Navigation Links
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

BRIDGEWATER, N.J., Nov. 3 /PRNewswire/ -- 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(R) 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.

For more information about Wolters Kluwer Health, visit

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

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 U.S.

Contact: Tom Kivett

Kivett & Company Communications

+1 212 727-2935

SOURCE Wolters Kluwer Health
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Wolters Kluwer Health Introduces Formulary Facts(TM), a Formulary Analytics Tool that Sets the Standard for Accuracy and Ease-of-Use
2. Wolters Kluwer Health Appoints Susan Driscoll as Executive Vice President & General Manager of the Books Business of its Professional & Education Unit
3. Wolters Kluwer Health Appoints Scott Lubeck Vice President, Technology of its Professional & Education Unit
4. Wolters Kluwer Appoints Robert Becker as President and CEO Wolters Kluwer Health; and Stacey Caywood as President and CEO Wolters Kluwer Law & Business (U.S.)
5. Figure Skater Peggy Fleming, HealthSaver Says: Take Pains For Back Strains, 2nd Most Common Doctor Complaint
6. HealthShares(TM) Announces Quarterly Rebalancing of HealthShares(TM) Indexes
7. Figure Skater Peggy Fleming Teams with HealthSaver: Raise Healthy Children Through Active Parenting
8. HealthSouth Declares Dividend on 6.5% Series A Convertible Perpetual Preferred Stock
9. Figure Skater Peggy Fleming Teams With HealthSaver: Cook Your Way to a Healthy Diet
10. HealthShares(TM) Announces Change to the HealthShares(TM) Cardio Devices Index
11. HealthSouth Corporation Appoints New Member to Board of Directors
Post Your Comments:
(Date:10/13/2015)... ... , ... Curly Hair Solutions® is thrilled to be a ... featuring the newest products and services to hit the market for women. With ... to unveil their recent partnership with Trade Secrets, a leading Canadian beauty retailer. ...
(Date:10/12/2015)... TN (PRWEB) , ... October 13, 2015 , ... ... recipients of its biannual Heroes in Recovery Awards at Foundations Recovery Network’s Moments ... Recovery Network presented the one-of-a-kind awards to Noah Levine and Dean Dauphinais who ...
(Date:10/12/2015)... ... 12, 2015 , ... According to an article from ... particularly in the area of track and field, are at a significantly higher ... peers in the same age group. Dr. Steven Meier of Meier Orthopedic Sports ...
(Date:10/12/2015)... ... October 12, 2015 , ... American Family Care (AFC), the nation’s ... by opening its 151st medical center. Located at 606A Boll Weevil Circle in Enterprise, ... continue fulfilling our mission of making quality health care accessible and economical with the ...
(Date:10/12/2015)... ROSA, CA (PRWEB) , ... October 12, 2015 , ... ... (DSM) at no charge to qualified Managed Care Organizations (MCOs) in order to ... insight and analysis into their decision making process. In addition, the DSM is also ...
Breaking Medicine News(10 mins):
(Date:10/12/2015)... COSTA MESA, Calif. , Oct. 12, 2015 ... reaffirmed the accreditation of Harbor Compounding Pharmacy in ... accreditation is awarded in recognition of the pharmacy,s ... --> ... --> ...
(Date:10/12/2015)... Calif. , Oct. 12, 2015 /PRNewswire/ ... and Chief Scientific Officer of Asterias Biotherapeutics, ... company in the emerging field of regenerative ... webcast, sponsored in part by Asterias Biotherapeutics, ... Lebkowski will discuss the progress to date ...
(Date:10/12/2015)... , Oct. 12, 2015  In a Sutter ... the Journal of Neurology, Neurosurgery, and Psychiatry, the blood ... brain atrophy and cognitive decline in patients in the ... --> --> IVIG, extracted from the ... to amyloid, an abnormal brain protein found in patients ...
Breaking Medicine Technology: