Abstract
Introduction
Paediatric pharmacovigilance is a recognised priority as off-label use of medicines is associated with a greater likelihood of adverse drug reactions (ADRs)1. The UK Yellow Card Scheme (YCS) is central to pharmacovigilance, but other methods have been suggested as useful adjuncts2. The inclusion of the community health index (CHI) in the recording of all NHS contacts in Scotland provides opportunities to link data and thereby identify ADRs by linking prescribing and health utilization data. The aim was to assess national professional stakeholders’ opinions of, and attitudes to, limitations of current pharmacovigilance systems, the linking of data at Scottish level and advantages of, and barriers to, this approach.
Method
Qualitative data was gathered through semi-structured interviews (audio-recorded and fully transcribed) which were conducted with a purposive sample (n=40) including experts on ethics, public health, data protection, pharmacovigilance, data linkage, legal issues, paediatrics and prescribing. Themes were identified via a framework approach.
Results
Six main themes were identified: views and understanding of pharmacovigilance, opinions on available NHS data, attitude to and discussion of proposed linkage, beliefs on the usage of linked data, as well as opinions on the dissemination of findings and the disclosure of personal data; each had a number of sub-themes. The proposal to link data for pharmacovigilance was generally regarded positively, with the caveats of strict governance mechanisms, fulfilment of all legal requirements and assured data security.
Conclusion
In general the proposal to use routinely collected data to create a pharmacovigilance resource for children in Scotland was received positively. Some practical, ethical and legal issues were identified but none seem to be insurmountable. Data from a Caldicott guardians’ and Research Ethic Chairs’ cohorts will add further to the results. The results are being further explored in focus groups with practitioners and will inform a national Delphi survey.
References
1 Ekins-Daukes S, Helms PJ, Simpson CR et al (2004). Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 2004; 60: 349-353
2 UKCRC, 2007. UKCRC R&D Advisory Group to Connecting for Health: The report of the research simulations. Available at: www.ukcrc.org/publications/report [accessed 04/03/2010]
Paediatric pharmacovigilance is a recognised priority as off-label use of medicines is associated with a greater likelihood of adverse drug reactions (ADRs)1. The UK Yellow Card Scheme (YCS) is central to pharmacovigilance, but other methods have been suggested as useful adjuncts2. The inclusion of the community health index (CHI) in the recording of all NHS contacts in Scotland provides opportunities to link data and thereby identify ADRs by linking prescribing and health utilization data. The aim was to assess national professional stakeholders’ opinions of, and attitudes to, limitations of current pharmacovigilance systems, the linking of data at Scottish level and advantages of, and barriers to, this approach.
Method
Qualitative data was gathered through semi-structured interviews (audio-recorded and fully transcribed) which were conducted with a purposive sample (n=40) including experts on ethics, public health, data protection, pharmacovigilance, data linkage, legal issues, paediatrics and prescribing. Themes were identified via a framework approach.
Results
Six main themes were identified: views and understanding of pharmacovigilance, opinions on available NHS data, attitude to and discussion of proposed linkage, beliefs on the usage of linked data, as well as opinions on the dissemination of findings and the disclosure of personal data; each had a number of sub-themes. The proposal to link data for pharmacovigilance was generally regarded positively, with the caveats of strict governance mechanisms, fulfilment of all legal requirements and assured data security.
Conclusion
In general the proposal to use routinely collected data to create a pharmacovigilance resource for children in Scotland was received positively. Some practical, ethical and legal issues were identified but none seem to be insurmountable. Data from a Caldicott guardians’ and Research Ethic Chairs’ cohorts will add further to the results. The results are being further explored in focus groups with practitioners and will inform a national Delphi survey.
References
1 Ekins-Daukes S, Helms PJ, Simpson CR et al (2004). Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 2004; 60: 349-353
2 UKCRC, 2007. UKCRC R&D Advisory Group to Connecting for Health: The report of the research simulations. Available at: www.ukcrc.org/publications/report [accessed 04/03/2010]
| Original language | English |
|---|---|
| Publication status | Published - 31 Mar 2011 |
| Event | Reducing harm, improving healthcare - Aberdeen, United Kingdom Duration: 31 Mar 2011 → 31 Mar 2011 |
Conference
| Conference | Reducing harm, improving healthcare |
|---|---|
| Country/Territory | United Kingdom |
| City | Aberdeen |
| Period | 31/03/11 → 31/03/11 |
