Pharmacy Practice Case - a counterfeit medicinal product in the legal supply chain

Pharmacy Practice Case - a counterfeit medicinal product in the legal supply chain

Oral presentation

Counterfeit medicinal products are a significant threat to human health and their entry into the pharmaceuticals market leads to a loss of confidence in public health. These products contain substandard or counterfeit ingredients, do not contain active substances, or contain ingredients or active substances that incorrectly dosed. Most often they are spread through illegal channels - the Internet, remote deliveries, "suitcase" trade, presenting themselves as products related to the health of the population: food, food additives, medical devices, cosmetic products, etc., but the main purpose is legal channels and chains for distribution of medicinal products - manufacturers / importers, wholesalers and retailers (pharmacies and drugstores). The regulatory framework for combating counterfeit medicines based on Directive 2011/62 / EU of 8 June 2011 introducing measures to prevent counterfeit medicinal products from entering the legal distribution chains. Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 introduced a system for the serialization and verification of prescription-only medicinal products to ensure that the medicinal products are authentic. The system does not cover medicines without a prescription except for INN Omeprazole. As of February 9, 2019, this system is (should be) functioning effectively in the EU, respectively Bulgaria. Despite the introduction of new regulations, we continue to discover counterfeit medicinal products. We present a case from real pharmacy practice - an established counterfeit medicinal product in legal distribution chain.
Keywords: counterfeit medicinal products, falsified medicinal product, verification