Tasmanian pharmacist immunisation program guidelines

Introduction

Immunisation is the safest and most effective way to control many of the world’s most important infectious diseases. It has been the single most important advancement in public health over the last century saving more lives than any other health intervention.

Australia has a strong and internationally recognised National Immunisation Program (NIP), with a national average of over 90 per cent coverage for most childhood vaccines (DTPa, hepatitis B, MMR, Hib, and polio). Australia’s achievements in immunisation meet international goals set by the World Health Organization under the Global Vaccine Action Plan as outlined in the National Immunisation Strategy for Australia. 

Opportunities remain to improve vaccination rates for all ages both locally and internationally. Achieving high vaccination coverage rates requires a competent workforce as well as effective clinical governance arrangements for all immunisation programs which are clear, accountable, and effective, with business processes in place to monitor and evaluate performance and provide feedback.

Pharmacist-administered immunisation programs commenced in 2016, with initial scope enabling administration of influenza vaccines to those aged 16 years and older.  Since this time, the number of vaccines available in community pharmacy has increased.

Enabling Authorised Pharmacist Immunisers (API) to administer vaccines in community pharmacy provides greater public access to immunisation. To independently initiate vaccination (i.e. without prescription) in Tasmania, pharmacists must be authorised as an API and be working under an immunisation program which has been approved by the Director of Public Health (DPH).

These Tasmanian Pharmacist Immunisation Program Guidelines (the ‘Guidelines’) describe the processes and conditions required to be an API in Tasmania and support pharmacies and APIs to conduct safe, high quality immunisation services.

Regulations

In Tasmania, the Regulation 82i (c)&(d) of the Poisons Regulations 2018 (the Regulations) enable the Secretary of the Department of Health (DoH) (or his/her delegate) to approve registered nurses, midwives and pharmacists who have met the Tasmanian authorisation requirements, to possess and administer medicines (in this case vaccines) independently of a medical or nurse practitioner. The delegate for the DoH Secretary is the DPH. 

The Regulations and these guidelines define the conditions under which an API is authorised to administer an approved Schedule 4 poison, and these are listed in Table 2A, Table 2B and Table 2C of these guidelines. These vaccines must only be administered under a current immunisation program approved by the DPH.

In summary, to independently provide approved vaccines in Tasmania a pharmacist must be: 

i)   working under a vaccination program approval (see Immunisation programs),

ii)  an Authorised Pharmacist Immuniser (see ‘Changes to Authorised Immuniser Requirements in 2024’ and the Tasmanian Authorised Pharmacist Immuniser Application Guidelines), and

iii)  adhering to requirements specified in these guidelines

Immunisation programs

Organisations are required to apply and have current immunisation program approval from the Department of Health before administering vaccines. Immunisation program approvals are required for all pharmacies that employ Authorised Immunisers (AI) - pharmacists and/or registered nurses. 

The nominated Responsible Officer of the Organisation/ Company is responsible for the program and for ensuring all employed AIs meet and maintain the requirements for authorisation. This includes policies and practices that support the delivery of safe immunisation services to the public.

Immunisation program approval enables organisations to:

• employ AIs to offer vaccination services
• order NIP-funded and/or state-funded vaccines
• receive important vaccine updates, such as changes to vaccination schedule(s), new resources and changes to vaccination recommendations.

Immunisation program requirements

To apply, a ‘Responsible Officer’ for the program approval must be nominated; this must be a pharmacist who is employed primarily at the pharmacy and is responsible for the program, as well as for ordering and reporting on vaccines, ensuring vaccines are stored appropriately and are administered only to person(s) eligible to receive funded vaccines.

Immunisation programs must be administered in accordance with the relevant legislation and best practice guidance, this includes:

• Managing cold chain as per the National Vaccine Storage Guidelines - ‘Strive for 5’  – this guideline outlines required cold chain practices, including use of a purpose-built vaccine refrigerators, data loggers, temperature reporting, training, and other considerations. 
• Maintaining vaccines in accordance with the Therapeutic Goods Administration (TGA) approved Product Information.
• Following clinical guidance outlined in the Australian Immunisation Handbook (AIH).
• Complying with the Australian Guidelines for the Prevention and Control of Infection in Healthcare.
• Delivering vaccines in settings that comply with the Tasmanian Pharmacy Authority’s (TPA) Pharmacy Guidelines.
• Adhering to the details provided in your program approval, including details relating to off-site immunisation clinics (see Off-Site Immunisation Clinics). 
• AIs must have access to the Australian Immunisation Register (AIR) and the following resources (including for any off-site vaccination clinics):
  • the Australian Immunisation Handbook
  • the National Vaccine Storage Guidelines – ‘Strive for 5’
  • National and State immunisation program schedules
• materials to support communication about vaccination, including Questions about vaccination and Sharing Knowledge About Immunisation.

