Physician Group Supports Making Birth Control Pills Available OTC

Making birth control pills available OTC would increase women’s access to them and reduce the rate of unintended pregnancy, but issues such as reimbursement for pharmacist services still need to be worked out, the group argues.

Birth control pills should be made available OTC as a means of increasing access to them and reducing the rate of unintended pregnancy, according to an opinion recently released by the American Congress of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice. The opinion appears in the December 2012 edition of Obstetrics & Gynecology.

The opinion notes that approximately half of all pregnancies in the United States are unintended, posing an estimated cost of $11.1 billion per year to taxpayers. In addition, women with unintended pregnancies have higher rates of a range of damaging behavior, including smoking and drinking during pregnancy, depression, domestic violence, and failure to obtain prenatal care or breastfeed. Short intervals between pregnancies have also been associated with low birth weight and prematurity.

The opinion presents results from a series of studies and surveys to argue that making birth control pills available OTC could reduce the number of unintended pregnancies without putting women at increased risk of adverse drug effects. In a 2004 telephone survey of 811 women aged 18 to 44 years, 47% of uninsured women and 40% of low-income women who were not using birth control pills or other contraceptives said they would start using them if they were available OTC. Another survey of 1271 women aged 18 to 49 years found that 60% of women not currently using an effective contraceptive method said they would be more likely to use one if it were available OTC. In addition, a survey of 2725 pharmacists found that 85% were interested in providing hormonal contraceptives OTC, although 66% were concerned about whether they would be reimbursed for doing so.

The opinion notes that there are safety concerns involved in the use of birth control pills, but argues that they are not very great. A primary concern is with increased risk of venous thromboembolism, but this risk is relatively low (3-10.22/10,000 patient-years), especially when compared with the risk during pregnancy (5-20/10,000 patient-years) and the post-partum period (40-65/10,000 patient-years). Another potential concern is that women with contraindications would ill-advisedly use birth control pills if they were available OTC. However, a number of studies suggest that women are capable of self-screening.

In one such study, 392 of 399 women aged 15 to 45 years came to the same conclusion as health care providers regarding eligibility criteria. In this and another study, patients were actually more likely to report contraindications than health care providers. However, one US-based study found that women who obtained birth control pills OTC in Mexican pharmacies were more likely to have relative contraindications but not absolute contraindications than those who received the pills via prescription. (There was at least 1 relative contraindication in 13% of the OTC group compared with 9% of the prescription group, but the rate of absolute contraindications was 7% in the OTC group compared with 5% in the prescription group.) Women in this study, however, did not use a standardized self-screening procedure and may have had demographic quirks that made them more likely to have contraindications.

There are also concerns that women purchasing birth control pills OTC might be less adherent, less likely to continue using their chosen contraceptive method, and less likely to choose more effective long-acting methods of contraception. However, a 2011 randomized trial found that women who received birth control pills OTC had a higher 6-month continuation rate than those who received them via prescription, although the difference was not statistically significant.

Yet another concern is that women receiving contraceptives OTC will skip screening and other preventive services. However, the opinion notes, screening for cervical cancer or sexually transmitted infection (STI) is not required for starting birth control pill use and should not be a barrier to using the pills. In addition, a 2012 study comparing the screening habits of US women who got birth control pills from US clinics and those who got them OTC from Mexican pharmacies found that both groups had high rates of having had a Pap test within the past 3 years, of ever having received STI testing, and of ever having had a clinical breast examination.

The opinion notes that some women could potentially lose insurance coverage for their preferred contraceptive if it were made available OTC and that this concern should be addressed. However, it notes that birth control pills already cost a significant amount, particularly for young women and the uninsured. In a recent national survey, the opinion notes, women reported paying an average of $16 per pill pack.

After taking these concerns into account, the ACOG Committee on Gynecologic Practice has determined that birth control pills should be made available OTC and that women should self-screen for most contraindications using checklists. The opinion notes, however, that any plan to do so should address concerns regarding payment for pharmacist services in providing contraceptives OTC, payment for OTC contraceptives by insurers, and the possibility that pharmacists may refuse to provide birth control OTC.