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
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
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
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
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>.▪