SIST-TS CEN ISO/TS 19293:2018

SLOVENSKI STANDARD
01-julij-2018
Zdravstvena informatika - Zahteve za zapise o izdaji zdravila (ISO/TS 19293:2018)
Health Informatics - Requirements for a record of the dispense of a medicinal product
(ISO/TS 19293:2018)
Medizinische Informatik - Anforderungen an die Akte zur Abgaben eines Arzneimittels
(ISO/TS 19293:2018)
Informatique de santé - Exigences relatives à un enregistrement de la délivrance d’un
médicament (ISO/TS 19293:2018)
Ta slovenski standard je istoveten z: CEN ISO/TS 19293:2018
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 19293
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health Informatics - Requirements for a record of the
dispense of a medicinal product (ISO/TS 19293:2018)
Informatique de santé - Exigences relatives à un Medizinische Informatik - Anforderungen an die Akte
enregistrement de la délivrance d'un médicament zur Abgaben eines Arzneimittels (ISO/TS 19293:2018)
(ISO/TS 19293:2018)
This Technical Specification (CEN/TS) was approved by CEN on 19 February 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19293:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Endorsement notice . 3
European foreword
This document (CEN ISO/TS 19293:2018) has been prepared by Technical Committee ISO/TC 215
"Health Informatics" in collaboration with Technical Committee CEN/TC 251 “Health Informatics”, the
secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 19293:2018 has been approved by CEN as CEN ISO/TS 19293:2018 without any
modification.
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
ISO/TS 19293:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part 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 ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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
5.2.7 Dispense location — Institution/department . 7
5.2.8 Confirmations, authorizations, or advice . 8
5.2.9 Additional information to support the adequate and legal dispensing . 8
5.2.10 Relevant findings elicited during the clinical review . 8
5.2.11 Decision not to dispense . 8
5.3 Prescription-related . 8
5.3.1 General. 8
5.3.2 Link to prescription . 9
5.3.3 Additional prescription linking data . 9
5.3.4 Previous prescription changes/advice . 9
5.3.5 Outcome of clinical review of the prescription. 9
5.4 Dispenser identification .11
5.4.1 Dispensing professional .11
5.4.2 Dispensing organization.11
5.4.3 Automated and semi-automated dispensing systems .11
5.5 Patient identification .11
5.5.1 General.11
5.5.2 Patient identification verification .11
5.6 Dispensed product .12
5.6.1 General.12
5.6.2 Dispensed product type .12
5.6.3 Dispensed physical item .13
5.7 Quantity .14
5.7.1 Dispensed product quantity.14
5.7.2 Retrieved product quantity .14
5.8 Dispense repeat number .14
5.9 Fulfilment notes .14
5.10 Patient instructions .14
5.10.1 General.14
5.10.2 Reimbursement .15
5.10.3 Transport .15
Annex A (informative) Examples of use cases (from NVN-ENV 13607) .16
ISO/TS 19293:2018(E)
Annex B (informative) Examples of use cases (other sources) .22
Annex C (informative) Dispensing processes — Examples and variation .28
Annex D (informative) Identifying dispensed products across jurisdictions — Using IDMP
and national identifiers .33
Annex E (informative) Use case-specific constraints of using dispense record .35
Annex F (informative) Informative typical data structures — Elements and vocabularies .36
Bibliography .38
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ISO/TS 19293:2018(E)
Foreword
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 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
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 standardization.
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 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 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 endorsement.
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 ISO's 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 Technical Committee ISO/TC 215, Health informatics.
ISO/TS 19293:2018(E)
Introduction
The record of dispensed medicinal product(s) plays an important role in the patient safety domain.
When a medicinal product has been prescribed, it then has to be dispensed before being administered
to the subject of care. The dispensed product may correspond exactly to what was prescribed, but it
may equally be different for various reasons, such as substitution, unavailability of medicinal product
in the prescribed dosage or route of administration, etc.
There are further situations, when medicinal products are dispensed or supplied without any
prescription. This should also be captured since a non-prescribed medicinal product may have
interactions or other influences with prescribed medicinal products.
