441-01652 (Health)

The health and safety of Canadians is Health Canada’s top priority. The Department's mandate as the regulator of health products involves administering the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR) to help Canadians maintain and improve their health.

Before a health product is approved in Canada, the Department conducts a rigorous scientific review of its safety, efficacy and quality. An authorization is only issued when the benefits of the product outweigh the risks of its use as intended based on the information available at the time.

Health Canada continues to monitor the safety of authorized health products available on the Canadian market through the Canada Vigilance Program (CVP) to ensure the benefits of the product continue to outweigh its risks. The CVP is Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products. Adverse reaction reports are submitted by healthcare professionals and consumers on a voluntary basis, whereas hospitals, manufacturers and distributors are required to report by law. The CVP provides a variety of tools to support adverse reaction reporting, which can be done online, by phone or by submitting the Side Effect Reporting Form by fax or mail. To search the Canada Vigilance Adverse Reaction Online Database, please visit the following website. When new safety issues are identified, Health Canada takes action, which could include communicating new safety information to Canadians and healthcare professionals, changing the recommended use of the health product, or, if warranted removing the health product from the Canadian market.

Health Canada works closely with manufacturers to implement risk mitigation measures for risks associated with the use of authorized health products. The Department uses several tools to inform and educate patients on these risks including, but not limited to, product labelling, and distribution of patient education and counselling materials. In addition, Health Canada encourages manufacturers to engage with physicians and pharmacists to ensure the appropriate implementation of these measures. The options considered should fit the clinical situation and also take into account patient confidentiality and access to medications.

The safe use of a medication is a shared responsibility. While Health Canada evaluates the overall benefits and risks of a health product and communicates those risks to help the public make informed decisions, individual benefits and risks are considered by the treating healthcare professional. The prescribing of drugs and patient counseling are part of the ‘practice of medicine’ or ‘practice of pharmacy’ and are regulated provincially and territorially by the various professional colleges.

Health Canada also funds the Canadian Medication Incident Reporting and Prevention System (CMIRPS). Under CMIRPS, hospitals report medication errors to the National System for Incident Reporting (NSIR); community pharmacies report medication errors to the National Incident Data Repository for Community Pharmacies, and individual practitioners and consumers can report medication errors to the Institute for Safe Medication Practices Canada (ISMP Canada). Reports of medication errors, as well as near misses and other reports of concern are collected and analyzed for shared learning in an effort to prevent medication errors. Further, amendments to the Food and Drug Act through the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law) have strengthened the regulation of therapeutic products and improve the reporting of adverse reactions by healthcare institutions.

Detailed information, including side effects associated with a marketed health product, is provided in its official Canadian Product Monograph (CPM), which is updated to reflect new safety information as required and can be accessed using the Drug Product Database. This information helps to ensure that both prescribers and patients have access to information to guide their decisions about whether or not to use a particular product. Suicidal ideation is a  known risk for various psychotropic medications. The Canadian product monographsfor these medications note the potential risk for suicidal ideation associated with their use in the Warning and Precautions section, and in the patient counselling information section.

In addition, the federal government focuses its efforts, through its funding for Healthcare Excellence Canada (formerly the Canadian Patient Safety Institute) on collaborative work with all jurisdictions and system stakeholders to support the different legal, regulatory, and care delivery processes that can be used to reduce the occurrence of unintentional harm. One example of this work is the Appropriate Use of Antipsychotics collaborative, which has leveraged a person-centered approach to care as a means to deprescribing antipsychotics that no longer benefit and potentially cause harm for people living with dementia. This approach can improve the person’s quality of life and safety, providers’ work–life balance, and family and care partners’ satisfaction.

Health Canada will continue to monitor the safety of health products available on the Canadian market, including psychotropic medications to identify and assess potential harms. Health Canada will take appropriate and timely action should any new health risk, or changes in known risks, be identified.