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Review
. 2022 Mar 10;19(6):3276.
doi: 10.3390/ijerph19063276.

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

Piotr Merks  1 , Urszula Religioni  2 , Nuno Pinto de Castro  3 , Anna Augustynowicz  2   4 , Katarzyna Plagens-Rotman  5 , David Brindley  6 , Anna Kowalczuk  7 , Justyna Kaźmierczak  8 , Agnieszka Neumann-Podczaska  9 , Eliza Blicharska  10 , Katarina Fehir Sola  11 , Martin J Hug  12 , Klaudiusz Gajewski  13 , Paweł Piątkiewicz  14
Affiliations
Review

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

Piotr Merks et al. Int J Environ Res Public Health. .

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.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Porter’s value chain analysis of the present supply chain of the case hospital.
Figure 2
Figure 2
Porter’s value supply chain analysis of the case hospital in a FMD environment.
See this image and copyright information in PMC

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