Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database

CHIMES

Research output: Contribution to conferencePoster

Abstract

Introduction
There is widespread recognition of the vulnerability of children to adverse drug reactions (ADRs) 1,2. Paediatric pharmacovigilance is a recognised priority. The UK Yellow Card Scheme (YCS) is central to medicine surveillance, but other methods have been suggested as useful adjuncts3. The inclusion of the community health index (CHI) in all NHS contacts in Scotland will facilitate linkage of multiple datasets on a routine basis to create a database which could be used for, for example, pharmacovigilance. However there are questions about the acceptability, and legal and ethical implications of this. We are engaged in a CSO funded programme of work to address these issues and develop novel methods of early ADR detection in children. The aim of the work reported here is to assess health care professionals’ opinions of, and attitudes to, current systems of pharmacovigilance, advantages of, and barriers to, the national linking of data, and to propose solutions.
Methods
Semi-structured interviews are exploring views on pharmacovigilance, confidentiality/patient privacy, data protection, acceptable and non- acceptable usage of data, and dissemination of findings. A purposive sample of national experts, REC chairs and Caldicott guardians from all Scottish Health Boards are participating. Ethical approval was granted (NoSREC).
Results
Analysis of the early interviews (n=15) demonstrates awareness of the YCS but identifies limitations: “it [spontaneous reporting] doesn’t produce data, it produces anecdotes” (A04). Practical, ethical and legal concerns are raised. Practical issues include physical security of data and anonymisation: “anonymisation [...] is not a science, it’s a craft” (A11). The need for consent is discussed widely, a blanket approach seen as “not feasible” (A) but public awareness perceived as crucial: “[the] patients need to be aware of what is proposed....... [the] use the data would be put to” (A05). Legal issues are related to Acts, professional standards and codes of conduct.
Conclusion
Data linkage is seen as beneficial but concerns are raised. These results cannot be quantified or generalised. They will inform a Delphi survey to be distributed to a national sample of professionals. The outcome will be agreed solutions to inform the next stage when datasets will be linked.

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
3) 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 - 2010
EventThe Society for Academic Primary Care (SAPC) - Norwich, United Kingdom
Duration: 7 Jul 20109 Jul 2010

Conference

ConferenceThe Society for Academic Primary Care (SAPC)
CountryUnited Kingdom
CityNorwich
Period7/07/109/07/10

Fingerprint

Pharmacovigilance
Databases
Pediatrics
Off-Label Use
Drug-Related Side Effects and Adverse Reactions
Health
Anecdotes
Pharmaceutical Preparations
Interviews
Computer Security
Safety
Privacy
Information Storage and Retrieval
Confidentiality
Scotland
Observational Studies
Publications
Primary Health Care
Retrospective Studies
Medicine

Cite this

CHIMES (2010). Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database. Poster session presented at The Society for Academic Primary Care (SAPC), Norwich, United Kingdom.

Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database. / CHIMES.

2010. Poster session presented at The Society for Academic Primary Care (SAPC), Norwich, United Kingdom.

Research output: Contribution to conferencePoster

CHIMES 2010, 'Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database' The Society for Academic Primary Care (SAPC), Norwich, United Kingdom, 7/07/10 - 9/07/10, .
CHIMES. Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database. 2010. Poster session presented at The Society for Academic Primary Care (SAPC), Norwich, United Kingdom.
CHIMES. / Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database. Poster session presented at The Society for Academic Primary Care (SAPC), Norwich, United Kingdom.
@conference{8da05a4f92034b8aa50b2bf230e6896f,
title = "Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database",
abstract = "Introduction There is widespread recognition of the vulnerability of children to adverse drug reactions (ADRs) 1,2. Paediatric pharmacovigilance is a recognised priority. The UK Yellow Card Scheme (YCS) is central to medicine surveillance, but other methods have been suggested as useful adjuncts3. The inclusion of the community health index (CHI) in all NHS contacts in Scotland will facilitate linkage of multiple datasets on a routine basis to create a database which could be used for, for example, pharmacovigilance. However there are questions about the acceptability, and legal and ethical implications of this. We are engaged in a CSO funded programme of work to address these issues and develop novel methods of early ADR detection in children. The aim of the work reported here is to assess health care professionals’ opinions of, and attitudes to, current systems of pharmacovigilance, advantages of, and barriers to, the national linking of data, and to propose solutions. Methods Semi-structured interviews are exploring views on pharmacovigilance, confidentiality/patient privacy, data protection, acceptable and non- acceptable usage of data, and dissemination of findings. A purposive sample of national experts, REC chairs and Caldicott guardians from all Scottish Health Boards are participating. Ethical approval was granted (NoSREC). Results Analysis of the early interviews (n=15) demonstrates awareness of the YCS but identifies limitations: “it [spontaneous reporting] doesn’t produce data, it produces anecdotes” (A04). Practical, ethical and legal concerns are raised. Practical issues include physical security of data and anonymisation: “anonymisation [...] is not a science, it’s a craft” (A11). The need for consent is discussed widely, a blanket approach seen as “not feasible” (A) but public awareness perceived as crucial: “[the] patients need to be aware of what is proposed....... [the] use the data would be put to” (A05). Legal issues are related to Acts, professional standards and codes of conduct. Conclusion Data linkage is seen as beneficial but concerns are raised. These results cannot be quantified or generalised. They will inform a Delphi survey to be distributed to a national sample of professionals. The outcome will be agreed solutions to inform the next stage when datasets will be linked. 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 3) 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 M} and Helms, {Peter J} and Haughney, {John A} and CHIMES",
year = "2010",
language = "English",
note = "The Society for Academic Primary Care (SAPC) ; Conference date: 07-07-2010 Through 09-07-2010",

