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.

Evaluation of community pharmacists’ readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis

“…We also do not know if there is likely to be a cluster effect (isolated to a specific area) or a nationwide effect of these detections. These findings are internationally relevant because of similar globally reported trends in major developed economies 3 51…”

“…To assess non-respondent bias, we examined dispensing statistics of the population, invited participants, respondents and non-respondents (table 4). Respondents tended to be from slightly busier pharmacies than non-respondents, though by a small margin, making our findings nationally and internationally representative51 and generalisable.…”

Polish patients use Google as a source of information on medication recalls on the example of drugs containing valsartan – a Google Trends analysis.

“…Results: The relative frequency of searches including the phrase "walsartan wycofany" (eng. valsartran recalled) during the periods of the drug recalls was λ1 = 1,69 [1,83] while outside those periods it equalled λ2 = 0,52 [0,48-0,56]. For the second analysed phrase -"dyrektywa fałszywkowa" (ang.…”

“…Apteki ogólnodostępne stanowią najważniejszy z punktu widzenia pacjenta element systemu dystrybucji produktami leczniczymi w Polsce [1]. Wraz z rozwojem koncepcji opieki farmaceutycznej jako zintegrowanego procesu ukierunkowanego na rozwiązanie problemów lekowych oraz jednoczesną identyfikację potrzeb lekowych pacjentów, apteki ogólnodostępne stały się również ważnym elementem aktywnej klinicznej opieki nad pacjentem [2].…”

Falsified drugs as a challenge to public health - an attempt to define the concept and scale of the phenomenon in the world as well as legal and sociological approach

“…Główny Inspektor Farmaceutyczny wskazuje, że nawet połowa leków dostępnych za pośrednictwem Internetu może być sfałszowana i co roku obserwowany jest wzrost rynku nielegalnych farmaceutyków [35]. Z uwagi na tranzytowy charakter i położenie geograficzne, Polska może stanowić istotne ogniwo w nielegalnym łańcuchu dystrybucji produktami leczniczymi [36]. W 2010 r. policjanci zabezpieczyli w ramach akcji PANGEA m.in.…”