Reports of Potential Drug Side Effects by Physicians, Pharmacists, Patients, and Manufacturers

The Adverse Event Reporting System, or AERS, is the FDA’s system to monitor potential side effects of a prescription drug after it has been approved for use by patients in the U.S.  This system is often referred to as the MedWatch program.  Experts have estimated that as few as ten percent of possible drug reactions are reported to the FDA through AERS, or MedWatch.  Under the current system, the FDA relies upon voluntary reports of possible drug adverse reactions from physicians, pharmacists and patients; drug companies are required to inform the FDA about reports of adverse events involving use of their prescription medications. 

In 2004, the FDA Medwatch program received about 400,000 reports, of which approximately 300,000 involved prescription drug events.  (MedWatch also accepts reports of problems concerning FDA-approved medical devices.)  Of the voluntary reports, 40% were submitted online at the MedWatch site: http://www.fda.gov/medwatch/   The majority of the remaining 60 percent of 2004 AERS reports were made in paper form, i.e., mailed or faxed to FDA; less than one percent were reported by phone.

On Wednesday, May 18, the FDA will begin a two-day meeting with outside consultants to evaluate and discuss possible improvements for the FDA MedWatch program.

Going into this May 2005 meeting top FDA officials acknowledged that, while the current MedWatch program can effectively detect drug-safety problems, their system is flawed.  In a recent letter to the outside panelists who will be participating in the meeting, Paul Seligman, head of the FDA’s statistical science office, said that at present AERS / MedWatch reports "are not systematically collected" and "are often missing important clinical information."  Separately, Anne Trontell, deputy director for FDA’s drug safety office, explained that it is often the case that when adverse event reports are entered into the FDA’s database, staff must call reporting or treating doctors for more details about the incident — such as whether there was any concomitant medication use by the subject patient which may be relevant to the adverse reaction reported.

Apart from tomorrow’s meeting, the FDA is already taking some steps which should allow the agency to discover sooner the various drug-safety "signals", or significant data, so that the FDA can respond more promptly to safety concerns.  On one front, the FDA is working on developing an updated and easier-to-use Web-based reporting system called "AERS II"; significantly, this would send many adverse reaction reports directly into the FDA’s database.  On a different front, the FDA will be working with Medicare on a project intended to discover drug-safety signals, and the FDA will be partnering with health maintenance organizations (HMO’s) like UnitedHealth Care and Kaiser Permanente for a similar purpose. 

• Read more about FDA-Medicare collaboration

http://www.drug-injury.com/druginjurycom/2005/05/medicare_wants_.html

• Read more about FDA-HMO partnership

http://www.drug-injury.com/druginjurycom/2005/04/drugsafety_info.html

(Posted by: Tom Lamb)