Estimating the quantity of substandard and falsified medical products purchased online

Background: The increasing distribution of Substandard and Falsified Medical Products is a well-known health risk. The quantity of these medicines sent to consumers is not known, and it can only be accurately estimated with a specific sample collection study. These consignments ordered via mail from illegal online sources pose a great health risk on the population. Methods: We used an observation-based cross-sectional study in order to obtain accurate data regarding the number of medicinal shipments from dubious origin. We collected data on-site to assess the number of Substandard and Falsified Medical Products arrived in Hungary via postal services in 2020. Results: The therapeutic category (according to the Anatomical Therapeutic Chemical Classification (ATC) system of the WHO) of the most frequently shipped products contained active ingredients for treating erectile dysfunction. These substances were sildenafil (G04BE03), tadalafil (G04BE08), and other analgesics and antipyretics, such as anilides (N02BE). In 2020 we estimated that the real Defined Daily Dose of SFMP was 1.2 DDD per 1000 inhabitants per day. This value is equivalent to one third of Hungary’s opioid analgesic use. We also calculated that the average exposure was approximately 4 ampoules per day and 40 oral preparations per day (without DDD value) for 1000 people in Hungary. Conclusions: This study accurately estimates the number of consignments received by post containing Substandard and Falsified Medical Products, and determines the quantity per 1000 persons per day expressed in DDD. This parameter may be used as a benchmark that helps more detailed research in the future.