No, prescription-only hormonal contraception is not extortion

by Russell Saunders on March 12, 2012

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It is one of my signal frustrations to come across articles or statements attributing some standard aspect of patient care to self-interest on the part of doctors.  Perhaps I am overly generous with my peers, but I generally think most of us went into medicine for reasons other than money, and hearing money cited as the reason we do what we do sets my teeth on edge.

Thus, it was with rising indignation that I read Virginia Postrel’s column (via Andrew Sullivan) arguing in favor of over-the-counter access for hormonal contraception.  Not only do I think she’s wrong about it being a good idea for patients, I think she’s being incredibly unfair to medical providers in the way she describes the current prescription requirement.

Anyone — a local teenager, a traveling businessman, a married mother of four, an illegal immigrant, even a student at a Jesuit university — can walk into my neighborhood CVS any time, day or night, and, for less than $30, buy a 36-count “value pack” of Trojan condoms.

That’s enough to last most Americans at least three months, according to Kinsey Institute surveys. If you want more, you can buy out the store’s entire stock. There’s no limit, and you don’t need to see a doctor for permission and a prescription.

Contrary to widespread belief, there’s no good reason that oral contraceptives — a far more effective form of birth control — can’t be equally convenient.

True, making the pill available over the counter could reduce the amount of outrage and invective available for entertaining radio audiences, spurring political fundraising and otherwise amusing the American public. But the medical risks are quite low.

That last is not entirely true.  The medical risks for most women are quite low.  But for certain women, the risks are actually quite a bit higher.  Women who have a certain kind of migraine headache are at increased risk of stroke if they take most forms of oral contraceptive pill (OCP), particularly if they smoke.  The same applies to women with high blood pressure, which is almost always undetectable without a medical exam.  Certain kinds of clotting disorders can make OCPs very dangerous, and while taking a detailed family history may not detect everyone with these disorders, it’s a lot better than not asking at all.  The list of risk factors is not as short as Postrel implies.  Who will do that screening and counseling about this risk if OCPs are available without a prescription?

Requiring a prescription “acts more as a barrier to access rather than providing medically necessary supervision,” argues Daniel Grossman of Ibis Reproductive Health, a research and advocacy group based in Massachusetts, in an article published in September in Expert Review of Obstetrics & Gynecology.

And this is me arguing back.  (Unfortunately for all of us, Dr. [I assume] Grossman’s article cannot be accessed without a subscription, so I cannot speak to its quality.)  Yes, a prescription does create a barrier to access.  Sometimes barriers actually exist for a reason.  Requiring women to meet with their medical providers to have a thorough discussion of their risk factors actually does them a service.

Birth-control pills can have side effects, of course, but so can such over-the-counter drugs as antihistamines, ibuprofen or the Aleve that once turned me into a scary, hive-covered monster. That’s why even the most common over-the-counter drugs, including aspirin, carry warning labels. Most women aren’t at risk from oral contraceptives, however, just as most patients aren’t at risk from aspirin or Benadryl, and studies suggest that a patient checklist can catch most potential problems.

The difference between drugs like Benadryl or Aleve is that, at the dosages one is instructed to use on the packaging, the risk of life-threatening side effects is minimal.  With OCPs, taking the pills exactly right doesn’t lower their risk.  [Edited to add:  It occurs to me that yes, taking OCPs right does, in a sense, lower their risk.  If you take them wrong, the risk is higher.  But the increased risk of clotting comes with perfectly correct use, not overdosage.]

Postrel doesn’t link to any of those studies touting the efficacy of checklists at catching at-risk patients, so again we’ll have to take her word for it, I guess.  However, one assumes those checklists will be reviewed by pharmacists, who will be doing in a more cursory fashion (and, one also guesses, for free) what I do when I meet with patients to discuss starting OCPs.  I take half an hour to ask about their risk factors, check their blood pressure, review the correct use, and discuss warning signs of potentially life-threatening adverse effects.  A checklist will accomplish the same thing?  Or are we hoping that pharmacists will somehow function as quasi doctors, taking the same time and care but without expecting payment for the additional labor?

To further increase safety, over-the-counter sales could start with a progestin-only formulation, sometimes called the “minipill,” rather than the more-common combinations of progestin and estrogen. (Although we casually refer to “The Pill,” oral contraceptives actually come in about 100 formulations.)

