Medicare Adverse-Event Data Now Available to Public

A long-discussed initiative to make Medicare data related to adverse medication reactions and malfunctioning devices publicly available went into effect in June.

Under the so-called Sentinel Initiative, the Department of Health and Human Services (HHS) began to release information on medications prescribed and medical devices reimbursed through Medicare—stripped of any personally identifiable information—to federal agencies, such as the National Institutes of Health and the Food and Drug Administration (FDA), as well as state agencies and any interested academic researchers. The goal is to provide data to ensure that medication and medical devices continue to be safe for consumers after they enter the market.

The new program aims to improve the safety of medications and medical devices because adverse reactions to these products account for as many as 100,000 deaths every year, according Rep. Jan Schakowsky (D-Ill.), who has urged stronger postmarketing surveillance.

Originally proposed in 2005 by HHS Secretary Mike Leavitt, the program was finally enacted under legislation (HR 3580, PL 110-85) passed by Congress in May 2007.

Sentinel will start with a database of more than 25 million people enrolled in Medicare's Part D prescription drug program, but HHS officials also are in discussions with private insurers to add their plans' drug and device data.

The system aims to go beyond the FDA's current approach, which calls for physicians, other health care providers, and patients voluntarily to report adverse reactions. Federal officials rethought that approach because they believed that it results in reporting of fewer than 10 percent of medication- and device-related problems.

Even when patients and health care providers do report such problems,“ it often takes many cases before someone detects a pattern worth reporting,” said Leavitt at a May press conference. “So getting enough reports to raise a red flag can take time.”

The new approach should reduce that reaction time, saving lives and money, its backers believe. The program could help reduce the nearly $900 million spent to treat preventable adverse drug reactions annually, according to Kerry Weems, acting administrator of the Centers for Medicare and Medicaid Services. The FDA also plans to use the data collected to study the cost and effectiveness of treatments.

Data on adverse drug reactions will be disseminated to physicians through the MedWatch Partners Program, in which APA and other physician organizations participate. The program educates physicians and other health care providers about the need to report serious adverse events and how to make those reports.

All drug and device data collected will exclude the personal information of Medicare beneficiaries, according to HHS officials. The program is designed so that the personal data stay with insurers, within medical practices, or within Medicare.

Potential problems with the Sentinel Initiative raised during congressional consideration of the program included whether Medicare data, which are collected only when a doctor, hospital, or other medical provider seeks payment, are as accurate as patient health records. Another potential problem with identifying adverse reactions is that they may occur because patients are sick, not because of the medication.

Additionally, because Medicare beneficiaries receive an average of 28 prescriptions annually, including refills, compared with a U.S. average for all age groups of 13, it could be difficult to determine which treatment caused a complication. Federal officials said the increased medication use among the elderly, in addition to their “multiple health problems,” makes the study of related Medicare statistics that much more critical to ensure the safety of those beneficiaries.

The pharmaceutical industry is generally supportive of the program, although it has cautioned that false concerns could be raised by data analyses that are less rigorous than those used in clinical trials.

Additional information on the Sentinel Initiative is posted at<www.fda.gov/oc/initiatives/advance/reports/report0508.html>.▪