Raffaella’s Literature Update

This message is courtesy of Dr Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium.

Ref. Biset Asrade Mekonnen, Muluabay Getie Yizengaw & Minichil Chanie Worku (2024) Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review, Journal of Pharmaceutical Policy and Practice, 17:1, 2375267, DOI: 10.1080/20523211.2024.2375267

Dear Friends,

The Authors of this systematic review, which covers a time-spam of ten years, looked at the prevalence of substandard, falsified, unlicensed and unregistered medicine -and its associated factors- in Africa.

Out of 310 research articles that were initially considered eligible, and after a quality assessment performed against the MEDQUARG checklist (2009) from the IDDO group, 26 studies were judged to have good methodological quality and were included in the analysis. Out of the 7508 medicine samples included in the selected studies, 1639 failed at least one quality test and were considered substandard/falsified (SF) medicines: “samples mainly failed because they did not contain the correct amount of the active pharmaceutical ingredient (API), may not contain API, failed dissolution and content uniformity testing, reduced bioavailability, microbial contamination, and other failures”.

The overall observed prevalence of SF medicines in this sample was therefore of 22.6% (1718/7592). The average prevalence of unregistered medicines was 34.6% (108/312) – and they were more likely to be SF. The average prevalence of SF antibiotics, antimalarial, and antihypertensive medicines was 44.6% (712/1596), 15.6% (530/3530), and 16.3% (249/1530), respectively. 

These findings must be critically considered, because prevalence is highly variable across studies; some categories of medicines are understudies or not studied at all; and the sample cannot be taken as representative of the continent as a whole. Nonetheless, the prevalence observed in this sample is of 22.6% SF medicines, and it suggests that  more needs to be done to correct the regulatory, socio-economic and health systems determinants of SF medicines in Africa.

Have a nice reading and -hopefully- a nice summer break,

Raffaella

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