TECHNICAL SPECIFICATION ISO/TS 20440 First edition 2016-06-01 Health informatics — Identification of medicinal products — Implementation guide for ISO 11239 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 Informatique de santé — Identification des produits médicaux — Guide de mise en oeuvre des éléments de données et structures pour l’identification unique et l’échange d’informations réglementées sur les formes des doses pharmaceutiques, les unités de présentation, les voies d’administration et les emballages de l’ISO 1 239 Reference number ISO/TS 20440:2016(E) © ISO 2016 ISO/TS 0440: 01 6(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise specified, no part o f 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 o f the requester ISO copyright o ffice Ch de Blandonnet • 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 ISO/TS 20440:2016(E) Contents Page Foreword iv Introduction v Scope Organisation of controlled terms 2.1 2.2 2.3 Terminologies 3.1 3.2 3.3 3.4 3.5 3.6 General Code-term pair and coded concept 2.2.1 General 2.2.2 Code-term pair 2.2.3 Coded concept Versioning 2.3.1 Versioning of the term 2.3.2 Versioning o f the terminology General Pharmaceutical dose form 10 3.2.1 Pharmaceutical dose form overview 10 3.2.2 Pharmaceutical dose form schema 10 3.2.3 Pharmaceutical dose form example: Prolonged-release tablet 16 Combined pharmaceutical form 21 3.3.1 Combined pharmaceutical dose form overview 21 3.3.2 Combined pharmaceutical dose form schema 22 3.3.3 Combined pharmaceutical dose form example: Powder and solvent for solution for injection 23 3.3.4 Other authorised combinations of terms — Combined terms and combination packs 25 Unit of presentation 26 3.4.1 Unit of presentation overview 26 3.4.2 Unit of presentation schema 27 3.4.3 Unit of presentation example: Tablet 27 Route of administration 28 3.5.1 Route of administration overview 28 3.5.2 Route of administration schema 29 3.5.3 Route of administration example: Intravenous use 29 Packaging 30 3.6.1 Packaging overview 30 3.6.2 Packaging schema 30 3.6.3 Packaging example: Ampoule (Packaging category: Container) 31 3.6.4 Packaging example: Screw cap (Packaging category: Closure) 33 3.6.5 Packaging example: Oral syringe (Packaging category: Administration device) 34 3.6.6 Packaging concept summaries 36 Mapping of regional terms 36 4.1 4.2 Di fferences in granularity between regional terminologies 36 Organisation of regional terms in the database 38 4.2.1 General 38 4.2.2 Addition of regional terms to the database 38 4.2.3 Mapping regional terms to central coded concepts 41 4.2.4 Versioning of mapped regional terms 41 4.2.5 Mapped regional term example: Extended-release caplet 41 Bibliography 43 © ISO 2016 – All rights reserved iii ISO/TS 20440:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work o f 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 o f electrotechnical standardization The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part In particular the different approval criteria needed for the di fferent types o f ISO documents should be noted This document was dra fted in accordance with the editorial rules of the ISO/IEC Directives, Part (see www.iso.org/directives) Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights ISO shall not be held responsible for identi fying any or all such patent rights Details o f any patent rights identified during the development o f 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 in formation given for the convenience o f users and does not constitute an endorsement For an explanation on the meaning o f ISO specific terms and expressions related to formity 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 in formation The committee responsible for this document is ISO/TC 215, Health informatics iv © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) Introduction The terminologies described in EN/ISO 11239:2012 (hereafter referred to as ISO 11239) and in this Te ch n ic a l Sp e ci fic ation are e s s enti a l E ach region trad itiona l ly uses its for the i mp lementation o f the I D M P s ta nda rd s a s a whole own s e ts o f term i nolo gie s to de s crib e the concep ts covere d in ISO 11239 within their regions; these terminologies are not harmonised with those of the other regions Therefore, harmonised controlled terminologies need to be provided to ensure that all regions can refer f these controlled vocabularies are constructed and illustrate their use for ISO 11239 implementation to a given concep t i n the s ame ma n ner T he pu rp o s e o © ISO 2016 – All rights reserved th i s Te ch n ic a l Sp e ci fic ation i s to de s c rib e how v TECHNICAL SPECIFICATION ISO/TS 20440:2016(E) Health informatics — Identification of medicinal products — Implementation guide for ISO 11239 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 Scope This Technical Specification describes 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 Based on the principles outlined in this Technical Specification, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification o f the appropriate terms The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identi fy those concepts This Technical Specification is intended for use by: — any organisation that might be responsible for developing and maintaining such controlled vocabularies; — any regional authorities or so ftware vendors who wish to use the controlled vocabularies in their own systems and need to understand how they are created; — owners of databases who wish to map their own terms to a central list of controlled vocabularies; — other users who wish to understand the hierarchy o f the controlled