EN ISO TS 19293-2018 Health Informatics - Requirements for a record of the dispense of a medicinal product.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018)PD CEN ISO/TS 19293:2018National forewordThis Published Document is the UK implementation of CEN ISO/TS 19293:2018

2、. It is identical to ISO/TS 19293:2018.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necess

3、ary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 85946 5ICS 35.240.80Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document

4、was published under the authority of the Standards Policy and Strategy Committee on 30 June 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 19293:2018TECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIONISO/TS 19293May 2018ICS 35.2

5、40.80EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. ISO/TS 19293:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national Me

6、mbersHealth Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018)Informatique de sant - Exigences relatives un enregistrement de la dlivrance dun mdicament (ISO/TS 19293:2018)Medizinische Informatik - Anforderungen an die Akte zur Abgaben eines Arzneimitt

7、els (ISO/TS 19293:2018)This Technical Specification (CEN/TS) was approved by CEN on 19 February 2018 for provisional application.The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on t

8、he question whether the CEN/TS can be converted into a European Standard.CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national s

9、tandards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic o

10、f Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionISO/TS 19293:2018 (E)European forewordThis do

11、cument (CEN ISO/TS 19293:2018) has been prepared by Technical Committee ISO/TC 215 “Health Informatics“ in collaboration with Technical Committee CEN/TC 251 “Health Informatics”, the secretariat of which is held by NEN.Attention is drawn to the possibility that some of the elements of this document

12、may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bul

13、garia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, T

14、urkey and the United Kingdom.iiPD CEN ISO/TS 19293:2018ISO/TS 19293:2018 (E)Endorsement noticeThe text of ISO/TS 19293:2018 has been approved by CEN as CEN ISO/TS 19293:2018 without any modification.iiiPD CEN ISO/TS 19293:2018ISO/TS 19293:2018Endorsement notice iiiForeword viIntroduction vii1 Scope

15、. 12 Normative references 13 Terms, definitions and abbreviated terms 13.1 Terms and definitions . 13.2 Symbols and abbreviated terms. 34 Dispense process and dispense event 44.1 General . 44.2 Dispense record in diverse dispense processes . 44.3 Dispense record information purposes . 45 Requirement

16、s 55.1 General considerations 55.2 Issuance of the dispense record . 55.2.1 General 55.2.2 Dispense record scenarios 65.2.3 Dispense record uniqueness 65.2.4 Dispense process unambiguity 65.2.5 Dispense record unequivocal identification 75.2.6 Dispense act date/time 75.2.7 Dispense location Institut

17、ion/department 75.2.8 Confirmations, authorizations, or advice . 75.2.9 Additional information to support the adequate and legal dispensing 85.2.10 Relevant findings elicited during the clinical review . 85.2.11 Decision not to dispense . 85.3 Prescription-related . 85.3.1 General 85.3.2 Link to pre

18、scription . 95.3.3 Additional prescription linking data 95.3.4 Previous prescription changes/advice . 95.3.5 Outcome of clinical review of the prescription 95.4 Dispenser identification . 105.4.1 Dispensing professional . 105.4.2 Dispensing organization. 115.4.3 Automated and semi-automated dispensi

19、ng systems 115.5 Patient identification 115.5.1 General. 115.5.2 Patient identification verification 115.6 Dispensed product 115.6.1 General. 115.6.2 Dispensed product type 125.6.3 Dispensed physical item . 135.7 Quantity 145.7.1 Dispensed product quantity 145.7.2 Retrieved product quantity . 145.8

20、Dispense repeat number . 145.9 Fulfilment notes 145.10 Patient instructions 145.10.1 General. 145.10.2 Reimbursement .155.10.3 Transport . 15iv ISO 2018 All rights reservedContents PagePD CEN ISO/TS 19293:2018ISO/TS 19293:2018Annex A (informative) Examples of use cases (from NVN-ENV 13607) .16Annex

21、B (informative) Examples of use cases (other sources) 22Annex C (informative) Dispensing processes Examples and variation 28Annex D (informative) Identifying dispensed products across jurisdictions Using IDMP and national identifiers 33Annex E (informative) Use case-specific constraints of using dis

22、pense record 35Annex F (informative) Informative typical data structures Elements and vocabularies .36Bibliography .38 ISO 2018 All rights reserved vPD CEN ISO/TS 19293:2018ISO/TS 19293:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standar

23、ds 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 organi

24、zations, 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 fu

25、rther 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/direct

26、ives).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 I

27、ntroduction 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 voluntary nature of standards, the meaning of ISO speci

