Access to Hormonal Contraception: Is It Time We Considered Over-the-Counter Status?


Regardless of how split Americans are with regard to the abortion debate, we should all be able to agree on the need to prevent pregnancies. However, an obvious approach to pregnancy prevention is being sidelined by the lack of over-the-counter availability of hormonal contraceptives.

Sadly, the US has one of the world’s highest of rates of unintended pregnancies, particularly among teenage girls.[1]  About half of all pregnancies are unintended, and in spite of Oklahoma and other states’ incremental policies to restrict abortion, 42 percent of those unintended pregnancies are voluntarily terminated.[2] While public policy discussions tend to focus on the hot-button issue of abortion, one approach that could substantially reduce the number of unplanned pregnancies is undermined by unnecessary roadblocks from the Federal government—as well as health care providers—and therefore has not been given a sufficient chance. Hormonal contraception, such as the birth-control pill (BCP), vaginal rings, and patches, should be available without a prescription.

Hormonal contraception meets the Federal Food & Drug Administration (FDA) standards for non-prescription status; consumers can easily identify contraindications, directions for use are uncomplicated, the benefits outweigh risks, and health providers are not necessarily required. Not only is hormonal contraception not available without a prescription, many clinicians force unnecessary medical examinations before allowing women access. In addition, the “conscience regulation” enacted by George W. Bush and not yet overturned by President Obama, allows health care providers to withhold prescriptions and even give patients inaccurate medical information, if they so choose.

Though we often hear of a possible association between BCPs and strokes or heart attacks, those risks are much lower than the risk of suffering liver damage from over-the-counter acetaminophen. Aspirin and ibuprofen have even more safety risks, such as ulcers, bleeding, high blood pressure, and kidney disease.[3]  Hormonal contraception has been proven safe—pregnancy is seven times more dangerous than pills, smoking is 50 times more dangerous than pills, driving is 12 times more dangerous than pills[4]—according to numerous respected medical organizations, including the World Health Organization, the American College of Obstetricians and Gynecologists, the Royal College of Obstetricians and Gynecologists, and the American Medical Association.

In a 2000 article, Emery University’s Robert Hatcher, professor of Gynecology and Obstetrics, stated that the BCP’s history has shown it to be perfectly safe for use over-the-counter. Arie Yeshaya, M.D. of the Department of Obstetrics and Gynecology, confirmed that severe complications are rare (venous thrombosis occurs in 6 out of 10,000 women using oral contraception, as opposed to 3 out of 10,000 non-oral contraception users). Daniel Grossman, Senior Associate at Ibis Reproductive Health, cites a 2004 US national survey of women that reported 41 percent of women not using contraception said they would begin using the pill, patch, or vaginal ring if it were available without a prescription in a pharmacy. Another similar study found that travel away from home and running out of pill packs were common reasons women missed pills—a frequent cause of contraceptive failure.[5]

Why then, is the US still illogically holding birth control captive? In reality, the reason behind these pointless policies may not be health considerations, but rather moral objections on the part of the FDA, which contends that it is the pharmaceutical industry’s responsibility to seek approval for over-the-counter marketing of drugs. However, in 2000, the agency held a hearing to consider making BCPs available on a non-prescription basis and then ruled against it. It did the same with Plan B, also known as the morning after pill, prompting the 2005 resignation of Susan Wood, former Assistant Commissioner for Women’s Health. Wood was protesting the insertion of abortion-era politics into what should be a strictly health issue.

Not only are women in the United States required to make costly and time-consuming visits to a doctor’s office to get birth-control pill prescriptions, they are often required to undergo unnecessary and perhaps unwanted physical examinations and tests. The World Health Organization, Planned Parenthood Federation of America, and the American College of Obstetricians and Gynecologists,[6] and the American Medical Association, do not consider breast or pelvic examinations necessary for distribution of birth control pills. Incredibly, Sarah Jarvis, women’s health spokesperson of Royal College of General Practitioners in London, when arguing against allowing hormonal contraception available without a prescription, even stated that the pill is safe.[7]  

Why might women not want to meet with doctors? There are several possibilities. Given the state of our current economy, many women are already struggling financially and medical procedures compound expenses. For others, time is an issue. Some women find themselves in need of a prescription refill and unable to visit a clinic or get an appointment with a doctor in time. For some women, the intrusiveness of the exams and test is enough to prevent them from seeking them. Yet another reason, as exemplified by the recent change in pap smear recommendations, is that some women simply think the exams are unnecessary.  Until recently the standard recommendation, which many doctors and university clinics required, was an annual pap smear on record. This has recently been changed to every two years (every three for women over thirty).