vocabularies in order to help identi fy the most appropriate term to describe a particular concept The terminology to be applied in the context o f this Technical Specification and set out in ISO 11239 is under development All codes, terms and definitions used as examples in this Technical Specification are provided for illustration purposes only, and are not intended to represent the final terminology Organisation of controlled terms 2.1 General This Clause describes how each controlled term is built, describing the data types used to convey the information and the versioning requirements for tracking their creation and evolution Clause describes the di fferent types o f terminologies and sub-vocabularies that use these data types, and any relevant relationships between them Each field in Clause is described under a separate subclause, consisting o f the title o f the field and a table containing the following: — “User Guidance”, a description o f the field; — “Data Type”, a description o f the data type; © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) — “Con formance”, a description o f whether the field is mandatory, optional, or conditional; — “Value Allowed”, indicating the possible values for the field; — “Business Rules”, providing technical guidance for the field 2.2 Code-term pair and coded concept 2.2.1 General The code-term pair and the coded concept are the data types that are used to represent the in formation that is required to describe each term in each terminology or sub-vocabulary, in each language/region combination 2.2.2 Code-term pair 2.2.2.1 Code-term pair overview This is the underlying class for each term, and is used to describe and define a term in a specific language and for a specific region It contains the core attributes for each concept, including the identifier, the textual representation o f the term (i.e the controlled term itsel f), the definition, an optional domain to indicate whether a term is restricted to veterinary use, an optional textual comment, and the language and region codes Each controlled term or sub-term has a unique code-term pair for each language/region combination This combination o f language and region allows for regional variants o f a specific language to be catered or; for example, where the spelling o f a term or definition di ffers between UK English and US English, it is possible to reflect this di fference Where terms and definitions already exist for a particular language f for a particular region, and the same language is used in a second region, it is a regional implementation issue to decide whether terms and definitions need to be provided for the second region, or whether the terms and definitions o f the first region shall be used When a new concept is required, a new coded concept must be created, and at least one code-term pair is required in order to hold the data to describe the concept The language/region combination chosen to represent the “value” shall always be created first to represent the concept, even when the request originates from a different language/region combination The maintenance organisation shall provide instructions on how to request a new term or a revision to an existing term 2.2.2.2 Code-term pair: Code User Guidance This field contains a unique, machine-readable identifier for the code-term pair In this Technical Specification, the following format is used for the code: — XXX-12345678-LL-RR where — XXX represents the class of term (see Table 1); — 12345678 represents a unique 8-digit number; for sub-vocabularies, a 4-digit number is used; — LL represents the language code; — RR represents the region/country code Data Type String Business Rule(s) Free text Each code-term pair shall have one code Conformance Value Allowed Mandatory © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) T he co de s u s e d i n th i s Te ch nic a l Sp e c i fic ation to repre s ent the va riou s cla s s e s o f term i n the example s that follow are shown in Table Table — Codes used to represent the class of term Code Class SOM BDF RCA TRA ISI AME PDF CDF UOP ROA PCA CON CLO DEV MAP 2.2.2.3 P ackagi ng c ate gor y Container Closure Administration device Mapped term Code-term pair: Term User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) 2.2.2.4 State of matter Basic dose form Release characteristics Transformation Intended site Administration method Pharmaceutical dose form Combined pharmaceutical dose form Unit of presentation Route of administration T h i s field conta i n s the te x tu a l ter m de s c r ip tio n String fo r the co de -ter m p a i r M a nd ator y Free text Each code-term pair shall have one term Code-term pair: De finition User Guidance f prehensive as possible, in order to guide the user to the most appropriate term to describe a given concept For example, it should be detailed enough to distinguish between similar T h i s field conta i n s the te x tu a l de fi n ition pharmaceutica l s e or the co de - ter m p a i r T he de fi n ition i s a s co m form s , and may e xcep tiona l ly ma ke d ire c t re ference to rel ate d term s i n o rder to e xclude them , a lthou gh s uch re ference s m ay b e co n s idere d more ap propr i ate D ata Typ e Conformance Value Allowed Business Rule(s) in the Comments section instead String M a nd ator y Free text for the de fau lt co de -ter m p a i r; op tio n a l for the tra n s l ation co de - ter m p a i rs E ach co de -ter m p a i r m ay h ave o ne de fi n ition For e ach co de d concep t, the de fau lt co de ter m p a i r (e g E N - GB ) s h a l l h ave one de fi n itio n I f a co de - ter m p a i r for a given l a ng u age/ re