FDA renews research contract with Symphony Health Solutions for outpatient prescription and drug utilization data

The contract renewal will extend over a five-year horizon. The company began working with the FDA in 2009.

Under the terms of the contract, Symphony Health Solutions will provide applications and data to access outpatient prescription and patient level drug utilization data through the use of the company’s Integrated Dataverse and the PHAST online national audit tool.

These tools provide an integrated, longitudinal view of prescription and medical healthcare services and their combined impacts on the consumption and delivery of healthcare in America.

"Being entrusted by FDA once again with this important initiative is very gratifying. Over the years, we have worked to develop information products that meet the exacting standards of the FDA to assist them in conducting the important work of safeguarding our nation’s health. We are pleased to continue this work," stated Robert Boyce, SVP Strategic Partnerships, Symphony Health Solutions.

The information will be used by FDA to support investigations related to the use of a prescribed product, and assess longitudinal patient data regarding paths of therapy, duration of use and concomitant drug therapies.

This will complement and strengthen the utility of the passive reporting system currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting.

In addition, these data provide a context for understanding adverse event reports, modeling drug risk based on usage patterns, calculating patient-based reporting rates for drugs used in the outpatient setting; and increasing the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk management plans and labeling changes on prescribing habits and usage patterns for prescription drugs.