Pharmacist Vaccination in Queensland – Frequently Asked Questions

• Are pharmacists now allowed to vaccinate in Queensland?
  On the March 24 2016, the Health (Drugs and Poisons) Regulation 1996 (HDPR) was amended to authorise trained pharmacists working in community pharmacies to administer certain vaccines to consenting adults under conditions specified in the Drug Therapy Protocol (DTP) and the Queensland Pharmacist Vaccination Standard (Standard). This was following the success of the Queensland Pharmacist Immunisation Pilot (QPIP).

QPIP aimed to investigate the benefits of registered pharmacists providing influenza vaccines to members of the public in the setting of a community pharmacy. The pilot ran from January 2014 until 31st March 2016. In that time over 35,000 vaccinations for influenza, pertussis and measles were administered to adults in Queensland. Approximately 13% of people in the trial had never had an influenza vaccination. Overall the pilot program demonstrated that appropriately trained pharmacist delivered vaccination for adults is effective and may safely be undertaken in the community pharmacy setting.

Pharmacists who participated in QPIP

• My pharmacy was part of QPIP, do I need to do anything else to comply with the amendment to the HDPR?
  QPIP pharmacists should refer to the Queensland Pharmacist Vaccination Standard for this information. The pharmacy premises itself no longer requires a separate approval. Vaccinating pharmacists should note that it is their responsibility to ensure the pharmacy premises complies with the Standard. If the pharmacy premises does not comply with the Standard, the vaccinating pharmacist should not administer vaccines and should consult with the pharmacy owner for rectification.

It is important for QPIP pharmacists to note information in the Standard about the pharmacy requirements, particularly those surrounding Infection Control Management Plans and patient record keeping.

• Do I still need a current Section 18 approval?
  No, pharmacists who completed the training program for the Queensland Pharmacist Immunisation Pilot I and II (QPIP I & II) are authorized to administer vaccines under the new amendment and no longer require a Section 18 approval. You will be sent a new “training certificate” to display in the pharmacy that will comply with the Standard.
• What if I’m currently waiting for Section 18 approval?
  Under the new amendment you no longer require a Section 18 approval. Having completed an approved training program you are authorized to administer vaccines under the amendment. You will be sent a “training certificate” to display in the pharmacy that can accompany the certificate of attainment you have already received on completion of the training program.
• Do I still need to complete the QPIP Research documents and send back to QUT?
  No, if you were participating in the QPIP pilot, you no longer need to complete the pilot documentation. The project team will be in contact with you soon to organize the return of the pilot documents. You will need to continue to record patient consent to receive the vaccination itself, as per the Standard, including retaining the necessary documentation and patient records.
• Do I need to return the MMRs provided by Queensland Health during the pilot?
  No, any remaining MMRs can be retained for use by pharmacies under the provisions of the new DTP for suitable patients. Queensland Health will not be providing any further MMR vaccines to pharmacies in the future, pharmacists can source and administer them in the same way they would whooping cough and influenza vaccinations.

General

• What does a pharmacist need to do to start vaccinating adults?
  The amendment to the Health (Drugs and Poisons) Regulation 1996 allows pharmacists to administer vaccinations under the pharmacist vaccination program Drug Therapy Protocol (DTP) which requires a pharmacist to act in accordance with:
  • The Australian Immunisation Handbook
  • Queensland Pharmacist Vaccination Standard (Standard)
    These documents specify the training a pharmacist must complete, the facilities and equipment required and the necessary procedures, records and reporting requirements (e.g. adverse drug reactions (ADRs) which need to be followed. The documents also specify the training required by non-pharmacist support staff in circumstances where two registered pharmacists are not present.
• Who can be vaccinated by a pharmacist?
  A pharmacist may vaccinate adults aged 18 years and over.
• Who can’t be vaccinated by a pharmacist?
  The HDPR does not allow pharmacists to vaccinate:
  • Children under 18 years of age
  • Patients with contraindications or cautions to vaccination as listed in the current edition of the Australian Immunisation Handbook, who are considered unsuitable for pharmacist vaccination and should be referred to their local medical practitioner.

