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

Rationale: 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. Methods: 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 was entered into descriptive statistics tool provided by the survey hosting server. Simultaneously a printed survey dedicated to patients was created to asses patterns of behaviour related to ATS. Results: According to Polish community pharmacy employees the main reason for ATS was price competitiveness, unavailability of the reference drug and patient’s 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. Conclusions: There is strong need of establishing explicit legislation regulating ATS between reference biopharmaceuticals and biosimilars. Introduction of the framework should be simultaneously accompanied by shared trainings for medical professionals participating in the pharmacotherapy.