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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

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 a...

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Autores principales: Sofia, Natalia, Mühlebach, Stefan, Musazzi, Umberto M., Khatib, Rani, Martinez Sesmero, José Manuel, Lipp, Hans-Peter, Surugue, Jacqueline, Di Francesco, Tiziana, Flühmann, Beat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8309126/
https://www.ncbi.nlm.nih.gov/pubmed/34371701
http://dx.doi.org/10.3390/pharmaceutics13071010
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author Sofia, Natalia
Mühlebach, Stefan
Musazzi, Umberto M.
Khatib, Rani
Martinez Sesmero, José Manuel
Lipp, Hans-Peter
Surugue, Jacqueline
Di Francesco, Tiziana
Flühmann, Beat
author_facet Sofia, Natalia
Mühlebach, Stefan
Musazzi, Umberto M.
Khatib, Rani
Martinez Sesmero, José Manuel
Lipp, Hans-Peter
Surugue, Jacqueline
Di Francesco, Tiziana
Flühmann, Beat
author_sort Sofia, Natalia
collection PubMed
description 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.
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spelling pubmed-83091262021-07-25 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 Mühlebach, Stefan Musazzi, Umberto M. Khatib, Rani Martinez Sesmero, José Manuel Lipp, Hans-Peter Surugue, Jacqueline Di Francesco, Tiziana Flühmann, Beat Pharmaceutics Article 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. MDPI 2021-07-02 /pmc/articles/PMC8309126/ /pubmed/34371701 http://dx.doi.org/10.3390/pharmaceutics13071010 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sofia, Natalia
Mühlebach, Stefan
Musazzi, Umberto M.
Khatib, Rani
Martinez Sesmero, José Manuel
Lipp, Hans-Peter
Surugue, Jacqueline
Di Francesco, Tiziana
Flühmann, Beat
How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries
title How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries
title_full How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries
title_fullStr How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries
title_full_unstemmed How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries
title_short How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries
title_sort how do hospital pharmacists approach substitution of nanomedicines? insights from a qualitative pilot study and a quantitative market research analysis in five european countries
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8309126/
https://www.ncbi.nlm.nih.gov/pubmed/34371701
http://dx.doi.org/10.3390/pharmaceutics13071010
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