The Canadian drug adverse reaction reporting program.

The origins and objectives of the Food and Drug Directorate's Drug Adverse Reaction Reporting Program are reviewed. A brief report from (F&D 123), which has been made available to all physicians, provides the means whereby suspected reactions to drugs can be reported to the Directorate. Information contained in these reports is treated as confidential. Twelve Canadian teaching hospitals have entered into a contractual agreement with the Directorate in order to investigate and evaluate suspected drug reactions occurring in the hospital setting. Manufacturers are notified if a problem appears to be arising in connection with a product, and discussions are held before any regulatory action is taken. Also, under the New Drug Regulations of 1963, pharmaceutical manufacturers are required to notify the F.D.D. if any unexpected reactions occur in association with their products. The Food and Drug Directorate is giving considerable thought to the means by which the interest of the profession in this program may be stimulated.