E-DRUG: PhD thesis Nhomsai Hagen - quality & stability of oxytocin & misoprostol
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Dear e-druggers
on Nov 27, 2020, my PhD student Nhomsai Hagen defended her PhD thesis,
titled 'Quality, availability and stability of misoprostol tablets and
oxytocin injections in Malawi and Rwanda', at Tuebingen University,
Germany. Her research results have been published in three open-access
publications:
'Quality, availability and storage conditions of oxytocin and
misoprostol in Malawi'
Hagen, N.; Khuluza, F.; Heide, L. BMC Pregnancy and Childbirth.
2020; 20(1):184.
https://doi.org/10.1186/s12884-020-2810-9
'Stability of oxytocin preparations circulating in Malawi and Rwanda,
carrying different storage recommendations. Stabilizing effect of
chlorobutanol'
Hagen, N.; Bizimana, T.; Kayumba, P.C.; Khuluza, F.; Heide, L.  - Â
American Journal of Tropical Medicine & Hygiene, 2020;103(5):2129-2141
https://doi.org/10.4269/ajtmh.20-0255
'Stability of misoprostol tablets collected in Malawi and Rwanda.
Importance of intact primary packaging'
Hagen, N.; Bizimana, T.; Kayumba, P.C.; Khuluza, F.; Heide, L. -
PloSOne, 2020; 15(9):e0238628.
https://doi.org/10.1371/journal.pone.0238628
During her research in Malawi, she found extremely substandard
misoprostol tablets, containing only 13% of the declared content.
Malawian authorities and WHO were alerted about this finding, which led
to a national recall of the substandard misoprostol brand. This was also
shared with E-drug, which revealed that the distributor of set brand,
Premiumway International, was located at the same address and run by the
same family as Unimed International Ltd, who distributed substandard
propofol to Zambia. Investigations by MHRA of these two distributors led
to voluntary liquidations of both companies. (Unfortunately, MHRA
authorized the opening of new companies led by these people),
https://find-and-update.company-information.service.gov.uk/officers/_FoP5eoqAftMRSUNkn7cYGcr5O0/appointments
She presented the results of her work to Malawian authorities and
national and international stakeholders during a meeting in Lilongwe,
Malawi in Sep 2019. Furthermore, the findings were also presented to
health workers in the study districts, including appropriate trainings
in cooperation with the Malawi National Pharmacovigilance Centre.
Nhomsa's work shows the need for continued efforts for quality
assurance in medicine procurement and registration, as well as for
post-marketing surveillance. It also highlights the importance of
immediately reporting substandard medicines, not only to national
authorities and international stakeholders, but also to communities like
E-drug, for a further improvement of patient safety within the country
and worldwide.
Prof. Dr. Lutz Heide
Pharmaceutical Institute
Tuebingen University
Germany
Lutz Heide <heide@uni-tuebingen.de>