Be-cause Health & QUAMED literature updates

Ref BizimanaT, Hagen N, Gnegel G, Kayumba PC, Heide L (2021) Quality of oxytocin and misoprostol in health facilities of Rwanda. PLoS ONE 16(1):e0245054

Dear Friend,

I am happy to share a further work from our friends at the University of Tuebingen, on the quality and storage conditions of oxytocin and misoprostol. These medicines are life-saving in the prevention and treatment of post-partum hemorrhage, and they are important to reduce maternal mortality, which is one of the Sustainable Development Goals. In a collaboration between the University of Tuebingen and the University of Rwanda, Bizimana and colleagues investigated the quality and the storage conditions of these medicines in randomly selected health facilities of Rwanda, following a similar protocol as in an earlier study conducted in Malawi (highlighted in 200406 BCH/QUAMED).

In contrast to reports from other African countries, in Rwanda the availability and the storage conditions for oxytocin and misoprostol were found to be very good in most places. Possibly related to these good storage conditions, no oxytocin samples with insufficient content were found, which again is clearly different from reports from other African countries. However, one batch by a stated Chinese manufacturer contained an excessive amount of oxytocin (about 120 % of the declared amount), and another batch from that manufacturer surprisingly contained extremely varying concentrations of an (undeclared) preservative in different vials of the same batch, indicating gross violations of good manufacturing practice.

Out of six investigated brands of misoprostol tablets, two brands extremely deviated from specifications, containing less than 50% of the declared amount in all investigated samples of these brands. The Rwanda authorities were notified by the authors of this study, re-checked and confirmed the analytical findings, and issued an immediate recall of both substandard misoprostol brands in Rwanda. 

Notably, all collected oxytocin and misoprostol samples which were either WHO-prequalified products or manufactured in a country with a stringent regulatory authority (SRA) were found to be of good quality at all collection sites along the supply chain. The authors concluded that for oxytocin and misoprostol, with their well-known problems of quality and stability, procurement should possibly be restricted to WHO-prequalified medicines and/or to medicines manufactured in countries with SRAs.

Sadly, our esteemed colleague Prof. Pierre Claver Kayumba, who co-organized and co-authored this study, passed away very recently and did not see its final publication. 

Have a nice reading,  

Raffaella

PS Until 31 January 2021 you can subscribe to ITM new short course on Pharmaceutical Policies in Health Systems! Please check  https://edu.itg.be/courses/pharmaceutical-policies-in-health-systems

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