ISO/TR 20831:2017

TECHNICAL ISO/TR
REPORT 20831
First edition
2017-07
Health infomatics — Medication
management concepts and definitions
Informatique de santé — Concepts et définitions relatifs à la gestion
de la médication
Reference number
ISO/TR 20831:2017(E)
©
ISO 2017

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ISO/TR 20831:2017(E)

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ISO/TR 20831:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 General process . 4
6 Data elements relevant to medication management . 5
6.1 General . 5
6.2 Prescription data . 5
6.3 Dispense data . 6
6.4 Medication administration data . 6
6.5 Medication statement data . 6
6.6 Health concern data . 7
6.7 Contraindication risks . 7
6.8 Specific laboratory results . 7
6.9 Drug and alcohol usage . 8
6.10 Smoking habits . . 8
7 Process steps . 8
7.1 The act of gathering data . 8
7.2 The act of making sense of the data . 8
7.3 The act of verification of the data . 9
7.4 The act of adding data to the collection . 9
7.5 The acts of carrying out the therapy and evaluating the outcome .10
8 Definitions of medication management .10
8.1 General .10
8.2 Medication lists.11
8.2.1 General.11
8.2.2 Unreconciled medication list .11
8.2.3 Reconciled medication list .11
8.2.4 Aggregated medication list .12
8.3 Medication profile .12
8.4 Medication management profile .12
8.5 Medication management .13
9 Example use case — Storyboard patient intake at hospital admission .13
Annex A (informative) External reference examples .16
Bibliography .19
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ISO/TR 20831:2017(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: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
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ISO/TR 20831:2017(E)

Introduction
The approach of this document is first to explain the logical steps in a medication therapy of a patient
and to state which data elements are required at that step and what is done with the data. The best
definition that would fit at that stage of medication therapy was identified. It was noticed that where a
listing of definitions that the interpretations of the various terms were to be made, this would lead to
endless discussion of the meaning of the terms.
IHE pharmacy, HL7 Pharmacy and ISO/TC 215 have been convening frequently and noticed that each
individual had a different interpretation of the terms used. As SDOs where communication of medication
information is the core purpose of these organizations, it is of course vital to understand what a noun
means so that all persons have a common understanding of the words used. Terms that have composite
ingredients are to a certain extent arbitrarily defined, but this document contains the definitions that
are agreed on by HL7 pharmacy, IHE Pharmacy and ISO/TC 215.
The scope in the first stage will be on the definitions of composite information, such as lists. This will
be set against the workflow and process in medication therapy.
Communicating information by means of IT can be separated into four layers:
1) The conceptual meaning of terms
2) The content and characteristics of terms
3) The container of information.
4) The communication of information.
The fourth and bottommost layer is the physical distribution of the information, such as pull or push
mechanisms. The logistical aspects are not in the scope of this document, nor is the method or required
infrastructure to obtain the information part of this document.
The third layer defines how the content is formatted so that senders and receivers can recognize the
elements of the content. Examples are CDA documents, HL7v3 or HL7v2 messages. This document is not
intended to go into this matter.
The second layer from the top is also called the syntax layer. It defines the content of a term. Some
of these elements in the content will be optional. In the context of this document the term syntax
refers to the rules governing the composition of meaningful elements. As an example the geographical
coordinates (i.e. 41°24′12.2”N 2°10′26.5”E) could have been chosen as the syntax for a location, but it
could as well be a street, number, postal code and city as the preferred notation of a logical address.
This document is not intended to dive into the syntax of the medication terms.
The top layer is also called the semantic layer. This document focuses on this layer. The intention is to
understand the meaning of a term. The result should be, that when a term as “unreconciled medication
list” is used, that all readers should interpret the term in the same manner. The context in which the
information is exchanged is also of importance for the concept. As an example a medication list for an
intake into a mental ward could put more emphasis on other data than a medication list for discharge at
a general hospital.
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TECHNICAL REPORT ISO/TR 20831:2017(E)
Health infomatics — Medication management concepts
and definitions
1 Scope
The purpose of this document is to define the various concepts and terminologies used in the pharmacy
domain when applied to the topic of creating medication lists from existing data.
2 Normative references
There are no normative references in this document.
NOTE For future considerations, the terms from ISO 13940 will be considered.
3 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 http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
contraindication
contra-indication
condition or factor that increases the risk involved in using a particular drug, carrying out a medical
procedure, or engaging in a particular activity
Note 1 to entry: Pursuing the intention is inadvisable.
[SOURCE: IHE Pharmacy, Standard terminology, modified]
3.2
dispensing
process of validation of the electronic prescription, preparation of the medicinal product, labelling,
informing and handing the medication to the patient or administering healthcare professional
[SOURCE: ISO 17523:2016, 3.2]
3.3
health concern
health-related matter about a patient that is of interest, importance or worry to someone
Note 1 to entry: This someone may be the patient, the patient’s family or a patient’s healthcare provider.
