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The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

Abstract:
By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.
Publication status:
Published
Peer review status:
Peer reviewed

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Files:
Publisher copy:
10.1136/ejhpharm-2016-000970

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Publisher:
BMJ Publishing Group
Journal:
European Journal of Hospital Pharmacy More from this journal
Volume:
25
Issue:
1
Pages:
10-15
Publication date:
2016-07-27
Acceptance date:
2016-07-05
DOI:
EISSN:
2047-9964
ISSN:
2047-9956


Keywords:
Pubs id:
pubs:641549
UUID:
uuid:6135a8d2-92a3-4307-a86b-79b7406e0cbd
Local pid:
pubs:641549
Source identifiers:
641549
Deposit date:
2016-09-05

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