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BSI PD CEN ISO/TS 19256:2017

BSI PD CEN ISO/TS 19256:2017

$189.07

Health informatics. Requirements for medicinal product dictionary systems for health care

Published By Publication Date Number of Pages
BSI 2017 48
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This Technical Specification defines the required characteristics for any MPD-system to support use cases in healthcare.

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 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 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 process of healthcare providers, like:

    • the wide range of knowledge about medicines, which would be handled in drug knowledge databases and decision support systems,

    • the medication record,

    • the dose instructions;

  • in terms of products:

    • traditional Chinese medicines,

    • medical devices, such as for 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.

    • veterinary medicines.

The 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.

PDF Catalog

PDF Pages PDF Title
5 European foreword
Endorsement notice
8 Foreword
9 Introduction
11 1 Scope
12 2 Normative references
3 Terms and definitions
19 4 Abbreviated terms
5 Boundary between MPD-systems and IDMP, ancillary information to build an MPD-system and local implementation
5.1 Boundary between MPD-systems and IDMP
5.2 Boundary between MPD-systems and ancillary information to build an MPD-system
5.3 Boundary between MPD-systems and local implementation
20 5.4 Content of the MPD-systems in terms of product coverage
5.5 Definition of Medicinal Product Dictionary MPD-systems
5.6 Benefits of the Technical Specification
5.7 Target users for the Technical Specification
21 6 Positioning of Medicinal Product Dictionary Systems for Healthcare
6.1 Base materials for MPD-systems
22 6.1.1 Relation with ISO IDMP standards
23 6.1.2 Relation with health/clinical/pharmacy information systems, decision support, EHR and dose instructions
24 6.1.3 Relation with EHR-S FM
6.2 Use cases for requirements for an MPD-system
25 6.2.1 Prescribing use case
6.2.2 Dispensing use case
6.2.3 Administration use case
6.2.4 Recording medication history use case
6.2.5 Reconciling medication list use case
26 6.2.6 Ordering and supply chain (logistics) use case
6.2.7 Analysis, statistics, and pharmacoepidemiology use case
6.2.8 Electronic data exchange of medicinal product information between healthcare systems and/or related systems, i.e. reporting use case
6.2.9 Reimbursement use case
6.2.10 Clinical research use case
27 6.2.11 Tracking and tracing for patient and public safety use case
6.2.12 Pharmacovigilance use case
28 6.2.13 Patient safety through linking personal data with the decision support system on medicinal products use case
6.2.14 Migration use case
7 The Functional Requirements for MPD-systems
7.1 Introduction
29 7.2 Goal of an MPD system
7.3 Normative content
7.3.1 Content of regulated medicinal products
33 7.3.2 Prescription
7.3.3 Dispensing
34 7.3.4 Administration
7.3.5 Recording and reconciliation
35 7.3.6 Order and supply chain and logistics
7.3.7 Analysis, statistics, pharmacoepidemiology, and clinical research
37 7.3.8 Ensuring patient safety through linking personal data with the decision support system on medicinal products
7.3.9 Interaction with reimbursement systems
7.3.10 Interaction of MPD-systems with pharmacovigilance systems
38 7.3.11 Data exchange and technical functions
39 7.4 Governance
40 7.5 Maintenance
7.5.1 Regular maintenance processes of the MPD-system
41 7.5.2 Interaction with regulatory information
42 7.6 Localization
43 Annex A (informative) IDMP series in context, serving this Technical Specification
45 Bibliography

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BSI PD CEN ISO/TS 19256:2017
$189.07