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The NSW Poisons and Therapeutic Goods Regulation 2008 (clause 48A) authorises appropriately trained pharmacists in NSW to administer privately funded influenza vaccine, diphtheria-tetanus-pertussis (dTpa) and measles-mumps-rubella (MMR) vaccine to selected patients.

In 2021, this Regulation was updated to include COVID-19 vaccines as approved by the Secretary. The COVID-19 vaccines approved by the Secretary are the Vaxzevria (ChAdOx1-S) COVID-19 vaccine (‘AstraZeneca vaccine’), Comirnaty (BNT162b2 [mRNA]) COVID-19 vaccine (‘Pfizer vaccine’) and  Spikevax (elasomeran) COVID-19 vaccine (‘Moderna vaccine’).

All COVID-19 vaccines are fully funded by the Australian Government and must be provided free of charge to all individuals. This includes no charge for dispensing fee or consultations.

A registered pharmacist initiating and administering vaccines under his/her own authority must comply with the following three components of clause 48A of the NSW Poisons and Therapeutic Goods Regulation 2008 which prescribes rules for:

This provision applies to a pharmacist immuniser who holds general registration or provisional registration with the Pharmacy Board of Australia. A pharmacist with provisional registration who has completed an accredited vaccination training course may initiate and administer vaccines only when under the direct supervision of a pharmacist immuniser who holds general registration, has completed an accredited vaccination training course and has determined the vaccination is appropriate for the particular person.  

Component 1/3: Pharmacist training

The pharmacist immuniser must complete a training course that complies with the Australian Pharmacy Council 'Standards for the Accreditation of Programs to Support Pharmacist Administration of Vaccines' (current version). The training course must be conducted by an Australian Pharmacy Council accredited pharmacy education program provider.

The pharmacist must ensure that they have completed training for all authorised vaccines that they intend to administer. To maintain authority to immunise, the pharmacist immuniser must annually review best practice policy for immunisation.

For the purpose of supply and administration of any COVID-19 vaccine, a pharmacist immuniser, in addition to the above requirements, must also successfully complete the Australian Department of Health COVID-19 Vaccination training Program as well as all the relevant additional training modules on the specific   COVID-19 vaccines being administered.

All pharmacist immunisers must ensure they remain up to date on any new advice from the Australian Technical Advisory Group on Immunisation (ATAGI) or the Therapeutic Goods Administration (TGA).

For the purpose of supply and administration of dTpa, MMR and influenza vaccinations, the pharmacist immuniser must annually review best practice policy for immunisation, to maintain authority to immunise. CPR certification is also required every 18 months to maintain authority.

Component 2/3: Practice standards

The following requirements are in the NSW Pharmacist Vaccination Standards:

General requirements

The pharmacist immuniser must hold a certificate confirming competency to vaccinate following completion of an accredited training program for all authorised vaccines that they intend to administer (see Pharmacist training), noting the additional training required for administration of any COVID-19 vaccines.

The pharmacist immuniser must obtain a cardio-pulmonary resuscitation (CPR) certificate every 18 months.

The pharmacist immuniser must vaccinate a person and provide management of an adverse event within the scope of pharmacist practice, professional knowledge and expertise.

The pharmacist immuniser must comply with the:

The pharmacist immuniser should adopt or follow:

The pharmacist immuniser must ensure that when administering vaccines an appropriately trained person is present. Appropriately trained person refers to a staff member who is able to directly monitor customers post injection if the pharmacist is unable to. This person should be able to identify if a person is having an adverse event and initiate first aid.

The pharmacist immuniser must check an individual’s vaccination status on the Australian Immunisation Register (AIR) prior to administering a vaccine and must subsequently report all vaccines to the AIR that they administer.

Patients who are not eligible for Medicare should be searched on the AIR using their details such as name and date of birth. Attempts should also be made to establish previous vaccination history. Vaccines that have been administered by the pharmacist are also able to be reported to the AIR using the patient’s personal details.

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Administration area and equipment

The pharmacist immuniser may administer authorised vaccines in the following settings:
  • Retail (community) pharmacy
  • General Practice
  • Aboriginal Medical Service
  • Local Council Clinic
  • Private Hospital
  • Public Hospital and health service
  • Community Health Centre
  • Residential Care Facility
  • Staff Occupational Health Clinic (clinics held in the workplace to vaccinate staff)

A pharmacist immuniser may supply/administer AstraZeneca (ChAdOx1-S) vaccine in the following settings:

  • Retail (community) pharmacy registered to participate in the COVID-19 vaccination program
  • Residential care facility
  • General Practice clinic registered to participate in the COVID-19 vaccination program
  • Aboriginal Medical Service registered to participate in the COVID-19 vaccination program
  • A clinic operated by the Royal Flying Doctor Service
  • Staff Occupational Health Clinic (clinics held in the workplace to vaccinate staff)
The pharmacist immuniser must conduct the vaccination in an immunisation service room, consulting room or immunisation area. This may be dedicated for the purpose during the vaccination service or an existing consulting room.

The immunisation service room, consulting room or immunisation area must:
  • not be used as a dispensary, storeroom, staff room or retail area
  • not permit the vaccination to be visible or audible to other persons
  • have adequate lighting
  • be maintained at a comfortable ambient temperature
  • have a hand sanitisation facility
  • have ready access to a hand washing facility
  • have sufficient floor area, be clear of equipment and furniture, to accommodate the person receiving the vaccination and an accompanying person, and to allow the pharmacist adequate space to manoeuvre.
  • have sufficient bench space (with an impervious surface), a chair and a first aid couch (or similar).

