On June 26, 2019, Health Canada announced new reporting requirements for hospitals, which will require hospitals to report serious adverse drug reactions (SADRs) and medical device incidents (MDIs) to Health Canada.
Drugs and medical devices are integral parts of the Canadian health care system, used by many to treat and prevent a variety of conditions. However, all drugs and devices come with risks, including the potential for serious side effects that may lead to emergency room visits or even further hospital admissions. These SADRs and MDIs are significantly under-reported in Canada.
The Minister of Health announced new regulations, coming into force December 16, 2019, that will amend both the Food and Drug Regulations and the Medical Devices Regulations. Hospitals will be required to provide a written report to Health Canada of SADRs or MDIs within 30 days of when the event is documented within the hospital.
The central objective of the regulations is to improve the quality and increase the quantity of reports Health Canada receives on SADRs and MDIs. The department will then be better able to monitor the safety of drugs and devices available on the market and take action when required to protect Canadians.
The regulations use the same definition for a serious adverse drug reaction as the Food and Drug Regulations, which define a SADR 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.”
For greater clarity, the regulations redefine medical device incident as “an incident related to the 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.”
Details the report must include
When a SADR occurs, the incident report must include the information of the hospital where the SADR took place, a description of the drug involved, the patient’s information, including any medical conditions relating or contributing to the SADR, and a description of the SADR.
Similarly, when a MDI occurs, the incident report must include the hospital’s information, the name of the medical device, the effect of the MDI on the patient as well as any patient health factors that may have contributed to the MDI, and a description of the MDI.
Applicable health care institutions
The regulations will apply to all hospitals regulated through provincial or territorial legislation, as well as to those operated by the federal government and that provide health services to persons who are in-patients. Health Canada views these institutions as most likely to treat patients presenting with SADRs and MDIs, well positioned to make and report these observations, and more likely to have the infrastructure needed to effectively support quality reporting while minimizing the relative burden.
Exemptions from reporting requirements
For SADRs, hospitals will be exempt from sending a report to Health Canada if the hospital cannot provide the name of the drug that caused the SADR, basic information about the patient or a description of the SADR. To avoid duplication of reporting, hospitals are also exempt from reporting SADRs when the reaction involves a routinely administered vaccine or select other drugs authorized by the Food and Drug Regulations.
Likewise, for MDIs, hospitals will be exempt from sending a report to Health Canada if the hospital cannot provide the name of the medical device involved or a description of the MDI. Certain medical devices authorized under the Medical Device Regulations are also exempt from reporting requirements.
The rationale for the exemptions is that these key pieces of information are necessary for Health Canada to conduct its basic assessment of the reports.
Health Canada has published a Guidance Document titled “Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals” that provides additional information about the new requirements.