Data Linkage for Pharmacovigilance: Views of Healthcare Professionals on the secondary use of administrative NHS data

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

Research output: Contribution to conferencePoster

Abstract

The Problem
Maximising patient safety, including through pharmacovigilance, is essential. Paediatric pharmacovigilance is a recognised priority. There is widespread use of medicines off-label in children and a recognised vulnerability to adverse drug reactions. Current systems of pharmacovigilance have deficiencies. Improvements have been suggested, such as facilitating the detection of adverse drug reactions through data linkage. Increasingly, routinely collected clinical data are kept electronically and the use of CHI numbers (unique patient identifiers used throughout the Scottish NHS) provides a mechanism for linkage. The views of healthcare professionals on the linkage of NHS data for pharmacovigilance purposes in children have not been explored; this work explores the acceptability of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children.
The Approach
A mixed methods study was conducted involving interviews with a purposive sample of professional stakeholders, focus groups with purposively selected frontline healthcare professionals (analysed using Framework analysis and a three-round Delphi survey with a random sample of healthcare professionals (nurses, pharmacists and doctors with an interest in paediatric medicine) in Scotland. The survey was structured using the Theoretical Domains Framework. Results were triangulated across the three arms of the study. Ethical approval was granted by the North of Scotland Research Ethics Service.
Findings
Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Recommendations included information to and involvement of the public as well as strict control of access to the data by vetting and imposing meaningful sanctions. Focus group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage as well as latent liability issues from results dissemination. Participants focused less on legal issues anticipating that standard governance protocols and current laws would be satisfied. The Delphi survey initially covered all the issues identified in the preceding work but after three rounds that retained items on which there was consensus, interest focused on professional standards, requirements for linkage and the use and form of potential feedback. The proposed data linkage was perceived as positive and necessary, with participants highlighting the benefits for research and for patients.
Consequences
The development of a paediatric linked database has support from professional stakeholders and healthcare professionals in Scotland. The proposed data linkage was perceived as addressing a gap in current knowledge. No insurmountable issues were identified, but a range of issues and concerns should be addressed prior to implementation. Front-line health professionals, ultimately responsible for collecting the data, saw feedback as a strong motivator for engaging with the project. The data from this study will be supported by and cross-referenced to a parallel study investigating the views of the public.
Original languageEnglish
Publication statusPublished - 2012
Event41st Annual Conference of the Society for Academic Primary Care - Glasgow, United Kingdom
Duration: 2 Oct 20124 Oct 2012

Conference

Conference41st Annual Conference of the Society for Academic Primary Care
CountryUnited Kingdom
CityGlasgow
Period2/10/124/10/12

Fingerprint

Pharmacovigilance
Information Storage and Retrieval
Delivery of Health Care
Scotland
Pediatrics
Drug-Related Side Effects and Adverse Reactions
Focus Groups
Off-Label Use
Research Ethics
Patient Safety
Pharmacists
Nurses
Medicine
Databases
Interviews
Health
Research
Surveys and Questionnaires

Cite this

Hopf, Y., Bond, C. M., Francis, J. J., Haughney, J. A. F., & Helms, P. J. B. (2012). Data Linkage for Pharmacovigilance: Views of Healthcare Professionals on the secondary use of administrative NHS data. Poster session presented at 41st Annual Conference of the Society for Academic Primary Care, Glasgow, United Kingdom.

Data Linkage for Pharmacovigilance : Views of Healthcare Professionals on the secondary use of administrative NHS data. / Hopf, Yvonne; Bond, Christine Margaret; Francis, Jillian Joy; Haughney, John Andrew Francis; Helms, Peter Joseph Benedict.

2012. Poster session presented at 41st Annual Conference of the Society for Academic Primary Care, Glasgow, United Kingdom.

