FDA launches Sentinel Initiative health system

WASHINGTON The Food and Drug Administration has unveiled its new health system, the Sentinel Initiative, according to published reports. This system will allow the agency to use information on Medicare claims to immediately assess the risks of drugs already on the market.

With Sentinel, the agency could ask Medicare officials to count the number of patients on a certain medication who later saw their doctors or checked themselves into a hospital with an ailment. Then, it could compare the overall number of that same ailment among Medicare beneficiaries.

The use of Medicare records may solve many of these problems because the agency could get a clear idea of what percentage of a drug’s recipients suffer a certain effect. But there are several problems with this new system.

Most importantly, Medicare collects data only when a doctor, hospital or other medical provider is seeking payment. These are called “claims data,” and they are far less accurate than actual patient health records.

For instance, when a hospital bills Medicare for treating a patient with a heart attack, it is not always the case that the patient actually suffered a heart attack any time recently. So using Medicare data to assess health outcomes is problematic.

Another issue is that sometimes patients suffer problems after receiving drugs because they are sick, not because the drug is to blame. Finally, Medicare beneficiaries use an average of 28 prescriptions in a year, compared with an average among all Americans of 13 prescriptions. Sorting out which medicine caused any single problem can be difficult in the elderly.

To assess the accuracy of the Sentinel system, the FDA will initially conduct studies of drug side-effects that are already well known, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. The agency is in discussions with private insurers to add their records to the system.

Health officials also said they could use the Sentinel system to identify drugs that are not working, a result that could save the government money and relieve patient suffering.

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said his organization supported the FDA initiative “because it allows regulators and health care professionals to move from reliance on voluntary reporting of side effects to proactive monitoring of medicines.”