World OF DRUG SAFETY MODULE

Procuring these databases is very expensive so FDA also obtains data from federal government agencies. OSE epidemiologists work with staff at the Centers for Medicare and Medicaid Services (CMS) to better understand the nature of healthcare insurance data for the purpose of monitoring the safety of the medicines.

CMS tracks data for more than 25 million Americans over the age of 65. Since CMS covers so many people, its data can provide information about the safety of medicines that is not available through other sources.

CMS is a very important source because the elderly take a lot of medications and they are more likely to use multiple medicines. These data enable FDA to learn more about drugs in this age group.