Another concern asserted by Michael Cackovic, MD and Michael J. Paidas, MD[8] is that women will stop going for annual exams and pap tests if health centers don’t have a paternalistic policy of withholding contraception. According to this logic, no one should be allowed any medications unless they have all recommended physical exams. Over 55 and haven’t had a colonoscopy? Sorry, no flu shot for you. Misleading women is a form of coercion, not informed consent. Respect for the individual and their ability to make decisions is a basic principle of medical ethics. Not doing so is nothing short of provider bias and paternalism. Would women miss out on other preventive services, such as cervical smear tests or breast exams, if they were not required to visit a clinician? How many men actually go for their annual prostrate exam? Let’s allow women, like all mentally competent adults, to make their own decisions regarding their bodies. Shouldn’t patients, including women of child-bearing age, have the right to autonomy and bodily integrity? This logic could also be used to withhold long-lasting birth control such and IUD’s and sterilization. Not a good idea given the number of unintended pregnancies in the US.

Another hypothesis voiced by health professionals is that women might not understand how to take their contraception, however several international studies have found that over-the-counter provision of oral contraceptives by pharmacists is a safe, effective, and practical. Additionally, two US studies found that women were able to identify if oral contraceptives would not be a good choice for them.[9]

Already in Washington State, there is an initiative to de-medicalize hormonal contraception, thus making it readily available to women. Pharmacy Access Partnership, a center within the Pacific Institute for Women’s Health, is working with advocates, researchers, and providers to make hormonal contraception over-the-counter. Thus far, they’ve found it to be a practical idea and currently, one in five states has regulations that would permit pharmacists to provide pharmacy access to HC.

one stands on the abortion debate, most Americans would agree that it should not be a form of birth control and most wish to see it rarely used as a last resort. The prevention of pregnancy is a choice that women should be entitled to make for themselves. As consumers, we have the power to help to decrease unwanted pregnancies and access to hormonal contraception in pharmacies can be within our reach. Let’s encourage efforts to decrease abortion and increase women’s bodily autonomy by freeing contraception from the ties that bind it.

[1] Singh, S. and Darroch, J.E., “Adolescent pregnancy and childbearing: levels and trends in developed countries.” Family Planning Perspectives, 2000, 32(1): pg 14–23. http://www.guttmacher.org/pubs/journals/3201400.html

[2] Finer, L.B. and Henshaw, S.K., “Disparities in rates of unintended pregnancy in the United States.” Perspectives on Sexual and Reproductive Health, 2006, 38(2): pg 90–96. http://www.guttmacher.org/pubs/fb_induced_abortion.html

[3] Childs, Dan. “FDA Scrutinizes Acetaminophen’s Liver Risk Concerns Over Unintentional Overdose Hazards May Change Drug’s Labeling,” June 29, 2009. http://abcnews.go.com/Health/PainManagement/story?id=7955370&page=1

[4] CNN.com “No prescription for the pill? FDA considers making the pill available over-the-counter.” June 29, 2009. http://archives.cnn.com/2000/HEALTH/women/06/29/pill.prescriptionns/index.html

[5] BMJ 2008;337:a3044 http://www.bmj.com/cgi/content/extract/337/dec23_2/a3044

[6] Leeman, L. “Medical barriers to effective contraception.” Obstet Gynecol Clin North Am. 2007; 34: pg 19–29.

[7] BMJ 2008;337:a3056 http://www.ncbi.nlm.nih.gov/pubmed/17472862

[8] Daniel Grossman, MD; Michael Cackovic, MD; and Michael J. Paidas, MD. “Viewpoints: Should oral contraceptives be sold over-the-counter?” Contemporary GYN/OB, September 1, 2008. http://contemporaryobgyn.modernmedicine.com/obgyn/author/authorInfo.jsp?id=36190

[9] BMJ 2008;337:a3044 http://www.bmj.com/cgi/content/extract/337/dec23_2/a3044

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  • kp

    I completely agree.  I think it’s a travesty that I have to be screened for cancer in order to get a prescription for a pill known to prevent the cancer I’m being screened for.  I’ve heard the following justifications for keeping the pill prescription-only:

     

    1.  Perscription only means that society ensures that at least women in hetero-relationships get STD/STI-tests on a yearly basis.   I disagree because some women who aren’t active are on the pill, some women who are active are not on the pill, and some active women on the pill are in long-term relationships where STDs aren’t an issue.  I think the issue to address is making STD testing and treatment affordable and available (for men and women), not forcing needless exams on women.

