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Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey
Y M Hopf1, J Francis2, P J Helms3
1Centre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Insights
Healthcare professionals support linking health data for pediatric pharmacovigilance in Scotland. Addressing professional, legal, and practical concerns will ensure acceptability of this vital patient safety initiative.
Area of Science:
- Pharmacovigilance and Patient Safety
- Health Informatics
- Pediatric Drug Safety
Background:
- Adverse drug events are a significant patient safety concern, particularly in children.
- Current pharmacovigilance systems under-report adverse drug reactions (ADRs), delaying identification, especially in pediatric populations.
- Children exhibit increased vulnerability to ADRs, necessitating improved monitoring.
Purpose of the Study:
- To achieve consensus among Scottish healthcare professionals (HCPs) on barriers and facilitators for linking routinely collected health data.
- To enhance pediatric pharmacovigilance through improved data linkage strategies.
- To identify key considerations for implementing a data linkage system for pediatric drug safety.
Main Methods:
- A three-round Delphi survey was conducted with a random sample of Scottish HCPs (nurses, pharmacists, doctors).
- Participants were recruited via postal invitation, with options for online or hard copy responses.
- The survey utilized the Theoretical Domains Framework of Behavior Change and informed by prior qualitative research.
Main Results:
- 121 out of 819 invited HCPs participated (15% response rate).
- Initial open questions generated over 1000 statements, refined to 149 items for rating.
- Consensus was reached on items related to professional standards and practical requirements, with overall support for data linkage and a multi-professional approach.
Conclusions:
- A data linkage system for pediatric pharmacovigilance is acceptable to stakeholders.
- Successful implementation requires addressing concerns regarding professional, legal, and ethical standards.
- Resolving practical issues is crucial for the adoption of the proposed data linkage system.
Background:
Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs.
Objectives:
The objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland.
Methods:
A Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation.
Results:
121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree - strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach.
Conclusions:
It would be acceptable to stakeholders to introduce a data linkage system for pharmacovigilance as long as identified concerns are addressed. Concerns included adherence to current professional, legal and ethical standards, as well resolving practical issues.
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