When creating a list of a patient’s medication history, prescriptions can provide valuable information,
but the dispensation is sometimes considered a better indicator of the medication taken by a patient
than a prescription, i.e. although neither is information about compliance or administration, the
dispense record is many times considered a more reliable indicator of actual medication use than a
prescription (even if it also not an unequivocal indication of administration). Therefore, there is a need
to capture the dispensation, as the dispensation either completes the logical chain from prescription
to administration, or provides information for later prescriptions or dispensation, for instance, if
interactions can be anticipated and avoided.
The dispense record should provide information in such a way that it is accurate and reusable; for
example, statistics and other information can be collected across the dispensers for public health
purposes, or for regulatory needs (e.g. controlled substances control).
Additionally, the dispense record is a traceability element. For clinical purposes, it supports recording
the process from prescribing to administration. For supply chain, it allows reconstruction of the supply
chain, for example, in the contexts of recalls or supply chain integrity.
This document defines the information that may be contained in a dispense record, and the applicability
and constraints of such information. It defines a set of conditions that should be verified on detailed
interoperability implementations.
This document also defines requirements for when the dispense record should be issued in the cases
where it is needed. This is not required as a specific moment in a process — which would depend on a
variety of processes and factors — but by providing a common set of activities that are included in a
dispense.
This document addresses the requirements which are to be fulfilled by the systems that record
medicinal product dispensation. It is based on use cases which are chosen from the daily life within the
same jurisdiction, and when the prescription and dispensation have occurred in different jurisdictions.
This document relies on the assumption that prescription and dispensation are supported by medicinal
product dictionaries that ensure interoperability.
One key aspect in this document is that the notion of dispense can vary according to context (hospital
versus community), jurisdiction, and other factors. The uses of the dispense record can also vary. These
variations can have a strong impact on the definition of dispense.
For example, the process of dispensing a medication varies considerably between hospital and
community settings, and even inside a hospital. Another example is if the dispense record is used
mostly for operational concerns (reimbursement), the relevant dispense information is obtained
when the medication is retrieved for that patient. But if the dispense record is supposed to support
clinical systems, it may be better to capture information until the medication is delivered to the patient
or handed to a next of kin and thus presumed to be delivered to the patient. It is important that the
medication dispense record contains sufficient information to support these different and variable uses.
Another example of process variability is how a dispense record can be a consequence of an electronic
prescription. However, in some cases, there are dispenses without a prescription. The scope of this
document considers dispensing with or without the existence of a prescription.
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ISO/TS 19293:2018(E)
There is an increasing number of scenarios for electronic capture of dispensing information and an
increasing need to exchange this information in electronic health information systems, in particular,
for purposes of clinical care, decision support, claiming and reimbursement, research, statistics,
regulation, as well as for product integrity.
This document is, thus, not about the processes but the information content. This document does not
impose any activity to be part of the dispense process, but informs what information may be captured
from each activity.
Other uses for this information are identified, not for exhaustively listing them — which would be
limiting and impractical — but to ensure that the scope of this document covers the expected scenarios
and uses.
In this way, the information in a dispense record can be correctly recorded and used in any of the
contexts of dispense, ensuring the global applicability of this document.
TECHNICAL SPECIFICATION ISO/TS 19293:2018(E)
Health informatics — Requirements for a record of a
dispense of a medicinal product
1 Scope
This document 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.
This document 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 this document 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
ISO 11239, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated information on pharmaceutical dose forms, units of
presentation, routes of administration and packaging
ISO 17523, Health informatics — Requirements for electronic prescriptions
ISO/TS 19256, Health informatics — Requirements for medicinal product dictionary systems for health care
3 Terms, definitions and abbreviated terms
3.1 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 https: //www .iso .org/obp
— IEC Electropedia: available at https: //www .electropedia .org/
ISO/TS 19293:2018(E)
3.1.1
dispense, noun
series of events and activities that have the purpose of giving a medicinal product to a patient, whether
or not as part of a planned treatment, or to be used in procedures such as anaesthesia or imaging, where
the key activity is the act or effect of assigning a product to a patient
Note 1 to entry: Typically, a dispense is done at a community pharmacy when the product is provided to a patient,
but also in care settings, where the product is either dispensed for a specific patient by a pharmacy, or picked for
the patient from the ward stock, after being distributed by a pharmacy.