Applying for program approval and renewal

• Pharmacies can apply for or renew their immunisation program approval online via the Immunisation Provider Portal (IPP).
• The Responsible Officer for the pharmacy must complete a ‘Pharmacy Immunisation Program Application’ on the IPP.
• Pharmacies applying for program approval for the first time must complete the Australian Immunisation Register – Application to register as a vaccination provider form (IM004) with their application. 
• This form should be emailed to the Immunisation team, Communicable Diseases Prevention Unit (CDPU) – [email protected] 
• Immunisation programs must be renewed annually.

Organisations and AIs must hold appropriate insurance for the administration of vaccines and provision of an immunisation service. AIs should consult with their insurance provider regarding insurance appropriate to their circumstances, which includes the provision of immunisation services outside of pharmacy premises (if applicable).

Changes to pharmacy programs in 2024

The range of vaccines that pharmacies can deliver was expanded in January 2024 to include National Immunisation Program (NIP) vaccines to individuals over 5 years of age. This allows eligible patients to access free NIP vaccines in community pharmacies, with no out-of-pocket costs and will increase patient access to vaccinations to help protect our community from vaccine preventable diseases.

In Tasmania this program expansion requires:

• additional immunisation training to be completed by ALL pharmacists to administer the additional vaccines within the expanded scope; and
• an expansion to the current pharmacy Program Approval from the DPH. 

Pharmacies participating in the National Immunisation Program Vaccinations in Pharmacy (NIPVIP) Program must adhere to the NIPVIP Program Rules. 

Pharmacies administering COVID-19 vaccines must adhere to the COVID-19 Vaccination in Community Pharmacy (CVCP) Program Rules.

Program approval and vaccine ordering

Pharmacies delivering NIP vaccinations in pharmacy are required to complete a new immunisation program approval application to obtain ‘full scope’ program approval.

Pharmacies with ‘full scope’ approval will be onboarded to the DoH’s Vaccine Ordering System (VOS), enabling them to order NIP funded vaccines. Initial cold chain evidence is required to be onboarded, including;

• four weeks of current data from the vaccine refrigerator(s) data logger(s), with data recorded every five (5) minutes, and
• the vaccine refrigerator(s) temperature chart(s) from the previous month to current (min-max charts).

Responsible Officers of vaccination programs must ensure all APIs working under the pharmacy’s immunisation program have completed the additional training requirements.

Immunisation providers will also be required to complete the following annual self-audits to review current immunisation practices and to evaluate and improve immunisation practices:

• ‘Strive for 5’ Appendix 2: Vaccine storage self-audit.
• The Tasmanian Pharmacist Immunisation Program self-audit.

Please note that evidence of completion of the above self-audits may be requested by the DoH at any time.

Changes to authorised immuniser requirements in 2024

The Tasmanian Authorised Pharmacist Immuniser Application Guidelines outline the process for pharmacists to apply for and renew immuniser authorisation in Tasmania. For further detail, including the minimum requirements to authorise with the department, please refer to those guidelines.

From 1 January 2024: all Tasmanian APIs are required to complete additional immunisation training to be competent to administer all vaccines within the expanded scope. To administer any vaccine, an API must have completed the specific module relevant to that vaccine (eg. to administer Meningococcal ACWY vaccines, the Immuniser must have successfully completed a meningococcal vaccine module). When a new vaccine is added to scope, it is the API’s responsibility to ensure they have completed the approved training module.

Responsible Officers of vaccination programs must ensure all APIs working under the pharmacy’s immunisation program have completed these additional requirements.

In 2024, APIs may continue to independently prescribe and administer COVID-19, influenza, MMR and dTpa vaccines to approved age cohorts, and may continue to administer age-appropriate, privately purchased vaccines prescribed by a medical or nurse practitioner without having completed the additional training up to (and including) 31 December 2024. 

