27 Jul Some Adverse Events Not Reported in Regulated Time Frame To FDA

MedicalResearch.com Interview with:
Dr. Pinar Karaca-Mandic Ph.D
Associate Professor, Health Policy & Management
School of Public Health
Division of Health Policy & Management Minneapolis MN
University of Minnesota

Medical Research: What is the background for this study? What are the main findings?

Dr. Karaca-Mandic: Drug safety has received a lot of attention recently, and FDA’s post-marketing drug surveillance program (FAERS) offers and important opportunity to monitor drug safety and update drug warnings. There has been an increasing trend in reports to FAERS of serious adverse drug events and earlier studies suggested that these trends were primarily driven by increased manufacturer reports of serious and unexpected adverse events. While these studies highlighted the overall increase in adverse event rates, manufacturer timeliness in reporting and compliance with the 15 calendar day regulation for expedited reports was unknown, though some recent media coverage has offered anecdotal examples of delay. My co-authors and I were interested in studying not only the reporting of these events, by manufacturers to FDA, but also their timely reporting as required by the Federal regulation. Delays in reporting can have important public health consequences because the FDA uses this information to update drug warnings.

We found that about 10% of serious and unexpected adverse events that are subject to the 15-day regulation were not reported by 15 days. We also found that events that involved a patient death were more likely to be delayed. For example, we found that after adjusting for other characteristics of the report and the patient, about 12% of events that involved patient death, and 9% of those that did not involve patient death were delayed beyond 15 days.

Medical Research: What should clinicians and patients take away from your report?

Dr. Karaca-Mandic: FDA uses FAERS reports to effectively monitor drug safety and update drug warnings. Therefore, timely reporting of adverse events is crucial from a patient safety perspective. While further enforcement is important for reducing delayed reporting from a policy perspective, a simple alternative would be for the patients, clinicians and other patient advocates to directly report the adverse events to FDA instead of through the manufacturer. Currently, very few reports (about 2% in 2013 example) are directly reported to the FDA.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Karaca-Mandic: The federal regulation requires the manufacturers to report the serious and adverse events as soon as possible, but no later than 15 days after receiving the information, and then continue investigating and provide periodic follow up reports. It may be that delayed reporting occurs because manufacturers want to investigate and verify the adverse events, especially those that involve death before they report to FDA. Our study is silent with respect to the optimality of the federal regulation, but it is important to conduct further research to investigate reasons of delayed reporting and of reporting quality in general.

Citation:

Dr. Pinar Karaca-Mandic Ph.D (2015). Some Adverse Events Not Reported in Regulated Time Frame To FDA 

Last Updated on July 28, 2015 by Marie Benz MD FAAD