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"The FDA is always looking for ways to employ newer and better technologyto support research toward a safer environment for patients and their decisionto utilize our unique, longitudinal drug data fits right into thisprogression," said Mark Spiers, President and CEO of Wolters Kluwer Health'sHealthcare Analytics business. "We were able to deliver the right balance ofpower and speed, that is, ongoing access to national drug utilization patternswith a turnaround that allows the FDA to act in the event of a public healthconcern."
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According to FDA specifications, Wolters Kluwer Health's data will "reportnational patterns of drug utilization in the outpatient setting" and examine"concomitant use of multiple drug products" over the same time period. Toachieve this, Wolters Kluwer Health is to analyze a statistically reliablesample of patients over time to allow FDA to examine patterns of drugutilization within the U.S. population.
To satisfy the FDA's rigorous requirements, Wolters Kluwer Health willutilize two of its most powerful health-related data-analytics tools. Thefirst is the Source(R) Lx Patient Studies Suite and Market Focus for capturinglongitudinal patient-level data (describes outpatient prescription drug use inindividuals over time). For the required prescription-level data, the companyplans to use PHAST, which captures 80% of the prescription transactions in theU.S., the greatest patient coverage in the industry. Both tools will be madeavailable to the FDA via a Web-based interface with Wolters Kluwer Healthproviding operational support.
Access to these data also increase the FDA's ability to perform regulatoryimpact studies; in particular, those studies that assess the impact of riskmanagements plans and labeling changes on prescribing habits and usagepatterns for prescription drugs. Finally, direct access to these dataenhances and accelerates the pace of FDA's regulatory decision-making process,according to the FDA as stated in the contract documentation.
For more information about Wolters Kluwer Health, visit www.wkhealth.com.
About Wolters Kluwer Health
Wolters Kluwer Health (Conshohocken, PA), a division of Wolters Kluwer, isa leading provider of information and business intelligence for students,professionals and institutions in medicine, nursing, allied health, pharmacyand the pharmaceutical industry. Major brands include traditional publishersof medical and drug reference tools and textbooks, such as Lippincott Williams& Wilkins and Facts & Comparisons(R); electronic information providers, suchas Ovid, Medi-Span(R) and ProVation(R); and pharmaceutical informationproviders such as Adis International and Source(R). Wolters Kluwer Health hasannual revenues (2007) of $1,044 million (€761 million) and employsapproximately 2,700 employees globally. For more information, visitwww.WKHealth.com.
About FDA's Mission to Protect the Public Health
In early 2005, FDA commissioned the Institute of Medicine (IOM) to conducta study to examine the US drug safety system. In September 2006, theInstitute of Medicine Report entitled, "The Future of Drug Safety: Promotingand Protecting the Health of the Public" was released and outlined numerousongoing and future activities designed to continue to strengthen the FDA'sdrug safety program. The Office of Surveillance and Epidemiology (OSE)contributes to this effort by evaluating drug risks and promoting the safe useof drugs by the American people. Specific recommendations in the IOM reportaddressed modernizing the drug safety program and outlined activities designedto modernize the process of pharmacovigilance, including activities for theexpansion of database resources. In furtherance of this effort and inconjunction with the recommendations in the IOM report, FDA seeks to continueto access drug utilization data in an outpatient setting at the national levelin the U.S.Contact: Tom Kivett Kivett & Company Communications +1 212 727-2935 [email protected]
SOURCE Wolters Kluwer Health
