<abstract xmlns="http://www.w3.org/1999/xhtml"><bold>Background.</bold> 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.<bold>Aim</bold> 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.<bold>Materials and methods:</bold> 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.<bold>Results and discussion:</bold> 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.</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.

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

Sofia University “Sv. Kliment Ohridski” – Sofia

Clinic of Rheumatology, Department of Internal Medicine

Acta Medica Bulgarica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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...

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

Published Online: Oct 15, 2019

Page range: 18 - 22

Received: Jul 01, 2019

Accepted: Jul 01, 2019

DOI: https://doi.org/10.2478/amb-2019-0024

Keywords
falsified medicinal products, safety features, verification, serialization

© 2019 N. Nedelkov et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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

Published Online: Oct 15, 2019

Page range: 18 - 22

Received: Jul 01, 2019

Accepted: Jul 01, 2019

DOI: https://doi.org/10.2478/amb-2019-0024

Keywordsfalsified medicinal products, safety features, verification, serialization

© 2019 N. Nedelkov et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
falsified medicinal products, safety features, verification, serialization