In which I reconsider a previously-stated opinion

I am on the record as opposing over-the counter access to oral contraceptive pills.

It seems that stance now puts me at odds with the American College of Obstetricians and Gynecologists.

Oh, dear.

From the ACOG committee that drafted their recent recommendations:

In the interest of increasing access to contraception, and based on the available data, the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice makes the following conclusions and recommendations:

  • Weighing the risks versus the benefits based on currently available data, OCs should be available over-the-counter.
  • Women should self-screen for most contraindications to OCs using checklists.
  • There are concerns about payment for pharmacist services, payment for over-the-counter OCs by insurers, and the possibility of pharmacists inappropriately refusing to provide OCs.
  • Screening for cervical cancer or STIs is not medically required to provide hormonal contraception.
  • Continuation rates of OCs are higher in women who are provided with multiple pill packs at one time.

My concerns about non-prescription status for OCs are several.  The first is that even proper use of these medications puts a small but significant number of women (eg. those with a predisposition for blood clots, those with a specific kind of migraine headache, etc.) at increased risk of certain very serious, potentially devastating health problems (eg. stroke, blood clots in the lungs or legs).

Is a medical visit to screen for risk factors necessary?  ACOG says no, and clearly believes a checklist is sufficient.  Further, they note:

However, it is important to understand that the rate of venous thromboembolism for OC users is extremely low (3–10.22/10,000 women-years) … and to put this risk in context by recognizing the much greater risk of venous thromboembolism during pregnancy (5–20/10,000 women-years) or in the postpartum period (40–65/10,000 women-years) …

It’s very hard to counter that argument.  Given that I prescribe OCs far less frequently than (presumably) the members of the ACOG Committee on Gynecological Practice, I am inclined to defer to their recommendations.  Sort of.

I can understand and accept the reasoning that women should be trusted to do their own screening for certain high-risk conditions.  And I obviously don’t dispute the science vis-à-vis the relative risk of OCs vs pregnancy.  But it’s not merely to mitigate the risk of the former that I think medical visits for prescriptions are of value.

As I said in my earlier post on the subject:

[T]here 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?

I suppose one could argue that patients already have to navigate a dizzying number of OTC medications, from treatments for allergies to acid reducers to analgesics.  All of these different medications and formulations have different side effects and benefits, yet we trust consumers to wade through and pick their own choice.  Why not with OCs?  And I can accept that point of view.  Perhaps women shouldn’t be required to get my advice about which formulation would be best for them.  But given that some are better for women who have heavy, painful periods while others are better for women who also want help with acne and so on, it seems to me that a benefit is lost when OCs are obtained without a medical evaluation.

Finally, when I prescribe OCs, not only do I do a thorough risk evaluation and try to tailor the prescription to the patient’s needs as comprehensively as possible, I also review the proper way to take them, and what side effects they can expect.  Admittedly, people do without this kind of advice when they take other OTC medications.  But the stakes are different when the medications are for allergies or acid reflux than when they’re for contraception.  An unintended pregnancy is a much bigger deal than persistent nasal congestion.  When I start my patients on OCs, I discuss what to do if they miss a pill, which can vary a bit from one formulation to another, and what medications may interact and lower their effectiveness.

Do I delude myself that these instructions lead to perfect OC use?  No.  I would have to be a nincompoop to believe that, and my own experience from follow-up appointments with my patients belies that conclusion.  Perhaps a set of written instructions will serve just as well.  But I must admit I’m skeptical, and wonder if some of the benefits of non-prescription OC status would be alloyed with an increase in incorrect use and unintended pregnancy.

As I have also already stated, I certainly agree that using the prescription-only status of OCs to corral patients into one’s office for unrelated gynecologic care is bad medicine.  It is paternalistic and coercive to do so, and of course I agree with ACOG’s penultimate bullet point above.  While I also think there’s some value in doing at least one or two follow-up visits to make sure patients are tolerating the medication and using it correctly (as well as to do a blood pressure check), there is likely little need for such visits for patients who have been on OCs safely for years, and there is certainly no basis to demand they get a pelvic exam, even if doing so would be a good idea for unrelated reasons.  Physicians who hold OC prescriptions hostage to such exams should be admonished to stop.

