Concept Foundation, Bâtiment F2F3, Avenue de Sécheron 15, Geneva, 1202, Switzerland.
Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Bull World Health Organ. 2022 Aug 1;100(8):503-510. doi: 10.2471/BLT.21.287561. Epub 2022 Jun 22.
Self-care interventions include over-the-counter contraceptives, which enable individuals to make informed, autonomous decisions about fertility management. As there is a substantial unmet need for contraception in many countries, increasing access by establishing sound, affordable and effective regulation of over-the-counter contraceptives could help reduce unintended pregnancies and improve maternal health. We performed a review of 30 globally diverse countries: (i) to assess national regulatory procedures for changing oral contraceptives, emergency contraceptives and injectable contraceptives from prescription-only to over-the-counter products; and (ii) to determine whether national lists of over-the-counter medicines included contraceptives. Of the 30 countries, 13 (43%) had formal regulatory procedures in place for changing prescription-only medicines to over-the-counter medicines, 11 (36%) had national lists of over-the-counter medicines, and four (13%) included contraceptives on those lists. Changing from prescription-only to over-the-counter medicines presents challenges for national medicines regulatory authorities and manufacturers, involving, for example, reporting side-effects, quality control and the often poorly-defined process of switching to over-the-counter products. To facilitate the over-the-counter availability of contraceptives, countries should consider adopting a formal regulatory procedure for reclassifying prescription-only contraceptives as over-the-counter contraceptives. Although the availability of over-the-counter contraceptives can increase users' independence and anonymity and improve access, there may also be disadvantages, such as higher out-of-pocket costs and the need for accurate self-assessment. Basic remedial actions to improve, harmonize and standardize regulatory procedures for the reclassification of contraceptives are proposed with the aim of enabling national medicines regulatory authorities to manage the switch to over-the-counter contraceptives and to control their quality.
自我保健干预措施包括非处方避孕药具，使个人能够就生育管理做出知情、自主的决定。由于许多国家对避孕的需求未得到满足，因此通过建立健全、负担得起和有效的非处方避孕药具监管来增加获取途径，可以帮助减少意外怀孕并改善母婴健康。我们对全球 30 个国家进行了审查：（i）评估各国将口服避孕药、紧急避孕药和注射避孕药从凭处方供应改为非处方产品的监管程序；（ii）确定非处方药物国家清单是否包括避孕药具。在这 30 个国家中，有 13 个（43%）国家制定了正式的监管程序，将处方药改为非处方药，11 个（36%）国家有非处方药国家清单，4 个（13%）国家将避孕药具列入这些清单。将处方药改为非处方药给国家药品监管当局和制造商带来了挑战，例如报告副作用、质量控制以及常常定义不明确的向非处方药转换的过程。为了促进避孕药具的非处方供应，各国应考虑为将处方避孕药具重新分类为非处方避孕药具制定正式的监管程序。虽然非处方避孕药具的供应可以提高用户的独立性和匿名性并改善获取途径，但也可能存在一些缺点，例如自付费用增加和需要准确的自我评估。建议采取基本的补救措施来改善、协调和标准化避孕药具重新分类的监管程序，目的是使国家药品监管当局能够管理向非处方避孕药具的转变并控制其质量。
