Wolters Kluwer Health's Prescription Data Tapped by FDA in Effort to Advance Drug Safety
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Wolters Kluwer Health, a provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry, was awarded a multi-year contract to provide both prescription and patient-level data to the U.S.
Food and Drug Administration (FDA) to provide the Agency with insight into the prevalence of prescription drug utilization within the U.S. population. This is the first time Wolters Kluwer Health has been selected as a primary source for this contract.
"The FDA is always looking for ways to employ newer and better technology to support research toward a safer environment for patients and their decision to utilize our unique, longitudinal drug data fits right into this progression," said Mark Spiers, President and CEO of Wolters Kluwer Health's Healthcare Analytics business.
"We were able to deliver the right balance of power and speed, that is, ongoing access to national drug utilization patterns with a turnaround that allows the FDA to act in the event of a public health concern," Spiers added.
According to FDA specifications, Wolters Kluwer Health's data will "report national patterns of drug utilization in the outpatient setting" and examine "concomitant use of multiple drug products" over the same time period. To achieve this, Wolters Kluwer Health is to analyze a statistically reliable sample of patients over time to allow FDA to examine patterns of drug utilization within the U.S. population.
To satisfy the FDA's rigorous requirements, Wolters Kluwer Health will utilize two of its most powerful health-related data-analytics tools. The first is the Source® Lx Patient Studies Suite and Market Focus for capturing longitudinal patient-level data (describes outpatient prescription drug use in individuals over time).
For the required prescription-level data, the company plans to use PHAST, which captures 80% of the prescription transactions in the U.S., the greatest patient coverage in the industry. Both tools will be made available to the FDA via a Web-based interface with Wolters Kluwer Health providing operational support.
Access to these data also increase the FDA's ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk managements plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to these data enhances and accelerates the pace of FDA's regulatory decision-making process, according to the FDA as stated in the contract documentation.
