Health Canada's role in the Management and Prevention of Harmful Medication Incidents
Patient safety is a concern worldwide and is a significant challenge facing healthcare systems today. An important part of patient safety is medication safety, as medication incidents are a leading cause of patient injury. Health Canada, as the federal regulator has a role to play in reducing and preventing harmful medication incidents, particularly those that result from a health product's name, package or label.
What is a Medication Incident?
A medication incident, also referred to as a medication error, is a mistake with medication, or a problem that could cause a mistake with medication. Medication incidents are generally preventable and include errors like receiving the wrong medication or dose, or using the wrong route of administration.
Medication Incidents versus Adverse Reactions
Medication incident and adverse reaction reports are both important sources of information about the safety of a health product.
Adverse reactions, also known as side effects, are unwanted effects that happen when drugs are used under normal conditions. Reactions may appear within minutes or years after taking a drug, and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage.
Unlike a medication incident, an adverse reaction doesn't involve a mistake and typically can't be prevented.
Adverse reactions should be reported to Health Canada's Canada Vigilance Program.
Medication incidents should be reported to
Canadian Medication Incident Reporting and Prevention System (CMIRPS) via the Institute for Safe Medication Practices in Canada (ISMP).
Medication incidents may involve a range of health products, including prescription and non-prescription drugs and natural health products. The health effects of a medication incident can range from no harm to very serious harm, even death.
What can cause a Medication Incident?
Many factors can cause or contribute to a medication incident. These may be related to the health products themselves - i.e. problems with a product's name, package or label - or they may be related to professional practice, procedures and systems, including prescribing, order communication, compounding, dispensing, distribution, administration, education, monitoring and use.
Medication Incidents Related to Product Names, Packages or Labels
When used safely and appropriately, health products play a vital role in the prevention and treatment of disease. Well-designed health product names, labels and packages can support their safe and appropriate use by healthcare professionals, patients and consumers.
Poorly designed health product names, labels and packages can however, contribute to or cause medication incidents.
For example, look-alike and sound-alike (LA/SA) health product names (products whose names share similar spellings or pronunciations or both) have been known to increase the risk of product 'mix-ups.' The Institute of Safe Medicine Practices maintains a list of look-alike, sound-alike drugs.
As with LA/SA product names, product labels and packages may be confusingly similar to those of other products. Other sources of confusion and potential medication incidents include labels or packages that:
- Do not place important information prominently
- Display text using a small font size, which may lead to poor readability
- Are poorly designed or cluttered, which may make it difficult to identify important information or use the product safely and appropriately
Health Canada's Role
Health Canada, as the federal regulator with its authorities to regulate the pharmaceutical industry derived from the Food and Drugs Act and Regulations has a role to play in reducing and preventing harmful medication incidents, particularly those that result from a health product's name, package or label.
The prevention and management of medication incidents requires a collaborative approach between Health Canada, industry, healthcare professionals and facilities, patient safety organizations, patients and consumers. Using a partnered approach, Health Canada works to minimize and prevent the risks associated with medication incidents, with a primary focus on managing and preventing harmful medication incidents that result from a health product's name, package or label.
Health Canada conducts ongoing analysis of medication incident reports to reduce and prevent the occurrence of medication incidents related to health product names, packages and labels. The Department also develops standards, guidelines and best practices to support the safe use of health products through optimal health product naming, packaging and labelling. This includes a Guidance for Industry to help identify potential LA/SA health product name issues during the review process.
Health Canada has working groups in place, with participants from Health Canada, external patient safety organisations and other regulatory bodies, that focus on reducing the risk of harm due to health product names, labels or packages. The Department is also an active partner in the Canadian Medication Incident Reporting and Prevention System (CMIRPS).
The Canadian Medication Incident Reporting and Prevention System
The Canadian Medication Incident Reporting and Prevention System is a national program that collects, analyzes, and distributes information on medication incidents. The knowledge gained through analyzing reports submitted to CMIRPS is used to make medication use safer.
The Institute for Safe Medication Practices Canada (ISMP Canada), Health Canada, the Canadian Institute for Health Information and the Canadian Patient Safety Institute worked closely together to develop and implement CMIRPS, and to coordinate CMIRPS with other patient safety initiatives.
The goal of the program is to reduce and prevent harmful medication incidents. CMIRPS supports a safe medication use system by:
- providing channels for medication incident reporting by healthcare facilities, individual healthcare practitioners, patients and consumers
- analysing medication incident reports and making recommendations for risk mitigation activities
- developing and broadly disseminating information on preventative measures and best practices for safe medication use
Health Canada is an active partner in CMIRPS. In addition to funding support, Health Canada contributes knowledge and expertise from its perspective as the federal regulator of health products, particularly with respect to mitigating health risks related to a health product's name, package or label. As well, Health Canada uses information gathered through CMIRPS as part of its ongoing activities to monitor and improve the safety of medications and other health products in Canada.
- Look-alike Sound-alike Health Product Names
- Adrenalin (epinephrine chloride 1:1000) Intended for Topical Use - Risk of Inadvertent Injection
- For Health Professionals [2010-08-17]
- Notice to Hospitals [2010-08-17]
- Maalox Multi Action (bismuth subsalicylate) - Confusion with Other Maalox Liquid Products - Novartis Consumer Health Canada Inc.
- For Health Professionals [2010-05-17]
- For the Public [2010-05-17]
Canadian Adverse Reaction Newsletter (CARN):
Articles Relating to Medication Incidents.
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