ISO/TS 17251:2023

Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products

Informatique de santé — Exigences d'affaire pour une syntaxe d'échange d'informations de dose structurée pour les produits médicaux

General Information

• Status: Published
• Publication Date: 23-Feb-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 6 - Pharmacy and medicines business
• Current Stage: 6060 - International Standard published
• Start Date: 24-Feb-2023
• Due Date: 08-Nov-2022
• Completion Date: 24-Feb-2023

Relations

• Consolidates: ISO 6502-3:2018 - Rubber — Measurement of vulcanization characteristics using curemeters — Part 3: Rotorless curemeter
• Effective Date: 06-Jun-2022
• Revises: ISO/TS 17251:2016 - Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products
• Effective Date: 23-Apr-2020

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 17251
Second edition
2023-02
Health informatics — Business
requirements for a syntax to exchange
structured dose information for
medicinal products
Informatique de santé — Exigences d'affaire pour une syntaxe
d'échange d'informations de dose structurée pour les produits
médicaux
Reference number
ISO/TS 17251:2023(E)
© ISO 2023

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ISO/TS 17251:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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Published in Switzerland
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ISO/TS 17251:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Relationship to other ISO deliverables . 4
5 Conformance . 5
6 Business requirements for structured dose instructions . 5
6.1 General . 5
6.2 Use cases . 5
6.3 Elements of a dose instruction . 5
6.4 Information requirements . 7
6.4.1 General . 7
6.4.2 Terminologies and Code Systems . 7
6.4.3 Information model . 7
6.4.4 Text representation. 8
6.4.5 Administration amount . 8
6.4.6 Route/site of administration . 9
6.4.7 Timing of dose event(s). 9
6.4.8 Conditional administration . 11
6.4.9 Subject of care-specific information . 11
6.4.10 Ancillary information .12
Bibliography .14
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ISO/TS 17251:2023(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 of 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO/TS 17251:2016), which has been
technically revised.
The main changes are as follows:
— editorial corrections and clarifications;
— added Clause 4 on the relationship to other standards;
— updated Clause 3;
— Clause 4 includes discussion on the relationship to the IDMP standards and clarifies the use of IDMP
terms;
— Subclause 6.4.9: removed height, added optional laboratory observations;
— Subclause 6.4.5 and 6.4.7.1 for elements described as a range (e.g. max/min dose, range for interval
or frequency) added discussion of 2-term and 3-term representations;
— Subclause 6.4.1: added discussion on complex instructions (e.g. multiple schedules, multiple dose
amounts);
— Subclause 6.4.5: clarified language around selection of unit of measurement versus unit of
presentation;
— Subclause 6.4.8: clarified that conditional administration is not necessarily the indication for the
medication order;
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ISO/TS 17251:2023(E)
— Subclause 6.4.9.4: added capability to provide date and/or time for subject of care characteristics;
— Subclause 6.4.4.1: added description and conformance for administration method;
— Subclause 6.4.7.1: added the option to have frequency based upon a period of time, such as “2 times
over 3 days”.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/TS 17251:2023(E)
Introduction
The requirements for the exchange of structured dose instructions are intended to be independent of
any technology standard or software platform and have been developed with the aim of specifying the
necessary clinical and business requirements precisely and unambiguously. Precise, unambiguous,
structured, and codified dose instructions permit the prescriber, pharmacy, and other clinical systems
to utilize that information for dose checking and other clinical decision support. Ultimately, precise and
unambiguous dose instructions are essential for the subject of care or caregiver to appropriately use
the medication for optimal benefit.
The primary audiences for this document are software developers building IT systems in the healthcare
sector.
The intent of this document is that all prescribing and dispensing systems can build and recognized
unambiguous dose instructions, preferably with structured and codified content which can enable
additional system capabilities (e.g. Clinical Decision Support).
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TECHNICAL SPECIFICATION ISO/TS 17251:2023(E)
Health informatics — Business requirements for a syntax
to exchange structured dose information for medicinal
products
1 Scope
This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.
2 Normative references
There are no normative references in this document.