3.1.2
dispense event
time or event when a dispense is considered complete (which can vary across processes, jurisdictions,
settings)
3.1.3
dispensing process
sequence of activities leading up to the dispense event, i.e. the activities done by the dispenser before
the dispense is complete
3.1.4
dispense record
data set that identifies and describes the dispense activity/activities
Note 1 to entry: The above definitions enhance the definition of "dispensing" in ISO TS 17523 (where "dispensing"
is the set of activities originating from a prescription until the actual delivery of the product to the patients). First,
the present definition of dispense also includes the cases where a dispense is not a consequence of an existing
prescription. Second, this definition of dispense also separates the actual dispense from the pharmaceutical
review, validation or advice that is usually associated with the dispenser and many times done immediately
prior to the dispense. Furthermore, actions upstream or downstream of this dispensing act are considered
distribution and are not related to a specific patient, so they are not part of the definition of dispense. Example of
upstream actions are bulk supply and inventory management. Examples of downstream actions are transport of
a dispensed medication to the place of consumption, or shipment to the patient, etc.
3.1.5
dosage
intended or actual amount of medicinal product to be taken by the patient, including the dose form,
route of administration as intended to be applied to be used in the patient’s treatment
3.1.6
dispense record system
system of record of dispense
information system that collects the information about the dispense activity and provides the
information contained in the dispense record
3.1.7
medicinal product
any substance or combination of substances that may be administered to human beings (or animals) for
treating or preventing diseases, with the view of making a medical diagnosis or to restore, correct or
modify physiological functions
3.1.8
encoding
detailing a (medication) order from implicit or less specific information into more specific or
detailed information
EXAMPLE 1 “1 tablet bid” can be encoded into detailed times: “one tablet at 8:00 and one tablet at 20:00”.
EXAMPLE 2 “Paracetamol 500 mg” can be encoded into a specific medicinal product: “Sweetdream 500 mg
tablets”.
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ISO/TS 19293:2018(E)
3.1.9
parapharmacy
non-pharmacy shop
place where medicinal products can be sold but not by a pharmacist or healthcare professional
evaluating the impact of the medicinal product in the patient
Note 1 to entry: It is usually a retailer that sells health and hygiene products which do not require a prescription.
3.1.10
packaged medicinal product
medicinal product in a container being part of a package, representing the entirety of the unit that has
been packaged for sale or supply
Note 1 to entry: Corresponds frequently to “secondary packaging”.
[SOURCE: ISO 11615:2017, 3.1.55, modified — the note in ISO/TS 16791 has been added.]
3.1.11
prescription
set of data (values of attributes) that is produced as the output of a prescribing act, instruction or
authorization for a patient to be administered a medicinal product
Note 1 to entry: It is beyond the scope of this document to define “prescription” — the definition provided here is
functionally restricted to the minimum for the scope of this document.
[SOURCE: ISO 17523:2016, 3.7, modified — the definition has been revised and the original notes have
been deleted.]
3.1.12
single dose
single item of medicine in an individual packaged component
Note 1 to entry: This could include a single medicine within a multi-dose blister pack, a syringe, a vial, or an
ampoule.
EXAMPLE A single tablet of paracetamol 500 mg in a blister pack.
3.1.13
unit dose
particular dose of a medicinal product for a specific patient according to the patient-specific prescription
EXAMPLE Two tablets of paracetamol 500 mg packed together, if the prescription is for 1 000 mg of
paracetamol.
3.1.14
supply
delivery and transport of (medicinal) products to a location, for dispensing or further distribution
3.1.15
subject of care
SoC
person that is expected to use the medicinal product
ISO/TS 19293:2018(E)
3.2 Symbols and abbreviated terms
ATC Anatomical Therapeutic Chemical – a classification system of active substances divided
into different groups according to the organ or system on which they act and their thera-
peutic, pharmacological and chemical properties, defined and maintained by the WHO.
EHR Electronic Health Record
MPD Medicinal Product Dictionary
[SOURCE: ISO/TS 19256]
GInAS Global Ingredient Archival System
4 Dispense process and dispense event
4.1 General
This document presents a common specification that can be used to capture and exchange structured
data in relation to the dispense of a medicinal product. This document serves to ensure the availability
of the right information to generate a more complete medication profile of a subject of care within an
electronic health record, as well as other clinical or operational purposes for which medication dispense
information is relevant.
