Access to Maternal Health

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Government Hospital in Aurangabad, Maharashtra, India

Every day, approximately 830 women die from preventable causes related to pregnancy and childbirth. 99% of all maternal deaths occur in developing countries. Maternal mortality is higher in women living in rural areas and among poorer communities. [WHO]

Women die as a result of complications during and following pregnancy and childbirth. Most of these complications develop during pregnancy and most are preventable or treatable. Other complications may exist before pregnancy but are worsened during pregnancy, especially if not managed as part of the woman’s care. The major complications that account for nearly 75% of all maternal deaths are (4):

  • severe bleeding (mostly bleeding after childbirth – postpartum hemorrhage)
  • infections (usually after childbirth)
  • high blood pressure during pregnancy (pre-eclampsia and eclampsia)
  • complications from delivery
  • unsafe abortion.

The maternal health team at Concept Foundation is working to reduce preventable maternal mortality through increasing access to quality maternal health medicines, primarily medicines for prevention and treatment of post-partum haemorrhage, pre-eclampsia and eclampsia. These medicines include oxytocin, misoprostol, carbetocin and magnesium sulfate.

Our activities are based on a number of transformational studies into the quality of reproductive and maternal health medicines in lower income countries. Concept Foundation has published and contributed to studies on the quality of uterotonics, stability of oxytocics in tropical conditions and capabilities of maternal health drug manufacturers which resulted in the Quality of Reproductive Health Medicines (QuRHM) program and subsequent inclusion of reproductive and maternal health medicines into the WHO Prequalification Program.

Starting with informative research, we work across the spectrum of issues related to access, availability and quality of maternal health medicines.

At the manufacturing end, we support manufacturers in producing quality assured maternal health medicines with technical advice, assessments of capabilities and quality problems and improvements in manufacturing processes through to regulatory approval and registration of products, with specific focus on increasing the number of low-cost quality medicines approved by a stringent regulatory authority such as the WHO Prequalification Program.

We also work with high level stakeholders to improve regulation, procurement, supply and use of quality assured maternal health medicines. Our activities have included workshops involving ministries of health, procurement agencies and international experts and expert input into guidelines and regulatory programs.

Our team also works on ensuring access through market shaping, advocacy, communications and policy shaping activities linked to international recommendations and guidelines.

Our goal is to ensure that every woman has access to quality, effective maternal health medicines when they need them at a price they can afford. Quality. Availability. Accessibility.

Current projects

Heat Stable Carbetocin for Prevention of PPH
Oxytocin Quality
Cost of PPH Study
Procurement Manual Project
Procurement Workshop Assessments
Heat Stable Carbetocin for Prevention of PPH

Heat stable carbetocin is a uterotonic used for the prevention of postpartum haemorrhage. The project involves clinical research led by the WHO into the effectiveness of the medicine in preventing postpartum haemorrhage following vaginal births which may lead to inclusion of heat stable carbetocin into WHO guidelines.

Concept’s activities include advocacy and communications support, regulatory strategy advice and expertise in commercialisation of products for public sectors of low income countries.

 

We are pleased to share the announcement of the results of the clinical trial comparing heat stable carbetocin and oxytocin in prevention of postpartum haemorrhage.

“The study, published today in the New England Journal of Medicine, has shown an alternative drug – heat-stable carbetocin – to be as safe and effective as oxytocin in preventing postpartum haemorrhage. This new formulation of carbetocin does not require refrigeration and retains its efficacy for at least 3 years stored at 30 degrees celsius and 75% relative humidity.”

WHO announcement:

http://www.who.int/news-room/detail/27-06-2018-who-study-shows-drug-could-save-thousands-of-women%E2%80%99s-lives

Link to study in the New England Journal of Medicine:

https://www.nejm.org/doi/full/10.1056/NEJMoa1805489

Merck for Mothers announcement:

http://www.mrknewsroom.com/news-release/corporate-news/merck-announces-findings-who-led-study-investigational-heat-stable-carbe

Ferring announcement:

https://www.ferring.com/en/media/press-releases/ferring-s-heat-stable-carbetocin-could-save-thousands-of-women-s-lives-by-preventing-excessive-bleeding-after-childbirth/

 

Oxytocin Quality

Concept Foundation recently completed a review of the evidence on the quality of oxytocin, the drug currently recommended by the World Health Organization as the preferred uterotonic for prevention of postpartum haemorrhage. Oxytocin Quality – Evidence for Action is a new publication collecting all the published evidence on oxytocin quality and causes for the high level of poor quality. The report identifies weaknesses that contribute to poor quality of the medicine, the impact of poor quality and recommends approaches that can be adopted to improve oxytocin quality. It is available as a tool for advocates and countries to use to drive improvements in the quality of maternal health medicines