Progestin-only pills, or POPs, have fewer contraindications. Unlike combination pills, they’re OK for women with hypertension, for instance, or smokers over the age of 35. The main dangers are fairly rare conditions such as breast cancer or current liver disease. “Not only are POP contraindications rare, but women appear to be able to accurately identify them using a simple checklist without the aid of a clinician,” declares an article forthcoming in the journal Contraception.

And here’s where I started a go a little nuts.  It is true that POPs are safer than OCPs containing estrogen, which is what increases the risk of clots.  However, pulling down my handy-dandy textbook, I can confirm that they are also less effective than combination OCPs, and are harder to use.  POPs must be taken at the same time every day, and patients cannot miss a pill and double up the next day like they can with combination pills.   They are a very fastidious medication, and for that reason I hardly ever prescribe them.  So, sure, it would probably be safe to make them available without a prescription, but with the notable downside that women may getting worse contraception than they think, particularly since nobody would be giving them detailed instructions.  (As an added downside, they cause menstrual irregularities in many or most women who take them.)

Aside from safety, the biggest argument for keeping birth- control pills prescription-only is, to put it bluntly, extortion. The current arrangement forces women to go to the doctor at least once a year, usually submitting to a pelvic exam, if they want this extremely reliable form of contraception. That demand may suit doctors’ paternalist instincts and financial interests, but it doesn’t serve patients’ needs. As the 1993 article’s authors noted, the exam requirement “assumes that it would be worse for a woman’s health to miss out on routine care than it would be to miss out on taking oral contraceptives.”

And here’s where I went completely nuts.  Extortion?  What a stupid, reprehensible overstatement.  I love that “aside from safety” bit  Aside from the cold, there’s no reason not to skinny sip in Juneau.  It is precisely for reasons of patient safety that OCPs are prescription-only.  Period.

Now, one might argue that patients who have taken OCPs safely for years should be able to get extended renewals without a follow-up exam.  I would counter that it is the standard of care for any long-term medication to require regular follow-ups, be it for antidepressants, acne medications, whatever.  We do them to make sure the medication is still working, to make sure patients aren’t having side effects they’re overlooking or tolerating that couldn’t be improved by changing medications, and so forth.  Doubtless this kind of oversight would full into the bucket that Postrel calls “paternalism,” but I prefer to think of as taking appropriate care of my fishing patients!  At the very least women should get annual blood pressure checks to make sure their risk factors for continuing to take OCPs haven’t changed.

I will also grant that pelvic exams should not be necessary for women to get OCPs.  As the reasons for doing them on adolescent girls are very limited, I perform them rarely and don’t require them for OCPs prescriptions.  However, as women get older they get more and more important as a screen for cervical cancer, and so annual pelvic exams are a good idea.  I can see an argument that pinning OCP renewal on having them is coercive, which speaks again to the notion of extended refills, but that’s not the same thing as extortion.

Postrel’s affection for a more laissez-faire approach to patient care really comes into full flower at the end:

Right now, the American women who have the most choice are those who live near the border with Mexico, where pharmacies sell oral contraceptives without a prescription, generally for about $5 for a one-month supply. A group of researchers including Grossman have conducted extensive interviews with more than 1,000 women who live in El Paso, Texas. Roughly half the women get birth-control pills from local clinics, often free, while the other half go across the border to pharmacies in Ciudad Juarez. The researchers find, not surprisingly, that those who cross the border have more ties to Mexico; 77 percent were born there, compared with 60 percent of clinic users. But there are also differences in priorities.

“Among pharmacy users, very large percentages noted both not having to go to a doctor to get a prescription and being able to send a friend or relative to pick up their pills as advantages of Mexican pharmacies,” the researchers write in a June 2010 article in the American Journal of Public Health. Clinic users, on the other hand, cite low cost and the availability of other health services.

Mexico!  Where you can get all kinds of wonderful medications without a prescription!  Why bother going to a doctor at all?  Just fire up WebMD and book a ticket to Tijuana.

This post has already gone on too long, so I need to wrap it up.  Let me conclude with this — as Postrel herself notes, there are about 100 different formulations of OCP available.  They vary in the type of hormones used, and the dosages throughout the cycle.  Different hormones have different benefits and different side effects.  Ortho-Cept is not the same as Ortho-Cyclen is not the same as Ovral.  Why is it paternalistic for me to maintain that, after having gone through medical school, residency and a fellowship specifically tailored to this kind of medicine, I have expertise that might help women get the best care?  (Is there a similar push with other professions?  Are people out there touting pro se legal representation?)  Yes, it is inconvenient to take time out of one’s day and come see me.  But there is value in doing so!  Just because something is easy doesn’t mean that it’s good.

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