Australian healthcare providers’ awareness of and practices related to vaccine safety surveillance
Nicola Carter A B * , Catherine King A C , Lucy Deng A C , Nicholas Wood A C Helen Quinn A CA
B
C
Abstract
Healthcare providers play a critical role in increasing vaccine coverage and public confidence in the safety of vaccines. The SARS-CoV-2 pandemic and COVID-19 vaccine responses have posed unique challenges to vaccine safety surveillance and community confidence in immunisation. The need to maintain confidence for high vaccine uptake, reinforces the need for a holistic, robust approach to post-licensure vaccine safety surveillance. This study aimed to examine healthcare providers’ perceptions of vaccine safety surveillance.
A cross-sectional study with Australian healthcare providers was conducted between November and December 2021. General practitioners, nurses, and pharmacists in current or previous roles administering vaccines were invited to participate in an online survey that assessed their awareness of, and practices related to, vaccine safety surveillance systems. The survey was disseminated via healthcare provider professional networks.
Of the 562 completed surveys, 552 were included in the analysis. The majority of the healthcare providers (96%) reported being aware that Australia has mechanisms in place to monitor the safety of vaccines after they are approved for use. However, almost a third of participants were not aware of the AusVaxSafety active vaccine safety surveillance system. Among healthcare providers, nurses were more aware of surveillance systems and reported the highest utilisation of vaccine safety surveillance data in their clinical practice. Participants reported confidence in the safety of vaccines as a result of the existence of vaccine safety surveillance systems.
Healthcare providers in this study showed confidence in the safety of vaccines. However, our findings indicate that despite providers demonstrating increased confidence as a result of the existence of vaccine safety surveillance systems, further efforts should be made to increase immunisation providers’ awareness of the systems, particularly in regards to the accessibility and utility of AusVaxSafety vaccine safety data.
Keywords: Active vaccine safety surveillance, passive (spontaneous) vaccine safety surveillance, vaccine safety surveillance systems, Therapeutic Goods Administration, AusVaxSafety.
Introduction
Vaccine safety surveillance, the ongoing assessment of the safety profile of a vaccine post-licensure, relies on the ability to detect adverse events following immunisation (AEFI) through robust surveillance systems. An AEFI is defined by the World Health Organization (WHO) as ‘any untoward medical occurrence which follows immunisation, and which does not necessarily have a causal relationship with the usage of the vaccine’.1 While all vaccines registered for use and included in national immunisation programs must pass stringent pre-licensure vaccine clinical trials before they are approved,2 vaccine safety surveillance is important for the detection of signals of rare, late-onset or unexpected events that may not be detected in the pre-licensure trials.3
In Australia, the Therapeutic Goods Administration (TGA) has the regulatory mandate for post-licensure surveillance of medicines, including vaccines, and monitors AEFI through the national passive (spontaneous) surveillance system. Passive surveillance relies on healthcare providers (HCPs), consumers, and pharmaceutical companies voluntarily submitting reports of suspected AEFI to jurisdictional public health units and/or the TGA;4 however, the usefulness of the system for near-real-time monitoring has limitations, such as under-reporting.4–6 Passive AEFI surveillance is complemented by an active vaccine safety surveillance system, AusVaxSafety, which solicits AEFI reports directly from the vaccine recipient post-vaccination in an online survey sent via SMS and/or email.7
HCPs play a critical role in increasing vaccine coverage and public confidence in the safety of vaccines. A recommendation from an HCP to a consumer is one of the best ways to increase vaccine uptake;8 therefore, it is imperative that HCPs have knowledge of, and are equipped to respond confidently to, a wide range of vaccine safety concerns. Vaccine safety surveillance can potentially improve HCP and vaccine recipients’ understanding of vaccine safety and improve awareness of AEFI, leading to the enhanced ability to identify and manage potential AEFI promptly. Previous research conducted through interviews with Australian HCPs suggests limited engagement with vaccine safety surveillance systems.4 Therefore, it is important to understand not only factors such as HCP awareness of, and utilisation of, vaccine safety surveillance systems in their clinical practice but also whether they have confidence in these systems and in turn promote confidence to the public regarding the safety of vaccines.
