The US Food and Drug Administration has launched MEDWatch, a scheme to encourage health care workers to report side effects associated with drugs and other medical products.
MEDWatch will cover adverse events linked with drugs, biological products, devices, dietary supplements, medical foods, infant formulas and other regulated products. Launching the scheme, the commissioner of the FDA said: “The question has been asked if a system like this would have prevented the breast implant tragedy. We believe that it would have stopped it much earlier.”
Manufacturers and distributors of drugs are legally obliged to report side effects. However, reporting is voluntary for doctors and nurses the very people who are most likely to come across any difficulties faced by patients. “The sooner they report it to the FDA the faster the agency can analyze the problem and take corrective action.”
MEDWatch will aim to make it “second nature” for these people to report side effects. It has created a simplified reporting form to replace the five separate forms currently used, and also set up a free 24 hour phone line to provide information on adverse events.
The FDA categorizes as “serious” an adverse event where the reaction is life threatening, when it leads to death, hospital admission, disability, congenital anomaly, or the need for intervention to prevent permanent impairment or damage.
The initiative is being widely supported. Dr Sidney Wolfe, director of the Washington based Public Citizen Health Research Group, told The Lancet (5 June, 1993): “If one of the five adverse reactions which occur are reported instead of FDA’s estimated one out of 10 it would take half as long for FDA to accumulate enough relevant adverse reaction reports to reach a decision to ban or add a warning label to drugs and medical devices.” Thousands of patients worldwide could be spared death or serious injury if the scheme is a success, he added..