Falsified medicines found to be riddled with bacteria

Some falsified medicines have high levels of microbial contamination and could pose a significant danger to patients, says a new study.

The findings come as no major surprise for anyone who has seen pictures of the conditions in which many fake drugs are produced, but are notable as they represent one of the first systematic of microbial contamination levels in counterfeits intercepted in western markets.

Falsified drugs are potentially harmful in all manner of ways, and can cause patient harm because they have no active ingredient and are ineffective, have the wrong dose of active or are contaminated with harmful materials.

The researchers behind the study - from the regulatory authorities in Austria and Canada - tested falsified and unapproved medicines seized in their respective countries for microbial contamination and - where possible - compared them to their genuine counterparts.

The legitimate products had no appreciable contamination, while 23 per cent of the illegal products in Canada and 6 per cent in Austria had contamination levels exceeding the limits laid down in the US and European Pharmacopoeias. The contamination represents a "potential threat to consumer health," they note.

The contaminating organisms were mostly Bacillus species, some of which can be harmful to humans although no major pathogenic strains were discovered in this study. The work is published in the journal BMC Pharmacology and Toxicology.

"We recommend the risk-based inclusion of microbiological quality studies in the surveillance of the illegal pharmaceutical market," conclude the authors.


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