gion combi n ation e s no t h ave a de fi n itio n p rovide d , the de fi n ition i n the co de -ter m pair for the default language/region combination is adopted © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) 2.2.2.5 Code-term pair: Domain User Guidance Data Type Conformance Value Allowed Business Rule(s) 2.2.2.6 Data Type Conformance Value Allowed Business Rule(s) ”Human and veterinary”; “Veterinary only” Each code-term pair may have one domain Although veterinary medicines are outside the scope o f IDMP, certain regions use a single terminology system to cover both medicines for human use and medicines for veterinary use; this optional field is there fore included in order to allow veterinary-only terms to be easily distinguished in such systems This optional field contains a textual comment for the code-term pair It is used to provide to the user additional in formation and guidance that would not be strictly appropriate to appear as part o f the definition String Optional Free text Each code-term pair may have one comment Code-term pair: Language code User Guidance Data Type Conformance Value Allowed Business Rule(s) 2.2.2.8 Concept Descriptor Optional Code-term pair: Comment User Guidance 2.2.2.7 This field is used to identi fy whether a term is considered appropriate for both human and veterinary use, or whether it is considered appropriate for veterinary use only This field contains the language in which the term, definition and comment are described; in this Technical Specification, the working language is English The language code used is in line with ISO 639-1 Concept Descriptor Mandatory ISO 639-1 code, OID reference 1.0.639.1 Each code-term pair shall have one language code Code-term pair: Region code User Guidance This field contains the region/country that uses this code-term pair, in the language de - scribed above; it can be used to differentiate between regional variants of that language; in this Technical Specification, the de fault region is the United Kingdom The region code used is in line with ISO 3166-1 Alpha-2 (i.e 2-letter) codes are used The additional code EU is also allowed to represent the European Union It should be noted that the United Kingdom is represented in ISO 3166-1 by the 2-letter code GB, as in the examples used in this Technical Specification Data Type Concept Descriptor Business Rule(s) ISO 3166-1 alpha-2 code, OID reference 1.0.3166.1.2.2 Each code-term pair shall have one region code Conformance Value Allowed 2.2.2.9 Mandatory Code-term pair example An example of a code-term pair for the concept “Tablet”, a pharmaceutical dose form, is shown in Table Since the working language of this Technical Specification is UK English, the language is English and the region is the United Kingdom © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) The route o f administration concept o f “Intravenous” is there fore represented by the identifier ROA20045000, and it is this identifier that is used to represent the concept, for example as part o f the medicinal product data The language- and region-specific codes (i.e the code-term pairs) such as ROA20045000-EN-GB are intended for use only within the terminology to arrange regional translations 3.6 Packaging 3.6.1 Packaging overview The packaging covers those parts of a packaged medicinal product that make up the packaging or are included in the packaging along with the manufactured items, and that are used to ensure the correct and safe storage, transport and/or administration of the manufactured items and/or pharmaceutical products As such they are an important part o f the packaged medicinal product It should be noted that packaging may not currently be described using a specific terminology in some regions such as Japan For this reason, the examples below not contain code-term pairs in Japanese The opportunity is taken to include examples o f English terms for the US, to indicate how the same language may be used in di fferent regions This is intended to allow for di fferences in regional spellings (e.g UK English compared to US English), but in most cases such terms will be identical 3.6.2 3.6.2.1 Packaging schema Schema overview The packaging schema consists o f a two-level hierarchy (see Figure 10) that classifies the packaging concept according to the role that it plays This hierarchy is similar to the relationship between the basic dose form and the pharmaceutical dose form Figure 10 — Packaging Both the packaging category and the packaging concept itsel f are represented by coded concepts in the same way as any other controlled term (see Figure 11) There are three packaging categories, and each contains a simple flat list o f packaging terms PackagingCategory Packaging +value: codedConcept +value: codedConcept Figure 11 — Packaging schema with crow’s feet entity-relationship notation These relationships reflect the following conditions — A packaging category may have one or more (i.e to many, optional) packagings associated with it; while it is possible that a given packaging category may have no packagings associated with it, this is unlikely in practice, bearing in mind the very limited number o f packaging categories — Each packaging shall be associated with one packaging category 30 © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) 3.6.2.2 Packaging category User Guidance The packaging category class is the grouping category that allows a packaging term to be classified according to the general type o f packaging that it is There are three packaging categories: container; closure; and administration device The packaging category class is the parent o f the packaging class