Linking NHS data for pediatric pharmacovigilance

Results of a Delphi survey

Y. M. Hopf, J. Francis, P. J. Helms, J. Haughney, C. Bond

Research output: Contribution to journalArticle

6 Citations (Scopus)
6 Downloads (Pure)

Abstract

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.
Original languageEnglish
Pages (from-to)267-280
Number of pages14
JournalResearch in Social and Administrative Pharmacy
Volume12
Issue number2
Early online date2 Jul 2015
DOIs
Publication statusPublished - Mar 2016

Fingerprint

Pharmacovigilance
Pediatrics
Information Storage and Retrieval
Scotland
Drug-Related Side Effects and Adverse Reactions
Delivery of Health Care
Consensus
Pharmaceutical Preparations
Delphi Technique
Professional Role
Secondary Care
Patient Safety
Pharmacists
Information Systems
General Practitioners
Primary Health Care
Nurses
Health
Sampling
Testing

Keywords

  • mixed methods
  • data linkage
  • pharmacovigilance
  • Delphi

Cite this

Linking NHS data for pediatric pharmacovigilance : Results of a Delphi survey. / Hopf, Y. M.; Francis, J.; Helms, P. J.; Haughney, J.; Bond, C.

In: Research in Social and Administrative Pharmacy , Vol. 12, No. 2, 03.2016, p. 267-280.

Research output: Contribution to journalArticle

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N2 - BackgroundAdverse 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.ObjectivesThe 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.MethodsA 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.Results121 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.ConclusionsIt 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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