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Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis

Author

Listed:
  • Laure Sillis

    (Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium)

  • Veerle Foulon

    (Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium)

  • Jan Y. Verbakel

    (Department of Public Health and Primary Care, KU Leuven, 3000 Leuven, Belgium
    Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK)

  • Michael Ceulemans

    (Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium
    L-C&Y, KU Leuven Child & Youth Institute, KU Leuven, 3000 Leuven, Belgium)

Abstract

Although marketing authorisation 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, organised 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.

Suggested Citation

  • Laure Sillis & Veerle Foulon & Jan Y. Verbakel & Michael Ceulemans, 2022. "Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis," IJERPH, MDPI, vol. 19(7), pages 1-13, April.
  • Handle: RePEc:gam:jijerp:v:19:y:2022:i:7:p:4248-:d:785803
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    References listed on IDEAS

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    1. Alana Cavadino & Lovisa Sandberg & Inger Öhman & Tomas Bergvall & Kristina Star & Helen Dolk & Maria Loane & Marie-Claude Addor & Ingeborg Barisic & Clara Cavero-Carbonell & Ester Garne & Miriam Gatt , 2021. "Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference," Drug Safety, Springer, vol. 44(7), pages 765-785, July.
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    Cited by:

    1. Michael Ceulemans & Kristel Van Calsteren & Karel Allegaert & Veerle Foulon, 2022. "Information Needs and Counseling Preferences among Potential Users of the Future Teratology Information Service in Belgium: A Cross-Sectional Study Involving the Public and Healthcare Professionals," IJERPH, MDPI, vol. 19(14), pages 1-14, July.
    2. Karel Allegaert, 2022. "Pharmacotherapy during Pregnancy, Childbirth, and Lactation," IJERPH, MDPI, vol. 19(18), pages 1-5, September.

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