FDA Taps Prescription Data To Track Treatment Of H1N1 And Other Flu Viruses

Main Category: Swine Flu
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 22 Oct 2009 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Wolters Kluwer Pharma Solutions, Inc., a leading provider of market data and competitive intelligence to the pharmaceutical and biotech industries, announced that the Food and Drug Administration (FDA) is using its prescription data to track the treatment of H1N1 and other influenza viruses. These weekly updates provide the FDA with visibility to clusters of patients across the U.S. being treated with the four most popular oral anti-viral prescriptions.

The data provided will allow officials to see areas of the country where oral anti-virals are being filled and to identify clusters where high concentrations of usage occur. In addition to a breakdown by geography, the data also provide FDA with specific demographic information associated with oral anti-viral patients.

"The FDA is using our prescription data as a means of tracking the treatment of populations affected by flu outbreaks including the H1N1 virus, and the specific medications being used to treat them," said Mark Spiers, President and CEO of Wolters Kluwer Pharma Solutions. "The data are typically not more than five days old upon delivery. This near real-time picture provides the FDA an ability to act quickly in the event of a public health crisis."

The updates provide detailed breakdowns for each of the four anti-virals including the ability to track nationally, regionally, and at the state, core based statistical area (CBSA) and combined statistical area (CSA) levels. The contract calls for Wolters Kluwer Pharma Solutions to provide two years' prescribing data for each drug to help FDA see historical norms of usage. This makes it possible for FDA to identify spikes in prescriptions used to treat flu and the H1N1 virus.

The weekly flu tracking commenced in early September and will continue for one year at a minimum.

"We've already been successful at identifying clusters of anti-viral prescriptions in various geographic pockets," said Joe Markmann, Director for Healthcare Policy, Wolters Kluwer Pharma Solutions. "One of them recently shows clear spikes within regions of Alabama, a finding that reflects what the CDC is reporting and further reinforces the reliability of the data."

To deliver the data, Wolters Kluwer Pharma Solutions utilizes two of its most powerful data-analytics tools. The first is Source Lx Patient Studies Suite for capturing patient-level data, which describe prescription drug use by patient demography. For the required prescription-level data, the company uses Pharmaceutical Audit Suite (PHAST), which captures 80% of the prescription transactions in the U.S., the greatest prescription coverage in the industry.

Last November, Wolters Kluwer Pharma Solutions was one of three awardees for a multi-year contract to provide both prescription and patient-level data to the FDA to give insight into the prevalence of prescription drug utilization within the U.S. population. Weekly flu tracker is an add-on assignment to that program.

About FDA's Mission to Protect the Public Health

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, FDA seeks to continue to access drug utilization data in an outpatient setting at the national level in the U.S.

About Wolters Kluwer Pharma Solutions

Wolters Kluwer Pharma Solutions, Inc. (Bridgewater, NJ) is a leading provider of information and analytics to the pharmaceutical, biotech, and medical device industries. The company's brands include Adis, Source® and VisionCare Group. A provider of business intelligence and services, Adis publishes peer-reviewed pharmacology publications and offers the most respected drug and clinical trials databases in the pharma industry. A longstanding provider of market data and healthcare analytics, Source® offers a unique set of comprehensive patient and physician-level prescribing and usage data. VisionCare Group is a publisher of business and specialty publications and producer of conferences and e-media products.

The company is a wholly owned subsidiary of Wolters Kluwer, U.S., part of Wolters Kluwer, a leading global information services and publishing company. The company provides products and services for professionals in the health, tax, accounting, corporate, financial services, legal, and regulatory sectors. Wolters Kluwer had 2008 annual revenues of 3.4 billion euros ($4.9 billion), employs approximately 20,000 people worldwide, and maintains operations in over 35 countries across Europe, North America, Asia Pacific, and Latin America. Wolters Kluwer is headquartered in Amsterdam, the Netherlands.

Source: Wolters Kluwer Pharma Solutions, Inc