Note 2 to entry: A health concern is sometimes called a problem concern. A difference is that a problem concern
is mostly related to one diagnosis, while a health concern can change overtime as the situation of the patient
aggravates, for example from a simple cough, to pneumonia ending in COPD.
[SOURCE: HL7 929, Health Concern Domain Analysis Model v.3, September 2015]
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3.4
medication administration
application of medicine to a subject of care
Note 1 to entry: In general only the medication administration that is registered in a system is taken into
consideration.
[SOURCE: IHE Pharmacy: Standard terminology, modified]
3.5
medication
substance that has an intended therapeutic effect on a patient and may influence the medication safety
of a patient
Note 1 to entry: This would include prescribed, but also non-prescribed medication such as cough syrups. A
placebo has the intent of a therapeutic effect and is thus considered medication. Alcoholic beverages however
also influence medication safety, but are not considered to be medication because they do not have the intent of
giving therapy.
3.6
medication management
act of exercising directives on the medication of a patient
Note 1 to entry: It includes reviewing the medication profile of a patient, providing new medication therapies,
adjusting or stopping existing therapies and evaluating its outcome.
3.7
medication statement
declaration given by the subject of care or a third party about the usage or non-usage of medicine by the
subject of care
Note 1 to entry: The primary information is about the medication, but it may include supporting information
about observations and conclusions, for example reasons for diverging from the intended dosage.
[SOURCE: IHE Pharmacy, Standard Terminology]
3.8
prescription
set of values or attributes that is produced as the output of a prescription act
Note 1 to entry: A prescription is a set of instructions written by a prescriber that authorizes a medicinal product
or treatment to be given to a patient. It is a) an instruction by an authorized healthcare professional, b) a request
to dispense by an authorized healthcare professional and c1) advice to a patient on his/her medication treatment,
or c2) an instruction to administer by an authorized healthcare professional.
Note 2 to entry: The word “prescription” is sometimes used when referring to the act of prescribing - “prescription
process”. To avoid confusion with the term “prescription” as an information object, throughout this document the
word “prescription” is reserved for the information object. For the act of prescribing, the term “prescribing” is used.
Note 3 to entry: An older definition of prescription can also be found in ENV 13607: “Direction created by an
authorized healthcare person, 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”. This definition is more appropriate when
referring to the act of prescribing.
[SOURCE: ISO 17523:2016, 3.7]
3.9
sex
biological background of a patient
Note 1 to entry: This is as opposed to gender, which is the preference of the patient.
Note 2 to entry: The biological background is considered to be more relevant for the purpose of medication
management.
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4 Abbreviated terms
ER Emergency room.
Unit of a hospital where emergency care takes place.
EHR Electronic Health Record.
Used as the abbreviation for Care Provider IT systems for health records with data struc-
tured and represented in a manner suited to computer calculation and presentation.
NOTE: The UK National Health Service (NHS) uses the term Electronic Health Record to
describe the concept of a longitudinal record of a patient’s health and healthcare from
cradle to grave and uses the term EPR to describe the record of the periodic care provided
mainly by one institution.
GP General Practitioner.
Doctor that performs general practice, in some countries also called as family doctor or
primary care provider (PCP).
INR International Normalized Ratio.
Ratio that gives an indication how much longer time the blood of a thrombosis patient would
need for coagulation than a normal patient.
IHE Integrating Healthcare Enterprises.
Standards organization that uses existing communication standards for the healthcare to
combine them in a workflow in the care. These workflows such as an ordering process, are
called IHE profiles.
OTC Over the counter.
Refers to medication that does not require a prescription to procure such as cough syrups,
painkillers, sterilizing liquids.
PHR Personal Health Record.
Health IT system in which a patient can manage their own personal health information by
downloading and storing information from a variety of sources.
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5 General process
Figure 1 — Cycle of treatment process
The medication process is actually a recurring cycle (symbolized in Figure 1). This is often not
recognized by healthcare providers, because the healthcare providers are frequently replaced, or the
patient is transferred from one institution to another, but certainly from the point of view of the patient
the events of the medication therapy can be seen as a recurring loop.
The loop does not have always have a smooth constant flow. While “gather data” is the logical starting
point in the medication management process diagram, it is not uncommon for the process to start at
a different step/point in the process. Events could happen all the time that could make intervention
necessary. For example admission of patient into hospital triggers review of patient’s existing
medication list and the medication profile. The condition of the patient changes (deteriorates or
improves) or new lab results are published that requires adjustments of the dosage. This all affects the
medication management and provides short cuts in the loop.
These steps in the flow of the medication management of the patient result in different kinds of lists,
profiles of medication of the patient. The purpose and the status of each type of list must not only
be understood by the author, but also by other care professionals who share the information with
the original source. The intent of this document is to distinguish the different steps in medication
management and which type of document belongs to which process part.
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The following sequence of sections is used for the explanation of definitions:
— identify the basic data elements relevant to medication management;
— define the possible process steps and the variations in the processes;
— name the various report types that can be linked to that part of the process.
