Access to Outpatient Prescription and Patient Level Drug Utilization Data

The Center for Drug Evaluation and Research (CDER) to acquire outpatient prescription and patient level drug utilization data subscription to provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level counts of outpatient prescriptions and unique patients utilizing prescription drug products in an outpatient setting over time; prescription-medical claims and patient-level information, in either the same or separate, linked resources; the ability to use these data to characterize the duration of exposure to prescription drug products at the patient level and to examine concomitant use of multiple drug products at the patient level over the same time period; the ability to use these data to describe national patterns of drug utilization in the outpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel; direct, unlimited, Internet or network-based access to all HIPAA-compliant data in a multi-user environment and in real time; and the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.