• Can I vaccinate patients who qualify for the National Immunisation Program?
  Patients who qualify for the National Immunisation Program (NIP) must be offered referral to their local General Practitioner or other participating NIP service, but may be vaccinated in the pharmacy if they decline the referral and are advised of the cost to them of the service.
• Which vaccines can be administered under the current drug therapy protocol?
  • Influenza vaccine – intramuscular injection
  • Diphtheria-tetanus-acellular pertussis vaccine – intramuscular injection
  • Measles-mumps-rubella vaccine – subcutaneous injection

Adrenalin (Epinephrine) in a strength of 0.1% or less in a preloaded device (auto injector) or in an ampoule can be administered as an intramuscular injection for use in the treatment of anaphylaxis only.

• Do I need a prescription from a doctor to administer the vaccinations?
  No, a pharmacist may supply and administer the vaccines as outlined in the DTP and in accordance with the HDPR without a prescription.

Training

• As a pharmacist, what training do I need to do?
  Pharmacists authorised to administer vaccines and adrenaline in accordance with the HDPR are to:
  • have successfully completed either of the following:
    o prior to 31 March 2016, the training program for the Queensland Pharmacist Immunisation Pilot I and II (QPIP I & II)
    or
  • from 1 April 2016 – successfully completed a training program accredited to meet the standards set by the Australian Pharmacy Council’s ‘Standards for the accreditation of programs to support Pharmacist Administration of vaccines’
    and
  • hold a current Australian recognised qualification in first aid which includes Cardiopulmonary Resuscitation (CPR) and anaphylaxis management
    or
  • hold a current first aid certificate and a certificate in anaphylaxis management.
• Do I need to complete ongoing training?
  Pharmacists must ensure that they undertake yearly Continuing Professional Development (CPD) in the area of immunisation to ensure they are up to date in their practice.

Where the time elapsed since initial practical training is more than 12 months and where a pharmacist has not administered at least two (2) subcutaneous measles vaccines in the preceding 12 months, practical refreshment of this subcutaneous injection technique and review of the measles recommendations, contraindications, precautions and possible adverse events as specified in the Australian Immunisation Handbook must be undertaken before administration of a measles-containing vaccine.

• Do I need to display evidence of my training?
  Yes, consumers must be able to assure themselves that the pharmacist who will vaccinate them has successfully completed the required training. This may be achieved in a number of ways such a displaying a copy of a certificate of training completion in the consulting room or including a statement of training completing the information materials provided to consumers at the time of consent.
• Where can I complete first aid and cardiopulmonary resuscitation qualifications?
  Pharmacists can complete first aid training and CPR through any accredited training provider. Please note that the CPR component has a currency of 12 months and the first aid component has a currency of 3 years.
• What training do I need to do to cover anaphylaxis management?
  The anaphylaxis management training can be completed online via the Australasia Society of Clinical Immunology and Allergy (ASCIA). In addition anaphylaxis management may be reinforced as a component of the first aid training.
• Do two pharmacists have to be present while vaccinating services are being provided?
  Ideally, the pharmacy should have two pharmacists available at any one time – one to act as the dedicated vaccinator and the other to manage the general business of the dispensary. Pharmacies with only one pharmacist on duty may provide vaccinating services but must assess their workflows to ensure they are able to provide uninterrupted care to an individual patient when vaccinating, and have staff on-site with current training in first aid (including CPR and management of anaphylaxis) that can assist in providing after-vaccination care or managing an emergency situation.
• What other requirements are there for the vaccinating pharmacist?
  Pharmacists must ensure they are registered with The Pharmacy Board of Australia (PBA) via The Australian Health Practitioner Regulation Agency (AHPRA) without any registration conditions of relevance to safe vaccination.
• Are intern pharmacists allowed to vaccinate?
  Pharmacists with provisional registration may provide vaccinations provided they have completed the appropriate training and are observed and directly supervised by a registered pharmacist who is also lawfully allowed to vaccinate in Queensland.
• Is a pharmacist allowed to vaccinate at locations other than a community pharmacy?
  No, vaccine administration by pharmacists is only to be conducted at pharmacy premises which are compliant with the Standard.
• Am I allowed to vaccinate in other states and territories?
  Pharmacists must consult and comply with the requirements of each state and territory health department.
• Where can I find the requirements of the pharmacy premises and the equipment needed for the service?
  Pharmacists should refer to the Queensland Pharmacist Vaccination Standard for this information. Please note that the pharmacy premises do not need to complete a separate approval process.

