Faster Information from FDA Means Improved Drug Safety for Patients

Mary E. Kremzner, PharmD, MPH, CAPT, U.S. Public Health Service

FDA is now making it easier and faster for health care professionals and patients to get the most up-to-date drug safety information on the more than 18,000 drugs available on our website. Our improved Drug Safety Labeling Changes Program enables FDA to post the latest safety information about a medicine almost at the same time we approve a change, as opposed to once a month.

Mary KremznerWhen your physician or other health care professional prescribes your medicine using their e-prescribing system, the new safety information now displays much faster than with our previous system. Here’s how – within days of FDA approval of new drug safety information for a drug product, the information is entered into the safety labeling changes database. Health IT vendors that provide clinical and drug information support for hospitals and pharmacies are then alerted to integrate the safety labeling changes data into their systems. So instead of waiting weeks for the monthly release of all safety labeling updates, this information is now accessible in days. From my point of view as a practicing pharmacist, the improved connection between new safety information and safety alerts on the pharmacy computer system builds more confidence into each prescription I fill for my patients.

For each FDA-approved drug, we provide detailed prescribing information, known as product “labeling.” Labeling helps those who prescribe medications understand key information about the drug, such as how much to prescribe, how often a patient should take a drug, which conditions the medicine treats, and what safety precautions should be followed for patients taking the drug.

Safety information can change multiple times over the lifetime of a drug as FDA learns about new risks, interactions with other medications and side effects. After we become aware of new safety information, changes to the drug product labeling may be required.

The public can access this information as well, now in a searchable database. Just key in the drug name and get a comprehensive listing of the labeling changes related to safety for that product.

Our new program is a game-changer for health care professionals seeking to provide the best quality care for their patients. FDA continues to pursue and provide innovative ways to rapidly access important information that protects and advances public health.

Mary E. Kremzner, PharmD, MPH, CAPT, U.S. Public Health Service, is the Director, Division of Drug Information, in FDA’s Center for Drug Evaluation and Research

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