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Spontaneous Reporting of Suspected Adverse Drug Reactions in the Swedish Pediatric Population:: A Qualitative Interview Study of Healthcare Professionals’ Experiences
Mid Sweden University, Faculty of Human Sciences, Department of Health Sciences (HOV).
2026 (English)Independent thesis Advanced level (degree of Master (Two Years)), 10 credits / 15 HE creditsStudent thesis
Abstract [en]

Background: Spontaneous reporting of adverse drug reactions (ADRs) in the pediatric population is considered an important tool for improving drug safety in children. ADRs in children are regarded as a significant public health problem. Understanding how healthcare personnel engage with this reporting process is therefore essential. Aim: This study aimed to explore healthcare personnel’s experiences of spontaneous reporting of suspected ADRs in children treated within organisations that care for pediatric patients in Sweden. Methods: This study was conducted qualitatively using an inductive approach based on semi‑structured interviews. The interviews were conducted digitally in the spring of 2025, and the participants were healthcare personnel working with children in Sweden. The interviews were recorded, transcribed, and subsequently analysed using qualitative content analysis. Results: The analysis resulted in three categories. The first category, reporting constraints, covered topics such as experiences of non‑reporting and perceived limitations. The second category, engagement, included awareness and encouraging factors, organisational dynamics, perceptions of reporting versus actual reporting, and other influencing factors. The third category, knowledge, highlighted limited understanding and learning conditions. Together, these findings emphasise the complexity of the phenomenon and the need for coordinated actions among various stakeholders. Conclusions: Coordinated efforts are needed to align organisational practices regarding spontaneous ADR reporting with national policy goals, supported by clear guidelines, accountability structures, and adequate resource allocation.

Place, publisher, year, edition, pages
2026. , p. 55
Keywords [en]
adverse drug reaction; children; pharmacovigilance; public health; spontaneous reporting
National Category
Public Health, Global Health and Social Medicine
Identifiers
URN: urn:nbn:se:miun:diva-57629OAI: oai:DiVA.org:miun-57629DiVA, id: diva2:2072171
Subject / course
Public health Science FH1
Educational program
Master Programme in Health Science VHÄAA 120 higher education credits
Supervisors
Examiners
Note

Betyg i Ladok 260603.

Available from: 2026-06-16 Created: 2026-06-15 Last updated: 2026-06-16Bibliographically approved

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CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf