FDA Announces Final Prescription Drug Bar Code Rule

As part of an effort to reduce medical errors, drug makers and blood suppliers will have to include bar codes on most of their products within two years, under a rule announced Wednesday by FDA, the Washington Post reports (Kaufman, Washington Post, 2/26). Newly approved prescription drugs, vaccines, over-the-counter drugs and blood products must include bar codes with the product's National Drug Code number, a unique identifier, within 60 days of approval. Products already on the market must implement the codes within two years (Middleton, Dow Jones/Wall Street Journal, 2/26). For blood and blood products, the bar code also must identify the collecting facility, the lot number pertaining to the donor, the product code and the donor's blood group and type, the Boston Herald reports (Heldt Powell, Boston Herald, 2/26). The rule is intended to "jump-start" adoption of bar code technology by hospitals and "eventually move drug makers and hospitals to a system where most patients will receive their drugs in a single blister pack with a tiny bar code" that corresponds to the bar code on a patient's identification bracelet, the Post reports (Washington Post, 2/26). "Bar coding systems have proved their dependability and effectiveness by ensuring the accuracy of a myriad of actions in commerce and industry. We're now advancing the adoption of these systems in settings where they can help save lives," FDA Commissioner Mark McClellan said. In some hospitals that have adopted such systems, medication error rates have fallen by as much as 85% (HHS release, 2/25). According to FDA, bar code systems could prevent an estimated 500,000 adverse events and transfusion errors over 20 years (Feder Ostrov, San Jose Mercury News, 2/26). Adoption of bar code technology also would reduce by 50% the 7,000 annual hospital deaths attributed to medication errors, according to federal estimates (Washington Post, 2/26).

The rule does not require hospitals to implement bar code scanners, but FDA estimates that by adopting the systems, hospitals could reduce record-keeping and reporting expenses by $4.8 billion to $7.6 billion (Goldfarb, USA Today, 2/26). Depending on hospital size, bar code systems cost between $200,000 and $1 million, according to Denean Rivera, president of Bridge Medical, a bar code software manufacturer. Currently, only 2% to 3% of hospitals have fully implemented bar code systems, Rivera said (Washington Post, 2/26). Few hospitals have the systems in part because only about 35% of their pharmaceuticals supplies have bar codes, according to Bridge Medical (Neergaard, AP/Newport News Daily Press, 2/25). "Now that we know a standardized format, hospitals will be able to purchase equipment to read the bar coding," Nancy Foster, senior associate director of policy at the American Hospital Association, said (USA Today, 2/26).