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Posts Tagged ‘FDA-approved labeling’

The FDA has announced a new program to help doctors check the approved indications and other information in drug “labels.”  These “labels” are the FDA-approved educational information sheets that drug companies package with medication. See information below:

Online Service Enables Physicians To Check FDA-Approved Medication Labeling Via EHRs.

Healthcare IT News (1/27, Merrill) reported that to “boost drug safety, a new online service has been launched that allows doctors to check the FDA -approved labeling for the most commonly prescribed drugs.” The service is part “of a new campaign” called “Know the Label,” which is being “launched in concert with the FDA’s efforts to provide up-to-date and complete prescribing information to physicians.” It is being delivered to all US physicians and providers “electronically via the websites of PDR Network, The Doctors Company and other liability carriers, via EHR systems. … ‘We congratulate The Doctors Company and PDR Network for finding a practical and novel way for physicians to access the full updated labeling through electronic means and have it available at the point of prescribing,'” said Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research.

I doubt this new program to disseminate the label information is going to help patients much.  At least in my field, use of medication is based on  patients’ individual conditions and results of studies that go far beyond what’s in the FDA-approved “label.”  Medications are used for conditions other than FDA-approved uses.  Different doses are used.  Combinations that the FDA-approved label says are bad may often be exactly what a patient needs. I guess it won’t hurt to give doctors the information on FDA-approved medication labeling, unless it discourages doctors from giving patients needed treatments for unapproved conditions.

For best results, a doctor’s  good judgment is the best guide to treatment.

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