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Heads Up from the FDA


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Heads Up from the FDA

By Jock Hoffman, CRICO

Related to: Ambulatory, Clinical Guidelines, Emergency Medicine, Primary Care, Medication, Obstetrics, Other Specialties, Surgery


Pharmaceutical companies must address risks that emerge even after a drug (e.g., Vioxx) has been approved by the United States Food and Drug Administration (FDA). Among the requirements: pharmaceutical companies must make drug study results publicly available, and they must complete follow-up studies even after a drug is approved. One likely result is an increase in the amount of risk-related information physicians need to know about an ever-expanding list of medications. Not being fully informed about what you are prescribing puts you at risk for an allegation of negligence.

Medication-related errors have been in the forefront of the patient safety movement, especially the process-related problems (order entry, preparation, and administration). 
On the other hand, medication-errors related to physician knowledge or judgment have had less attention paid to them. Patients expect that the ordering physician will be aware of any risks related to prescribed drugs. Consequently, when adverse drug events occur, the prescribing physicians may well be deemed at fault for what they should have known.

Our Recommendation

Each time a new drug is FDA approved, physicians need to assess its benefits and risks and how they jibe with existing medications. By adding to the mix ongoing testing and public access to those test results—and, thus the potential for even more information to be absorbed—the FDA has increased the burden of staying fully informed.

Fortunately, the FDA is also offering a way to ease that burden through the MedWatch website and a free safety alert e-mail subscription service to deliver the latest drug risk news to physicians directly and quickly. The alerts (about two per week, says the FDA) announce changes in prescribing information, drug recalls, emerging risks, and strategies for avoiding known usage errors. In addition to information from pharmaceutical companies and the FDA, the MedWatch alert system also draws on issues raised by physicians who report problems directly to the FDA.

Additional Materials

What are the risks of using an FDA-approved drug for a non-approved use? (CRICO)

Pharmacists on rounding teams reduce preventable adverse drug events in hospital (Arch Int Med)

November 1, 2007
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