FDA Tracks Influenza A Treatment with Prescription Data - Pharmaceutical Technology

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FDA Tracks Influenza A Treatment with Prescription Data


ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration is using prescription data from market research firm Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses, according to a statement that the company released last week. Wolters Kluwer is providing the agency with weekly updates so that the latter can track groups of patients throughout the United States who are being treated with the four most popular oral antiviral prescriptions.

The data show agency officials where prescriptions for oral antivirals are being filled and help FDA identify areas of high concentrations of antiviral use. The information sorts oral antiviral use by location and provides FDA with demographic information about 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, in the press release. “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.”

Wolters Kluwer’s updates provide details about the four antivirals and permit the agency to track use nationally, regionally, and by state. The data also reveal antiviral use at core-based statistical area and combined statistical area levels.

FDA contracted Wolters Kluwer to provide two years of prescribing data for each drug to help the agency evaluate historical norms of use and identify spikes in prescriptions. The weekly flu tracking began in early September 2009 and will continue for at least one year, according to the company.

“We’ve already been successful at identifying clusters of antiviral prescriptions in various geographic pockets,” said Joe Markmann, the company’s director for healthcare policy, in the press release. “One of them recently shows clear spikes within regions of Alabama, a finding that reflects what the Centers for Disease Control and Prevention [CDC] is reporting and further reinforces the reliability of the data.”

CDC recommends that all people with suspected or confirmed influenza who require hospitalization be treated with oseltamivir or zanamivir. Roche (Basel) sells oseltamivir under the trade name Tamiflu, and GlaxoSmithKline (London) sells zanamivir under the trade name Relenza. Rimantadine and amantadine are also used to treat influenza A, but currently circulating influenza A viruses resist these drugs, according to CDC.

See related PharmTech articles:

Single Dose H1N1 Vaccines Get FDA OK (ePT article)

Continued Steps toward H1N1 Vaccine (blog post)

HHS Orders H1N1 Vaccines and Vaccine Antigen (ePT article)

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Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
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