The global trade in illicit pharmaceuticals persists as a profitable criminal enterprise, despite the concerted efforts of international agencies and collaborative initiatives like Operation Pangea[76]. Over the past five years, instances of pharmaceutical crime have surged by nearly 65%, spanning 142 countries, posing significant threats to the health and well-being of unsuspecting individuals worldwide[100]. While substandard and falsified life-saving medications are mainly encountered in developing region, the criminal focus in western countries seems to center more on lifestyle medicines, including sexual performance enhancers, sport performance boosters, and weight loss aids. One of the driving forces behind the demand for these substandard and falsified products is their affordability, accessibility, and lack of prescription requirement, thereby offering an appealing alternative to legitimate medications[9]. A prominent concern in this landscape pertains to the compromised quality of these illicit pharmaceuticals, often deviating from established good manufacturing practices (GMP). The potential health risks associated with consuming such compromised medications range from toxic impurities to contamination with pathogenic microorganisms.
In this bachelor’s degree thesis, I present the results obtained for the bacterial and fungal contamination preset in illicit PDE-5 inhibitors, seized by Belgian authorities, by determining their bioburden. Bioburden refers to the amount and type of microorganisms present in a sample and reflects the level of biological contamination and associated potential health risks upon consumption of the product. We initially set out to see if these products were contaminated with bacteria and fungi and performed enumeration tests. Next, we also conducted a series of microbiological assays on those bacterial strains that could potentially be pathogenic upon oral uptake of the samples.
Our results indicate that 50% of the samples were not compliant for their microbial quality (see Table 7), indicating that improper hygienic standards were used during production of these medicinal products. Startlingly, 2 samples were severely contaminated with a pathogenic microorganism, bearing the required toxin producing genes that are known to be encoding proteins that can cause gastrointestinal illness upon ingestion. These results indicate that at least 16 samples from the 32 substandard and falsified medicinal products analyzed could potentially have an adverse effect on patient health and thus increase the chance for undesired side effects.
The scope of this thesis is focused on the bioburden component of a larger research project, which has been published in a peer-reviewed article[1] (see appendix 13.5). In addition to the biological risks associated with the use of these type of medicinal products, also the chemical risks (e.g. lack of dosage accuracy, etc.) are highlighted in this study. Taken together, the obtained results indicate that at least 68% of the analyzed products harbored an unneglectable chemical or biological risk. These findings plead for a continuing vigilance of the international and national regulatory agencies and law enforcement agencies and to informing and warn the patients of the possible risks, exemplified by potentially dangerous real-life data, in order to safeguard this aspect of public health.