The emphasis of this document is focused on steps 1 to 5 (gathering data up to determine the
medication management and therapy). The actual therapy, such as administering the medication is
performed in step 6. Steps 7 and 8 (evaluate outcome and generate new data) of course do have effect
on the medication management, but it will be apparent if the process restarts with step 1.
6 Data elements relevant to medication management
6.1 General
Effective medication therapy management requires the inputs of relevant historic and current
information including medication and related clinical information. This clause provides an overview of
the information important for medication therapy management planning and review processes. Details
of the information requirement (including data elements, data types and terminology constraints) for
each of these data components are out-of-scope for this document.
The collection of data elements is seen as a list of possible data components. It is evident that it is not
possible to make a compulsory list of data elements. The ultimate goal would be to know everything,
but there is a cost incurred to put information into systems. That effort might not always be worthwhile.
Tradition, but certainly also a level of computerization, accessibility of that information, jurisdictional
restrictions and the differences in workflow are factors that influence the availability of data.
6.2 Prescription data
A prescription is a medication request usually authorized by a qualified practitioner such as medical
practitioner, dentist, nurse practitioner (and in some jurisdictions, pharmacist). The medication request
could be part of larger care plan, including other treatment and therapies such as nutrition requests,
procedures (e.g. dialysis, dressing, operations).
Prescribed medications are drugs that can only be made available to patients by a medication request
(usually written and signed) of a qualified practitioner.
It is important to recognize that the data of a prescription consists of two distinct components:
— a therapy that the prescriber has agreed with the patient;
— a logistical order to supply a tangible product, most commonly the medication.
In certain settings these elements might be seen as separate entities. An order to stop medication can
be seen as an example of a request where there is a therapy instruction to stop using the medication
and where the supply is left void.
Depending on the constituency and the type of process the prescriber might leave the level of detail
of the order open for others to fill in. In many cases the medication on the prescription would be
prescribed on a generic level with the focus on the active ingredient while what is dispensed is most
certainly a tangible product.
Prescription (together with dispense and administration) data are key components of a patient’s
medication list and medication profile. These data are very important for safe and effective
management of a patient’s medication therapy and are an integral component of the patient’s
medication management plan.
The most common source for prescription data are the prescribing systems.
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6.3 Dispense data
The dispensing of medication includes the act of preparing and supplying medications.
Medication dispense data capture details about (prescribed) medication dispensed for use by the
patient. Dispense information is usually collected from pharmacy systems.
In the institutional setting the administration of medication to a patient might be from the ward stock;
the replenishment from the pharmacy stock to the ward is not on a patient’s name. In such a case no
dispense can be identified. In the view of medication management medication is defined as dispensed,
if it is in the possession of, or ready to be administered to the patient.
Certain systems define the medication as dispensed as soon as the order is ready for dispatch (i.e.
ready to be picked up by the patient). In the view of medication management a medication is defined
as dispensed if it is in the possession of the patient. This is to exclude medication that is not picked up.
In the community setting, medication dispense data provides feedback on what was prescribed. The
presence of medication dispense data against a prescription gives certain confidence that the patient
is more likely to comply with medication management plan. The dispense should be matched with a
prescription via a reference to the prescription id.
In many cases a dispense list will provide complementary information to a listing of prescriptions,
because pharmacies will also show dispense from (external) healthcare providers who use paper
prescriptions. Prescriptions where no dispenses can be found to link with could indicate that patients
are not compliant with the suggested therapy.
OTC medication supplies are often not visible in the dispense list, because they cannot be linked to a
patient, for example because they are acquired in a supermarket and are shared within a household.
The dispense list is likely to give more detail, because it will contain a product that can be dispensed
while prescriptions contain a generic product code or an active ingredient.
The dispenser might also have added dates (or time interval), which the prescriber might have left open.
This will influence whether the medication will appear in the requested period of the dispense list.
6.4 Medication administration data
Medication administration data capture details about (prescribed and non-prescribed) medications
administered to or taken by a patient. Each medication administration record/entry is an account of
one administration event, which may be a point in time event (representing a dose of medication), or
may be an occurrence over a time interval (e.g. intravenous administration of antibiotic over duration
of 30 min).
Medication administration data differs from medication statement, which represents an assertion of
known use of medication in general.
Medication administration is usually registered in the institutional setting, but not in the community
setting. The presence of medication administration data in the community setting allows more accurate
assessment of patient compliance profile. An example is the report of patients with thrombosis who
register their use of anti-coagulant medication or pharmacists who administer vaccines to patients.
Medication administration data originate from nurses, patients or relatives, home care aids or even
administration machines and have various sources ranging from EHR to telemedicine systems.
6.5 Medication statement data
A medication statement is a declaration of medication actually used, known to be used, as well as
intended to be used by the patient in the future. A medication statement refers to exactly one medication.
This information might be obtained as a result of the process of medication review and reconciliation
(e.g. by interviewing the patient or by querying and reviewing trustworthy data sources).
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A medication statement captures information that is not formally captured in prescription, dispense
and administration repositories. It provides important additional information that adds to the
completeness of a patient’s medication profile and is important input to facilitate safe and effective
patient medication management.
Statements from the pat
...