Articles on Law, Science, and Engineering

The MedWatch Program[index]

The FDA launched its new postmarket surveillance program on June 3, 1993. Christened the MedWatch program, it is based on a unified reporting form for drugs, biologics (except for vaccines), devices (including in-vitro diagnostics), and special nutritional products. This form has two variants: 3500 for voluntary reporting by health professionals, and 3500a for mandatory reporting by manufacturers, distributors, and user facilities.[2] The forms are identical as regards the information about the patient, the device, and the injury, which occupies the front of the form. The back of 3500a asks for additional information about the reporting entity.

Reporting by health care professionals is voluntary because the FDA has no legal authority to require health care professionals to report device or drug problems. While the FDA has long depended on voluntary reporting for adverse drug reactions, it has made little effort to actively encourage reporting. Each different class of reportable event required a different form, and few physicians knew the forms existed or when to use them. This, in combination with the general reluctance of physicians in the United States to report anything (compliance with mandatory disease reporting laws is very low) resulted in few voluntary reports.

In hopes of improving the rate of voluntary reporting, the FDA is engaged in a substantial public relations effort, including articles in medical and nursing journals and conferences with medical organizations. [3] This campaign is based on reciting examples of drugs that were withdrawn based on voluntary reports and speculating that voluntary reporting would have uncovered the risks of breast implants years earlier. The FDA has also made it easier to make reports, allowing them to be faxed in or sent by modem. While it is difficult to predict the future of this program, it is reasonable to expect it to increase voluntary reporting by health care professionals.

The instructions for the voluntary reporting form emphasize the prejudice in favor of reporting: "Report even if: you're not certain the product caused the event[; or] you don't have all the details." More illuminating is the example in the instructions of a reportable problem: "A nurse noted a frayed cable to the pendant (hand control) of a hospital bed. An investigation showed that the wiring was faulty and had a tendency to fray at its point of entry in the pendant housing. This presented a potential electric shock and/or fire hazard. A recommendation for recall affected 33,155 pendants in distribution." This emphasis on reporting problems that have not yet resulted in injuries corrects the major flaw in the current reporting system. Given that manufacturers and user facilities have usually taken a narrow view of what constitutes a reportable event, the MedWatch program may prove to be problematic because it will generate an independent source of reports that can be used as a check against the completeness of mandatory reporting.

Next - Problems with User Facility Reporting

Previous - Postmarket Surveillance