COUNTERFEIT AND ILLEGAL MEDICINAL PRODUCTS AS AN EXAMPLE OF DRUGS THAT DO NOT MEET THE BASIC QUAITY REQUIREMENTS

Abstract

Falsification or counterfeiting of medicinal products is a severe pharmaceutical crime. According to the World Health Organization, about 10% of medicinal products in developing countries are falsified. In the case of medicines sold over the Internet, the figure is as high as 50%, and this phenomenon's scale is increasing yearly. The illegally sourced preparations are not manufactured in accordance with Good Manufacturing Practice (GMP). Among the most frequently falsified medicinal products are preparations used for erectile dysfunction, weight loss aids, or anabolic-androgenic steroids. The presence of undeclared active ingredients and impurities, incorrect dosage due to different than declared contents, and the sourcing of over-the-counter medicines from unknown sources can lead to serious side effects that threaten patients' lives and health. In addition, inaccurate or incomplete descriptions of product formulation can additionally cause the risk of drug interactions, which can consequently lead to serious medical incidents. The purpose of this paper is to discuss the requirements for medicinal products and to present the problem of the quality of counterfeit and illegal medicinal products. This issue is discussed using phosphodiesterase type 5 inhibitors (applied to the treatment of erectile dysfunction) as an example. KEYWORDS: falsified medicinal products, quality of medicinal products, PDE-5 inhibitors