Assessment of nanomedicines and nanosimilars: Clinical pharmacists' knowledge and regulatory gaps.

Abstract

BackgroundNon-Biological Complex Drugs (NBCDs), including nanomedicines, are characterized by complex manufacturing processes. The slightest change in this process can lead to changes in the efficacy, safety, and quality of the product. New legislation to be adopted in the EU will help ensure a proper regulatory assessment which will improve patient safety. Meanwhile, there is currently no robust integrated curriculum on the use and interchangeability of nanomedicines and their respective follow-on medicine, commonly referred to as nanosimilars. Nanomedicines have been available in the EU since 1996. As the patents of these medicines expire, it is important that healthcare professionals are suitably prepared for future interchangeability programs.ObjectivesTo analyze clinical pharmacists' understanding of nanomedicines, nanosimilars, and the requirements needed to prepare the clinical ground to ensure safe and optimum interchangeability.MethodsA fourteen-question survey was constructed for clinical pharmacists in Germany, Italy, and Portugal, comprising a variety of hospital sizes and specializations. A combination of numerical ranking, yes/no, and open-ended questions was utilized.Results20 pharmacists in Germany, 9 in Italy, and 20 in Portugal completed the survey in entirety. On a scale ranging from 0 to 10, the three countries combined indicated an understanding of nanomedicines as 3.69 and their understanding of nanosimilars as 2.92. Open-ended prompts contained statements indicating the lack of clinical familiarity, regulations/policies provided, and the additional resources they would like to receive.ConclusionThe survey confirmed the need for more guidance from health-system institutions, medical agencies, and pharmaceutical manufacturers. Respondents desired opportunities to learn from webinars, newsletters, guidelines, and/or informational sessions.