1、Health informatics Medication management concepts and definitions PD ISO/TR 20831:2017 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 ISO 2017 Health infomatics Medication management concepts and definitions Informatique de sant Concepts et dfinitions relatifs la
2、gestion de la mdication TECHNICAL REPORT ISO/TR 20831 Reference number ISO/TR 20831:2017(E) First edition 2017-07 National foreword This Published Document is the UK implementation of ISO/TR 20831:2017. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health infor
3、matics. 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 necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by B
4、SI Standards Limited 2017 ISBN 978 0 580 94869 5 ICS 35.240.80Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017. Amendments/corrigenda issued
5、since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TR 20831:2017 ISO 2017 Health infomatics Medication management concepts and definitions Informatique de sant Concepts et dfinitions relatifs la gestion de la mdication TECHNICAL REPORT ISO/TR 20831 Reference number ISO/TR 20831:2017(E) F
6、irst edition 2017-07 PD ISO/TR 20831:2017 ISO/TR 20831:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, 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 mea
7、ns, 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 ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-
8、1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TR 20831:2017 ISO/TR 20831:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part
9、of 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 ISOs member body
10、 in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgISO/TR 20831:2017(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 Terms and definitions .
11、1 4 Abbreviated terms 3 5 General process . 4 6 Data elements relevant to medication management 5 6.1 General . 5 6.2 Prescription data . 5 6.3 Dispense data . 6 6.4 Medication administration data . 6 6.5 Medication statement data . 6 6.6 Health concern data 7 6.7 Contraindication risks 7 6.8 Specif
12、ic laboratory results 7 6.9 Drug and alcohol usage 8 6.10 Smoking habits 8 7 Process steps 8 7.1 The act of gathering data 8 7.2 The act of making sense of the data 8 7.3 The act of verification of the data . 9 7.4 The act of adding data to the collection . 9 7.5 The acts of carrying out the therapy
13、 and evaluating the outcome 10 8 Definitions of medication management 10 8.1 General 10 8.2 Medication lists11 8.2.1 General.11 8.2.2 Unreconciled medication list .11 8.2.3 Reconciled medication list .11 8.2.4 Aggregated medication list 12 8.3 Medication profile .12 8.4 Medication management profile
14、 .12 8.5 Medication management .13 9 Example use case Storyboard patient intake at hospital admission 13 Annex A (informative) External reference examples .16 Bibliography .19 ISO 2017 All rights reserved iii Contents Page PD ISO/TR 20831:2017 ISO/TR 20831:2017(E) Foreword ISO (the International Org
15、anization 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 which a technical committee has been establi
16、shed 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 of electrotechnical standardizatio
17、n. The procedures 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
18、the editorial rules 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
19、 patent rights identified 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 endorsem
20、ent. For an explanation on the voluntary nature of standards, the meaning of ISO specific 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 UR
21、L: www .iso .org/ iso/ foreword .html. This document was prepared by Technical Committee ISO/TC 215, Health informatics.iv ISO 2017 All rights reserved PD ISO/TR 20831:2017 ISO/TR 20831:2017(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national st
22、andards 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 o
23、rganizations, 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
24、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 rules of the ISO/IEC Directives, Part 2 (see www .iso .or
25、g/ 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 identified during the development of the document will b
26、e 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 explanation on the voluntary nature of standards, the meani
27、ng of ISO specific 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 Te
28、chnical Committee ISO/TC 215, Health informatics.iv ISO 2017 All rights reserved ISO/TR 20831:2017(E) Introduction The approach of this document is first to explain the logical steps in a medication therapy of a patient and to state which data elements are required at that step and what is done with
29、 the data. The best definition that would fit at that stage of medication therapy was identified. It was noticed that where a listing of definitions that the interpretations of the various terms were to be made, this would lead to endless discussion of the meaning of the terms. IHE pharmacy, HL7 Pha
30、rmacy and ISO/TC 215 have been convening frequently and noticed that each individual had a different interpretation of the terms used. As SDOs where communication of medication information is the core purpose of these organizations, it is of course vital to understand what a noun means so that all p
31、ersons have a common understanding of the words used. Terms that have composite ingredients are to a certain extent arbitrarily defined, but this document contains the definitions that are agreed on by HL7 pharmacy, IHE Pharmacy and ISO/TC 215. The scope in the first stage will be on the definitions