Paediatric authorisation

APIs can administer vaccines to children between five and 10 years of age where:

• the API and pharmacy have received the appropriate paediatric approval from the department to independently provide COVID-19 and/or influenza vaccines, and the child is 5 years of age or older.
• a vaccine has been prescribed by a medical or nurse practitioner, and the API and pharmacy have received the appropriate paediatric approval from the department, and the child is 5 years of age or older.

The Responsible Officer must ensure that:

• all APIs administering vaccines to children from age five years have paediatric approval and are competent to identify and manage an adverse event following immunisation (AEFI) for this age group
• the pharmacy’s vaccination program enables vaccination of this paediatric cohort.

Supervision of registered health practitioners by authorised immunisers

It is essential that pharmacists administering vaccines to children are familiar with the additional clinical and communication skills required to administer vaccines to younger children. 

It is strongly recommended that APIs access additional training opportunities, such as those available from the Melbourne Vaccine Education Centre, Health Ed and the National Centre for Immunisation Research and Surveillance.

In accordance with Regulation 82(e) of the Poisons Regulations 2018 an experienced AI (minimum of two years recent clinical experience in the administration of vaccines and compliant with all training requirements), may only supervise the administration of a vaccine by another health practitioner when the other health practitioner is undertaking an approved immunisation education program or has been approved to administer vaccines specified by the DPH.

Intern pharmacists are not permitted to administer vaccines unsupervised until they hold general registration with the Pharmacy Board of Australia and have received written confirmation to practice as an API from the DPH.

For further information please refer to the Tasmanian Authorised Pharmacist Immuniser Application Guidelines

Vaccination scope of practice 

The scope of vaccines APIs are authorised to administer, and the circumstances in which pharmacists may administer these vaccines, are outlined in Tables 2A, 2B and 2C. Excluded vaccines and their rationale for exclusion are listed in Table 1.

For independently initiated and prescription-initiated vaccines: 

• The API must be providing the vaccine within a setting that has a current vaccination program approved by the DPH. 
• The vaccine should be administered in accordance with the clinical recommendations for the specific vaccine as outlined in the AIH and should consider the funding source.
• Where there is variation in advice provided in the AIH and the Product Information (PI), the advice of the AIH should be considered best practice. 
  • Please note for the Respiratory Syncytial Virus (RSV) vaccine Arexvy®, the Australian Technical Advisory Group on Immunisation (ATAGI) ‘Statement on the Clinical Use of Arexvy® (RSV Pre-F3) Vaccine for Prevention of RSV Disease in Older Adults in Australia’ should be used for clinical guidance until the AIH disease chapter is published.
• The API should conduct a pre-vaccination check on the AIR and reports all immunisation encounters to the AIR. 
• Live vaccines are contraindicated in pregnancy and are used only under specialised medical supervision for immunocompromised individuals. 
• Please be aware of vaccine schedules and the recommended timeframes for administration to ensure efficacy and ensure recalls are in place for multi-dose schedules.

Vaccine funding

• Vaccines that APIs administer may be NIP-funded, Commonwealth funded (COVID-19), State Government funded (eg Hepatitis B, MMR) or privately funded.
• An assessment of eligibility for funding source should be undertaken in the pre-vaccination assessment. 
• Table 2A must be reviewed in conjunction with the National Immunisation Program Schedule and Funded Immunisation Schedule Tasmania when considering eligibility for funded vaccine(s).

Classes of vaccines

In relation to API vaccine scope, there are three classes of vaccines: 

1. Independent-initiated vaccines (no prescription required).
2. Prescription-initiated vaccines.
3. Out of scope: must not be administered by an Authorised Pharmacist Immuniser;
   • specialised or infant-only vaccines as listed in Table 1
   • vaccinations for travel purposes without a prescription by a medical or nurse practitioner.

For prescription-initiated vaccines

• The vaccine must have been prescribed by a medical or nurse practitioner (within 12 months of prescribing).
• The minimum age APIs may administer a prescription-initiated vaccine is 10 years old, unless the API has completed a paediatric module and has specific paediatric authorisation from the DPH to administer vaccines from five years old. Please ensure the prescribed vaccine is appropriate for use in these age groups.
• It is the responsibility of the API to complete a pre-vaccination screening checklist and consent form immediately before administering any vaccine. Refer to the AIH for current contraindications, precautions, and dose intervals.
• Please refer to the prescribing medical or nurse practitioner if you have any concerns.
• The API must report provision of the prescription-initiated vaccine dose to the prescriber. 
• Please follow all directions on the prescription.