The SARS-CoV-2 pandemic and COVID-19 vaccine responses have posed unique challenges to vaccine safety surveillance and community confidence in immunisation. Due to HCP and consumer concern about the short development and deployment time for novel vaccines, more intensive safety surveillance of COVID-19 vaccines was undertaken, resulting in a greater publishing frequency of vaccine safety data.9,10 This reinforces the need for a holistic, robust approach to post-licensure vaccine safety surveillance in order to maintain confidence for high vaccine uptake.11
This study aimed to examine HCPs’ awareness of, and practices in regards to, vaccine safety surveillance in order to identify any perceived gaps in their awareness and clinical practice and to describe the impact on their confidence levels.
Methods
Study design
A cross-sectional study using online surveys was conducted to assess the awareness, practices, and confidence of Australian HCPs in relation to vaccine safety surveillance systems. This study was approved by the Sydney Children’s Hospital Network Human Research Ethics Committee (HREC/16/SCHN/19).
Participants
A sample of Australian HCPs (general practitioners (GPs), nurses, and pharmacists) in a role administering vaccines were invited to voluntarily participate in the survey between November and December 2021 using three targeted recruitment methods. Firstly, an email with a link to the survey was disseminated via the mailing list of professional development provider Healthed,12 Australia’s largest private provider of continuing professional development, to thousands of GPs, nurses, pharmacists, and specialists across Australia. Secondly, the link to the survey was also distributed via the Primary Health Networks immunisation support program e-newsletter and via the National Centre for Immunisation Research and Surveillance (NCIRS) email distribution list, which includes healthcare professionals, including immunisation providers, around Australia. Thirdly, the link directed interested HCPs to the participant information sheet, consent form and online survey. Participation was voluntary and anonymous with no identifying information collected. Due to the anonymous nature of the survey, no mechanism was in place for controlling participants completing the survey more than once; however, no incentive was offered for survey completion.
Survey design
The survey, provided in Supplementary File S1, was developed and disseminated using the web-based platform ‘REDCap’ and consisted of a combination of open and closed questions. Questions were developed by the authors and refined by input from immunisation experts and feedback from pilot testing with NCIRS clinical staff. Demographic data (gender, provider type, clinic type and years of experience as an immunisation provider) was also collected (Table 1). The 30-question survey explored a range of topics, including awareness of vaccine safety surveillance, impact of vaccine safety surveillance on HCP vaccine confidence, and utilisation of vaccine safety surveillance data in provider practice.
| Characteristics | General practitioners | Nurses A | Pharmacists | Total | |
|---|---|---|---|---|---|
| n = 229 | n = 279 | n = 44 | n = 552 | ||
| n (%) | n (%) | n (%) | n (%) | ||
| Gender | |||||
| Male | 79 (35) | 7 (3) | 16 (36) | 102 (18) | |
| Female | 150 (66) | 272 (97) | 28 (64) | 450 (82) | |
| Clinic type | |||||
| General practice | 202 (88) | 82 (29) | 2 (5) | 286 (52) | |
| Pharmacy | 0 (0) | 2 (1) | 42 (95) | 44 (8) | |
| ACCHOS B | 4 (2) | 8 (3) | 0 (0) | 12 (2) | |
| Outpatient clinics | 8 (4) | 68 (24) | 0 (0) | 76 (14) | |
| Council clinics C | 7 (3) | 106 (38) | 0 (0) | 113 (20) | |
| Other D | 8 (3) | 13 (5) | 0 (0) | 21 (4) | |
| Years of clinical experience | |||||
| <30 years | 101 (44) | 124 (44) | 26 (59) | 251 (45) | |
| >31 years | 128 (56) | 155 (56) | 18 (41) | 301 (55) | |
Note: denominator data is the sum of respondents for each question by HCP group.
Data analysis
Data cleaning was done in Microsoft Excel, and recoding and statistical analysis were performed using STATA v14. Where appropriate, response variables were collapsed into dichotomous variables (‘yes’ or ‘no’). Percentages were calculated, with a chi-squared test used when comparing dichotomous variables. A P-value of <0.05 was considered statistically significant.
For some analysis, survey responses from two questions were combined to be reported as a single response. In this situation, the numerator was taken as ‘yes’ if the respondent answered ‘yes’ to either or both questions and ‘no’ if they answered ‘no’ to both questions. Surveys were included in the final analysis even if not all questions were completed. The denominator was the total number of respondents who answered at least one of the questions. Questions analysed in this way were being confident about the safety of vaccine (combining the safety of the National Immunisation Program (NIP) and COVID-19 vaccines), increasing confidence in vaccine safety due to existence of surveillance systems (combining the passive and active systems), and use of safety surveillance data in clinical practice (combining data from passive and active systems).
