Cleland Kelly, Bass Jamie, Doci Florida, Foster Angel M
Office of Population Research, Princeton University, Princeton, New Jersey; American Society for Emergency Contraception, Princeton, New Jersey.
American Society for Emergency Contraception, Princeton, New Jersey.
Womens Health Issues. 2016 Nov-Dec;26(6):622-627. doi: 10.1016/j.whi.2016.08.003. Epub 2016 Sep 24.
After years of complex regulatory changes, levonorgestrel (LNG) emergency contraception (EC) is now approved for unrestricted sale in the United States. Timely access to EC pills is critical because they are more likely to work the sooner they are taken. This study assesses whether LNG EC is sold in accordance with current Food and Drug Administration regulations.
We distributed an online questionnaire through an EC-focused listserv for reproductive health professionals, asking data collectors to visit local stores and document product names, price, over-the-counter shelf availability, and misinformation about age restrictions. We used χ analysis to assess bivariate associations and t tests and Wilcoxon rank-sum tests to determine differences in means.
We collected information about 220 stores. The majority (65%) stocked EC on over-the-counter shelves, although only 22% of these displayed it without a locked security enclosure. Chain pharmacies were more likely to shelf-stock EC than independent pharmacies (77% vs. 5%; p = .000), but variation existed among stores within the same chain. Among stores that were asked, 40% incorrectly reported an age restriction for non-prescription purchase of LNG EC, whereas 95% correctly reported that men can buy LNG EC. The average price of branded and generic LNG EC was $49.64 and $40.05, respectively.
Changes in the regulatory status of LNG EC have resulted in widespread confusion about how EC can be sold, and its high price contributes to access barriers. Retailers should ensure that consumers can access LNG EC quickly and easily by stocking the product on over-the-counter shelves and educating staff about current regulations.
经过多年复杂的监管变革，左炔诺孕酮（LNG）紧急避孕（EC）现已在美国获批可无限制销售。及时获取紧急避孕药物至关重要，因为服药越早，药物起效的可能性越大。本研究评估了LNG紧急避孕药物的销售是否符合美国食品药品监督管理局的现行规定。
我们通过一个专注于紧急避孕的专业生殖健康人员邮件列表分发了一份在线调查问卷，要求数据收集者走访当地商店，并记录产品名称、价格、非处方货架上的可获得性以及有关年龄限制的错误信息。我们使用χ分析来评估双变量关联，并使用t检验和Wilcoxon秩和检验来确定均值差异。
我们收集了220家商店的信息。大多数商店（65%）在非处方货架上储备了紧急避孕药物，尽管其中只有22%在没有上锁的安全防护装置的情况下展示该药物。连锁药店比独立药店更有可能在货架上储备紧急避孕药物（77%对5%；p = 0.000），但同一连锁店内的不同商店之间存在差异。在被询问的商店中，40%错误地报告了非处方购买LNG紧急避孕药物的年龄限制，而95%正确地报告男性可以购买LNG紧急避孕药物。品牌和非专利LNG紧急避孕药物的平均价格分别为49.64美元和40.05美元。
LNG紧急避孕药物监管状态的变化导致了关于紧急避孕药物如何销售的广泛混乱，其高昂的价格也造成了获取障碍。零售商应通过在非处方货架上储备该产品并对员工进行现行法规教育，确保消费者能够快速便捷地获取LNG紧急避孕药物。
