Abstract
Focal Points:
• The study aim is to assess national stakeholders’ opinions of and attitudes to the linking of routinely acquired NHS data as a means of identifying adverse drug reactions (ADRs) in children.
• Preliminary findings show practical and legal issues with data linkage as well as a need for public involvement.
• The creation of said database is received as beneficial but several concerns have been raised that will need to be addressed.
Introduction
Paediatric pharmacovigilance is a recognised priority. There is widespread use of medicines off-label in children and a recognised vulnerability to adverse drug reactions (ADRs)1,2. The introduction of the community health index (CHI) in all NHS contacts in Scotland provides opportunities to link data and opportunities to identify ADRs by linking prescribing and health utilization data. A large NHS Applied Research Programme Grant - Pharmacovigilance for children: Signal generation from linked NHS administrative data -funded by the Chief Scientist Office- is exploring the feasibility of constructing a database of linked routinely collected data for the purposes of paediatric pharmacovigilance. Assessing the acceptability is important so that solutions can be tailored to address concerns.
The aim is to gather the opinion and attitudes of health care professionals to the linkage of routinely collected paediatric data for pharmacovigilance purposes in Scotland and to identify concerns, if any, before said database is created.
Method
Ethically approved semi-structured interviews are being used to capture views on pharmacovigilance, confidentiality/patient privacy, data protection, acceptable and non-acceptable usage of data and their dissemination. The sample has been purposively designed and includes national experts on these topics plus REC chairs and Caldicott guardians from all Scottish Health Boards. All interviews are audio-recorded and fully transcribed. A framework approach is used to identify themes inductively, but the researcher is open for emergent themes.
Results
Preliminary findings of the early interviews (n=15) have shown that current schemes are perceived as being limited: “it [spontaneously reporting] doesn’t produce data, it produces anecdotes” (interview A04). The creation of the proposed database has raised concerns about data linkage at both practical and legal levels. Practical points included the logistics of the data linkage and the usability of hospital data. Legal issues centre on data protection and consent. Data access will have to be clearly defined and controlled. A need has been recognised for the public to be to be fully informed of the research, its purpose and emergent results. Concerns have been expressed about the possible use of the data for audits and its potential to call the performance of health professionals into question rather than increasing the safety and efficacy of medication used in children. In general, the idea of linking routinely collected data for children in Scotland is recognized as beneficial in view of the extensive use of off-label and unlicensed medicines in children which effectively mean “trialling drugs each time you use them” (interview A01).
Conclusion
Preliminary findings are concerns on a technical, cognitive and emotive level that will need to be addressed prior to linking NHS data routinely at a national level. The creation of a linked database for pharmacovigilance in children is seen as beneficial and long overdue. Further themes are likely to emerge during further analyses of existing and future interviews. The generalisability of these results will be further explored in focus groups across Scotland and a 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) Choonara I, Conroy S (2002). Unlicensed and off-label drug use in children: implications for drug safety. Drug Safety 2002; 25: 1-5
• The study aim is to assess national stakeholders’ opinions of and attitudes to the linking of routinely acquired NHS data as a means of identifying adverse drug reactions (ADRs) in children.
• Preliminary findings show practical and legal issues with data linkage as well as a need for public involvement.
• The creation of said database is received as beneficial but several concerns have been raised that will need to be addressed.
Introduction
Paediatric pharmacovigilance is a recognised priority. There is widespread use of medicines off-label in children and a recognised vulnerability to adverse drug reactions (ADRs)1,2. The introduction of the community health index (CHI) in all NHS contacts in Scotland provides opportunities to link data and opportunities to identify ADRs by linking prescribing and health utilization data. A large NHS Applied Research Programme Grant - Pharmacovigilance for children: Signal generation from linked NHS administrative data -funded by the Chief Scientist Office- is exploring the feasibility of constructing a database of linked routinely collected data for the purposes of paediatric pharmacovigilance. Assessing the acceptability is important so that solutions can be tailored to address concerns.
The aim is to gather the opinion and attitudes of health care professionals to the linkage of routinely collected paediatric data for pharmacovigilance purposes in Scotland and to identify concerns, if any, before said database is created.
Method
Ethically approved semi-structured interviews are being used to capture views on pharmacovigilance, confidentiality/patient privacy, data protection, acceptable and non-acceptable usage of data and their dissemination. The sample has been purposively designed and includes national experts on these topics plus REC chairs and Caldicott guardians from all Scottish Health Boards. All interviews are audio-recorded and fully transcribed. A framework approach is used to identify themes inductively, but the researcher is open for emergent themes.
Results
Preliminary findings of the early interviews (n=15) have shown that current schemes are perceived as being limited: “it [spontaneously reporting] doesn’t produce data, it produces anecdotes” (interview A04). The creation of the proposed database has raised concerns about data linkage at both practical and legal levels. Practical points included the logistics of the data linkage and the usability of hospital data. Legal issues centre on data protection and consent. Data access will have to be clearly defined and controlled. A need has been recognised for the public to be to be fully informed of the research, its purpose and emergent results. Concerns have been expressed about the possible use of the data for audits and its potential to call the performance of health professionals into question rather than increasing the safety and efficacy of medication used in children. In general, the idea of linking routinely collected data for children in Scotland is recognized as beneficial in view of the extensive use of off-label and unlicensed medicines in children which effectively mean “trialling drugs each time you use them” (interview A01).
Conclusion
Preliminary findings are concerns on a technical, cognitive and emotive level that will need to be addressed prior to linking NHS data routinely at a national level. The creation of a linked database for pharmacovigilance in children is seen as beneficial and long overdue. Further themes are likely to emerge during further analyses of existing and future interviews. The generalisability of these results will be further explored in focus groups across Scotland and a 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) Choonara I, Conroy S (2002). Unlicensed and off-label drug use in children: implications for drug safety. Drug Safety 2002; 25: 1-5
| Original language | English |
|---|---|
| Publication status | Published - 2010 |
| Event | Royal Pharmaceutical Society Conference (2010) - London, United Kingdom Duration: 5 Sept 2010 → 6 Sept 2010 |
Conference
| Conference | Royal Pharmaceutical Society Conference (2010) |
|---|---|
| Country/Territory | United Kingdom |
| City | London |
| Period | 5/09/10 → 6/09/10 |