ISO/TS 19293:2018
(Main)Health informatics — Requirements for a record of a dispense of a medicinal product
Health informatics — Requirements for a record of a dispense of a medicinal product
ISO/TS 19293:2018 specifies requirements for a record of a dispense of a medicinal product. It is intended to be adopted by detailed, implementable specifications, such as interoperability standards, system specifications, and regulatory programs. ISO/TS 19293:2018 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 pharmacies 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 ISO/TS 19293:2018 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 contains information that medication was expected to be dispensed but was not dispensed.
Informatique de santé — Exigences relatives à un enregistrement de la délivrance d’un médicament
General Information
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 19293
First edition
2018-04
Health informatics — Requirements
for a record of a dispense of a
medicinal product
Informatique de santé — Exigences relatives à un enregistrement de
la délivrance d’un médicament
Reference number
ISO/TS 19293:2018(E)
©
ISO 2018
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ISO/TS 19293:2018(E)
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ii © ISO 2018 – All rights reserved
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ISO/TS 19293:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Symbols and abbreviated terms. 4
4 Dispense process and dispense event . 4
4.1 General . 4
4.2 Dispense record in diverse dispense processes . 4
4.3 Dispense record information purposes . 5
5 Requirements . 5
5.1 General considerations . 5
5.2 Issuance of the dispense record . 6
5.2.1 General. 6
5.2.2 Dispense record scenarios . 6
5.2.3 Dispense record uniqueness. 6
5.2.4 Dispense process unambiguity . . 7
5.2.5 Dispense record unequivocal identification . 7
5.2.6 Dispense act date/time . 7
5.
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