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How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries

Sofia, Natalia and Mühlebach, Stefan and Musazzi, Umberto M. and Khatib, Rani and Martinez Sesmero, José Manuel and Lipp, Hans-Peter and Surugue, Jacqueline and Di Francesco, Tiziana and Flühmann, Beat. (2021) How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries. Pharmaceutics, 13 (7). p. 1010.

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Official URL: https://edoc.unibas.ch/84635/

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Abstract

We conducted research to assess hospital pharmacists' familiarity with/interpretation of data requirements for the different regulatory approval frameworks and the impact of this on their approach to substitution in the formulary. The online questionnaire included a small molecule (acetylsalicylic acid-follow-ons approved via the generic pathway), two biologic drugs (insulin glargine and etanercept-follow-ons approved via the biosimilar pathway), a non-biologic complex drug (NBCD; glatiramer acetate-follow-ons approved via the hybrid pathway) and a nanomedicine, ferric carboxymaltose (no follow-ons approved as yet). The study was conducted in two phases: an initial qualitative pilot study with 30 participants, followed by a quantitative stage involving 201 pharmacists from five European countries. Most expected negligible safety/efficacy differences between reference and follow-on products. Head-to-head clinical data showing therapeutic equivalence as a prerequisite for reference product/follow-on substitution was perceived to be needed most for biologics (47%), followed by NBCDs (44%)/nanomedicines (39%) and small molecules (23%). Overall, 28% did not know the data requirements for follow-on approval via the hybrid pathway; 16% were familiar with this pathway, compared with 50% and 55% for the generic and biosimilar pathways, respectively. Overall, 19% of respondents thought the European Medicines Agency (EMA) was responsible for defining the substitutability of follow-ons. Education is required to increase hospital pharmacist's knowledge of regulatory approval frameworks and their relevance to substitution practices.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Klinische Pharmazie/Spitalpharmazie (Meier)
UniBasel Contributors:Mühlebach, Stefan F
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:MDPI
e-ISSN:1999-4923
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:10 Nov 2021 14:33
Deposited On:10 Nov 2021 14:33

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