Biosimilars in community pharmacy practice

Abstract

Biopharmaceutical manufacturers have been prompted by high costs and patent expiration of biologicals to explore development of biosimilars. The lower costs of biosimilars makes them a promising avenue for increased cost-effective healthcare systems and patient accessibility. The aims were to identify the perceptions, knowledge, and concerns that patients have with regards to biosimilars, and to identify whether a pharmacist intervention can help improve patient perceptions and understanding of biosimilars. The objectives were: i) To assess patients’ perceptions, knowledge, and concerns of biosimilars and clarify information needs using validated educational infographics and a questionnaire, and ii) To assess how pharmacist interventions affect patient perceptions, knowledge, and confidence with biosimilar use. A questionnaire and educational material in the form of infographics were developed in Maltese and English and validated through a panel (2 doctors, 2 pharmacists, 2 patients). The three infographics i) explained what generic medications are, ii) provided an overview on biological medications and biosimilars and similarities between them, and iii) detailed the regulatory criteria that biosimilars must satisfy to be placed onto the market. Research was conducted in ten community pharmacies around Malta which were geographically selected to include the north, centre, and south regions. The pharmacies were selected out of 27 pharmacies managed by a pharmacy group, where the researcher practices at one of these pharmacies. Seventy patients, six to eight patients from each pharmacy, took part in the study. Patients were provided with the validated questionnaire to identify perceptions and concerns on biosimilars, and were all subjected to an educational pharmacist intervention with the aid of infographics. Fifty-three out of 70 patients lacked biosimilar awareness. Pre-pharmacist intervention, 9 patients believed biosimilars were as effective as the originator biological. Post-intervention this increased to 53 patients. The pharmacist intervention significantly improved perceptions (p= 0.025). Twenty-two patients were apprehensive that they were receiving a biosimilar pre-intervention, whereas post-intervention, 7 patients remained apprehensive. When apprehension pre-pharmacist educational intervention was correlated with patients’ confidence with biosimilar use post-intervention, statistical significance was observed (p=0.008). While 38 patients had no concerns post-intervention, of those with concerns (n=32), the primary issue was the potential occurrence of side-effects (n=19), and 42 patients sought the need for further education regarding this. The consultant was referred to the most when patients required information about biosimilars (n=65), followed by the family doctor (n=40) and the pharmacist (n=33). Fifty-nine patients found the infographic information to be a novel educational medium. Out of the 70 interviewed patients, the number of patients that strongly agreed or agreed that i) there is not enough biosimilar education was 63, ii) the pharmacist intervention helped improve their understanding of biosimilars was 66, and iii) a pharmacist intervention prior to initiating a biosimilar would have been beneficial was 49. Development of validated and easily understood educational material in the form of infographics proved beneficial in closing knowledge gaps and improving patient confidence and acceptance of biosimilars. Educational initiatives targeting patients are a way forward to facilitate biosimilar uptake and enable the pharmacist contribution to evolve the concept whereby the patient moves from a compliant mode to adherence and further more to concordance.