Cost of PPH Study

As part of its advocacy efforts around the importance of using quality medicines to prevent maternal mortality due to postpartum haemorrhage (PPH), Concept Foundation identified the need to quantify the Cost of PPH to complement the evidence to present to decisionmakers considering new or alternative approaches to preventing or treating PPH. With the support of the WHO, the CHAMPION (Heat Stable Carbetocin) trial data set provided an opportunity to conduct an ancillary study to quantify the cost incurred by health facilities when a woman suffers from PPH. The research is being conducted in 10 of the trial sites across 4 countries, aiming to quantify the cost of treating PPH, by costing interventions, drugs used, and labour time of the medical practitioners involved. The study will provide evidence to support improved decision making on maternal healthcare, particularly regarding PPH prevention and management. The study will be the most comprehensive study of its kind.

Procurement Manual Project

We are currently working with Chemonics PSM on the development of a Quality Assurance Manual for the procurement and supply of maternal and child health commodities/medicines. The objective of the project is to provide procurement agents in LMICs with a tool to use to ensure quality assurance in procurement and supply. The manual will include technical specifications on the 8 maternal, newborn and child health medicines identified as essential and high priority by the UN Commission on Life Saving Commodities.

Procurement Workshop Assessments

Concept is currently completing follow-up assessment to workshops on optimal procurement of affordable and quality assured medicines that were conducted under the UNCOLSC in Uganda and Tunisia (anglophone and francophone) to assist countries in increasing access to quality RMNCH medicines. The assessment is seeking to understand the progress that has been achieved, how the workshops supported the countries and the remaining gaps that need to be filled to inform further work in this field.

Past Projects

Provision of technical assistance to manufacturers of generic maternal health medicines
Research
Access to markets
Provision of technical assistance to manufacturers of generic maternal health medicines

Since 2009, Concept Foundation has worked with several manufacturers of generic maternal health (MH) products to assist them to achieve World Health Organization’s Prequalification (WHO PQ) of their products. This activity started under the Accessing Quality Assurance Supplies (AQAS) initiative funded by the Reproductive Health Supplies Coalition (RHSC) and continued under the Quality Reproductive Health Medicines (QuRHM) programme supported by the UK’s Department for International Development (DFID). Concept Foundation continued this work under a grand from the United Nations Commission on Life-Saving Commodities for Women and Children (UNCoLSC) and Jhpiego. Our activities included:

  • Technical support provided to manufacturers of oxytocin, misoprostol and magnesium sulfate Finished Pharmaceutical Products (FPPs) in order to support prequalification and ultimately increase the supply of quality maternal health medicines.
  • Technical support for the conduct of bioequivalence (BE) studies.
  • Technical assistance to achieve WHO quality assurance (QA) requirements.
  • Support on preparation of all Chemistry, Manufacturing and Controls (CMC) documentation required to submit a dossier to the WHO PQ programme.

More information can be found on WHO PQ procedures on our Resources page.

Research

Concept Foundation has conducted a number of studies on the quality of maternal health products including:

  • “A survey of misoprostol products collected from 11 lower and middle-income countries”: funded by Gynuity Health Projects as part of a grant from the Bill & Melinda Gates Foundation (BMGF)
  • A survey on “Providing quality-assured misoprostol and oxytocin products for the prevention of post-partum haemorrhage” undertaken in Nepal and Nigeria with funding from Gynuity Health Projects, UNFPA Nigeria and UNFPA Nepal.
  • Study on oxytocin storage conditions providing evidence for the WHO statement on storage conditions funded by the UNCoLSC.
  • Study on the quality of oxytocin and misoprostol in Bangladesh supported by UNFPA Bangladesh.
Access to markets

Under a grant awarded by the UNCoLSC, Concept Foundation rolled out planning tools to support countries in ensuring access to quality-assured MNCH drugs from manufacturing facility to point of use through electronic and face-to-face consultations with key stakeholders.

Concept Foundation’s maternal health team also collaborated with the WHO and the Maternal health Technical Resource Team on regional consultations in West Africa (Nigeria, Ghana, Sierra Leone) and Southern Africa (Malawi, Mozambique, Zambia, Zimbabwe) to roll out and support use of improved quantification and forecasting for medicines supplies.

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