Definitions of Terms

This glossary provides definitions for a minimum number of terms that are considered essential to the discussion of Medication Incidents in the context of a Canadian medication incident reporting and prevention system today. Revisiting the selected definitions will be required periodically to align with national and international patient safety initiatives as they develop.

Adverse Drug Event

An injury from a medicine or lack of an intended medicine. Includes adverse drug reactions and harm from medication incidents.

Adapted from Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, Small SD, Sweitzer BJ and Leape LL, “The Costs of Adverse Drug Events in Hospitalized Patients. Adverse Drug Events Prevention Study Group,” Journal of the American Medical Association 277, 4 (January 22, 1997): pp. 307–11.

Developed by the collaborating parties¹ of the Canadian Medication Incident Reporting and Prevention System. 2005.
Best Possible Medication History

Best Possible Medication History:

A complete and accurate list of all the medications a patient is taking created using at least 2 sources of information including a client and/or family interview.

From Medication Reconciliation in Acute Care: Getting Started Kit. 2011
Cognitive Walkthrough

“A cognitive walkthrough involves physically walking through the process or task of interest, examining the mental activities required at each step and the challenges experienced. It is one of many tools employed by human factors engineers to gain an in-depth understanding of a process or task from the perspective of the primary end-user (e.g., front-line practitioner)”

From Include Cognitive Walkthrough in Proactive Risk Assessments. ISMP Can Saf Bull. 2009 [cited 2012 Jan 23];12(1):1. Available from: www.ismp-canada.org/download/safetyBulletins/2012/ISMPCSB2012-01-Cognitive_Walkthrough.pdf
Concerned Reporting

Concerned reporting is the voluntary reporting of incidents to assist with identifying new or undetected safety issues.

ISMP Canada, 2012.

Adapted from a published discussion about pharmacovigilance and the reporting of adverse drug reactions.¹ In their discussion, Härmark and van Grootheest¹ suggested that “concerned reporting” would be a better term to describe the reporting systems commonly referred to as “spontaneous reporting”, because the individuals who provide such reports are often highly selective in what they convey. Edwards² first introduced the idea of concerned reporting when he described spontaneous reports from healthcare professionals as genuine concerns about a drug and a suspected harmful reaction. The term “concerned reporting” also captures the essence and value of voluntary medication incident reporting programs. The reporting of harmful or potentially harmful medication incidents by individual practitioners or by consumers can assist in detecting safety issues.
1. Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64(8):743-752.
2. Edwards IR. Spontaneous reporting.of what? Clinical concerns about drugs. Br J Clin Pharmacol. 1999;48(2):138-141.
Critical Incident

An incident resulting in serious harm (loss of life, limb, or vital organ) to the patient, or the significant risk thereof. Incidents are considered critical when there is an evident need for immediate investigation and response. The investigation is designed to identify contributing factors and the response includes actions to reduce the likelihood of recurrence.

From Davies J, Hebert P and Hoffman C, Canadian Patient Safety Dictionary (Ottawa: Royal College of Physicians and Surgeons of Canada, 2003).
Culture of Safety

A culture of safety is defined as the underlying beliefs and values of an organization as they relate to safety as a priority.

ISMP Canada, HSO, CPSI; 2019.
Dangerous Abbreviations, Symbols and Dose Designations

Abbreviations, symbols and dose designations that have been identified as easily misinterpreted or involved in medication incidents leading to harm and should be avoided in medication-related communications.

ISMP Canada, 2012

The list is available from: http://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2006-04Abbr.pdf.
Deprescribing

Deprescribing is the planned process of reducing or stopping medications that may no longer be of benefit or may be causing harm. The goal is to reduce medication burden or harm while improving quality of life.

https://deprescribing.org/
Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a technique used to identify process and product problems before they occur.

From Canadian Failure Mode and Effects Analysis Framework: Proactively Assessing Risk in Healthcare, Version III. Institute for Safe Medication Practices Canada, Toronto ON, 2017.
Handoff

The process by which one healthcare provider transfers responsibility for a patient’s care to another care provider. A handoff involves communicating essential patient-specific information, including medication-related information, to the next care provider.

ISMP Canada, 2016.
Harm

Harm is defined as a temporary or permanent impairment in body functions or structures. Includes mental, physical, sensory functions and pain.

Developed by the collaborating parties¹ of the Canadian Medication Incident Reporting and Prevention System. 2005.
Hierarchy of Intervention Effectiveness

A risk management theory that rates interventions related to human behaviour (e.g. education and training) at the lower end of its scale, and technological interventions (e.g. forcing functions and automation) as higher leverage actions and more reliable.

Institute for Safe Medication Practices. 1999. Medication Error Prevention “Toolbox”.
High-Alert Medications

High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error.

ISMP’s List of High-Alert Medications. Available at: www.ismp.org/Tools/highalertmedications.pdf.
Human Factors Engineering

Human factors engineering is the discipline concerned with understanding how humans interact with the world around them. It draws upon applied research in many areas, such as biomechanics, kinesiology, physiology, and cognitive science, to define the parameters and restraints that influence human performance. This knowledge can be used to design systems so that they are compatible with human characteristics. Conversely, if systems are not compatible with human characteristics, performance can be adversely affected.

From Failure mode and effects analysis (FMEA): a framework for proactively identifying risk in healthcare. Version 1. Toronto (ON): ISMP Canada; 2006.
Incident Analysis

A structured process that aims to identify what happened, how and why it happened, what can be done to reduce the risk of recurrence and make care safer, and what was learned.

