Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.
OBJECTIVE
Health Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review.


METHODS
A list of drugs approved between January 1 1998 and March 31 2013 was developed and serious safety warnings for these drugs were identified. Drugs were put into one of three groups based on the way that they were approved. Kaplan-Meier curves were generated to examine the likelihood of NOC/c drugs receiving a serious safety warning compared with drugs with a priority and a standard review. The time spent in the review process for each of the groups was also measured.


RESULTS
Compared with drugs with a priority review, NOC/c drugs were not more likely to receive a serious safety warning (P = 0.5940) but were more likely than drugs with a standard review (P = 0.0113). NOC/c drugs spent less time in the review process compared with drugs with a standard review.


CONCLUSIONS
Possible reasons for the increase likelihood of a serious safety warning are the limited knowledge of the safety of NOC/c drugs when they are approved and the length of time that they spend in the review process. Health Canada should consider spending longer reviewing these drugs and monitor their post-market safety more closely.
School of Health Policy and Management, York University, 4700 Keele St., Toronto, Ontario, Canada, M3J 1P3.
Joel
J
Lexchin
D002170:Canada; D016208:Databases, Factual; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing / Q000592:standards / Q000706:statistics & numerical data*; D056737:Safety-Based Drug Withdrawals / Q000706:statistics & numerical data*
Health Canada; new active substances; post-market safety warnings; priority review; standard review