ISO/TS 22703:2021

TECHNICAL ISO/TS
SPECIFICATION 22703
First edition
2021-10
Health informatics — Requirements
for medication safety alerts
Informatique de santé — Exigences relatives aux alertes de sécurité
sur les médicaments
Reference number
© ISO 2021
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 5
5 Requirements . 5
5.1 General . 5
5.2 Potential medication problem types for medication safety alerts. 7
5.2.1 General . 7
5.2.2 Selection of potential medication problem types . 7
5.2.3 Other potential medication problem types . 10
5.2.4 Predetermined standards for potential medication problem types . 10
5.3 Data sources of potential medication problem types and predetermined standards . 11
5.3.1 Evidence-based resources . 11
5.3.2 Other resources . 11
5.3.3 Patient data sources .12
5.4 Alert processor .12
5.5 Alerting guidelines (methods) . 14
5.5.1 General . 14
5.5.2 Severity or safety risk grading . 14
5.5.3 Alert schema . . 16
5.5.4 Display of medication safety alert . 16
5.5.5 Alert receivers . 17
5.5.6 Alert timings . 18
5.5.7 Alert interventions . 18
5.5.8 Audit trail . 18
5.6 Interfaces and relations . 19
5.6.1 General . 19
5.6.2 Clinical information system . 19
5.6.3 Pharmacy information system . 20
5.6.4 Relation to international standards . 21
6 Other recommendations .21
6.1 General . 21
6.2 Pre-development steps . 22
6.3 Development steps . 22
6.4 Implementation step . 23
6.5 M onitoring and management of the system . 23
Annex A (informative) Example of definition and requirement of predetermined standards .24
Annex B (informative) A flexibility configuration setting screen shot of a CDSS system (a
case in Korea) .25
Annex C (informative) Recommendations for DDI alert display .27
Annex D (informative) An alert display screen shot of a CDSS system (a case in Korea) .31
Bibliography .33
iii
Foreword
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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
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iv
Introduction
To improve the quality and safety of patient care in digital work-flow environments, computer assisted
clinical decision support systems (CDSSs) have been emphasized and implemented in healthcare
organizations and pharmacies, especially focusing on medication safety.
CDSSs for medication safety have been developed and used in many countries as an essential
component for decision support for clinicians in prescribing, dispensing and administering medication
in connection with an electronic health record (EHR), computerized physician order entry (CPOE)
system or pharmacy electronic health record (PEHR) and digitized knowledge bases.
Depending on the availability of knowledge bases and functionalities, CDSS can be classified into four
[12]
types :
Type 1 CDSS: provides categorized information that requires further processing and analysis by
users before a decision can be made. This type of decision support includes direct access to relevant
information, such as web-based access to current rules for travel inoculation.
Type 2 CDSS: presents the clinician with trends of a patient’s changing clinical status and alerts
clinicians to out-of-range assessment results and intervention strategies. Clinicians are prompted to
review information related to the alerts before arriving at a clinical decision.
Type 3 CDSS: uses deductive inference engines to operate on a specific knowledge base and automatically
generate diagnostic or intervention recommendations based on changing patient clinical condition, with
the knowledge and inference engines stored in the knowledge base. These systems include systems that
consider the disease and medication of the patient and whether these have contraindications for new
medication. These systems require computer-readable rules and an underlying computer EHR system
that is also computer processable. They also require computerized terminological representation of
clinical concepts.
Type 4 CDSS: uses more complex knowledge management and inference models than the other three
decision support types. These systems include case management reasoning, neural networks and
statistical discrimination analysis to perform outcome or prognostic predictions. Such systems possess
self-learning capabilities and use fuzzy set formalism and similarity measures or confidence level
computation as mechanisms to deal intelligently and accurately with uncertainty.
Among the four types of CDSS, type 3 has been focused on developing CDSS for medication safety alerts
in the countries where EHRs are in use, though type 4 is available in some countries.
Since the primary purpose of a medication CDSS implementation is the prevention of potential harmful
effects of medication or errors, all types of CDSS have been designed to have the functionality of alerting
or warning clinicians in a prospectively actionable fashion for all settings.
