Health Canada Regs Would Strengthen Surveillance of Drugs, Medical Devices
The proposed regulations would require hospitals to report all serious adverse drug reactions and medical device incidents, in writing, within 30 days of when the incident was first documented within the hospital.
Health Canada has proposed regulations aimed at improving the reporting of serious adverse drug reactions and medical device incidents by hospitals. The proposed regulations would amend the Food and Drug Regulations and Medical Devices Regulations to require hospitals to report all serious adverse drug reactions and medical device incidents, in writing, within 30 days of when the incident was first documented within the hospital.
The agency said the proposed regulations are intended to improve the quality of serious adverse drug reaction and medical device incident reports provided to Health Canada and also increase their quantity. Adverse reactions to drugs and incidents involving medical devices account for many hospital admissions and emergency room visits in Canada every year; the agency said these serious incidents are significantly under-reported by clinicians, which is a longstanding problem both in Canada and internationally.
The proposed regulations are based on feedback that Health Canada received during its consultations on the issue during the past two years. Canadians and stakeholders are invited to provide comments on the regulatory proposal between by Aug. 29.
"Our government is continuously looking for ways to strengthen product safety to help ensure better health outcomes for Canadians. Improved reporting will allow Health Canada to take action much more quickly against products that may pose a risk to the health and safety of Canadians," said Ginette Petitpas Taylor, Canada's minister of Health.