}

TY - CONF

T1 - Acceptability of linking routinewly collected NHS data sets to create a paediatric pharmacovigilance database

AU - Hopf, Yvonne

AU - Bond, Christine M

AU - Helms, Peter J

AU - Haughney, John A

AU - CHIMES

PY - 2010

Y1 - 2010

N2 - Introduction There is widespread recognition of the vulnerability of children to adverse drug reactions (ADRs) 1,2. Paediatric pharmacovigilance is a recognised priority. The UK Yellow Card Scheme (YCS) is central to medicine surveillance, but other methods have been suggested as useful adjuncts3. The inclusion of the community health index (CHI) in all NHS contacts in Scotland will facilitate linkage of multiple datasets on a routine basis to create a database which could be used for, for example, pharmacovigilance. However there are questions about the acceptability, and legal and ethical implications of this. We are engaged in a CSO funded programme of work to address these issues and develop novel methods of early ADR detection in children. The aim of the work reported here is to assess health care professionals’ opinions of, and attitudes to, current systems of pharmacovigilance, advantages of, and barriers to, the national linking of data, and to propose solutions. Methods Semi-structured interviews are exploring views on pharmacovigilance, confidentiality/patient privacy, data protection, acceptable and non- acceptable usage of data, and dissemination of findings. A purposive sample of national experts, REC chairs and Caldicott guardians from all Scottish Health Boards are participating. Ethical approval was granted (NoSREC). Results Analysis of the early interviews (n=15) demonstrates awareness of the YCS but identifies limitations: “it [spontaneous reporting] doesn’t produce data, it produces anecdotes” (A04). Practical, ethical and legal concerns are raised. Practical issues include physical security of data and anonymisation: “anonymisation [...] is not a science, it’s a craft” (A11). The need for consent is discussed widely, a blanket approach seen as “not feasible” (A) but public awareness perceived as crucial: “[the] patients need to be aware of what is proposed....... [the] use the data would be put to” (A05). Legal issues are related to Acts, professional standards and codes of conduct. Conclusion Data linkage is seen as beneficial but concerns are raised. These results cannot be quantified or generalised. They will inform a Delphi survey to be distributed to a national sample of professionals. The outcome will be agreed solutions to inform the next stage when datasets will be linked. 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 3) 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 There is widespread recognition of the vulnerability of children to adverse drug reactions (ADRs) 1,2. Paediatric pharmacovigilance is a recognised priority. The UK Yellow Card Scheme (YCS) is central to medicine surveillance, but other methods have been suggested as useful adjuncts3. The inclusion of the community health index (CHI) in all NHS contacts in Scotland will facilitate linkage of multiple datasets on a routine basis to create a database which could be used for, for example, pharmacovigilance. However there are questions about the acceptability, and legal and ethical implications of this. We are engaged in a CSO funded programme of work to address these issues and develop novel methods of early ADR detection in children. The aim of the work reported here is to assess health care professionals’ opinions of, and attitudes to, current systems of pharmacovigilance, advantages of, and barriers to, the national linking of data, and to propose solutions. Methods Semi-structured interviews are exploring views on pharmacovigilance, confidentiality/patient privacy, data protection, acceptable and non- acceptable usage of data, and dissemination of findings. A purposive sample of national experts, REC chairs and Caldicott guardians from all Scottish Health Boards are participating. Ethical approval was granted (NoSREC). Results Analysis of the early interviews (n=15) demonstrates awareness of the YCS but identifies limitations: “it [spontaneous reporting] doesn’t produce data, it produces anecdotes” (A04). Practical, ethical and legal concerns are raised. Practical issues include physical security of data and anonymisation: “anonymisation [...] is not a science, it’s a craft” (A11). The need for consent is discussed widely, a blanket approach seen as “not feasible” (A) but public awareness perceived as crucial: “[the] patients need to be aware of what is proposed....... [the] use the data would be put to” (A05). Legal issues are related to Acts, professional standards and codes of conduct. Conclusion Data linkage is seen as beneficial but concerns are raised. These results cannot be quantified or generalised. They will inform a Delphi survey to be distributed to a national sample of professionals. The outcome will be agreed solutions to inform the next stage when datasets will be linked. 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 3) 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 - Poster

ER -