Each packaging cate gory can have between zero and many packagings associated with it The reason that a packaging category may have zero packaging associated with it is that a packaging category must be created be fore any packaging can be associated with it This situation usually exists for a short period o f time only, since it is expected that a packaging category will be created only when it is needed in order to categorise an anticipated new packaging Because of the limited possible packaging categories, this is only likely to occur during the initial population o f the database Data Type Conformance Value Allowed Business Rule(s) String Mandatory Coded concept identifier The packaging category class is a sub-vocabulary that is used solely in this schema; the identifiers o f the coded concepts used for this class are not intended to be used outside of this schema 3.6.2.3 Packaging User Guidance Conformance Value Allowed Business Rule(s) 3.6.3.1 packaging The packaging class is the child o f the packaging category class Each packaging has one packaging category associated with it Data Type 3.6.3 The packaging class contains the identifier o f the coded concept that represents the String Mandatory Coded concept identifier This is the central class in the schema, and it is the identifiers o f the coded concepts used for this class that are used elsewhere to represent the packaging These are the only identifiers in the schema that are intended to be used outside o f the schema Packaging example: Ampoule (Packaging category: Container) Example overview The concepts contained in the packaging category “Container” are those packaging items that are used or storage, identification and/or transport o f the components o f a medicinal product They include the f immediate container (the container in direct contact with the medicinal product), the outer packaging (the outermost container in which the medicinal product is supplied, and which is not in direct contact with the medicinal product except where it also acts as the immediate container), and any intermediate containers between the immediate container and the outer packaging An immediate container may have a closure or administration device incorporated into it This Clause gives an example of a packaging concept, that of an ampoule, and its hierarchical position under the packaging category “Container” © ISO 2016 – All rights reserved 31 ISO/TS 20440:2016(E) 3.6.3.2 Packaging category code-term pairs Table 27 — Example code-term pairs for the packaging category “Container” code term PAC-0001-EN-GB PAC-0001-EN-US PAC-0001-FR-FR container container récipient catégorie d’emballage incluitems used for storage, iden- items used for storage, iden- ant les articles utilizés pour f f the components of a medici- the components of a medici- et/ou le transport des comnal product nal product posants d’un médicament p ackagi n g c ate gor y i nclud i n g p ackagi ng c ate gor y i nclud i ng de finition ti fic atio n a nd/o r tra n s p o r t o ti fic atio n a nd/or tra n s p o r t o le s to ckage , l’identi fic ation comment languageCode regionCode EN GB EN US FR FR Here is an example of a single language (English) being used in two regions (GB and US) Since there i s no d i fference i n the s p el l i ng i n th i s c as e, the term s a nd defi n ition s are the s ame I t m ight b e de c ide d that no defi n ition i s re qui re d T he co de s for for the US tra n sl ation where th at o f the GB term i s s u fficient p ackagi ng c ategor y co de -term p a i rs s hown i n categor y co de d concep t, a s shown i n 3.6.3.3 3.6.3.3 Table 27 are used to build the packaging Packaging category coded concept Table 28 — Example coded concept for the packaging category “Container” code value PAC-0001 translation T he for co de the p ackagi ng packaging as a container 3.6.3.4 c ategor y co de d PAC-0001-EN-GB PAC-0001-EN-US PAC-0001-FR-FR concep t shown in Table 28 is used to categorise the Packaging code-term pairs Table 29 — Example code-term pairs for the container “Ampoule” code term CON-30001000-EN-GB ampoule co nta i ner s e a le d b y de finition comment languageCode regionCode fu s ion CON-30001000-EN-US ampule conta i ner s e a le d b y fu s ion a nd to b e op ene d e xclu s ivel y a nd to b e o p ene d e xclu s ivel y b y bre a ki n g , who s e contents are intended for use on one b y b re a ki ng , who s e contents o cc a s io n o n l y o cc a s io n o n l y EN GB EN US are intended for use on one CON-30001000-FR-FR ampoule récipient scellé par fusion, être ouvert exclusivement par la cassure, dont le contenu est destiné être utilizé une seule fois FR FR Here is an example of a single language (English) being used in two regions (GB and US) where the s p el l i ng o f the term d i ffers , a lthough the defi nition rema i n s the s ame The codes for packaging code-term pairs shown in Table 29 are used to build the packaging coded concept, as shown in 3.6.3.5 32 © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) 3.6.3.5 Packaging coded concept Table 30 — Example coded concept for the container “Ampoule” code value translation CON-30001000 CON-30001000-EN-GB CON-30001000-EN-US CON-30001000-FR-FR The container concept o f “Ampoule” is there fore represented by the identifier CON-30001000, and it is this identifier that is used to represent the concept, for example as part o f the medicinal product data The language- and region-specific codes (i.e the code-term pairs) such as CON-30001000-EN-GB are intended for use only within the terminology to arrange regional translations 3.6.4 3.6.4.1 Packaging example: Screw cap (Packaging category: Closure) Example