However, the desired outcome of prevention of harmful drug therapy with the use of CDSS for
medication safety has not been clearly defined. This can be attributed to factors such as poor and varied
stratification (mainly due to lack of clear consensus on terminology and rules) of safety risk warnings
or alerts. In addition, alert fatigue (the result of frequent alerts to clinicians which are not clinically
significant or tailored to speciality interests) is known to be one of the major factors contributing to
alert overrides, which can result in serious clinical consequences.
Unclear content and verbose language in medication safety alerts can also be barriers to clear
communication with clinicians of the clinical significance of potential safety risks.
In addition, since the alerts are linked to the embedded CDSS knowledge base through specifically
designed algorithms, the differences between algorithms to produce alerts, even though they are based
on the same knowledge base, can be another inhibiting factor in getting uniform and maximal benefit
from safety alert systems operating on the same patient population with the same clinical condition or
situation.
v
In the USA, a number of EHR and CPOE vendors, as well as several drug knowledge bases, are in use
with wide differences in content, alert types and displays. Medication safety alerts in computerized
information systems have typically been developed for pharmacy software, often in connection with
pharmacy benefit management, the requirement for a prospective drug utilization review (DUR)
programme for outpatients using a prescription filling service in community pharmacies, or both. For
prospective DUR programmes, the potential medication problem types for medication safety alerts
were defined by federal regulation and have been used for developing CDSS for pharmacy practitioners
and CPOE by system vendors.
In the Republic of Korea, a number of drug knowledge bases (in the form of CDSS) with the functionality
of safety alerts which are developed by system vendors and pharmacy benefit managers of national
health insurance bodies are in use, mostly benchmarking the prospective DUR programme in the USA.
However, they are not detailed enough to meet individual use cases and thus healthcare organizations
resort to commercial vendors for more in-depth and user-friendly coverage of medication alert content.
In other countries, various types or methods for providing medication safety alerts in connection
with digitized knowledge bases have been developed and implemented in digitized health information
systems. However, there are no internationally or regionally standardized requirements for improving
patient safety by alerting healthcare professionals to potential safety risks.
Given the wide variability of medication safety alert content and implementation approaches across
different system vendors and drug knowledge bases, there is a need for medication alert standardization
both nationally and internationally.
Stakeholders can use this document for developing common and structured medication safety alert
systems to improve patient safety.
The actors included in the scope of this document include, but are not limited to:
— healthcare organisations which deploy EHR or PEHR systems incorporating medication safety
alerts;
— vendors and implementors of systems with medication safety alerts or those who provide
information for the alerts, such as:
— CDSSs
— EHRs
— pharmacy systems
— clinical information systems
— practice management systems (EHR-like systems for individual or small-group settings).
vi
TECHNICAL SPECIFICATION ISO/TS 22703:2021(E)
Health informatics — Requirements for medication safety
alerts
1 Scope
This document specifies the requirements for medication safety alert systems and the topics which are
relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs)
whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;
— requirements for choosing a knowledge base for medication safety alert systems;
— requirements for the proper functionality of CDSSs as related to medication safety alert systems;
— requirements for medication safety alert display;
— requirements for quality measurements to improve the effectiveness of medication safety alerts.
The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.
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/TS 22756, Health informatics — Requirements for a knowledge base for clinical decision support
systems to be used in medication related processes
ISO 27789, Health informatics — Audit trails for electronic health records
IEC 82304-1, Health software — Part 1: General requirements for product safety
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 https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
administration
(self-) administering a (prescribed) medicinal product to the patient, using a specified method, and via
a defined route, and recording that the act has actually happened at a particular date and time
[SOURCE: ISO/TS 19256:2016, 3.1, modified]
3.2
clinical decision support
CDS
software system that assists healthcare providers in making medical decisions
Note 1 to entry: These types of systems typically require input of patient-specific clinical variables and as a result
provide patient-specific recommendations.
[SOURCE: ISO/TR 14639-2:2014, 2.8, modified]
3.3
clinical decision support system
CDSS
software that is designed to be a direct aid to clinical decision-making, in which the characteristics of
an individual patient are matched to a computerized clinical knowledge base
Note 1 to entry: Patient-specific assessments or recommendations are then presented to the clinician or the
patient to aid in the process of making evidence-based clinical decisions
[SOURCE: ISO/TS 22756:2020, 3.2, modified]
3.4
dispensing
process by which an individual healthcare provider takes in a prescription, assesses that prescription,
selects the prescribed medicinal product and delivers that medicinal product to the subject of care
or their representative
Note 1 to entry: In most cases, but not necessarily always, the individual healthcare provider concerned will be a
Pharmacist.
