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.
For more information about Wolters Kluwer Health, visit
http://www.wkhealth.com.
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(R);
electronic information providers, such as Ovid, Medi-Span(R) and
ProVation(R); and pharmaceutical information providers such as Adis
International and Source(R). Wolters Kluwer Health has annual revenues
(2007) of $1,044 million (€761 million) and employs approximately 2,700
employees globally. For more information, visit http://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
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SOURCE Wolters Kluwer Health Copyright©2008 PR Newswire. All rights reserved | |
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