1、 Reference number ISO/TR 25257:2009(E) ISO 2009TECHNICAL REPORT ISO/TR 25257 First edition 2009-09-01 Health informatics Business requirements for an international coding system for medicinal products Informatique de sant Exigences daffaire pour un systme de codage international pour les produits md
2、icaux ISO/TR 25257:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.
3、 In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be foun
4、d in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the
5、address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either
6、 ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reservedISO/TR 25257:2009(E) ISO
7、2009 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Terms and definitions. 1 3 Abbreviated terms 4 4 Business requirements for an international coding system to identify the medicinal product. 5 5 Description and assessments of existing coding systems 6 5.1 Selection
8、rationale 6 5.2 GS1 system . 7 5.3 NDC 7 5.4 WHO DD . 8 5.5 Country status of coding of healthcare products (01/05/2003) 13 6 Analysis of existing coding systems with international business requirements 23 7 Discovery of international business concepts for an international coding system 23 8 Benefit
9、s of an international coding system for medicinal products . 25 8.1 Knowledge sources for decision support (clinical parameters and guidelines) . 25 8.2 Prescribing, dispensing and ordering (e-prescription and e-pharmacy) 25 8.3 EHR (electronic health record) system. 26 8.4 Global comparison of mark
10、et statistics . 27 8.5 Inventory control and purchasing. 27 8.6 Supply chain 27 8.7 Pharmacovigilance tracking: Adverse Drug Reactions (ADR) recall 27 8.8 Coding transparency 27 9 Issues in achieving an international coding system to fulfill business requirements 27 10 Recommendations for next steps
11、 . 28 Annex A (informative) WHO Drug Dictionary 29 Annex B (informative) GS1 36 Annex C (informative) RxNORM 39 Annex D (informative) UNIque Identifier (UNII) 40 Annex E (informative) National Drug File Reference Terminology (NDF-RT) 41 Bibliography . 42 ISO/TR 25257:2009(E) iv ISO 2009 All rights r
12、eservedForeword 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 wh
13、ich 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
14、matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are ci
15、rculated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from that which is normally published as an Inter
16、national Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it provides are considered to be no longer val
17、id or useful. 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. ISO/TR 25257 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO/TR
18、 25257:2009(E) ISO 2009 All rights reserved v Introduction As pharmacy and medication business computerisation expands across all aspects of the health sector, there are increasing demands for interoperability and integration across distinct domains and among health platforms. Therefore, the compute
19、risation of the health sector extends to drug administration and management including the prescribing, dispensing, administration and management of commercial supply chains. The satisfactory free flow of information concerning medicinal products locally, nationally and internationally will depend on
20、 the efficient and unambiguous use of international medicinal product drug codes. For the electronic sharing of pharmacy information (e-pharmacy) at an international level, an international coding system is a core product. The purpose of this Technical Report is to define the business requirements o
21、f an interoperable electronic health record at an international level as the exchange of information relates to medication and medicinal products. Government agencies, healthcare providers and healthcare related companies all face obstacles in managing drug information due to the absence of a unifie
22、d international medicinal code system as it relates to international sharing, not necessarily for domestic use. There is currently considerable duplication of effort in this area created by divergent coding systems. For example, in Korea, a national policy for implementing a Drug Utilisation Review
23、(DUR) program is being enforced to improve medication safety and quality of prescribing and dispensing. Because there are no national identification drug codes for all products, each medical institute or system vendor is facing difficulties in mapping codes for sharing DUR information. The Korean go
24、vernment therefore commissioned a research project to develop a national coding system for medicinal products and to establish ancillary coded information by 2006. Whereas the EAN (European Article Number) system was evaluated and seen to have very efficient code structures, the EAN was deemed to ha
25、ve weaknesses in that there is no systemic ancillary code system. Other countries are experiencing similar problems and seeking similar solutions since code mapping requires a large expenditure of resources and imposes considerable expense. If an international coding system for medicinal products co
26、uld be created and maintained, this would be a major contribution to solving some of the problems currently being experienced. The aim of this Technical Report is to: 1) identify the international business requirements an international coding system will need to satisfy; 2) determine the extent to w
27、hich existing international coding systems meet the business requirements; i.e. why and to what extent an existing system could provide the basis of a unified international medicinal code structure; 3) discover the key international business concepts for a unified international coding system for med
28、icinal products; 4) consider the issues involved in reconciling divergent systems into a satisfactory international system; 5) identify the next steps to bring forth or produce a unified international coding system. TECHNICAL REPORT ISO/TR 25257:2009(E) ISO 2009 All rights reserved 1 Health informat
29、ics Business requirements for an international coding system for medicinal products 1 Scope The scope of this Technical Report covers: a) specifying the international business requirements for an international coding system for medicinal products; b) analysing the most significant international codi
