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    When lawmakers prescribe

    I have a question for you. When you see amitriptyline prescribed to treat neuralgia, what do you do? How about trazodone prescribed for insomnia, gabapentin for migraine prophylaxis, or montelukast given to a COPD patient? How do you handle these situations?

    If this were a conversation, many folks would probably just give me a funny look right now, followed by an answer something like “I'd fill them, just like any of the other prescriptions I see all day long. Why wouldn't I?” This is precisely my point.

    See also: On the record with APhA


    Every one of the examples above is a medication being used for a non-FDA-approved or “off-label” use — and everyone reading this column knows that “off-label” doesn't make a bit of difference in how a prescription is handled.

    The FDA itself says on its website that “because physicians exercise their judgment in prescribing what they feel is best for the patient, they may decide to use an ‘off-label’ regimen, rather than the approved regimen.” Anyone who has ever worked in a pharmacy knows that’s what physicians do. Some estimates indicate that up to 25% of all prescriptions filled each year are for “non-approved” uses.

    Obviously it is an integral part of the practice of medicine for physicians to use their knowledge and judgment; otherwise we could just do away with your family doctor and replace her with someone following written guidelines from which no one ever strays.


    Before you go any further, read that again and decide whether what I've said so far makes sense. Off-label prescribing is common and necessary for the effective practice of medicine. I don't think many of you would disagree with me at this point.

    See also: Community pharmacy's secret weapon


    Some people do, though, and not surprisingly, they are politicians, not doctors. At least three states have enacted laws that prohibit a doctor from prescribing a particular drug in any way other than that stated in the official, FDA-approved labeling.

    Again, despite the fact that one in four prescriptions that make their way to your counter are for off-label uses, people sitting in state legislatures have decided that one particular drug should never be used that way.

    Maybe you’re thinking of off-label use of antipsychotics in the elderly, a common, and the evidence suggests, dangerous use of these medications. If so, you would be wrong. The self-appointed medicine police in state capitols have shown no concern for this type of inappropriate prescribing. You'll probably fill some of those prescriptions today, if you're at work.

    Instead, the drug that has caught the attention of the politicians is commonly prescribed off-label at a lower dose than its official labeling, and with an easier regimen to follow.

    David Stanley, RPh
    David Stanley is a pharmacy owner, blogger, and professional writer in northern California. Contact him at [email protected]


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