In-Hospital Production of Medicines: Preparing for Disruption

Shona Kalkman; Marlous Arentshorst; Jarno Hoekman; Wouter Boon; Esther Uijtendaal; Ghislaine van Thiel; Ellen Moors

doi:10.1016/j.tibtech.2019.09.011

In-Hospital Production of Medicines: Preparing for Disruption

Trends Biotechnol. 2020 Oct;38(10):1045-1047. doi: 10.1016/j.tibtech.2019.09.011. Epub 2019 Oct 31.

Authors

Shona Kalkman¹, Marlous Arentshorst², Jarno Hoekman², Wouter Boon², Esther Uijtendaal³, Ghislaine van Thiel⁴, Ellen Moors²

Affiliations

¹ Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: [email protected].
² Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands.
³ Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
⁴ Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

PMID: 31679825
DOI: 10.1016/j.tibtech.2019.09.011

Abstract

In-hospital production of affordable medicines holds potential to address problems of drug accessibility. However, expanding the scope of magistral preparation to include high-cost drugs and complex biologicals gives rise to new challenges. We discuss ethical and regulatory complexities faced by Dutch initiatives defying the current pharmaceutical system through magistral preparation.

Keywords: disruptive innovation; ethics; in-hospital production; magistral preparation; regulatory science.

Publication types

Review

MeSH terms

Drug Compounding*
Hospitals*
Humans
Pharmaceutical Preparations*
Pharmacies

Substances

Pharmaceutical Preparations