TY - JOUR
T1 - Oxytocin quality
T2 - evidence to support updated global recommendations on oxytocin for postpartum hemorrhage
AU - Lambert, Peter
AU - McIntosh, Michelle P.
AU - Widmer, Mariana
AU - Evans, Lawrence
AU - Rauscher, Megan
AU - Kuwana, Rutendo
AU - Theunissen, Fiona
AU - Yeager, Beth
AU - Petach, Helen
N1 - Funding Information:
In October 2017, an expert group of scientists, researchers, manufacturers and health experts from public and private sectors was convened in Geneva by WHO to review current evidence on quality issues for oxytocin at a meeting titled, “A Technical Consultation on Messaging for Management of Oxytocin: A Current Review of Evidence.” The recommendations in this document were derived from that expert meeting. The contents are the responsibility of the authors and do not necessarily reflect the views of USAID or the United States Government.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12
Y1 - 2020/12
N2 - 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 processesDuring 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.
AB - 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 processesDuring 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.
UR - http://www.scopus.com/inward/record.url?scp=85099640736&partnerID=8YFLogxK
U2 - 10.1186/s40545-020-00205-7
DO - 10.1186/s40545-020-00205-7
M3 - Review Article
AN - SCOPUS:85099640736
SN - 2052-3211
VL - 13
JO - Journal of Pharmaceutical Policy and Practice
JF - Journal of Pharmaceutical Policy and Practice
IS - 1
M1 - 14
ER -
