1、STD-ES1 DD ENV L3b07-ENGL 2000 E Lb24bb9 0858b84 DRAFT FOR DEVELOPMENT 45b DD ENV 13607:2000 Health informatics - Messages for the exchange of information on medicine prescriptions ICs 35.240.80 NO COPYING WITEIOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPRIGHT LAW STD-BSI DD ENV L3b07-ENGL 2000 m L
2、b24bb7 0858b85 372 = DD ENV 13607:2000 been prepared under the direction of the DISC Board, was Amd. No. D The strength and quantity to be contained in capsules, lozenges, tablets, etc. should be stated; Instructions for use should describe precisely how and in which cases the medicinal product is u
3、sed. STDaBSI DD ENV L3607-ENGL 2000 1624669 0858693 696 M Page 6 ENV 13607:2000 Health informatics - Messages for the exchange of information on medicine prescriptions 1 Scope This European Prestandard specifies general messages for electronic information exchange between computer systems used by he
4、althcare parties prescribing, dispensing or administering medicinal products/medicinal appliances“. The content and stnicture of the messages specified in this European prestandard have been developed with the aim of optimising the safety of prescribing and dispensing and to facilitate compliance mo
5、nitoring and secure audit trails. Whenever medicinal products are mentioned within this European prestandard, medicinal appliances may be substituted if they serve similar purposes and can be represented in similar ways in a message as medicinal products. This European prestandard is applicable to m
6、essages for electronic information exchange of prescription sets issued (i.e. prescribed) by healthcare persons (and possibly other persons who on this occasion act as healthcare persons) authorised by national regulations. This European prestandard is applicable to messages for electronic informati
7、on exchange of prescription sets sent by a prescriber to a dispensing healthcare party (dispensing agent) and to healthcare persons/organisations or official authorities as permitted by national regulation. This European prestandard is also applicable to messages for electronic information exchange
8、of prescription sets sent by the prescriber to a relaying agent and from a relaying agent to a dispensing agent. NOTE agent may retrieve any single prescription set; once only, upon the request of the party for whom the prescription message is issued or their agent. A relaying agent is a special Ele
9、ctronic Message Handling Service from where one and only one dispensing This European prestandard is applicable to messages for electronic information exchange of prescription sets issued for single human patients, single animals, a group of animals, for personal use by the prescriber or for use at
10、the prescribers premises without specified end user. The categories for which any authorised prescriber may prescribe are regulated nationally. This European prestandard specifies a message, new prescription message, for electronic prescribing of medicinal products/medicinal appliances sent from the
11、 prescriber to a dispensing agent, possibly via a relaying agent. This European prestandard specifies messages for retrieval of a new prescription message temporarily stored by a relaying agent. This European prestandard specifies: Prescription query message querying if any or specified prescription
12、 set(s) exist for a single subject of care at a relaying agent matching a set of selection criteria. This message is sent from a dispensing agent to a relaying agent. Prescription set list message listing the prescription set(s) (and the contained prescription items) stored at a relaying agent in re
13、ply to a prescription query message. This message is sent from a relaying agent to a dispensing agent. Prescription set selection message for requesting a relaying agent to transmit new prescription message(s) referenced by one or more prescription set identifier(s). Identifiers are either obtained
14、by a previous prescription query message/prescription set list message or supplied by the subject of care or animal carer without a previous query. The message is sent from a dispensing agent to a relaying agent who will respond by sending the new prescription messages identified by the prescription
15、 set selection message. NOTE prescription set cannot be handled individually. Locally it may be agreed to allow only one prescription item per prescription set, thus permitting individual handing of prescription items. The above three messages always handle prescription sets as a whole, a single pre
16、scription item in a Not ail medicinal appliances can be prescribed, this will depend on local traditions, regulations, rules and coding schemes. Examples of suitable medicinal appliances are syringes, bandages, diagnostic kits, colostomy bags, diapers for incontinent persons. Page 7 ENV 13607:2000 S