Results
Of the 562 HCPs who completed the survey, 10 survey responses were excluded because we did not deem administering vaccination in the participants’ scope of practice, leaving 552 responses for inclusion in the analysis. Denominator data were unavailable; thus, a response rate was unable to be calculated. Most respondents were female (82%; n = 450/522); nurses comprised the largest group of participants (51%; n = 279/552) as well as the most clinically experienced across all surveyed HCP types. Demographics of the respondents are summarised in Table 1.
Sources of vaccine safety information
The three sources of vaccine safety information most often selected by HCPs were (1) the Australian Government Department of Health and Aged Care (DoHAC) (64%; n = 353/552), (2) the TGA (68%; n = 378/552), and (3) NCIRS (61%; n = 339/552) (Table 2). For some sources of information, there was variation between HCPs; for example, a higher proportion of nurses reported obtaining information on vaccine safety from NCIRS (77%; n = 216/279) whereas a higher proportion of GPs reported obtaining vaccine safety information from medical newsletters (66%; n = 152/229) and webinars/conferences (72%; n = 166/229).
| Sources of information | General practitioners | Nurses | Pharmacists | All | |
|---|---|---|---|---|---|
| n = 229 | n = 279 | n = 44 | n = 552 | ||
| n (%) | n (%) | n (%) | n (%) | ||
| Australian Government Department of Health and Aged Care | 129 (56) | 190 (68) | 34 (77) | 353 (64) | |
| Therapeutic Goods Administration | 146 (64) | 198 (71) | 34 (77) | 378 (68) | |
| State or territory health departments | 52 (23) | 113 (40) | 19 (43) | 184 (33) | |
| National Centre for Immunisation Research and Surveillance | 103 (45) | 216 (77) | 20 (45) | 339 (61) | |
| Primary Healthcare Network | 106 (46) | 124 (44) | 18 (41) | 248 (45) | |
| Media | 41 (18) | 29 (10) | 4 (9) | 74 (13) | |
| Scientific journals | 80 (35) | 111 (40) | 19 (43) | 210 (38) | |
| Medical newsletters from RACGP/PHN | 152 (66) | 83 (30) | 7 (16) | 242 (44) | |
| Webinars/conferences | 166 (72) | 138 (49) | 18 (41) | 322 (58) | |
| Colleagues | 72 (31) | 65 (23) | 9 (20) | 146 (26) | |
| Friends/family | 3 (1) | 8 (3) | 1 (2) | 12 (2) | |
| Other | 10 (4) | 20 (7) | 3 (7) | 33 (6) |
Note: Denominator data is the sum of respondents for each question by HCP group. HCPs were able to select more than one source. RACGP, Royal Australian College of General Practitioners; PHN, Primary Health Networks.
Respondents who selected ‘other’ (6%; n = 33/552) commonly reported WHO, Centers for Disease Control and Prevention, Australian Primary Health Care Nurses Association, and the Australian Immunisation Handbook. Of those that selected the survey response ‘other’, 6% (n = 2/33) specified ‘AusVaxSafety’ in the free text response as a source of vaccine safety information.
Awareness of vaccine safety surveillance systems
Overall, 96% (n = 516/539) of participating HCPs reported being aware that Australia has mechanisms in place to monitor the safety of vaccines after they are approved for use. Data also revealed 96% (n = 516/539) of participating HCPs were aware of the passive vaccine safety surveillance system. Of those HCPs aware of the passive vaccine safety surveillance system (96%; n = 516/339), 7% (n = 446/510) were aware that the TGA makes information publicly available on the safety of vaccines. In comparison, only 61% (n = 316/518) of participating HCPs reported they were aware of the AusVaxSafety active vaccine safety surveillance system (Table 3). Nurses formed the largest proportion (72%; n = 188/261) of HCPs who reported awareness of the active vaccine safety surveillance system. Among those HCPs aware of the active vaccine safety surveillance system (61%; n = 316/518), only 52% (n = 164/314) reported viewing the vaccine safety data on the AusVaxSafety website.
