Canadian government mandates reporting of serious ADRs & other adverse events in healthcare

The Canadian government has taken a leadership role by mandating the reporting of ADRs and other serious adverse events in hospitals. The new regulations will take effect in late 2019 and will require reporting within a 30 day time frame of events. The reporting requirements apply to all hospitals licensed, approved or designated as a hospital by a province or territory of Canada to provide care or treatment, or which are operated by the Government of Canada and provide health services to in-patients. The requirements will apply to prescription and non-prescription drugs, medical devices, disinfectants, vaccines (except those administered under a routine immunization program of a province or territory), plasma proteins and radiopharmaceuticals. More detail of the new requirements can be found in this guidance document. This approach is an excellent example of leadership in the medicines safety arena.