Spotlight on: Heat-Stable Carbetocin Project
Concept Foundation is contributing expertise in maternal health supplies for low income countries, advocacy and communication to the partnership between MSD for Mothers, the World Health Organization (WHO) and Ferring Pharmaceuticals to provide access to a heat-stable formulation of the uterotonic carbetocin, a medicine used to prevent postpartum hemorrhage in women after childbirth.
The availability of a medicine that does not require refrigeration during transportation and storage, and can be kept at elevated temperatures for at least three years, has the potential to significantly improve the prevention and management of bleeding following childbirth in the many areas of the world where cold storage is difficult to achieve and maintain. This will help reduce maternal deaths in those areas.
A WHO-led multi-centre Phase III clinical study is comparing the effectiveness of Heat-Stable Carbetocin (HSC) and oxytocin (delivered intramuscularly) in the prevention of postpartum haemorrhage and severe postpartum haemorrhage after vaginal births. The study, which will include approximately 30,000 women, is taking place in 10 countries: Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda, and the United Kingdom. Enrolment of subjects has passed 22,000 with the trial expected to be completed in Q3 2017.
If the results of the study are positive, the aim of the collaborating organizations is to provide access to Heat-Stable Carbetocin in the public sector of low income countries that have a high burden of maternal mortality, at an affordable and sustainable price
Heat-Stable Carbetocin is a uterotonic medicine used for the prevention of postpartum haemorrhage.
A single 100µg dose of Heat-Stable Carbetocin is effective in preventing postpartum haemorrhage after caesarean section.
Heat-Stable Carbetocin remains stable (retains potency) for at least 36 months (3 years) in hot and humid climatic conditions. It does not require cold-chain transport or storage.
Heat-Stable Carbetocin was developed and patented by Ferring Pharmaceuticals. Carbetocin is already registered and widely used in over 80 countries and the heat stable formulation has been introduced into 27 countries to date including Australia, Mexico and across Europe. Carbetocin has been shown in various studies to be effective in the prevention of postpartum haemorrhage following caesarean deliveries. Carbetocin, manufactured by Ferring since 1997, has been used for the prevention of PPH in over 8.5 million women. 7 countries have approved it for use following vaginal deliveries.
Broad engagement across a wide variety of stakeholders is needed to ensure that women in low income countries have access to Heat-Stable Carbetocin. Normally, the introduction of a medicine into a market would entail large, expensive marketing campaigns. In this case, on successful completion of the WHO trial, low cost advocacy and community engagement will be necessary in order to ensure that HSC is available to the public sector in low income countries at an affordable price. Some of the changes that will be necessary in order for women to receive HSC to prevent postpartum haemorrhage include:
Updating global guidelines on the recommended prevention and treatment of PPH
Updating country and facility level guidelines on the prevention and treatment of PPH
Including HSC in country formularies, essential medicines lists and registered drugs lists
Country level registration and marketing approval for HSC
Updating pre-service and in-service training programs for healthcare professionals including midwives, physicians and obstetricians on the correct use of HSC for PPH
Including HSC in medicines procurement decision
Development of job aids and tools to ensure correct usage of the HSC.
Members of the global maternal health community can assist the project partners in achieving the goal of ensuring access to quality assured Heat-Stable Carbetocin in all low-income countries through engagement in advocacy, collaboration on community awareness activities and expert contributions.
View the full project brochure for more information about this programme.