[SOURCE: ISO/TS 19256:2016, 3.9]
3.5
dispenser
specialization of a healthcare professional which is a representation of an individual professionally
responsible for filling/dispensing the prescription
Note 1 to entry: The dispenser is usually a pharmacist but can be other individuals according to local jurisdiction.
[SOURCE: ISO 21549-7:2016, 3.5, modified]
3.6
drug (pharmacy) and therapeutics committee
DTC
forum to bring together all stakeholders involved in decisions about drug use
Note 1 to entry: The described forum can exist at any level within the health-care system – at district level
(overseeing primary health-care facilities), in hospitals, or at the national level.
[SOURCE: Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]
3.7
drug utilization review
DUR
authorized, structured, ongoing review of healthcare provider prescribing, pharmacist dispensing and
patient use of medication
[SOURCE: Academy of Managed Care Pharmacy – Managed Care Glossary]
3.8
electronic health record
EHR
logical representation of information regarding or relevant to the health of a subject of care
[SOURCE: ISO/TS 13972:2015, 2.24]
3.9
formulary list
list of medicines approved for use in a specific health-care setting
[SOURCE: Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]
3.10
formulary system
principles, criteria, procedures and resources for developing, updating and promoting the formulary
(essential medicines) list
[SOURCE: Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]
3.11
knowledge database
system in which knowledge on a specific topic is specified as a set of declarative statements, hierarchical
organization of such statements, and relationships between declarative statements, which serves as
the underpinning of decision support systems
[SOURCE: ISO/TS 19256:2016, 3.19]
3.12
medication history
record keeping of the specificities of the prescribed/dispensed/OTC medicinal product (e.g.
identification, brand, type, form, quantity, dosage)
Note 1 to entry: this record contains the medication still in use as well as the medication no longer in use.
[SOURCE: ISO/TS 19256:2016, 3.23, modified]
3.13
medication safety
freedom from preventable harm with medication use
[SOURCE: ISMP Canada, 2007, available at https:// www .ismp -canada .org/ definitions .htm #: ~: text =
Medication %20Safety %3A ,did %20not %20reach %20the %20patient]
3.14
medication use evaluation
performance improvement method that focuses on evaluating and improving medication use processes
with the goal of optimal patient outcomes
Note 1 to entry: medication use evaluation may be applied to a medication or therapeutic class, disease state or
condition, a medication-use process (prescribing, preparing and dispensing, administering and monitoring) or
specific outcomes.
[SOURCE: ASHP Guidelines on Medication-Use Evaluation, available at https:// www .ashp .org/ -/ media/
assets/ pharmacy -informaticist/ docs/ sopit -formulary -guideline -medication -use -evalutation .ashx ?la =
en]
3.15
medicinal product
substance or combination of substances that may be administered to human beings (or animals) for
treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or
modify physiological functions
[SOURCE: ISO 11615:2017, 3.1.50, modified]
3.16
monograph
written, unbiased evaluation of a specific medication
Note 1 to entry: Such a document includes the drug name, therapeutic class, pharmacology, indications for use,
summary of clinical trials, pharmacokinetics/dynamics, adverse effects, drug interactions, dosage regimens and
cost.
[SOURCE: ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System,
available at https:// www .ashp .org/ -/ media/ assets/ policy -guidelines/ docs/ guidelines/ gdl -pharmacy
-therapeutics -committee -formulary -system .ashx]
3.17
overutilization
use of a drug in a quantity, strength or duration that is greater than necessary to achieve a desired
therapeutic goal or that puts the recipient at risk of a clinically significant undesirable effect, or both
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
3.18
pharmacy electronic health record
PEHR
logical representation of information regarding or relevant to the health of a subject of care in
pharmacies in community or organized healthcare organizations
[SOURCE: Pharmacy Health Information Technology Collaborative HL7 EHR-System for a Pharmacist/
Pharmacy Electronic Health Record Implementation Guide for Community Practice, available at https://
www .hl7 .org/ documentcenter/ public/ standards/ informative/ 13 -294 _HITSbook _HL7 _Web .pdf]
3.19
predetermined standard
criteria and standard that has been established in accordance with the requirements of a drug use
review programme
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
3.20
prescribing
creating a prescription
[SOURCE: ISO/TS 19256:2016, 3.33]
3.21
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
Note 1 to entry: The term “prescription” alone should be avoided as it is colloquially used at random for the
following terms: new prescription message, prescription set and prescription item. Further, it is also used to
describe a prescription form. The use of the terms prescription set, prescription item and new prescription
message where appropriate is recommended.
