NATION FDA-required bar codes aim to reduce medication errors

Patients would wear a wristband to reduce the chance of medication error.
WASHINGTON (AP) -- Almost all medications given in the hospital soon must bear a supermarket-style bar code that health workers will match to patients to help ensure they get the right dose of the right drug at the right time.
The code, just an eighth of an inch tall on individual pill packs, is a major new requirement for manufacturers. The Food and Drug Administration says the requirement could cut in half the drug errors now thought to kill about 7,000 hospitalized patients a year.
"Medication errors are a serious health problem, but they're a preventable problem," said Health and Human Services Secretary Tommy Thompson in announcing the regulation Wednesday.
Added FDA Commissioner Mark McClellan, "This is a proven approach to reducing errors." He said the change could prevent half a million adverse events -- new or worsening symptoms resulting from the treatment that patients received -- in the next 20 years and save $5 billion a year.
Hospitals, patient advocates and drug manufacturers eagerly have awaited the rule. In fact, the FDA heeded pleas to speed up enforcement. All new medications will have to bear bar codes within 60 days of FDA approval; medicines already on the market must bear them within two years, a year earlier than first planned.
Preventing errors
Drug errors can happen when busy health workers misread a patient's chart and administer the wrong drug or wrong dose, or give a drug to the wrong patient, or give a drug too often.
When patients are admitted to a hospital that uses a bar code system, they are given a wristband with their own identifying code. After the wristband and the intended medicine are scanned, if the drug does not match the patient's medical chart, a computer beeps an alarm.
Errors plummeted when veterans hospitals adopted bar codes several years ago, relabeling all their in-house drugs for electronic identification.
But as of December, only about 125 of the nation's 5,000-plus hospitals were using bar code systems, according to Bridge Medical Inc., a leading manufacturer of bar code readers. That is partly because only about 35 percent of their pharmaceutical supplies came with the codes affixed to them.
The government's new rule means more hospitals probably will start using the safety system because virtually all the prescription drugs and most over-the-counter medicines that they administer -- including blood products and vaccines -- will arrive already with a bar code.
Hospitals will not be required to use the codes. But the regulation does set standards to ensure that even the cheapest, most basic scanner will recognize any medicine.
Nursing homes likely will use the systems, too, McClellan said.
Useful applications
The challenge, say manufacturers, has been getting bar codes onto medications in useful ways.
For example, attaching a bar code to a bottle of 100 pills does not really help; hospitals dispense a pill at a time to different patients. Last year, Pfizer Inc. led the way in making bar codes tiny enough to fit onto blister packs of individual pills, so each could be scanned at bedside.
Baxter Healthcare Corp. had to figure out how to imprint bar codes onto IV bags -- a challenge because their clear background interfered with traditional bar-code scanning. A type of reverse-image printing worked, said the company's bar code chief, Joe Mase. All Baxter products should bear bar codes by early next year, he said.
According to Bridge, the bar code maker, a hospital's cost for bar code scanning technology can range from $200,000 to more than $1 million, depending on its size and how complex a system it desires.
For example, basic software may just ensure that a patient really gets the heart drug digoxin and not the epilepsy medicine Dilantin. A more sophisticated system could add such safeguards as sounding an alarm when doctors prescribe a drug that a patient is allergic to or that will interact dangerously with his other medicines.
Future technology
Bar coding is just the first step in a promised wave of safety technology. For all its benefits, a bar-coded wristband is not easy to read if it gets wet or the patient is on an emergency-room gurney or operating table.
Next-generation systems promise to use radio frequency waves, tiny transmitters like those used by highway toll booths to read speed passes, that will let nurses identify patients from across the room.