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    Home Latest News

      FDA Requires Electronic Drug Labels

      By
      Stacy Lawrence
      -
      November 3, 2005
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        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.

        /zimages/1/28571.gifClick 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.

        /zimages/1/28571.gifRead the full story on CIO Insight: FDA Requires Electronic Drug Labels

        Stacy Lawrence
        Stacy Lawrence is co-editor of CIOInsight.com's Health Care Center. Lawrence has covered IT and the life sciences for various publications, including Business 2.0, Red Herring, The Industry Standard and Nature Biotechnology. Before becoming a journalist, Lawrence attended New York University and continued on in the sociology doctoral program at UC Berkeley.

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