[SOURCE: ISO/TS 19256:2016, 3.34]
3.22
screening
process of inspecting data for errors and correcting them prior to doing data analysis
Note 1 to entry: The screening can involve checking raw data, identifying outliers and dealing with missing data.
[SOURCE: Business Dictionary, WebFinance Inc.]
3.23
substance
matter of defined composition that has discrete existence, whose origin may be biological, mineral or
chemical
[SOURCE: ISO 11238:2018, 3.84, modified]
3.24
underutilization
use of a drug by a beneficiary [recipient] in insufficient quantity, strength or duration to achieve a
desired therapeutic goal or that puts the recipient at risk of a clinically significant undesired effect, or
both
[SOURCE: US CFR 42§456.702, available at https:// www .govinfo .gov/ content/ pkg/ CFR -2011 -title42
-vol4/ pdf/ CFR -2011 -title42 -vol4 -sec456 -702 .pdf]
4 Abbreviated terms
CPOE computerized physician order entry
DDI drug–drug interaction
IDMP identification of medicinal products
MPD medicinal product dictionary
ORCA operational classification
PBM pharmacy benefit manager
5 Requirements
5.1 General
This document applies to medication safety alerts which will be prospectively presented to healthcare
providers at the point of care during medication use processes in clinical settings where a digitized
health information system is operational to manage medication therapy for patient care.
The prospective safety alerts are displayed on visually verifiable devices before medication is
prescribed, dispensed or administered to the patients, whereas the retrospective alerts occur after the
patient has received the medication.
Since the ultimate goal of medication safety alerts is to prevent adverse drug reactions (ADRs) and
ineffectiveness of the drug by minimizing or preventing medication and device error as depicted in
Figure 1, this document focuses on drug use processes at any time before the prescribed medication is
actually administered to the patient.
[13]
Figure 1 — Preventing ADRs
A knowledge base can be the basis for detecting potential drug-related problems in a specific patient
considering his or her clinical conditions (e.g. age, sex, concurrent medical diagnosis and medication,
drug allergy history).
It is not within the scope of this document to create knowledge bases or gather patient clinical
information. Rather, this document defines the requirements for selecting potential medication
problem types for safety alerts based on the available knowledge, guides the method for how to find
the conflicts between the predetermined thresholds (or standards) and prescription information (to
be prescribed, dispensed or administered) based on specific patient clinical information and creates
the signals to be alerted to healthcare providers in computerized health information system shown in
Figure 2.
Although the rule-based knowledge base described in ISO/TS 22756 can contain a broader spectrum
of rules for medication safety alerts than the scope of this document, this document focuses on the
potential medication problem types which are more commonly selected in clinical settings to prevent
or minimize drug-related problems and safety risks.
Figure 2 — Conceptual model for medication safety alert
5.2 Potential medication problem types for medication safety alerts
5.2.1 General
In principle, all potential safety risks of medication use fall into the scope of a medication safety alert
system. However, the findings of potential safety risks for a specific patient can vary depending on the
availability of data (e.g. patient clinical status, active problems, medication history, medication adverse
event history), system capabilities (e.g. CDSS screening capabilities) and the information available in
the associated drug knowledge base.
Ideally, the medication safety alert system should include as many of the potential problem types in this
document as possible. However, the actual problem types implemented are determined by healthcare
organizations in compliance with regional jurisdictions, pertinent regulations and guidelines for safe
use of medication, while considering the available drug knowledge base and screening capability of the
system.
5.2.2 Selection of potential medication problem types
There is no internationally agreed standard for selecting potential medication problem types for safety
alerts. However, some national or regional jurisdictions have established requirements for medication
safety alerts in the form of prospective and/or retrospective drug utilization review (DUR).
