Adverse Drug Reactions and Medical Device Incidents
- Serious adverse drug reaction: “ 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; 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.” (Part C, Division 1, subsection C.01.001(1.1) of the Food and Drug Regulations)
- Medical device incident: “an incident related to a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were it to recur.” (Section 62(4) of the Medical Devices Regulations)
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.
On December 16, 2019 regulations supporting the Act come into effect. As of that date all hospitals in Canada are required to report to Health Canada information about any serious adverse drug reaction or medical device incident. The hospital has 30 calendar days from when the event was first documented in the hospital to submit the information to Health Canada. This requirement is in keeping with the requirements laid out in sections C.01.020.1 in the Food and Drug Regulations and section 62 of the Medical Device Regulations.
This mandatory reporting will supply Health Canada with additional post-market safety information about therapeutic products and therefore help Health Canada and others to take appropriate action when a serious risk to health is identified.
Interested in learning more? Check out the following resources.
- Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document. Health Canada (2019).
- Educational support modules developed by the following collaborating parties: Health Canada, Canadian Patient Safety Institute, ISMP Canada, and Health Standards Organization (HSO). The modules are downloadable and can be modified for individual study or for organizations. The modules cover the following topics.
- Overview of Vanessa's Law and Reporting Requirements
- Reporting Processes to Health Canada
- Strategies to Promote and Support Mandatory Reporting
- Health Canada's Review and Communication of Safety Findings
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