Report
Cites Prescription Deaths
By The Associated
Press
December 15, 1999
WASHINGTON
(AP) -- The government uncovers too few
of the injuries and deaths caused by
prescription drug side effects, concludes
a new report that recommends getting more
doctors and hospitals to report
medication problems so health officials
can try to protect patients.
Studies
have estimated that 2 million Americans
are hospitalized annually from drug side
effects, and 100,000 die.
Part of
the Food and Drug Administration's job is
to track side effects of the drugs it
approves for sale, taking action if
unexpected injuries arise and hunting
ways to lower patients' risk.
But the
FDA learned of just 9,961
medication-related deaths and 33,541
hospitalizations in 1997, says a report
by the Department of Health and Human
Services' inspector general, obtained
Tuesday by The Associated Press.
The
problem is not that the FDA isn't trying
-- it's that the injury-reporting system
is largely voluntary, the report said.
The FDA
can only require drug manufacturers to
report the injuries they learn about that
involve their drugs. The FDA does not
have the authority to require doctors and
hospitals to report injuries, either to
the government or to manufacturers who
then pass on the word.
But the
FDA should use more proactive ways to
uncover injuries, including asking
Medicare to require that hospitals
accepting Medicare patients report all
serious side effects to the drug agency,
the inspector general concluded.
``We need
to do more to correct the serious
problems revealed by this report,'' said
Sen. Edward Kennedy, D-Mass., who
requested it. ``It's a tragedy that so
many of these 100,000 deaths a year are
preventable. Many of them could be
avoided by more effective oversight. ...
Clearly, Congress has a responsibility to
give high priority to these important
reforms.''
The report
comes weeks after the Institute of
Medicine, which advises the government on
scientific matters, reported that medical
mistakes kill 44,000 to 98,000
hospitalized Americans a year.
The two
issues are related: Some deaths caused by
prescription drugs occur when doctors
make a mistake in prescribing them.
However, some dangerous drug side effects
are simply a consequence of taking
medicine, like the fact that cancer
chemotherapy leaves patients vulnerable
to infection. Plus, other drug-caused
deaths occur not in hospitalized
patients, but those taking medicines at
home.
The FDA
recognizes the problem.
``We can't
just sit here in Washington and receive
reports (from drug makers) and know
what's going on in the community,'' FDA
drug chief Dr. Janet Woodcock said.
The agency
wants to set up ``sentinel hospitals''
that would specially track and
investigate side effects, helping find
ways to prevent them.
President
Clinton had asked Congress to give the
agency an additional $15.7 million to
improve side-effects reporting, including
adding the sentinel hospitals. But
Congress refused, keeping the agency's
program to track problems with drugs
level at about $12 million, officials
said.
``There's
no doubt the toll of deaths and injuries,
and the economic costs of adverse drug
reactions, is really staggering. It
really does cry for investment,''
Woodcock said.
Every
medication, even aspirin, has some risks.
Some are a
surprise. New drugs are tested on only a
few hundred to a few thousand patients
before they're sold to millions, meaning
rare side effects that didn't show up in
small clinical trials can wind up hurting
hundreds of people.
The FDA
says its passive side-effects reporting
program actually works fairly well in
detecting those. But the inspector
general recommended better coordination
to ensure that when such injuries are
reported, the separate branch of FDA
responsible for warning the public does
so quickly.
In
addition, a proactive side-effects
program would uncover patterns of more
common injuries. For example, some drugs
cause deadly side effects only if
patients take them for too many days, a
pattern that sentinel hospitals could
uncover so the FDA could issue warnings
to use the drug properly.
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