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

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

Open Access
|Oct 2019

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.

DOI: https://doi.org/10.2478/amb-2019-0024 | Journal eISSN: 2719-5384 | Journal ISSN: 0324-1750
Language: English
Page range: 18 - 22
Submitted on: Jul 1, 2019
Accepted on: Jul 1, 2019
Published on: Oct 15, 2019
Published by: Sofia Medical University
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2019 N. Nedelkov, E. Yordanov, E. Hristov, V. Petkova, S. Ognianov, K. Andreevska, Tz. Delyiski, I. Parvova, published by Sofia Medical University
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.