Tran Gia, Wollen Joshua, Davis Shantera, Wang Elisabeth M, Arriazola Julia, Rosario Natalie
University of Houston College of Pharmacy, United States of America.
Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4349 Martin Luther King Boulevard,Houston, TX 77204-5039, United States of America.
Explor Res Clin Soc Pharm. 2025 Mar 11;18:100591. doi: 10.1016/j.rcsop.2025.100591. eCollection 2025 Jun.
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.
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.
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.
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.
本叙述性综述探讨了炔诺孕酮(一种仅含孕激素的口服避孕药)在美国新获批非处方(OTC)销售的影响。目标是探讨非处方仅含孕激素避孕药(POPs)的药物治疗、作用机制、疗效、安全性及其对临床实践的影响,以及这可能如何影响避孕措施的可及性和公共卫生。
该综述综合了临床研究、公共卫生报告、全球视角及近期政策变化的数据,以评估在美国非处方获取炔诺孕酮的潜在影响。分析包括对0.075毫克炔诺孕酮对卵巢活动的药效学评估、POPs的有效性以及避孕措施可及性的益处和障碍。
证据表明,POPs可使宫颈黏液变稠,在使用后48小时内提供有效的避孕效果。虽然抑制排卵可能需要长达28天,且约一半使用者会出现,但预计POPs非处方销售将显著降低避孕措施获取的障碍。这可能导致更广泛地使用有效的避孕方法,并有可能减少意外怀孕。此外,综述强调非处方避孕药的引入可能会增加历史上在获取处方方面面临困难的人群的可及性。
使炔诺孕酮非处方销售是避孕措施可及性方面的一项重大进展,有可能通过减少意外怀孕来促进公共卫生。然而,其影响程度将取决于广泛的教育和正确使用的依从性。综述强调需要进一步研究,以监测非处方销售后的结果,并评估对生殖健康和公平性的更广泛影响。