FDA Requires Electronic Drug Labels

The Food and Drug Administration recently began requiring drug manufacturers to submit prescription drug label information in a new electronic format that will allow health care providers and the general public to more easily access the product information found in the package inserts for all approved medicines in the United States.

These new electronic product labels will be accessible at DailyMed, a new online health information site that will provide free medication information. A database fully populated with approved medications is expected in about one year, with the subsequent addition of biologics and medical devices.

“Providing health care providers and patients with clear, concise information about their prescriptions will help ensure safe use of drugs and better health outcomes,” says Health and Human Services secretary Mike Leavitt.

“Now medication information will be easy to access on a publicly available Web site, and this will lead to future innovations with health information technology,” concludes Leavitt.

Under regulations that just became effective, drug manufacturers are now required to submit to FDA prescribing and product information in an SPL (structured product labeling) format that provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format.

Click here to read about the process of making electronic health records consumer-friendly.

Using embedded computer tags, the prescribing and product information in the SPL format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label, including product names, indications, dosage and administration, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied.

With this information, physicians will be able to search and access specific information they need before prescribing a treatment, potentially resulting in fewer prescribing errors and better informed decision making. In addition, having the labels submitted to FDA in SPL will improve the FDA drug labeling review process, so that FDA can provide immediate access to the most recent information about medications to doctors and patients.

“This unprecedented health technology partnership builds a solid foundation for enhanced e-health initiatives to be realized in the very near future,” said Acting FDA Commissioner Andrew von Eschenbach.

“The electronic standards established with structured product labeling pave the way for future health information innovations in areas such as electronic prescribing and electronic health record keeping, that can transform the way we gather, use and share medication information from bench to bedside,” argues von Eschenbach.

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