The Evolution of Pharmacist Administered Vaccinations in Australia: A Narrative Review of Legislation and Regulatory Documents

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Thank you kindly for the opportunity to review your work with the expansion of vaccine administration by pharmacists in Australia.  I found the choice to track laws and regulations unique and fascinating.  Your Background was exceptionally well written and a wonderful read.  

I have very few comments, but those that I want to stress to you are, I believe, important.

Line 110 - Table 1

I do not know what know "documents superseded before 2014" means.  

Line 144 "ACT added 11 new vaccines..." but when one looks at Figure 1, line 200, there isn't a line that increased by 11 in 2023.  Figure 1 is pretty, but I cannot distinguish the colors so I don't know which line is which.  It may be helpful to describe the authorization in South Australia by telling readers how many vaccine are listed in the Australian Immunization Handbook or approved by the Minister of Health (Line 156) from Figure 1 it appears that there are 23, but that doesn't intuitively feel correct.  

Remember that not everyone who reads your work will be from Australia.  They will need more information to inform their understanding of what they are reading.  Is there a recommended vaccines for Australia chart that could be included?  It would be helpful - in some regions the maximum age for rotavirus vaccine is 36 weeks, yet it is approved in the Northern Territory for children over the age of 5.  Being able to read the Australian standards in a single table would be very helpful.

I agree that harmonizing across the country (line 282) would be helpful to all Australian pharmacists. I believe that showing what the standards are for other providers the comparison to restrictions on pharmacists (or lack thereof in South Australia) would be even more clear and would support your discussion.

Thank you again for your work and for considering my comments

Author Response

Point-by-Point Response to Reviewer 1 comments
Comment 1: Line 110 - Table 1: I do not know what know "documents superseded before 2014" means.

Authors response:  Thank you for this comment. We agree that the original wording was unclear. To improve clarity, we revised the exclusion criterion in Table 1 to specify that documents issued before December 2014 were excluded if they were not implemented or in effect during the study period.  The revised text now reads: Documents issued before December 2014 that were not in effect during the study period.

Comment 2: Line 144 "ACT added 11 new vaccines..." but when one looks at Figure 1, line 200, there isn't a line that increased by 11 in 2023.

Authors response: Thank you for this observation. After re-examining the figure, we identified errors in the reported number of authorised vaccines at several time points. We have corrected these inaccuracies and replaced the previous figure with an updated version that incorporates your comment.

Comment 3: Figure 1 is pretty, but I cannot distinguish the colors so I don't know which line is which.  It may be helpful to describe the authorization in South Australia by telling readers how many vaccines are listed in the Australian Immunization Handbook or approved by the Minister of Health (Line 156) from Figure 1 it appears that there are 23, but that doesn't intuitively feel correct.

Authors response: Thank you for this helpful feedback. To improve the readability and interpretability of figure 1, we have revised the figure and replaced it with an updated version that provides clearer visual differentiation between jurisdictions and includes data labels to facilitate interpretations of temporal trends.

Regarding South Australia, we acknowledge that the number of authorised vaccines may not be immediately apparent from the regulatory framework. Prior to the implementation of the expanded scope-of -practice model, Pharmacist immunisers in South Australia were authorised to administer a defined list of vaccines approved under state regulations. As of December 2023, approximately 17 vaccines were explicitly authorised for pharmacist administration. However, from January 2025, South Australia transitioned to a broader scope-of-practice approach, allowing pharmacist immunisers to administer any vaccine within their individual scope of practice.  Since vaccines are available for 26 diseases based on the Australian Immunisation Handbook and some vaccine products available are available in combination form (e.g. DTPa, dTpa/IPV, MMR) for pharmacist-administered vaccination, approximately 23 vaccines products are available in the Australian Immunisation Program. To clarify which vaccine products are available, we have included detailed information in the Supplementary Table.

Comment 4: Remember that not everyone who reads your work will be from Australia.  They will need more information to inform their understanding of what they are reading.  Is there a recommended vaccines for Australia chart that could be included?  It would be helpful - in some regions the maximum age for rotavirus vaccine is 36 weeks, yet it is approved in the Northern Territory for children over the age of 5.  Being able to read the Australian standards in a single table would be very helpful.

Authors response: Thank you for this thoughtful comment. We appreciate the importance of providing sufficient context for international readers. However, the inclusion of a full Australian recommended vaccine schedule is beyond the scope of our review. Our aim is specifically to the evolution of vaccines authorised for administration by pharmacist immunisers, rather than to present the national immunisation schedule or the broader set of standard vaccines recommended in Australia.

