Woman's Health
Loren Bonner
Pharmacists can add norgestrel (Opill–Perrigo), a progestin-only birth control pill, to the list of reproductive health care options offered to patients.
On July 13, 2023, FDA approved norgestrel, also known as a mini-pill or non-estrogen pill. The manufacturer expects it to be available on pharmacy shelves in early 2024.
“Data clearly demonstrate that women can safely and effectively use this product, and FDA acknowledged this in their unanimous decision to grant this product OTC status,” said Rebecca Stone, PharmD, from the University of Georgia College of Pharmacy.
The daily oral contraceptive contains 75 μg of norgestrel.
Progestin only
In general, progestin-only pills work by thickening the cervical mucus—which inhibits the luteinizing hormone surge and thereby possibly prevents ovulation—and by causing atrophy of the endometrial lining, said Kassandra Bartelme, PharmD, from Concordia University Wisconsin School of Pharmacy.
According to Sally Rafie, PharmD, founder of Birth Control Pharmacist, progestin-only birth control pills are safer than the more commonly prescribed combined hormonal contraception and have almost no contraindications.
“Pharmacists should familiarize themselves with this new product, primarily with regard to efficacy and instructions for use,” said Rafie, who testified in support of the manufacturer’s application for OTC status at the FDA Advisory Committee hearing in May 2023. She was later told her testimony helped make the decision to recommend approval.
“The current guidance for progestin-only pills calls for them to be taken at the same time each day, within a 3-hour window,” said Rafie.
However, Rafie said that data show that taking a progestin-only pill containing norgestrel 6 hours late or missing one pill entirely appears to have little impact on contraceptive efficacy, such as cervical mucus thickening.
Brushing up on contraceptive knowledge
Bartelme said pharmacists should learn from their store or district managers where Opill will be located in the store: on shelves or behind the pharmacy counter.
“Pharmacists will be patients’ primary in-person resource for questions regarding the OTC birth control pill,” she said.
Pharmacists can brush up on their contraceptive knowledge though continuing education programs specific to this topic, according to Stone. Pharmacists may encounter situations in which patients use oral emergency contraception and may not be able to refill their regular prescription contraceptive, using Opill as a bridge.
“This is an appropriate use of this product but may require more in-depth counseling regarding the logistics of how to do this effectively,” said Stone. “I recommend referring to the U.S. Selected Practice Recommendations as a counseling resource.”
The U.S. Selected Practice Recommendations for Contraceptive Use (2016) and the U.S. Medical Eligibility Criteria for Contraceptive Use are two key guideline documents that provide information for safe and effective use, she noted.
Price and access
Patients will be able to obtain Opill with a prescription from their health care provider, including pharmacists in some states, or OTC, according to Rafie.
Provided that Opill is affordable, it would expand access. Opill’s manufacturer has expressed its commitment to making the product affordable and accessible.
“The cost is expected to be around $20, but we will have to wait and see,” said Rafie.
In some states, health plans will be required to cover the OTC birth control pill, and pharmacies will likely be involved in processing those claims.
Although the Affordable Care Act mandates that health insurance plans cover prescription contraception, that does not extend to OTC versions. Only a few states have laws requiring coverage for OTC birth control.
“We are still working on how to operationalize health plan coverage of the OTC pill. Pharmacists will continue to provide patient education on OTC and Rx birth control products,” said Rafie.
A recent executive order by President Biden called on the federal government to soon take action to require insurance companies to cover OTC birth control. ■
Brief counseling points
- Opill can be started at any time. If not started on the first day of the period, use condoms for the first 2 days.
- Take the pill within a 3-hour window each day.
- Patients may have irregular bleeding and/or spotting.
- Medical contraindications are rare but include a history of or current breast cancer, liver tumors, and severe cirrhosis.
- Do not take Opill with strong CYP3A4 inducers (e.g., some anticonvulsants, rifabutin, rifampin), as they degrade Opill and it may not work. Interacting drugs may include those taken for seizures, tuberculosis, HIV/AIDS, pulmonary hypertension, or supplements containing St. John’s Wort.
- Patients should not take Opill if they are already using a hormonal contraceptive.
- Opill currently is not approved as an emergency contraceptive, nor does it protect against STIs. ■