World OF DRUG SAFETY MODULE

Epidemiology

Epidemiologists analyze data from drug utilization databases. When FDA receives adverse event reports, the Agency often wants to know how many people are taking the medicine. If FDA gets five reports about a certain adverse event and a medicine, it needs to know if the reports are based on 1,000 users, 10,000 users, 100,000 users or millions of users. This information helps determine the potential of the medicine and the impact of the adverse event.

OSE buys data from private vendors that track prescription drug utilization. The data are obtained from pharmacies, health insurance companies and insurance claims. The data can give a national projection of usage about a particular drug.