PATI ENT SAFE T Y
Falsified medicines and the hospital setting
The EU Falsified Medicines Directive (EU FMD) introduced new requirements for hospitals to verify the authenticity of prescription medicines. A year on and hospitals are working to reduce the cost impacts and starting to leverage significant additional benefits. A new report published by Be4ward, the supply chain transformation consultancy, looks beyond the prevention of falsified medicines to understand what other benefits can be gained in the hospital setting.
Why the EU FMD was introduced Fake medicines are often perceived to be an issue primarily affecting developing countries. While this is true, it is easy to overlook the very real threat that Europe is facing from falsified products. We only need to consider what has occurred over the past six months during the COVID outbreak and we see an influx of fake PPE and medicines onto the market. Between 2013-2017 there were 400 incidents of falsification reported in the EU and, following an Interpol operation in 2017, nearly €7 million medicines were seized at the EU border. This is not just an issue related to internet sales of medicines or supply to retail/ community pharmacies, falsified products have found their way onto the shelves of European hospitals. Between 2001-2014 more than 10,000 units of medicines stolen from Italian hospitals by criminal gangs found their way back into the legitimate supply chain. These packs had been removed from the controlled supply chain and therefore their condition could not be guaranteed, they were therefore considered falsified. The products involved included treatments for epilepsy, prostate cancer and schizophrenia. Falsified medicines could be fatal or cause irrevocable harm to a patient; they also contribute to antimicrobial resistance.
Dealing with the impacts caused by fake medicines puts a cost burden on health systems in addition to the economic and societal impacts. Faced with this very real and increasing threat, the European Commission acted and introduced The EU Falsified Medicines
Between 2013-2017 there were 400 incidents of falsification reported in the EU and following an Interpol operation in 2017, nearly €7 million medicines were seized at the EU border.
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Directive (EU FMD) (2011/62/EU). The scope impacts almost all prescription medicines with a Marketing Authorisation and came into force in February 2019.
How the EU FMD impacts hospitals The EU FMD introduced new harmonised measures to help ensure medicines within the European Union are safe and trade in these medicines is properly controlled. The concept is relatively simple – every individual pack now includes two safety features; the first is a 2D barcode (DataMatrix) that holds a unique identifier (UI). This barcode must be scanned by the hospital and the UI checked in a national repository to verify it is
OCTOBER 2020
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