     

    2.  Perscription-only means that the pill can be covered by Medicare/Insurance.  I would argue that the perscription-only status keeps costs artificially high.  For example, my yearly exam was $700-most of which was paid for by my insurance.  For my perscription (and the portions of the exam not covered by insurance), I’ll pay another $300 out of my HSA for a generic pill.  That’s $1k/yr for a generic!  An OTC pill pack in Mexico was, what, $5?  Even tripling that for U.S. distribution, we are talking $180 out of pocket-just over half what I pay now.  As for medicare recipients, why can’t we give WIC-like stamps for generics?

     

    I do disagree, however, with making non-generics OTC.  I think NPR had a program on how dangerous the non-generics can be just because there isn’t enough data yet.  I think that if women go through available generics, and can’t find anything suitable, perhaps they should see a doctor.

  • plume-assassine

    Excellent article! I had no idea that so many medical organizations have said that breast or pelvic examinations are not necessary for distribution of birth control pills. It is incredibly annoying to me that I have to undergo an invasive yearly exam (even though I am in a long-term monogamous relationship) just so I can have access to hormonal contraception.

     

    On top of that, I had to switch to a new insurance provider recently and the co-pay cost of my birth control pills literally doubled. I can no longer afford to pay for them every month. Because of this, I called a local OB/GYN office and asked if they provided copper IUD’s for nulliparous women. (I figured that an IUD would be much cheaper in the long run.) The woman I spoke to on the phone was incredibly vague, dodging a direct answer, and just told me to come in anyway so I could “talk” to someone.

     

    The nurse I spoke to at the office knew why I was there and what I wanted, but told me that they only provided IUD’s to women who had been pregnant and had a vaginal delivery. I asked if there was any particular reason or risk at to why they wouldn’t give me one and she actually said there wasn’t a reason, they just “preferred not to.” (I suspected that it has to do with their fears of uterine perforation and sterility, although it has been shown that this is incredibly rare.)

    She then tried to convince me to go on the shot [horrible idea! everyone I know who has used this method has gained ~80 pounds and felt generally miserable]. I told her that, no, I was set on a copper IUD, and if they couldn’t do that for me, I would need some referrals to a provider who would. She had to get up and ask the nurse practitioner while I sat and waited, then she came back in with no referrals, and told me to go look through the phone book. I was so pissed off that I just got up and left without saying a word. Waste of my frickin’ time.

     

    In another article on this site of a similar topic, I also mentioned that a friend of mine had a lapse in her insurance coverage and could not afford birth control. I went to the doctor and got a free sample of a 3-month supply of NuvaRing that I mailed to her. The ridiculously high cost of hormonal contraception leads to desperate situations like that one, and almost certainly contributes to a high rate of abortions in this country.

     

    There is definitely a lot of paternalistic bullcrap in women’s reproductive healthcare. Some places really like to give you the runaround when it comes to choosing contraception. I know my options, I know the risks, I know what I want, and it’s my body. I would like to find a doctor who will respect that… and I would love to see healthcare reform respect that, in the form of OTC hormonal birth control!

  • aligatorhardt

    When the hormonal birth control has been shown to be less risky than common asperin there is no need for it to remain prescription only. There is no incentive to over use the drug, since it does not get you high. This seems more like religious prejudice and financial exploitation. Many common drugs remain only available by prescription, and one has to consider that requiring regular doctor visits to be a strategy for forcing patients to provide regular earnings for doctors. The rulings of the FDA are consistant with the FDA’s capitulation to industry profits rather than to function as an agency for public health. The needs of the consumer/patient are not well served by withholding drugs, or requiring unnecessary examinations as a lever to force consumption by holding one’s health for ransom. An examination would make sense for new patients, but medications that are used long term for documented reasons should be available to those who need them. This includes other areas of public health. Contraception is the best way to avoid the need for abortions. Anti-abortion groups should be in favor of easy access to contraceptives, if lessening abortions is actually their goal. Many drugs are priced excesively high just because they are needed and therefore represent a captive market. Countries with socialized health care would not be well served by witholding medication from patients, this is a result of our capitalist health care system.