The Department of Health and Human Services, Food and Drug Administration has a continuing requirement for Access to Outpatient Longitudinal Drug Utilization Data.

A vital part of FDA and CDER’s mission is to protect the public health. In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the US drug safety system. In September 2006, the Institute of Medicine Report entitled, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” was released and outlined numerous ongoing and future activities designed to continue to strengthen the FDA’s drug safety program. The Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Specific recommendations in the IOM report addressed modernizing the drug safety program and outlined activities designed to modernize the process of pharmacovigilance, including activities for the expansion of database resources. In furtherance of this effort and in conjunction with the recommendations in the IOM report, FDA seeks to continue to access drug utilization data in an outpatient setting at the national level in the US.

The ability of FDA to respond expeditiously to the increasing number of postmarketing issues is of paramount importance to the overall public safety. Continued access to these data complements and strengthens the utility of the current passive reporting system by providing estimates of the number of patients exposed to drugs and the number of prescriptions dispensed nationwide in the outpatient setting. These data provide a denominator, or context, for understanding adverse event reports; modeling drug risk based on usage patterns; and calculating patient-based reporting rates for drugs used in the outpatient setting. Access to these data also increase the FDA’s ability to perform regulatory impact studies, particularly those that assess the impact of risk management plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to these data in real time enhances and accelerates the pace of FDA’s regulatory decision-making process.

To provide FDA personnel with:

• Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of outpatient prescriptions over time
• Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of unique patients over time who received dispensed prescription drug products from outpatient settings
• Prescriptions, medical claims, and patient-level demographic information, in either the same or separate, linked resources. If separate linked data resources are proposed, all individuals in the patient-level data resource shall link directly to their dispensed prescription data
• The ability to use these data to characterize the duration of drug exposure to prescription drug products at the patient level and to examine concomitant use of drug products at the patient level
• The ability to use these data to analyze and describe national-level estimates of drug utilization patterns in the outpatient setting through the use of projection or other appropriate methodologies based on a nationally representative sample 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
• The ability to download (or obtain in a timely manner using other means) large datasets as needed