A registered pharmacist initiating and administering influenza vaccine under his/her own authority to a person aged 18 years or older in a NSW retail pharmacy 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 influenza vaccine only when under the supervision of a pharmacist who holds general registration, has completed an accredited vaccination training course and has determined influenza vaccination is appropriate for the particular person.
The pharmacist must complete a training course accredited to accord with the current version of Australian Pharmacy Council Standards for the Accreditation of Programs to Support Pharmacist Administration of Vaccines.
The training course must be conducted by an accredited Continuing Professional Development Accrediting Organisation.
Training courses for pharmacists are currently provided by the Pharmaceutical Society of Australia and Pharmacy Guild of Australia. Pharmacists should contact the Society and/or the Guild for further information on course availability.
Pharmacists that have completed previous training on conducting vaccinations, including interstate, should contact the training provider to ascertain if the course meets the NSW requirements under the Regulation.
The following requirements are in the NSW Pharmacist Vaccination Standards.
The pharmacist must hold a certificate confirming competency to vaccinate following completion of an accredited training program (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 following:
The pharmacist should adopt or follow the following professional guidelines:
The pharmacist must ensure that when administering the influenza vaccine an appropriately trained pharmacy staff member is present.
Pharmacy premises and equipment
The pharmacist must conduct the vaccination in an immunisation service room, consulting room or immunisation area of the pharmacy premises. The room or area may be dedicated for the purpose or an existing consulting room used. The room or area is not to be used as a dispensary, storeroom, staff room or retail area.
The immunisation service room, consulting room or immunisation area must be consistent with the following:
- not permit the vaccination to be visible or audible to other persons in the pharmacy
- 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, 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, and
- 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 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
- 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
- the Australian Immunisation Handbook
- National Vaccine Storage Guidelines – Strive for 5, and
- a process to regularly monitor on-line updates to The Australian Immunisation Handbook, including prior to administering influenza vaccine.
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 not vaccinate a person with a contra-indication or precaution to vaccination listed in the The Australian Immunisation Handbook.
Reporting to the person’s general practitioner
The pharmacist must provide a copy of the person’s record of vaccination (as specified in Recording vaccinations) directly to the general practitioner nominated by the person to receive the information.
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 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.
The pharmacist must record the vaccination with the following information:
- the person’s name, address, date of birth and contact details
- the name and contact details of the person’s primary medical practitioner
- the brand, batch number and expiry date of the vaccine
- the part of the body to which the vaccine was administered
- the date on which the vaccine was administered
- the pharmacist’s name and contact details and his or her certificate of accreditation number
- the address of the pharmacy at which the vaccination was administered, and
- a 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.
For further information contact the Duty Pharmaceutical Officer at Pharmaceutical Services Unit, NSW Ministry of Health by telephone on (02) 9391 9944 or email email@example.com. See also the NSW Ministry of Health TG79/32 Guide to the Poisons and Therapeutic Goods Legislation for Pharmacists.