title: Pediatric immunization-related safety incidents in primary care: A mixed methods analysis of a national database.
abstract: BACKGROUND
  Children are scheduled to receive 18-20 immunizations before their 18th birthday in England and Wales; this approximates to 13 million vaccines administered per annum. Each immunization represents a potential opportunity for immunization-related error and effective immunization is imperative to maintain the public health benefit from immunization. Using data from a national reporting system, this study aimed to characterize pediatric immunization-related safety incident reports from primary care in England and Wales between 2002 and 2013.
  
  
  METHODS
  A cross-sectional mixed methods study was undertaken. This comprised reading the free-text of incident reports and applying codes to describe incident type, potential contributory factors, harm severity, and incident outcomes. A subsequent thematic analysis was undertaken to interpret the most commonly occurring codes, such as those describing the incident, events leading up to it and reported contributory factors, within the contexts they were described.
  
  
  RESULTS
  We identified 1745 reports and most (n=1077, 61.7%) described harm outcomes including three deaths, 67 reports of moderate harm and 1007 reports of low harm. Failure of timely vaccination was the potential cause of three child deaths from meningitis and pneumonia, and described in a further 113 reports. Vaccine administration incidents included the wrong number of doses (n=476, 27.3%), wrong timing (n=294, 16.8%), and wrong vaccine (n=249, 14.3%). Documentation failures were frequently implicated. Socially and medically vulnerable children were commonly described.
  
  
  CONCLUSIONS
  This is the largest examination of reported contributory factors for immunization-related patient safety incidents in children. Our findings suggest investments in IT infrastructure to support data linkage and identification of risk predictors, development of consultation models that promote the role of parents in mitigating safety incidents, and improvement efforts to adapt and adopt best practices from elsewhere, are needed to mitigate future immunization-related patient safety incidents. These priorities are particularly pressing for vulnerable patient groups.
authors.affiliation: Primary Care Patient Safety (PISA) Research Group, Division of Population Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Electronic address: ReesPC1@cf.ac.uk.
authors.forename: Philippa
authors.initials: P
authors.lastname: Rees
authors.affiliation: Primary Care Patient Safety (PISA) Research Group, Division of Population Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Electronic address: EdwardsAG@cardiff.ac.uk.
authors.forename: Adrian
authors.initials: A
authors.lastname: Edwards
authors.affiliation: Primary Care Patient Safety (PISA) Research Group, Division of Population Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Electronic address: PowellC7@cardiff.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Powell
authors.affiliation: Primary Care Patient Safety (PISA) Research Group, Division of Population Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Electronic address: EvansSH@cardiff.ac.uk.
authors.forename: Huw Prosser
authors.initials: HP
authors.lastname: Evans
authors.affiliation: Primary Care Patient Safety (PISA) Research Group, Division of Population Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Electronic address: CarterBR@cardiff.ac.uk.
authors.forename: Ben
authors.initials: B
authors.lastname: Carter
authors.affiliation: Australian Institute for Healthcare Innovation, Macquarie University, Level 6, 75 Talavera Road, Sydney 2109, NSW, Australia. Electronic address: peter.hibbert@mq.edu.au.
authors.forename: Peter
authors.initials: P
authors.lastname: Hibbert
authors.affiliation: Australian Institute for Healthcare Innovation, Macquarie University, Level 6, 75 Talavera Road, Sydney 2109, NSW, Australia. Electronic address: meredith.makeham@mq.edu.au.
authors.forename: Meredith
authors.initials: M
authors.lastname: Makeham
authors.affiliation: Centre for Medical Informatics, The University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG, UK; Harvard Medical School, Harvard University, Department of Medicine, 1620 Tremont St, Boston, MA 02120, USA. Electronic address: Aziz.Sheikh@ed.ac.uk.
authors.forename: Aziz
authors.initials: A
authors.lastname: Sheikh
authors.affiliation: Imperial College London, 1090a, Queen Elizabeth the Queen Mother Wing (QEQM), St Mary's Campus, Norfolk Place, London W2 1PG, UK. Electronic address: l.donaldson@imperial.ac.uk.
authors.forename: Liam
authors.initials: L
authors.lastname: Donaldson
authors.affiliation: Primary Care Patient Safety (PISA) Research Group, Division of Population Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK; Australian Institute for Healthcare Innovation, Macquarie University, Level 6, 75 Talavera Road, Sydney 2109, NSW, Australia; Centre for Medical Informatics, The University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG, UK; Department of Family Practice, University of British Columbia, 3rd Floor, 5950 University Boulevard, Vancouver, BC, Canada V6 T 1Z3. Electronic address: carson-stevensap@cardiff.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Carson-Stevens
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology; D004739:England / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011320:Primary Health Care; D014611:Vaccination / Q000009:adverse effects*; D014852:Wales / Q000453:epidemiology
keywords: Health services; Patient safety; Primary care; Public health; Quality improvement