32、 of composite information, such as lists. This will be set against the workflow and process in medication therapy. Communicating information by means of IT can be separated into four layers: 1) The conceptual meaning of terms 2) The content and characteristics of terms 3) The container of informatio
33、n. 4) The communication of information. The fourth and bottommost layer is the physical distribution of the information, such as pull or push mechanisms. The logistical aspects are not in the scope of this document, nor is the method or required infrastructure to obtain the information part of this
34、document. The third layer defines how the content is formatted so that senders and receivers can recognize the elements of the content. Examples are CDA documents, HL7v3 or HL7v2 messages. This document is not intended to go into this matter. The second layer from the top is also called the syntax l
35、ayer. It defines the content of a term. Some of these elements in the content will be optional. In the context of this document the term syntax refers to the rules governing the composition of meaningful elements. As an example the geographical coordinates (i.e. 412412.2”N 21026.5”E) could have been
36、 chosen as the syntax for a location, but it could as well be a street, number, postal code and city as the preferred notation of a logical address. This document is not intended to dive into the syntax of the medication terms. The top layer is also called the semantic layer. This document focuses o
37、n this layer. The intention is to understand the meaning of a term. The result should be, that when a term as “unreconciled medication list” is used, that all readers should interpret the term in the same manner. The context in which the information is exchanged is also of importance for the concept
38、. As an example a medication list for an intake into a mental ward could put more emphasis on other data than a medication list for discharge at a general hospital. ISO 2017 All rights reserved v PD ISO/TR 20831:2017PD ISO/TR 20831:2017 Health infomatics Medication management concepts and definition
39、s 1 Scope The purpose of this document is to define the various concepts and terminologies used in the pharmacy domain when applied to the topic of creating medication lists from existing data. 2 Normative references There are no normative references in this document. NOTE For future considerations,
40、 the terms from ISO 13940 will be considered. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at h t t p
41、:/ www .iso .org/ obp IEC Electropedia: available at h t t p :/ www .electropedia .org/ 3.1 contraindication contra-indication condition or factor that increases the risk involved in using a particular drug, carrying out a medical procedure, or engaging in a particular activity Note 1 to entry: Purs
42、uing the intention is inadvisable. SOURCE: IHE Pharmacy, Standard terminology, modified 3.2 dispensing process of validation of the electronic prescription, preparation of the medicinal product, labelling, informing and handing the medication to the patient or administering healthcare professional S
43、OURCE: ISO 17523:2016, 3.2 3.3 health concern health-related matter about a patient that is of interest, importance or worry to someone Note 1 to entry: This someone may be the patient, the patients family or a patients healthcare provider. Note 2 to entry: A health concern is sometimes called a pro
44、blem concern. A difference is that a problem concern is mostly related to one diagnosis, while a health concern can change overtime as the situation of the patient aggravates, for example from a simple cough, to pneumonia ending in COPD. SOURCE: HL7 929, Health Concern Domain Analysis Model v.3, Sep
45、tember 2015 TECHNICAL REPORT ISO/TR 20831:2017(E) ISO 2017 All rights reserved 1 PD ISO/TR 20831:2017 ISO/TR 20831:2017(E) 3.4 medication administration application of medicine to a subject of care Note 1 to entry: In general only the medication administration that is registered in a system is taken
46、 into consideration. SOURCE: IHE Pharmacy: Standard terminology, modified 3.5 medication substance that has an intended therapeutic effect on a patient and may influence the medication safety of a patient Note 1 to entry: This would include prescribed, but also non-prescribed medication such as coug
47、h syrups. A placebo has the intent of a therapeutic effect and is thus considered medication. Alcoholic beverages however also influence medication safety, but are not considered to be medication because they do not have the intent of giving therapy. 3.6 medication management act of exercising direc
48、tives on the medication of a patient Note 1 to entry: It includes reviewing the medication profile of a patient, providing new medication therapies, adjusting or stopping existing therapies and evaluating its outcome. 3.7 medication statement declaration given by the subject of care or a third party
49、 about the usage or non-usage of medicine by the subject of care Note 1 to entry: The primary information is about the medication, but it may include supporting information about observations and conclusions, for example reasons for diverging from the intended dosage. SOURCE: IHE Pharmacy, Standard Terminology 3.8 prescription set of values or attributes that is produced as the output of a prescription act Note 1 to entry: A prescription is a set of instructions written by a prescriber that authorizes a
