FDA-Sponsored Project to Promote Physician Reporting of Adverse Drug Events in Maryland 1985–1988

Abstract

The FDA's Spontaneous Reporting System (SRS) has unique public health utility in monitoring drug safety but its functioning requires attention to encourage physician participation. The State of Maryland undertook an FDA-sponsored project to promote direct physician reporting in 1985. During the first year, intervention consisted of education and a telephone reporting service. The effect of the intervention was evaluated by survey. Knowledge of the FDA-SRS increased (p<.001) but no statistically significant difference in reporting between study and control groups was observed. However, overall state reporting increased four-fold over the previous year's performance (p<.001). In the project's second year, a hospital network was added before funding for the Maryland project was unexpectedly discontinued. The project concludes that physician reporting can be encouraged but that any program directed at accomplishing this objective must have long range planning, a guaranteed source of funding, and employ a wide array of strategies.