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Open Access Highly Accessed Research article

Microbiological contamination in counterfeit and unapproved drugs

Dieter Pullirsch1*, Julie Bellemare2, Andreas Hackl1, Yvon-Louis Trottier2, Andreas Mayrhofer1, Heidemarie Schindl1, Christine Taillon2, Christian Gartner1, Brigitte Hottowy1, Gerhard Beck1 and Jacques Gagnon2*

Author Affiliations

1 AGES - Austrian Agency for Health & Food Safety, Austrian Medicines and Medical Devices Agency, Traisengasse 5, Vienna AT-1200, Austria

2 Health Canada, 1001 St-Laurent West, Longueuil, Qc J4K 1C7, Canada

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BMC Pharmacology and Toxicology 2014, 15:34  doi:10.1186/2050-6511-15-34

Published: 26 June 2014

Abstract

Background

Counterfeit and unapproved medicines are inherently dangerous and can cause patient injury due to ineffectiveness, chemical or biological contamination, or wrong dosage. Growth of the counterfeit medical market in developed countries is mainly attributable to life-style drugs, which are used in the treatment of non-life-threatening and non-painful conditions, such as slimming pills, cosmetic-related pharmaceuticals, and drugs for sexual enhancement. One of the main tasks of health authorities is to identify the exact active pharmaceutical ingredients (APIs) in confiscated drugs, because wrong API compounds, wrong concentrations, and/or the presence of chemical contaminants are the main risks associated with counterfeit medicines. Serious danger may also arise from microbiological contamination. We therefore performed a market surveillance study focused on the microbial burden in counterfeit and unapproved medicines.

Methods

Counterfeit and unapproved medicines confiscated in Canada and Austria and controls from the legal market were examined for microbial contaminations according to the US and European pharmacopoeia guidelines. The microbiological load of illegal and legitimate samples was statistically compared with the Wilcoxon rank-sum test.

Results

Microbial cultivable contaminations in counterfeit and unapproved phosphodiesterase type 5 inhibitors were significantly higher than in products from the legal medicines market (pā€‰<ā€‰0.0001). Contamination levels exceeding the USP and EP limits were seen in 23% of the tested illegal samples in Canada. Additionally, microbiological contaminations above the pharmacopoeial limits were detected in an anabolic steroid and an herbal medicinal product in Austria (6% of illegal products tested).

Conclusions

Our results show that counterfeit and unapproved pharmaceuticals are not manufactured under the same hygienic conditions as legitimate products. The microbiological contamination of illegal medicinal products often exceeds USP and EP limits, representing a potential threat to consumer health.