"The more you link, the more you risk....": Health professionals on data linkage

Focal points
• The aim of this study was to assess the views and opinions of healthcare professionals in the NHS to the linking of routinely acquired NHS data as a means of identifying adverse drug reactions in children.
• Preliminary findings show that the main concerns are data ownership, data security and securing funding.
• Anonymisation of the data, public information about how the data will be used and national linkage to increase the sample size were seen as enablers of data linkage.
• There was general support of the proposed data linkage by healthcare professionals if the identified issues are addressed.

Introduction
Many widely used paediatric medicines do not have a UK license for use in children and are adult medicines used ‘off label’ (ie outwith the summary of product characteristics/ licensed indications) 1. This practice is linked to an increased risk of suffering an adverse drug reaction (ADR) 2. However adverse drug reactions are known to be underreported by current systems. A programme of work is ongoing to explore whether linkage of routinely collected Scottish health related datasets using the unique Community Health Index (CHI) could be the basis for an alternative or complementary system of pharmacovigilance. The views of policy makers to the proposed linkage have already been studied. The aim of this study was to assess the opinions of health care professionals to the use of linked NHS data for paediatric pharmacovigilance.
Methods
Pharmacists, nurses, general practitioners and paediatricians were invited to take part in focus groups by postal invitation and email. Subjects were included from purposively selected Health Boards (including a range of urban, rural, and remote settings and geographic locations across Scotland) and the sampling approach was a combination of purposive and convenience. Each participant received a study information sheet and signed consent was obtained. The focus group explored views of the proposed linkage and identified any perceived barriers. All focus groups were transcribed verbatim; transcriptions, summaries and field notes informed analysis. A priori and emergent themes were identified via a framework approach3. Ethical approval was obtained.
Results
Five focus groups have been conducted to date (participants n=20). One was multidisciplinary and four unidiscipliniary (pharmacists (2), nurses (1), general practitioners (1)). Attitudes to the proposed data linkage were generally positive: “As a professional I can see the huge advantages of linking the data […], I think it would be fantastic if it works” (paediatric pharmacist). Several barriers to data linkage were identified, data ownership featured recurrently: “I think they [medical records] are the individual’s records” (nurse). There was concern about funding the project from limited NHS resources: “The health service is not exactly over-financed at this moment […], so why use the extra money, do we need to use it,[or] do we put it towards patient care and that, rather then developing systems that are not required” (nurse). Individual consent was deemed not to be feasible but information for the public was seen as crucial to facilitate the data linkage: “We wouldn’t require informed consent for every patient, but what we would require is the patient’s ability to say ‘I don’t want my data to be used in research’ ‘’ (GP).
Discussion
Health care professionals generally supported the proposed linkage and their range of views is similar to those of national opinion leaders4. However they were more worried about finances and funding of the project, indicating a fear of losing financial support for their own area of practice. The findings will inform a pan Scotland Delphi survey of Scottish health care professionals.

References:
1) McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice. Arch. Dis. Child. 2000 December 1;83(6):498-501
2) Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001;52:77-83.
3) Ritchie, Spencer and O’Connor, 2003. Carrying out qualitative analysis. In: J. Ritchie & J. Lewis, ed. Qualitative Research Practice: A guide for social science students and Researchers. Sage publications, 2003.
4) Hopf YM, Bond C, Haughney J, Helms P. Linkage of routinely collected NHS data to create a paediatric pharmacovigilance database: opinions of national stakeholders. IJPP 2010; 18 (supplement 2); 77-78