Methodology Considerations in Planning and Analysis of Studies of Drug-Disease Associations Using a Medicaid Data Base

For post-marketing surveillance of drugs, the U.S. Food and Drug Administration (FDA) has been exploring the use of a computerized data base containing records of paid claims for health services provided to patients covered by the Medicaid programs of the states of Minnesota and Michigan. The data base currently consists of longitudinal records of up to 2 years coverage on almost 1.6 million patients, all of whom have prescription drug codes (NDC) or diagnosis codes (ICD-9CM) representing services for their periods of health coverage. The patient record is identified by demographics of age, sex, state, and geographic area, and the codes are indexed chronologically by date of service and provider identification.