Pediatric immunization-related safety incidents in primary care: A mixed methods analysis of a national database

Abstract

BackgroundChildren 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.MethodsA 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.ResultsWe 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.ConclusionThis 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.

Improving the safety of vaccine delivery

“…5 Research and improvement efforts may now mitigate harm occurring during the vaccination process, which commonly include: giving the wrong vaccine; giving vaccines at the wrong time in a schedule; giving extra (unnecessary) vaccines; administering vaccines via the wrong route; and prescribing or administering the wrong dose. 2,6,7 Several studies have shown that approximately one-third of patients experience at least one vaccine error. 8,9 Feikema and colleagues estimated the United States wastes $26.5 million per annum on unnecessary vaccines given to infants between 19 and 35 months.…”

“…5,7 Surveillance systems primarily capturing data about adverse drug reactions, such as the Vaccine Adverse Event Reporting System, can also contain reports about the vaccine delivery process. 11 Whilst safety incident reporting systems cannot accurately measure the frequency of vaccination errors, they can support the identification of priorities for improvement.…”

“…12 Research led by the PISA Group at Cardiff University into vaccine-related safety incidents reported from primary care in England and Wales mirror issues reported in other healthcare systems across the world. 2,7 Although these concerns are not new, 9 we recognize a systems improvement approach is essential.…”

“…How easy it would be to detect and prevent such error with a simple computer algorithm, should all vaccine-related data be centralized. 7 Uniting safety report data systematically, nationally and internationally, will enable the identification of signals that are too small to be seen on a local level. Working internationally will garner the greatest benefits, by prioritizing efforts together and sharing context-specific solutions between countries.…”

Opportunities for incident reporting. Response to: ‘The problem with incident reporting’ by Macraeet al

“…There is, however, an opportunity to target specific discipline or professional groups to stimulate a culture of reporting, and efforts in anaesthetics have been commendable. From our analysis of incidents involving children in primary care3 4 we would advocate initiatives that promote reporting across multiple sectors, not least patient-reporting, at local and national levels. Further, encouraging reports about specific safety incident types and specific patient groups (eg, delays in treatment received by socially deprived children) would support capture of a diverse range of issues underpinning the most common or most important problems for those patients.…”