New study sets benchmark for post-marketing surveillance process

As the FDA focuses more of its attention on post-marketing surveillance for adverse events (AE), a new study shines light on the reporting practices of some of the largest biopharmaceutical companies in the US.

Best Practices LLC, a research and consulting company, surveyed drug safety executives from 15 biopharmaceutical companies, including Amgen, Boehringer Ingelheim, Novartis, Novo Nordisk and Takeda, on a variety of topics related to post-marketing surveillance of adverse drug events. Best Practices says the study’s objective was to “identify best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training.”

Among the findings:

• 50% percent receive more than 1,000 adverse event reports a month.
• Serious reports make up less than 10% of the reports received monthly for 57% of respondents.
• 80% of companies use physicians to review adverse event reports; more than 50 percent also use pharmacists and nurses as reviewers.
• 73% receive adverse event reports from company call centers or disease management programs, followed by company healthcare professionals in the field (67%). Other sources include marketing booths/face-to-face events, consumers who represent the company, distributors, sales force, marketing partners, licensing partners and patients.
• 50% do not collect adverse event reports from Internet sources such as blogs and interactive web events.

The report, entitled “Best Practices for Post-Marketing Surveillance of Adverse Events within the US,” is available at www.best-in-class.com.