Evaluation of ‘SAEFVIC’, A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia

Hazel J. Clothier (), Nigel W. Crawford, Melissa Russell, Heath Kelly and Jim P. Buttery
Additional contact information
Hazel J. Clothier: Murdoch Childrens Research Institute
Nigel W. Crawford: Murdoch Childrens Research Institute
Melissa Russell: University of Melbourne
Heath Kelly: Australian National University
Jim P. Buttery: Murdoch Childrens Research Institute

Drug Safety, 2017, vol. 40, issue 6, No 5, 483-495

Abstract: Abstract Introduction Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called ‘SAEFVIC’ (Surveillance of Adverse Events Following Vaccination In the Community). Objective The aim of this study was to evaluate Victoria’s current AEFI surveillance system ‘SAEFVIC’ and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia. Methods We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination. Results AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35–3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1–58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population. Conclusion SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia.

Keywords: Passive Surveillance; Adverse Event Follow Immunisation; Trivalent Influenza Vaccine; Ongoing Quality Improvement; Incidence Risk Ratio (search for similar items in EconPapers)
Date: 2017
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-017-0520-7 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:40:y:2017:i:6:d:10.1007_s40264-017-0520-7

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-017-0520-7

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().