A refresher on the key responsibilities for pharmacists who conduct vaccinations
The Australian Federal Government has announced that pharmacists will play a key role in the COVID-19 vaccination rollout strategy. Phases 2 and 3 of the vaccine rollout involve administering the vaccine in multiple locations, including community pharmacies. Phase 2 of the vaccine rollout commenced in May 2021 and on 22 July 2021, Prime Minister Scott Morrison announced that 3930 community pharmacies across Australia would be eligible to join the COVID-19 vaccination roll-out. All pharmacies/ pharmacists seeking to join the COVID-19 vaccination roll-out will need to have undergone all relevant training to ensure that all vaccines are administered in a safe and legal manner.
There are strict legal requirements for any pharmacist who wishes to become involved in vaccination. In NSW for example, section 48A of the Poisons and Therapeutic Goods Regulation 2008 (NSW) permits pharmacists to administer certain vaccines and NSW Health has published the NSW Pharmacist Vaccine Standards. Similar Pharmacist Vaccination Standards, Guidelines or Codes apply in other states and territories and it is important that pharmacists across Australia are familiar with the vaccination requirements relevant to the state or territory in which they practise.
In NSW, the standards set out three main requirements that pharmacists have to achieve:
- Completing an accredited vaccination training course
- Conducting all aspects of vaccination, including storage, to the approved practice standards, and
- Recording each vaccination sufficiently.
Any pharmacist who wishes to administer vaccines needs to complete a training program accredited by the Australian Pharmacy Council. They must also hold a CPR certificate which is not greater than 12 months old.
Pharmacists need to ensure that they have completed training for all authorised vaccines that they intend to administer.
For the supply and administration of a COVID-19 AstraZeneca vaccine, pharmacists must also complete core and additional COVID-19 training modules from the COVID-19 vaccination training program developed by the Commonwealth Department of Health; and a training module on the Oxford University AstraZeneca vaccine.
In addition, pharmacists must remain up to date on any new advice from the Australian Technical Advisory Group on Immunisation (ATAGI) or the Therapeutic Goods Administration (TGA) regarding additional precautions or consent requirements for COVID-19 vaccines.
Standards and Practice
Storage and transportation
All vaccines must be transported and stored within specific temperature ranges to ensure they retain their efficacy. In order to achieve this, pharmacists must:
- Comply with the Department of Health’s ‘National Vaccine Storage Guidelines – Strive for 5’ and have a copy accessible.
- Store vaccines in a purpose-built refrigerator within the required temperature range.
- Audit vaccine storage at least every 12 months and monitor the temperature of vaccine refrigerators twice daily.
- Report any breaches of sufficient storage temperatures and obtain advice as to the viability of affected vaccines.
- Train staff in correct storage procedures.
- Ensure regular maintenance of refrigerator, data logger and thermometer.
- If transporting any vaccines offsite, ensure an appropriate cooler with sufficient ice packs is used.
Administration of Vaccines
When administering a vaccine:
- Comply with the Department of Health’s ‘The Digital Australian Immunization Handbook’ and have a copy accessible.
- Undertake a pre-vaccination assessment (including a medical and allergy/ hypersensitivity history), and not administer any vaccine if contraindicated. Refer the patient to a medical practitioner if the patient has a contraindication or precaution to the vaccine.
- Check the individual’s status on the Australian Immunisation Register (AIR) prior to administration of a vaccine.
- Vaccinations must be administered in a separate room/area which fulfils the requirements.
- Advise all patients to remain on the premises for 15 minutes after vaccination, to be observed by the pharmacist or a qualified member of staff.
- Warn patients of the potential risks.
- Manage any adverse reactions and notify the local public health unit by telephone.
- In the event of anaphylaxis, properly administer adrenaline and ensure an ambulance is called.
- Ensure that at least one other appropriately trained pharmacy staff member is also present, who is trained to assist in an emergency situation.
The guidelines also require that specific equipment be available in any pharmacy where vaccines are to be administered. This includes:
- 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 safely and securely 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
- A process to regularly monitor on-line updates to ‘The digital Australian Immunisation Handbook’, including prior to administering any vaccine.
The pharmacy must have a dedicated room or area which is properly outfitted for vaccination. This means it must have the following features:
- Not used as a dispensary, storeroom, staff room or retail area
- Adequate privacy
- Adequate lighting
- Comfortable ambient temperature
- Hand sanitisation facility
- Ready access to a hand washing facility
- Sufficient clear floor area to accommodate the person receiving the vaccination and an accompanying person, and to allow the pharmacist adequate space to move
- Sufficient bench space, a chair and a first aid couch (or similar).
There are strict requirements as to the information that must be recorded after each vaccination. As well as keeping a copy on a pharmacist’s own records, Australia utilises the nationwide Australia Immunisation Register, and pharmacists are responsible for ensuring that the following information is uploaded after each vaccination:
- 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 or another means to link the pharmacist’s identity and registration status to the administration.
- The address of the pharmacy or premises at which the vaccination was administered, and
- A unique reference number for the supply and administration.
Prior to administering a vaccine, the pharmacist must also ensure that they obtain written consent from the patient, which they are required to retain for seven years. In some circumstances, verbal consent may be obtained, proof of which must also be recorded and retained for seven years. They must also make a note of any patient who chooses to leave the premises less than 15 minutes after the vaccine has been administered.
For each patient to whom a COVID-19 vaccine is supplied, the pharmacist must obtain written consent (or in some circumstances, verbal consent that is documented) and retain a copy of that consent, using the Australian Government Department of Health’s COVID-19 Vaccination Consent Form for COVID-19 vaccination.
As Australians roll up their sleeves in the race to get vaccinated, now is a key time to ensure that pharmacists are properly trained and ready to join the COVID-19 vaccination roll out.
Pharmacists must maintain the applicable legal standards relevant to their state or territory to administer all vaccines, not only for the safety of patients, but to maintain and bolster their reputation as a legitimate option for vaccine distribution.
This article was written by Solicitor Nick Audet and Principal Chandrika Darroch. Please contact Chandrika if you have any questions or require further information.
The Australian Immunisation Handbook – https://immunisationhandbook.health.gov.au/
National Vaccine Storage Guidelines – ‘Strive for 5’ – https://www.health.gov.au/sites/default/files/documents/2020/04/national-vaccine-storage-guidelines-strive-for-5.pdf