overview The concepts contained in this packaging category are those packaging items that are used to close a container for the purpose of the correct storage and, where appropriate, use of the product A closure may have an administration device incorporated into it, and a closure may be an integral part o f an immediate container This Clause gives an example of a packaging concept, that of a screw cap, and its hierarchical position under the packaging category “Closure” 3.6.4.2 Packaging category code-term pairs Table 31 — Example code-term pairs for the packaging category “Closure” code term PAC-0002-EN-GB de finition comment languageCode regionCode closure PAC-0002-EN-US closure PAC-0002-FR-FR EN GB EN US FR FR fermeture d’emballage packaging category includ- packaging category includ- catégorie comprenant articles ing items used for closing a ing items used for closing a utilizés pourles la fermeture container for the purpose container for the purpose d’un récipient dans le but du of the correct storage and, of the correct storage and, stockage correct et, le cas where appropriate, use of where appropriate, use of échéant, l’utilisation correcte the product the product du produit The codes for packaging category code-term pairs shown in Table 31 are used to build the packaging category coded concept, as shown in 3.6.4.3 3.6.4.3 Packaging category coded concept Table 32 — Example coded concept for the packaging category “Closure” code value translation © ISO 2016 – All rights reserved PAC-0002 PAC-0002-EN-GB PAC-0002-EN-US PAC-0002-FR-FR 33 ISO/TS 20440:2016(E) The code for the packaging category coded concept shown in packaging as a closure 3.6.4.4 Table 32 is used to categorise the Packaging code-term pairs Table 33 — Example code-term pairs for the closure “Screw cap” code term CLO-30056000-EN-GB screw cap de finition comment languageCode regionCode CLO-30056000-EN-US screw cap CLO-30056000-FR-FR bouchon vis hollow, cylindrical object hollow, cylindrical object objet cylindrique, creux, avec un filetage, destiné fermer EN GB EN US FR FR with a screw thread, meant with a screw thread, meant to close a container to close a container un récipient The codes for packaging code-term pairs shown in Table 33 are used to build the packaging coded concept, as shown in 3.6.4.5 3.6.4.5 Packaging coded concept Table 34 — Example coded concept for the closure “Screw cap” code value translation CLO-30056000 CLO-30056000-EN-GB CLO-30056000-EN-US CLO-30056000-FR-FR The closure concept o f “Screw cap” is there fore represented by the identifier CLO-30056000, and it is this identifier that is used to represent the concept, for example as part o f the medicinal product data The language- and region-specific codes (i.e the code-term pairs) such as CLO-30056000-EN-GB are intended for use only within the terminology to arrange regional translations 3.6.5 3.6.5.1 Packaging example: Oral syringe (Packaging category: Administration device) Example overview The concepts contained in this packaging category are those packaging items that are used for the correct administration o f the product An administration device may be an integral part o f a closure or o f an immediate container It is emphasised that the administration device concept is only used to describe the equipment supplied as part of the medicinal product, in the packaging; it is not intended to describe complex, large pieces o f equipment that are supplied independently, such as electrically powered nebulisers or infusion pumps 34 © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) 3.6.5.2 Packaging category code-term pairs Table 35 — Example code-term pairs for the packaging category “Administration device” code term PAC-0003-EN-GB comment languageCode regionCode for administration device administration device p ackagi ng c ate gor y i nclud i ng p ackagi ng c ate go r y i nclud i ng EN GB EN US p ackagi ng c ate gor y co de -term p a i rs s hown i n c ategor y co de d concep t, a s shown i n 3.6.5.3 PAC-0003-FR-FR dispositif d’administration catégorie d’emballage comprenant les articles utilizés items used for the correct items used for the correct pour coradministration of the product administration of the product recte l’administration du produit de finition T he co de s PAC-0003-EN-US 3.6.5.3 FR FR Table 35 are used to build the packaging Packaging category coded concept Table 36 — Example coded concept for the packaging category “Administration device” code value translation T he for co de the p ackagi ng c ategor y co de d packaging as an administration device 3.6.5.4 PAC-0003 PAC-0003-EN-GB PAC-0003-EN-US PAC-0003-FR-FR concep t shown in Table 36 is used to categorise the Packaging code-term pairs Table 37 — Example code-term pairs for the administration device “Oral syringe” code DEV-30045000-EN-GB DEV-30045000-EN-US term o l s yr i nge o l s yr i n ge administration device for administering a liquid or semi-solid pharmaceutical administration device for administering a liquid or semi-solid pharmaceutical p ro duc t to the o l c avity pro duc t to the ora l c avity EN GB EN US de finition comment languageCode regionCode DEV-30045000-FR-FR seringue pour administration orale dispositif d’administration utilizé pour l’administration d’un produit pharmaceutique liquide ou semi-solide la cavité orale FR FR The codes for packaging code-term pairs shown in Table 37 are used to build the packaging coded concept, as shown in 3.6.5.5 © ISO 2016 – All rights reserved 35 ISO/TS 20440:2016(E) 3.6.5.5 Packaging coded concepts Table 38 — Example coded concept for the administration device “Oral syringe” code value DEV-30045000 translation