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.
If the inline PDF is not rendering correctly, you can download the PDF file here.
1. Counterfeit medicines: a public health challenge. WHO. January 2010 http://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products.
2. IMPACT International Medical Products Anti-counterfeiting Taskforce. The Handbook. Facts Activities Documents Developed by the Assembly and the Working Groups 2006-2010 (2011; 164 pages) http://apps.who.int/medicinedocs/en/m/abstract/Js20967en/.
3. International Medical Products Anti-counterfeiting Taskforce Principles and Elements for National Legislation against Counterfeit Medical Products. Text endorsed by IMPACT General Meeting. Lisbon 12 December 2007 http://apps.who.int/medicinedocs/documents/s20967en/s20967en.pdf.
4. Preliminary Draft Survey on national legislation on “Counterfeit medicines” Working document WHO/ACM/1 4 may 2010. https://www.who.int/medicines/services/counterfeit/WHO_ACM_Report.pdf.
5. Hristov EI Kulaksazova RJ. Bulgarian Drug Agency experience with counterfeit medicines. Oral report. 53 meeting of Heads of Medicine Agencies Brdo Slovenia 13-14.04.2008.
6. Hristov EI Kulaksazova RJ. Counterfeit medicinal products-Introduction in theory and practice. Oral report. Pharmaceutical Fourth Symposium on Southeast Europe. EGA Istanbul Turkey 2008.
7. Hristov EI Spassova SS. Bulgaria tackles increasing numbers of counterfeit drugs. Pharmaceutical Dialogue. German Association of Pharmaceutical Parallel Distributors 2010;12(4):4.
8. Hristov EI Dimitrova ZD Parvova IA et al. Scientific Regulatory and Practical Approaches to the Fight against Counterfeit Medicinal Products. Bul Exp J US-China Med Sci 2016; (13):1-12.
9. Resolution on Counterfeiting Medicinal Products. European Parliament September 2006. http://www.europarl.europa.eu/sides/getDoc.do?type=MOTION&reference=B6-2006-0483&language=EN.
10. European Parliament. (Brussels 14 May 2007) First European Parliamentary Symposium on Pharmaceuticals Putting an End to Drug Counterfeiting. www.epp-ed.eu/Press/peve07/docs/070514programme_pharmaceuticals_en%20.pdf.
11. Summary of the Impact Assessment Commission staff working document: Accompanying document to the Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity history or source. SEC (2008) 2674 Brussels 10 Dec 2008. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52014SC0208.
12. Impact Assessment Commission staff working document: Accompanying document to the Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity history or source. SEC (2008) 2674 Brussels 10 Dec 2008. https://eur-lex.europa.eu/legal-content/BG/TXT/?uri=CELEX:52016SC0410.
13. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use as regards the prevention of the entry into the legal supply chain of falsified medicinal products. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32011L0062.
14. Commission delegated regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0161].
15. National register of BPhU https://bphu.bg/19_РЕГИСТЪР/22_София-столична.htm?search:13.
16. Medicines verification system goes live across EU to better protect patients from falsified medicines https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/medicines-verification-system-goes-live-across-eu-to-better-protect-patients-from-falsified-medicines/.
17. Official start of Bulgarian medicines verification system https://www.bgmvo.org/en/single-new/51/.