July 30, 2018
To enhance the safety of drugs and devices with real-world experience Health Canada is proposing new regulations that will require hospitals to report Serious Adverse Drug Reactions (SADRs) and Medical Device Incidents (MDIs) directly to the federal agency.
Prior to Vanessa’s Law, only industry was required to report SADRs or MDIs; reports from health care professionals were voluntary. While Vanessa’s Law amended the Food and Drugs Act (the Act), regulatory amendments are required in section 21.8 of the Act to specify the types of reportable SADRs and MDIs and the types of health care institutions that would be required and report such events. Health Canada expects these new amendments will help monitor the safety and effectiveness of therapeutic products that may result in necessary label changes or improve risk communications to the public.
The types of medications identified for listing of SADRs include pharmaceuticals (prescription and non-prescription), biologic drugs (excluding vaccines), radiopharmaceuticals, disinfectants and medical devices. Natural health Products (NHPs) do not fall within Vanessa’s Law and are therefore do not require mandatory reporting of SADRs by these health care institutions.
These changes are outlined in Canada Gazette, Part I: Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals). The proposed regulations would come into force six months after the day on which they are published in the Canada Gazette, Part II.
Yet again NHPs are not subject to the same requirements as drugs and it is the consumer who ultimately loses out. As well, there does not appear to be any mention of how or whether manufacturers will be informed of any direct reporting of SADR’s or MDI’s from hospitals to Health Canada.
For more information, please contact Marla Weingarten.