| Surveillance system | General practitioners | Nurses | Pharmacists | Total | P value | ||
|---|---|---|---|---|---|---|---|
| n/N (%) | n/N (%) | n/N (%) | n/N (%) | ||||
| Awareness | Passive | 210/221 (95) | 266/275 (97) | 40/43 (93) | 516/539 (96) | 0.43 | |
| Active | 112/215 (53) | 188/261(72) | 16/42 (38) | 316/518 (61) | <0.001 | ||
| Practices A | Passive | 114/170 (67) | 163/235 (69) | 24/35 (69) | 301/440 (68) | 0.89 | |
| Active | 42/110 (38) | 108/185 (58) | 4/14 (29) | 154/309 (50) | <0.001 |
Confidence in vaccine safety
When asked if they were confident in the safety of the NIP and COVID-19 vaccines, 95% (n = 522/547) of surveyed HCPs reported that they were. Results were consistent among HCPs (Table 4). Having confidence in the safety of COVID-19 and NIP vaccines was not significantly different based on gender, clinic type, or years of clinical experience.
| General Practitioners | Nurses | Pharmacists | Total | P value | ||
|---|---|---|---|---|---|---|
| n/N (%) | n/N (%) | n/N (%) | n/N (%) | |||
| Confident in the safety of NIP and COVID-19 vaccines | 215/225 (96) | 267/278 (96) | 40/44 (91) | 522/547 (95) | 0.32 | |
| Existence of safety surveillance systems increases vaccine safety confidence | 82/84 (98) | 159/161 (99) | 9/9 (100) | 250/254 (98) | 0.74 |
Note: Denominator data is the total number of respondents who answered at least one question. NIP; national immunisation program.
Among HCPs who reported awareness of either the passive or active vaccine safety surveillance system, 98% (n = 250/254) reported that the existence of vaccine safety surveillance systems increased their confidence in vaccine safety (Table 4). Having increased confidence in vaccine safety due to the existence of vaccine safety surveillance systems was not significantly different based on HCP type, gender, clinic type, or years of experience as an immunisation provider.
Practices towards vaccine safety surveillance systems
Among the surveyed HCPs aware of the passive vaccine safety surveillance system (96%; n = 516/539), 98% (n = 474/485) reported they trusted the system and 68% (n = 301/440) reported utilisation of passive vaccine safety data during a consultation with a vaccine-hesitant patient. Results were consistent among HCPs (Table 3). Of the HCPs who reported awareness of the active vaccine safety surveillance system (61%; n = 316/518), 98% (n = 271/276) reported they trust the system, but only 50% (n = 154/309) of HCPs reported utilisation of the data during a consultation with a vaccine-hesitant patient. Nurses reported the highest utilisation of active vaccine safety surveillance data in patient consultations (58%; n = 108/185).
Among those HCPs who were confident in the safety of vaccines (95%; n = 522/547), 20% (n = 53/266) reported never using the vaccine safety data in their clinical practice. All HCPs who reported utilisation of the vaccine safety surveillance data in their clinical practice reported increased confidence in vaccine safety due to the existence of surveillance systems (n = 182/226; P < 0.001).
Discussion
The success of immunisation programs relies in part on robust and effective post-marketing vaccine safety surveillance.11 Given the increasing concerns among consumers related to vaccine safety and its impact on vaccine uptake,13 efforts should be made to ensure that HCPs have access to timely vaccine safety data to maintain public confidence in immunisation. This study has provided some important insights into HCPs’ attitudes to vaccine safety surveillance following a period of heightened interest in the safety profile of COVID-19 vaccines.
This study showed that between November and December 2021, HCPs were aware of the existence of the national passive vaccine safety surveillance system. This finding is consistent with results obtained by the TGA in their 2023 stakeholder survey, in which HCPs were asked to comment on their knowledge of the TGA and its roles and responsibilities. Results from the TGA stakeholder study found awareness and trust in the TGA among HCPs has climbed significantly since the start of the COVID-19 pandemic.14 HCPs were, however, less aware of the AusVaxSafety active vaccine safety surveillance system. This finding might be explained by the fact that for vaccine safety, active surveillance is a relatively new concept in comparison to passive surveillance. Given the TGA’s responsibility for the regulation of drugs in Australia, it is possible that higher rates of reported awareness of passive surveillance of vaccines may be a direct result of the TGA’s prominent involvement in the COVID-19 pandemic for both vaccine approvals and response to vaccine safety issues.
While providers were familiar with vaccine safety surveillance systems, they lacked awareness of publicly available vaccine safety data generated by these systems, which subsequently may have led to low utilisation of vaccine safety data, particularly in relation to AusVaxSafety. Organisations that HCPs trust as their source of vaccine safety information, such as DoHAC, TGA, and NCIRS, should ensure they have readily available and up-to-date vaccine safety surveillance information. Further efforts could be made to specifically educate HCPs in the accessibility and utilisation of active vaccine safety data to promote discussions with vaccine-hesitant patients. This could include continuing professional education for HCPs, the continued timely dissemination of regular updates to HCPs through professional channels alongside appropriately funded paid media campaigns targeted at HCPs.