Out of scope 

• The following specialised vaccines must not be administered by an API: Haemophilus influenzae type B, yellow fever, tuberculosis, smallpox (mpox), Q fever or rotavirus vaccines (refer to Table 1).
• The following must be referred to a medical practitioner and include: 
  • clients with contraindications or precautions as defined in the AIH 
  • administration of live vaccines to pregnant people or people who are or will soon be immunocompromised (including those prescribed by a medical or nurse practitioner)
  • vaccines for the purposes of upcoming travel, unless prescribed by a medical practitioner following a travel consultation
  • vaccination of people aged under five years of age 
  • vaccination of people who are contacts in the event of an outbreak, unless directed by the DPH
  • administration of any immunoglobulin preparation
  • administration of pharmaceuticals for the purposes of clinical trials.
• Pharmacists should understand the risks associated with immunising clients in medical risk groups. Where there is uncertainty or incomplete medical information, the client must be referred to their medical practitioner for assessment and/or vaccination.

Table 1: Vaccines that are outside of scope for administration by authorised pharmacist immuniser

In scope

Table 2A, Table 2B and Table 2C outline the vaccines approved for independent initiation by an Authorised Pharmacist Immuniser and conditions of use. For all listed vaccines, providers must follow best practice clinical guidance specific to the vaccine, as outlined by the AIH. 

Please note Authorised Pharmacist Immunisers with restricted practice scope are only permitted to independently initiate the following: 

• COVID-19 (Commonwealth funded) and influenza (NIP and privately funded) vaccines to individuals ≥10 years of age (may administer from five years of age if API holds paediatric approval).
• Diphtheria-tetanus-pertussis (privately purchased) and measles-mumps-rubella (state and privately funded) vaccines to individuals ≥16 years.

Restricted scope APIs may also administer privately purchased vaccines upon receipt of a valid prescription, provided these are approved antigens as per Tables 2A, 2B and 2C.

Vaccine schedules

Table 2A: NIP and State funded vaccines approved for administration by Authorised Pharmacist Immunisers, column one, includes preparations funded under the NIP and/or state funded programs, which are available for pharmacies to order. These preparations are not deigned to restrict APIs to supplying solely these preparations. Alternative preparations may be provided privately, where all antigens within the preparation are suitable for administration by APIs (i.e. within scope). 

For example, Adacel^® is the Diphtheria-Tetanus-Pertussis containing-vaccine available in pharmacies which is funded under the NIP. Boostrix^® vaccine may be administered to patients recommended to receive a Diphtheria-Tetanus-Pertussis containing-vaccine who are not eligible under the NIP (i.e. privately funded). 

Table 2A: NIP and State funded vaccines approved for administration by Authorised Pharmacist Immunisers

Table 2B: Private funded vaccines approved for independent initiation by Authorised Pharmacist Immunisers

Table 2C: Prescribed, private funded vaccines approved for administration by an Authorised Pharmacist Immuniser

Adolescent vaccinations and the school-based immunisation program

Diphtheria-tetanus-pertussis (acellular), human papillomavirus and conjugated meningococcal ACWY vaccines are funded under the NIP and administered to children in school years seven and 10. In Tasmania, these vaccines are routinely delivered in the school-based Immunisation Program (SBIP) run by local councils. 

Pharmacies are well placed for catch-up of adolescents who missed their vaccination at school, or those who prefer not to have their vaccines in the school setting. 

Pharmacists must consider the possibility of inadvertent duplicate vaccination in children and adolescents, particularly those in age groups who are likely to be immunised via a SBIP. Routine checking of the AIR prior to vaccine administration should prevent vaccine administration errors, including inadvertent administration of duplicate doses. 

It is important that pharmacists discuss the implications with parents if consent form(s) for school vaccination(s) have already been returned to the school for the year ahead. If permission has already been provided, but the adolescent now presents at the pharmacy, the pharmacist should advise the parent to take the necessary steps to withdraw the SBIP consent. Withdrawal of consent must be a written withdrawal via email to the council managing their child’s SBIP.

Equipment

All equipment must comply with the recommendations contained in the AIH and Strive for 5 documents, and should include:

• an anaphylaxis response kit 
• purpose-built vaccine refrigerators with an automated temperature data logger (refrigerator may also be used for the storage of medicines requiring cold storage)
• coolers, data loggers, ice packs and insulation materials suitable for off-site vaccination clinics or for transporting vaccines.

