Updated AE Reporting Requirements Needed: Study
Researchers studying drug adverse event reports submitted to FDA in 2014 say that report completeness from manufacturers was poor compared with direct submissions to the agency. They say that FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers.
Writing online in Pharmacoepidemiology and Drug Safety, the researchers note that spontaneous adverse event drug reports collected in FDA’s Adverse Event Reporting System are the primary source for new warnings after drug approval. “While FDA’s new Sentinel Initiative is capable of surveillance using electronic health data, its primary use has been for confirmatory analysis, and it has not yet produced data that served as the primary source for any new Boxed Warning, Contraindication, or other Warning,” the article says.
The basic agency guidance to manufacturers about what to report was issued in 1997 and the latest draft guidance was dated 3/2001, the researchers say.
Their data show that a majority of case reports from drug manufacturers do not include the basic information of age, sex, event date, and a specific medical term. “The findings are robust and parallel a previous study in 2013 and early 2014 data using different criteria,” the report says. “The reasons for these results involve in part an interaction between FDA requirements about what industry must report and new risk management tools and digital era marketing that can result in extensive industry contact with health professionals and consumers.”
The article says that many adverse drug event reports are generated by “commercial marketing activities” and the nature of those activities has changed in the digital era. It says it is now common for manufacturers to offer Web-based services directly to patients such as 24-hour nurse hotlines, health insurance navigators, and online instruction, and all of these interactions may generate large numbers of adverse event reports.
In addition, the researchers say, existing regulations and guidances were published before the enactment of restricted distribution schemes for some of the highest risk drugs. Central pharmacies and similar requirements can also result in manufacturer contact with every patient.
“FDA regulations and guidances created years ago do not suit the changed reporting environment of the digital era in which manufacturers engage in many forms of systematic contact with consumers and health professionals,” the report concludes. “Creating pharmacovigilance protocols for manufacturer-initiated contact programs, increasing detail about why data are collected, rethinking the standards for patient death reporting, and increasing direct reports to FDA can provide opportunities for improved post-market surveillance.”