Napke E, Bishop J
Can Med Assoc J. 1966 Dec 17;95(25):1307-9.
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.
对食品药品管理局药品不良反应报告计划的起源和目标进行了审查。已向所有医生提供的一份（F&D 123）简要报告，提供了向管理局报告药品疑似反应的途径。这些报告中的信息被视为机密信息。十二家加拿大教学医院已与管理局签订合同协议，以调查和评估医院环境中发生的药品疑似反应。如果某一产品似乎出现问题，会通知制造商，并在采取任何监管行动之前进行讨论。此外，根据1963年的《新药法规》，药品制造商如果其产品出现任何意外反应，必须通知食品药品管理局。食品药品管理局正在深入思考如何激发该行业对这一计划的兴趣。
