FDA Bar-Code Rule Aimed At Improving Drug SafetyFDA Bar-Code Rule Aimed At Improving Drug Safety

The U.S. Food and Drug Administration today released a rule requiring drugmakers to include bar codes on many of the over-the-counter and prescription drugs, vaccines, and blood products administered in hospitals and other care settings.

The rule, first proposed last March, is expected to make it easier and more affordable for hospitals to deploy electronic drug-tracking systems that allow nurses at a patient's bedside to electronically match a drug with patient information. By scanning the bar codes on a patient's ID bracelet and on a drug's package, the nurse can be electronically alerted to potential errors such as giving the drug to the wrong patient, providing an incorrect dose, or overlooking an allergy or adverse interaction with other medications.

"This would prevent errors such as a child receiving an adult dose of a medicine," says FDA Commissioner Mark McClellan.

Hospitals aren't required to deploy bar-code scanning systems, but the FDA is hoping this will make it more likely they'll do so, since more drugs will have the bar code. Drugmakers need to include bar codes on packing for all medicines, regardless of package size, including large bottles of many pills and single-dose "blister packages" of drugs. Drugmakers don't have to package their products in single doses, but it's a common form for hospital sale, which makes it easier for hospitals to deploy the bedside-scanning systems since the medications are ready for individual administration to patients.

McClellan says the FDA estimates that the bar-code rule, when fully implemented in two years, will help prevent nearly 500,000 adverse events and transfusion errors over 20 years. The economic benefit of reducing health-care costs, reducing patient pain and suffering, and reducing lost work time due to adverse events is an estimated $93 billion over the same period, McClellan says. An estimated half of all drug errors in health settings are preventable through technologies such as bar-code scanning, says U.S. Health and Human Services secretary Tommy Thompson.

The ruling says the drug bar code must contain, at a minimum, the drug's National Drug Code number. Companies also may include information about lot number and product expiration dates. In addition, the rule requires the use of "machine-readable information" on container labels of blood and blood components intended for transfusion. These labels, which already are used by most institutions handling blood, contain FDA-approved, machine-readable symbols identifying the collecting facility, the lot number relating to the donor, the product code, and the donor's blood group and type.

Thompson calls the ruling "a giant step" to protect Americans from preventable drug errors and is part of his department's overall mission to promote the use of technology to improve the nation's health-care system. "I'm confident that we can enhance patient safety by leveraging the latest technologies," Thompson says.

A week ago, the FDA also announced an initiative for the drug industry to use RFID technology to combat counterfeit drug activities. McClellan says RFID technology might also in the future be promoted by the FDA to reduce medical errors.

Although the FDA isn't mandating hospitals to deploy bedside bar-code scanning systems, the rule is likely to kick-start more widespread adoption. "A lot of hospitals have already embraced bar codes for drug administration, and some have implemented it at the bedside [in addition to inventory systems]," says Mary Beth Navarra, director of medication safety at McKesson, a distributor of pharmaceuticals and IT services in the health-care industry. "Others are waiting for the FDA rule to take effect for logistical reasons."

Health-care providers that have recently began rolling out bedside bar-code systems include Brigham and Women's Hospital in Boston, which also has created an internal central re-packaging center to add bar codes to single doses of medicines that are shipped to the hospital in bulk. Steve Flammini, chief technology officer of Partners HealthCare System, which operates Brigham and Women's, says the bedside system will "close the loop" for errors that occur at the time medicines are administered to patients.