The federal government adopted new mandatory reporting requirements for hospitals across Canada under the authorities granted by the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
Amendments are made to the Food and Drugs Regulations (FDRs) and the Medical Device Regulations (MDRs) create reporting requirements for Serious Adverse Drug Reactions (SADRs) and Medical Device Incidents (MDIs) (collectively, "Adverse Incidents") affecting around 775 hospitals.
Requirements apply to the hospitals that are either licensed and approved by province or operated by Canada Government. Reports should be submitted to Health Canada by hospitals within 30 days from the date of adverse event.
These reports must include, Hospital information, adverse event information, drug information, medical device information, patient information and important dates.
Hospitals are exempted from reporting adverse events related to vaccines administered under immunization program, drugs/devices used in clinical trials and drugs or devices for sale as part of the Special Access Programme. If all information is not available then also the hospital is exempted but in case of multiple devices, reporting of not exempted device is necessary.
Goal of this guidance is to avoid unnecessary cost and improve safety.
Mr Vinod Arora, Principal Advisor, IGMPI
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