'The more you link, the more you risk …' - a focus group study exploring views about data linkage for pharmacovigilance.

AIMS The aim of this study was to assess opinions of frontline healthcare professionals on the linking of routinely collected national (Scottish) paediatric data for the purpose of identifying earlier signals of adverse drug reactions. METHODS Stratified purposive sampling led to profession-specific focus groups with pharmacists, nurses and medical doctors from primary and secondary care in different Scottish Health Boards. A topic guide was used to explore the proposed data linkage of routinely collected paediatric data. Discussions were audio recorded and transcribed verbatim. Transcripts were analysed using a framework approach to identify themes. Ethical approval was obtained from the North of Scotland Research Ethics Service. RESULTS Six focus groups were conducted in 2011 with 22 participants. Views of the proposed data linkage were generally positive. Several issues were identified, including lack of clarity on data ownership and concerns about diversion of funding. Identified issues were at a practical rather than a strategic level. CONCLUSIONS This study identified that professional stakeholder groups are likely to find linkage of paediatric patient data acceptable. Barriers identified could be addressed. Focus group participants commented on the importance of informing patients and members of the public about the benefits of linking healthcare data. These findings clarify the steps that should be taken to ensure the acceptability of data linkage for pharmacovigilance.