28、fic terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO

29、/TC 215, Health informatics.vi ISO 2018 All rights reservedPD CEN ISO/TS 19293:2018ISO/TS 19293:2018IntroductionThe record of dispensed medicinal product(s) plays an important role in the patient safety domain. When a medicinal product has been prescribed, it then has to be dispensed before being ad

30、ministered to the subject of care. The dispensed product may correspond exactly to what was prescribed, but it may equally be different for various reasons, such as substitution, unavailability of medicinal product in the prescribed dosage or route of administration, etc.There are further situations

31、, when medicinal products are dispensed or supplied without any prescription. This should also be captured since a non-prescribed medicinal product may have interactions or other influences with prescribed medicinal products.When creating a list of a patients medication history, prescriptions can pr

32、ovide valuable information, but the dispensation is sometimes considered a better indicator of the medication taken by a patient than a prescription, i.e. although neither is information about compliance or administration, the dispense record is many times considered a more reliable indicator of act

33、ual medication use than a prescription (even if it also not an unequivocal indication of administration). Therefore, there is a need to capture the dispensation, as the dispensation either completes the logical chain from prescription to administration, or provides information for later prescription

34、s or dispensation, for instance, if interactions can be anticipated and avoided.The dispense record should provide information in such a way that it is accurate and reusable; for example, statistics and other information can be collected across the dispensers for public health purposes, or for regul

35、atory needs (e.g. controlled substances control).Additionally, the dispense record is a traceability element. For clinical purposes, it supports recording the process from prescribing to administration. For supply chain, it allows reconstruction of the supply chain, for example, in the contexts of r

36、ecalls or supply chain integrity.This document defines the information that may be contained in a dispense record, and the applicability and constraints of such information. It defines a set of conditions that should be verified on detailed interoperability implementations.This document also defines

37、 requirements for when the dispense record should be issued in the cases where it is needed. This is not required as a specific moment in a process which would depend on a variety of processes and factors but by providing a common set of activities that are included in a dispense.This document addre

38、sses the requirements which are to be fulfilled by the systems that record medicinal product dispensation. It is based on use cases which are chosen from the daily life within the same jurisdiction, and when the prescription and dispensation have occurred in different jurisdictions. This document re

39、lies on the assumption that prescription and dispensation are supported by medicinal product dictionaries that ensure interoperability.One key aspect in this document is that the notion of dispense can vary according to context (hospital versus community), jurisdiction, and other factors. The uses o

40、f the dispense record can also vary. These variations can have a strong impact on the definition of dispense.For example, the process of dispensing a medication varies considerably between hospital and community settings, and even inside a hospital. Another example is if the dispense record is used

41、mostly for operational concerns (reimbursement), the relevant dispense information is obtained when the medication is retrieved for that patient. But if the dispense record is supposed to support clinical systems, it may be better to capture information until the medication is delivered to the patie

42、nt or handed to a next of kin and thus presumed to be delivered to the patient. It is important that the medication dispense record contains sufficient information to support these different and variable uses.Another example of process variability is how a dispense record can be a consequence of an

43、electronic prescription. However, in some cases, there are dispenses without a prescription. The scope of this document considers dispensing with or without the existence of a prescription. ISO 2018 All rights reserved viiPD CEN ISO/TS 19293:2018ISO/TS 19293:2018There is an increasing number of scen

44、arios for electronic capture of dispensing information and an increasing need to exchange this information in electronic health information systems, in particular, for purposes of clinical care, decision support, claiming and reimbursement, research, statistics, regulation, as well as for product in

45、tegrity.This document is, thus, not about the processes but the information content. This document does not impose any activity to be part of the dispense process, but informs what information may be captured from each activity.Other uses for this information are identified, not for exhaustively lis

46、ting them which would be limiting and impractical but to ensure that the scope of this document covers the expected scenarios and uses.In this way, the information in a dispense record can be correctly recorded and used in any of the contexts of dispense, ensuring the global applicability of this do

47、cument.viii ISO 2018 All rights reservedPD CEN ISO/TS 19293:2018Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018)1 ScopeThis document specifies requirements for a record of a dispense of a medicinal product.It is intended to be adopted by detai

48、led, implementable specifications, such as interoperability standards, system specifications, and regulatory programs.This document applies to information systems in which a dispense of a medicinal product is registered, and the systems that consume such information. These systems are usually in pha

49、rmacies or other healthcare institutions. This document does not necessarily apply to non-pharmacy shops or other non-clinical systems (e.g. supermarket cashiers).The scope of this document includes the activities relating to the dispensing of a medicinal product and the information content for the capture of structured information produced in those events.These activities include any actual dispense, cancellation or other outcome that may have occurred at the time of planned or actual dispense. In other words, the dispense record also contain