Falsified Medicines Directive in a Secondary Care Environment-Impact on Supply Chain

Piotr Merks; Urszula Religioni; Nuno Pinto de Castro; Anna Augustynowicz; Katarzyna Plagens-Rotman; David Brindley; Anna Kowalczuk; Justyna Kaźmierczak; Agnieszka Neumann-Podczaska; Eliza Blicharska; Katarina Fehir Sola; Martin J Hug; Klaudiusz Gajewski; Paweł Piątkiewicz

doi:10.3390/ijerph19063276

Falsified Medicines Directive in a Secondary Care Environment-Impact on Supply Chain

Int J Environ Res Public Health. 2022 Mar 10;19(6):3276. doi: 10.3390/ijerph19063276.

Authors

Affiliations

¹ Faculty of Medicine, Collegium Medicum, Cardinal Stefan Wyszyński University, 01-938 Warsaw, Poland.
² School of Public Health, Centre of Postgraduate Medical Education of Warsaw, 01-826 Warsaw, Poland.
³ Open University Business School, Walton Hall, Kents Hill, Milton Keynes MK7 6AA, UK.
⁴ Department of Economics of Health and Medical Law, Medical University of Warsaw, 02-091 Warsaw, Poland.
⁵ Institute of Health Sciences, Hipolit Cegielski State University of Applied Sciences, 62-200 Gniezno, Poland.
⁶ UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Oxford OX2-0JB, UK.
⁷ National Institute of Medicines, 00-725 Warsaw, Poland.
⁸ Zdrowit sp. z o.o., Pharmacy Chain, 41-940 Piekary Śląskie, Poland.
⁹ Chair and Department of Palliative Medicine, Poznan University of Medical Sciences, 61-245 Poznan, Poland.
¹⁰ Department of Analytical Chemistry, Medical University of Lublin, Chodźki 4a, 20-093 Lublin, Poland.
¹¹ Pharmacy of Bjelovar, Petra Preradovića4, 43000 Bjelovar, Croatia.
¹² Medical Center-University of Freiburg, 79085 Freiburg, Germany.
¹³ Imed Poland Sp. z o.o., 02-819 Warsaw, Poland.
¹⁴ Department of Ophthalmology, Medical University of Warsaw, 02-091 Warsaw, Poland.

Abstract

The Falsified Medicines Directive (FMD) and the Delegated Regulation (DR) impact the pharmaceutical supply chain. Ahead of the deadline for implementation, in February 2019, every entity of the supply chain had to adapt its operations to the regulatory requirements to be compliant with the directive. This paper analyzes the supply chain of a hospital pharmacy and the impact of the FMD implementation. Furthermore, a cost analysis was performed demonstrating that the FMD increases expenditure in the secondary care environment dispensing operations. Governments should be aware that this regulation will certainly impact public healthcare institutions in the long term.

Keywords: delegated regulation; falsified medicines directive; hospital; supply chain.

Publication types

Review

MeSH terms

Counterfeit Drugs*
Secondary Care

Substances

Counterfeit Drugs