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ISO/TS 17251:2023(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology 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/
3.1
administration method
action taken by the subject of care (3.14) or caregiver (3.2) for the administration of a medication
EXAMPLE Take, apply, inject.
3.2
caregiver
carer
person who provides care
Note 1 to entry: A carer can be a healthcare professional or an informal caregiver.
[SOURCE: ISO 13131:2021, 3.2.1]
3.3
dose event
dosing event
administration of a medication to a subject of care (3.14) based upon specified dose instructions (3.4)
3.4
dose instructions
instructions pertaining to the medication, which describe the amount of medication per administration,
method of administration, the frequency or interval of administration, associated instructions for
dosing or skipped administrations, and other associated parameters necessary for appropriate
administration of the medication
Note 1 to entry: Dose instructions can apply to a specific subject of care (3.14) or can be general statements, for
example, as the set of appropriate dose instructions for a given medication or dose instructions in a treatment
protocol.
3.5
dose syntax
structured information (3.13), which represents the dose instructions (3.4) in a consistent, computable
format
3.6
medication order
documented instruction on intended therapy for an individual person with a medicinal product issued
by an authorized health professional
Note 1 to entry: A medication order contains information on the medicinal product(s), the intended dosage
instruction and the period of time during which the medication was intended to be given.
Note 2 to entry: There is no inherent limitation on the setting for the medication order (inpatient, ambulatory,
etc.)
3.7
message syntax
structured information (3.13), which represents the medication order in a consistent computable format
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ISO/TS 17251:2023(E)
3.8
prescription
direction created by an authorized health professional to instruct a dispensing agent regarding the
preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of
care
Note 1 to entry: The term “prescription” alone is best avoided as it is colloquially used at random for the following:
"new prescription message", "prescription set" and "prescription item". It is also used to describe a prescription
form. The use of "new prescription message", "prescription set" and "prescription item" where appropriate is
recommended.
Note 2 to entry: In the context of this document, “prescription” or “medication order” could be used. This
document uses “medication order”. In this sense, it is implied that “medication order” is inclusive of “prescription.”
[SOURCE: ISO/TS 19256:2016, 3.34, modified — Note 2 to entry added.]
3.9
semantic interoperability
ability for data shared by systems to be understood at the level of fully defined domain concepts
[SOURCE: ISO 18308:2011, 3.45]
3.10
semi-structured dose instructions
dose instructions containing both structured information (3.13) and unstructured information (3.18)
3.11
sig
directions written on a package or label for the use of the subject of care (3.14) or caregiver (3.2)
Note 1 to entry: Sig (sometimes written as SIG) appears to be an acronym but is an abbreviation of the Latin term
“signā”.
Note 2 to entry: In the context of this document, “sig” had the same meaning as “dose instructions” (3.4)
3.12
storage and handling information
information provided to the subject of care (3.14)/caregiver (3.2) regarding the appropriate conditions
to maximize the shelf life of the medicinal product
3.13
structured information
information assembled from predefined concepts (vocabulary or code set) using an organizational
scheme (information model)
3.14
subject of care
person who uses, or is a potential user of, a health care service
Note 1 to entry: Subjects of care may also be referred to as patients, health care consumers or subjects of care.
[SOURCE: ISO/TS 22220:2011, 3.2]
3.15
syntactic interoperability
capability of two or more systems to communicate and exchange data through specified data formats
and communication protocols
[SOURCE: ISO 18308:2011, 3.48]
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ISO/TS 17251:2023(E)
3.16
unit of measurement
measurement unit
real scalar quantity, defined and adopted by convention, with which any other quantity of the same
kind can be compared to express the ratio of the two quantities as a number
Note 1 to entry: Depending on the nature of the reference scale, the unit of measurement expression may stand
either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily
defined unit of measurement, which may refer to a certain reference material, a standard measurement
procedure, a material measure or even to a combination of those.
[SOURCE: ISO 11240:2012, 3.1.33]
3.17
unit of presentation
qualitative term describing the discrete countable entity in which a pharmaceutical product or
manufactured item is presented, in cases where strength or quantity is expressed referring to one
instance of this countable entity
EXAMPLE 1 To describe strength: puff, spray, tablet “contains 100 mcg per spray” (unit of presentation =
spray).
EXAMPLE 2 To describe quantity: bottle, box, vial “contains 100 ml per bottle” (unit of presentation = bottle).
Note 1 to entry: A unit of presentation can have the same name as another controlled vocabulary, such as a basic
dose form or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary
term identifier.
[SOURCE: ISO 11240:2012, 3.1.34]
3.18
unstructured information
information assembled from narrative words and word fragments, following either casual conventions
or language-specific grammatical rules
4 Relationship to other ISO deliverables
There are several International Standards, Technical Specifications, and Technical Reports addressing
elements of medications and prescribing. Figure 1 illustrates some of the relationships between
relevant ISO deliverables.

