On November 6th, 2014, the Canadian government introduced amendments to the Foods and Drugs Act through “Vanessa’s Law” – the Protecting Canadians from Unsafe Drugs Act – which includes the mandatory reporting of serious adverse drug reactions in health institutions to Health Canada. A serious adverse drug reaction is defined as a “noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening, or results in death”. 23
As of December 16th, 2019, hospitals are now required to report serious adverse drug reactions associated with the use of pharmaceuticals, biologic drugs (except routine vaccinations), radiopharmaceuticals, disinfectants, and medical devices to Health Canada within 30 days of the event being first documented by the hospital. Our work to integrate adverse drug event reporting into BC’s health care system can help support healthcare institutions in BC to meet federal mandatory reporting requirements.
· For more background on Vanessa’s law, click here. (Backgrounder Series)
· For a timeline of how Bill C-17 developed, click here. (Backgrounder Series)
Currently, less than 5% (and likely lower than 1%) of serious adverse drug reactions are reported to oversight bodies. We hope to increase reporting rates by making reporting user-friendly, convenient, and directly relevant to patient care.