Research output: Contribution to conferencePoster

Hopf, Y, Bond, CM, Francis, JJ, Haughney, JAF & Helms, PJB 2012, 'Data Linkage for Pharmacovigilance: Views of Healthcare Professionals on the secondary use of administrative NHS data' 41st Annual Conference of the Society for Academic Primary Care, Glasgow, United Kingdom, 2/10/12 - 4/10/12, .
Hopf Y, Bond CM, Francis JJ, Haughney JAF, Helms PJB. Data Linkage for Pharmacovigilance: Views of Healthcare Professionals on the secondary use of administrative NHS data. 2012. Poster session presented at 41st Annual Conference of the Society for Academic Primary Care, Glasgow, United Kingdom.
Hopf, Yvonne ; Bond, Christine Margaret ; Francis, Jillian Joy ; Haughney, John Andrew Francis ; Helms, Peter Joseph Benedict. / Data Linkage for Pharmacovigilance : Views of Healthcare Professionals on the secondary use of administrative NHS data. Poster session presented at 41st Annual Conference of the Society for Academic Primary Care, Glasgow, United Kingdom.
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abstract = "The Problem Maximising patient safety, including through pharmacovigilance, is essential. Paediatric pharmacovigilance is a recognised priority. There is widespread use of medicines off-label in children and a recognised vulnerability to adverse drug reactions. Current systems of pharmacovigilance have deficiencies. Improvements have been suggested, such as facilitating the detection of adverse drug reactions through data linkage. Increasingly, routinely collected clinical data are kept electronically and the use of CHI numbers (unique patient identifiers used throughout the Scottish NHS) provides a mechanism for linkage. The views of healthcare professionals on the linkage of NHS data for pharmacovigilance purposes in children have not been explored; this work explores the acceptability of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children. The Approach A mixed methods study was conducted involving interviews with a purposive sample of professional stakeholders, focus groups with purposively selected frontline healthcare professionals (analysed using Framework analysis and a three-round Delphi survey with a random sample of healthcare professionals (nurses, pharmacists and doctors with an interest in paediatric medicine) in Scotland. The survey was structured using the Theoretical Domains Framework. Results were triangulated across the three arms of the study. Ethical approval was granted by the North of Scotland Research Ethics Service. Findings Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Recommendations included information to and involvement of the public as well as strict control of access to the data by vetting and imposing meaningful sanctions. Focus group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage as well as latent liability issues from results dissemination. Participants focused less on legal issues anticipating that standard governance protocols and current laws would be satisfied. The Delphi survey initially covered all the issues identified in the preceding work but after three rounds that retained items on which there was consensus, interest focused on professional standards, requirements for linkage and the use and form of potential feedback. The proposed data linkage was perceived as positive and necessary, with participants highlighting the benefits for research and for patients. Consequences The development of a paediatric linked database has support from professional stakeholders and healthcare professionals in Scotland. The proposed data linkage was perceived as addressing a gap in current knowledge. No insurmountable issues were identified, but a range of issues and concerns should be addressed prior to implementation. Front-line health professionals, ultimately responsible for collecting the data, saw feedback as a strong motivator for engaging with the project. The data from this study will be supported by and cross-referenced to a parallel study investigating the views of the public.",
author = "Yvonne Hopf and Bond, {Christine Margaret} and Francis, {Jillian Joy} and Haughney, {John Andrew Francis} and Helms, {Peter Joseph Benedict}",
year = "2012",
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AU - Hopf, Yvonne

