FDA To Increase Scrutiny Of Drug Risks With Sentinel System

Posted by Greg WebbJune 17, 2008 9:00 AM

Because there have been repeated instances of popular medications proving to be deadly, federal health officials have announced a major effort to use information on Medicare claims to evaluate the risks of pharmaceuticals already on the market. The current, unsystematic system allows for months or years to pass before an unexpected side effect is detected; the Food and Drug Administration (FDA) estimates only a fraction of actual drug effects are reported. Patients, manufacturers and doctors are on their own to report problems with drugs and medical devices. One doctor can see an infection following the use of a drug important, while another may not. Unexpected side effects, and lag time before official detection, can cost dozens or even thousands of lives.

For the first time, however, the new system, called the Sentinel Initiative, will allow FDA officials to almost immediately monitor how drugs affect health. They will be able to get a clear idea of what percentage of a drug’s recipients experience a certain side effect. For example, if the FDA would like to know how often antibiotics like Cipro and Factive cause ruptured tendons, with Sentinel, Medicare officials could be asked to count the number of patients who receive the antibiotic and later see a doctor or check into a hospital with tendon difficulties. Sentinel will also allow officials to see which drugs are not working, saving the government money and patients’ suffering. FDA officials have repeatedly ensured the public that the agency and other researchers will not have access to any personal information of Medicare beneficiaries.

The Sentinel Initiative has been in the works for the past few years. In 2005, the FDA was asked to explore the creation of such a system, and in 2006 the Institute of Medicine recommended one. Last fall, Congress voted to require the agency to create the system. Researchers have praised the new government initiative, however many say its positive results will take years to realize. Several researchers have also stated the Bush administration’s policy of delivering the Medicare drug benefit through countless private plans have made the effort much more difficult.

Critics of the initiative have pointed out that Medicare only collects data when a doctor, medical provider or hospital is seeking payment. This data is far less accurate than actual patient health records. Another problem is sometimes patients develop an illness after receiving drugs and the drug is not to blame. Finally, on average, patients with Medicare use twenty-eight prescriptions, far more than the sixteen prescriptions used by the rest of the American public. To assess the accuracy of Sentinel, the FDA will first test drug side-effects that are already widely known. http://www.nytimes.com/2008/05/23/washington/23fda.html?_r=1&ref=health&oref=slogin