Knowledge and attitude of community pharmacy employees towards an automatic drug substitution of generics and biosimilars

Abstract

In recent years many patent protections of original biopharmaceuticals have expired and biosimilar medicines are being developed and are entering the pharmaceutical market. Polish legal framework does not narrow down automatic therapeutic substitution (ATS) of biopharmaceuticals at the pharmacy level. The aim was to assess the awareness of Polish community pharmacy employees and their attitude towards ATS of generics and biosimilar medicines. A self-designed online questionnaire consisting of 27 questions addressing ATS of generics and biopharmaceuticals was created. The survey respondents were approached personally at local pharmacies, via pharmacy managers, chain pharmacy owners and Chambers of Apothecaries. Data collected were entered into descriptive statistics tool provided by the survey hosting server. Simultaneously a printed survey dedicated to patients was created to asses patterns of behavior related to ATS. According to Polish community pharmacy employees the main reason for ATS was price competitiveness, unavailability of the reference drug and patientís wish. 7.3% of respondents have ever taken part in any drug safety monitoring program. 9.1% of pharmacy technicians and 46.8% masters of pharmacy claimed to have considerable knowledge about biosimilar drugs and evaluated biosimilars as carrying a higher risk of adverse events than generics. 17.2% would offer a substitution of a biopharmaceutical. 33.3% of patients did not tell their prescribing doctor about the ATS. The results of the study should be interpreted with caution since they might have been influenced by the selection of survey respondents. Nevertheless, the results suggest that there is a lack of knowledge and information, lack of national guidance on the conduct of ATS, and deficient communication between prescribers, pharmacies, and patients. Thus, there is a need for communication between the stakeholders to deliver information, guidance, and training for the ATS of all medicinal products, including biopharmaceuticals. Explicit legislation regulating ATS between reference biopharmaceuticals and biosimilars may be considered depending on the national policy.