Adverse Drug Reactions
The Food and Drug Regulations define a serious adverse drug reaction 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.”
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), assented to on November 6, 2014, amends the Food and Drugs Act to introduce mandatory reporting by Canadian healthcare institutions, as follows:
- Section 21.8: “A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.”
- Section 30(1.3): “Before recommending to the Governor in Council that a regulation be made … the Minister shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens.”
This requirement is intended to improve the reporting of serious adverse drug reactions and medical device incidents to Health Canada. The improved reporting of these types of events would enable the timelier identification and communication of emerging safety issues associated with the use of drugs and medical devices. For these powers to come into effect, sections 21.8 and 30(1.3) must come into force through an Order in Council and changes to both the Food and Drug Regulations and the Medical Devices Regulations must be enacted. These changes will define the applicable healthcare institutions, the information to be provided, and how and when information must be provided to Health Canada.
Key Messages from CSHP
Regulatory proposal on mandatory reporting requirements for Serious Adverse
Drug Reactions and Medical Device Incidents by hospitals–2018
Health Canada's Questions related to Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions–2016
To design a regulatory framework that supports the collection of sufficient data while being respectful of the operational impacts that will be placed on the health system, Health Canada requires a better understanding of the current Canadian healthcare landscape, including existing programs, responsibilities and, information management systems. As such, Health Canada has engaged with the provincial and territorial health ministries and groups that represent the organization and delivery of health care in Canada.
Bill C-17, An Act to amend the Food and Drugs Act, Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
Post-market surveillance of pharmaceutical products, prescription and non-prescription
- Parliament of Canada's Standing Committee on Health – February 14, 2008