1、DD ISO/TS22224:2009ICS 35.240.80NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWDRAFT FOR DEVELOPMENTHealth informatics Electronic reporting ofadverse drug reactionsThis Draft for Developmentwas published underthe authority of theStandards Policy andStrategy Committee on 30Nove
2、mber 2009. BSI 2009ISBN 978 0 580 60636 6Amendments/corrigenda issued since publicationDate CommentsDD ISO/TS 22224:2009National forewordThis Draft for Development is the UK implementation of ISO/TS22224:2009.This publication is not to be regarded as a British Standard.It is being issued in the Draf
3、t for Development series of publications andis of a provisional nature. It should be applied on this provisional basis,so that information and experience of its practical application can beobtained.Comments arising from the use of this Draft for Development arerequested so that UK experience can be
4、reported to the internationalorganization responsible for its conversion to an international standard.A review of this publication will be initiated not later than 3 years afterits publication by the international organization so that a decision can betaken on its status. Notification of the start o
5、f the review period will bemade in an announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period,the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechni
6、cal Specification or to withdraw it. Comments should be sent tothe Secretary of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of or
7、ganizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligatio
8、ns.DD ISO/TS 22224:2009Reference numberISO/TS 22224:2009(E)ISO 2009TECHNICAL SPECIFICATION ISO/TS22224First edition2009-10-15Health informatics Electronic reporting of adverse drug reactions Informatique de la sant Reportage lectronique des ractions dfavorables de drogue DD ISO/TS 22224:2009ISO/TS 2
9、2224:2009(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. In downloadin
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12、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 ISO at the ad
13、dress 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 reservedDD ISO/TS 22224:2009ISO/TS 22224:2009(E
14、) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Business processes in ADR reporting4 5 Modification of ICH guideline (E2BM) for implementing electronic reporting of ADRs.6 6 ADR vocabularies10 7 Other considerat
15、ions 10 Bibliography11 DD ISO/TS 22224:2009ISO/TS 22224:2009(E) iv ISO 2009 All rights reservedForeword 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 carri
16、ed 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. I
17、SO collaborates closely with the International Electrotechnical Commission (IEC) on all 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 Internati
18、onal Standards. Draft International Standards adopted by the technical committees are circulated 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 other circumstances, particularly when there is an urg
19、ent market requirement for such documents, a technical committee may decide to publish other types of document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 5
20、0 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is rev
21、iewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an I
22、nternational Standard or be withdrawn. 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/TS 22224 was prepared by Technical Committee ISO/TC 215, H
23、ealth informatics. DD ISO/TS 22224:2009ISO/TS 22224:2009(E) ISO 2009 All rights reserved vIntroduction This Technical Specification is considered to be an international guideline for developing and implementing the electronic system in which national or international organizations can receive and tr
24、ansfer ICSRs (individual case safety report) from healthcare professionals and/or consumers. In this Technical Specification, ISO guidelines for electronic reporting of ADR are presented by describing business processes to be considered nationally and internationally in implementing ADR reporting sy
25、stems with the modifications of the existing international guidelines of the following ICH documents: ICH E2B6; ICH ICSR DTD Version 2.1. Since ICH guidelines (E2B6and other revised documents) were well developed and are being adopted in the EU, US, Japan and other countries, there might be no need
26、to develop the ISO guidelines independently from ICH. Since ICH guidelines have been developed for electronic transmissions of individual case safety information between pharmaceutical companies and regulatory bodies in ICH member countries, these do not fully reflect the needs of other non-member c
27、ountries and also do not contain consumer perspectives in reporting processes. From this point of view, the ISO working group has studied the ICH guidelines and developed the International Standards for electronic reporting of adverse drug reactions by modifying the existing ICH guidelines which all
28、 the member countries can use for implementing electronic reporting systems for ADRs. DD ISO/TS 22224:2009DD ISO/TS 22224:2009TECHNICAL SPECIFICATION ISO/TS 22224:2009(E) ISO 2009 All rights reserved 1Health informatics Electronic reporting of adverse drug reactions 1 Scope This Technical Specificat
29、ion encompasses the electronic reporting of adverse reactions caused by drugs for human uses. Thus, other businesses relating to adverse events caused by blood transfusions, medical devices and veterinary drugs are excluded from the scope of this Technical Specification. 2 Normative references The f
30、ollowing 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. HL7/ANSI Approved ICSR standard in Domain, Public Heal
