Rafaella’s Literature Update
Ref. Gnegel, G., Häfele-Abah, C., Neci, R. et al. Surveillance for substandard and falsified medicines by local faith-based organizations in 13 low- and middle-income countries using the GPHF Minilab. Sci Rep 12, 13095 (2022). https://doi.org/10.1038/s41598-022-17123-0
Dear Colleagues,
This interesting manuscript from our friends of EPN and University of Tubingen, evaluates the use of the Global Pharma Health Fund (GPHF) Minilab for medicine quality screening by 16 faith-based drug supply organizations located in 13 low- and middle-income countries, in 2019 and 2020.
In total 1,919 medicine samples were screened by the researchers using the GPHF Minilab, and samples showing serious quality deficiencies were subjected to compendial analysis in fully equipped laboratories. Overall, thirty-four (1.8%) of the samples were reported as probably falsified, as they did not contain the declared active pharmaceutical ingredient (API), or less than 50% of it, or undeclared APIs; and fifty-four (2.8%) were reported as substandard, although it is important to note, as reminded by the authors, that “the true number of substandard medicines may have been higher due to the limited sensitivity of the GPHF Minilab”. Interestingly, the number of probably falsified products increased during the COVID-19 pandemic, especially due to falsified preparations of chloroquine, which had been incorrectly promoted and sold as treatment for COVID-19.
Noteworthy, the reports from this project resulted in four international WHO Medical Product Alerts and several national alerts. The authors conclude that, even if the GPHF Minilab cannot detect all the substandard medicines (“the role and the limitations of the GPHF Minilab in medicine quality assurance in low-resource settings need to be considered responsibly. The compliance with pharmacopeial standards can only be proven conclusively by (expensive) pharmacopeial methods”), it remains “a cost-effective way to contribute to the global surveillance for substandard and falsified medical products”.
Last not least, the model of the Difäm-EPN Minilab Network is very interesting, as “the involvement of private or civil society organizations, as described here, clearly offers the prospect to increase the outreach and speed of the detection and removal of SF medicines”.
Thus….have a nice reading, and a nice summer!
Raffaella