17、TD.BSI DD ENV L3607-ENGL 2000 m Lb24bb9 0858b92 522 m This European prestandard specifies a message, prescription dispensing report message, containing information about prescription items in a prescription set as they have actually been dispensed (or not dispensed), normally in response to a new pr
18、escription message. This message may be sent from a dispensing agent to the original prescriber and/or to any other party that is legally permitted to receive such message This European prestandard specifies two messages for cancelling a previously sent new prescription message or prescription dispe
19、nsing report message: - prescription cancellation message and - prescription dispensing report cancellation message. For a number of reasons the end user may decide not to take delivery of some of the originally prescribed items. The handling of these non-delivered prescription items may require sol
20、utions best dealt with locally. NOTE prescription set may be handed over (in paper form) to the subject of care or hisher representative or may be kept by agreement with the subject of care by the dispensing agent for later dispensing or (by local agreement) the dispensing agent may issue a new pres
21、cription message containing the non-delivered part of the prescription set (maintaining information about the original prescriber). This European prestandard is applicable to repeat prescription messages. If permitted locally, new prescription messages containing repeat prescribing of prescription i
22、tems, whether sent directly to a dispensing agent or via a relaying agent, may only, according to this European prestandard, be transferred to a dispensing agent in their entirety. Depending on national legislation and available printing facilities the non-delivered part of a retrieved NOTE general.
23、 Non-delivered repeat prescribing of prescription items may be dealt with as non-delivered prescription items in This European prestandard is applicable to the issue of new prescription messages carrying a first date for dispensing. Such messages may be used according to national regulations e.g. in
24、 countries where repeat prescribing is not allowed. The mechanisms and rules for checking and releasing these new prescription messages are outside the scope of this European prestandard. When implementing information exchange based upon this European prestandard, data protection and confidentiality
25、 principles have to be guaranteed according to the laws actually in force in the different CEN member countries. The mechanisms needed to secure data integrity, data protection and confidentiality, authentication of communicating parties and patients are outside the scope of this European prestandar
26、d. While the messages specified in this European prestandard may convey clinical and administrative information concerning patients, the way in which this information is treated in this European prestandard does not constrain the development of future standards for the electronic healthcare record o
27、r for other clinical and administrative messages. The provisions of this European prestandard have been validated for the purposes described above. However, since the messages described in this European prestandard are designed for general application in prescribing, the users are required to decide
28、 for themselves whether or not these messages meet their particular requirements. A requirement for using other messages, e.g. generic messages for cancellation or acknowledgement, in addition to or instead of messages specified in this European prestandard, does not invalidate the use of this Europ
29、ean prestandard. This European prestandard is not applicable to messages related to medicinal product orders exchanged between pharmacies and medicinal product suppliers. 2 Normative references The following normative documents contain provisions that, through reference in this text, constitute prov
30、isions of this European Prestandard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this European Prestandard are encouraged to investigate the possibility of applying the most recent editions of the no
31、rmative documents below. For undated references, the latest edition of the normative document referred to applies. Members of IS0 and IEC maintain registers of currently valid International Standards. STD-BSI DD ENV L3b07-ENGL ZOO0 = lb24bb7 0858673 4b7 Page 8 ENV 13607:2000 Directive 65/65/EEC, Cou
32、ncil Directive of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (65/65/EEC). As amended by Directives 83/570/EEC, 87RUEEC and 93/39/EEC. Directive 92/27/EEC, Council Directive of 31 March 1992 on the labelling
33、of medicinal products for human use on package leaflets. ENV 12610: 1997, Medical Informatics - Medicinal product identification. ENV 1613: 1995, Medical Informatics - Messages for exchange of laboratory information. EN 375: 1992 E, Requirements for labelling of in vitro diagnostic reagents for prof
