New FDA Ruling Will Force Changes in Drug Packaging Process

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas). Part of the Food and Drug Administration's (FDA) role is to oversee all aspects of drug safety and minimize danger to patients. It is estimated that 7,000 patients die every year as a result of hospital drug errors. Currently, only a small number of single-dose drugs carry bar codes on their packaging, including Dilantin for seizures and Lipitor for cholesterol. A hand-held scanner matches each pill's bar code to a patient's wristband and chart, ensuring the right dose of the right drug for the right person.

In response to the increasing problem of medication mix-ups in hospitals, the agency will issue orders next month that would apply to all prescription drug products, including biological products and vaccines (except for physician samples), and Over-The-Counter (OTC) drugs that are commonly used in hospitals and dispensed in a hospital. Standardized bar codes would also be required on prescription drug products used in other locations, such as retail pharmacies. The bar code would, at a minimum, contain the drug's National Drug Code number, which uniquely identifies the drug, its strength, and its dosage form. The FDA is predicting that the ruling will result in over 400,000 fewer adverse events over the next 20 years.

While the financial impact of the new ruling is uncertain, it is an absolute that drug manufacturers will be forced to modify their drug packaging process. Hospitals will also have to invest in the hand-held scanners and associated equipment. With over 5,000 hospitals in the country, less than 150 now use bar-code systems.

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