Microbiological contamination in counterfeit and unapproved drugs

Abstract

BackgroundCounterfeit 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.MethodsCounterfeit 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.ResultsMicrobial cultivable contaminations in counterfeit and unapproved phosphodiesterase type 5 inhibitors were significantly higher than in products from the legal medicines market (p < 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).ConclusionsOur 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.

Over-the-Counter Herbal Weight Loss Supplements in Egypt: Label Claim, Microbiological and Pharmaceutical Quality, and Safety Assessments

“…Microbial contamination has many hazardous effects on patients and may decrease or eliminate the therapeutic effect of the active constituents [24]. It could also convert the main active constituent into toxic metabolites, which may be hazardous [25].…”

Substandard and falsified antimicrobials: A potential biohazard in disguise?

“…2 The past decade has been marked with numerous actions that were taken to prevent SF medical products from infiltrating legal supply chains. [5][6][7][8][9][10] The majority of these analytical findings is focused on the chemical characterization, i.e. This directive provides a preventive system for falsified medicines, e.g.…”

“…4 In addition to the regulatory efforts, many efficient analytical methods were also developed for the analysis and risk evaluation of SF medical products. 8 Taking into account the popularity of antimicrobial drugs and the fact that they are utilized by vulnerable patients, the aim of this study was to investigate the microbial quality of 20 different SF antimicrobials. presence of the active pharmaceutical ingredients (APIs) and impurities.…”

“…4 In addition to the regulatory efforts, many efficient analytical methods were also developed for the analysis and risk evaluation of SF medical products. [5][6][7][8][9][10] The majority of these analytical findings is focused on the chemical characterization, i.e. presence of the active pharmaceutical ingredients (APIs) and impurities.…”

Counterfeit Medicines in Socioeconomic Perspective

“…8,9 In developed countries, counterfeiters aim for high demand or costly products, such as medicines used to treat erectile dysfunction, hypercholesterolemia, hypertension and cancer. 10,11 Thus, it is unclear whether counterfeit medicine is prevalent in the countries that have a low per capita income and low education level, or if counterfeit medicines are increasing in developed countries because counterfeiters target high demand and resale value.…”