31、th Reporting, 2002 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 adverse drug reaction ADR response to a drug which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseas
32、e, or for the modification of physiological function NOTE 1 This, as defined by the World Health Organization (WHO), is intended to govern the scope of standards. NOTE 2 In the above definition, drug or medicine is defined as any substance in a pharmaceutical product that is used to modify or explor
33、e physiological systems or pathological states for the benefit of the recipient. The term drug or medicinal product is used in a wider sense to include the whole formulated and registered product, including the presentation and packaging, and the accompanying information. NOTE 3 There are many other
34、 terms that pertain to or are related to ADR, but should be differentiated from the definition of ADR such as in 3.2 and 3.3. 3.2 adverse event adverse experience any untoward medical occurrence that may appear during treatment with a pharmaceutical product but which does not necessarily have a caus
35、al relationship with the treatment 3.3 side effect any unintended effect of a pharmaceutical product occurring at a dose normally used in man, which is related to the pharmacological properties of the drug DD ISO/TS 22224:2009ISO/TS 22224:2009(E) 2 ISO 2009 All rights reserved3.4 ANSI American Natio
36、nal Standards Institute first organization for fostering development of technology standards in the United States NOTE ANSI works with industry groups and is the U.S. member to ISO. 3.5 drug any chemical compound that may be used on or administered to humans or animals as an aid in the diagnosis, tr
37、eatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiological condition Dorlands Illustrated Medical Dictionary, 27th edition 3.6 DTD document type definition hierarchical organization or representation of the informatio
38、n contents of a document utilized by SGML 3.7 HL7 Health Level 7 ANSI standard used to facilitate the electronic interchange of data in a healthcare environment 3.8 ICH international conference on harmonization of technical requirements for registration of pharmaceuticals for human use 3.9 ICSR indi
39、vidual case safety report healthcare report describing untoward incidents, therapeutic misadventures, iatrogenic injuries or other adverse occurrences directly associated with care delivery or services provided within the jurisdiction of a medical centre, outpatient clinic or other medical facility
40、3.10 interim reporter professional or public organization that is monitoring, receiving and assessing ADR reports from health professionals and consumers and reporting significant ADRs to a regulatory authority in its own region 3.11 interoperability degree or extent to which diverse environments (h
41、ardware and software) are able to exchange information without loss of content and in a manner transparent to the user 3.12 messaging technology that enables messages to be sent by electronic mail NOTE Messaging includes directory services, allows composition of the message and addressing and transf
42、er over the network. 3.13 national pharmacovigilance centre single, governmentally recognised centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety DD ISO/TS 22224:2009ISO/TS 22
43、224:2009(E) ISO 2009 All rights reserved 33.14 non-proprietary drug (generic) name drug name that is not protected by a trademark, usually descriptive of its chemical structure, sometimes called a public name NOTE In the US, most generic drug names are assigned by the US Adopted Name Council (USAN).
44、 Other generic names in common use are the National Formulary (NF) and the US Pharmacopoeia. 3.15 product manufacturer organization that is responsible for the manufacture of a product and is usually the entity that holds the marketing authorization for the product 3.16 receiver intended recipient o
45、f the transmission 3.17 regulatory agency regulatory authorities agency/authorities responsible for regulating products used in health care NOTE The agencies are collectively referred to as regulatory agencies. 3.18 reporter primary source of the information (i.e., a person who initially reports the
46、 facts) NOTE This should be distinguished from the sender of the message, though the reporter could also be a sender. 3.19 SNOMED clinical terms SNOMED CT clinical terminology maintained and distributed by the SNOMED International Authority under the editorial guidance of the SNOMED International Ed
47、itorial Board 3.20 spontaneous reporting system whereby case reports of adverse drug events are voluntarily submitted by health professionals and pharmaceutical manufacturers to the national regulatory authority 3.21 sender person or entity creating the message for transmission NOTE Although the rep
48、orter and sender might be the same person, the function of the sender should not be confused with that of the reporter. 3.22 serious adverse drug reaction adverse product reaction that is fatal (i.e. results in death) or is life threatening or requires hospitalization or prolongation of a hospitaliz
49、ation or results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect 3.23 SGML standard generalized markup language ISO standard metalanguage for describing structured information in a platform independent manner DD ISO/TS 22224:2009ISO/TS 22224:2009(E) 4 ISO 2009 All rights reserved3.24 standard technical specification that addresses a business requirement, has been implemented in viable commercial products and, to a practical extent, complies with recognised standards organizati
