FDA Rule Requiring Bar Codes on Medications Should Go Farther, Pharmacists Say

Newswise -- The American Society of Health-System Pharmacists (ASHP) applauds the Food and Drug Administration (FDA) announcement of its final rule requiring bar codes on all medication packages, a mandate that is expected to significantly improve patient safety in the nation's hospitals.

The final rule, announced yesterday by Secretary of Health and Human Services Tommy G. Thompson and FDA Commissioner Mark B. McClellan, MD, PhD, would require bar codes to include the National Drug Code (NDC) number, a system that contains the drug name, dosage form, and strength.

"Requiring bar codes that include the NDC number is an important first step, and we applaud the FDA for this regulation," said Henri R. Manasse, Jr., PhD, ScD, ASHP executive vice president and CEO.

While the rule does not require that bar codes include a medication's lot number and expiration date -- elements which ASHP and other health care organizations have called for as critical to patient safety -- the FDA has assured ASHP that it will encourage manufacturers to include this information.

"Lot numbers and expiration dates are essential to assure that medications that have been recalled or have expired are not given to patients," said Manasse. "ASHP continues to strongly urge the FDA to make these elements a requirement."

ASHP is a founding member of the National Alliance for Healthcare Information Technology, which has called for the FDA to establish a five-year phase-in period for including expiration date and lot number in the bar code. ASHP has also called for bar codes to be placed on both the inner and outer wrap of all drug packages, including single-unit doses. Pfizer Inc., one of the nation's largest drug manufacturers, announced in 2003 that it would voluntarily add bar codes, including the lot number, expiration date, and NDC, to all its packages, including unit-dose packages.

ASHP has long been an outspoken advocate on this critical public health issue and in 2001 urged the Bush administration to implement this important safeguard.

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. ASHP, which has a long history of medication-error prevention efforts, believes that the mission of pharmacists is to help people make the best use of medicines. Assisting pharmacists in fulfilling this mission is ASHP's primary objective.

Source: American Society of Health-System Pharmacists (ASHP)