When lawmakers prescribe

July 10, 2015

Article

Is it really good medicine when legislators call the shots?

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.

Off-label

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.

Right?

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.

Label-only

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.

Higher, higher, and more

You read that right. State governments have started to force doctors to prescribe a higher-dose, higher-priced, and more complicated regimen for patients. Before I tell you the name of the drug involved, I want you to think about how you feel about that. I'll bet most of you will say that's ridiculous.

That's because your minds are in the world of medicine and not the world of politics.

As soon as I tell you that the drug involved is mifepristone, also known as RU-486 or “the abortion pill,” you'll probably start to understand.

Even the most “pro-life” people in the world, if they have any medical training at all, will know that laws like these have nothing to do with patient safety or the good practice of medicine. They are simply a disingenuous use of the political process to further the social agenda of one faction in a bitter policy fight. Were this any other drug, these laws would be laughed out of the building.

Legislating bad medicine

Now I know that abortion is one of the most contentious issues in the history of our country, and I'm not saying that both sides shouldn't advocate for their respective positions. Freedom of speech is one of the foundations of this country, after all.

But you do that tradition of free speech a disservice when you use it to co-opt the good name of medical professionals to pull the wool over the eyes of lay people.

You knew that limiting off-label use of drugs was ridiculous after reading the second paragraph of this column. And no matter where you stand on the abortion issue, you were right.