Post-Marketing Surveillance: The Approach of the Drug Epidemiology Unit

Abstract

The goal of the Boston University School of Medicine Drug Epidemiology Unit (DEU) is to quantify the serious side effects of drugs, including those that are unknown at the time the drug is first marketed (post-marketing surveillance). Side effects include illnesses serious enough to warrant admission to the hospital and birth defects. To achieve this goal, the DEU collects its own information by personal interview. Although the DEU is carrying out a follow-up study of children in hospitals to assess the acute effects of drugs in pediatric populations, the chief strategy currently used is the case-control approach. Multiple case-control studies of relatively common illnesses are carried out within a relatively small number of institutions. Over 50,000 men and women have been studied, including over 11,000 having cancers of sites of special interest, and over 5,500 children with congenital malformations. For very rare illnesses, the DEU has set up case-locator networks. One of the remaining gaps in post-marketing surveillance is the monitoring of other extremely rare illnesses. The study of these conditions will be costly because of the difficulty and expense in acquiring sufficiently large samples.