In a 2016 statement, the WHO stated that “ there are many estimates of the scope and scale of the market in counterfeit medical products, but little validated evidence to underpin those estimates.” Furthermore, the WHO has withdrawn all of their previous estimations of the scale of the problem ( 1). However, the WHO has since become less definitive in estimating the scope of the problem, as there is an inherent difficulty in quantifying counterfeit products, which have become increasingly sophisticated and difficult to differentiate from genuine medicines. In 2006, the WHO estimated that 10% of drugs worldwide were counterfeit, with the figure at 25% in developing countries, and as high as 50% in certain African and Asian countries ( 3). Counterfeit medications bypass all these safeguards ( 2).ĭespite these potential dangers, the market for counterfeit products has grown astronomically. Then, all sanctioned medications are manufactured under heavily monitored conditions. Legitimate pharmaceuticals must pass vigorous standards and undergo large, randomized trials before being formally approved for the public. In addition to the intellectual property rights that counterfeiters violate, the products they make can place consumers in danger. Regardless of the definition, drug counterfeiting has become a global problem. For the purposes of this paper, the term “counterfeit” will be used to encompass all forms of SSFFC medications. Currently, the WHO is using the term “ Substandard, Spurious, Falsely labeled, Falsified, and Counterfeit (SSFFC)” for medical products until a new definition is agreed upon ( 1). This can include products with bona fide ingredients, but with insufficient or excessive quantities, products with the wrong ingredients, or products with deceptive packaging. Counterfeiting can apply to both branded and generic products. In 2009, the World Health Organization (WHO) defined a “counterfeit medicine” as one “ which is deliberately and fraudulently mislabeled with respect to identity and/or source.” However, many in the organization have disputed this definition of counterfeit medicine, and there appears to be no universally agreed upon definition amongst member states of the WHO. The counterfeit drug market is a nebulous and constantly evolving entity that has become increasingly difficult to define and quantify. This communication reviews the literature regarding counterfeit PDE-5i, and summarizes both the scope and dangers of the illicit PDE-5i market. Furthermore, PDE-5i can have potentially dangerous interactions with other pharmaceuticals that are rarely warned against with counterfeit PDE-5i. Bypassing the legitimate healthcare system also endangers consumers indirectly, as erectile dysfunction (ED) is often associated with other medical comorbidities that patients should be screened for. However, taking illicit PDE-5i may harm consumers directly, as many illicit products contain detrimental contaminants and inaccurate amounts of the active ingredient without the appropriate warnings. Others seek to bypass the legitimate healthcare system due to either embarrassment of the underlying condition or desire for cheaper alternatives. Consumers of illicit PDE-5i often do not realize they are using counterfeit products and placing themselves at an unnecessary health risk. Many factors are contributing to the rapid growth of the illicit market, such as the low risk of prosecution, potentially high financial reward, and ease of distribution via Internet pharmacies. Counterfeiters are taking advantage of this growing market by developing illicit and counterfeit PDE-5i products. Already in widespread use, the market for PDE-5i is steadily growing as the population ages. Counterfeit phosphodiesterase-5 inhibitors (PDE-5i) are an increasing problem.
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