Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Experiences and Perspectives of Marketing Authorisation Holders Towards the Monitoring of Medication Safety during Pregnancy: A Qualitative Analysis on a Pan-European Level

Version 1 : Received: 24 February 2022 / Approved: 25 February 2022 / Online: 25 February 2022 (08:54:01 CET)

A peer-reviewed article of this Preprint also exists.

Sillis, L.; Foulon, V.; Verbakel, J.Y.; Ceulemans, M. Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis. Int. J. Environ. Res. Public Health 2022, 19, 4248. Sillis, L.; Foulon, V.; Verbakel, J.Y.; Ceulemans, M. Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis. Int. J. Environ. Res. Public Health 2022, 19, 4248.

Journal reference: Int. J. Environ. Res. Public Health 2022, 19, 4248
DOI: 10.3390/ijerph19074248

Abstract

Although marketing authorization holders (MAHs) are involved in monitoring medication safety, it was unclear how they experience their role and current monitoring activities in pregnancy. Therefore, a qualitative study using online focus groups with MAHs and the Belgian umbrella organisation of MAHs was conducted in June-July 2021. In total, 38 representatives of nine organisations participated. Overall, participants reported multiple difficulties with data collection, including underreporting, collection of incomplete information and loss to follow-up. The limited number of high-quality data collected, the unknown denominator and the lack of comparator data complicate MAHs’ data processing activities, preventing them to timely provide evidence in the pregnancy label. Three ‘conflicts’ inherent to the specific position of MAHs were identified explaining the difficulties they experience, i.e., 1) mistrust from patients and healthcare professionals (HCPs); 2) MAHs’ legal obligations and regulatory framework; 3) MAHs’ position outside the healthcare context. To overcome these barriers, MAHs suggested that data registration should occur in close collaboration with patients and HCPs, organized within the healthcare context and performed by using a user-friendly system. In conclusion, the reported difficulties and underlying conflicts of MAHs highlight the need for more effective, collaborative data collection strategies to generate new evidence on this topic.

Keywords

pregnancy; medicines; drug information; drug safety; pharmacovigilance; pharmacoepidemiology; pharmaceutical industry; stakeholders

Subject

MEDICINE & PHARMACOLOGY, Pharmacology & Toxicology

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