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• Commentary on how to use heat stable carbetocin and tranexamic acid for postpartum haemorrhage in practice
  A. Metin Gülmezoglu, Sara Rushwan
  Published on: 5 May 2022

• Published on: 5 May 2022

  Commentary on how to use heat stable carbetocin and tranexamic acid for postpartum haemorrhage in practice

  • A. Metin Gülmezoglu, Executive Director Concept Foundation
  • Other Contributors:
    • Sara Rushwan, Programme Officer

  How to use heat stable carbetocin and tranexamic acid for postpartum haemorrhage in practice

  A. Metin Gülmezoglu1, Sara Rushwan1
  1 Concept Foundation, Geneva, Switzerland
  We welcome the paper by Tran et al [1]. There are increasing number of options for postpartum haemorrhage (PPH) prevention and management as recommended by WHO and the context is important. We agree that at the national level the first step is to update the national policies including the guidelines and essential medicine lists (EMLs). Since 2019, Concept Foundation and its partners have been working in 14 East and West African sub-Saharan countries to facilitate those updates [2]. We are pleased to report that in 10 out of the 14 countries – Burkina Faso, DRC, Ethiopia, Ghana, Ivory Coast, Liberia, Rwanda, Sierra Leone, South Sudan, and Uganda – the national guideline and/or EML were updated during this period.
  The strength of the project lies in the engagement with policy makers, Ministry of Health officials, clinicians, professional associations, and civil society organizations concurrently. However, competing national policy priorities such as COVID-19, timing of the previous updates, political instability and national capacity and leadership (or lack of) can make the updating process long and challenging even when there is an agreement to update. Secondly, even when the updates happen, proactive dissemination and training within the country can also take time. Thirdly, in the...

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  How to use heat stable carbetocin and tranexamic acid for postpartum haemorrhage in practice

  A. Metin Gülmezoglu1, Sara Rushwan1
  1 Concept Foundation, Geneva, Switzerland
  We welcome the paper by Tran et al [1]. There are increasing number of options for postpartum haemorrhage (PPH) prevention and management as recommended by WHO and the context is important. We agree that at the national level the first step is to update the national policies including the guidelines and essential medicine lists (EMLs). Since 2019, Concept Foundation and its partners have been working in 14 East and West African sub-Saharan countries to facilitate those updates [2]. We are pleased to report that in 10 out of the 14 countries – Burkina Faso, DRC, Ethiopia, Ghana, Ivory Coast, Liberia, Rwanda, Sierra Leone, South Sudan, and Uganda – the national guideline and/or EML were updated during this period.
  The strength of the project lies in the engagement with policy makers, Ministry of Health officials, clinicians, professional associations, and civil society organizations concurrently. However, competing national policy priorities such as COVID-19, timing of the previous updates, political instability and national capacity and leadership (or lack of) can make the updating process long and challenging even when there is an agreement to update. Secondly, even when the updates happen, proactive dissemination and training within the country can also take time. Thirdly, in the case of heat-stable carbetocin (HSC), even when policy updates are accomplished, the regulatory approval that is essential for the drug to enter the country can take time.
  In 2021, we expanded our collaboration to include the International Federation of Gynecology and Obstetrics (FIGO) and International Confederation of Midwives (ICM) and their national counterparts to support the transition from policy updates to the development of clinical management protocols and job aids. FIGO and ICM developed a generic protocol on PPH prevention and treatment [3] and engagements with key national stakeholders were held to discuss its usability and adaptability to the country context, and how it could support existing country practices. So far, Ethiopia, Ghana, Rwanda, and Uganda have developed a national PPH clinical protocol that has been approved by the Ministry of Health, and these countries will develop supporting job aids. This work is planned to be completed in 4 other countries – Burkina Faso, Liberia, Sierra Leone, and South Sudan.
  The main determinant of choosing which drug(s) to use should be the presence of a skilled birth attendant and reliable cold chain and storage. The more established injectable uterotonics must be kept in cold chain and storage, and quality-assured products must be prioritized for procurement. Implementation considerations must include ensuring that staff know and adhere to the fact that HSC is contraindicated for labour induction and augmentation. HSC is often used for PPH treatment, but this is off-label and the benefits and potential harms are uncertain. Both HSC and tranexamic acid (TXA) should be considered for implementation in peripheral and referral levels of the health care system since at peripheral level the cold chain issues are likely to be more prevalent and the lifesaving role of a quality-assured uterotonic and timely administered TXA in cases of haemorrhage is likely to be crucial. The fact that there seems to be support for intramuscular administration for TXA will make implementation at the periphery easier [4]. In referral settings with surgical capacity, it is essential that TXA is kept in a place where accidental mix-up with local anesthetics that are used in intrathecal anesthesia is avoided, since there have been case reports of deaths due to accidental TXA administration into the intrathecal space [5,6]. 
  We also agree that HSC and TXA should be carefully integrated into the health system in an enabling environment and considering the context perspectives mentioned above. Concept Foundation will conduct implementation pilots in Burkina Faso, Ethiopia, Ghana, Sierra Leone, and Uganda to assess appropriate use following training of healthcare providers, and integration of the two medicines into routine PPH care management. The results of this research will be useful in better understanding the enablers and barriers for successful introduction of essential PPH medicines into clinical practice.
  Our experience demonstrates that there are several barriers to access essential, heat-stable PPH medicines that require operationalization of end-to-end thinking at the national level. By end-to-end thinking, we mean addressing the challenges from the highest national policy level right down to the practicing care provider in the most peripheral level of health care where childbirth takes place. To date, most existing programs have focused either on policy level change or health care provider behavior change. Our project adopts a holistic approach, that seeks to align normative change, clinical protocol development, pilot implementation, procurement, and product introduction.
  Progress in our project presents a great opportunity to allow the objectives and approach to be achieved in most high-burden countries with modest resources. However, there is undoubtedly a greater need for investment in advocacy, training, and dissemination tools to support the implementation of national guidelines in a locally appropriate way, while ensuring the WHO recommendations are reflected accurately.

  References:

  [1] Tran NT, Schulte-Hillen C, et al. How to use heat-stable carbetocin and tranexamic acid for the prevention and treatment of postpartum haemorrhage in low-resource settings. BMJ Global Health. 2022; 7:e008913.
  [2] Concept Foundation, Country Support page. Geneva; 2021. https://www.conceptfoundation.org/what-we-do/country-support/. Accessed April 28, 2022.
  [3] International Federation of Gynecology and Obstetrics (FIGO), Current FIGO projects, IAP page, Project Resources. London; 2022. https://www.figo.org/improving-access-essential-medicines-reduce-postpar.... Accessed April 29, 2022.
  [4] Arribas M, Roberts I, et al. WOMAN-PharmacoTXA trial: Study
  protocol for a randomised controlled trial to assess the pharmacokinetics and
  pharmacodynamics of intramuscular, intravenous and oral administration of
  tranexamic acid in women giving birth by caesarean section. Wellcome Open Res. 2021; 6:157.
  [5] Patel S, Robertson B, et al. Catastrophic drug errors involving tranexamic acid administered during spinal anaesthesia. Anaesthesia. 2019; 74: 904-914.
  [6] Palanisamy A, Kinsella SM. Spinal tranexamic acid – a new killer in town. Anaesthesia. 2019; 74: 831-833.

  The activities in this narrative were supported by funding from MSD, through its MSD for Mothers initiative and are the sole responsibility of the authors. MSD for Mothers is an initiative of Merck & Co., Inc., Rahway, NJ, USA

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  Conflict of Interest:
  None declared.

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