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Timely adverse event following immunisation (AEFI) signal event detection is essential to minimise further vaccinees receiving unsafe vaccines. We explored the proportional reporting ratio (PRR) ability to detect two known signal events with influenza vaccines with the aim of providing a model for prospective routine signal detection and improving vaccine safety surveillance in Australia. Passive AEFI surveillance reports from 2008–2017 relating to influenza vaccines were accessed from the Australian SAEFVIC (Victoria) database. Proportional reporting ratios were calculated for two vaccine-event categories; fever and allergic AEFI. Signal detection sensitivity for two known signal events were determined using weekly data; cumulative data by individual year and; cumulative for all previous years. Signal event thresholds of PRR ≥2 and Chi-square ≥4 were applied. PRR provided sensitive signal detection when calculated cumulatively by individual year or by all previous years. Known signal events were detected 15 and 11 days earlier than traditional methods used at the time of the actual events. Utilising a single jurisdiction's data, PRR improved vaccine pharmacovigilance and showed the potential to detect important safety signals much earlier than previously. It has potential to maximise immunisation safety in Australia. This study progresses the necessary work to establish national cohesion for passive surveillance signal detection and strengthen routine Australian vaccine pharmacovigilance. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aim: To identify factors predictive of function 12 months after a fall and emergency department (ED) presentation. Methods: This was a prospective cohort study with 608 older people who had a fall. After presentation and discharge from the ED, a baseline assessment was initially undertaken and then repeated after 12 months. The Human Activity Profile Adjusted Activity Score (HAP-AAS) at the 12-month follow-up assessment was the functional outcome measure. Results: Over the follow-up period, 37.3% (95% CI 33.4, 41.2) of participants declined in their HAP-AAS score. Increased age, pre-index fall functional impairment, poorer mobility/balance, and sustaining falls and severe injuries over the 12-month follow-up period were some of the factors predictive of a lower HAP-AAS score. Conclusion: This study highlights the importance of preventing falls in the 12 months after discharge from an ED. Some of the factors identified as being predictive of lower function are the same as those previously found to be predictive of falls. [ABSTRACT FROM AUTHOR]

Background: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018., Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described., Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association., Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities., (© Commonwealth of Australia CC BY-NC-ND.)

Background: Attitudes to aging have been investigated in non-carer populations and found to have important relationships with physical and mental health. However, these have not been explored in an older carer sample, although it is becoming increasingly important to clarify variables which are linked with positive carer outcomes. This is one of the first studies to report on older carers, their attitudes to aging, and the relationship with carer-related factors., Methods: A cross-sectional study of 202 carers with a mean age of 70.8 years was conducted in Victoria, Australia, using carer demographic data, carer factors such as depression (using the Geriatric Depression Scale), burden (using the Zarit Burden Inventory, ZBI), physical health, personality, and attitudes to aging (using the Attitudes to Aging Questionnaire, AAQ). Spearman rank correlation and hierarchical regression analyses were used., Results: This study showed that carers had overall positive attitudes to aging inspite of their caring role. It also identified that carer factors including depression and burden contributed a significant amount of the variance to attitudes to aging in terms of physical change and psychosocial loss. Personality traits, specifically neuroticism, and extraversion, were also important contributors to attitudes to aging., Conclusions: Results from this study demonstrated that inspite of moderate levels of depression and spending significant time caring, carers reported positive attitudes to aging. Treating depression, decreasing burden, and investigating the benefits of caring may assist older carers maintain their well-being.

Background: Bacillus Calmette-Guérin (BCG) vaccine is used worldwide, with high efficacy against childhood Mycobacterium tuberculosis (TB) meningitis and miliary TB. BCG vaccine is considered safe, with serious systematic adverse events following immunization (AEFI) of immunocompetent recipients being rare, although adverse event rates vary between differing BCG strains. In Victoria, Australia, AEFI are reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community), an enhanced passive surveillance system operational since 2007., Objective: To describe the epidemiology of reported BCG AEFI in Victoria, Australia, particularly following the 2012 recall of Connaught BCG vaccine, substitution with Denmark-SSI vaccine and subsequent programme delivery adjustments., Methods: Retrospective analysis of reported BCG AEFI in Victoria, Australia, for the 6-year period 2008-2013. Incidence rates were calculated using available doses-distributed, doses-administered and population data denominators with 95 % confidence intervals., Results: The predominant BCG AEFI reported were abscess and lymphadenopathy, with higher reports for males than for females (p = 0.039).The rates of AEFI per 10,000 doses distributed were similar for the Connaught and Denmark-SSI strains, at 11.6 and 15.4, respectively (p = 0.414). When doses administered rather than doses distributed were considered, the rate of reported Denmark-SSI AEFI was much higher, at 62.8 per 10,000 doses administered. Meaningful result interpretation was hampered by a lack of a BCG vaccination register, multiple disparate providers and absent doses-administered data prior to the recall., Conclusion: Effective AEFI surveillance is of paramount importance as countries are faced with unplanned vaccine strain changes following the 2012 BCG recall and subsequent global vaccine supply shortages. The Australian experience and lessons learned serve as a timely reminder to BCG vaccination programmes worldwide to review AEFI surveillance systems.