From: Incident Analysis Collaborating Parties. Canadian Incident Analysis Framework. Edmonton, AB: Canadian Patient Safety Institute; 2012. Incident Analysis Collaborating Parties are Canadian Patient Safety Institute (CPSI), Institute for Safe Medication Practices Canada, Saskatchewan Health, Patients for Patient Safety Canada (a patient-led program of CPSI), Paula Beard, Carolyn E. Hoffman and Micheline Ste-Marie.
Incident Management

The various actions and processes required to conduct the immediate and ongoing activities following an incident. Incident analysis is part of incident management.

From: Incident Analysis Collaborating Parties. Canadian Incident Analysis Framework. Edmonton, AB: Canadian Patient Safety Institute; 2012. Incident Analysis Collaborating Parties are Canadian Patient Safety Institute (CPSI), Institute for Safe Medication Practices Canada, Saskatchewan Health, Patients for Patient Safety Canada (a patient-led program of CPSI), Paula Beard, Carolyn E. Hoffman and Micheline Ste-Marie.
Independent Double Check

An independent double check is a process in which a second practitioner conducts a verification. Such verification can be performed in the presence or absence of the first practitioner. In either case, the most critical aspect is to maximize the independence of the double check by ensuring that the first practitioner does not communicate what he or she expects the second practitioner to see, which would create bias and reduce the visibility of an error.

Institute for Safe Medication Practices Canada © January 2005. Adapted with permission from: Institute for Safe Medication Practices (US). The virtues of independent double checks – they really are worth your time! ISMP Safety Alert. 2003 March 6;8(5):1
Long-Term Care

Long-term care is defined as care provided in facilities offering accommodation for people who require on-site delivery of supervised care, 24 hours a day, 7 days a week, including professional health services and high levels of personal care and services (e.g., in nursing homes and residential continuing care facilities). The acuity of people receiving long-term care is generally less than that of patients in acute care or complex continuing care settings. Medications for residents in long-term care are usually provided by community pharmacies.

Definition adapted from: Long-term facilities-based care [Internet]. Ottawa (ON): Health Canada; 2005 [cited 2007 Dec 28]. Available from: http://www.hc-sc.gc.ca/hcs-sss/home-domicile/longdur/index_e.html
Medication Incident

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/ packaging/ nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

Adapted with permission from the National Coordinating Council for Medication Error Reporting and Prevention, What Is Medication Error?

Developed by the collaborating parties¹ of the Canadian Medication Incident Reporting and Prevention System. © 2001.

Simplified Definition for Medication Incident:
A mistake with medication, or a problem that could cause a mistake with medication.

ISMP Canada, 2010.

Similar Term: Medication Error
Medication Management

Medication management is defined as patient-centred care to optimize safe, effective and appropriate drug therapy. Care is provided through collaboration with patients and their health care teams.

Developed collaboratively by the Canadian Pharmacists Association, Canadian Society of Hospital Pharmacists, Association of Faculties of Pharmacy of Canada, and ISMP Canada, 2012.
Medication Reconciliation

A formal process in which healthcare providers work together with patients to ensure accurate and comprehensive medication information is communicated consistently across transitions of care.

ISMP Canada. Medication Reconciliation in Acute Care: Getting Started Kit. 2011
Medication Safety

Freedom from preventable harm with medication use.

ISMP Canada, 2007.
Near Miss or Close Call

An event that could have resulted in unwanted consequences, but did not because either by chance or through timely intervention the event did not reach the patient.

Developed by the collaborating parties¹ of the Canadian Medication Incident Reporting and Prevention System. 2005.

Similar Terms: Near Hit or Good Catch
Never Event

Never events are patient safety incidents that result in serious patient harm or death, and that can be prevented by using organizational checks and balances.

Never Events for Hospital Care in Canada. Canadian Patient Safety Institute, Edmonton: September, 2015.
No Harm Event

An incident occurs which reaches the patient, but results in no injury to the patient. Harm is avoided by chance or because of mitigating actions.

Developed by the collaborating parties¹ of the Canadian Medication Incident Reporting and Prevention System. 2005.
Opioid Stewardship

Opioid Stewardship:

Coordinated interventions designed to improve, monitor, and evaluate the use of opioids in order to support and protect human health.

ISMP Canada, 2017.
Root Cause Analysis

An analytic tool that can be used to perform a comprehensive, system-based review of critical incidents. It includes the identification of the root and contributory factors, determination of risk reduction strategies, and development of action plans along with measurement strategies to evaluate the effectiveness of the plans.

From Hoffman C, Beard P, Greenall J, U D, White J. Canadian Root Cause Analysis Framework, Canadian Patient Safety Institute, Edmonton: March, 2006.
Safety

Freedom from accidental injuries.

From Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: Building a safer health system. Washington, DC, National Academy Press, 1999.
Safety Signal
- Preliminary indication of a medication safety related issue that was identified through data analysis, including review of medication incident reports.
ISMP Canada, 2022
System

A set of interdependent elements (people, processes, equipment) that interact to achieve a common aim.

From World Alliance for Patient Safety. WHO draft guidelines for adverse event reporting and learning systems. Geneva (Switzerland): World Health Organization; 2005
TALLman Lettering

TALLman lettering is a method used to assist in the differentiation of look-alike/sound-alike drug names through the application of UPPER CASE lettering to certain sections of drug names. TALLman lettering has typically been applied to syllables or groups of letters within drug names to bring attention to the points of dissimilarity between confusable names.

From Application of TALLman Lettering for Drugs Used in Oncology. ISMP Can Saf Bull. 2010 Nov 11 [cited 2010 Nov 19];10(8):1. Available from: http://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2010-08-TALLmanforOncology.pdf

¹Collaborating parties for the development and implementation of the Canadian Medication Incident Reporting and Prevention System (CMIRPS) are: Institute for Safe Medication Practices Canada, Canadian Institute for Health Information and Health Canada.