ISO TS 19256-2016 Health informatics - Requirements for medicinal product dictionary systems for health care《健康信息学 医疗保健药品字典系统的要求》.pdf

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1、 ISO 2016 Health informatics Requirements for medicinal product dictionary systems for health care Informatique de sant Exigences pour les systmes de dictionnaires de produits mdicaux pour les soins de sant TECHNICAL SPECIFICATION ISO/TS 19256 Reference number ISO/TS 19256:2016(E) First edition 2016

2、-06-01 ISO/TS 19256:2016(E)ii ISO 2016 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, inclu

3、ding 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 ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland T

4、el. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO/TS 19256:2016(E)Foreword v Introduction vi 1 Scope . 1 2 Normative references 2 3 T erms and definitions . 2 4 Abbreviated terms 9 5 Boundary between MPD-systems and IDMP , ancillary information to build an MPD- system and lo

5、cal 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 Medicin

6、al 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 Rela

7、tion 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 Recordin

8、g 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

9、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 case17 6.2.13 Patient safety through linking personal data with the decision support s

10、ystem 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 Administ

11、ration 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 Inte

12、raction with reimbursement systems 27 ISO 2016 All rights reserved iii Contents Page ISO/TS 19256:2016(E)7.3.10 Interaction of MPD-systems with pharmacovigilance systems 27 7.3.11 Data exchange and technical functions .28 7.4 Governance 29 7.5 Maintenance .30 7.5.1 Regular maintenance processes of t

13、he MPD-system .30 7.5.2 Interaction with regulatory information .31 7.6 Localization .32 Annex A (informative) IDMP series in c ont e xt , serving this T echnical Specification33 Bibliography .35 iv ISO 2016 All rights reserved ISO/TS 19256:2016(E) Foreword ISO (the International Organization for St

14、andardization) 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 rig

15、ht 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 procedure

16、s 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 ru

17、les 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 iden

18、tified 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 explanatio

19、n on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs 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

20、is ISO/TC 215, Health informatics. ISO 2016 All rights reserved v ISO/TS 19256:2016(E) Introduction This introduction contains the following topics: a) What is a Medicinal Product Dictionary system? b) What are the use cases and who are the stakeholders? c) What are the benefits for the different st

21、akeholders? 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

22、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 ID

23、MP (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 developmen

24、t 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 syste

25、ms 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 (s

26、et 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 con

27、cepts, 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 par

28、ts 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 determin

29、e 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

30、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

31、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 stake

32、holders 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 Te

33、chnical 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 ISO/TS 19256:2016(E) It facilitates

34、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 internati

35、onal 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 o

36、n 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 Function

37、al characteristics of prescriber support systems. ISO 2016 All rights reserved vii 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.

38、 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

39、 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

40、 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 pro

41、cess 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

42、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. T

43、he 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. TECHNICAL SPECIFICATION ISO/TS 19256:2016(E) ISO 2016 All rights reserved 1 ISO

44、/TS 19256:2016(E) 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1161

45、5, 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

46、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 pro

47、ducts 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 u

48、nique 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 T erms a nd definiti ons For the purpos

49、es 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 me