A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception

Purpose: This narrative review examines the implications of norgestrel, a progestin-only oral contraceptive, becoming newly available over-the-counter (OTC) in the United States. The objectives are to explore the pharmacotherapy,mechanism of action, efficacy, safety, and implications to clinical pra...

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Main Authors: Gia Tran, Joshua Wollen, Shantera Davis, Elisabeth M. Wang, Julia Arriazola, Natalie Rosario
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Exploratory Research in Clinical and Social Pharmacy
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Online Access:http://www.sciencedirect.com/science/article/pii/S2667276625000320
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author Gia Tran
Joshua Wollen
Shantera Davis
Elisabeth M. Wang
Julia Arriazola
Natalie Rosario
author_facet Gia Tran
Joshua Wollen
Shantera Davis
Elisabeth M. Wang
Julia Arriazola
Natalie Rosario
author_sort Gia Tran
collection DOAJ
description Purpose: This narrative review examines the implications of norgestrel, a progestin-only oral contraceptive, becoming newly available over-the-counter (OTC) in the United States. The objectives are to explore the pharmacotherapy,mechanism of action, efficacy, safety, and implications to clinical practice of OTC progestin-only pills (POPs), and how this may impact contraceptive access and public health. Methods: The review synthesizes data from clinical studies, public health reports, global perspectives, and recent policy changes to assess the potential impact of OTC access to norgestrel in the United States. The analysis includes the evaluation of the pharmacodynamics of norgestrel 0.075 mg on ovarian activity, the effectiveness of POPs, and benefits and barriers to contraceptive access. Findings: The evidence indicates that POPs thickens cervical mucus, providing effective contraception within 48 h of use. While ovulation inhibition may take up to 28 days and occurs in approximately half of users, the availability of POPs OTC is anticipated to significantly reduce barriers to contraceptive access. This could lead to a broader use of effective contraception and potentially reduce unintended pregnancies. Additionally, the review highlights that the introduction of OTC contraceptives could increase access among populations historically facing difficulties in obtaining prescriptions. Conclusions: Making norgestrel available OTC represents a critical advancement in contraceptive access with the potential to enhance public health by reducing unintended pregnancies. However, the extent of its impact will depend on widespread education and adherence to proper use. The review underscores the need for further research to monitor outcomes post-OTC availability and to assess the broader implications for reproductive health and equity.
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spelling doaj-art-bbb6f3d2ca3d4a798179b840ea37383e2025-08-20T01:51:04ZengElsevierExploratory Research in Clinical and Social Pharmacy2667-27662025-06-011810059110.1016/j.rcsop.2025.100591A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraceptionGia Tran0Joshua Wollen1Shantera Davis2Elisabeth M. Wang3Julia Arriazola4Natalie Rosario5University of Houston College of Pharmacy, United States of AmericaPharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4349 Martin Luther King Boulevard,Houston, TX 77204-5039, United States of AmericaPharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4349 Martin Luther King Boulevard,Houston, TX 77204-5039, United States of AmericaDept. of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4349 Martin Luther King Boulevard | Office 4011, Houston, TX 77204, United States of AmericaUniversity of Houston College of Pharmacy, United States of AmericaPharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4349 Martin Luther King Boulevard,Houston, TX 77204-5039, United States of America; Corresponding author.Purpose: This narrative review examines the implications of norgestrel, a progestin-only oral contraceptive, becoming newly available over-the-counter (OTC) in the United States. The objectives are to explore the pharmacotherapy,mechanism of action, efficacy, safety, and implications to clinical practice of OTC progestin-only pills (POPs), and how this may impact contraceptive access and public health. Methods: The review synthesizes data from clinical studies, public health reports, global perspectives, and recent policy changes to assess the potential impact of OTC access to norgestrel in the United States. The analysis includes the evaluation of the pharmacodynamics of norgestrel 0.075 mg on ovarian activity, the effectiveness of POPs, and benefits and barriers to contraceptive access. Findings: The evidence indicates that POPs thickens cervical mucus, providing effective contraception within 48 h of use. While ovulation inhibition may take up to 28 days and occurs in approximately half of users, the availability of POPs OTC is anticipated to significantly reduce barriers to contraceptive access. This could lead to a broader use of effective contraception and potentially reduce unintended pregnancies. Additionally, the review highlights that the introduction of OTC contraceptives could increase access among populations historically facing difficulties in obtaining prescriptions. Conclusions: Making norgestrel available OTC represents a critical advancement in contraceptive access with the potential to enhance public health by reducing unintended pregnancies. However, the extent of its impact will depend on widespread education and adherence to proper use. The review underscores the need for further research to monitor outcomes post-OTC availability and to assess the broader implications for reproductive health and equity.http://www.sciencedirect.com/science/article/pii/S2667276625000320OpillProgestin-only pillContraceptionContraceptive accessOver-the-counter
spellingShingle Gia Tran
Joshua Wollen
Shantera Davis
Elisabeth M. Wang
Julia Arriazola
Natalie Rosario
A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception
Exploratory Research in Clinical and Social Pharmacy
Opill
Progestin-only pill
Contraception
Contraceptive access
Over-the-counter
title A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception
title_full A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception
title_fullStr A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception
title_full_unstemmed A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception
title_short A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception
title_sort review of recommendations efficacy and patient safety for over the counter norgestrel for daily contraception
topic Opill
Progestin-only pill
Contraception
Contraceptive access
Over-the-counter
url http://www.sciencedirect.com/science/article/pii/S2667276625000320
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