US Regulation Would Require Bar Codes on All Drugs

At a minimum, the bar code would contain the drug's National Drug Code number, which identifies the drug, its strength, and its dosage form. The FDA is also considering whether to include lot number and expiration date. The agency estimates that the bar code rule will result in a 50% increase in the interception of medication errors at the dispensing and administration stages. In a study at a US Veterans Affairs Medical Center, 5.7 million doses of medication were administered to patients with no errors when a bar code scanning medication dispensing system was used.

A bar-coded identification bracelet will link patients to their computerized medical record. Before administering a drug, a healthcare worker would scan the patient's computerized record, then scan the drugs provided by the pharmacy for the patient. The computer compares the patient's medical record to the drug(s) being administered to ensure they match what is prescribed for the patient. If they do not, the computer sends an error message and the problem is investigated. The regulation is designed to prevent problems such as the wrong drug, the wrong dose, the wrong time to administer the drug, or a change in the patient's medication.

Along with this regulation, the FDA has proposed new rules governing the reporting of safety information. These were developed jointly with authorities in the pharmaceutical and biologic industry and regulatory authorities in the European Union, Canada, Switzerland, and Japan to improve the quality and consistency of safety information reporting. Other new rules would require expedited reporting of suspected adverse drug reactions (SADR) that are serious and unexpected, new safety findings from clinical studies, and improved data in all reporting.

These proposals are part of a new framework of FDA programs to identify and manage safety problems associated with regulated medical products, using modern information technology, partnerships with healthcare organizations, and more-effective communication tools. Automatic, real-time transmission of safety data from healthcare systems will be an important part of these programs.




Related Links:
FDA