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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.

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 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 supervision of a pharmacist 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 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.

Component 2/3: Practice standards

The following requirements are in the NSW Pharmacist Vaccination Standards:

General requirements

The pharmacist 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).

The pharmacist must obtain a cardio-pulmonary resuscitation (CPR) certificate annually.

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

The pharmacist must comply with the:

The pharmacist should adopt or follow:

The pharmacist must ensure that when administering vaccines an appropriately trained person is present.

The pharmacist must check an individual’s vaccination status on the Australian Immunisation Register (AIR) prior to administering a vaccine and subsequently record any vaccines 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 may administer authorised vaccines in the following settings:

  • Retail pharmacy
  • General Practice
  • Aboriginal Medical Services
  • Local Council Clinics
  • Private Hospitals
  • Public Hospitals and health services
  • Community Health Centres
  • Aged Care Facilities
  • Staff Occupational Health Clinics (clinics held in the workplace to vaccinate staff)

The pharmacist 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 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 must obtain written consent from the person before the vaccination and must retain this consent for seven years (in accordance with the Health Records Information and Privacy Act).

The pharmacist must undertake a thorough pre-vaccination assessment in accordance with the recommendations in the digital Australian Immunisation Handbook.

During pre-vaccination assessment, the pharmacist 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 must not vaccinate a person with a contra-indication or precaution to vaccination listed in the digital Australian Immunisation Handbook.

Post vaccination care of the patient

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

The pharmacist 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 must notify the adverse event to the local Public Health Unit by telephone on 1300 066 055.

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Component 3/3: Recording vaccinations

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

In the event that the patient being vaccinated has no primary medical practitioner the pharmacist should include in the patient record the name and contact details of the medical practitioner last seen by the patient or record that the patient has no primary medical practitioner

NSW Health is undertaking quality assurance audits of randomly selected pharmacies to gain a greater understanding of pharmacist compliance with the NSW Pharmacist Vaccination Standards. The Pharmaceutical Society of Australia and the Pharmacy Guild of Australia were consulted on the development of the Audit Tool.

 

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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Page Updated: Monday 10 August 2020
Contact page owner: Immunisation