Filed at 2:26 p.m. ET
WASHINGTON (AP) -- Sick New Yorkers could start making prescription drugs
safer for everybody this spring.
When medical tests diagnose signs of liver trouble or other problems
among users of certain medications, a city hospital's computers will send
those red flags straight to the Food and Drug Administration -- the first
step toward an early-warning system for new drug risks.
It's one of a series of experiments that FDA scientists hope will cut
medical mistakes and preventable drug side effects that claim tens of
thousands of lives each year.
``There's clear evidence we have a lot of room for improvement,'' says
FDA Commissioner Mark McClellan.
The idea: If doctors, patients and regulators alike get better risk
information faster, they might make safer choices -- even catch a mistake or
newly appearing health threat in time to save someone.
And just as car manufacturers added air bags and other safety features
over the years, at least one of the experiments may persuade industry to add
safeguards that prevent certain errors.
Car makers ``do not just say, 'Cars are crashing -- if people would just
drive better,''' notes Susan Gardner, who oversees FDA's new tracking of
malfunctions and mistakes with medical devices at 80 hospitals and nursing
Too often, medical manufacturers just blame a hurried or poorly trained
health worker, Gardner adds.
``In a way I'm sympathetic. ... On the other hand, have they really
thought about how they can make a safer product? I think in many instances
Some medical errors are quickly obvious, like last weekend's death of a
girl who received a heart-and-lung transplant that didn't match her blood
type. Other problems are harder to detect, such as choosing a drug too risky
for a particular patient, or using a medicine incorrectly. Discovering rare
side effects can take months or years, as doctors voluntarily alert FDA when
they spot red flags.
FDA's experiments aim to:
--Speed discovery of drug side effects and preventable user errors by
cutting out the middleman needed to report them.
New York-Presbyterian Hospital is the first participant, says FDA's Dr.
Randy Levin. The agency will designate drugs of concern. With special
IBM, hospital computers will
automatically send to FDA medical test results -- minus patient identities
-- that suggest problems brewing.
--Help doctors and patients learn about drug risks with a computer
Every prescription drug today bears pages of complex warnings that,
unfortunately, few physicians read. Indeed, FDA has banned several drugs
because doctors kept using them incorrectly. Even McClellan, FDA's new
chief, admits bypassing the labels when he treated patients. Yet other
sources -- pharmaceutical salesmen or Web sites -- seldom offer complete,
unbiased safety information.
With ``Daily Med,'' doctors will read electronic medicine labels,
locating in seconds via computer or Palm Pilot only the portion they need,
such as lists of dangerous drug interactions. New warnings will be added
daily; it now takes months.
Daily Med should begin running next year, says FDA drug chief Dr. Janet
Woodcock. FDA will provide it free to companies that sell doctors
computerized prescription programs, and to everyone via the National Library
of Medicine Web site.
--Prevent medical device errors and detect defective devices faster,
through Gardner's network for health workers to report equipment problems.
Topping the complaints so far are infusion pumps -- bedside devices that
control how much intravenous medicine flows into a patient's bloodstream.
For example, there's no safeguard against nurses accidentally programming
pumps to flow too fast by hitting an extra button, Gardner says.
A newsletter tells participating hospitals about others' mistakes so they
don't repeat them, and one manufacturer already is redesigning a safer pump,
--Stay tuned: FDA also plans to put supermarket-style bar codes on
hospital-administered drugs so fewer patients get the wrong pills.
Patient safety experts are closely watching the experiments. But some
critics warn they won't offer much change unless FDA uses the surveillance
to ban risky drugs faster.
Safety monitoring has ``been the sorry stepchild'' to better-funded FDA
divisions that approve the sale of new treatments, complains Dr. Sidney
Wolfe of the consumer advocacy group Public Citizen. ``There needs to be a
huge shift in that balance of power.''
EDITOR'S NOTE -- Lauran Neergaard covers health and medical issues for
The Associated Press in Washington.