Regulation and marketing of cannabidiol-containing products in European countries. Pharmacists’ knowledge in Bulgaria

Abstract

To assess the current regulatory frameworks of cannabidiol-containing products/preparations on the European market, we analyzed data gathered from 19 European countries using the functionalities of the computer software EPITT (European Pharmacovigilance Issues Tracking Tool). In addition, we investigated pharmacists’ knowledge, awareness and attitudes toward cannabidiol (CBD) in Bulgaria. We used questionnaires covering various domains including availability of CBD products or preparations, some of their general characteristics (dosage forms, CBD and THC content, safety profile, etc.) and use for medical conditions in accordance with the countries’ national regulatory requirements. The results indicate three main approaches for the application of CBD: (1) according to its licensed therapeutic indications (Sativex®, Epidiolex®); (2) for additional specific indications (drugs, magistral or standardized preparations) and (3) as an Investigational New Drug or for supplementation. The results for CBD on the pharmacy market in Bulgaria (2019) showed that it is sold as a food supplement in various formulations (oral drops, oils, sprays, capsules, etc.) but is also used for one or more medical conditions. Top three are: pain, anxiety and cancer. Good tolerance was reported in 96% of the cases. Bulgarian pharmacists showed a good knowledge of the differences between Marijuana and industrial hemp, and are well aware of the THC content in the available hemp-derived products. In conclusion, a compelling rationale exists for further scientific research and legal regulation in order to better use the therapeutic value of the non-psychotropic cannabidiol for the treatment of many medical conditions.