Serialization and Verification of Medicinal Products – A Pilot Study Among Pharmacists in Bulgaria

Abstract

Background. In an attempt to stop the distribution of falsified medicinal products, the EU has adopted Directive 2011/62/EU. Since 9th February 2019, each package of medicinal product must be given a unique number in combination with a mandatory indicator of integrity. The Directive requires the creation of a system of serialization and verification of the medicinal products. Aim of the study: To determine the level of awareness about the serialization and verification system among masters of pharmacy and the preparedness of Bulgarian pharmacies to meet the new challenges. Materials and methods: A pilot survey was conducted in 25 pharmacies in Sofia. 41 specialists in pharmacy holding a master degree were interviewed using the “direct individual survey” method. Results and discussion: The knowledge about the availability of new regulatory requirements is in serious dissonance with the established high level of non-awareness of the forthcoming initiatives. Over 2/3 (78%) of the respondents do not know what the practical challenges to their pharmacy practices will be.