The pharmacist immuniser must have the following equipment consistent with the digital Australian Immunisation Handbook and National Vaccine Storage Guidelines – Strive for 5:

  • a temperature-monitored refrigerator manufactured (either exclusively or principally) for the purpose of storage of vaccines or temperature monitored portable cooler for mobile clinics
  • all necessary consumables required for vaccine administration
  • an appropriately sized sharps container to dispose of clinical waste including used syringes and needles
  • an in-date and complete anaphylaxis response kit
  • an emergency response protocol (preferably laminated) on display
  • access to the digital Australian Immunisation Handbook via website or phone app
  • National Vaccine Storage Guidelines – Strive for 5
  • a process to regularly monitor on-line updates to the Australian Immunisation Handbook, including prior to administering vaccines.

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Patient consent and eligibility

The pharmacist immuniser must obtain verbal or written consent (for all non-COVID vaccines) from the person before the vaccination and must retain proof of consent for seven years (in accordance with the Health Records Information and Privacy Act) (excluding COVID-19 vaccines).

COVID-19 vaccines require written or other electronic evidence of consent from each patient to whom a COVID-19 vaccine is supplied and retain a copy of that consent. The Australian Government Department of Health COVID-19 vaccination – Consent form is to be used in obtaining consent. The pharmacist immuniser must:

  • Provide information on the risk, benefits, rationale and purpose of the vaccine to the patient or parent/guardian for individuals aged 12-15 years of age or an adult that cannot consent for themselves.
  • Ensure that the consenting person has the authority to consent for the child or adult presenting for vaccination.
  • Provide the patient/parent/guardian with the vaccine specific COVID-19 vaccination – Consent form for COVID-19 vaccination.
  • Ensure the patient/parent/guardian understands the information sheet and has the opportunity to ask questions
  • Ensure the patient/parent/guardian has the opportunity to discuss benefits and risks using the latest benefits and risks information and advice provided by ATAGI and the TGA.
  • Refer the patient to a medical practitioner, if the patient/parent/guardian have further questions regarding benefits and risks of vaccination.
  • Ensure they remain up to date on any new advice from ATAGI or the TGA regarding additional precautions or consent requirements for the COVID-19 vaccines.

The pharmacist immuniser must undertake a thorough pre-vaccination assessment in accordance with the recommendations in the digital Australian Immunisation Handbook, in addition for all vaccines the pharmacist immuniser must also take a medical and allergy/hypersensitivity history. 

During pre-vaccination assessment, the pharmacist immuniser must check if the person is eligible for funded vaccines and advise all individuals who are identified as eligible of this, and of how to access the funded vaccines.

The pharmacist immuniser must not vaccinate a person with a contra-indication or precaution (other than those on anti-coagulant therapy) to vaccination listed in the digital Australian Immunisation Handbook, the ATAGI recommendations, or the TGA product information.

Post vaccination care of the patient

The pharmacist immuniser must advise the person to remain on the pharmacy premises for 15 minutes post vaccination and must advise the person of possible risks in leaving earlier than 15 minutes.

The pharmacist immuniser must provide each patient (and/or parent/guardian) with post-vaccination care as per the latest Australian Government, ATAGI or TGA advice in relation to what to expect following vaccination and provide advice on when to seek medical attention, following each administration of a vaccine.

The pharmacist immuniser must either observe, or direct an appropriately trained pharmacy staff member to observe, the person for 15 minutes post vaccination to monitor for acute adverse events or anaphylaxis.

The pharmacist immuniser must make notes in the record of vaccination (as specified in Recording vaccinations) when the person leaves the pharmacy premises earlier than 15 minutes post vaccination.

Management of adverse events

The pharmacist immuniser must be competent to manage anaphylaxis post vaccination including use of adrenaline consistent with the digital Australian Immunisation Handbook.

The pharmacist immuniser must ensure an ambulance is called to attend a person who experiences anaphylaxis post vaccination.

Immediately after the response to an adverse event is effected, the pharmacist immuniser must notify the adverse event to the local Public Health Unit by telephone on 1300 066 055. The pharmacist immuniser must also complete a National Adverse Events Following Immunisation (AEFI) reporting form. This is required for all vaccine adverse events, including COVID-19 vaccine AEFIs.

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Component 3/3: Recording vaccinations

The pharmacist immuniser must record the vaccination with the:

 

  • person’s name, address, date of birth and contact details
  • name and contact details of the person’s primary medical practitioner (if no current practitioner, record last medical practitioner seen or 'no primary medical practitioner') 
  • brand, batch number and expiry date of the vaccine
  • part of the body to which the vaccine was administered
  • date on which the vaccine was administered
  • pharmacist’s name and contact details and his or her certificate of accreditation number
  • address of the pharmacy at which the vaccination was administered
  • unique reference number for the supply and administration.

A copy of this record should be kept at the pharmacy for seven years. The pharmacist immuniser should make this record in the pharmacy’s computer dispensing system in the first instance, as for a medication dispensed on prescription. A printed or scanned copy of the record may be retained at the pharmacy after the two year retention period required under the NSW Poisons and Therapeutic Goods Regulation 2008.

The pharmacist immuniser must also record the details of the vaccine administered in the Australian Immunisation Register (AIR).

Additional information on the COVID-19 vaccination program for pharmacist immunisers is available on the COVID-19 vaccination: information for community pharmacists webpage 

For further information contact the Duty Pharmaceutical Officer at the Pharmaceutical Regulatory Unit, NSW Ministry of Health by telephone on (02) 9391 9944 or email MOH-PharmaceuticalServices@health.nsw.gov.au.

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Current as at: Friday 24 September 2021
Contact page owner: Immunisation