All of this is to say that I’ve softened by earlier position, and wouldn’t actively oppose making OCs available without a prescription.  It seems relatively convincing that the benefits of doing so outweigh the costs.  But I definitely think there would be a cost in doing so.  I worry that checklists may be inadequate to prevent some high-risk women from starting OCs and suffering adverse effects.  I worry that, absent counseling about warning signs of such things as blood clots in the leg, some women may not realize they are related to their medication and might not give them proper heed, delaying medical intervention when time may be of the essence.  And I worry that other undesirable outcomes, while less dire, may still come to pass, even if it’s as simple as taking one pill when another will work better.

Do I think women must see a medical provider before they have access to OCs?  I guess not as much as I used to.  But I still think it’s a good idea to see one anyway.

Russell Saunders

Russell Saunders is the ridiculously flimsy pseudonym of a pediatrician in New England. He has a husband, three sons, daughter, cat and dog, though not in that order. He enjoys reading, running and cooking. He can be contacted at blindeddoc using his Gmail account. Twitter types can follow him @russellsaunder1.


    • Remember when Winchester called Radar a noncompoop? Good times, good times.

        • I love the word “nincompoop”. Primarily because Hannah thinks it’s one of the most hilarious words, like, ever.

  1. It seems like if OC were that easy to get a lot of parents are going to be giving them to their 13 year-olds and telling them they are vitamins. I know I would be tempted. That’s exactly why the pediatrician should be involved.

    • tenyearolds.
      While giving such things as “vitamins” is completely and utterly unethical… I can certainly see the parent who wishes to give them out. (I’d counsel against, as Plan B is markedly safer… but if your kids can’t be trusted to talk with you…)

  2. “But I still think it’s a good idea to see one anyway.”

    I’m with you 100% here, doc. However, it takes a bit of a leap to go from there to, let’s-restrict-access-to-the-pill-for-all-women. We can have pharmacists act as gatekeepers for the drug, going through a checklists, talking about risks, suggesting they consult a doctor, or whatever. But in the end, we just need to let adults make decisions for themselves.

    • That’s pretty much where I’ve landed. I’m sufficiently convinced that the benefits outweigh the risks to support OTC status for OCs, but I still think women who opt to see medical providers first are going to end up with better outcomes.

    • I’m in agreement with Jon, and part of my position is a “who am I to tell someone else what they can’t have access to?” I’m particularly hesitant given the gender differences involved.

    • The average person isn’t going to have an in-depth understanding of their own medical characteristics and risk factors, so I understand Russell’s position. Leaving the function of the pills out it, if a medication is safe for many people but highly dangerous for people will certain characteristics (characteristics that would typically only be discovered by a medical examination), requiring a prescription to identify if people have those characteristics is a smart way of going about things.

      I don’t think it needs to be seen as a gender issue. OCs should simply be treated the same as other, gender-neutral medications with similar characteristics (safe for most people, unsafe for some, and most people won’t know without a doctor’s visit whether it’s safe for them or not).

      • many drugs are “unsafe” even with a doctor’s visit. at least for people who are “normally nonstandard” 😉

      • Historically, the bodies that determine who can by the pill and how have been incredibly male-dominated. There’s a pretty unavoidable gender issue there.

        Elsewhere in this thread, the risks of other OTCs are noted. As well, ACOG noted the risks of being pregnant and giving birth. I’m not sure why we would determine that of all these risky things, it’s only the pill that poses such a risk as to require a prescription.

        Anyway, I think I’ll head out right now and buy some smokes.

        • Historically, the bodies that determine who can by the pill and how have been incredibly male-dominated. There’s a pretty unavoidable gender issue there.

