Background: Paediatric pharmacovigilance is a recognised priority due to the vulnerability of children to adverse drug reactions (ADRs). The UK Yellow Card Scheme is central to pharmacovigilance, but other complementary methods have been suggested. The introduction of the community health index (CHI) in all NHS contacts in Scotland provides opportunities to link prescribing and health utilization data and thereby identify new ADR signals. The views of healthcare professionals (HCPs) on the linkage of NHS data for pharmacovigilance purposes in children have not been explored: the aim of this research was to explore the acceptability of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children. Methods: A mixed methods study was conducted involving interviews, focus-groups and a threeround Delphi survey with HCPs in Scotland. The survey was structured using the Theoretical Domains Framework of behaviour change. Results were triangulated. Ethical approval was granted by the North of Scotland Research Ethics Service. Results Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Focus-group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage and latent liability issues from dissemination of findings. The Delphi survey initially covered the issues identified in the preceding work. Retained items after three rounds focused on professional standards, requirements for linkage and the use and format of feedback. The proposed data linkage was perceived as positive and necessary, with participants in all three studies highlighting the benefits for research and for patients. Conclusion: The development of a paediatric linked database has support from professional stakeholders and HCPs in Scotland. The proposed data linkage was perceived to meet a service need. No insurmountable issues were identified, but key issues should be addressed prior to implementation.
|Hopf, Yvonne Marina
|University of Aberdeen
|Electronic Thesis or Dissertation
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