DEV-30045000-EN-GB DEV-30045000-EN-US DEV-30045000-FR-FR The administration device concept o f “Oral syringe” is there fore represented by the identifier DEV30045000, and it is this identifier that is used to represent the concept, for example, as part o f the medicinal product data The language- and region-specific codes (i.e the code-term pairs) such as DEV30045000-EN-GB are intended for use only within the terminology to arrange regional translations 3.6.6 Packaging concept summaries The three packaging concepts described above are summarised in Table 39 and in the schema in Figure 12, arranged according to their respective packaging categories Table 39 — Summary of packaging concepts “Ampoule”, “Screw cap” and “Oral syringe” and their packaging categories Packaging category Packaging PAC-0001 CON-30001000 PAC-0002 CLO-30056000 PAC-0003 DEV-30045000 Figure 12 — Summary schema of packaging concepts “Ampoule”, “Screw cap” and “Oral syringe” and their packaging categories Mapping of regional terms 4.1 Differences in granularity between regional terminologies Many o f the concepts covered in ISO 11239 are already described in various regions using their own sets o f terminologies (re ferred to here as “regional terms”), which are usually not harmonised with those o f other regions This is o ften because o f di fferent levels o f granularity between regions, which means that one-to-one mapping between those regions’ terms is not possible For example, if the terms used in region A have a relatively low level o f granularity compared to the terms used in region B, one term from region A will often map to several terms from region B Indeed, the purpose of ISO 11239 is to allow for the development of a single set of controlled vocabularies (referred to here as “central terms”) that can be used by all regions to communicate with each other, and to which all regions can map their own regional terms Figure 13 gives an example of how terms from Europe, the US and Japan might map to a list of central terms In this example: — central terms distinguish between injection and in fusion products but not between lyophilised and non-lyophilised powders; 36 © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) — E urop e d i s ti ngu i s he s b e twe en i nj e c tion and i n fus ion pro duc ts but no t b e twe en lyoph i l i s e d a nd non-lyoph i l i s e d p owders (i e the s a me as the centra l term s) ; — the US d i s ti ngu i s he s b e twe en lyoph i l i s e d and non-lyoph i l i s e d p owders but no t b e twe en i nj e c tion and infusion products; — Japan uses a single term to describe all injection and infusion products As a result, with respect to the central terms there is one-to-one mapping for each European term, there i s one -to -two mappi ng for e ach US term, and there i s one -to -ma ny mappi ng for the Jap ane s e term Figure 13 — Mapping of equivalent terms in the US, Europe and Japan I t i s i mp or ta nt to encou rage the corre c t u s e o f the centra l term s b y the us ers i n e ach region and, s ideri ng the varie ty o f ways i n wh ich re giona l term s c an map to centra l term s , it i s i mp or ta nt to fac i l itate the identi fic ation o f the e qu iva lent centra l term for a given regiona l term I n order to th i s , mappi ng c an b e c arrie d out b y a re gion s o a s to l i n k thei r regiona l term s to the centra l term s T h i s would allow a user to search for a regional term and be directed to the proposed central term(s) that the region considers to be equivalent T he defi n ition o f regiona l term s , a s wel l a s thei r u s e to de s crib e me d ici na l pro duc ts , i s the re s p on s ibi l ity of the regional authorities The mapping of regional terms to central terms shall therefore be considered f terms, since it cannot be guaranteed that the central term will be appropriate for the regional product as gu ida nce on ly, rather tha n a gua rante e b y the mai ntena nce organ i s ation o © ISO 2016 – All rights reserved e qu iva lence b e twe en the 37 ISO/TS 20440:2016(E) 4.2 Organisation of regional terms in the database 4.2.1 General This Clause describes the way that a regional term is added to the database, including the data types used to convey the in formation, and describes the method by which regional terms are mapped to central terms Since regional terms may be represented by varying amounts o f in formation depending on the sophistication o f the particular regional source, only the minimum necessary amount o f in formation can be made mandatory Furthermore, i f complete in formation on a regional term is required, the original source in the region should be consulted; it is not the intention that complete information on be considered as a method to refer to regional terms that are held in external databases regional terms is maintained in the central database in parallel The mapping functionality is rather to 4.2.2 Addition of regional terms to the database 4.2.2.1 Mapped regional term Authorised users from regional authorities shall be able to enter into the database specific in formation relating to a regional term The mappedRegionalTerm data type is used to represent the in formation that is required to describe each mapped regional term This underlying class contains the identifier for use in the central database (code), the regional term language, the region code, the authority code, a re ference to the source o f the data, the regional term ID, the regional term, a hyperlink to the regional term, the status o f the term, a synonym indicator, a comment, and a repeatable section consisting o f the mapped central concept 4.2.2.2 Mapped