E-DRUG: Publication "Quality, availability and storage conditions of oxytocin and misoprostol in Malawi"
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Dear e-druggers,
the quality of oxytocin has been a topic of discussion in this forum
several times. It might be of interest to you that our Paper "Quality,
availability and storage conditions of oxytocin and misoprostol in
Malawi" has just been published in BMC Pregnancy and Childbirth:
https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-2810-9
ABSTRACT:
BACKGROUND: Postpartum haemorrhage (PPH) is the leading cause of
maternal mortality in low- and middle-income countries (LMICs). Oxytocin
and misoprostol are used for the prevention and treatment of PPH.
However, both medicines are chemically unstable and sensitive to
environmental conditions. Previous studies reported a high prevalence of
substandard oxytocin and misoprostol preparations in LMICs.
METHODS: In randomly selected health facilities of four districts of
Malawi, the availability of oxytocin and misoprostol was determined, and
the knowledge of health workers on storage requirements and use of
oxytocics was assessed. Temperature loggers were used to record the
storage temperature of oxytocics. Samples of oxytocin injections and
misoprostol tablets were collected from the health facilities and from
wholesalers. Oxytocin samples were analysed for identity, assay (=
quantity of oxytocin) and for pH value according to United States
Pharmacopeia 40. Misoprostol samples were analysed for identity, assay,
dissolution and related substances according to the International
Pharmacopeia 2017.
All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic’s storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2–8 °C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2–86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7–30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter.
CONCLUSION: Availability of oxytocin was excellent in Malawi, and its
quality was better than reported in previous studies in other LMICs.
However, storage conditions at the health facilities often did not meet
the requirements. Extremely substandard misoprostol tablets were found,
representing a serious risk to maternal health. This shows the need for
continued efforts for quality assurance in medicine procurement and
registration, as well as for post-marketing surveillance.
You are welcome to share this paper with persons and organizations who
may be interested!
Kind regards,
Nhomsai Hagen
Nhomsai Hagen
Apothekerin, Doktorandin
Eberhard Karls Universität Tübingen
Pharmazeutische Biologie, Pharmazeutisches Institut
Auf der Morgenstelle 8
D-72076 Tubingen
Email: nhomsai.hagen(at)uni-tuebingen.de