New Innovations to Increase Contraception Access in Massachusetts

Advances in OTC Birth Control

Norgestrel (OPill), a progestin-only contraceptive pill (POP or “mini-pill”), was granted over-the-counter (OTC) status in 2023 by the Food and Drug Administration (FDA). [1]. Pharmacy and online sales are planned for early 2024. [1]. There are numerous advantages to OTC contraception, but two concerns were noted during the approval process:

1. Unknown effect of obesity on real-world efficacy: The FDA cited a lack of studies investigating the efficacy of norgestrel in the last 20 years, a time frame in which obesity rates have drastically increased. [2]. Pharmacokinetic evidence demonstrates a link between increased body mass and decreased concentration of progestins, theoretically leading to contraceptive failure. [2]. Although there is a theoretical concern, the U.S. Medical Eligibility Criteria for Contraceptive Use (USMEC) currently lists obesity as a category 1 for POPs, meaning there are no restrictions for use and patients with obesity can use without precautions. [3].

2. Appropriate Use: Non-adherence can result in an immediate return to fertility and contraceptive failure.[2]. Patients need to understand the critical administration timing of norgestrel, as it must be taken within three hours of the same time every day.[2]. If a patient is more than three hours late taking a dose, back-up contraception, such as a condom, is required for 48 hours. [2]. Efficacy data with POPs are cited as 99% with “perfect use,”, yet only 91% with “typical use,” highlighting the dramatic effect that non-adherence has on efficacy.[4]. Encouragingly, OTC label comprehension study patients were able to follow appropriate use directions from the label on 97% of days.[5].

Compared to other types of contraception POPs are not commonly used in the U.S., causing a significant paucity of current real-world efficacy data.[3]. Post-marketing reporting will be critical to determine if these two concerns alter efficacy rates once available OTC.

POPs are considered relatively safe. Side effects of norgestrel are similar to other POPs including spotting or irregular bleeding, headaches, nausea, cramps, and bloating.[1]. There are contraindications that patients will need to identify from the OTC labeling. Contraindications include breast cancer history, liver disease, and potential drug interactions that decrease progestin efficacy, including seizure medications and St. John’s Wort.[5]. Although results met standards, in a label comprehension study 6 out of 205 subjects with a history of breast cancer erroneously identified the drug as safe for them. [3]. Users should also note that OPill is safe for patients with migraines but requires provider evaluation if migraine severity increases due to an increased stroke risk. [5]. Patients with FD&C Yellow No. 5 allergy should not take OPill. [5].

There are other recommendations not included in the OTC label. Data indicates that oral contraceptives may deplete folate and other B vitamins, so patients, particularly those at higher risk of nutrient deficiencies like adolescents or those on a vegan diet, may consider use of a quality multivitamin or B-complex vitamin. [6]. As OPill users have the potential to become pregnant due to the lower efficacy rates with typical use, it is advisable to take folic acid.

The limitations with OTC norgestrel should be a reminder that clinicians need to have age-appropriate family planning discussions with patients at each visit. As OPill will soon be available online, patients may purchase this drug without ever speaking to a provider about its efficacy, safety, limitations, or appropriate use.

Advances in Digital Health for Contraception

The Natural Cycles app was FDA approved as contraception in 2018. [7]. This new technology harnesses an “old-school” method, basal body temperature for natural family planning, to provide non-pharmacologic contraception from your phone. Daily temperatures are automatically synced from an Oura ring or Apple watch or can be manually logged with a basal thermometer. The app displays a green indicator when unprotected intercourse would result in a low likelihood of pregnancy. The app displays a red indicator when the user is fertile and must practice abstinence or use a barrier method such as condoms to avoid pregnancy. [8]. Natural Cycles provides 93.5% efficacy with ‘typical use’ and 98.2% efficacy with perfect use, indicating similar efficacy to a contraceptive pill. [7]. The cost of the monthly app is relatively low, but users should consider the additional costs of an Oura ring or Apple Watch to get the full benefit of this technology.

Advances in Pharmacist-Prescribed Contraception

In Fall 2023, Massachusetts approved pharmacist-prescribed birth control. [8]. This authorizes pharmacists to prescribe and dispense contraceptive pills and patches. [8]. To prescribe, the law requires pharmacists to complete an approved training and utilize a patient screening tool based on the USMEC. [8]. Pharmacists must provide counseling and may dispense up to a 12-month supply. [8]. Per regulations, patients are not required to schedule an appointment, allowing for immediate access to prescription contraception. [8]. In MA, contraception must be covered by most insurances at no-cost to a patient, making this service free for most patients. Although the law was designed to be immediately implemented, it is not yet available in most pharmacies. Pharmacies are not required to participate, so patients will need to inquire if their pharmacy will be offering this service.

Katharine Nault, PharmD, MBA, BCCCPAssistant Professor of Pharmacy PracticeSchool of Pharmacy – Worcester/Manchester Massachusetts College of Pharmacy and Health Sciences katharine.nault@mcphs.edu

Aimee Dawson, PharmDAssociate Professor and Vice Chair of the Department of Pharmacy PracticeSchool of Pharmacy – Worcester/Manchester Massachusetts College of Pharmacy and Health Sciences aimee.dawson@mcphs.edu