Abstract
Background
Paediatric pharmacovigilance is a recognised priority. There is widespread off-label use of medicines in children which 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.
Aim
The aim was to assess national stakeholders’ opinions of, and attitudes to, limitations of current pharmacovigilance systems, the linking of data at national level and advantages of, or 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=23) including experts on ethics, public health, data protection, pharmacovigilance, data linkage, legal issues, paediatrics and prescribing. A priori and emergent themes were identified via a framework approach.
Results
Six main themes were identified- views and understanding of pharmacovigilance, opinions on available data within the NHS, 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 with a number of sub themes. The proposal to link data for pharmacovigilance was generally regarded positively- “clearly doing things to stop medicines being used inappropriately in children would be a good thing” (A24), with the caveats of strict governance mechanisms, fulfilment of all legal requirements and assured data security- “But I am also in favour of making sure that we’re fully accountable for what we do with the data afterwards.” (A05).
Conclusions
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 guardian and a REC cohort will add further to the results. The generalisability of these results will be further explored in focus groups across Scotland and a Delphi survey.
Paediatric pharmacovigilance is a recognised priority. There is widespread off-label use of medicines in children which 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.
Aim
The aim was to assess national stakeholders’ opinions of, and attitudes to, limitations of current pharmacovigilance systems, the linking of data at national level and advantages of, or 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=23) including experts on ethics, public health, data protection, pharmacovigilance, data linkage, legal issues, paediatrics and prescribing. A priori and emergent themes were identified via a framework approach.
Results
Six main themes were identified- views and understanding of pharmacovigilance, opinions on available data within the NHS, 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 with a number of sub themes. The proposal to link data for pharmacovigilance was generally regarded positively- “clearly doing things to stop medicines being used inappropriately in children would be a good thing” (A24), with the caveats of strict governance mechanisms, fulfilment of all legal requirements and assured data security- “But I am also in favour of making sure that we’re fully accountable for what we do with the data afterwards.” (A05).
Conclusions
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 guardian and a REC cohort will add further to the results. The generalisability of these results will be further explored in focus groups across Scotland and a Delphi survey.
| Original language | English |
|---|---|
| Publication status | Published - Apr 2011 |
| Event | Scottish School of Primary Care Conference - edinburgh, United Kingdom Duration: 19 Apr 2011 → 20 Apr 2011 |
Conference
| Conference | Scottish School of Primary Care Conference |
|---|---|
| Country/Territory | United Kingdom |
| City | edinburgh |
| Period | 19/04/11 → 20/04/11 |
