Should the Pill go OTC? ACOG says ‘yes’ to move

Combined oral contraceptives should be sold over the counter in drugstores without a provider’s prescription, according to a new committee opinion issued by the American College of Obstetricians and Gynecologists (ACOG).1

“There are no OCs currently approved for over-the-counter (OTC) access, but the College believes OTC availability will improve women’s access to and usage of contraception,” said the organization in a statement issued with the publication of the committee opinion. “The benefits of making OCs easily accessible OTC outweigh the risks.”

Although important questions remain, ACOG has appropriately concluded that oral contraceptives should become available over the counter, says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. The recommendation should enhance prospects for a pharmaceutical company approaching the Food and Drug Administration (FDA) to make one or more pill formulations available to women without their consulting a clinician, he notes.

What are the concerns?

While no drug is risk-free, the overall consensus is that OCs are safe, the opinion notes. While there is a risk of blood clots with Pill use, it is extremely low and significantly lower than the risk of blood clots during pregnancy and the postpartum period, the opinion states.1 Current OTC products such as aspirin and acetaminophen are readily available, even though they have well-known health risks, the opinion notes.

The benefits of making OCs easily accessible to women outweigh the risks, the opinion states. Easy access might make an impact on unintended pregnancy, which remains a major public health problem in the United States. Over the past 20 years, the overall rate of unintended pregnancy has not changed and remains unacceptably high, accounting for approximately 50% of all pregnancies, the opinion notes.2

As the discussion proceeds, it might be prudent to first consider progestin-only pills (POPs) for over-the-counter use, because they are extremely safe with very few contraindications, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles.

However, there will have to be a concerted effort to inform women about progestin-only pills as part of any OTC switch for this formulation, says Dan Grossman, MD, vice president of research for Ibis Reproductive Health of Oakland, a nonprofit reproductive health research and advocacy group. Ibis Reproductive Health is coordinating the Oral Contraceptives (OCs) Over-the-Counter (OTC) Working Group, which represents reproductive health and rights organizations, nonprofit research and advocacy groups, university-based researchers, and prominent clinicians who share an interest in women’s health and access to contraception.

“I think clinicians have pigeon-holed this formulation as being appropriate for a very narrow population, including breastfeeding moms and older women with medical problems,” says Grossman. “But it’s a great option for women who want to use an oral contraceptive and want to avoid estrogen.”

A recent study bears out Grossman’s observation of clinicians’ approach to using progestin-only pills. In looking at nationally representative data, analysts found only about 4% of Pill users used progestin-only pills during 1996-2008. Compared to women who took combined pills, progestin-only pill users were more likely to be older, in the postpartum period, or to have certain medical conditions such as high blood pressure, the report notes.3 From looking at this data, it appears that providers might think POPs are appropriate only for a narrow segment of the population with certain conditions.

Many hurdles to clear

What is the current status of bringing OCs over the counter? According to Grossman, the next step would be for a pharmaceutical company to do the necessary research to bring before the FDA. This step would include a label comprehension study showing that women can read and understand a simple OTC label and use that information to determine if the product is appropriate for them. Another requirement would be an actual use study, demonstrating that women take the product correctly in a simulated OTC environment. Grossman says he is not aware of any pharmaceutical company that has already started such research.

If oral contraceptives do move to OTC status, clinicians will need to be as creative as possible to help women be successful in using an OTC product, says Susan Wysocki, WHNP-BC, FAANP, president & chief executive officer of Washington, DC-based iWomansHealth, which offers information on women’s health issues for clinicians and consumers.

Women now live in an age when information is instantaneous and in one’s pocket, notes Wysocki. Pill instructions for an OTC product also could include when and why a woman should see a provider for an exam, she notes.

Financial issues also are important to consider, notes Nelson. Pills still will be available by prescription so that third-party partners will continue to cover pills, notes Nelson. According to the OCs OTC Working Group, it is unclear how women on Medicaid will be affected if the Pill were to go over the counter. Federal Medicaid funds cannot be used to pay for OTC medications without a prescription, although in some states, Medicaid funds are used to cover OTC emergency contraception without a prescription for women 17 and older, the group notes.

Clinicians have concerns that women might not access providers for needed healthcare information if they were to purchase the Pill directly from the pharmacy.4

“If women bypass clinics to get pills OTC, we will lose access to women who might be better candidates for implants and intrauterine devices,” says Nelson.

References

  1. American College of Obstetricians and Gynecologists. Committee opinion No 544: Over-the-counter access to oral contraceptives. Obstet Gynecol 2012; 120(6):1527-31.
  2. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health 2006; 38:90-96.
  3. Liang SY, Grossman D, Phillips KA. User characteristics and out-of-pocket expenditures for progestin-only versus combined oral contraceptives. Contraception 2012; 86(6):666-672.
  4. Grossman D, Blanchard K. Provider perspective: What do clinicians and pharmacists think about OTC provision of OCs? Presented at the annual meeting of the American Public Health Association. San Diego; October 2008.