The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists
| Autor: | Katarzyna Krupa, Bernard D Naughton, David Brindley, Damian Swieczkowski, Miłosz Jaguszewski, Piotr Merks, Mariola Drozd, Michal Byliniak |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Legislation
Accounting Pharmacy Review Pharmacy Service 03 medical and health sciences 0302 clinical medicine Pharmaceutical care Medicine 030212 general & internal medicine General Pharmacology Toxicology and Pharmaceutics Hospital pharmacy Pharmacy Legislation Pharmaceutical industry business.industry 030503 health policy & services Directive Authentication (law) Product (business) Counterfeit Drugs PUBLIC HEALTH 0305 other medical science business |
| Zdroj: | European Journal of Hospital Pharmacy. Science and Practice |
| ISSN: | 2047-9964 2047-9956 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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