Data linkage for paediatric pharmacovigilance

perspectives of policy makers and key stakeholders

Yvonne Hopf, Christine Margaret Bond, John Andrew Francis Haughney, Peter Joseph Benedict Helms

Research output: Contribution to conferenceOther

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 stakeholders’ –including Caldicott guardians’ and ethic chairs’- 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=40) 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).
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 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.
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 languageEnglish
Publication statusPublished - Jul 2011
Event40th Annual Conference of the Society for Academic Primary Care - Bristol, United Kingdom
Duration: 6 Jul 20118 Jul 2011

Conference

Conference40th Annual Conference of the Society for Academic Primary Care
CountryUnited Kingdom
CityBristol
Period6/07/118/07/11

Fingerprint

Pharmacovigilance
Information Storage and Retrieval
Administrative Personnel
Pediatrics
Scotland
Ethics
Off-Label Use
Computer Security
Drug-Related Side Effects and Adverse Reactions
Health
Disclosure
Focus Groups
Information Systems
Observational Studies
Publications
Primary Health Care
Retrospective Studies
Public Health
Interviews
Research

Cite this

Hopf, Y., Bond, C. M., Haughney, J. A. F., & Helms, P. J. B. (2011). Data linkage for paediatric pharmacovigilance: perspectives of policy makers and key stakeholders. 40th Annual Conference of the Society for Academic Primary Care, Bristol, United Kingdom.

Data linkage for paediatric pharmacovigilance : perspectives of policy makers and key stakeholders. / Hopf, Yvonne; Bond, Christine Margaret; Haughney, John Andrew Francis; Helms, Peter Joseph Benedict.

2011. 40th Annual Conference of the Society for Academic Primary Care, Bristol, United Kingdom.

Research output: Contribution to conferenceOther

Hopf, Y, Bond, CM, Haughney, JAF & Helms, PJB 2011, 'Data linkage for paediatric pharmacovigilance: perspectives of policy makers and key stakeholders' 40th Annual Conference of the Society for Academic Primary Care, Bristol, United Kingdom, 6/07/11 - 8/07/11, .
Hopf Y, Bond CM, Haughney JAF, Helms PJB. Data linkage for paediatric pharmacovigilance: perspectives of policy makers and key stakeholders. 2011. 40th Annual Conference of the Society for Academic Primary Care, Bristol, United Kingdom.
Hopf, Yvonne ; Bond, Christine Margaret ; Haughney, John Andrew Francis ; Helms, Peter Joseph Benedict. / Data linkage for paediatric pharmacovigilance : perspectives of policy makers and key stakeholders. 40th Annual Conference of the Society for Academic Primary Care, Bristol, United Kingdom.
@conference{c166671a3ae446e4b1da329c742102aa,
title = "Data linkage for paediatric pharmacovigilance: perspectives of policy makers and key stakeholders",
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 stakeholders’ –including Caldicott guardians’ and ethic chairs’- 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=40) 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). 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 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. 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]",
author = "Yvonne Hopf and Bond, {Christine Margaret} and Haughney, {John Andrew Francis} and Helms, {Peter Joseph Benedict}",
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note = "40th Annual Conference of the Society for Academic Primary Care ; Conference date: 06-07-2011 Through 08-07-2011",

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T1 - Data linkage for paediatric pharmacovigilance

T2 - perspectives of policy makers and key stakeholders

AU - Hopf, Yvonne

AU - Bond, Christine Margaret

AU - Haughney, John Andrew Francis

AU - Helms, Peter Joseph Benedict

PY - 2011/7

Y1 - 2011/7

N2 - 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 stakeholders’ –including Caldicott guardians’ and ethic chairs’- 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=40) 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). 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 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. 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]

AB - 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 stakeholders’ –including Caldicott guardians’ and ethic chairs’- 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=40) 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). 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 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. 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]

M3 - Other

ER -