FDA Will Monitor Medical Records Of Medicare Beneficiaries

HHS on Thursday announced the creation of a newprogram that will allow FDA, state agencies and academic researchers touse medical record data to ensure drugs and medical devices are safe forconsumers after they enter the market, the WashingtonPost reports(Stein, Washington Post, 5/23). The so-called "SentinelInitiative" has been discussed for years, according to the NewYork Times. In2005, HHS Secretary Mike Leavitt asked FDA to explore launching such a program.In 2006, the Institute of Medicine recommended the creation of adrug-monitoring program. In fall 2007, Congress passed legislation (HR 3580)that required the creation of a drug-monitoring program and President Bush signedit into law (Harris, New York Times,5/23).

Sentinel will begin by allowing access to data from more than 25 millionMedicare drug benefit beneficiaries (Washington Post, 5/23). TheMedicare data will become available in 30 days under the regulation announcedon Thursday, according to the AP/San Francisco Chronicle (Freking, AP/San FranciscoChronicle, 5/22). Leavitt said FDA also is speaking with privateinsurers about allowing their plans' data to be included in Sentinel. WellPoint last month said it plans to contract with FDAto provide data from its plans. According to Bloomberg/BostonGlobe,WellPoint has 35 million members, more than any other insurer (Bloomberg/BostonGlobe, 5/23).

Currently, FDA uses voluntary self-reporting to discover adverse reactions. Accordingto the Los Angeles Times, self-reporting from health care providers reveals an estimated 1% to 10%of problems with drugs and medical devices. Because U.S. seniors are large consumers ofprescription medications, "Medicare's trove of inpatient, outpatient andprescription plan data is considered particularly rich," the LosAngeles Times reports (Alonso-Zaldivar, Los Angeles Times,5/23).

Acting CMS Administrator Kerry Weems said the initiativealso could help reduce the $900 million spent on treating outcomes of adversedrug events each year. He added that data collected by Sentinel will be usedfor comparative effectiveness -- a study technique that compares cost andeffectiveness of treatments (Armstrong, CQ HealthBeat, 5/22).

Privacy Issues, OtherConcerns

Federal officials in twonews conferences announcing the initiative repeatedly assured that FDA andother agencies with access to the data would not have access to personalinformation of Medicare beneficiaries, according to the New York Times(New York Times, 5/23). "FDA will not receive informationthat identifies individual patients, so patient privacy will remainprotected," Leavitt said (Washington Post, 5/23).

Mark McClellan, former Medicare administrator and a senior fellow at the Brookings Institution, said the initiative was a goodmodel for preserving patient privacy because the data stay with an insurer,within a medical practice or within Medicare, according to the AP/Chronicle.McClellan added that FDA does not need personal information for the initiative."What FDA mainly needs to know is what's going on in the population beingtreated by all these different components of our health care system," McClellansaid (AP/San Francisco Chronicle, 5/23).

According to the New York Times, there could be "severalproblems" with the Sentinel Initiative. Medicare data, which are collectedonly when a doctor, hospital or other medical provider seeks payment, are"far less accurate" than patient health records, the New YorkTimes reports.

In addition, the data could be skewed because patients are already sick beforethey receive the medication. Also, Medicare beneficiaries on average receive 28prescriptions annually, compared to an average of 13 for all U.S. residents,which could make it difficult to determine which treatment is at fault forcomplications (New York Times, 5/23).

Reaction

The pharmaceutical industryis concerned Sentinel will raise unnecessary worries because the analysis ofdata will not be as rigorous as a clinical trial, the Wall Street Journalreports. However, FDA Center for Drug Evaluation and Research Director Janet Woodcock said that the agency will work with its partners in the public and private sectors to help subdue false conclusions (Favole/Mundy, Wall Street Journal, 5/23).

Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said that the trade group supports Sentinel "because it allows regulators and health care professionals to move from reliance on voluntary reporting of side effects to proactive monitoring of medicines" (New York Times, 5/23).

Leavitt said, "Before Sentinel, tracking drug safety was like looking at the stars in your back yard with the naked eye. After Sentinel, it's like giving you the strongest telescope on the market, which allows you to see precise details in great distances" (Washington Post, 5/23).

Weems said, "The reduction of adverse drug events will not only promote the health care of our beneficiaries but is a key step in reducing unnecessary costs to the Medicare trust fund" (Young, The Hill, 5/22).

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