The American Society of Health-System Pharmacists (ASHP) is encouraged by today's Food and Drug Administration (FDA) announcement of its proposed rule requiring bar codes on all medication packages, a mandate that would significantly improve patient safety in the nation's hospitals.
The proposed rule, announced by Secretary of Health and Human Services Tommy Thompson, would require bar codes to include the National Drug Code (NDC), a system that contains the drug name, dosage form, and strength. But the proposed regulation stops short of mandating the inclusion of the medication's lot number and expiration date in the bar code, citing the cost as well as the need for more evidence of its value.
"Requiring bar codes that include the NDC is an important first step, and we applaud the FDA for this proposal," said Henri R. Manasse, Jr., PhD, ScD, ASHP Executive Vice President and Chief Executive Officer. "But including the lot number and expiration date is a critical element to protect patients from medications that may have been recalled or are past their expiration date. We will continue to work with the FDA and other organizations to clearly demonstrate the value of including this vital information."
ASHP is a founding member of the National Alliance for Healthcare Information Technology, which has called for the FDA to establish a 5-year phase-in period for including expiration date and lot number in the bar code. Pfizer Inc., one of the nation's largest drug manufacturers, recently announced 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 new Bush administration to implement this important safeguard. In that year, the ASHP House of Delegates adopted policy supporting a requirement that all drug packages, including unit-dose packages, include machine-readable coding. Most recently, Manasse and other ASHP officials met last week with FDA Commissioner Mark B. McClellan, MD, to urge immediate action.
There is substantial public support for these requirements. In its 1999 report, "To Err is Human: Building a Safer Health Care System," the Institute of Medicine noted that bar coding "is an effective remedy" for medication errors when used to ensure the right dose is administered to the right patient.
"Bar coding technology is entrenched throughout America in all types of venues--grocery stores, department stores, libraries. It is something that everyone expects, and it is found everywhere...except where it can do the greatest good--saving lives," Kasey Thompson, Pharm.D., director of the ASHP Center on Patient Safety told the FDA at a hearing last July. ASHP also called for bar codes to be placed on both the inner and outer wrap of all drug packages, including single-unit doses.
The ASHP Center on Patient Safety is leading a broad effort to help health-system pharmacists use this technology to improve the medication-use system in their institutions. "Bar codes can be the last line of defense against making a dangerous medication error," Thompson added. "This technology can help hospitals ensure that the right medication is given to the right patient at the right time."
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. The Society has extensive publishing and educational programs designed to help members improve their professional practice, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs. For more information, visit www.ashp.org or www.safemedication.com.
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