Comment 5: I agree that harmonizing across the country (line 282) would be helpful to all Australian pharmacists. I believe that showing what the standards are for other providers the comparison to restrictions on pharmacists (or lack thereof in South Australia) would be even more clear and would support your discussion.

Authors response. Thank you for this thoughtful suggestion. We appreciate your idea in strengthening the discussion through a comparison with other immunisation providers. After careful consideration, we respectfully maintain our current approach for the following reasons.

First, scope-of-practice inconstancies are not unique to pharmacists. As outline in national guidance documents (Administration of vaccines – Scope of practice for healthcare professionals - Search), substantial variation also exists for medical practitioners, nurse practitioners, authorised nurse/midwife immunisers, registered nurses, enrolled nurses, and Aboriginal and Torres Strait Islander health practitioners in relation to vaccine administration. For example, the national resource on vaccine administration states that:

• “Medical practitioners can prescribe, prepare, and administer vaccines” but require specific accreditation for Q fever and yellow fever in several jurisdictions.
• “Authorised nurse or authorised midwife immunisers can prepare and administer vaccines listed within their jurisdictional regulations” but may require medical authorisation for certain vaccines such as herpes zoster.
• “Registered nurses and midwives cannot administer vaccines without a medication order from a medical practitioners or nurse practitioners” in most jurisdictions.
• “Aboriginal and Torres Strait Islander health practitioners can prepare and administer vaccines under direct or indirect supervision depending on jurisdictional legislation”.

These examples demonstrate that fragmentation is a system-wide approach issue, not one that uniquely affects pharmacists. Introducing a detailed comparison of all provider groups would require substantial expansion beyond the scope of this this review, which is specifically focused on evolutions of pharmacist administered vaccination services (PAVs).

Second, our study aims to synthesise pharmacist-specific legislative changes across states and territories from 2014-2026. Adding a full comparative analysis of all other provider groups would shift the manuscript away from its core objectives and dilute the focus on PAVs.  Such an analysis would also require a separate methodological framework, as the regulatory structures governing pharmacist providers differ substantially in purpose, design, and legislative origin.

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

This manuscript provides a comprehensive and timely overview of the evolution of pharmacist-administered vaccinations (PAVs) across Australia. The topic is highly relevant to contemporary pharmacy practice and public health, particularly given the expanding role of pharmacists in immunisation services. The review successfully documents legislative and regulatory developments across all Australian jurisdictions and offers valuable insight into the progression of vaccine access and pharmacist scope of practice.

Furthermore, the manuscript addresses an important and evolving area of pharmacy practice and presents a comprehensive longitudinal review of legislative and regulatory documents of all Australian states and territories. Moreover, the presentation of changes in vaccine authorisation, age eligibility, and practice settings provides useful information for policymakers and practitioners with a discussion that appropriately highlights the impact of the COVID-19 pandemic as a catalyst for regulatory change.

However, the authors should provide more detail regarding the document screening and selection process. A flow diagram illustrating the number of documents identified, screened, excluded, and included would improve reproducibility.There are several inconsistencies in terminology and abbreviations throughout the manuscript (e.g., "Monkeybox" instead of "Monkeypox" in Table 1, variations in vaccine abbreviations). A careful editorial review is recommended. In addition, while the manuscript effectively describes legislative changes, the discussion would benefit from deeper critical analysis of the factors driving differences between jurisdictions and the practical implications of regulatory fragmentation.

The review focuses primarily on legislative developments. Including more discussion of the impact of pharmacist vaccination services on vaccination coverage, public health outcomes, patient satisfaction, and healthcare accessibility would strengthen the manuscript.

1. Table Presentation
   • Tables 1 and 2 contain substantial information but are difficult to follow in their current format. They must be simplified.
2. Limitations Section
   • The limitations section should be expanded to discuss potential challenges associated with reliance on legislative and regulatory documents, including possible delays between legislative approval and practical implementation.
3. Future Directions
   • The conclusion could be strengthened by discussing future research needs, particularly regarding harmonisation of vaccination regulations, workforce development, and evaluation of patient outcomes.

As a conclusion this manuscript addresses an important area of pharmacy practice. Subject to minor-to-moderate revisions focused on methodological clarification, language editing, and strengthening the discussion and in my opinion, it would make a useful contribution to the literature on pharmacist-administered vaccination services.

Comments on the Quality of English Language

The manuscript is generally understandable and communicates its findings effectively. However, the quality of English language requires improvement before publication. Several grammatical errors, typographical mistakes, inconsistent terminology, punctuation issues, and formatting irregularities are present throughout the text. Examples include inconsistent use of vaccine names and abbreviations, occasional incorrect word choices, and minor sentence construction problems that affect readability.

A thorough professional English-language edit is recommended to improve clarity, consistency, and overall presentation. 

