Abstract
Aim
Children are often subject to off-label prescribing (1,2), i.e. prescribing of a medicine outwith its summary of product characteristics. This is often necessary as children are not routinely participants in clinical trials and the dosage tested in those trials is aimed at adults. As part of the CHIMES project we aim to gather the opinion of health professionals as well as children and their parents/guardians to the linkage of routinely collected paediatric data for Pharmacovigilance purposes in Scotland to tailor solutions to address those concerns before the database is created.
Methodology
This is a mixed qualitative study involving interviews with national key stakeholders, separate focus groups with health professionals and children and parents/guardians as well as a postal survey for the public and a Delphi survey for health professionals.
Outcomes/Results
Preliminary findings from the early interviews (n=14) with key stakeholders (health professionals) have shown that current schemes are perceived as being limited. The creation of the proposed database has raised concerns about data linkage at practical, legal and ethical levels.
For the public involvement study, a pilot interview has been conducted that corroborates concerns with data protection, consent, confidentiality and ownership (of health data) as previously identified in the literature.
Conclusion
The creation of a linked database for pharmacovigilance in children is seen as beneficial and long overdue but several concerns on a practical, legal and ethical level will have to be addressed prior to linking NHS data routinely at a national level.
References
(1) Ekins-Daukes S, Helms P, Simpson CR, Taylor MW, McLay J. Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 2004;60:349-353.
(2) 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.
Children are often subject to off-label prescribing (1,2), i.e. prescribing of a medicine outwith its summary of product characteristics. This is often necessary as children are not routinely participants in clinical trials and the dosage tested in those trials is aimed at adults. As part of the CHIMES project we aim to gather the opinion of health professionals as well as children and their parents/guardians to the linkage of routinely collected paediatric data for Pharmacovigilance purposes in Scotland to tailor solutions to address those concerns before the database is created.
Methodology
This is a mixed qualitative study involving interviews with national key stakeholders, separate focus groups with health professionals and children and parents/guardians as well as a postal survey for the public and a Delphi survey for health professionals.
Outcomes/Results
Preliminary findings from the early interviews (n=14) with key stakeholders (health professionals) have shown that current schemes are perceived as being limited. The creation of the proposed database has raised concerns about data linkage at practical, legal and ethical levels.
For the public involvement study, a pilot interview has been conducted that corroborates concerns with data protection, consent, confidentiality and ownership (of health data) as previously identified in the literature.
Conclusion
The creation of a linked database for pharmacovigilance in children is seen as beneficial and long overdue but several concerns on a practical, legal and ethical level will have to be addressed prior to linking NHS data routinely at a national level.
References
(1) Ekins-Daukes S, Helms P, Simpson CR, Taylor MW, McLay J. Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 2004;60:349-353.
(2) 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.
| Original language | English |
|---|---|
| Publication status | Published - 2010 |
| Event | NHSScotland Event - Edinburgh, United Kingdom Duration: 7 Jun 2010 → 8 Jun 2010 |
Conference
| Conference | NHSScotland Event |
|---|---|
| Country/Territory | United Kingdom |
| City | Edinburgh |
| Period | 7/06/10 → 8/06/10 |