOURCE: ISO 11239:2012, 3.1.27]
3.45
unit of presentation
discrete countable entity in which a pharmaceutical product or manufactured item is presented, in
cases where strength or quantity is expressed referring to one instance of this countable entity
EXAMPLE 1 To describe strength: spray, “contains 100 mcg per spray” (unit of presentation = spray).
EXAMPLE 2 To describe quantity: bottle, “contains 100 ml per bottle” (unit of presentation = bottle).
Note 1 to entry: A unit of presentation can have the same name as another controlled vocabulary, such as a basic
dose form or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary
term identifier.
8 © ISO 2016 – All rights reserved

[SOURCE: ISO 11239:2012, 3.1.28, modified]
4 Abbreviated terms
For the purposes of this document, the following abbreviations apply.
ADR adverse drug reaction
CDSS clinical decision support system
CEN Comité Européenne de Normalisation
EHR Electronic Health Record
EHR-S FM Electronic Health Record — System Functional Model
HL7 Health Level Seven
ICSR individual case safety report
IDMP identification of medicinal products
ISO International Organization for Standardization
SPC summary of product characteristics
5 Boundary between MPD-systems and IDMP, ancillary information to build an
MPD-system and local implementation
5.1 Boundary between MPD-systems and IDMP
IDMP Standards guide the regulation processes for medicines in specified jurisdictions, and contain
a maximum of detail. It is not required to cover every detail in an MPD-system which the ISO IDMP
Standards specify. Concepts or elements from IDMP that do not support the use cases in this
Technical Specification are not included. Further, the MPD-system can add locally required concepts,
characteristics and data fields, for instance a historic identifier, necessary for a medication history for a
patient, or to facilitate ongoing trends analysis. See Clause 6 for further description of the relationship
between the MPD-system and IDMP.
5.2 Boundary between MPD-systems and ancillary information to build an MPD-system
Furthermore this Technical Specification addresses the MPD-system as it is offered by the MPD
maintenance organization to hospitals, pharmacies, software vendors or other parties. To maintain the
MPD-system, ancillary information may be needed, like the list of substances, dose forms and routes
of administration from the databases which are specified in the implementation guides for the ISO
IDMP Standards. These lists are not part of the MPD-system themselves, but can be used to deploy the
concepts in the MPD-system.
5.3 Boundary between MPD-systems and local implementation
The MPD-system needs to be implemented in some way in health, clinical and/or pharmacy information
systems, which creates a local implementation of the MPD-system. Such a local implementation
can contain parts of the MPD-system, depending on the use case(s) that is/are supported. A local
implementation can be considered as an implementation of the MPD-system functional requirements,
as long as the subset used is exactly the same as the MPD-system itself, and hence from the ISO IDMP
standards. A local implementation can use the MPD-system in the following way:
— It can use a certain subset of the medicines included in the MPD-system.
— It can use a certain part of the structure (e.g. only the pharmaceutical or medicinal product part but
not the packaged medicinal products).
— If for a certain use case a different set of elements is needed apart from what is defined in the MPD-
system, it should be possible that the local implementation can use the separate elements to build
its own view of a particular set of elements as needed for the particular use case.
5.4 Content of the MPD-systems in terms of product coverage
In terms of product coverage, the scope of the MPD-system includes all authorized medicinal products
and may include medicinal products without authorization (including extemporaneous preparations).
The implementations of the MPD-systems should describe more precisely which kind of products
are included in the MPD-system and to what extent it is exhaustive. Concerning the authorized
medicinal products, ISO IDMP Standards will be consistently adopted internationally to facilitate
further harmonization and possible establishment of a common reference source for all regulated
medicinal products. The reference source may be maintained and governed through a consortium
of affected stakeholders such as authorizing bodies, bio/pharmaceutical manufacturers, and other
IDMP terminology maintenance organizations. Further it is assumed that all concepts, characteristics,
relationships, data model, data fields and data content as described in the IDMP standards are also
available for the MPD-system. In case the ISO IDMP Standards are not yet fully implemented, the missing
data cannot be present in the MPD-system based on the IDMP implementation, but may be added by the
maintainer of the MPD-system.
Concerning the authorized medicinal products, the assumption is that the identifiers based on the ISO
IDMP Standards are available. The identifiers used in the MPD-system shall be the identifiers of IDMP
for the products that are covered by IDMP. It is not desirable to create new identifiers for concepts
existing in IDMP. Concerning the products that are not covered by IDMP but need to be included in the
MPD-system, the elements of the IDMP should be used as the model to create the information for these
products. In case of products that are not covered by IDMP, it can be necessary to create new identifiers
for the product (e.g. package ID), especially if the identifying characteristics or concepts do not exist in
the underlying IDMP standards.
5.5 Definition of Medicinal Product Dictionary MPD-systems
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
use cases in healthcare in which medication plays a role.
5.6 Benefits of the Technical Specification
The potential benefits of the Technical Specification for MPD-systems is that the functional requirements
to which such systems should adhere are made explicit and organized into core and supporting sections,
and that the relationships between MPD-systems with other health information systems are specified.
Hence it becomes possible to determine to what extent MPD-systems meet requirements, and facilitate
their (continued) development, maintenance and selection.
5.7 Target users for the Technical Specification
The target users of the Technical Specification for MPD-systems include:
• system developers,
• system maintainers,
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• healthcare professionals
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