Author Response

Point-by-Point Response to Reviewer 2 comments

Comment 1: the authors should provide more detail regarding the document screening and selection process. A flow diagram illustrating the number of documents identified, screened, excluded, and included would improve reproducibility.

Authors response: Thank you for this valuable comment. We have added a flow diagram to visually present the number of documents identified, screened, excluded, and included

Comment 2: There are several inconsistencies in terminology and abbreviations throughout the manuscript (e.g., "Monkeybox" instead of "Monkeypox" in Table 1, variations in vaccine abbreviations). A careful editorial review is recommended.

Authors response: Thank you for highlighting the inconsistencies in terminology and abbreviations. We undertook a comprehensive review of the full manuscript, including all tables and supplementary materials, to ensure accuracy and uniformity. All identified inconsistencies have been corrected in the revised manuscript.

Comment 3: while the manuscript effectively describes legislative changes, the discussion would benefit from deeper critical analysis of the factors driving differences between jurisdictions and the practical implications of regulatory fragmentation.

Authors response: We thank you for this insightful comment. We have expanded the Discussion section to provide a more critical analysis of the factors that may contribute to differences in pharmacist-administered vaccination regulations across Australia jurisdictions. Specifically, we now discuss how variations in regulatory approaches, healthcare priorities, workforce capacity, and stakeholder engagement may have influenced the pace and extent of scope-of-practice expansion. We have also elaborated on the practical implementations of regulatory fragmentation, including potential impacts on service consistency, workforce mobility, public understanding of vaccine availability, equitable access to vaccination services, and the implementation of coordinated national immunisation strategies.

Comment 4: The review focuses primarily on legislative developments. Including more discussion of the impact of pharmacist vaccination services on vaccination coverage, public health outcomes, patient satisfaction, and healthcare accessibility would strengthen the manuscript.

Authors response: We thank you for this valuable suggestion. We have strengthened the Discussion section by incorporating a broader consideration of the implications of pharmacist-administered vaccination services beyond legislative developments. The revised discussion now highlights the contributions of community pharmacies to improving healthcare accessibility, particularly for rural, remote, and underserved populations. We have also discussed the role of pharmacists in expanding vaccination capacity during the COVID-19 vaccination rollout, their potential contribution to improving vaccine uptake and coverage, and evidence demonstrating high level of patient acceptance and satisfaction with pharmacist-administered vaccination services.  

 Comment 5: Table Presentation: Tables 1 and 2 contain substantial information but are difficult to follow in their current format. They must be simplified.

Authors response: We thank you for this thoughtful suggestion and appreciate the concern regarding table readability. However, we have elected to retain the current structure of Tables 1 and 2 because the primary aim of this review is to provide a comprehensive chronological record of regulatory changes in pharmacist administered vaccination across all Australian jurisdictions. Simplifying the tables further would require the aggregation or omission of vaccine-specific and jurisdiction-specific details, which are central to the objectives of the review and may reduce the utility of the tables for policymakers and researchers seeking detailed regulatory information. Nevertheless, to improve readability, we have carefully reviewed the formatting, abbreviations, and presentation of the tables and made minor adjustments where appropriate to enhance clarity while preserving the completeness and accuracy of the information presented.  

  Comment 6:  Limitations Section: The limitations section should be expanded to discuss potential challenges associated with reliance on legislative and regulatory documents, including possible delays between legislative approval and practical implementation.

Authors response: We thank the reviewer for this valuable suggestion. We have substantially expanded the Limitations section to acknowledge the challenges associated with relying on publicly available legislative and regulatory documents. We have also acknowledged that legislative approval may not immediately translate into practical implementation due to various factors. Furthermore, we have added a statement recognising the rapidly evolving nature of pharmacist-administered vaccination regulations in Australia and the possibility that some findings may require periodic updating to remain current.  

 Comment 7: Future Directions: The conclusion could be strengthened by discussing future research needs, particularly regarding harmonisation of vaccination regulations, workforce development, and evaluation of patient outcomes.

Authors response: We thank the reviewer for this constructive recommendation. We have expanded the Conclusion section to include future research priorities (please see in the revised manuscript)

 

Comment 8: The manuscript is generally understandable and communicates its findings effectively. However, the quality of English language requires improvement before publication. Several grammatical errors, typographical mistakes, inconsistent terminology, punctuation issues, and formatting irregularities are present throughout the text. Examples include inconsistent use of vaccine names and abbreviations, occasional incorrect word choices, and minor sentence construction problems that affect readability.

Authors response: We thank you for this constructive feedback. We have addressed this comment in the revised version of the manuscript.

Author Response File: Author Response.pdf