ISO/TR 22790:2007
(Main)Health informatics — Functional characteristics of prescriber support systems
Health informatics — Functional characteristics of prescriber support systems
ISO/TR 22790:2007 provides a common conceptual model of information management related to the process of prescribing or ordering medication. This Technical Report provides a set of optional business requirements that could be selected by the buyer in a procurement process to be responded to by a tendering supplier. This report shall not provide any mandatory requirements but, as an informative document, give a common expression of various possible functions meeting different objectives for the health care system. ISO/TR 22790:2007 is intended to be used as a guide for a specific organization in formulating and prioritizing a subset of characteristics tailored to national or local needs. The complete list here is thus not intended to be a minimum set of requirements that all systems must comply with. There may also be good reasons to further specify the generic characteristics presented here and to add other characteristics. This Technical Report contains the following sections: introduction to concepts with agreed definitions and recommended terms; overview of the relationships between different actors and information flows; overview of the functional model taking as its starting point the objectives of the health care system; overview of the different information resources needed to achieve the requirements; a list of detailed characteristics to select from in a procurement process.
Informatique de santé — Caractéristiques fonctionnelles des systèmes de support prescripteur
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 22790
First edition
2007-12-01
Health informatics — Functional
characteristics of prescriber support
systems
Informatique de santé — Caractéristiques fonctionnelles des systèmes
de support prescripteur
Reference number
ISO/TR 22790:2007(E)
©
ISO 2007
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ISO/TR 22790:2007(E)
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ISO/TR 22790:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 Medication related communication — General model. 4
3.1 Co-operating parties. 4
3.2 Information content . 4
3.3 Scenarios for electronic communication . 7
4 The components of a prescription support system. 9
4.1 Functional overview . 9
4.2 Information needed for prescription support . 10
5 Detailed list of possible requirements. 12
5.1 The intended use . 12
5.2 Assessing the patient’s need for medication . 13
5.3 Selecting a medication that can give an optimal result for the patient and current problem . 14
5.4 Making cost conscious selections that can contribute to the cost containment of the
insurance or publicly funded health care system as well as patient costs. 15
5.5 Issuing a complete prescription in a time efficient manner. 16
5.6 Transfer the information to a pharmacy. 17
5.7 Communicating the medication order to the patient . 17
5.8 Communicating the medication orders to other healthcare professionals. 18
5.9 Periodically follow up the total prescribing by the prescriber and/or unit in this system. 18
Bibliography . 19
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ISO/TR 22790:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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.
ISO/TR 22790 was prepared by Technical Committee ISO/TC 215, Health informatics.
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ISO/TR 22790:2007(E)
Introduction
Medication is an effective means of improving health though the use of medication is costly and introduces
risks to patient safety. Many countries have listed information systems to improve the processes related to
prescribing, as a top priority for health IT. However, the great differences between countries regarding
information on medicinal products makes it difficult to develop international standards for all the relevant
aspects. This informative document provides an agreed description of the various functionalities and
information used in a common terminology is intended to be helpful for the development of prescriber support
solutions and for the procurement processes of such systems.
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TECHNICAL REPORT ISO/TR 22790:2007(E)
Health informatics — Functional characteristics of prescriber
support systems
1 Scope
This Technical Report provides a common conceptual model of information management related to the
process of prescribing or ordering medication. This Technical Report provides a set of optional business
requirements that could be selected by the buyer in a procurement process to be responded to by a tendering
supplier. This report shall not provide any mandatory requirements but, as an informative document, give a
common expression of various possible functions meeting different objectives for the health care system.
This document is intended to be used as a guide for a specific organization in formulating and prioritizing a
subset of characteristics tailored to national or local needs. The complete list here is thus not intended to be a
minimum set of requirements that all systems must comply with. There may also be good reasons to further
specify the generic characteristics presented here and to add other characteristics.
This Technical Report contains the following sections:
a) introduction to concepts with agreed definitions and recommended terms;
b) overview of the relationships between different actors and information flows;
c) overview of the functional model taking as its starting point the objectives of the health care system;
d) overview of the different information resources needed to achieve the requirements;
e) a list of detailed characteristics to select from in a procurement process.
The last part e) in Clause 6 is the main part of this Technical Report.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
active ingredient
ingredient that alone or in combination with one or more other ingredients is considered to fulfil the intended
activity of a medicinal product
[ENV 12610]
2.2
central prescription store
repository for electronic prescriptions in a geographical area which receives prescriptions from several
prescriber locations and serves several, possibly all, pharmacies in that area
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2.3
magistral medicinal product
extemporaneous medicinal product
medicinal product manufactured in a pharmacy or a pharmacy department based on a recipe and intended to
be used for one and only one subject of care
NOTE A magistral medicinal product is also a pharmaceutical product.
