Vaccinations Outside of General Practice - 2011 (Revised 2016)

25 Nov 2011

1. Introduction

Vaccination is one of the most successful and cost-effective health interventions. Vaccination against vaccine-preventable disease (VPD) is a proven method of reducing the incidence of, and deaths from, diseases such as measles, tetanus, diphtheria, and Haemophilus influenza type B. Australia’s comprehensive vaccination program means that the occurrence of VPD is now very rare[1]. This, together with improved vaccination rates[2] means Australia has an excellent record of achievement in the prevention of disease through immunisation.

The Global Vaccine Action Plan 2011-2020[3] encourages countries to demonstrate a commitment to immunisation by setting ambitious but attainable national targets. Australia has set the national aspirational coverage target at 95 per cent for the percentage of children who have received all the vaccines recommended for their age.

In order to maintain Australia’s vaccination record and strive towards the national aspirational target the community must be confident in the safety and quality of vaccination services. This position statement outlines the principles for conducting vaccinations outside of general practice that the AMA believes will ensure safety and quality.

2. Delivery of vaccination services

Vaccination services are delivered by a range of providers in a variety of settings. GPs, however are the predominant provider of vaccination services in Australia. GPs see 93%[4] of children in the 0-6 year age group an average of seven times a year and currently deliver 73%[5] of all vaccinations in this cohort. In addition to delivering vaccinations in their general practices, GPs are regularly contracted by State Governments to deliver the childhood vaccination programs provided through schools and community centers.

Vaccination clinics may also be provided by GPs outside of their practice. GPs may be contracted to provide workplace seasonal influenza vaccinations or in cases of emergency, such as a pandemic or outbreak of a preventable disease where herd immunity levels are low, may provide vaccinations at a place convenient to the community.

3. Safety and Quality

The vast majority of GPs (90.4%[6]) work in an accredited practice. Where vaccinations are provided within an accredited general practice patients can be confident that the practice has appropriate processes in place to maintain the potency of vaccines. Such processes are a requirement under the RACGP Standards of General Practice against which practices are accredited. Approximately 67% of general practices are accredited.[7]

Whether vaccinations are provided by accredited or non-accredited practices, it is incumbent upon all medical practitioners that they adhere to the principles of good medical practice as provided for in the Medical Board of Australia’s Good Medical Practice: A Code of Conduct for Doctors in Australia[8].

From a safety and quality perspective, vaccinations provided outside of general practices, such as in pharmacies, nurse clinics, aged care facilities, and military posts, whether delivered by GPs or by other medical or health professionals, should be subject to the same safety and quality requirements as those provided within a general practice, and the providers should be subject to the same level of accountability.

This is particularly important with regard to:

  • ensuring patients are medically advised so they may give informed valid consent;
  • pre-vaccination screening;
  • vaccine potency;
  • adherence to occupational health and safety standards;
  • being prepared for, equipped and trained to manage anaphylaxis;
  • monitoring for, recognising and treating any adverse reaction;
  • record keeping; and
  • reporting adverse events to the appropriate authorities.

To ensure patient safety and the potency of vaccines, providers of vaccinations outside of general practices should therefore be required to meet a minimum set of standards that are compliant with governing regulations and existing guidelines and best practice.

4. Existing Guidelines for Vaccinations

The National Vaccine Storage Guidelines: Strive for 5[9] provides practical advice to Australian vaccination service providers about maintaining the cold chain and preventing and managing cold chain breaches. The guidelines highlight the importance of storing vaccines at between +2°C to +8°C to maintain potency. They also discuss protocols for purchasing, transporting, storing, managing and monitoring the temperature consistency of vaccine stocks.

Australian General Practice Accreditation Limited (AGPAL) and General Practice Accreditation (GPA) utilise the procedures and protocols outlined in the guidelines when assessing if general practices meet criterion regarding vaccine potency, under the standard for clinical support processes in the current edition of the RACGP standards for general practice.

