The health consequences of falsified medicines‐ A study of the published literature

Abstract

Objectives To analyse and present the literature describing the health consequences of falsified medicines, focusing on mortality and morbidity, as well as the scale of the issue, the geographic extent, the medicines affected, and the harm caused at both the individual and population levels. Methods We searched for articles in PubMed, using pre‐optimized keywords ‘(counterfeit OR fake OR bogus OR falsified OR spurious) AND (medicine OR drug)’. Searches up to February 2017 yielded 2006 hits, of which 1791 were full‐length articles in English. Among them, we found 81 papers that qualitatively or quantitatively described 48 incidents in which falsified medicines caused patients to suffer serious adverse effects, injury, symptoms or death. Results The distribution of incidents was examined according to the economic status of the countries involved, regional location in the world, therapeutic category of the medicines, number of incidents and victims by year, and characteristics of the falsified medicines. Among the 48 reported incidents, 27 (56.3%) occurred in developing countries and 21 (43.7%) in developed countries. These incidents involved a total of approximately 7200 casualties including 3604 deaths. Conclusions Despite the poor quality of much of the reported data, the results of this study indicate that all types of medications have been targeted for falsification, and falsified medicines have had a serious impact on the health of both adults and children worldwide, with similar numbers of incidents in developing and developed countries.

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Journal policy on publishing studies with negative results

“…More seriously, there are some reports on scientific misconduct of falsifying the data among researchers. 17…”

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“…W krajach rozwiniętych do najczęściej fałszowanych należą środki stosowane w zaburzeniach erekcji. Sfałszowane leki często nie zawierały substancji aktywnej, zawierały jej niewłaściwą ilość (dawkę), zawierały inną substancją aktywną niż zadeklarowana w specyfikacji produktu leczniczego oraz dużą zawartość zanieczyszczeń [19].…”