regional term: Code User Guidance Data Type Conformance Value Allowed Business Rule(s) 4.2.2.3 This field contains a unique, machine-readable identifier to represent the mapped regional term in the central database String Mandatory Free text Each mapped regional term shall have one code, for example, MAP-01234567-LL-RR, where LL represents the language code and RR represents the region code Mapped regional term: Language code User Guidance This field contains the language in which the regional term is described The language Data Type code used is in line with ISO 639-1 Concept Descriptor Business Rule(s) ISO 639-1 code, OID reference 1.0.639.1 Each mapped regional term shall have one language code Conformance Value Allowed 4.2.2.4 Mapped regional term: Region code User Guidance Data Type Conformance Value Allowed Business Rule(s) 38 Mandatory This field contains the country/region in which the regional term is used The region code used is in line with ISO 3166-1 Alpha-2 (i.e 2-letter) codes are used The additional code EU is also allowed to represent the European Union It should be noted that the United Kingdom is represented in ISO 3166-1 by the 2-letter code GB Concept Descriptor Mandatory ISO 3166-1 alpha-2 code, OID reference 1.0.3166.1.2.2 Each mapped regional term shall have one region code © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) 4.2.2.5 Mapped regional term: Authority code User Guidance T h i s field conta i n s the n ame o f the authority that control s the re gion a l ter m i n the re gion T he l i s t o f autho r itie s i s on l y i ntende d fo r u s e with i n the d atab a s e a nd m ay there fo re b e m a i nta i ne d b y the m a i nten a nce orga n i s atio n o f the centra l d atab a s e D ata Typ e Conformance Value Allowed Business Rule(s) 4.2.2.6 Concept descriptor M a nd ator y C o ntro l le d vo c ab u l a r y c re ate d a nd m a i nta i ne d b y the m a i nten a nce o rga n i s ation o f the central database E ach m app e d re gion a l ter m s h a l l h ave o ne author ity co de Mapped regional term: Source link User Guidance T h i s o p tio n a l field conta i n s a l i n k to the s ou rce o f the re gio n a l ter m , s uch a s a n o n l i ne datab a s e o r l i s t T he l i s t o f s o u rce s i s on l y i ntende d for u s e with i n the d atab a s e a nd m ay there fore b e m a i nta i ne d b y the m a i nten a nce o rga n i s ation o f the centra l datab a s e D ata Typ e Conformance Value Allowed Business Rule(s) Concept descriptor Optional C o ntro l le d vo c abu l a r y c re ate d a nd m a i nta i ne d b y the m a i nten a nce orga n i s ation o f the central database E ach m app e d re gion a l ter m m ay h ave one s o u rce hyp erl i n k T h i s i s m a i nta i ne d b y the - m a i nten a nce orga n i s ation o f the centra l d atab a s e i n o rder th at, i f ne ce s s a r y, a l l s uch hy p erl i n ks c a n b e ch a nge d at o nce; a lter n ativel y, i f it wa s kep t a s fre e te x t, e ach re ference wou ld ne e d to b e up date d m a nu a l l y T he re gion a l autho r ity i s ne ver thele s s re s p o n s ib le for ensuring that the maintenance organisation of the central database is kept up to date with the correct information 4.2.2.7 Mapped regional term: Regional term ID User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) T h i s field conta i n s the identi fier th at i s u s e d i n the re gio n to identi fy the re gio n a l ter m String Optional Free text E ach m ap p e d re gio n a l ter m m ay h ave one re gion a l term I D ; i f s uch a n I D e xi s ts i n the re gion a nd i s pub l icly ava i l ab le , it i s s idere d b e s t p rac tice th at th i s field b e co mp le te d 4.2.2.8 Mapped regional term: Regional term User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) T h i s field conta i n s the te x tu a l ter m de s c rip tion fo r the re gio n a l ter m (i e the re gion a l ter m its el f i n the l a ng u age s p e c i fie d b y the l a ng u age co de) String M a nd ator y Free text Each mapped regional term shall have one regional term © ISO 2016 – All rights reserved 39 ISO/TS 20440:2016(E) 4.2.2.9 Mapped regional term: Regional term link User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) T h i s o p tio n a l field co nta i n s a d i re c t l i n k to the re g io n a l te r m , s uch a s a n entr y i n a n online database String Optional Fre e te x t (u s u a l l y i n the fo r m o f a hyp erl i n k) E ach m app e d re gio n a l ter m m ay h ave one ter m hyp erl i n k T he m a i nten a nce o f s uch a l i n k i s the re s p on s ib i l ity o f the re gion a l autho rity 4.2.2.10 Mapped regional term: Status User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) T h i s o p tio n a l field conta i n s the s tatu s o f the re gio n a l ter m Concept descriptor Optional ”Current”; “Deprecated”; “Rejected”; “Pending” E ach m app e d re gion a l ter m m ay h ave a s tatu s T he m a i nten a nce o f the s tatu s i s the re s p on s ib i l ity o f the re gio n a l author ity - 4.2.2.11 Mapped regional term: Synonym indicator User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) T h i s op tion a l field co nta i n s a n i nd ic ato r o f whe ther the re gion a l ter m i s s idere d a s yno nym i n the re gion , rather th a n a p re ferre d ter m Boolean operator Optional True; False E ach m app e d re gio n a l ter m m ay h ave a s yno nym i nd ic ato r T he m a i nten a nce o f the s yn o nym i nd ic ator i s the re s p on s ib i l ity o f the re gion a l autho r ity - 4.2.2.12 Regional term: Comment User Guidance D ata Typ e Conformance Value Allowed Business Rule(s) T h is op tiona l field