Figure 1 — Relationships between ISO deliverables
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ISO/TS 17251:2023(E)
5 Conformance
Systems that create or consume electronic medication orders can claim conformance to this document
when they fulfil all requirements in Clause 6. Each requirement or recommendation is labelled with an
identifier in the form of “[DOSESYN-NNN]” (where NNN is a sequential, zero left-filled, number).
6 Business requirements for structured dose instructions
6.1 General
The goal of this document includes
— that structured information will be available for clinical decisions support and other system
functions, to ensure that dose and administration information is appropriate for the subject of care,
and
— that the dose instructions provided to subject of care or caregiver are clear and understandable.
In addition to requirements related to the dose instructions specifically, there are subject of care
information elements as well. The following requirements address both subject of care and information
aspects.
The following conformance statements refer to either, or both, the message syntax and the dose
syntax. Requirements which are not unique to the dose instructions, or useful in other components of a
medication order, are described as part of the “message syntax”. Requirements which are specific to the
dose instructions are described as part of the “dose syntax”.
6.2 Use cases
Dose instructions serve the following use cases.
— Indicating the intended dosage during prescribing.
— Recording the indicated dosage in the EHR:
— to be used in clinical decision support systems, e.g. dose checking;
— exchange of information between health care providers.
— To provide instructions for administration by a healthcare professional.
— Indicating comprehensible dose instructions on the label to make clear how to use the medicine.
Comprehension may not be a component of the dose instructions specifically, but comprehension
does influence the presentation of the dose instructions to the subject of care or caregiver. Subject of
care/caregiver comprehension information shall be present in the medication order in some manner
such that the dispenser can create appropriate instructions for the subject of care/caregiver.
6.3 Elements of a dose instruction
Based on the use cases, the elements of a dose instruction include the following.
— Text representation. The purpose of this document is to specify requirements for structured
dose instructions. However, some parts of a dose instruction cannot be captured in structured
information. To support a human readable text of the whole dose instruction of a certain medicine, a
textual representation of the whole dose instructions will remain an important element. This textual
representation includes both the structured and the unstructured parts of the dose instruction.
Also, if a scenario occurs which prevents the structured content from being produced, the textual
representation is then necessary for communicating the dose instruction. The structured content
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ISO/TS 17251:2023(E)
and the textual content, if both are present, shall agree, neither omitting nor adding any significant
content between the two.
— Amount of medication to be administered at each dose event.
— This may be comprised of a number of units of presentation (e.g. “1 tablet”) or a number and
unit of measurement (e.g. “5 ml”, “500 mg”). Calculated amounts (e.g. “50 mg/kg body weight")
may be appropriate in some cases, however an explicit amount is generally preferred over an
implied amount.
— The amount to be administered may vary over time (e.g. tapered dose or alternating doses
during day or week) or relative to other parameters (e.g. insulin sliding scale).
— The administered amount may be a range (1 to 2 tablets).
— Indeterminate terms (e.g. “apply a thin film”, “use a pea-sized amount”) should be quantified
wherever possible (e.g. “apply 1 to 2 ml”, “use 1 to 2 g”) or the non-quantifiable portion included
in a text representation element.
— Route of administration.
— Timing of dose event(s). A wide range of dose timing shall be considered. Possibilities include the
following.
— Dosing by frequency (e.g. “twice a day”, “once a month”), dosing by time interval (e.g. “every
6 hours”). Both frequency and interval require a numeric portion and a time portion, frequency
being “ per ” and interval expressing “every ”. The
numeric portions may involve ranges (e.g. “every 3 to 4 days”).
— Dosing at specific times (e.g. “at 9 am”), or relative to other events (e.g. meals, sleep, procedures).
— There may be a date and/or time for administration events. This may be specific (e.g. “begin on
3 October 2015”) or relative (e.g. “the day prior to the procedure”).
— Dose timing can also be a combination of timing patterns running consecutively (e.g. tapers) or
concurrently (e.g. “daily and as needed”).
— Conditional administration. Administration may be dependent upon other factors. Such factors may
be symptoms (e.g. “as needed for cough”), measurable parameters (e.g. “blood glucose > 200 mg/
