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Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania.
Ammerdorffer, Anne; Rushwan, Sara; Timms, Rebecca; Wright, Philip; Beeson, Leanne; Devall, Adam J; Mammoliti, Kristie-Marie; Alwy Al-Beity, Fadhlun M; Galadanci, Hadiza; Hofmeyr, G Justus; Singata-Madliki, Mandisa; Qureshi, Zahida; Lambert, Pete; Gallos, Ioannis D; Coomarasamy, Arri; Gülmezoglu, A Metin.
Affiliation
  • Ammerdorffer A; Concept Foundation, Geneva, Switzerland.
  • Rushwan S; Concept Foundation, Geneva, Switzerland.
  • Timms R; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
  • Wright P; Drug Delivery Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
  • Beeson L; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
  • Devall AJ; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
  • Mammoliti KM; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
  • Alwy Al-Beity FM; Department of Obstetrics and Gynecology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
  • Galadanci H; Africa Center of Excellence for Population Health and Policy, Bayero University, Kano, Kano, Nigeria.
  • Hofmeyr GJ; Department of Obstetrics and Gynecology, University of Botswana, Gaborone, Botswana.
  • Singata-Madliki M; University of the Witwatersrand, Johannesburg, South Africa.
  • Qureshi Z; Walter Sisulu University, South Africa.
  • Lambert P; Effective Care Research Unit, Department of Obstetrics and Gynaecology, Universities of the Witwatersrand, East London, South Africa.
  • Gallos ID; Department of Obstetrics and Gynecology, School of Medicine, University of Nairobi, Kenyatta National Hospital Campus, Nairobi, Kenya.
  • Coomarasamy A; Drug Delivery Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
  • Gülmezoglu AM; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Int J Gynaecol Obstet ; 158 Suppl 1: 46-55, 2022 Jun.
Article in En | MEDLINE | ID: mdl-35762808
ABSTRACT

OBJECTIVE:

To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.

METHODS:

Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.

RESULTS:

Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.

CONCLUSION:

While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Tranexamic Acid / Postpartum Hemorrhage Type of study: Guideline Limits: Female / Humans / Pregnancy Country/Region as subject: Africa Language: En Journal: Int J Gynaecol Obstet Year: 2022 Document type: Article Affiliation country: Suiza

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Tranexamic Acid / Postpartum Hemorrhage Type of study: Guideline Limits: Female / Humans / Pregnancy Country/Region as subject: Africa Language: En Journal: Int J Gynaecol Obstet Year: 2022 Document type: Article Affiliation country: Suiza