CTUpates: Drug label information moves to the Internet
Drug label information moves to the Internet
In preparing for a counseling session on contraceptives, you decide to review labeling for a number of birth control pills. How can you be sure you have the most up-to-date information in your files?
Look to the Internet. By 2007, all prescription drug labeling will be available on DailyMed, a new federal interagency on-line health information clearinghouse operated by the National Library of Medicine at dailymed.nlm.nih.gov. Similar product information also will be available in the future through the Food and Drug Administration (FDA) web site, [email protected], which is envisioned as a comprehensive internet resource for one-stop access for information about all FDA-regulated products.
At press time, FDA officials were to begin loading label information on the DailyMed site for some 9,000 drugs as of January, says Lisa Stockbridge, FDA spokeswoman. The project is scheduled for completion by January 2007, says Stockbridge. According to the FDA, future additions to the DailyMed site will include labels for biologics (such as vaccines), medical devices, veterinary drugs, and some food products.
New format in use
Drug manufacturers are now required to submit prescribing and product information to the FDA in a new format known as structured product labeling (SPL).
The new format is designed to provide accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format. 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.
Reducing errors
Health care providers should be able to quickly search and access specific information they need before prescribing a treatment, which will result in fewer prescribing errors and better informed decision-making, according to the FDA. By using the SPL format, the FDA hopes to improve the drug labeling review process so it can provide immediate access to the most recent information about medications to providers and patients. Updated product labels will be posted on the DailyMed site within one business day of an approval action by FDA.
In preparing for a counseling session on contraceptives, you decide to review labeling for a number of birth control pills. How can you be sure you have the most up-to-date information in your files?Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.