dl”, “temperature > 38 °C”), event or encounter (e.g. “after bee sting”). The use of unspecified or
indeterminate conditions (e.g. “as needed” without condition) is not supported in this document.
— Ancillary information. As with the textual representation, this information is not typically
represented in the structured dose instructions and is included here as they are often discussed in
relation to dose instructions. Examples include:
— storage and handling information (e.g. keep refrigerated, shake well before use);
— advice on proper administration (e.g. take with food);
— reference to dosing information provided elsewhere (e.g. medications following a documented
protocol).
Dose instructions do not exist on their own; they are a component of the medication order, and thus
the prescriber and dispenser systems. These systems are, in turn, related to other health, clinical, and/
or pharmacy information systems. Some aspects of the dose instructions, and the dose syntax model,
may be dependent on information in these other systems. Examples of such “other information” include
subject of care weight for weight-based dosing, and procedure schedules for doses administered relative
to that event. It is recognized that this document includes requirements which are not specifically
elements of dose instruction but may be needed for appropriate interpretation and implementation of
the dose instructions. Conformance of a dose syntax model, and dose instructions produced from that
model, are not dependent on these “other information” requirements.
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ISO/TS 17251:2023(E)
6.4 Information requirements
6.4.1 General
The requirements for structured dose information, or the “dose syntax,” are described in 6.4. These
requirements build on the elements discussed in 6.3.
Dose syntax can only be assessed for structured (no textual representation present) and semi-
structured (textual representation present) dose instructions. The requirements are defined for
structured dose instructions, and the structured portion of semi-structured dose instructions. Some
of these requirements describe “capabilities” or “features” which will not be used in all structured dose
instruction instances.
Dose instructions can be very complex. Aggregates of sequential and alternating dosing are not
uncommon [e.g. “4 tablets once a week (2 in the morning, 2 in the evening)” for methotrexate]. Another
complex example involves dosing multiple products dispensed as one “kit” [e.g. Didrokit, “once a week
1 tablet (=Didronel) in the morning, 6 times a week 1 tablet (=Cacit) in the evening”]. This document
addresses the information requirements for dose syntax models and derived dose instructions. This
document does not address all the possible combinations and permutations of the elements.
6.4.2 Terminologies and Code Systems
6.4.2.1 The need for standardized terminologies and code systems
Defining an information model assures that structured information is provided in a consistent manner,
this is syntactic interoperability. However, for information to be understood by the receiver, the sender
shall use terminologies and code systems the receiver recognizes. This is semantic interoperability.
Therefore, a basic information requirement is that an information model support terminologies and
code systems which are reasonably assured to be known to all parties to whom the information may be
communicated.
This document does not identify specific terminologies and code systems to be used. The appropriate
selection needs to take into consideration relevant local, regional, and national prescribing practices.
System designers and implementers are encouraged to employ internationally recognized and
standardized terminologies and code systems.
6.4.2.2 Regarding Latin abbreviations
Medication orders, and healthcare generally, are known for the use of Latin abbreviations. Latin
abbreviations can refer to dose timing (e.g. qd, bid), route of administration (e.g. po, pr), conditional
administration (e.g. prn), site of administration (e.g. os, od), other components of dose instructions
or the medication order (i.e. sig). While there is a trend to retire the use of Latin abbreviations in
healthcare, they are still in use and this document does not preclude their use in dose instructions.
However, to maintain semantic interoperability, any abbreviations used shall be known and
understandable to the receiver. Many terminologies and code systems recognize this and have
incorporated Latin and other abbreviations as either synonyms or defined concepts. Therefore, this
document supports the use of Latin and other abbreviations which are incorporated into recognized
terminologies and code systems.
6.4.3 Information model
— The dose syntax shall employ an information model. [DOSESYN-001]
— The information model shall support the use of standardized vocabularies. [DOSESYN-002]
— The dose syntax and the information model may or may not directly produce the dose instructions
presented to the subject of care/caregiver but shal
...