In the USA, the National Committee for Quality Assurance (NCQA), Centers for Medicare & Medicaid
Services (CMS) and many other government agencies mandate that drug reviews be performed
to ensure appropriate drug therapy. Specifically, the Omnibus Budget Reconciliation Act of 1990
[14]
(OBRA 90) mandates that pharmacists conduct prospective and retrospective medication reviews
whenever an outpatient prescription is dispensed to a Medicaid recipient. In US federal regulations, the
following potential medication problem types for prospective DUR are specified for medication safety
alerts when pharmacists are dispensing medication to patients in the community:
a) Therapeutic duplication – the prescribing and dispensing of two or more drugs from the same
therapeutic class such that the combined daily dose puts the recipient at risk of an adverse medical
result or incurs additional programme costs without additional therapeutic benefit.
b) Drug–disease contraindication – the potential for, or the occurrence of:
1) an undesirable alteration of the therapeutic effect of a given drug because of the presence, in
the patient for whom it is prescribed, of a disease condition; or
2) an adverse effect of the drug on the patient's disease condition.
c) Adverse DDI – the potential for, or occurrence of, a clinically significant adverse medical effect as a
result of the recipient using two or more drugs together.
d) Incorrect drug dosage – the dosage lies outside the daily dosage specified in predetermined
standards as necessary to achieve therapeutic benefit. Daily dosage is the strength multiplied by
the quantity dispensed divided by day's supply.
e) Incorrect duration of drug treatment – the number of days of administered therapy exceeds or
falls short of the recommendations contained in the predetermined standards.
f) Drug–allergy interactions – the potential for, or the occurrence of, an allergic reaction as a result
of drug therapy.
g) Clinical abuse or misuse – the occurrence of situations referred to in the definitions of abuse,
gross overuse, overutilization and underutilization, and incorrect dosage and duration.
To support this federal requirement for prospective DUR programmes, several drug knowledge bases
have been developed and integrated in pharmacy software in the form of CDSSs and further integrated
in health information systems (EHR) for hospitals in connection with the CPOE system.
In the Republic of Korea, the national authority (Ministry of Health and Welfare Affairs) mandates a
prospective DUR programme similar to the prospective DUR programme in the USA when reimbursing
pharmacy benefit costs to healthcare providers in both community pharmacies and health institutions.
The potential medication problem types for prospective DUR are relatively fewer than those in the
USA because of limited information resources for potential medication problem types and different
definitions for predetermined standards. There are some additional types used for medication safety
alerts (drug–age and drug–pregnancy contraindications).
In other countries it is possible that there are regional or national requirements for the potential
medication problem types for medication safety alerts.
ISO/HL7 10781 should be referenced when choosing potential medication problem types. This
document lists the functional requirements for managing medication orders including the following
care provision domains and required supports for medication alerts:
1) Medication interaction and allergy checking
— Determine and present the presence of interactions between medication ordered and medication
already on the current medication list, true allergies on the current allergy list.
— Determine and present the presence of contraindications between medication ordered and
patient health condition and characteristics (e.g. gender, age, weight, smoking status, pregnancy
status, renal function).
2) Patient-specific medication dosing and warning
— Determine and render contraindications to the ordered dosage range (e.g. pregnancy, breast-
feeding or occupational risks, hepatic or renal insufficiency).
3) Medication order efficiencies
— Present a medication compendia or formulary content (e.g. drug, dose, route and SIG) to facilitate
the selection of the medication to be ordered.
Though the potential medication problem types for medication safety alerts will be broader or
narrower depending on the availability of knowledge bases, the frequently used types for medication
safety alerts in connection with CDSS include:
— therapeutic duplication
— drug–disease contraindication
— adverse DDI
— incorrect drug dosage
— incorrect duration of drug treatment
— drug–allergy interactions
— drug–age contraindication
— drug–pregnancy contraindication
To enable medication safety alert systems in conjunction with an EHR, the potential medication problem
types should be derived from the information and rules in the knowledge base (hereafter referred to
as rule-based knowledge base systems), presumably abstracted from most trusted drug information
resources. In other words, the availability of trigger rules based on the selected drug knowledge base
will limit the medication alert types that can be chosen.
Considering these limits on the potential medication problem types used for medication safety alert
internationally and the specific needs of healthcare organizations and specialities (e.g. intensive care
units or paediatricians might want to cover fewer types, but more in-depth and specific types), the
following factors need to be taken into account in selecting the potential medication problem types:
— availability (accessibility) of patient clinical information (patient health records);
— capacity (hardware or software) of the health information system;
— formulary and formulary systems (national or institutional);
— drug knowledge base (digitized) availability for predetermined standards;
— decision support capability of health information systems.