          Well, yes and no. Most doctors being men raises a definite possibility of disparity between how the pill is dealt with and how other medications with similar characteristics are dealt with, but we’d still need to look at whether that disparity actually exists before we can say it’s a policy issue. If there’s no difference compared to other, gender-neutral medication, the fact that doctors tend to be male and patients for this prescription are female isn’t by itself a problem, in my view. If there is a difference, than it’s something that should be taken into account and corrected for.

          • In Japan, there is certainly a difference. Quite a market in smuggling black market birth control, though the pill is legal over there.

  3. A bunch of semi-related questions:

    1.) How often does a woman need to visit her doctor to maintain her prescription? I probably SHOULD know this, but Zazzy stopped taking them when she was identified as being high-risk for clotting (she made the identification herself via family history and made the decision herself). Before that, as a Naval nurse, she could quickly visit her doctor while at work and get the script same day, so I have no idea how often that actually happened. I ask because if women must visit their doctor every month, that seems onerous, both logistically and financially. If it is an annual visit, that seems much more reasonable.
    2.) Would you consider making certain OC’s OTC but not all? Perhaps there are formulations that work reasonably well for the vast majority of women, which have low risks of side-effects or contraindications, and which can be made available without a script. Others would require a script. Basically, a two-tier system.
    3.) How do you feel about common meds like penicillin or conjunctivitis drops being OTC? These are two common medications, with (as I understand it) minimal risk that treat highly contagious but highly treatable conditions. As a teacher of young children, these are meds I often require but which are difficult to come by via script because of the time required to get to a doctor. They also turn a $5 medicine into a $25 or $35 medicine, which isn’t a major issue for me but I’m sure is for many folks.

    • 1) I think most providers would see a patient for contraceptive maintenance every 6-12 months. Anything more frequent would be ridiculous, and I would usually err on the 12-month side of things.

      2) There isn’t sufficient difference between formulations that piecemeal OTC status makes much sense. While some have a higher estrogen content than others (with resulting increased risk of estrogen-related side effects such as nausea and headaches), the difference is not great enough to merit keeping some prescription-only if you’ve made others OTC.

      3) I could see an argument for making antibiotic eyedrops OTC, were it not for the fact that in the overwhelming number of cases they are completely worthless. Pediatricians overprescribe them to a preposterous degree, myself more than I wished. The vast, vast majority of cases of conjunctivitis are viral and the drops do nothing at all. But since schools and daycares treat conjunctivitis like it’s ebola (for some reason) and are under the mistaken impression that the drops make kids less contagious (they don’t), parents are pressured to seek them and we are pressured to provide them. They do little harm, so for that reason I wouldn’t mind their being OTC, but I’m opposed to people buying medications for no good reason.

      Penicillin, like all antibiotics, should be prescription-only. Antibiotic over-use is already a significant problem due to insufficiently judicious prescribing practices, and making it OTC would already worsen the already very frightening issue of antibiotic resistance.

    • Regarding #1, Darlene would get prescriptions for a year or 13 months… enough to last to next year’s check up. If she had to delay the appointment, the doctor would phone in a few more refills.

      It’s my understanding that that is how it works for many women. It’s sort of the carrot to ensure that they see their doctor once a year.

  4. I like the idea of easy-to-obtain birth control, but OTC hormonal drugs just makes me feel ooky. Especially knowing that it will massively increase access to young, and still developing, girls.

    Can access to hormonal contraceptives change the physiological development of, say, a 13-year old?

    • Snarky,
      All due respect, but we’ve got enough estrogenlike compounds in the river to have intersex fish. And water treatment does not get them out (in fact, we see more moobs in the city because of the pollution.)

      We’re already seeing a dramatic drop in age of onset of menarche. (some populations used to get it at 16-17, if you can believe it).

      Access to many things can change the development of a 13-year old.

      • We’re already seeing a dramatic drop in age of onset of menarche. (some populations used to get it at 16-17, if you can believe it).

        The science which I am familiar with on that subject is very much on the side of it being the result of better nutrition and general health, rather than of hormonal contamination of the water supply.