[ENV 12610 (modified)]
2.4
medicinal appliance
device or piece of equipment that may be used by human beings or administered to animals for treating or
preventing disease, with the view to making medical diagnosis, to restore, correct or modify physiological
functions or to alleviate handicap
NOTE In order to be prescribable a medicinal appliance should fall within the purpose of prescribing as accepted by
local rules/traditions in the area. The production of a prescription may also be required for formal reimbursement,
restrictions on general sale of the appliance or need for labelling the appliance with individual instructions for use.
EXAMPLE Syringes, spacers for inhalation, diagnostic kits for pregnancy, bandages, catheters, nappies for
incontinence, orthopaedic shoes, colostomy bags, wheel chairs, pneumatic mattresses.
[ENV 12610]
2.5
medicinal product
any substance or combination of substances, which may be administered to human beings or animals for
treating or preventing disease, with the view to making medical diagnosis or to restore, correct or modify
physiological functions
NOTE Some medicinal products are prescribed as a combination of a medicinal product and a medicinal appliance.
Such combinations are regarded in this Technical report as medicinal products.
[ENV 12610]
2.6
medicinal product package
package
delivery unit of a medicinal product in an outer container
[ENV 12610]
2.7
medication order
documented instruction on intended therapy for an individual person with a medicinal product issued by an
authorized health professional
NOTE 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.
2.8
medication record
record related to an individual person, which includes information about prescribed medicinal products, the
intended dosage instruction and the period of time during which the medication was intended to be given
NOTE 1 A medication record should preferably contain information not only on medicinal products prescribed for
community dispensation and home care but also medication ordered for administration to in-patients in hospital care.
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NOTE 2 A medication record should be updated even when no prescription is issued to reflect current dosage and
possible withdrawal of prescribed medication.
NOTE 3 A medication record considered here is part of the more general concept Electronic Health Record and as
such other information should be associated to the core information in the definition such as date and place of recording,
responsible person, signature etc.
2.9
payment guarantor
organization responsible for the total or partial reimbursement or payment of the price of the medicinal product
2.10
pharmaceutical product
product consisting of one or more ingredients
NOTE 1 A pharmaceutical product may have a different pharmaceutical form from the final intended medicinal product.
NOTE 2 This Technical Report does not make a distinction between a bulk product, an intermediate or a final product.
EXAMPLE 1 An amount of penicillin powder and physiologic solution to be mixed together are both pharmaceutical
products. They are both part of a medicinal product, e.g. Combicillin 1 g.
EXAMPLE 2 Adepal (Fr) is a medicinal product with two types of tablets containing ethinyloestradiol and
progresterone in different ratio composition. Each of these tablets are pharmaceutical products. They are both part of this
medicinal product.
2.11
prescriber
healthcare person authorized to issue prescriptions
2.12
prescribing
process of creating a prescription
2.13
prescription
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
[ENV 13607]
NOTE The term prescription alone should be avoided as it is colloquially used at random for the following terms used
in prescription message standards: new prescription message, prescription set and prescription item. Further, it is also
used to describe a prescription paper form. The use of the terms prescription set, prescription item and new prescription
message, where appropriate, is recommended.
2.14
prescription item
specification created by an authorized healthcare person, to instruct a dispensing agent regarding the
preparation and use of single medicinal product/medicinal appliance or to inform other parties following
dispensing regarding the preparation and use of a single dispensed medicinal product/medicinal appliance
NOTE A prescription item may contain administrative details needed for dispensing or derived from dispensing, but
does not contain information about the prescriber or the subject of care for whom the prescription item is prescribed or to
whom it has been dispensed.
2.15
prescription set
collection of one or more prescription item(s) prescribed and/or dispensed as a unit
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3 Medication related communication — General model
3.1 Co-operating parties
NOTE This figure only depicts the core relationships essential for the provision of quality care. Communication with
various bodies related to payment issues vary between countries and are considered outside the scope of this TR.
Figure 1 — Co-operating parties for prescription of medication
3.2 Information content
3.2.1 Prescriptions and medication orders
A prescription in this context is a direction of an authorized health professional (often a physician but in some
countries also other professions have at least limited prescription rights) to a dispensing agent here called a
pharmacy to dispense medicinal products to a patient.