The requirements for a dispense record depend on the definition of
— the dispense event (i.e. when is the dispense record to be issued),
— the information available and the activities done by the dispenser in order to complete a dispense,
— the intended purpose of dispense information.
For this document, a generic definition of the above is important, so that this document applies globally.
4.2 Dispense record in diverse dispense processes
As illustrated by the examples in Annex D, the concept of dispensing can have diverse meanings across
contexts (different national regulations and definitions, hospital vs. community settings). This is
because dispensing entails a process, and this process varies across those contexts.
Basing a technical specification on one definition of a dispense process would require either
a) finding and globally agreeing upon one dispense process,
b) settling for one definition of dispense process in a given context (e.g. capturing community dispense
for summary medication lists), or
c) analysing the different definitions and reach a common ground to which all the different dispense
processes can relate.
This document favors option c) — a common base definition of dispense is used, which can be
implemented and derived for concrete implementations. While this is more demanding and not
implementable, it provides a reasonable level of abstraction for this document to be adopted globally.
Only this option allows, for example, that a dispense record issued within one context or region is still
useful in a different context or region.
The base definition provided for dispense is “when a medication is assigned for a patient”. In practice,
the dispense is considered complete when the dispensed product leaves the responsibility of the
dispenser.
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ISO/TS 19293:2018(E)
4.3 Dispense record information purposes
The dispense information can be used for:
— transactional or workflow purposes, i.e. to enable subsequent processes after dispensing, such as
administration, reimbursement, resupply, etc. or to update the prescription status and workflow.
The dispense record can be a placeholder for information that is used by the different clinical actors
when providing care;
— reporting or monitoring purposes, i.e. to add to the EHR and complement the patient's information,
or to support traceability information, etc.;
— supporting or enriching the clinical decision processes, for example, provide information about
prior dispenses when evaluating a new treatment or handling a follow-up dispense.
Any of these uses is optional. For example, there may not be an EHR to update, or there may not be a
prescription to update.
For this reason, the dispense record and its content should not assume or assert one or another use, but
rather support the diverse possible uses. Figure 1 presents an overview of some of these possible uses.
Figure 1 — Relation between dispense and adjacent processes
5 Requirements
5.1 General considerations
The requirements for the dispense record are derived from the scope and analysis in this document,
and from the different scenarios covered by several references available. The bibliography mentions
some references that encounter or address these requirements (use cases, technical implementations).
These requirements cover the logistical/inventory aspects of the dispense record as well as the clinical
aspects. These are overlapping, and it is not convenient or feasible to separate them. For example, the
lot number is usually logistically relevant, but also useful for pharmacovigilance or recalling products.
ISO/TS 19293:2018(E)
5.2 Issuance of the dispense record
5.2.1 General
There should be a dispense record every time that a medication is assigned to a patient, independently of
any other preceding or subsequent activities. If the medication is dispensed for fulfilling a prescription,
the dispense record shall be issued. If there is no prescription, the dispense record should be issued.
The dispense record shall be captured by the time the dispensing process is completed (see 3.1.2).
Depending on the use cases (see Annexes A and B), the dispense information may be captured as soon
as the medication is assigned to the patient or when other activities are completed.
In cases where a medication should be dispensed but is not (e.g. there is a decision not to dispense), the
dispense record should also be issued.
5.2.2 Dispense record scenarios
The dispense record shall be issued for any of the following scenarios:
— dispensing in a healthcare institution (e.g. hospital) in response to a prescription;
— unplanned use of medication in an administration in an institution;
— dispensing in a community pharmacy from a prescription;
— dispensing in a community pharmacy without a prescription, if it is clear the patient that is intended
to take the medication.
A dispense record should be issued in the following scenario:
— products, such as anaesthetics and radiology contrasts, that are not dispensed by a pharmacy, or
that are used as an implicit part of a procedure are still considered relevant for the dispense record.
The dispense record can be issued in the following scenarios, but the constraints of these scenarios
might not meet all the requirements described in these specifications (see Annex E for use case-specific
constraints).
a) Use of medication products for a clinical trial
— In this case, the product may not be revealed at the time of the dispense, but the dispense record
may contain the product identification and this can be used for the patient record.
b) OTC sale or sale of medicinal products in a parapharmacy or similar (e.g. supermarket)
— In this case, the dispense medication is given to a person but it is not usually possible to assert
who is the patient that will take medication.
c) Use of medication samples for patients
— In this case, the process of assigning the medication sample for a patient is varied and may or
not be covered. It is, however, clinically relevant and may be included in systems of record.
