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FDA TO DISTRIBUTE PRODUCT ADVERSE EVENT REPORTING GUIDE

This article was originally published in The Tan Sheet

Executive Summary

FDA TO DISTRIBUTE PRODUCT ADVERSE EVENT REPORTING GUIDE to health professionals under MedWatch, its new medical products reporting program. FDA Commissioner David Kessler and FDA staffers discussed MedWatch at a May 4 meeting with health professional organizations. FDA also is in the process of devising an adverse reporting system for OTC drugs exclusively. A proposal for the OTC ADR program is slated for release in September, according to FDA's recent regulatory agenda. The "FDA Desk Guide for Adverse Event and Product Problem Reporting" will contain copies of FDA's new reporting form for over-the-counter and prescription drugs, biologics and devices, guidelines on how to complete the form, examples of filled-in forms, and case studies of serious events. The desk guide will be unveiled with other initiatives at a June 3 commissioner's conference on MedWatch ("The Pink Sheet" May 3, In Brief). FDA wants to increase reports of serious adverse events that are life-threatening or debilitating and hopes to make it easier for health professionals to report adverse events while increasing awareness of the importance of making such reports. "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 drugs, biologics, devices and other products such as dietary supplements, which 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 a toll-free telephone number for health professionals to report product quality problems, a FAX number for sending adverse event forms, and a computer program for submitting reports that can be accessed by modem. Center for Drug Evaluation and Research Division of Epidemiology and Surveillance Acting Director Joyce Johnson suggested that "very, very crude estimates" indicate that "probably somewhere between about 5% and 10% of [serious] events are reported." MedWatch Senior Advisor Dianne Kennedy reported that during 1992, one-third of direct drug-related reports to FDA were serious. At the May 4 meeting, FDAers encouraged health professional organizations to get involved in the new reporting program by signing on as an "FDA MedWatch Partner." 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 has been working with professional associations on the adverse events reporting issue for the past year. FDA suggested that MedWatch partners could: reprint the new reporting form in publications on a regular basis; send a letter to members informing them about MedWatch and encouraging them to report; write articles about reporting in publications; and run public service announcements about reporting in publications. FDA has a model PSA that organizations can use. Some organizations are already initiating such activities. 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 will also run ads in its publications that encourage physicians to report and contact FDA for the reporting desk guide. The American Society of Hospital Pharmacists will run an article about MedWatch in the June issue of its journal. The American College of Clinical Pharmacy has agreed to print the reporting form in its monthly publication. The American Society of Clinical Pathologists has offered to develop a school curriculum about reporting. Advisor to the Commissioner for Strategic Initiatives Sharon Natanblut said that FDA 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 boxed warnings or recalls that resulted from adverse event reporting.
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