Literature DB >> 28551064

Stability of oxytocin along the supply chain: A WHO observational study.

Umit Kartoglu1, Mariana Widmer2, Metin Gulmezoglu2.   

Abstract

Postpartum haemorrhage is the leading cause of maternal mortality in low-income countries and oxytocin is the drug recommended by WHO for preventing and treating it. There are concerns about the quality of oxytocin available at the service level provider. The study aimed to document how temperature variations along the supply chain affect quality of oxytocin. The study was run from March to June 2015 in four regions of Ghana. 130 ampoules of oxytocin were shipped from the manufacturer to service level following Ghanaian public sector supply chain. Along the supply chain, temperatures were recorded continuously. After one month storage at central, regional and service level, ampoules were sent to laboratory for testing. Quality of the initial oxytocin sample from the manufacturer and the 130 oxytocin samples received from study points were tested according to International Pharmacopeia monograph. Samples fully complied with specifications. Temperature profile showed that the lowest and highest temperatures experienced were -9.9 °C and +30.1 °C. The results of this study indicate that the activity of oxytocin was not affected by these temperature excursions which occurred along the supply chain. The quality of the oxytocin from the manufacturer as well as from the service level was within the required specifications.
Copyright © 2017 World Health Organization. Published by Elsevier Ltd.. All rights reserved.

Entities:  

Keywords:  Oxytocin; Postpartum haemorrhage; Quality; Supply chain; Temperature monitoring

Mesh:

Substances:

Year:  2017        PMID: 28551064     DOI: 10.1016/j.biologicals.2017.05.004

Source DB:  PubMed          Journal:  Biologicals        ISSN: 1045-1056            Impact factor:   1.856


  4 in total

1.  Temperature stability of oxytocin ampoules labelled for storage at 2°C-8°C and below 25°C: an observational assessment under controlled accelerated and temperature cycling conditions.

Authors:  Tri-Hung Nguyen; Peter Lambert; Rajpreet Singh Minhas; Claire McEvoy; Kim Deadman; Philip Wright; Richard J Prankerd; Seloi Mogatle; Michelle P McIntosh
Journal:  BMJ Open       Date:  2019-07-26       Impact factor: 2.692

2.  Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs.

Authors:  David Jenkins; Aida Cancel; Thomas Layloff
Journal:  BMC Public Health       Date:  2022-02-14       Impact factor: 3.295

3.  Quality of oxytocin ampoules available in health care facilities in the Democratic Republic of Congo: an exploratory study in five provinces.

Authors:  Peter Lambert; Tri-Hung Nguyen; Claire McEvoy; Rajpreet Singh Minhas; Philip Wright; Kim Deadman; Luc Mulimbalimba Masururu; Michelle P McIntosh
Journal:  J Glob Health       Date:  2018-12       Impact factor: 4.413

Review 4.  Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage.

Authors:  Peter Lambert; Michelle P McIntosh; Mariana Widmer; Lawrence Evans; Megan Rauscher; Rutendo Kuwana; Fiona Theunissen; Beth Yeager; Helen Petach
Journal:  J Pharm Policy Pract       Date:  2020-05-15
  4 in total

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