HHS mandates bar codes on all hospital drugs

The U.S. Department of Health and Human Services (HHS) has mandated that pharmaceutical companies put bar codes on all drugs dispensed in hospitals, a move HHS Secretary Tommy Thompson called a key step "in reducing medication errors."

Though the regulations apply only to drug manufacturers and not hospitals, as a practical matter hospital pharmacists and vendors expect widespread use of bar code readers, and networks will be needed to support them in a majority of the nation's hospitals.

The new bar-code regulations issued today by the Food and Drug Administration mandate the use of the National Drug Code, which identifies the type of medication and the dose. They will go into effect three years after the FDA publishes its final rules. That's expected to happen later this year, after the agency assesses comments filed in the next 90 days.

The FDA said it expects the new rules to eliminate 413,000 medication errors during the next 20 years by using technology to ensure that the right patient receives the right drug in the right dose at the right time.

Hospitals will have to bear a hefty financial burden to deploy the bar-code technology, with the FDA estimating the cost at $7.2 billion. Jeff Schou, director of worldwide health care markets at Symbol Technologies Inc. in Holtsville, N.Y., estimated that close to $1 billion of that would come from spending on wireless LAN technology to provide connectivity for nurses dispensing drugs at a patient's bedside.

Schou said the bar code readers could function in a batch or disconnected mode, but he added that WLANs will be the best way to manage the system. In batch mode, the reader remains unconnected to a network until the user hooks it up. Users can periodically update information on several patients and their prescriptions at one time.

Steve Rough, director of the Pharmacy Service Organization at the University of Wisconsin Hospital and Clinic in Madison, agreed with Schou, saying batch mode doesn't provide nurses with real-time information, a key to medication management.

The University of Wisconsin started deploying a medication management system, Admin-Rx from McKesson Corp., in December 2001. That system incorporates bar codes, and according to Rough, it will revolutionize patient care and safety. Rough said the hospital has experienced an 87% reduction in the number of medication errors.

That's because the bar-code system provides multiple checks to ensure that a patient receives the correct drug. When nurses dispense medications, they first scan a bar code on their badge and then the code on the patient's bracelet and finally the code on the drug. All this information is sent to a back-end database, which contains patient and prescription information, and if something fails to match up, an audible alert sounds.

Marybeth Navarra, director of patient safety at McKesson Automation Group, called the FDA's bar-code regulations a "huge step forward" in the potential elimination of patient errors. She said the regulations would also help break a standoff among drug manufacturers, resellers and hospitals about the use of bar codes. The manufacturers didn't want to use bar codes because the hospitals didn't have readers, while the hospitals didn't want to install the technology because so few drugs had the bar codes.

Chip Kahn, president of the Federation of American Hospitals, said in a statement, "No other step could help bring about improvements in patient safety as immediately, and as effectively, as the use of standardized bar coding technology."

Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said in a statement that the industry has been "a steadfast proponent of the use of prescription drug bar codes to ensure hospital patients receive the right drug at the right time. Patients have a right to expect that the medicine their doctor prescribed is the medicine that they receive. Our industry led the drive in establishing the first bar-code standard."

Copyright © 2003 IDG Communications, Inc.

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