Prescriptions have traditionally been made on paper forms or in some countries also oral prescriptions via
telephone occur. Nowadays prescriptions may also be transferred electronically as structured data often
referred to as messages or sometimes documents, a distinction which is not necessary for the purposes of
this Technical Report.
There has been a confusing use of the term prescription which may be taken to mean either what is here
defined as a prescription item for a single medicinal product or a set of prescription items grouped together on
a form or an electronic message.
A medication order is a term that sometimes includes prescriptions as defined here but which also and
preferably denotes the instruction by a physician to a nurse in a hospital to administrate medication to a
specific patient. Such medication orders will in some countries be checked and be executed via a hospital
pharmacy whereas medication orders in in-patient settings in other countries do not include pharmacists at all.
There are certainly many similar characteristics of the requirements for IT systems supporting medication
orders and for prescriptions and thus much of what is said in this document applies to both. However, there
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are some requirements described herein that are not relevant (in case a pharmacy is not involved) and there
are additional detailed requirements that should be made on systems, to support hospital ward medication
management, that are not covered.
In many countries there are different classes of medicinal products that require special handling, e.g. for what
is called narcotics or controlled substances. Since these vary considerably we do not attempt to detail such
requirements in this document.
In some countries medication can be prescribed for single dose packaging performed by the dispenser where
a period of treatment is specified rather than a total amount. This is a growing and important type of
prescription that is included in the set of requirements even if it is by no means mandatory to support.
3.2.2 Medication Record
In this technical report Medication Record means a record kept or at least made available to the prescribers of
medication that has been prescribed or ordered. It may take several different forms and have various contents.
It is to be regarded as a part of an Electronic Health Record although Medication Records are in some cases
kept in separate systems from the rest of the health record.
The patient is often but not always authorized to read his/her EHR including the medication record. In some
cases the patient also provides information directly to a medication record e.g. on the actual dosage taken
which may vary over time and/or the use of medicinal products that are not obtained via prescription.
A Medication Record must, as a minimum, contain information identifying a prescribed medicinal product, the
intended dosage instruction and the period of time during which the medication was intended to be given (if
known).
Additional related information such as allergies to pharmaceutical products etc is not considered part of the
core medication record but rather as other relevant information from the EHR even if some separate
medication systems would include such information.
NOTE With this definition, a record of medication dispensed at a pharmacy is not a Medication Record unless it is
available to the prescriber.
3.2.3 Information on dispensed medicinal products
If information can be made available to the prescriber on what medicinal products have been dispensed to the
subject of care, at least for the last year, this can be very valuable information. In some countries, e.g.
Sweden, a national database is available which, with the consent of the patient, can be made available to any
prescriber of the country. In other circumstances information on dispensing is sent to the person/institution
that issued a prescription but no total picture is available. Information on dispensed products can often be
made available to the patients just as medication records.
3.2.4 Request for dispensing
In some systems with electronic transfer of prescriptions, there is a possibility of separating the transfer of the
prescription from the request to dispense. The electronically transferred prescription items may be stored in a
central prescription store and then, upon reques,t be transferred to an individual pharmacy for dispensing. The
dispensing request may also be directed to an individual pharmacy that has received an electronic
prescription, particularly when one prescription may be used to request a number of separate dispensing
actions at different times.
An alternative method for transfer of the prescription information to a dispensing agent/pharmacy is the use of
a portable device such as a microprocessor card held by the subject of care. In this case the request for
dispensing is a verbal activity when presenting a prescription holding card to the pharmacy.
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Figure 2 — State transitions of the prescription process
3.2.5 Knowledge information
This includes various types of information that is needed for the prescriber support system that is not related
to the individual patient. It includes relatively static lists of information on available products and “on demand”
request for specific prescription situations. Also included in this category are clinical guidelines although
generally clinical guideline documents may contain lots of advice on issues other than medication and may
need separate software to be managed. However, functional advice on medication to be prescribed should be
possible to directly interact with a prescription support system.
3.2.6 Report on medicines taken
In order to obtain a complete picture of medication history it can be beneficial to also have in the outpatient
situation a system of reporting the medication actually taken. This is still quite rare but implemented in some
areas, particularly for patients with certain chronic diseases that are well educated on their treatment and
instructed to vary dosage or use as required by current (sometimes daily) measures of objective or subjective
symptoms. Various methods are applied from special devices to on-line reporting via web applications.
