FDA TO DISTRIBUTE PRODUCT ADVERSE EVENT REPORTING GUIDE

FDA TO DISTRIBUTE PRODUCT ADVERSE EVENT REPORTING GUIDE to health professionals under MedWatch, its new medical products reporting program. FDA Commissioner Kessler and FDA staffers provided a brief introduction to MedWatch at a May 4 meeting with health professional organizations. The "FDA Desk Guide for Adverse Event and Product Problem Reporting" will contain copies of FDA's new reporting form for devices, drugs and biologics, guidelines on how to fill out the form, examples of filled-in forms, and case studies of serious events. The desk guide officially will be unveiled with other initiatives at a June 3 commissioner's conference on MedWatch ("The Gray Sheet" April 19, p. 21). One of the objectives of MedWatch is to increase reports of serious adverse events that are life-threatening or debilitating by making it easier for health professionals to report adverse events and increasing awareness of reporting. "The unfortunate fact," Kessler said, "is that most practitioners...do not know what to report, how to report, when to report and we haven't made it easy. We need to get that into the culture of health professionals." As part of the program, FDA drafted a common reporting form for devices, drugs, biologics and other products such as dietary supplements that was published in the Feb. 26 Federal Register. Kessler said that "right now we are in the process of refining the form based on many of the constructive comments; we received over 70 comments on the draft form." The form will be final in time for the June 3 meeting, he said. Other initiatives that will be announced at the June conference include the establishment of a toll-free telephone number for health professionals to report product quality problems, a facsimile number for sending adverse event forms, and a computer system for sending reports via modem. At the May 4 meeting, Center for Drug Evaluation and Research Division of Epidemiology and Surveillance Acting Director Joyce Johnson said that "very, very crude estimates" are that "probably somewhere between about 5% and 10% of [serious] events are reported." FDAers encouraged health professional organizations to get involved in the new reporting program by signing on as "FDA MedWatch Partners." Kessler told the meeting participants: "We need you to think about ways you can help us and deal with your members...so that in the end, reporting of important adverse events to the agency becomes...almost second nature." FDA suggested that MedWatch partners could: reprint the new reporting form in publications on a regular basis; send letters to members informing them about MedWatch and encouraging them to report; write articles about reporting in publications; and run public service ads about reporting in publications. FDA has a model public service announcement that organizations can use. Some organizations already are initiating activities. For example, the American Medical Association is inserting the reporting form into "every issue" of its newsletter AMA News and will publish an article about the program in the Journal of the American Medical Association, Kessler said. AMA also will run ads in its publications to encourage physicians to report and contact FDA for the reporting desk guide. Advisor to the Commissioner for Strategic Initiatives Sharon Natanblut said that the agency wants to provide feedback on what actions FDA takes in response to adverse event reports. The FDA Medical Bulletin will have a regular column informing health professionals about warnings or recalls that resulted from adverse event reporting.