HHS on Thursday announced the creation of a new program that will allow FDA, state agencies and academic researchers to use medical record data to ensure drugs and medical devices are safe for consumers after they enter the market, the Washington Post reports (Stein, Washington Post, 5/23).
The so-called "Sentinel Initiative" has been discussed for years, according to the New York Times. In 2005, HHS Secretary Mike Leavitt asked FDA to explore launching such a program. In 2006, the Institute of Medicine recommended the creation of a drug-monitoring program. In fall 2007, Congress passed legislation (HR 3580) that required the creation of a drug-monitoring program and President Bush signed it into law (Harris, New York Times, 5/23).
Sentinel will begin by allowing access to data from more than 25 million Medicare drug benefit beneficiaries (Washington Post, 5/23). The Medicare data will become available in 30 days under the regulation announced on Thursday, according to the AP/San Francisco Chronicle (Freking, AP/San Francisco Chronicle, 5/22). Leavitt said FDA also is speaking with private insurers about allowing their plans' data to be included in Sentinel. WellPoint last month said it plans to contract with FDA to provide data from its plans. According to Bloomberg/Boston Globe, WellPoint has 35 million members, more than any other insurer (Bloomberg/Boston Globe, 5/23).
Currently, FDA uses voluntary self-reporting to discover adverse reactions. According to 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 of prescription medications, "Medicare's trove of inpatient, outpatient and prescription plan data is considered particularly rich," the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 5/23).
Acting CMS Administrator Kerry Weems said the initiative also could help reduce the $900 million spent on treating outcomes of adverse drug events each year. He added that data collected by Sentinel will be used for comparative effectiveness -- a study technique that compares cost and effectiveness of treatments (Armstrong, CQ HealthBeat, 5/22).
Privacy Issues, Other Concerns
Federal officials in two news conferences announcing the initiative repeatedly assured that FDA and other agencies with access to the data would not have access to personal information of Medicare beneficiaries, according to the New York Times (New York Times, 5/23). "FDA will not receive information that identifies individual patients, so patient privacy will remain protected," Leavitt said (Washington Post, 5/23).
Mark McClellan, former Medicare administrator and a senior fellow at the Brookings Institution, said the initiative was a good model 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 being treated by all these different components of our health care system," McClellan said (AP/San Francisco Chronicle, 5/23).
According to the New York Times, there could be "several problems" with the Sentinel Initiative. Medicare data, which are collected only when a doctor, hospital or other medical provider seeks payment, are "far less accurate" than patient health records, the New York Times reports.