30、ng systems for medicinal products in current use and within the context of the objectives that each system was designed to serve; c) assessing the potential ability of each international coding system to fulfil the identified international business requirements of an international coding system for
31、medicinal products; d) considering the issues involved in producing a unified international coding system which will meet all business requirements; e) recommending next steps for a unified international coding system for medicinal products. 2 Terms and definitions For the purposes of this document,
32、 the following terms and definitions apply. 2.1 medicinal product manufactured product intended to be administered to human beings for treating or preventing disease, with the view to making health diagnosis or to restore, correct or modify physiological functions 2.2 medicinal product code code ass
33、igned to each uniquely identified medicinal product. The code is used once within the lifetime of the database without duplication internationally for each medicinal product 2.3 country code unique identifier code for a country in which the product is marketed 2.4 company code A unique identifier fo
34、r a company that manufactures and/or distributes the drug product 2.5 drug formulation code potential coding structure/schema that supports ISO/TR 25257 business requirements ISO/TR 25257:2009(E) 2 ISO 2009 All rights reservedNOTE 1 This is a unique identifier code that is a concatenation representi
35、ng the unique combination of active ingredient name, product name, route of administration, dose form, strength and strength unit of measure, country code, company code and package size. NOTE 2 The drug formation code supports a hierarchy naming concept consisting of several levels each providing mo
36、re specific information about the medicinal product. 2.6 route of administration path by which a drug is administered in the body. In the case of injection, an intravenous route is injection in a vein NOTE 1 In the case of parenteral/non-injection route, inhalation is medication to be taken by inhal
37、ing. NOTE 2 Other examples are oral, translingual, buccal, injection, perfusion, topical and nasal. 2.7 pharmaceutical form physical presentation of a drug, such as tablet, capsule, or liquid NOTE The pharmaceutical form can incorporate the delivery and release mechanism of the drug. ENV 12610 2.8 s
38、trength and strength unit of measure potency of the drug, usually expressed in a metric quantity EXAMPLE 500 mg 2.9 package size code number of billing units in the labelled quantity which the pharmacist dispenses; identifier code for the package size of the products where a product may have more th
39、an a single type of package EXAMPLE 100 tablets or 10 capsules or 10 vials. PLAVIX Film Coated Tablet 75 mg 100. Packaged as 100 tablets per container. For the lowest level of pack size to identify a unit of the product, the package size code can be assigned as dummy code “00”. 2.10 virtual product
40、name concept permanent numeric identifier for the varying levels of medicinal product specificity virtual forming the framework of the proposed international coding system for medicinal products See Table 1. ISO/TR 25257:2009(E) ISO 2009 All rights reserved 3 Table 1 Type of virtual product name con
41、cept Virtual Product Name Concept (class) Description Example (similar to) Virtual Active Ingredient Name Ingredient Name Warfarin Sodium Virtual Active Ingredient Name Virtual Product Name Ingredient Name + Product Name Warfarin Sodium; Coumadin Virtual Active Ingredient Name Virtual Product Name R
42、oute of Administration Ingredient + Product Name + Route of Administration Warfarin Sodium, Coumadin, Oral Virtual Active Ingredient Name Virtual Product Name Route of Administration Dose Form Ingredient + Product Name + Route of Administration + Dose Form Warfarin Sodium, Coumadin, Oral, Tablet Vir
43、tual Active Ingredient Name Virtual Product Name Route of Administration Dose Form Strength and Strength Unit Ingredient + Product Name + Route of Administration + Dose Form + Strength + Strength Unit Warfarin Sodium, Coumadin, Oral, Tablet, 10mg Virtual Active Ingredient Name Virtual Product Name R
44、oute of Administration Dose Form Strength and Strength Unit Country Code Ingredient + Product Name + Route of Administration + Dose Form + Strength + Strength Unit + Country Code Warfarin Sodium, Coumadin, Oral, Tablet, 10mg, US Virtual Active Ingredient Name Virtual Product Name Route of Administra
45、tion Dose Form Strength and Strength Unit Country Code Company Code Ingredient + Product Name + Route of Administration + Dose Form + Strength + Strength Unit + Country Code + Company Code Warfarin Sodium, Coumadin, Oral, Tablet, 10mg, US, Bristol Myers Squibb Virtual Active Ingredient Name Virtual
46、Product Name Route of Administration Dose Form Strength and Strength Unit Country Code Company Code Package Size Ingredient + Product Name + Route of Administration + Dose Form + Strength + Strength Unit + Country Code + Company Code + Package Size Warfarin Sodium, Coumadin, Oral, Tablet, 10mg, US,
47、Bristol Myers Squibb, 100 NOTE The examples above are intended only for illustrative purpose and to help the reader with understanding the document. The examples are not dictating the design of the international coding system for medicinal drug products. 2.11 virtual active ingredient name name of a
48、ctive ingredients (substance included as a component in a product that has the intended pharmaceutical effect) 2.12 virtual product name actual label name label name given by the manufacturer EXAMPLE Coumadin is the product name for the ingredient name Warfarin. If the active ingredient is available
49、, the product name is Warfarin and the ingredient name is also Warfarin. NOTE The virtual product name represents the most general concept. 2.13 virtual active ingredient product name name linked to the one or more routed products EXAMPLE Warfarin Sodium, Coumadin. 2.14 virtual active ingredient product route of administration name name linked to the one or more ingredient products which adds the route of administration for the product EXAMPLE Warfarin Sodium, Coumadin, oral.