In addition, the quality of knowledge base is an important factor in selecting potential medication
problem types. In the era of evidence-based medical practice, the strength of the scientific evidence for
each knowledge base will be based on the hierarchy of evidence level shown in Figure 3.
SOURCE “Research design and evidence” by CFCF, available at https:// commons .wikimedia .org/ wiki/ File:
Research _design _and _evidence .svg. Used with permission from Wikimedia Commons.
Figure 3 — The hierarchy of research designs and levels of scientific evidence
In choosing a knowledge base for CDSS, the quality or strength of scientific evidence is also important.
There is general consensus among healthcare professions that the evidence-based practice is the best
choice in pursuing the best possible outcomes in caring for patients.
Regarding the quality of knowledge bases, the US Code of Federal Regulations (CFR) 42§456.702
explicitly describes the requirement of the information resource for knowledge base (specifically
predetermined standards) as described in 5.2.4.
5.2.3 Other potential medication problem types
Potential medication safety risks should be prospectively identified and minimized or prevented across
a broad scope of alert types. Hence, the potential medication problem types shall not be limited to the
ones suggested in this document.
The types listed in 5.2.2 are purely clinical context focused detectable safety risks from the perspective
of prescribers and dispensers. However, the larger healthcare organizations (hospitals) may include
more types from the perspectives of prescriber and persons responsible for drug administration,
while also considering patient specific clinical data (e.g. clinical laboratory data, vital signs, blood
drug concentration data, nutrition) and drug use policies (or guidelines) (e.g. antibiotics use guideline,
diagnosis and drug choice matching, drug and laboratory test interaction, drug and food interaction,
injectable drug incompatibility).
Also, though not directly related to patient safety, other administrative or managerial requirements
can be added to the system to improve the outcomes of patient care if system capacity allows.
5.2.4 Predetermined standards for potential medication problem types
Once the potential medication problem types for medication safety alert are chosen for organizational
or national level, the predetermined triggering standards (safe range of dose, for example, maximum
and minimum dosage range for specific indication) for each type should be decided.
If there is no appropriate knowledge base in the region, ISO/TS 22756:2020, Clause 7, can be referenced
to assess potential sources for a rule-based knowledge base.
The predetermined trigger standards can be abstracted from the available information resources
(specifically rule-based knowledge bases defined in ISO/TS 22756 or defined by the regional or
institutional authorities).
One example for defining predetermined trigger standards for prospective DUR programmes is
described in USA federal regulations (requirements for predetermined standards) (see Annex A).
In conclusion, if there are no specific regulatory requirements for the predetermined standards in the
region (or country), choose a knowledge base that conforms with ISO/TS 22756.
In some countries, an organized drug (pharmacy) and therapeutics committee (DTC) has been shown
[16]
to be effective in safeguarding and promoting efficient and rational use of medicines by, for example:
— establishing documented rules and policies for all aspects of drug management, including the
selection of formulary list medicines and agreement of treatment protocols;
— conducting continuing education, audit and feedback, DUR and monitoring of adverse drug reactions
and medication errors.
In such cases, national or institutional authorities (such as DTC) shall be the best bodies responsible for
choosing the potential medication problem types for safety alerts and defining the scope of rule-based
knowledge bases (predetermined alert trigger standards) in developing and implementing medication
safety alert systems at organizational or national level.
5.3 Data sources of potential medication problem types and predetermined standards
5.3.1 Evidence-based resources
Once the types of medication safety alerts have been reviewed and selected, the appropriate
drug knowledge base (rule-based knowledge base for CDSS) should be examined to establish the
predetermined alert trigger standards that will be used for prospective screening and detecting the
potential safety risks of new medication orders by the specific algorithms of the CDSS.
For developing or selecting the drug knowledge database, the concept of evidence-based resources
may be safest and best since the context of safety alerts should be objectively and clinically proven by
quality evidence.
A typical example of defining evidence-based resources for medication safety alert is found in the USA
federal regulation for the prospective DUR programme regarding the predetermined standards for DUR
as described in 5.2.4. One example of information resources in compliance with this federal regulation
requirement is American Hospital Formulary Service (AHFS) - Drug Information which is a compilation
of peer-reviewed drug monographs for the approved medicinal products in US markets.
Thus, the requirements for predetermined standards as described in 5.2.4 are recom
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