To reduce and prevent medication errors, the FDA turns to bar codes

Efforts may be turning point in patient safety

The U.S. Food and Drug Administration (FDA) has finally delivered on its promise to propose a mandatory bar code program for medications. Although pleased with the effort, the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD, wishes the FDA had gone a bit further.

The FDA proposed two rules in the March 14 issue of the Federal Register. These rules are designed to reduce medication errors and more quickly identify potential errors that may occur, the agency says.

The first proposal calls for bar-coding of all prescription drug products, including biological products and vaccines (except for physician samples) and over-the-counter (OTC) drugs that are commonly used in hospitals and dispensed in a hospital pursuant to an order. Standardized bar codes also would be required on prescription drug products used in other settings such as retail pharmacies.

The required bar code would contain the National Drug Code number in a linear bar code as part of the drug label. The label would include the drug name, dosage form, and strength. The proposed design would allow manufacturers to include additional information, and more information could be added to the bar code standards as information technology progresses.

ASHP, however, says including the medication’s lot number and expiration date in the bar code is important, too. "[Including that information] is a critical element to protect patients from medications that may have been recalled or are past their expiration date," says Henri R. Manasse, Jr., PhD, ScD, ASHP executive vice president and chief executive officer. In the proposal, the FDA said it had "neither found nor received data to show that the benefits of bar coding lot number and expiration date information would exceed the costs of putting that information in the bar code."

Complying with the proposal would be expensive for both drug manufacturers and hospitals. Under the proposal, most manufacturers, repackers, relabelers, and private-label distributors of human prescription drug products and OTC drug products regulated under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act would be subject to the bar-code requirement. The FDA estimates it would cost pharmaceutical companies $50 million to meet the requirement and that hospitals would spend more than $7 billion on scanners and computers.

Some say the proposal is worth the cost. Mark B. McClellan, MD, PhD, FDA commissioner, estimates that the bar code requirement would prevent 400,000 adverse drug reactions over the next 20 years.

The proposed rule has a 90-day comment period. After that, the FDA will evaluate the comments and intends to finish work on a final rule in 2003. The bar code requirement would become effective three years after the FDA publishes a final rule.

The FDA also announced a proposal to revamp its safety reporting requirements. The proposed rule would:

  • improve the quality and usefulness of safety reports submitted to the agency as well as facilitating the consistency of safety reporting around the world;
  • require the submission of all suspected serious reactions for blood and blood products on the market; and
  • require reports on important potential medication errors.

To expedite the agency’s review of and response to medication errors, the proposed amendments would require companies to submit to the FDA, within 15 calendar days, all reports they receive of actual and potential medication errors occurring in the United States. The proposal also would require the use of universally recognized medical terminology and other safety reporting standards.

Under this proposal, blood establishments would be required to submit to the FDA reports of all suspected serious reactions, not just fatalities, as is required now.

Each of these proposals is expected to have an enormous impact on patient safety, say officers of the Institute for Safe Medication Practices (ISMP) in Huntingdon Valley, PA. Along with recent bills passed by the U.S. House of Representatives, these efforts may prove to be "a turning point in health care," say Michael Cohen, RPh, MS, DSc, ISMP president, and Judy Smetzer, RN, BSN, ISMP vice president.

Both proposed rules can be found on the FDA’s web site at The FDA invites written comments from the public on these proposed rules to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.