- The Washington Times - Friday, March 14, 2003

Hospital patients will wear wristbands imprinted with bar codes under a federal proposal to help eliminate the 7,000 deaths caused by medication errors each year.

The Food and Drug Administration rule, introduced yesterday, would create a system that allows nurses to match the coded label on medication to a code on a patient's wristband.

"I am so excited about the possibility we now have to reduce patient deaths and improve patient safety and the quality of health care in America," Health and Human Services Secretary Tommy G. Thompson told reporters.

An estimated 7,000 patients die each year from being given the wrong drug or the wrong dose, the FDA said.

Drug makers, which have embraced the idea, will have three years to comply. Thirty-five percent of all drugs administered bedside are now packaged with a bar code, according to the National Alliance of Health Information Technology, an organization that represents hospitals, medical vendors and suppliers.

The program, which is open for public comment for three months and is expected to be finalized early next year, will cost the drug industry about $50 million, said FDA Commissioner Mark McClellan.

The cost to hospitals, which are being asked to adopt the program voluntarily, could reach $7.2 billion, he said.

For each hospital, a bar-code scanning system could be installed for a little more than $100,000, including wireless hookups and hand-held computers to read the codes, said Rich Bravman, chief executive officer of Symbol Technologies Inc., the world's largest maker of bar-code scanners.

The rule would apply to drug makers and packaging companies and some over-the-counter and prescription drugs.

In some cases, pills that are now packaged in a bottle will have to be individually packaged so that they can be assigned individual bar codes, pharmaceutical executives say.

"We applaud today's initiative and look forward to implementation as we work together to create more effective and efficient care for patients," Gary Mecklenburg, chairman of the National Alliance of Health Information Technology, said in a statement.

The FDA, which has come under fire for not doing more to police drug safety, is trying to reduce medical mistakes and update its safety programs.

With bar coding, nurses scan a code on a patient's wristband to show what medicines are needed and when, then scan the intended medication. If they pick the wrong drug, the wrong dose or a pill when a liquid is required, a computer sounds an alarm.

The computer can be programmed to catch other errors. For example, it could detect whether a doctor prescribes a drug to which the patient is allergic or a drug that will react dangerously with another medication.

"This adopts a technology that is very widely used in other industries. Grocery stores and other parts of our economy that people think of as lower tech are ahead of our health care system," Mr. McClellan said.

The bar-code plan will cut medication errors in half and prevent more than 400,000 medical problems over 20 years, he said.

"It will really eliminate a lot of the errors we see now," said Michael R. Cohen, president of the Institute for Safe Medication Practices, a nonprofit group that has pushed the FDA to adopt the rule. He said some studies have indicated that bar coding could cut medication errors as much as 80 percent.

"It covers the five rights in dispensing medicine: the right drug, the right patient, the right dose, the right time and the right method, meaning whether it's given orally or through an IV," Mr. Cohen said.

Many hospital medicines have to be mixed and administered according to a patient's specific illness, age and weight. Most errors involve simple mistakes caused by illegible handwriting and inaccurate computer entries, a 2002 study of 368 hospitals by U.S. Pharmacopeia found.

Bar coding, which includes a series of vertical bars that can be read by a laser scanner, is already in place at veterans hospitals.

Wired, a technology magazine, reported in January on an Ohio State University study that examined some of the bar-coding problems experienced by nurses at veterans hospitals.

"I found myself walking away from important conversations with patients and families in order to fulfill the computer's demands. I feel like robo-nurse, and I don't like it," one nurse said.

Ron Schneider, a pharmacist at the Veterans Affairs Medical Center in the District who has managed its bar-coding project, said the system works well as long as nurses are trained properly.

The FDA also proposed changes yesterday in how doctors and drug manufacturers report to the government about adverse reactions both side effects and errors in hopes of more quickly uncovering preventable problems.

The reporting system will be standardized so drug companies can submit one report to authorities in the United States, the 15-nation European Union, Japan, Canada and Switzerland.

This article is based in part on wire service reports.

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