Adverse Reaction Reporting Mechanisms

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Key Messages- Sentinel Event Communication and Reporting

Purpose- The purpose of the key messages is to assist and encourage health care professionals in meeting the adverse reaction reporting requirements for blood and blood products to Health Canada.

Currently, there are dual mechanisms for reporting adverse reactions:

1. The Canada Vigilance Adverse Reaction Database- This database is part of Canada’s regulatory pharmacovigilance system. Reporting of adverse reactions is mandated by federal legislation and subject to regulatory actions by Health Canada.

  • Required by Law: Mandatory reporting of serious and/or serious unexpected adverse reactions to blood products (plasma derivatives) by the manufacturer and to blood components by the blood establishments within fifteen (15) days, and within twenty-four (24) hours for fatalities associated with blood components (Food and Drug Regulations and Blood Regulations).
  • Encouraged/Desired: Voluntary reporting of adverse reactions to blood products by health professionals and consumers to Health Canada.

2. Public Health Surveillance- Transfusion Transmitted Injury Surveillance System (TTISS)

  • Encouraged/Desired: Voluntary reporting of serious, moderate, and selected minor transfusion-related adverse reactions by hospitals. TTISS is retrospective, not real-time and provides annual trending and reports.

The rate of adverse reactions to IVIG infusion is reported to be in the range of 3% to 15%. A significant number are serious affecting renal, cardiovascular, central nervous system, integumentary and hematologic systems. The risk and severity factors in adverse reactions include the patient age, co-morbidity, history (migraine, cardiovascular or renal), dose, concentration, rate of infusion, proprietary formulation and lot(s).

The minimum reporting information for serious and serious unexpected adverse reactions include:

  • Case Identifiers (personal health information legislative considerations);
  • Description of the adverse reaction experienced, including treatment and outcome;
  • Name and lot number of the blood product or blood component suspected to cause the adverse reaction;
  • MAH/ Provider’s contact information in case Health Canada needs further information.

The adverse reaction reporting mechanisms to the Canada Vigilance Program include:

  • By completing a form which you can send preferably by fax (1-866-678-6789)
  • The adverse reaction form is available online at www.health.gc.ca/medeffect and at the back of the Compendium of Pharmaceuticals and Specialties (CPS).
  • By calling toll free at 1-866-234-2345
  • In addition, the Transfusion Medicine stakeholders can send a heads-up email to: MHPD.Blood@hc-sc.gc.ca about lot-associated issues, particularly potential clusters of serious and non-serious reactions.

Safety signals can be identified by Health Canada using the Canada Vigilance Adverse Reaction Database. A signal is the first sign of a product-related adverse reaction triggering the need for further investigation.

  • Some adverse reactions may become evident only after a product is in use by the general population over time.