Safety and Ethics
2.3 Legal Foundations and National Guidelines
There are many federal and provincial laws, as well as national guidelines, that have been established to protect public health and safety. This section will explain how Health Canada and provincial/territorial nursing governing bodies protect the public from medication harm.
Health Canada Health Products and Food Branch
To protect the public, the Health Products and Food Branch (HPFB) of Health Canada is responsible for regulating, evaluating and monitoring the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians. These products include drugs, medical devices, disinfectants and sanitizers with disinfectant claims. [1] Some of the ways that the HPFB protects the public health regarding medications include: enforcing an official drug approval process based on evidence-based research; issuing safety warnings for medications with serious adverse reactions; and regulating over-the-counter (OTC) medications. Each of these actions is further explained below.
Developing New Drugs
Canadian consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. Drug companies conduct extensive research and work to develop and test a drug and follow the Development and Approval Process of Drugs by Health Canada.
Health Canada Approval: What it Means
Health Canada approval of a drug means that data on the drug’s effects have been reviewed by the HPFB, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
The HPFB reviews all new drug submissions and all the information about the drug captured during the development process (quality, preclinical and clinical) and evaluates the risks of the drug versus its benefits to the Canadian population. More specifically, HPFB reviews information regarding the drug’s manufacturing, packaging and labelling, as well as information about the drug’s therapeutic claims and side effects. What doctors and clients will be told about the drug will also be reviewed, through the drug’s monographs and information sheets. All drugs allowed to be sold in Canada are reviewed to ensure that they meet the requirements of the Food and Drugs Act and its Regulations.[2] Once these requirements are met, the drug developer/sponsor receives a Notice of Compliance, confirming the dossier’s compliance with the Food and Drugs Act and its Regulations.
Safety Warnings
The HPFB posts a database of safety alerts, public health advisories, press releases and other notices related to therapeutic health products. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada.[3] In the United States, if a safety problem surfaces, Black Box Warnings are issued by the FDA and appear on a prescription drug’s label. The purpose is to call attention to serious or life-threatening risks.
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