两种药物的故事:需要所有权,端到端的规划和执行,以开发和引进孕产妇保健药物。

International Journal of MCH and AIDS Pub Date : 2024-09-23 eCollection Date: 2024-09-01 DOI:10.25259/IJMA_21_2024
Metin Gülmezoglu, Lester Chinery, Sara Rushwan, Anne Ammerdorffer
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引用次数: 0

摘要

产后出血一直是低收入和中等收入国家孕产妇死亡的主要直接原因,是一项重大的全球卫生挑战。根据关键疗效临床试验的有利证据,世界卫生组织(WHO)推荐使用热稳定型卡贝菌素来预防PPH,作为在热敏性子宫张力维持冷链受到损害的情况下可行的替代品,并将氨甲环酸作为PPH治疗的辅助疗法。然而,这些药物的实施受到若干挑战的阻碍,例如采购分散和无组织、质量保证差、供应链管理不足以及许多中低收入国家的获取有限。虽然将孕产妇保健药物列入基本药物清单并采用最新的全球建议是向前迈出的必要步骤,但除非对孕产妇保健基本商品进行端到端(E2E)思考、规划和执行,否则这些措施不足以保证获取。我们描述了两种药物之间不同的获取挑战,两者都具有令人信服的安全性和有效性数据以及大约同一时间的规范性建议;一项专利由一家制药公司保护和拥有,另一项由多家仿制药制造商拥有。我们强调需要采取协调行动,促进获得循证孕产妇保健商品。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Tale of Two Medicines: The Need for Ownership, End-to-End Planning and Execution for Development and Introduction of Maternal Health Medicines.

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.

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