Anaphylaxis response kit

An anaphylaxis response kit must be readily accessible when administering vaccines. All equipment should comply with the recommendations in the online version of the AIH. Please refer to  the AIH Preparing an anaphylaxis response kit.

An emergency response protocol (preferably laminated and on display) should also be available which includes assigned roles and responsibilities of staff. All clinical and non-clinical staff should be aware of the emergency response protocol, and their roles and responsibilities in the event of an emergency.

Adrenaline autoinjectors may be included within an anaphylaxis response kit in addition to 1:1000 adrenaline ampoules. The preferred response to anaphylaxis is to prepare the age-appropriate adrenaline dose from an adrenaline ampoule as specified in the AIH. However, if this is likely to delay emergency treatment, an adrenaline autoinjector may be used.

Please note the following dose considerations:

• For clients aged 5 to <10 years: a 300-microgram adrenaline autoinjector (eg. Epipen®) may be used, however a 500-microgram adrenaline autoinjector (eg. Anapen®) can be used if the 300-microgram preparation is not available.
• For clients aged 10 years and above: a 500-microgram adrenaline autoinjector may be used (eg. Anapen®). 

Note: Adrenaline autoinjectors must not replace adrenaline ampoules in the anaphylaxis response kit but may be included as an additional item.

Code of conduct and professional practice standards

APIs are expected to comply with all elements of the Pharmacy Board of Australia’s Code of conduct, including, but not limited to the following:

• liaising with other health practitioners
• ensuring continuity of care 
• recognising and working within the limits of a practitioner’s competence and scope of practice
• providing treatment options based on best practice information
• maintaining knowledge and skills to ensure that practitioners continue to work within their competence and scope of practice.

APIs must maintain current knowledge of vaccines and immunisation policies and be able to provide information about vaccines and vaccination services to individuals. 

Where information gathered during the pre-vaccination assessment identifies health concerns or uncertainties in relation to health conditions (including vaccine precautions), pharmacists should refer the individual to their medical practitioner for vaccination or advice. 

APIs and pharmacies are expected to comply with the following documents:

• The PSA’s Professional Practice Standards 2023
• The PSA’s Practice Guidelines for pharmacists providing immunisation services (current edition)
• The Pharmacy Guild of Australia’s Guidelines for Conducting Pharmacist Initiated and Administered Vaccinations Service with a Community Pharmacy (NSW Edition), February 2020

Policies and procedures to support immunisation service delivery

Protocols and processes

APIs must have a process to ensure they remain current with the AIH and Strive for 5 to inform their practice. Additionally, pharmacies must ensure they practice within The Pharmaceutical Society of Australia’s Competency Standards Framework for Pharmacists, The PSA’s Clinical Governance Principles for Pharmacy Services, the TPA’s Pharmacy Guidelines, these guidelines, and any other key resources.

Pharmacies providing immunisation service(s) must have documented policies and/or procedures in place to support a safe, high-quality service, including:

• checking of anaphylaxis response kit
• monitoring of vaccine storage systems 
• managing the transport of vaccines when providing clinics off site
• responding to a cold chain breach
• back-up plan for vaccine storage during power failures
• re-screening assessment process
• consent process
• when and how to seek further advice following outcome of screening process
• routine immediate post-vaccination observation and management 
• responding to a needle stick injury
• responding to adverse event reports
• managing anaphylaxis and vasovagal (syncope) episodes
• documentation and record keeping including reporting of vaccination on the AIR
• disposal of infectious and non-clinical waste
• complaints process.

Vaccination space requirements

When pharmacists are conducting a pre-vaccination assessment and administering vaccines, they must not engage in any other activity, including dispensing.

Many of these policies are also covered in accreditation processes (such as via the Quality Care Pharmacy Program) and should be in place in accredited immunising pharmacies. It is therefore strongly recommended that pharmacies performing immunisation services be accredited via a quality assurance program. 

Community pharmacies must have been assessed by the Tasmanian Pharmacy Authority (TPA) and be adhering to the requirements outlined in section 13 of the TPA’s Pharmacy Guidelines. 