Previous research has shown that a conversation with an HCP about vaccine safety may impact positively on a patient’s attitudes towards immunisation; however, HCPs may need additional training and support to effectively respond to patient questions about COVID-19 vaccination.15–17 Communication strategies for COVID-19 vaccines may differ from those of routine NIP vaccines due to the unfamiliar nature of COVID-19 vaccines and lack of post-marketing safety profiles. Well-framed discussions with vaccine-hesitant patients explaining the risks and benefits of vaccines can assist in vaccine decision-making.18 Therefore, educating HCPs on systems such as AusVaxSafety, could enable them to utilise timely and reliable vaccine safety surveillance data in patient conversations to address the challenges of vaccine hesitancy.
It is important to note that the context in which our study has taken place may have shaped HCPs’ awareness of vaccine safety surveillance. In February 2021, Australia commenced the rollout of COVID-19 vaccines.9 By mid-2021, concerns about vaccine safety had emerged globally, including reports of myocarditis and cases of thrombosis with thrombocytopenia syndrome linked to the AstraZeneca vaccine.19,20 By the time this survey was disseminated in late 2021, there was increased public concern about the safety of COVID-19 vaccines, along with significant promotion of the need for robust vaccine safety monitoring.11 Future research should investigate whether HCPs’ awareness of vaccine safety surveillance has continued or declined as the urgent threat of the pandemic has subsided.
Our results revealed that participants, regardless of provider type, reported high confidence in the safety of vaccines. While the use of vaccine safety data were not associated with confidence in the safety of vaccines, those HCPs who reported that the existence of safety surveillance systems increased their confidence in vaccine safety were more likely to use the data in their clinical practice. Further investigation should be undertaken into the overarching and ongoing purpose of vaccine safety surveillance in Australia and how it can be enhanced to ensure the systems are utilised effectively amongst all HCPs.
Strengths and limitations
The study was conducted during a period of increased attention to pharmacovigilance as a result of the introduction of COVID-19 vaccines, and therefore, a significant limitation to the findings may be the inability of the survey to capture the views of HCPs from both the pre- and post-pandemic periods. Additionally, participants may have had a heightened awareness of vaccine safety surveillance when the survey was conducted. Although this was conducted after the vaccine rollout and amidst concerns about vaccine-related issues, it may not reflect the most current sentiments regarding vaccine safety, as perceptions among HCPs may have continued to evolve. To our knowledge, there is no single sampling pool of HCPs from which to draw survey responses. Therefore, we used three different sources for recruitment, which we believed would collectively represent the target population. Our study may be subject to sample bias, as recruitment was geared towards HCPs who receive and engage with up-to-date clinical information, including vaccine safety surveillance information, and noting that from a large pool of invited HCPs a relatively small number participated, the findings cannot be generalised to HCPs outside of these recruitment mechanisms. We could not locate exact data on the proportion of immunisation provider types in Australia. As a result, our data might not accurately reflect the distribution of healthcare provider types in the Australian population, which could limit the generalisability of our analysis. Our findings showed that confidence in the safety of COVID-19 vaccines was similar to that of NIP vaccines. Consequently, we reported them together, which could be considered a limitation.
Conclusions
While HCPs across the groups surveyed showed general awareness of the existence of post-marketing surveillance in Australia, gaps were identified in HCP awareness of existing surveillance systems, particularly AusVaxSafety. While HCP confidence in vaccine safety monitoring is high, efforts should be made to increase HCPs’ awareness of the systems, particularly in regards to the accessibility and utility of AusVaxSafety vaccine safety data.
Data availability
All data generated/analysed during this study are available from the author on reasonable request.
Acknowledgements
AusVaxSafety active surveillance is coordinated by NCIRS which employs all authors and receives funding under a contract with the Australian Government DoHAC. We acknowledge researchers at NCIRS who piloted the survey and the participants of this study. We thank staff at NCIRS and Healthed for assisting with participant recruitment.
Author contributions
NC, HQ and CK were responsible for designing the study and drafting the manuscript. All authors were responsible for reviewing and editing the manuscript. NC was responsible for the collection and analysis of the survey data. HQ was responsible for overseeing the data analysis. NW was responsible for providing strategic advice.
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