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

Abstract

Introduction:The counterfeit phenomenon is a largely under-reported issue, with potentially large burden for healthcare. The market for counterfeit drugs used in sexual medicine, most notably type 5 phosphodiesterase inhibitors (PDE5i), is rapidly growing. Aims: To report the health risks associated with the use of counterfeit medications, the reasons driving their use, and the strategies enacted to contain this phenomenon. Methods: A systematic scoping review of the literature regarding counterfeit PDE5i was carried between January and June 2021, then updated in August 2021. Main Outcome Measure: We primarily aimed to clarify the main drivers for counterfeit PDE5i use, the health risks associated, and the currently available strategies to fight counterfeiters. Results: One hundred thirty-one records were considered for the present scoping review. Production of fake PDE5i is highly lucrative and the lacking awareness of the potential health risks makes it a largely exploitable market by counterfeiters. Adulteration with other drugs, microbial contamination and unreliable dosages make counterfeit medications a cause of worry also outside of the sexual medicine scope. Several laboratory techniques have been devised to identify and quantify the presence of other compounds in counterfeit medications. Strategies aimed at improving awareness, providing antitampering packaging and producing non-falsifiable products, such as the orodispersible formulations, are also described. Clinical implications: Improving our understanding of the PDE5i counterfeit phenomenon can be helpful to promote awareness of this issue and to improve patient care. Strengths & Limitations: Despite the systematic approach, few clinical studies were retrieved, and data concerning the prevalence of counterfeit PDE5i use is not available on a global scale. Conclusion:The counterfeit phenomenon is a steadily growing issue, with PDE5i being the most counterfeited medication with potentially large harmful effects on unaware consumers. Sansone A, Cuzin B, and Jannini EA.

Assessment of a New Formulation of Sildenafil on Common Practice: An Observational Study

“…Furthermore, the study confirmed the safety profile of sildenafil-ODF with the most commonly reported AEs being those listed in the summary of the product's characteristics [ 13 ]. It is also to be stressed that while PDE5-I are among the most counterfeited medication, the specific ODF formulation appears virtually exempt from the risk of counterfeiting [ 30 ]. This study, like other real-life studies, has several limitations.…”

The Italian Society of Andrology and Sexual Medicine (SIAMS), along with ten other Italian Scientific Societies, guidelines on the diagnosis and management of erectile dysfunction

“…In addition to the benefit of all orodispersible formulations, in that they reduce first-pass metabolism, an enhanced bioavailability and a decreased incidence of side effects may also be possible [ 249 ]. Moreover, the ODF formulation respects the need for privacy felt to be essential by several patients for a perfect compliance with the ED oral treatments [ 251 ].…”

“…Finally, PDE5i is the most counterfeited medication with potentially large harmful effects on unaware consumers. Patients, sexologists, pharmacists, physicians, and healthcare authorities should collaborate to find educational strategies to face this risky and widespread phenomenon [ 251 ]. Addressing this topic when counseling the patient with ED should be considered of pivotal importance.…”

“…Finally, the SIAMS and the scientific Societies involved in these guidelines are not against, in principle, a non-prescription, over-the-counter (OTC) regimen for low and intermediate dosages of PDE5i instead of the current prescription (Rx) regimen[ 251 ]. In fact, in some European countries, sildenafil 50 mg has been available OTC since 2018.…”

Orodispersible Film (ODF) Platform Based on Maltodextrin for Therapeutical Applications

“…So far, strategies to face counterfeits (education of clinicians and pharmacists, involvement of international authorities, social media interventions) have substantially failed to meet their aim [ 76 ]. The relatively expensive, high-tech ODF formulation described here may represent a unique strategy for the purpose of countering the spread of counterfeits, as demonstrated by the apparent absence of this formulation on the black market [ 77 ].…”