Off-site immunisation clinics

Pharmacies may deliver an immunisation service outside of the pharmacy premises where it is included on the Program Approval, for example client homes, corporate workplaces, Residential Aged Care Homes. Additionally, pharmacies may receive requests to access third-party organisations, such as a community health service or RACH to provide an immunisation service. Please note the consent requirements for immunising in a RACH which are discussed in the section on providing immunisation services in RACHs above.

Where off-site vaccination services are conducted, APIs are responsible for ensuring all requirements within these guidelines are met and maintained, and the clinical setting is appropriate for the administration of vaccines. The following conditions must be met when operating off-site vaccination services:

• The service must be linked to a community or hospital pharmacy with an existing program approval
• Adherence to the requirements of the AIH and Strive for 5, including for any equipment and cold chain requirements.
• The immunisation space allows for privacy and is of sufficient size to accommodate the patient (including space to manage an adverse event), an accompanying person and the AI.
• In addition to the AI,  another person who holds current first aid and cardiopulmonary resuscitation (CPR) qualification is also present when the vaccines are administered and during the post-vaccination period.
• Patients are monitored during the post-vaccination period in line of sight of the AI or other first aid and CPR trained staff member for a minimum of 15 minutes post-vaccination.
• An emergency response protocol and an anaphylaxis response kit which complies with the recommendations of the AIH is accessible during sessions.
• Pharmacist Interns may only vaccinate under the direct supervision of an approved person as stipulated in the Tasmanian Authorised Pharmacist Immuniser Application Guidelines.
• Robust clinical documentation, including that all vaccines administered are recorded on the AIR.

Note – please contact the immunisation team if you are intending to conduct an immunisation program at a public event.

Emergency response protocol

An emergency response protocol must be kept as part of the anaphylaxis response kit (preferably laminated and on display or easily accessible during off-site vaccination clinics). The protocol should identify assigned roles and responsibilities of staff members. 

The emergency response protocol should ensure that:

• systems are in place to regularly review the anaphylaxis response kit and emergency response protocol
• all APIs have current paediatric and adult CPR and first aid certification
• a suitably qualified staff member with a current paediatric and adult CPR (updated annually) and first aid certification (updated every three years) is on duty during vaccination sessions 
• all APIs maintain recency of practice and continuing professional development in the management of Adverse Events Following Immunisation (AEFI)
• vaccinees are monitored for at least 15 minutes after vaccine administration.

Adverse events following immunisation

Equipment necessary for the management of anaphylaxis and protocols, including the emergency response protocol, should be checked and available before each immunisation session, regardless of the setting (including mobile or off-site vaccination services). Staff involved in vaccination sessions must be aware of their roles and responsibilities, including after-care or emergency response. 

Individuals (or their parent and/or guardian) must be informed about the potential side effects of vaccination as a component of obtaining informed consent, including how to manage them, and who to notify of delayed adverse events that may occur once they have left the premises.

Reporting adverse events following immunisation and vaccine administration errors

APIs must report any AEFI to the Immunisation team, CDPU. This also includes any vaccine administration errors (VAE), for example giving expired vaccines, incorrect intervals between vaccines, incorrect age for vaccine etc. The requirements and forms for reporting an AEFI or VAE are available on the DoH Immunisation webpage; completed AEFI forms must be returned via email to [email protected].

AEFI surveillance is conducted by the CDPU and the Therapeutic Goods Administration (TGA) to establish vaccine safety in Australia. CDPU supports consumers and providers to complete a report and provides advice after individuals who have experienced an AEFI. Providing information about an AEFI to CDPU will help detect potential problems with vaccines or systems as early as possible and, will help to deliver safe vaccination program in Tasmania.

Maintaining cold chain

All immunisation providers must follow the principles of safe vaccine storage and cold-chain management to ensure clients receive the most effective and potent vaccines possible.

Immunisation providers are required to maintain vaccines in a manner that is consistent with the recommendations in Strive for 5, noting this is a condition to receive a Program Approval. This also includes off-site immunisation clinics.

Reporting a cold chain breach

• Cold chain breaches involving government funded vaccines must be reported to the Immunisation team, CDPU as soon as possible on 1800 671 738. 
• Cold chain breaches involving COVID-19 vaccines must be reported to the Vaccine Operations Centre (VOC) on 1800 318 208.

Pre-vaccination assessment and consent

Vaccine temperatures recorded below +2°C or above +8°C must be reported to the Immunisation team immediately. This does not include temperature deviations or excursions in which the temperature reaches a maximum of up to +12°C for ≤15 minutes. 