        I find that a more plausible explanation. We already know that people can miss their periods if they’re undernourished or overstresssed.

        • From what I’ve read, the trend towards obesity is also playing a factor. There are also a handful of studies which are looking into uterine in utero exposure to compounds such as BPA and resulting early menarche – but there’s a lot of socio-economic confounders which must be adequately accounted for.

          • FFS, I want an edit button.


            “Uterine” should be ‘in utero’… damn you autocorrect!

          • I can see that. It makes sense as something that would send signals of “Plenty of food around, don’t need to worry about starving, good time for earlier reproduction”. It’s the same general biological association with “good times” –> earlier puberty.

        • Yeah. I’ll buy that (at least for the rise we saw up until the 1960’s). We’re also seeing a statistical trend toward birthing girls instead of boys. We’re also seeing a dramatic rise in breast cancer.
          “Better nutrition” doesn’t exactly explain why South America has a very different age of onset than other places. It may very well be “better nutrition”, but that’s more likely coded as “tropical fruits send signals to the body that other foods don’t”

  5. I tend to agree with putting OCs OTC, however with huge red-lettered warning regarding smoking and thrombosis.

    When I hear people (read: religious conservatives) scream about side effects, I just show them the stats on acetaminophen (which, IMHO should NOT be available OTC) overdoses and liver shredding. (it doesn’t help, mind you, but it makes me feel better).

    • So your argument that OC should be OTC is that…other OTC drugs have worse side effects?

      Not really sure you thought your clever plan all the way through, there.

      • Tylenol is a dangerous substance, and really ought to be given with a doctor’s appt only.
        (Just like super mega doses of advil or asprin).

  6. But I must admit I’m skeptical, and wonder if some of the benefits of non-prescription OC status would be alloyed with an increase in incorrect use and unintended pregnancy.

    This is what I saw happening as well until I asked myself about the likely behaviors of folks without this option… and I came to the conclusion that while incorrect use will increase, it’ll increase primarily among those who weren’t using at all. Correct use, however, will increase among these folks.

    Then I asked myself about whether the people who weren’t using at all avoided potentially procreative sex because of their lack of The Pill.

    I came to the conclusion that, no, they probably didn’t.

    As such, I actually see the margins moving toward *FEWER* unintended pregnancies.

    But more lawsuits.

    • My colleagues and I were discussing this again this morning.

      Among our concerns is that young women (and, just for the record, it should be noted that I am the only male provider at my practice who prescribes birth control — all the rest are women, too) will self-start on OCs but, as is so often the case with any medication, will fail to take it the right way. They’ll think they’re protected when they aren’t, and they’ll make choices predicated on that mistaken belief. Perhaps they’ll think barrier contraception is no longer necessary, for example. And they’ll end up pregnant.

      • Oh, I completely and totally understand that concern. That said: I’m wondering if that number is smaller than the number of pregnancies that will be prevented by proper use… and I don’t know the answer to that but I’m leaning that it would be.

        (Now I’m also assuming that the information that gets out there will be more of the form “seriously, take it for a month before not wrapping it up” than “those don’t work! I took one and got pregnant the next day!” because I’m optimistic like that.)

        • I’m wondering if that number is smaller than the number of pregnancies that will be prevented by proper use

          Well, that certainly seems to be ACOG’s line of reasoning.

      • I’d like to see an initial consultation with the GP with a recommendation for the OC type to start, and then the ability to buy them OTC until the followup appointment.

        It’d allow for the ‘talk’ about risks and whatnot, the need for barrier protection, etc but if there’s no untoward side effects, it allows the consumer the freedom of being able to pick up their OC whenever they need it – without having to get a prescription sent from their GP or the like.

          • I assume you would basically have unlimited refills for a year or whatever.

          • You and the GP agree on a type of OC, and that’s what you buy until you have the follow-up where you can discuss any side effects, etc.

            I guess ‘ability’ was the wrong word to use there. But, no edit abilities, so I couldn’t do much else.

