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两种药物的故事:孕产妇保健药物研发与引进所需的自主权、端到端规划及执行

A Tale of Two Medicines: The Need for Ownership, End-to-End Planning and Execution for Development and Introduction of Maternal Health Medicines.

作者信息

Gülmezoglu Metin, Chinery Lester, Rushwan Sara, Ammerdorffer Anne

机构信息

Concept Foundation, Avenue de Sécheron, Geneva, Switzerland.

出版信息

Int J MCH AIDS. 2024 Sep 23;13(Suppl 1):S9-S14. doi: 10.25259/IJMA_21_2024. eCollection 2024 Sep.

Abstract

Postpartum hemorrhage (PPH) persists as the leading direct cause of maternal mortality in low- and middle-income countries (LMICs) and is a major global health challenge. Following favorable evidence from pivotal efficacy clinical trials, the World Health Organization (WHO) recommends the use of heat-stable carbetocin to prevent PPH as a viable substitute in settings where maintaining a cold chain for thermosensitive uterotonics is compromised, and tranexamic acid as an adjunct therapy for PPH treatment. However, the implementation of these drugs has been hindered by several challenges, such as decentralized and disorganized procurement, poor quality assurance, inadequate supply chain management, and limited access in many LMICs. While including maternal health drugs in the essential medicines list and adopting updated global recommendations are necessary steps forward, they are not enough to guarantee access unless there is end-to-end (E2E) thinking, planning, and execution for essential maternal health commodities. We describe distinct access challenges between the two drugs, both having compelling safety and efficacy data and normative recommendations around the same time; one patent protected and owned by a pharmaceutical company and another with multiple generic manufacturers. We highlight the need for coordinated action to facilitate access to evidence-based maternal health commodities.

摘要

产后出血(PPH)仍然是低收入和中等收入国家(LMICs)孕产妇死亡的主要直接原因,也是一项重大的全球卫生挑战。鉴于关键疗效临床试验的有力证据,世界卫生组织(WHO)建议使用热稳定的卡贝缩宫素在维持热敏宫缩剂冷链存在困难的环境中作为预防产后出血的可行替代药物,并建议使用氨甲环酸作为产后出血治疗的辅助疗法。然而,这些药物的实施受到了若干挑战的阻碍,如采购分散和无序、质量保证不佳、供应链管理不足以及许多低收入和中等收入国家的可及性有限。虽然将孕产妇保健药物列入基本药物清单并采纳最新的全球建议是向前迈出的必要步骤,但除非对基本孕产妇保健商品进行端到端(E2E)的思考、规划和执行,否则这些措施不足以确保药物的可及性。我们描述了这两种药物在获取方面面临的不同挑战,这两种药物都有令人信服的安全性和有效性数据以及同时期的规范性建议;一种受制药公司专利保护并由其生产,另一种有多个仿制药制造商。我们强调需要采取协调行动,以促进获取基于证据的孕产妇保健商品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e14/11583814/b320a21fc66b/IJMA-13-S1-9-g1.jpg

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