FDA proposes Rx bar coding rule

May 1, 2003

Pharmaceutical Representative

The FDA is proposing two new patient safety rules in an effort to reduce medication errors.

The Food and Drug Administration is proposing two new patient safety rules in an effort to reduce medication errors. The new rules would require bar coding on medications and improve reporting requirements for safety problems involving medicines.

Food and Drug Administration Commissioner Mark B. McClellan said the proposals were "the start of a comprehensive strategy to build a medical patient protection system for the 21st century."

Bar codes

The proposed rule for bar codes would apply to all prescription drug products, including biological products and vaccines (except for physician samples), as well as over-the-counter drugs commonly used in hospitals. Standardized bar codes would also be required on prescription drug products used in other settings, such as retail pharmacies.

The proposed bar codes would contain the National Drug Code number as part of the drug label. The proposed design would allow manufacturers to include additional information, and more information could also be added to the bar code standards as information technology progresses. The FDA said it hoped the system would prevent medication errors, including those due to administering the wrong drug, administering a drug to a patient who is known to be allergic, administering the wrong dose, administering the drug at the wrong time or using the wrong route of administration.

The Washington-based Pharmaceutical Research and Manufacturers of America said it supported the proposal and that the expected three-year phase-in period for the bar codes was a realistic time frame.

"PhRMA 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," said PhRMA President Alan F. Holmer. "Patients have a right to expect that the medicine their doctor prescribed is the medicine that they receive."

Safety reporting requirements

The second FDA proposal - for the revamping of safety reporting requirements - 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 would also raise the quality and consistency of safety reports by requiring the use of internationally agreed-upon definitions, reporting formats and other safety reporting standards. If the proposed safety reporting standards are implemented, companies will be able to devote their resources to preparing a single, high-quality report for submission to all major regulatory agencies around the world. PR

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