FDA Proposes Putting Bar Codes on Drugs
Posted on: Thursday, 13 March 2003, 06:00 CST
By LAURAN NEERGAARD
WASHINGTON (AP) -- Supermarket-style bar codes will soon be required on every medication given to hospitalized patients, to help ensure they get the right dose of the right drug at the right time.
Thursday's proposal by the Food and Drug Administration is part of a series of new government steps to help prevent deadly medical mistakes that claim tens of thousands of lives each year.
One type of medical mistake is a drug error, such as giving the wrong drug or wrong dose to someone. Scientists estimate at least 7,000 hospitalized patients die annually because of those drug errors alone.
With a bar-code system, health care industry workers use computer equipment to scan an identifying code on a patient's wristband that reveals what medicines he or she needs - and when. Then they scan the intended medication. If they picked the wrong drug, the wrong dose, or a pill version when a liquid was required, the computer beeps an alarm.
The computer also can be programmed to catch other errors, such as if a doctor prescribes a drug the patient is allergic to or that will react dangerously with another medication he or she already takes.
Veterans hospitals have found medication errors plummeted after they adopted a bar-code system. The FDA proposal would make it easier for every hospital to adopt such a safety system, by requiring all prescription and over-the-counter drugs administered in hospitals to bear standardized codes.
It's part of a "patient protection system for the 21st century," said Commissioner Mark McClellan.
Also Thursday, the FDA proposed changes in how doctors and drug manufacturers report adverse reactions - both side effects and errors - to the government. The hope in this instance is to uncover preventable problems faster. Among the changes:
_Companies would have 15 days to report to FDA any suspected medication error, such as when health workers mix up drugs with similar names, such as the epilepsy drug Lamictal and the antifungal pill Lamisil. Companies today must report such problems that fast only if they cause serious injury.
_Blood banks would have to report all suspected serious reactions to blood transfusions or use of blood-derived products. Today, only fatalities must be reported.
Medical errors have garnered increased concern since a teenager died last month after doctors at Duke University Medical Center gave her a heart-lung transplant from a donor with the wrong blood type. But the Institute of Medicine estimates that medical errors contribute to up to 98,000 deaths each year.
Pharmacists and drug manufacturers have long supported the idea of bar codes, although companies have some reservations about just how much information should be included. The FDA's proposal will be open for public comment, from manufacturers and others, before the new rules are put into effect. The FDA didn't say how soon it would act, but calls the measure a priority.
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