          • Ah, so it would be an unregulated OTC – but GPs would as a best practice discuss it with you? Just wondering how that would differ from any other OTC you use on a regular basis – my doc checks in with me about those every year.

            (Not trying to be all quibbly – just to me it sounds like you are either talking about an unregulated OTC (eg OTC allergy meds) that a person would still discuss with their doctor, or a long-term refill as Kazzy described – but then it also sounds like you are talking about some 3rd different thing that I don’t understand, whereby there would be a special OTC section or people would have to be registered or something? I had 3 hours of sleep last night so I’m sure any confusion is utterly mine.)

          • Unregulated OTC which you discuss with your GP.

            In theory I’d like it to be available otc only after a consult, but that’s just not practical or really possible to implement and still have it available as an OTC.

            No, the confusion isn’t yours; I wrote it last night when I was wicked tired after doing a day’s worth of technical writing so I’m sure I effed it up.

  7. I thought about posting re: side effects and how they affect my opinions on this issue (and how weird it is that they affect my opinions considering that my pills were prescribed by a doctor), but every time I went to write things down, it got way more personal/revelatory than I wanted and I stopped.

    Suffice it to say, I suppose, that I can see both sides of the issue. Also, if you felt like proffering your opinions / experience / some of the good research I haven’t done into whether OCs are less or equally likely than they were in the 90s to have psychological effects on women with a family history of depression and bipolar – even though it’s highly tangential to the question – you’d be doing past-me a solid. (Present me is very happy that Jaybird has a vasectomy.)

    Or we could just talk about it in person someday, in the imaginary future where we all hang out all the time.

    • 1) Or we could just talk about it in person someday, in the imaginary future where we all hang out all the time.

      May the heavens hasten the day.

      2) Concern about mood effects of OCs would be another perfectly good reason to have a medical provider involved before starting them. Finding a formulation with a less potent/androgenic progestin, for example, might be a worthwhile reason for an appointment.

      3) I adore that, in a comment in which you expressed wariness of being too revelatory, I learned that Jaybird has a vasectomy.

      • 3) He’s an outright vasectomy evangelist; I’m actually surprised y’all aren’t sick of hearing about it already like the rest of us (and yes, Jaybird, when you see this, you could certainly write the vasectomy comment you wanted to leave on my first comment, without fear of derailing a conversation about OCs, now that I’ve done it first 😀 ). I suppose he doesn’t feel much need to evangelize *you*, but I figured the site at large would’ve had an earful by now. I mean, there’s not much need to evangelize me, either, but yet, I feel quite competent to advise someone on vasectomy aftercare due to the number of conversations I have had about such.

        2) Yes. My concern, I suppose, is that if every doctor were like you, such appointments would be helpful. If every doctor were like the one I had in college, they might take a thorough family medical history, explain why they were doing so, and then reassure a naive-and-good-at-acting-healthy 19-year-old that since she herself obviously had no previous struggles with depression, she would have no need whatsoever to worry about that side effect. (Which an OTC warning would *never* tell someone.) Lacking data, I am uncertain as to which of those scenarios is more likely.

        1) Amen.

        • After you get your vasectomy, wait at least a week before taking the car out of the garage and seeing what the new transmission is like.


          • A vasectomy is done under local anesthesia. My surgeon was a heavy investor in high-tech stocks, so while he was cutting and snipping, he was asking my advice on relational database company stocks. Very surreal. (Given when it was, I probably said good thing about Informix. I hope for his sake he didn’t listen.)

          • I remember back in my Navy days one of the Supply P.O.s got a vasectomy and couldn’t sit down for a week. I guess sometimes there’s swelling but then it prevents another kind of swelling later, so…

  8. Well, the upside, all those uninsured women I’ve been talking to will have more (affordable) access to birth control and fewer unintended pregnancies. But OCs do not protect against sexually transmitted diseases, so there’s that. I would hate for people to opt for the OC instead of the condom.

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