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National Office Of Drug Safety Is Needed, Experts Say In JAMA

oblems that are most commonly induced by drugs, such as birth defects, aplastic anemia, and certain irregular heart rhythms.

The authors also say that the new office should identify the priority targets for prevention efforts. "Are preventable drug-related injuries occurring because of inadequate initial testing, a breakdown in post-market surveillance, physician prescribing errors or a lack of patient compliance?" they ask.

"The nation needs an office of drug safety with the authority, independence, funds and legal mandate to undertake all four of the major tasks that define a basic drug safety monitoring program," the three conclude. "The funds to pay for this expanded safety program should come from user fees collected from pharmaceutical companies."

They contend that just one penny per prescription would yield approximately $24 million for an enhanced drug safety monitoring program. Additional funds raised the same way "could finance other needed initiatives in long-term drug testing, safety research and education at the nation's medical centers."

They add, "This investment in drug safety has the potential to save thousands of lives and prevent tens of thousands of serious injuries each year."

Furberg is a professor and chairman of the Department of Public Health Sciences at Wake Forest University Baptist Medical Center. He has been instrumental in raising questions about the safety of a group of drugs called calcium channel blockers, which are used in the treatment of high blood pressure. Research has implicated the drugs in connection with cardiovascular diseases, stomach and intestinal bleeding, cancer and brain damage and memory loss.

Moore is with the Center for Health Policy Research at George Washington University Medical Center, and Psaty is with the Cardiovascular Health Research Unit at the University of Washington.


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Contact: Robert Conn
Rconn@wfubmc.edu
336-716-4587
Wake Forest University Baptist Medical Center
20-May-1998


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