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Bulletin

New Mandatory Reporting Requirements For Hospitals

Fasken
Reading Time 3 minute read
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Life Sciences Bulletin

On June 26, 2019, the federal government, under the authorities granted by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), adopted new mandatory reporting requirements for hospitals across the country. These reporting requirements will come into force on December 16, 2019.

The amendments 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 roughly 775 hospitals in Canada.

The mandatory reporting requirements apply to hospitals that are: (a) licensed, approved or designated as a hospital by a province or territory to provide care or treatment; or (b) operated by the Government of Canada and provide health services to in-patients.

Hospitals will be given 30 days from the date of an Adverse Incident, to file their report directly to Health Canada, as well as any additional information that emerges during that 30-day period.

These reports must include:

  • Hospital Information: name and contact information of a representative of that hospital;
  • Event Information: description of the Adverse Incident;
  • Drug Information: drug's brand name or common name, and its DIN; or
  • Medical Device Information: device's name or identifier, manufacturer and the lot or serial number;
  • Patient Information: age, sex, medical condition(s) related to the Adverse Incident, other products being used by the patient and the effects of the Adverse Incident on the patient's health; and
  • Dates: patient's first use of the product, when the patient stopped using the product, when the Adverse Incident occurred and the date of the patient's recovery.

Exemptions

There are a number of exemptions to the new reporting requirements. Hospitals are exempt from reporting Adverse Incidents related to:

  • Vaccines administered under a routine provincial immunization program;
  • Drugs or devices used in clinical trials; and
  • Drugs or devices that are authorized for sale as part of the Special Access Programme.

Lastly, there is a more general exemption to the reporting requirements which exempts hospitals from reporting certain information when the hospital does not possess such information.

Note however that where multiple products are involved, even though one such product might be considered exempt from the reporting requirements, such exemptions do not apply to all products involved.

Intent

The intended goals of the new mandatory reporting requirements for hospitals is the avoidance of costs to the health care system, the generation of greater public confidence in the safety of marketed therapeutic products on the Canadian market, and to avoid costs to the Canadian economy from the loss of productivity.

Additional Resources

Health Canada has also published a Guidance Document: Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals("Guidance"). This Guidance provides additional detail regarding the operational aspects of the reporting including, e.g."

  • Standard forms for the reporting of Adverse Incidents;
  • Methods of submitting Adverse Incident reports;
  • The obligation of hospitals to design and implement reporting procedures;
  • The public availability of data;
  • Inclusion of Adverse Incidents for the off-label use;
  • Consequences of non-compliance with reporting requirements;
  • Etc.

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