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.

Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review

“…The majority (56%, 15/27) of the included studies were conducted in Europe [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43], followed by North America (n = 4) [44][45][46][47], Australia (n = 2) [48,49], Pakistan (n = 1) [50], Russia (n = 1) [51], Tunisia (n = 1) [52], Latin America (n = 1) [53], mixed in France and Canada (n = 1) [54], and mixed in Asian countries (n = 1) [55]. The study…”

“…participants were physicians (n = 12) [30,36,37,39,44,45,47,48,[51][52][53]55], pharmacists (n = 5) [31,38,43,50,54], patients (n = 4) [32,34,40,49], payers (n = 1) [46], or various stakeholders (n = 5) [29,33,35,41,42]. All semi-structured interviews had participants of various stakeholders and were from Europe [29,33,35,42].…”

“…In 44% of the studies (12/27), the data collection had begun in 2015 or earlier [29, 30, 36-41, 45-47, 53]. Almost one third of the studies (8/27) were conducted in countries that allowed limited pharmacist-led automatic substitution of biologics [32,38,39,48,49] or substitution was not specifically prohibited at the time of data collection [31,33,43]. Most of the studies (81%, 22/27) had a primary focus other than automatic substitution of biologics.…”

“…Most of the studies (81%, 22/27) had a primary focus other than automatic substitution of biologics. Substitution or replacement of biologics was mentioned as an objective only in five studies [30,33,34,43,48], of which one was a qualitative study focusing on automatic substitution of biologics [33].…”

“…The pharmaceutical industry was reported as one of the affiliations in three studies [41,44,51]. Studies that reported any funding were partly or fully funded by either a public sector, i.e., government authority, university grant or bursary (3/27) [33,43,47], research fund [35], pharmaceutical industry (5/27) [40,[44][45][46]51], or a lobbying organization (3/27) [30,48,53]. One study [41] had received both public and pharmaceutical industry funding.…”