Any vaccine impacted by a cold chain breach should be immediately isolated and retained within a monitored vaccine refrigerator and be clearly labelled with “do not use” until a thorough assessment has been conducted by a member of the Immunisation team; do not use or discard any vaccine(s) without an assessment first being conducted. 

In the event of a cold chain breach related to privately purchased vaccine stock (i.e. non-NIP vaccines), the pharmacist should contact the vaccine manufacturer for advice.

An API must obtain valid consent from any individual being vaccinated and/or their parent/guardian. As part of informed consent, a pre-vaccination screening must be completed prior to administering a vaccine to identify if contraindications or precautions to vaccination exist. 

A pre-vaccination screening checklist is included in the AIH and must be completed prior to all vaccinations. It is recommended that the AIR is routinely checked as part of pre-vaccination screening to avoid vaccination administration errors (eg. incorrect dose intervals or dose numbers being administered).

Prior to obtaining consent, the individual or the parent/guardian of the individual being vaccinated, should be:

• supplied information (preferably written) which includes the risks and benefits of vaccination and what to do in the event of side effects. This should include the name and contact details of the Pharmacy 
• provided with information of any fees that will be charged to the individual or the individual’s parent/ guardian for the vaccine and the service
• notified that the individual’s vaccination record will be reported to the AIR.

APIs should have a process to obtain and document individual consent, and to ensure that individual privacy and confidentiality are always upheld. 

Providing immunisation services in RACHs

Consent must be obtained from the resident or medical power of attorney. It is recommended that the AIR is routinely checked as part of pre-vaccination screening. To support robust clinical documentation and communication, the AI must inform the resident’s general practitioner of the vaccination encounter and must report provision of that vaccine to the AIR in a timely fashion.

Pharmacists should understand the potential risks associated with vaccinating residents of RACHs and should seek advice from the resident’s general practitioner where there is uncertainty or incomplete medical information. The client should be referred to their general practitioner for assessment and/or vaccination if any uncertainty remains or the client cannot provide consent. 

Consent on behalf of a child or adolescent

In general, a parent or legal guardian of a child or adolescent has the authority to consent to that individual being vaccinated. 

Some Australian states and territories have legislation that addresses the issue of a child’s consent to medical treatment. The common law applies in the states and territories that do not have specific legislation relating to children’s consent to medical treatment. This common-law position is often referred to as Mature Minor or Gillick Competence.

For certain procedures, including vaccination, a child or adolescent may be determined to be mature enough to understand the proposed procedure, and the risks and benefits associated with it. These young people may have the capacity to consent under certain circumstances.

As outlined in the AIH, where the parent and/or guardian of the individual being vaccinated is not present, AIs must assess whether the individual is mature enough and has the capacity and sufficient maturity to understand the advice and implications of the vaccine and consent to the procedure.

AIs who elect not to administer a vaccine based on their assessment of the individual’s maturity and understanding should refer the individual back to their medical practitioner.

If a child or adolescent refuses a vaccination that a parent and/or guardian has provided consent for, respect the child/adolescent’s wishes. Do not vaccinate and inform the parent or guardian.

Post-vaccination observation

The AI must advise the individual or the individual and their parent and/or guardian to remain on the premises for a minimum of 15 minutes post-vaccination, to allow for immediate assistance in the event of an AEFI.

The AI must either observe, or direct an appropriate person to observe, the vaccinee for 15 minutes after vaccination for acute adverse events or anaphylaxis.

The AI must inform the individual, or the parent/guardian of the person being vaccinated, of the potential risks associated with leaving during the post-vaccination period and put a note in the record of vaccination if the individual chooses to do so.

If a vaccinated person begins to display signs and symptoms of anaphylaxis, typically within 15 minutes of receiving a vaccine, a dose of adrenaline should be administered as soon as possible, and an ambulance called. The risk of death due to anaphylaxis is far greater than the risk posed by administering a dose of adrenaline.

Record keeping

Consent forms and vaccination records must be retained in a form that can be recovered and printed for a minimum of seven years, or longer. These documents should be stored in a format and location that allows timely access, easy retrieval and protects individual confidentiality. Records must be retained and provided in accordance with the relevant legislation and regulations. 