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Another but only related issue is the reporting of compliance to physician's order which is known to be quite
low. This can take the form of asking patients what medication they have actually taken over a certain period
of time, irrespective of any known prescription. An alternative approach sometimes employed is to have home
care teams checking the presence of packages of medicinal products (sometimes scanning bar code labels
for easy entry) to be able to capture the actual medication history, of course respecting patient privacy and in
dialogue with the patient or next of kin in the home.
3.3 Scenarios for electronic communication
3.3.1 Communication of a prescription to an identified pharmacy
The simplest sequence is the prescriber sending a new prescription message directly to the dispensing agent,
possibly followed by a prescription cancellation message (these diagrams are adopted from ENV 13607).
⎯ A new prescription message sent from prescriber to dispensing agent initiates the sequence.
⎯ A new prescription message may be sent simultaneously to one or more alternate message receiver(s).
⎯ A prescription cancellation message may follow, sent by the prescriber, cancelling the previously sent
new prescription message. It will only have effect if received at the dispensing agent before dispensing
and delivery of the medicine.
⎯ The dispensing agent may be requested to forward the prescription cancellation message to alternate
message receiver(s). This should only happen if cancellation is effective.
Figure 3 — Prescription message directly to dispensing agent
3.3.2 Direct communication of dispensing report messages
Another simple sequence is the dispensing agent sending a prescription dispensing report message directly to
the prescriber and/or an alternate destination, informing on the medicine(s) actually dispensed, possibly
followed by a prescription dispensing report cancellation message.
⎯ The prescription dispensing report message sent from the dispensing agent to the prescriber initiates the
sequence.
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⎯ A prescription dispensing report message may be sent simultaneously to one or more alternate
destination(s).
⎯ A prescription dispensing report cancellation message, sent by the dispensing agent to the same parties,
may follow, cancelling the previously transmitted prescription dispensing report message.
Figure 4 — Prescription dispensing report message
3.3.3 Prescription store/relaying agent
In addition to the direct communication between prescriber and pharmacy there are several possible
scenarios being implemented in different countries with an intermediate.
One scenario is the following with a relaying agent that is storing prescription messages, awaiting a query
from a dispensing agent to select a specific prescription message.
That there are several variants to this scenario which are not important for the purposes of this Technical
Report.
Figure 5 — Query service message communication, direct prescription set selection
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3.3.4 Communication of medication record
The availability of a medication record is essential for many of the functions desired for prescription support
systems. In some systems, where all prescriptions for a patient are done by essentially only one prescriber or
at least organization with one record system, this is easily available. However, in many countries the real
situation may be different. A patient may be given prescriptions from several different institutions during the
same period. These may be different hospitals and outpatient clinics that in many circumstances will have
different record systems (products and installations). In order to provide a complete medication record for the
prescriber (usually with the consent of the patient required) several approaches are being pursued in different
areas.
a) Prospective common record
A system may require all prescribers in an area to deliver the prescription information (and possibly
medication orders, e.g. changing dosage) to a certain central repository.
b) Search and view function on the web
A system where a common web portal allows authorized prescribers and, in some jurisdictions, the patient to
request information on medication record which will generate a request to all connected separate local
systems which will retrieve current medication records and deliver them to the portal for view functionality.
NOTE The view-only function does not allow the use of decision support functions looking e.g. for interactions.
c) Request and transfer of local medication record
A system that is informed that information on a medication record is available at another or several other
organizations may issue a request for such information which is then transferred to the requester in a
structured format that allows the import to the local medication record. This may be regarded as a special
case of the general communication of EHR information such as described by the ISO/EN 13606 series but
there may also be other specialized messages restricted to medication record information defined for this
purpose in various areas.
d) Patient data card
Finally, patient data cards have been used in some countries to provide a medication history to all prescribers.
This may or may not be combined with the function of being dispensable prescriptions. This approach may
have difficulty ensuring that a card is always present when needed to be updated. On the other hand the
advantage of this approach is that authorization to access may be easier to control in an international context
with a card than with a database solution. This is assuming that the patient is given the access rights to
his/her card and can control access for a prescriber from a foreign system (usually another country).
4 The components of a prescription support system
4.1 Functional overview
A prescriber support system can assist the prescriber with the following tasks:
4.1.1 Assessing the patient’s need for medication
⎯ Electronic health records
4.1.2 Selecting a medication that can give an optimal result for the patient and current problem
⎯ Clinical guidelines for diagnosis and therapy recommendations
⎯ Advice on dosage and information on risks for adverse effects
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4.1.3 Making cost conscious selections that can contribute to the cost containment of the insurance
or publicly-funded health care system a
...
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