Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage
Abstract Background The use of quality injectable oxytocin effectively prevents and treats postpartum hemorrhage, the leading cause of maternal death worldwide. In low- and middle-income countries (LMICs), characteristics of oxytocin—specifically its heat sensitivity—challenge efforts to ensure its...
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doaj-49ba8ab8a4774db29209f72823b5f5cc2020-11-25T03:33:40ZengBMCJournal of Pharmaceutical Policy and Practice2052-32112020-05-0113111310.1186/s40545-020-00205-7Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhagePeter Lambert0Michelle P McIntosh1Mariana Widmer2Lawrence Evans3Megan Rauscher4Rutendo Kuwana5Fiona Theunissen6Beth Yeager7Helen Petach8Drug Delivery Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash UniversityDrug Delivery Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash UniversityDepartment of Reproductive Health and Research, World Health OrganizationPromoting Quality of Medicines Plus Program, U.S. Pharmacopeial ConventionGlobal Health Supply Chain Program-Procurement and Management Project, Chemonics InternationalRegulatory Systems Support, World Health OrganizationIndependent ConsultantPromoting Quality of Medicines Plus Program, U.S. Pharmacopeial ConventionOffice of Maternal and Child Health and Nutrition, Bureau for Global Health, United States Agency for International DevelopmentAbstract Background The use of quality injectable oxytocin effectively prevents and treats postpartum hemorrhage, the leading cause of maternal death worldwide. In low- and middle-income countries (LMICs), characteristics of oxytocin—specifically its heat sensitivity—challenge efforts to ensure its quality throughout the health supply chain. In 2019, WHO, UNFPA and UNICEF released a joint-statement to clarify and recommend that oxytocin should be kept in the cold chain (between 2 and 8 °C) during transportation and storage; however, confusion among stakeholders in LMICs persists. Objectives and methods To further support recommendations in the WHO/UNFPA/UNICEF joint-statement, this paper reviews results of oxytocin quality testing in LMICs, evaluates product stability considerations for its management and considers quality risks for oxytocin injection throughout the health supply chain. This paper concludes with a set of recommended actions to address the challenges in maintaining quality for a heat sensitive pharmaceutical product. Results Due to the heat sensitivity of oxytocin, its quality may be degraded at numerous points along the health supply chain including: At the point of manufacture, due to poor quality active pharmaceutical ingredients; lack of sterile manufacturing environments; or low-quality manufacturing processes During storage and distribution, due to lack of temperature control in the supply chain, including cold chain at the end user health facility Safeguarding the quality of oxytocin falls under the purview of national medicines regulatory authorities; however, regulators in LMICs may not adhere to good regulatory practices. Conclusions Storing oxytocin from 2 to 8 °C throughout the supply chain is important for maintaining its quality. While short temperature excursions may not harm product quality, the cumulative heat exposure is generally not tracked and leads to degradation. National and sub-national policies must prioritize procurement of quality oxytocin and require its appropriate storage and management.http://link.springer.com/article/10.1186/s40545-020-00205-7 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Peter Lambert Michelle P McIntosh Mariana Widmer Lawrence Evans Megan Rauscher Rutendo Kuwana Fiona Theunissen Beth Yeager Helen Petach |
spellingShingle |
Peter Lambert Michelle P McIntosh Mariana Widmer Lawrence Evans Megan Rauscher Rutendo Kuwana Fiona Theunissen Beth Yeager Helen Petach Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage Journal of Pharmaceutical Policy and Practice |
author_facet |
Peter Lambert Michelle P McIntosh Mariana Widmer Lawrence Evans Megan Rauscher Rutendo Kuwana Fiona Theunissen Beth Yeager Helen Petach |
author_sort |
Peter Lambert |
title |
Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage |
title_short |
Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage |
title_full |
Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage |
title_fullStr |
Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage |
title_full_unstemmed |
Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage |
title_sort |
oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage |
publisher |
BMC |
series |
Journal of Pharmaceutical Policy and Practice |
issn |
2052-3211 |
publishDate |
2020-05-01 |
description |
Abstract Background The use of quality injectable oxytocin effectively prevents and treats postpartum hemorrhage, the leading cause of maternal death worldwide. In low- and middle-income countries (LMICs), characteristics of oxytocin—specifically its heat sensitivity—challenge efforts to ensure its quality throughout the health supply chain. In 2019, WHO, UNFPA and UNICEF released a joint-statement to clarify and recommend that oxytocin should be kept in the cold chain (between 2 and 8 °C) during transportation and storage; however, confusion among stakeholders in LMICs persists. Objectives and methods To further support recommendations in the WHO/UNFPA/UNICEF joint-statement, this paper reviews results of oxytocin quality testing in LMICs, evaluates product stability considerations for its management and considers quality risks for oxytocin injection throughout the health supply chain. This paper concludes with a set of recommended actions to address the challenges in maintaining quality for a heat sensitive pharmaceutical product. Results Due to the heat sensitivity of oxytocin, its quality may be degraded at numerous points along the health supply chain including: At the point of manufacture, due to poor quality active pharmaceutical ingredients; lack of sterile manufacturing environments; or low-quality manufacturing processes During storage and distribution, due to lack of temperature control in the supply chain, including cold chain at the end user health facility Safeguarding the quality of oxytocin falls under the purview of national medicines regulatory authorities; however, regulators in LMICs may not adhere to good regulatory practices. Conclusions Storing oxytocin from 2 to 8 °C throughout the supply chain is important for maintaining its quality. While short temperature excursions may not harm product quality, the cumulative heat exposure is generally not tracked and leads to degradation. National and sub-national policies must prioritize procurement of quality oxytocin and require its appropriate storage and management. |
url |
http://link.springer.com/article/10.1186/s40545-020-00205-7 |
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