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

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.

Keywords: End-to-End Planning; Heat-Stable Carbetocin; Market Access; Maternal Health; Maternal Mortality; Postpartum Hemorrhage; Tranexamic Acid.

Figure 1:

Pharmaceutical and health commodities end-to-end approach from discovery to care.