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Wolters Kluwer Health's Unique Prescription Data Tapped by FDA in Effort to Advance Drug Safety

Multi-year contract to provide U.S. drug utilization patterns allows FDA to evaluate unexpected market events

Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry, today 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 prestigious 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."

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.

About Wolters Kluwer Health
Wolters Kluwer Health (Conshohocken, PA), a division of Wolters Kluwer, is a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry. Major brands include traditional publishers of medical and drug reference tools and textbooks, such as Lippincott Williams & Wilkins and Facts & Comparisons® electronic information providers, such as Ovid, Medi-Span® and ProVation®; and pharmaceutical information providers such as Adis International and Source®. Wolters Kluwer Health has annual revenues (2007) of $1,044 million (€761 million) and employs approximately 2,700 employees globally. For more information, www.wkhealth.com.

About FDA's Mission 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.