Stakeholders’ perspectives on a patient-reported outcome measure-based drug safety monitoring system for immune-mediated inflammatory diseases

Published on Aug 12, 2020in Expert Opinion on Drug Safety3.383
· DOI :10.1080/14740338.2020.1803826
L. Kosse2
Estimated H-index: 2
,
Naomi T. Jessurun5
Estimated H-index: 5
+ 7 AuthorsMarieke de Vries19
Estimated H-index: 19
(Radboud University Nijmegen)
Sources
Abstract
BACKGROUND Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics are widely used, knowledge on the post-marketing experience of patients is limited. Therefore, a framework was established for a patient-reported outcome measure (PROM)-based drug safety monitoring system for ADRs attributed to biologics, known as the 'Dutch Biologic Monitor'. OBJECTIVE Generation of a multi-stakeholder perspective on the preferred setup, potential and added value of a PROM-based national drug safety monitoring system. METHODS Nineteen stakeholders were interviewed following a structured interview guide. Transcribed data were coded and analyzed to count frequencies and to generate recurring themes. RESULTS Stakeholders (84.2%) support the establishment of a national drug safety monitoring system, but the feasibility depends on the implementation process. The need for integration and assessment of PROMs on ADRs in clinical practice and the preference to monitor small molecules and new drugs was emphasized. Preferably, all pharmacological options per indication should be monitored. CONCLUSIONS Stakeholders recommend to establish a PROM-based national drug safety monitoring system focused on ADRs attributed to biologics, small molecules and new drugs. Moreover, PROMs on ADRs ideally need to become integrated in clinical practice to provide healthcare providers more insight in patients' perspectives.
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