ACOG backs OTC oral contraceptive

Low VTE risk, but cost may be an obstacle

Oral contraceptives should be available without a prescription, according to a committee opinion paper released by the American College of Obstetricians and Gynecologists (ACOG) in December 2012. The rate of unintended pregnancies remains high, accounting for approximately 50% of all pregnancies, according to ACOG, and these unintended pregnancies cost taxpayers an estimated $11.1 billion annually. ACOG argued that allowing OTC sale of oral contraceptives would increase their access and use and potentially decrease the burden of unintended pregnancies.

Safety not a major issue

ACOG contended that patients could use OTC oral contraceptives safely because of the rarity of venous thromboembolism (VTE) and because data support patients’ ability to self-screen for potential contraindications. The rate of VTE is “extremely low,” ACOG wrote, at 3 to 10.22 events per 10,000 women–years—much lower than the risk of VTE during pregnancy (5–20 per 10,000 women–years) or the postpartum period (40–65 per 10,000 women–years).

Regarding self-screening for contraindications to oral contraceptive therapy, ACOG cited a study comparing self-assessment with clinical assessment by a provider. In this study, 392 of 399 women came to the same conclusions as a health care provider on their medical eligibility for contraceptive therapy. In cases of discrepancy, the patients were more likely to take a conservative approach compared with their provider by reporting more contraindications.

In another study cited by ACOG, women who obtained oral contraceptives from a pharmacy were no more likely to have a contraindication than those who obtained the drug from a clinic. And in a third study, women who purchased oral contraceptives online were just as knowledgeable about the contraindications and adverse events associated with therapy as patients seen in a clinic. Based on this research, ACOG concluded that women can self-screen for most contraindications by using checklists.

Cost a potential obstacle

ACOG did note, however, that payments for OTC oral contraceptives by insurers and payment for pharmacist services present real issues. Women often have to pay for oral contraceptives, and many have reported limits on the number of pills packs they can receive, according to ACOG.

“Any plans to improve access to oral contraceptives by moving toward behind-the-counter or over-the-counter access should address the issue of cost,” ACOG wrote. The association noted that the recent U.S. Department of Health & Human Services guidelines regarding women’s preventive services will require new private plans to cover—without cost sharing—all FDA-approved contraceptive methods, including counseling and education of women with reproductive capacity.

Pharmacist involvement a proven success

The concept of behind-the-counter or OTC access to oral contraception is not new. In 2008, results of the Direct Access study, a pilot project showing that community pharmacists can efficiently screen women for safe use of hormonal contraceptives and select appropriate products for them, were published in the Journal of the American Pharmacists Association.

In this community-based intervention study, conducted in Seattle from June 2003 to December 2005, pharmacists identified women at risk for unintended pregnancy, evaluated them, and prescribed hormonal contraceptives according to protocol guidelines. Self-administered screening tools and physical measurements of weight and blood pressure enabled pharmacists to evaluate women and appropriately select candidates for therapy.

The pharmacist prescribed contraceptive therapy to a total of 195 women in this study. After 12 months, 70% of women responding to an interview reported continuing use of hormonal contraceptive therapy, and most reported satisfaction with the experience of obtaining the product from a pharmacist. In addition, nearly all respondents expressed willingness to continue to see pharmacist prescribers and to receive other services from them if available.