The National Immunisation Handbook 10th Edition[10] provides clinical guidelines for health professionals on the safest and most effective use of vaccines. The Handbook is updated as an online resource between editions. Electronic updates to the Australian Immunisation Handbook are available via the Immunise Australia website. The handbook currently consists of:

  • Part 1 – Introduction
  • Part 2 – Vaccination procedures, which outlines the procedures necessary with each vaccination including:
    • Pre-vaccination (cold chain, anaphylaxis response kit, consent, pre- vaccination screening and catch-up)
    • Administration of vaccines (route, needle size and injection site)
    • Post-vaccination (adverse event reporting and recording of vaccinations)
  • Part 3 – Vaccination of special risk groups
  • Part 4 – Vaccines-preventable diseases
  • Part 5 – Passive immunisation

State/Territory legislations determine who has access to and can administer vaccines and the reporting requirements of an adverse event following immunisation. State/Territory legislations are not always consistent with each other in this regard. The principles listed below account for the legislative differences. All vaccines must be administered in accordance with relevant legislation, best practice and the guidelines and recommendations as outlined in the Australian Immunisation Handbook (current edition and update).

5. Principles for Conducting Vaccinations Outside of General Practice

The AMA believes best practice is for vaccination to be provided by a medical practitioner or by a nurse under the supervision of a medical practitioner.

Where States/Territories have legislated to allow “Authorised Immunisers” (including nurses, midwives, pharmacists and ATSI Health Care Workers) to administer vaccines independent of a medical order, each jurisdiction should have guidelines for immunisation providers who employ an “Authorised Immuniser”.  These guidelines should be used in conjunction with the professional standards and guidelines that apply to each health discipline.

The following principles have been developed to provide a consistent framework for immunisations conducted outside of general practices:

Providers of vaccination outside general practice must:

  • Be authorised under State/Territory legislation to obtain and administer vaccines. (In some jurisdictions a nurse administering a medication without the express consent of a (governing) doctor is a breach of the Medical Act, as it is deemed to be 'prescribing'. Mass immunisations should not proceed unless legislative requirements are met.)
  • Be a medical practitioner; or
    • Be a registered nurse; under the relevant National legislation and practising in line with relevant State/Territory legislation; and
      • Hold a statement of proficiency in cardio-pulmonary resuscitation; and
      • Have completed an immunisation accreditation program and maintain authority to immunise; and
      • Be employed in connection with a vaccination program in a health service or a place of work.
    • Act in accordance with the procedures specified in the National Health and Medical Research Council’s The Australian Immunisation Handbook – particularly with regard to:
      • appropriate pre-vaccination screening;
      • obtaining valid informed consent; and
      • having an appropriately prepared anaphylaxis response kit on site.
    • Have appropriate procedures in place to maintain cold chain as specified in the National Vaccine Storage Guidelines: Strive for 5[11]; at all stages of receiving, holding and transporting the vaccines, together with supporting documentation.
    • Act in accordance with relevant State/Territory legislation.
    • Report any suspected adverse reaction following immunisation to the Therapeutic Goods Administration (TGA).
    • Keep complete records of administration including patient name, address, contact details, vaccination name and brand, batch no, site of immunisation and length of stay at place of administration after giving the vaccination.
    • Provide the vaccine recipient with a record/certificate of vaccination.
    • Advise the vaccine recipient’s nominated GP of the vaccination.
    • Adhere to all Privacy and confidentiality requirements including relevant guidelines for documentation maintenance and duration of storage. 

The AMA is of the view that the Australian Commission on Safety and Quality in Healthcare (or similar body) should use these principles as the basis for developing standards to ensure safe and quality practice where immunisations are provided outside of accredited general practices.

At a minimum, in the interests of patient health, the AMA encourages any provider delivering vaccine services outside of general practice to adhere to the above principles.

[1] The Australian Immunisation Handbook, 10th Edition, Department of Health, 2015

[4] Immunise Australia: The Seven Point Plan, Dept. of Health and Ageing 1997.

[5] ACIR provider statistics as at December 2015

[6] BEACH Report (2015) General Practice Activity in Australia 2014-15

[7] ANAO (2011) PIP Performance Audit Report No. 5, 2010-11

[8] Medical Board of Australia (2014) Good medical practice: a code of conduct for doctors in Australia.

[10] Ibid

[11] Ibid