Behandeling met een niet-geregistreerd geneesmiddel

Translated title of the contribution: Expanded Access in The Netherlands: prescribing unregistered medicine

Tobias B. Polak*, David G. J. Cucchi, Joost van Rosmalen

*Corresponding author for this work

Research output: Contribution to journalArticleProfessional

Abstract

Expanded access is a pathway to access unregistered medicines if there are no registered treatments available and patients cannot enroll in clinical trials. Expanded access may serve as a last resort for patients who are in dire need of treatment options and cannot await the completion of drug development and for patients who may benefit from treatments that are not (or not anymore) registered in their jurisdiction. Unregistered medicine can be acquired via named-patient pathways ('Leveren op Artsenverklaring') or via group programs ('Compassionate Use Programma's). We describe the origins of expanded access and its daily practice in the Netherlands. We observe an increasing trend in expanded access requests. The potential risks these treatments provide, the possibility of ceasing further treatment and the preferences of individual patients should all inform the decision whether or not to pursue expanded access.
Translated title of the contributionExpanded Access in The Netherlands: prescribing unregistered medicine
Original languageDutch
Article numberD5168
JournalNederlands Tijdschrift voor Geneeskunde
Volume165
Issue number9
Publication statusPublished - 25 Feb 2021

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