Contraception
Loren Bonner
In late September, the American College of Obstetricians and Gynecologists (ACOG) published an update to its position on OTC hormonal contraceptives. For years the medical association has supported OTC status of oral contraceptives for women. But in the updated opinion from ACOG’s Committee on Gynecologic Practice, which was published in Obstetrics & Gynecology, the group broadened the recommendation for OTC access to include not only pills but also vaginal rings, the contraceptive patch, and depot medroxyprogesterone acetate (DMPA) injections.
The opinion cites evidence on the safety of these methods.
“Hormonal contraceptives have been used extensively for decades,” said Rebecca Stone, PharmD, BCPS, BCACP, a clinical associate professor from the University of Georgia College of Pharmacy in Augusta. “They are highly effective and medically appropriate for the vast majority of women.”
While hormonal contraceptives, particularly estrogen-containing contraceptives, are not recommended for patients with some medical conditions, studies have demonstrated that women are able to self-screen for these contraindications just as effectively as their primary care provider.
A significant number of countries worldwide have unrestricted or nonprescription access for women to obtain birth control. Safety has not been an issue. Hormonal contraceptives have been shown to be safe both when prescribed and when women receive them without barriers in place.
Stone believes that overall, transitioning hormonal contraceptives to OTC status in the United States is a smart way to expand patient access to more contraceptive options.
In the updated recommendation, ACOG recognized that some states are providing direct access to hormonal contraceptive through pharmacists’ prescriptive authority. But the association said OTC access should be the ultimate goal.
Sally Rafie, PharmD, BCPS, APh, NCMP, pharmacist specialist at UC San Diego Health, said that women should have more than one way to obtain hormonal contraceptives. “We want patients to be able to go to their OB/GYN, their primary care provider, a pharmacist, or grab it off the shelf,” she said.
Kathleen Hill Besinque, PharmD, professor at Chapman University School of Pharmacy in Irvine, CA, agrees.
“The more routes and ways to access, the better,” she said. For instance, a young women who is taking birth control for the first time may want the reassurance of speaking with a professional, Besinque said.
Age as a nonissue
ACOG added in the updated recommendation that OTC hormonal contraception options should not come with age restrictions.
In a comprehensive study from 2017 published in the Journal of Adolescent Health, researchers found no evidence to support the idea that hormonal contraceptives pose a greater risk to adolescent women than adult women. In fact, the opposite may be true. Combination estrogen and progestin oral contraceptives put women at risk of venous thromboembolism. But it’s older women who are more at risk for this type of blood clot than adolescent women.
In California, pharmacists are able to prescribe birth control without limitations on age.
“Age restrictions in the pharmacy world aren’t as big an issue as people think,” said Besinque.
OTC progestin-only pill in the making
Since 2017, the French pharmaceutical company HRA Pharma has been working to submit an application to FDA for an OTC progestin-only pill.
Oral contraceptives that are progestin only do not have many contraindications. According to Rafie, there is already an example on shelves to prove this—levonorgestrel, the progestin-only emergency contraceptive pill, which is available OTC.
“I think that the progestin-only pill may become available OTC in the next few years, especially since this process is already underway,” said Stone. “However, I think that pharmacist prescribing can and will happen in a lot of states before estrogen-containing products are available OTC. In my opinion, pharmacists’ prescribing is a good way to bridge this gap.”
FDA approves every drug product for OTC status individually. In other words, it would take time to transition all hormonal contraceptives to OTC status.
If and when hormonal contraceptives gain OTC status, Besinque said her biggest concern is that cost will affect access. As most pharmacists know, OTC products are often not covered by insurance. Under the Affordable Care Act, insurance companies are required to cover OTC hormonal contraceptives like emergency contraception or spermicide but may require a prescription for coverage. If hormonal contraceptives were OTC, they may fall outside the law’s coverage mandate, and if a prescription is required for coverage, access would not be improved by OTC status, said Besinque.
With these gaps in mind, groups like the Oral Contraceptives Over-the-Counter Working Group are advocating for insurance coverage. Even if OTC hormonal contraceptive products were covered by insurance, Besinque said the billing mechanism to provide for coverage could be limited in certain places.
“Perhaps a grocery store does not have [a way] to bill medical insurance. If required to pay out of pocket and be reimbursed, it could result in a significant burden to users,” she said.
Pharmacists can continue to have a role in educating and counseling patients about hormonal contraceptives as well as facilitating insurance and coverage issues, especially in states where pharmacists can provide the prescription directly.
Do you know what telecontraception is?
Telecontraception is proving to be another option for women to access hormonal contraceptives. Several telecontraception vendors exist that connect patients—through a website or smartphone app—to prescription hormonal contraceptives. Virtual visits include a questionnaire that patients must fill out. Women can receive the prescription hormonal contraceptives at their local pharmacy after completing this questionnaire online.
The practice of telecontraception appears safe and may reduce barriers to hormonal contraception access because vendors are convenient and accessible, according to a research letter published September 26, 2019, in the New England Journal of Medicine.
Study researchers launched a “secret shopper” study in which they enlisted seven standardized patients who subsequently requested oral contraceptives from nine telecontraception vendors during a collective 63 visits between October 2018 and March 2019. The volunteers either had traits representing various contraindications to oral contraceptives based on the Medical Eligibility Criteria for Contraceptive Use from CDC MEC or could not tolerate taking oral medication every day. A medical contraindication presented in 45 of the 63 encounters, but contraceptives were provided in only 3 of those visits. That equates to 93% adherence to CDC MEC guidelines—which, according to the study authors, suggests telecontraception vendors may outperform clinics in this respect. A prescription was sent to a local pharmacy electronically on the same day as the visit or mailed to the patient’s house within 7 days.
However, the authors added, the companies could do a better job of more aggressively screening for patient tolerance for daily ingestion of oral medication and educating patients on the availability of long-acting, reversible contraceptives.