Canadian healthcare institutions will soon be legally required to report serious adverse drug reactions, a subset of adverse drug events. On November 6th, 2014, the Canadian government introduced amendments to the Food and Drugs Act through “Vanessa’s Law” – the Protecting Canadians from Unsafe Drugs – which includes mandatory reporting of serious adverse drug reactions to Health Canada. Regulations that will define the parameters of the mandatory reporting are pending enactment. Hospitals will be required 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 will potentially increase reporting and enable healthcare institutions in BC to better 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)
Now is the time to re-evaluate current adverse drug event reporting and communication practices, recognize their limitations, and offer alternative models that work not only for researchers but also patients and clinicians.
Currently, less than 5% (and likely lower than 1%) of serious adverse drug reactions are ever reported to oversight bodies. We hope to increase reporting rates by making reporting user-friendly, convenient, and directly relevant to patient care as opposed to an additional documentation burden.