E-DRUG: Quality of oxytocin & misoprostol in health facilities of Rwanda
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[Study conducted in 2018 - see complete article]
Dear e-druggers,
in addition to findings previously discussed in this forum on the quality
of oxytocin and misoprostol, I am sharing with you a new paper entitled
"Quality of oxytocin and misoprostol in health facilities of Rwanda", which
has just been published in PloS ONE:
https://doi.org/10.1371/journal.pone.0245054
ABSTRACT:
BACKGROUND: Sustainable Development Goal 3.1 calls for a reduction of the
maternal mortality ratio to less than 70 per 100,000 live births by 2030.
The most important cause of maternal mortality is post-partum hemorrhage
(PPH). Oxytocin injections and misoprostol tablets are medicines of the
first choice for the management of PPH in low- and middle-income countries
(LMICs). Unfortunately, both substances are chemically unstable, and
previous studies have revealed serious quality problems of these medicines
in LMICs. The present study is the first report on their quality in Rwanda.
METHODS: From 40 randomly selected health facilities (hospitals, health
centers, retail pharmacies, and private clinics) in different parts of
Rwanda, as well as from six wholesalers and government stores, oxytocin
injections and misoprostol tablets were collected. Oxytocin storage
temperatures in the health facilities were monitored for six months using
temperature data loggers, and found to correctly follow the storage
requirements stated by the manufacturers (2–8 ̊C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia.
RESULTS: Twenty- four samples from three European manufacturers passed all
tests. However, all nine samples of one batch of a Chinese manufacturer
showed an excessive content of oxytocin (range 117.2 - 121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia.
Fifteen samples passed, but all 10 samples of two brands from India failed
with extreme deviations, containing only 42.5 - 48.7% of the stated amount
of misoprostol.
CONCLUSION: Oxytocin quality in Rwanda was better than reported from other
African countries. However, two extremely substandard brands of misoprostol
tablets were found. The Rwandan authorities reacted quickly and efficiently
and recalled these substandard medicines from the market. For oxytocin and
misoprostol, with their well-known problems of quality and stability,
procurement should possibly be restricted to medicines that are
WHO-prequalified or which have been manufactured in countries with
stringent regulatory authorities.
Do not hesitate to share this paper with persons and organizations whom you
think may be interested!
Kind regards,
Thomas Bizimana
University of Rwanda
Assistant Lecturer and Ph.D. student at the University of Rwanda - CMHS -
SMP - Pharmacy
International Researcher at the Pharmaceutical Institute of Tuebingen
University, Germany
bizimanathomas@gmail.com