All Tasmanian AIs are required to comply with the record-keeping requirements, relevant legislation, and the documentation recommendations of the AIH. They must record the following details for each vaccine administered:

• time and date of the vaccination
• name, form, and strength of the vaccine, including brand name, batch number and dose number
• name, date of birth and address of persons to whom the vaccine is administered
• name and contact details of the AI carrying out the administration
• injection site and route
• date the next vaccination is due (if applicable)
• any adverse events observed or reported (including delayed responses).

NIP vaccine reporting

All vaccination providers (including pharmacies) are required to report on NIP vaccine use and stock on hand prior to ordering additional vaccines, which includes vaccine wastage (i.e. expired stock) and leakage (vaccines given to non-eligible patients). This is to ensure Tasmania meets the national reporting requirements as part of the NIP agreement. The CDPU is the custodian for NIP vaccines in Tasmania.

All NIP vaccine providers are subject to random audits, including for vaccine use, orders, and wastage.

Immunisation registers

The AIR is a national register that records vaccinations given to people of all ages in Australia.

Pharmacies must register with the AIR as part of the requirements to provide a vaccination service in Tasmania. Pharmacies can apply as a business to register with the AIR to obtain login details which enables the reporting of all vaccinations administered to the AIR. An AIR provider number is required to enable automated uploads to the AIR from your pharmacy’s software. Registration forms are available from the Australian Government Services Australia webpage. 

Vaccination Providers must register with the AIR as part of the requirements to provide a vaccination service in Tasmania. 

Registration forms are available from the Australian Government Services Australia webpage.

Under the AIR Act (2015), it is mandatory to report all NIP funded, influenza and COVID-19 vaccine encounters to the AIR. It is strongly recommended that all private and state funded vaccine encounters are also uploaded to the AIR.

For further information about the AIR and reporting vaccinations visit Australian Immunisation Register for Health Professionals

Fees

NIP funded vaccines

The NIPVIP Program commenced in January 2024. Eligible pharmacies can register for the program through the Pharmacy Programs Administrator (PPA) Portal. The NIPVIP Program Rules state that pharmacies may either:

• receive payment for the administration of NIP vaccines to eligible individuals from the Australian government, 

OR 

• charge the patient a service fee for the administration of that vaccine.

Please note that: 

• pharmacies cannot receive concurrent payments for the administration of NIP vaccines (i.e. through the PPA and private remuneration), and 
• cannot selectively charge NIP eligible patients for the administration of some NIP funded vaccines but not others; full participation is required to participate in the program. 

State funded vaccines

Please refer to the NIPVIP Program webpage for more information.

If choosing to charge clients a service for administration of the vaccine, the immuniser must advise the recipient (vaccinee) about the availability of funded vaccines and free vaccination services through other pharmacies, general practitioners and council vaccination clinics.

Pharmacies may charge a service fee(s) for the administration of vaccines to people who are eligible for state-funded vaccines (Hep B and MMR), however, cannot charge clients for the cost of the vaccine. 

Tasmania does not provide funding to support the administration of these vaccines.

Please note that a fee for the administration of state-funded vaccines cannot be claimed for under the NIPVIP Program.

Other vaccines

For those persons who are not eligible for government-funded vaccines, the pharmacist may charge for the cost of the vaccine plus an administration fee.

Complaints

The Department reserves the right to revoke or terminate authorisation of any AI or organisation who demonstrates unsatisfactory conduct. Where necessary, serious deviations from acceptable professional standards will be reported to the appropriate organisation.

APIs and pharmacies should develop a process for complaints regarding vaccination services. All individuals and providers who receive vaccination services should be aware that: 

• Complaints relating to the pharmacist’s professional practice should be directed to the AHPRA by phoning 1300 419 495 or visiting the AHPRA website at www.ahpra.gov.au.
• Complaints relating to the pharmacy premises should be directed to the Tasmanian Pharmacy Authority at [email protected]. 
• Complaints relating to the vaccination setting (non-pharmacy setting) should be directed to the Immunisation team, Tasmanian DoH by email to [email protected] or by phone (03) 6166 0632. 
• Individuals may also bring a complaint against a pharmacy to the Pharmaceutical Services Branch on (03) 6166 0400 or [email protected].

Contact Us

If you have any questions regarding these guidelines or for clinical guidance, please contact the Immunisation Unit, CDPU, via email: [email protected] or phone on (03) 6166 0632.

To obtain a copy of the Approved Pharmacy Program Independently Initiated Vaccines Flowchart please email: [email protected] or phone on (03) 6166 0632.