Pharmacists working in QCPP accredited pharmacies should refer to the QLD QCPP support team on 07 3831 3788 or qcpp@qldguild.org.au for further information on the QCPP requirements regarding consultation rooms.

• What documented procedures do I need?
  Pharmacists should refer to the Queensland Pharmacist Vaccination Standard for the list of procedures required.

Pharmacists working in QCPP accredited pharmacies should refer to the QLD QCPP support team on 07 3831 3788 or qcpp@qldguild.org.au for further information on how QCPP assists with meeting these requirements.

• What is an Infection Control Management Plan?
  In addition to the written policies and procedures listed above, pharmacy business owners are required to have an infection control management plan that has been prepared in accordance with the requirements of Chapter 4 of the Public Health Act 2005. Click here for more information.
• Do I need to get written consent from patients?
  The pharmacist is to obtain informed consent in accordance with requirements of the most recent edition of the Australian Immunisation Handbook. The pharmacist must record that informed consent was given and retain this information for seven (7) years from the date that consent was obtained as part of the documentation for the vaccination.
• What records do I need to keep?
  Pharmacists should refer to the Queensland Pharmacist Vaccination Standard for the recording requirements of the service. Records must be kept for seven (7) years from the date on which the vaccine was administered. Records may be kept electronically (e.g. Guildcare) or in hardcopy form.
• What do I need to do if a patient reports an adverse event following immunization?
  All vaccine reactions are to be notified to the Department of Health via the Adverse Event Following Immunisation (AEFI) reporting form available on the Queensland Health website.
• How much can the pharmacy charge for the vaccination (to the patient)?
  While QPIP had standardised pricing for research purposes, the new arrangements permit pharmacists to charge what is commercially appropriate to support the service.
• What advertising can a pharmacy do to promote its vaccination services?
  The Therapeutic Goods Administration has issued a reminder recently that pharmacists may advertise a ‘vaccination service’ to consumers but must not promote the vaccines, which are Schedule 4 medicines.
  Pharmacists are encouraged to refer to: Guidelines for advertising regulated health services (AHPRA, May 2014) and Advertising of vaccination services (TGA, 24 Mar 2016).
• Where do I order stock?
  Stock for approved vaccinations should be able to be sourced from the pharmacy’s wholesaler. Stock should be stored and managed in accordance with the National Vaccine Storage Guidelines Strive for 5 (current edition).
• Will pharmacists be audited to ensure their compliance with the standards?
  Yes, Officers authorised under the Queensland Health Act 1937 may request evidence to ensure that requirements have been met.

Health (Drugs and Poisons) Regulation 1996
http://www.legislation.qld.gov.au/LEGISLTN/CURRENT/H/HealDrAPoR96.pdf

Drug Therapy Protocol – Pharmacist Vaccination Program
https://www.health.qld.gov.au/publications/system-governance/licences/medicines-poisons/dtp-pharmacist-vaccination.pdf

Pharmacist Vaccination Standard
https://www.health.qld.gov.au/publications/system-governance/licences/medicines-poisons/standard-pharmacy-vaccination.pdf