UnitedHealth Group To Launch Prescription Drug Safety Registry This Summer
UnitedHealth Group this summer plans to launch a registry that will provide "nearly real-time information" on potential prescription drug safety problems, the Wall Street Journal reports. The registry, which will use a database of 11 million members with prescription drug coverage, will analyze claims data on almost all medications introduced on the market since 2004.
After the database has at least 1,000 members who take a certain prescription drug, the registry will compare the number of claims filed by the group of members who take the medication to that of a similar group who take a similar treatment. Computers will analyze the claims data to track patterns that could indicate medication safety problems, such as a high number of hospitalizations or reports of certain adverse effects.
UnitedHealth also will sell quarterly and annual reports of the results from the registry. The first set of reports, which will become available this June, include a comparison of the erectile dysfunction medications Viagra and Cialis and studies of the antibiotic Ketek, the antidepressant Cymbalta and the pulmonary disease treatment Spiriva. UnitedHealth will market the registry and the reports to pharmaceutical companies and FDA.
FDA has entered discussions with UnitedHealth and others about the use of such registries and reports "to the extent we have the funding," according to Steven Galson, acting director of the agency Center for Drug Evaluation and Research. He added that such registries represent "an evolution in drug-safety information."
FDA also has discussed collaborating with Kaiser Permanente on prescription drug-safety efforts. According to the Journal, FDA "had been talking to health plans and systems about accessing their databases to conduct large safety studies" prior to the withdrawal of Merck's COX-2 inhibitor Vioxx last September and subsequent criticism about the ability of the agency to monitor prescription drug safety.
Under the current system, FDA in large part relies on pharmaceutical companies, which must submit reports of adverse prescription drug events to the agency, to monitor medication safety. However, pharmaceutical companies often rely on physicians, who are not required to report adverse events, often lack the time and in some cases have liability concerns about such reports (Fuhrmans, Wall Street Journal, 4/28).