34、essional use. EN 376: 1992 E, Requirements for labelling of in vitro diagnostic reagents for self-testing. IS0 639: 1988, Symbols for languages, geographical areas and authorities. IS0 528 1 : 1977, Information interchange -Representation of human sexes. ISOAEC 7826-1: 1994, Information technology -
35、 General structure for the interchange of code values - 1 Part I: Identification of coding schemes. ISO/IEC 7826-2: 1994, Information technology - General structure for the interchange of code values - I Part 2: Registration of coding schemes. 3 Normative definitions and abbreviations For the purpos
36、es of this European prestandard, the following definitions (listed in alphabetical order) apply: 3.1 batch amount of material which is uniform in character and quantity as shown by compliance with production and quality assurance test requirements and produced during a defined validated process of m
37、anufacture EN 3751992 E EN 376:1992 E 3.2 clinical information information about a subject of care, relevant to the health or treatment of that subject of care, that is recorded by or on behalf of a heaithcare person NOTE about related persons where this is relevant. Clinical information about a sub
38、ject of care may include information about the subject of cares environment or ENV 16131 3.3 code meaning element within a coded set EXAMPLE “Paris Charles-De-Gaulle which is mapped on to the three-letter abbreviation “CDG by the coding scheme for three-letter abbreviations of airport names. ISO/IEC
39、 78261 This International Standard may be superseded by another International Standard in which case ail references shall be changed to the current standard and ICs1 be replaced by the appropriate term. Page 9 ENV 13607:2000 STDmBSI DD ENV L3b07-ENGL 2000 1624667 0858694 3T5 = 3.4 code value result
40、of applying a coding scheme to a code meaning EXAMPLE “CDG“ as the representation of “Paris Charles-De-Gaulle“ in the coding scheme for three-letter representations of airport names. ISO/IEC 78261 IS0 2382:1987, modified 3.5 coding scheme collection of rules that map the elements of one set on to th
41、e elements of a second set ISO/IEC 78261 IS0 2382-1987, modified 3.6 domain information model conceptual model describing common concepts and their relationships for communication parties required to facilitate exchange of information between these parties within a specific domain of healthcare CR 1
42、2.5871 3.7 general message description subset of a domain information model prescribing the information content and semantic structure of a healthcare message used to meet one or more identified information interchange requirements NOTE provide statement of the information interchange requirements i
43、n a form that can be implemented using different syntaxes. General message descriptions are independent of the syntax used for constructing an actual message. They CR 125871 3.8 international coding scheme identifier unique permanent identifier of a coding scheme registered for use in information in
44、terchange under the terms of the International Standard ISOAEC 7826 3.9 heaithcare agent healthcare person, healthcare organisation, healthcare device or healthcare software component that performs a role in a healthcare activity ENV12265, modified 3.10 heaithcare organisation organisation involved
45、in the direct or indirect provision of healthcare services to an individual or to a population NOTE 1 as organisations where there is need to identify them. Groupings or subdivisions of an organisation, such as departments or sub-departments, may also be considered NOTE 2 Healthcare organisations ar
46、e a subset of healthcare agents. ENV 16 13, modified 3.1 1 healthcare party organisation or person involved in the direct or indirect provision of healthcare services to an individual or to a population NOTE Healthcare parties are a subset of healthcare agents. STD.BSI DD ENV 13b07-ENGL 2000 1624bb7
47、 0858b75 231 Page 10 ENV 13607:2000 3.1 2 healthcare person person involved in the direct or indirect provision of healthcare services to an individual or to a population NOTE Healthcare persons are a subset of healthcare parties, which again are a subset of healthcare agents. EXAMPLE Frimary care p
48、hysician, dentist, nurse, social worker, pharmacist, medical secretary. 3.13 hierarchical general message description a general message description specified using a strictly hierarchical structure with the same functionality as the corresponding non-hierarchical general message description NOTE 1 N
49、OTE 2 component. A hierarchical general message description must have a single root. A lower level component of a hierarchical general message description must always have exactly one parent CR 125871 3.1 4 immediate container container that is in direct contact with the pharmaceutical product ENV 126101 3.1 5 implementable message specification of a general message description in a particular message syntax CR 125871 3.16 ingredient substance included as a component in a product NOTE In this context product refers to pharmaceutical product. 3.1
