Traditionally, Health Canada has only required drug and medical device manufacturers to report serious adverse drug reactions and adverse events involving these products. Health Canada has now rolled out amendments to its Food and Drug Regulations and Medical Device Regulations, both made under Canada’s criminal law powers and the authority of the Food and Drugs Act, that require hospitals to report to Health Canada serious adverse drug reactions and medical device incidents. Health Canada has set December 16, 2019 as the coming into force date for these new mandatory reporting requirements.
According to Health Canada, there are approximately 775 hospitals in Canada that are expected to be subject to these reporting requirements1. These hospitals will be tasked with updating education modules and training for front line staff to identify reportable events under the new regulations, and updating policies and operating procedures to manage their collection of information and reporting obligations.
Below are some considerations for hospital administrators:
- Hospitals may wish to carefully consider the defining parameters of what is reportable. There are two buckets of mandatory reportable events: “serious adverse drug reactions” (SADRs) and “medical device incidents” (MDIs):
- A SADR is “a noxious and unintended response to a drug that occurs at any dose 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 MDI is “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 serious deterioration in the state of health of a patient, user or other person or could do so were it to recur”2.
- These new regulations do not create mandatory reporting obligations for individual health professionals. These regulatory obligations rest solely with “hospitals”, which are defined as “a facility (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or (b) that is operated by the Government of Canada and that provides health services to in-patients”. However, health professionals would be required to cooperate under hospital professional staff by-laws, rules and regulations, and policy.
- Subject to available exemptions, the timeline for reporting such incidents is 30 days from the date on which the event is first documented by the hospital. While the required reporting content for SADRs and MDIs is not identical, some required reporting for both include: the name of the hospital, identifying information for the drug or medical device, the date on which the event was first documented, the description of the event, any contributing factors to the event or any medical condition of the patient that directly relates to the event on the patient’s health.
- Control is an important element for triggering reporting obligations. Specifically, the hospital is exempt from reporting SADRs when the hospital does not have in its “control” all of the following information: the drug’s name (whether its brand, proper, or common name), the patient’s age and sex, and the description of the SADR. Similarly, the hospital is exempt from MDI reports, if the hospital does not have in its control the name or identifier of the medical device and a description of the MDI. As well, these new reporting requirements exempt certain therapeutic products including: a vaccine administered under a routine immunization program, cells, tissues and organs, blood and blood components, semen, and drug and devices regulated under clinical trial and Special Access Program frameworks.
- The process of reporting does not require hospitals to perform a causality assessment to determine whether a drug or medical device causes the reportable reaction or incident.
- Health Canada has prepared a guidance document3 and other materials including posters and reporting forms to assist hospitals with compliance.4
It is expected that these mandatory reporting requirements will increase the number of reports received by Health Canada and hospitals must carefully prepare and consider internal reporting protocols in the next six months.
It remains to be seen how the information collected by Health Canada will be used by Health Canada and other relevant stakeholders. We expect that, at least in any future litigation involving the particular event, a hospital’s disclosure to Health Canada will be considered a relevant production for the purpose of the litigation, whether the hospital is a party to the litigation or not. This increases the importance of ensuring a robust compliance system for these new mandatory reporting obligations.
1 Regulations Amending the Food and Drug Regulations and Medical Device Regulations (Serious Adverse Drug Reaction Reporting- Hospitals): SOR/2019-190, Canada Gazette, Part II, Volume 153, Number 13. Retrieved from the Canada Gazette website.
3 Draft Guidance Document, Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Hospitals, Retrieved from the Health Canada website.