Safety of biodrugs- pharmacistsí knowledge and practice with regard to polish and european legal aspects and substitution of biotechnology drugs: Multicenter study in Poland

Abstract

The primary goal of the study was to evaluate the level of knowledge regarding biotechnology drugs among pharmacists in Poland. Another aim was to estimate the frequency of the phenomena of substitution and off-label substitution of biotechnology drugs in Poland. This was a cross-sectional, prospective, multicentre study covering the region of 4 Polish provinces. The evaluation involved 1,500 professional pharmacists working at community pharmacies. The face-to-face questionnaire method was used to interview the pharmacists. A custom-made questionnaire, based on the literature, was the key tool in the study. The results demonstrated that licensed pharmacists showed a significantly higher level of knowledge on biotechnology drugs than pharmacy technicians. The results demonstrated that merely 18% of licensed pharmacists and 22% of pharmacy technicians had encountered in their careers the phenomenon of substitution of a reference product with a biosimilar drug. The investigation revealed that only a slight percentage of pharmacists had encountered the phenomenon of off-label substitution of biologic drugs (16% of licensed pharmacists vs 20% pharmacy technicians). The investigation revealed that the level of knowledge regarding basic legal regulations governing the biotechnology drug market is unsatisfactory among pharmacists. From a broader perspective, the legislator should consider restricting automatic substitution in order to ensure the safety of using biologic drugs.