The occurrence of non‐anatomical therapeutic chemical‐international nonproprietary name molecules in suspected illegal or illegally traded health products in Europe: A retrospective and prospective study

Abstract

The General European Official Medicines Control Laboratory (OMCL) Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), regularly organises market surveillance studies on specific categories of suspected illegal or illegally traded products. These studies are generally based on a combination of retrospective and prospective data collection over a defined period of time. This paper reports the results of the most recent study in this context with the focus on health products containing non-Anatomical Therapeutic Chemical-International Nonproprietary Name (ATC-INN) molecules. In total 1104 cases were reported by 16 countries for the period between January 2017 and the end of September 2019. The vast majority of these samples (83%) were collected from the illegal market, while only 3% originated from a legal source. For the rest of the samples, categorisation was not possible. Moreover, 69% of all the reported samples were presented as medicines, including sexual performance enhancers, sports performance enhancers, physical performance enhancers and cognitive enhancers or nootropic molecules that act on the central nervous system (CNS).Although the popularity of anabolics, PDE-5 inhibitors and CNS drugs in illegal products has already been reported, the study showed some new trends and challenges. Indeed, 11% of the samples contained molecules of biological origin, that is, research peptides, representing the second most reported category in this study. Furthermore, the study also clearly shows the increasing popularity of Selective Androgen Receptor Modulators and nootropics, two categories that need attention and should be further monitored.

Facing Counterfeit Medications in Sexual Medicine. A Systematic Scoping Review on Social Strategies and Technological Solutions

“…121 Lifestyle drugs are the most counterfeited products found by police investigations in developed countries, such as in Europe and North America, with PDE5i having the largest share of the market and other appearance and performance enhancing drugs, such as anabolic androgen steroids, being close second. 65,73,125,126,135 For the largest part, the high prevalence of counterfeit PDE5i can be related to the well-known efficacy of these drugs, their supposed safety, and their commercial success. 45,126 Indeed, analysis of urban wastewater showed that in some European cities the concentration of sildenafil and its urinary metabolites was significantly higher than expected based on prescriptions, suggesting large illegal sources of drug acquisition.…”

“…Additionally, although several well conducted in vitro and in vivo studies demonstrated a role of herbal remedies in the management of male sexual health, 164−169 the potential effects of these remedies are largely disputed. 116 While this is a relatively smaller phenomenon, some reports of counterfeit drugs being legally sold has been collected, 73,111 highlighting the potential of counterfeit products to reach the "regular" supply chain. It is, therefore, necessary to educate potential consumers in order to prevent them from falling prey to counterfeiters.…”

Illegal products containing selective androgen receptor modulators purchased online from Italy: health risks for consumers

“…The study clearly showed the increasing popularity of SARMs, emphasizing the need of attention and further monitoring of such substances, which are the subject of illegal (internet) trade. 29 However, research focused on specific geographic markets is limited, leading to a deficiency in understanding the nature and diffusion among users.…”

Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

“…Meanwhile, in Western countries, although there is prevalence of substandard and falsified lifesaving medicines, they are encountered less frequently. The focus in the west is directed toward lifestyle medicines like sexual performance enhancers, sport performance enhancers and weight-loss enhancers [12]. Based on the scientific literature, the major health risks associated with the use of these SF medicinal products are supplemented by the fact that they are not produced in accordance with the good manufacturing practices (GMP).…”

“…In Europe, sexual-performance-enhancing SF medicinal products have been quite popular since the last decade, as illustrated by the many entries in the Know-X database that has been put in place by the European Directorate for the Quality of Medicines and HealthCare (EDQM) [29]. Likely, these products are purchased as a cheaper, easily accessible alternative to genuine products, and there is no requirement for a doctor's prescription for their purchase and thus no coincidental potential embarrassment [12]. In order to assess the online claims of these rogue online pharmacies and their potential threat to public health, we set out to perform a mapping of the potentially dangerous chemicals and biological risks, encountered in 32 real-life substandard or falsified PDE-5 inhibitors.…”