Counseling Points for Progestin-Only, OTC Birth Control

Counseling Points for Progestin-Only, OTC Birth Control
Izzy Schnake, PharmD
Coborn’s Pharmacy Community Resident

On July 11, 2022, HRA Pharma (Perrigo) submitted an application to the United States Food and Drug Administration (FDA) for over-the-counter (OTC) approval of their prescription birth control medication, Opill®. This progestin-only-pill (POP), containing 0.075 mg of norgestrel, would be the first ever daily oral contraceptive available OTC in the United States. Advocates for reproductive access celebrated the prospect, including the American Medical Association, the American Academy of Family Physicians, and the American College of Obstetrics and Gynecology (ACOG). In a statement released shortly after Perrigo’s announcement, ACOG president Iffath Abbasi Hoskins, MD highlighted the application’s significance on the heels of the overturn of Roe vs Wade: 

Amidst the current reproductive health crisis, today’s news is positive. We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons. However, by increasing access to birth control through over-the-counter oral contraception, we have an opportunity to empower more people to control their own reproductive futures, including avoiding pregnancy.

While accessibility is critical to effective reproductive health care, POPs come with their own considerations and risks. The FDA is expected to review Perrigo’s application in the first half of 2023, and if approved, health care professionals will face an abundance of questions. The following review provides key counseling points for POPs, based on Morbidity and Mortality Weekly Report (MMWR), applicable to today’s prescription patients and - potentially - to future OTC patients. 

POPs do not protect against sexually transmitted infections (STIs)

  • As with all hormonal contraceptives, POPs do not reduce the risk of STI transmission 

Initiate at any time in the menstrual cycle

  • If started ≤5 days from the beginning of most recent menstrual cycle, there is no need for backup contraception 

  • If started >5 days from the beginning of most recent menstrual cycle, advise the patient to use a backup contraceptive method (such as condoms) for 48 hours  

There are no placebo pills

  • Patients will take active pills every day with no breaks 

Consistent timing is critical 

  • Counsel patients to take at the same time every day 

    • Unlike combined oral contraceptives (COCs), which have a window of 24 hours before a dose is considered “missed”, POPs have a window of only 3 hours

  • If a patient misses a dose (>3 hours late for a dose):

    • Advise the patient to take one pill as soon as possible and the next dose at its regular time, even if it means taking two pills at once 

    • Advise the patient to use a backup contraceptive method (such as condoms) for 48 hours

      • If a patient does have unprotected sex after a missed dose, emergency contraception can be considered 

Take with or without food

  • Taking POPs with food may reduce associated nausea/stomach upset 

Menstrual changes are common

  • POP patients may experience a prolonged or irregular menstrual cycle, or they may have little to no change in their menstrual cycle

    • “Spotting” (light instances of bleeding between cycles) is reported by many POP patients 

  • Patients should contact their provider if they experience repeated postcoital bleeding, prolonged episodes of bleeding, amenorrhea, or severe abdominal pain 

Other risks and adverse events 

  • Unlike with COCs, POPs are not associated with increased risk of cardiovascular disease or venous thromboembolism

  • POPs may be associated with mood changes such as fatigue, depression, nervousness, and irritability 

  • Modest weight gain is possible 

    • A 2016 Cochrane review concluded that there is some evidence for weight gain with POPs (less than 2 kg for most patients after 6-12 months), though authors noted some studies showed POPs to be weight-neutral

 

References:

  1. Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill. Perrigo company plc. Published July 11, 2022. Accessed September 1, 2022. https://investor.perrigo.com/2022-07-11-Perrigos-HRA-Pharma-Submits-Application-to-FDA-for-First-Ever-OTC-Birth-Control-Pill
  2. Hoskins IA. ACOG Statement on FDA Submission for Over-the-Counter Access to Contraception. acog.org. Published July 11, 2022. Accessed September 1, 2022. https://www.acog.org/news/news-releases/2022/07/acog-statement-on-fda-submission-for-over-the-counter-access-to-contraception
  3. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. Published July 29, 2016. Updated May 21, 2021. Accessed September 1, 2022. https://www.cdc.gov/mmwr/volumes/65/rr/rr6504a1
  4. Lopez LM, Ramesh S, Chen M, et al. Progestin-only contraceptives: effects on weight. Cochrane Database Syst Rev. 2016;2016(8):CD008815. Published 2016 Aug 28. doi:10.1002/14651858.CD008815.pub4