Abstract
BackgroundHealthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. The aim of this study was explore the knowledge, experience and attitudes of medical and nursing professionals towards detecting and reporting AEFI.MethodsWe conducted a qualitative study, using semi-structured, face to face interviews with 13 Paediatric Emergency Department consultants from a tertiary paediatric hospital, 10 General Practitioners, 2 local council immunisation and 4 General Practice nurses, recruited using purposive sampling in Adelaide, South Australia, between December 2010 and September 2011. We identified emergent themes related to previous experience of an AEFI in practice, awareness and experience of AEFI reporting, factors that would facilitate or impede reporting and previous training in vaccine safety. Thematic analysis was used to analyse the data.ResultsAEFI reporting was infrequent across all groups, despite most participants having reviewed an AEFI. We found confusion about how to report an AEFI and variability, according to the provider group, as to the type of events that would constitute a reportable AEFI. Participants’ interpretation of a “serious” or “unexpected” AEFI varied across the three groups. Common barriers to reporting included time constraints and unsatisfactory reporting processes. Nurses were more likely to have received formal training in vaccine safety and reporting than medical practitioners.ConclusionsThis study provides an overview of experience and beliefs of three healthcare professional groups in relation to identifying and reporting AEFI. The qualitative assessment reveals differences in experience and awareness of AEFI reporting across the three professional groups. Most participants appreciated the importance of their role in AEFI surveillance and monitoring the ongoing safety of vaccines. Future initiatives to improve education, such as increased training to health care providers, particularly, medical professionals, are required and should be included in both undergraduate curricula and ongoing, professional development.
Highlights
Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems
In Australia, the spontaneous reporting of adverse events following immunisation (AEFI) is the primary mechanism used for post-marketing passive surveillance (PMS) of licensed vaccines
Vaccine manufactures are mandated to report to the federal authority, the Therapeutic Goods Administration (TGA), and in four of the eight Australian states/territories, but not South Australia, health professionals are mandated by jurisdictional legislation to report to the local public health authority
Summary
Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. In Australia, the spontaneous reporting of adverse events following immunisation (AEFI) is the primary mechanism used for post-marketing passive surveillance (PMS) of licensed vaccines. Vaccine manufactures are mandated to report to the federal authority, the Therapeutic Goods Administration (TGA), and in four of the eight Australian states/territories, but not South Australia, health professionals are mandated by jurisdictional legislation to report to the local public health authority. At the federal level up until 2013, the Advisory Committee for Safety of Medicines (ACSOM), a subcommittee of the TGA was responsible for the ongoing evaluation of all drug and vaccine safety. An established causal association with vaccination is not a pre-requisite for reporting [9]
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