Cargando…
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...
Autores principales: | , , , , , , , , |
---|---|
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 |
_version_ | 1783728448278102016 |
---|---|
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. |
format | Online Article Text |
id | pubmed-8309126 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT sofianatalia howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT muhlebachstefan howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT musazziumbertom howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT khatibrani howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT martinezsesmerojosemanuel howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT lipphanspeter howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT suruguejacqueline howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT difrancescotiziana howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries AT fluhmannbeat howdohospitalpharmacistsapproachsubstitutionofnanomedicinesinsightsfromaqualitativepilotstudyandaquantitativemarketresearchanalysisinfiveeuropeancountries |