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Posts Tagged ‘drug safety’

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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Clinical trials bring us the new wonder drugs that would have been considered either magical or miraculous in earlier times. Are you interested in how drugs are tested to assure efficacy and safety?

On two episodes of Getting Better Health Care, clinical researcher Bea Abrams, PhD, with over 30 years experience in pharmaceutical development, explains the process of clinical trials done to bring a new drug to market.  She shares with us critical information that lets us know how much we can trust new drugs and what to look out for.

In a subsequent episode, I’ll be talking with Dr. Lawrence Friedhoff — author of the book, New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients — about myths that surround new drug development.

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