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AU - Francis, Jillian Joy

AU - Haughney, John Andrew Francis

AU - Helms, Peter Joseph Benedict

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N2 - The Problem Maximising patient safety, including through pharmacovigilance, is essential. Paediatric pharmacovigilance is a recognised priority. There is widespread use of medicines off-label in children and a recognised vulnerability to adverse drug reactions. Current systems of pharmacovigilance have deficiencies. Improvements have been suggested, such as facilitating the detection of adverse drug reactions through data linkage. Increasingly, routinely collected clinical data are kept electronically and the use of CHI numbers (unique patient identifiers used throughout the Scottish NHS) provides a mechanism for linkage. The views of healthcare professionals on the linkage of NHS data for pharmacovigilance purposes in children have not been explored; this work explores the acceptability of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children. The Approach A mixed methods study was conducted involving interviews with a purposive sample of professional stakeholders, focus groups with purposively selected frontline healthcare professionals (analysed using Framework analysis and a three-round Delphi survey with a random sample of healthcare professionals (nurses, pharmacists and doctors with an interest in paediatric medicine) in Scotland. The survey was structured using the Theoretical Domains Framework. Results were triangulated across the three arms of the study. Ethical approval was granted by the North of Scotland Research Ethics Service. Findings Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Recommendations included information to and involvement of the public as well as strict control of access to the data by vetting and imposing meaningful sanctions. Focus group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage as well as latent liability issues from results dissemination. Participants focused less on legal issues anticipating that standard governance protocols and current laws would be satisfied. The Delphi survey initially covered all the issues identified in the preceding work but after three rounds that retained items on which there was consensus, interest focused on professional standards, requirements for linkage and the use and form of potential feedback. The proposed data linkage was perceived as positive and necessary, with participants highlighting the benefits for research and for patients. Consequences The development of a paediatric linked database has support from professional stakeholders and healthcare professionals in Scotland. The proposed data linkage was perceived as addressing a gap in current knowledge. No insurmountable issues were identified, but a range of issues and concerns should be addressed prior to implementation. Front-line health professionals, ultimately responsible for collecting the data, saw feedback as a strong motivator for engaging with the project. The data from this study will be supported by and cross-referenced to a parallel study investigating the views of the public.

AB - The Problem Maximising patient safety, including through pharmacovigilance, is essential. Paediatric pharmacovigilance is a recognised priority. There is widespread use of medicines off-label in children and a recognised vulnerability to adverse drug reactions. Current systems of pharmacovigilance have deficiencies. Improvements have been suggested, such as facilitating the detection of adverse drug reactions through data linkage. Increasingly, routinely collected clinical data are kept electronically and the use of CHI numbers (unique patient identifiers used throughout the Scottish NHS) provides a mechanism for linkage. The views of healthcare professionals on the linkage of NHS data for pharmacovigilance purposes in children have not been explored; this work explores the acceptability of linking routinely collected healthcare data to inform the design of a new system for pharmacovigilance in children. The Approach A mixed methods study was conducted involving interviews with a purposive sample of professional stakeholders, focus groups with purposively selected frontline healthcare professionals (analysed using Framework analysis and a three-round Delphi survey with a random sample of healthcare professionals (nurses, pharmacists and doctors with an interest in paediatric medicine) in Scotland. The survey was structured using the Theoretical Domains Framework. Results were triangulated across the three arms of the study. Ethical approval was granted by the North of Scotland Research Ethics Service. Findings Interviews (n=23) identified issues with security, anonymisation and legal challenges that should be addressed prior to implementation. Recommendations included information to and involvement of the public as well as strict control of access to the data by vetting and imposing meaningful sanctions. Focus group participants (n=22, 6 groups) additionally identified potential issues with the feasibility of the planned data linkage as well as latent liability issues from results dissemination. Participants focused less on legal issues anticipating that standard governance protocols and current laws would be satisfied. The Delphi survey initially covered all the issues identified in the preceding work but after three rounds that retained items on which there was consensus, interest focused on professional standards, requirements for linkage and the use and form of potential feedback. The proposed data linkage was perceived as positive and necessary, with participants highlighting the benefits for research and for patients. Consequences The development of a paediatric linked database has support from professional stakeholders and healthcare professionals in Scotland. The proposed data linkage was perceived as addressing a gap in current knowledge. No insurmountable issues were identified, but a range of issues and concerns should be addressed prior to implementation. Front-line health professionals, ultimately responsible for collecting the data, saw feedback as a strong motivator for engaging with the project. The data from this study will be supported by and cross-referenced to a parallel study investigating the views of the public.

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