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

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.

Tackling Counterfeit Drugs: The Challenges and Possibilities

“…The FMD directive recommends the placement of safety features, including a unique identifier and an anti-tampering device, on the packaging of specific medicinal products for human use. Additionally, the FMD offers a tool to help with security while purchasing medications online [ 36 , 37 ].…”