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Off-label use of drugs: How much does your doctor know?

An argument could be made — and frequently has been made — that the off-label use of certain drugs in certain situations is a good thing.

And, indeed, prescribing drugs off-label (for uses not specifically approved by the Food and Drug Administration) is quite common. A study published in 2006 found that about 21 percent of all physician-prescribed medications in the United States were for off-label purposes.

But when it comes to off-label prescribing, I would expect at least two things from my doctor:

1) that I be told that the drug I’m receiving has not been specifically approved for my medical condition, and

2) that my doctor know this.

Amazingly, a new survey has found that a “substantial minority” — 41 percent — of physicians are unaware that one or more of the uses for which they’re prescribing certain drugs are off-label.

In fact, of the 1,199 physicians surveyed (599 primary care physicians and 600 psychiatrists), only half were able to correctly identify the FDA-approval status of the 22 drug-indication pairs (particular drugs prescribed for particular conditions) included in the survey. (The survey used psychiatric medications because they’re among those most often prescribed for off-label uses by psychiatrists and generalists alike.)

A couple of disquieting examples of findings from the survey (which was published online this month in the journal Pharmacoepidemiology and Drug Safety):

[A]mong the 42% of physicians who prescribed quetiapine (Seroquel) for dementia with agitation during the previous 12 months, nearly one in five (19%) erroneously believed it was FDA-approved for this use, when in fact quetiapine has never been FDA-approved for this indication and at the time of our survey carried a black-box warning for “increased risk of death compared to placebo” in elderly patients with dementia.
[A]mong the 72% of physicians who reported having used lorazepam to treat chronic anxiety during the previous year, one in three (33%) reported that it was FDA approved for this use, when in fact an FDA warning specifically advises against this application.

Yet 95 percent of the physicians surveyed reported — often wrongly, as it turned out — that they generally know the FDA-labeled indications of the medications they prescribe!

“These findings highlight a pressing need for more effective methods to inform physicians about the evidence base, or lack thereof, for drugs they prescribe off label,” concluded the survey’s authors.

They also highlight the need for us patients to continually ask questions of our physicians.

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Comments (3)

  1. Submitted by Mike Wyatt on 08/25/2009 - 01:47 pm.

    Excellent article. I absolutely cringed this past legislative session as representatives (who know less than doctors, I presume) rattled on about the lack of a FDA approval process as one of the reasons why they would not support medical marijuana. When doctors don’t even know what they are prescribing, it certainly makes you think twice about the medical community in general, the pharma industry, and the FDA. No one seems to be on the same page when it comes to our supposed “safety.”

  2. Submitted by Bernice Vetsch on 08/25/2009 - 02:56 pm.

    Sounds like that was a made-up “reason” to deny pain-afflicted terminally ill patients this method to relieves pain and nausea when nothing else works. Opponents also fear such patients will move on to harder drugs because it is a “gateway” drug. Why, for the terminally ill, would that matter even if it were true?

  3. Submitted by jeoff quilt on 05/17/2011 - 04:00 am.

    A dietary and health supplement company has recalled a large share of its goods, which are sold in nine states, for allegedly promoting its products as medications. Multi-Mex Distributors Inc., is suspected of intentionally naming and packaging Amoxilina, a dietary supplement, to resemble an over-the-counter antibiotic sold in Mexico, to be able to trick consumers into buying it. I found this here: Pill maker ordered to stop marketing diet pills as antibiotics: read on newsytype.com.

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