contai ns a textual com ment for the regional term I t is u se d to provide to the user additional information and guidance regarding the regional term and the mapping String Optional Free text E ach m ap p e d re gio n a l ter m m ay h ave one co m ment 4.2.2.13 Regional term: Mapped central concept User Guidance T h i s re p e atab l e , o p ti o n a l fi e ld co n ta i n s the i de nti fi e r o f a ce ntra l te r m to wh i ch the re gion a l ter m i s m app e d I t wi l l u s u a l l y b e emp ty o n l y i n the c a s e th at a re gio n a l ter m D ata Typ e Conformance Value Allowed Business Rule(s) 40 has been entered into the database but a decision is still being considered regarding the appropriate central term(s) to which it is to be mapped String Optional C o de d concep t identi fier E ach m ap p e d re gio n a l ter m m ay h ave one or m a ny m ap p e d centra l concep ts © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) 4.2.3 Mapping regional terms to central coded concepts Authorised users from regional authorities shall be able to link a regional term to one or more coded concepts representing central terms A single regional term can be associated with (i.e can map to) zero to many central concepts, and a single central concept can be associated with (i.e can be mapped from) zero to many regional terms The one-to-many links occur only in one direction, i.e from the mapped term to the central term; however, this allows any associations to be seen from either direction, so it will be possible to analyse a mapped term and see which central term(s) it is mapped to, and also to analyse a central term and see which mapped term(s) have been associated with it 4.2.4 Versioning of mapped regional terms Regional terms may need to be modified and there fore versioning o f the mapped terms in the database is also necessary This is similar to the versioning o f code-term pairs described in 2.3, insofar that it includes the following elements: — code; — creationDate; — createdBy; — versionDate; — modificationMade; — modificationBy; — versionNumber 4.2.5 Mapped regional term example: Extended-release caplet This Clause gives an example o f how an imaginary term from an imaginary external database might be described within the central database and mapped to a central term In this example, there is only a single central term that is the target o f the mapping but, where necessary, multiple central terms may be selected as the targets of the mapping A user from the organisation that has ownership o f an external database first contacts the maintenance organisation of the central database in order to request authorisation to introduce mapped regional authorisation for the user to add mapped terms, including recording and associating the appropriate details of the organisation and of the external database with that user terms from their database The maintenance organisation creates the necessary access and The imaginary term used in the external database is “Extended-release caplet” The authorised user from the organisation that has ownership o f the external database has identified that this term maps directly to the central term “Prolonged-release tablet”, which has the coded concept PDF-10226000 The user creates a new entry for the external term, completing the necessary fields, while the central database pre-fills other fields according to the details that were provided during the initial authorisation of the user The central database also assigns a code to represent the mapped term within the central database In this example, the fields shown in yellow in Table 40 are completed by the authorised user from the external organisation, while the other fields are completed by the maintenance organisation © ISO 2016 – All rights reserved 41 ISO/TS 20440:2016(E) Table 40 — Example entry for a regional term that is mapped to a central term code languageCode regionCode authorityCode sourceLink regionalTermId regionalTerm regionalTermLink status synonymIndicator comment mappedCentralConcept MAP-90000123-EN-GB EN GB Made-up Regional Code Authority (MRCA) http://www.madeup-rca-lists.org madeupid44569 Extended-release caplet http://www.madeup-rca-lists.org/44569.html current No The MRCA considers “Prolonged-release tablet” to be equivalent to “Extended-release caplet” PDF-10226000 In this way, the association is created between the central term “Prolonged-release tablet” and the external term “Extended-release caplet” Someone who is used to using terms from the external database will now be able to find their regional term “Extended-release caplet” in the central database and see that the central term “Prolonged-release tablet” has been identified as the equivalent term 42 © ISO 2016 – All rights reserved ISO/TS 20440:2016(E) Bibliography [1] [2] ISO 639-1, Codes for the representation of names of languages — Part : Alpha-2 code ISO 3166-1, Codes for the representation of names of countries and their subdivision s — Part : [3] ISO 8601, Data elements and interchange formats — Information interchange — Representation of [4] ISO/TR 14872 1) , Health informatics — Identification of Medicinal Products [5] ISO 11239:2012, Health informatics — Identification of medicinal products — Data elements and Country codes dates and times — Core Principles for Maintenance of Identifiers and Term s structures for the unique identification and exchange of regulated information on pharmaceutical dose form s, units of presentation, routes of administration and packaging 1) Under preparation © ISO 2016 – All rights reserved 43 ISO/TS 0440: 01 6(E) ICS 40.80 Price based on 43 pages © ISO 2016 – All rights reserved