World OF DRUG SAFETY MODULE

Epidemiology Databases

Contract specialists in OSE procure linked pharmacy-medical claims databases. These databases give FDA access to the healthcare data of more than 24 million people in the United States, covering geographically and financially diverse populations. These linked databases cover about 8 percent of the U.S. population.

With these data OSE performs formal epidemiologic analysis and tests certain hypotheses about drug safety. For example, using these data OSE can assess the risk of heart disease in persons taking stimulants commonly used to treat attention deficit hyperactivity disorder. This type of information cannot be obtained from spontaneous reports or other sources.