5.2.3 Dispense record uniqueness
One dispense record entry shall be issued for each assignment of a medication to a patient, independently
of the dispensing processes.
EXAMPLE In the case of hospital ward dispense, if the dispense process includes the pharmacist supplying
the items to the ward, the nurse to retrieve the medicinal product for a patient, there is only one dispense process
and as such one unique dispense record entry.
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ISO/TS 19293:2018(E)
In case a medication is assigned to a patient and then individually repacked (e.g. an entire box is
given to a patient and then the medication is repackaged), this is still one dispense and as such only
one dispense record entry shall be issued. In this case, the dispense record is issued at first and then
updated to inform of the later processes such as repackaging.
5.2.4 Dispense process unambiguity
The dispense record shall be clear about the context of the dispense, and unambiguous about what the
dispensing process entails, and the event that triggers the record. The dispense record shall contain
sufficient information for the interested parties to be informed about the activities in the dispensing
process.
Rationale: While the dispensing process can vary and as such cannot be globally standardized, it is
important to follow the local rules. When a medicinal product is dispensed, this may trigger processes
like billing, administration, etc., and it is important to have an unambiguous record of what activities or
events were part of that dispense. Besides enabling processes, the dispense record may also be useful
for quality assurance.
EXAMPLE 1 In some countries, a hospital prescription must be validated by a pharmacist before dispensing,
so the information about validation shall be explicit in the dispense record.
EXAMPLE 2 If a patient has some medication dispensed in a hospital setting, and some medication dispensed
in the community. In a hospital, the dispense may not have required a check for falsification of the product, but
in community it may have. Therefore, the dispense record includes the information (implicit or explicit) that in
the first case there was no verification, but in the second case, that verification was made and was considered
correct.
5.2.5 Dispense record unequivocal identification
Each dispense record entry shall include a unique identification that can sufficiently identify that
dispense record entry.
The dispense record can be used to update the prescribing system about the act of dispensing, or it can
be used in combination with other documents to contribute to the EHR. Each dispense entry has its
own identity and needs to be uniquely identifiable for information lineage, and for proper updates.
EXAMPLE If there are two activities of dispensing the same product for the same patient (e.g. an automated
dispenser and a pharmacist picking the medication and delivering it to the patient’s cart), it is important to
distinguish them if they are indeed different activities, or to combine them if they are just a duplicate of each
other. In some cases, the unique dispense ID can be used to link the dispense to a prescription that will only be
created later — in the case of an emergency dispense that will be subject of a prescription afterwards.
5.2.6 Dispense act date/time
The dispense record shall identify the date and time of the dispense.
Each dispense record entry shall contain only one date and time information.
In case the dispense entails different activities, and if it is deemed relevant to capture the time stamps
for these activities, these time stamps should be associated with the data structure for those activities
(see Annex F), and not superimposed on the dispense entry time stamp.
5.2.7 Dispense location — Institution/department
The dispense record should identify the location of the dispense.
Each dispense record should contain at least one identification of a location. In case the dispense
entails different activities, the locations of several activities may be present, but the dispense record
main location shall inform about the location where the most relevant activity has occurred. The most
relevant activity may be defined differently across processes and legislations.
ISO/TS 19293:2018(E)
5.2.8 Confirmations, authorizations, or advice
For dispensing some medicinal products, or in some locations, there may be need for authorizations,
confirmations issued, etc. For example, narcotics may need a special permit or form to be filled.
It is sometimes legally imperative that the dispenser captures that authorization, to confirm that
the dispense is legal. Sometimes, the authorization can be inferred from the simple existence of the
dispense. If the medication is dispensed, then it is obvious that it has been authorized. These shall be
part of the dispense record.
If the dispense activity entails any authorizations that are not captured elsewhere, because they are
intrinsic to the dispense activity, these authorizations shall be captured in the dispense record.
In case the dispense entails different confirmation activities, all or part of these activities may be
present in the dispense record.
5.2.9 Additional information to support the adequa
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