UNCONTROLLED WHEN PRINTED
Indications
  • A person who requires immunisation against seasonal Influenza (recommended annually).
Contraindications
  • Past history of Guillain-Barré syndrome
  • FLUARIX TETRA should not be administered to individuals with known hypersensitivity after previous administration of FLUARIX TETRA or influenza vaccines or to any component of the vaccine.
Patient Factors & Considerations
  • Patients must be well on the day of vaccination and provide voluntary consent prior to receiving the vaccination.
  • FLUARIX TETRA should under no circumstances be administered intravascularly.
  • As with other vaccines, vaccination with FLUARIX TETRA should be postponed in individuals suffering from an acute severe febrile illness.
  • Adverse event following immunisation (AEFI) may occur. These AEFI must be reported to WA Department of Health through the Western Australian Vaccine Safety Surveillance (WAVSS) reporting system.
Procedure

Consent

  • Consent must voluntary be given by the person receiving the vaccination after understanding appropriate information about the procedure, including the potential risks and benefits, prior to the vaccination taking place.

Criteria for valid consent

  • For consent to be legally valid, the following elements must be present:
    • It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of receiving a vaccine.
    • It must be given voluntarily in the absence of undue pressure, coercion, or manipulation.
    • It must cover the specific procedure that is to be performed.
    • It can only be given after the potential risks and benefits of the relevant vaccine, the risks of not having it, and any alternative options have been explained to the person.
  • The person must have the opportunity to seek more details or explanations about the vaccine or its administration.
  • The information must be provided in a language or by other means that the person can understand. Where appropriate, involve an interpreter or cultural support person.
  • Obtain consent before each vaccination, after establishing that there are no medical condition(s) that contraindicate vaccination. Consent can be verbal or written.

    Resources

    • Information about the vaccine, including risks, benefits, and type of vaccine, should be provided to the person who is going to be vaccinated.
    • Fact sheets should be available to all people at the vaccination site prior to vaccination.

    Preparation

    • Ensure vaccines have been compliant with cold chain and have remained within the minimum and maximum temperatures.
    • All relevant infection control methods to be utilised.
    • Prepare equipment required:
      • Medication
      • Vanishpoint™ Syringe 23G (3cc)
      • Sharps container
    • Explain the procedure to the patient and ensure voluntary consent is obtained.
    • Remove vaccine from vaccine refrigerator, ensure the vaccine is within the expiry date and any diluent container is not damaged or potentially damaged.
    • If the vaccine is in a vial, remove the cap carefully to maintain sterility of the rubber bung.
      • There is generally no need to wipe the rubber bung of single-dose vials with an alcohol swab if it is visibly clean.
      • If there is visible contamination or the rubber bung is inadvertently touched, clean the bung with a single-use swab; allow time for the bung to dry before drawing up the contents.
    • Use a sterile, disposable 19- or 21-gauge needle to draw up the recommended dose through the bung (or through the top of the ampoule), if required.
    • Change the needle after drawing up from a vial with a rubber bung or ampoule, before giving the injection. If using a safety needle system, draw up the vaccine, then draw back on the syringe to remove as much vaccine as possible from the tip of the needle. Then remove any air to the tip of the syringe without re-priming the needle.
    • Do not push small air bubbles through the needle for injection. In the rare case of a large air bubble in a pre-filled syringe:
      • Draw back on the needle to ensure that no vaccine is expelled along with the air
      • Expel the air through the needle, taking care not to prime the needle with any of the vaccine, because this can increase injection site reactions.

    Procedure

    • Draw up medication.
    • Select and prepare the injection site (either Deltoid or Lateral thigh) with antiseptic swab.
    • Injection site should be free from oedema, inflammation, bruising or damaged skin.
    • Insert needle swiftly at 90° and deep into the muscle.
    • Withdraw the plunger, confirming no blood aspiration.
    • Depress the plunger, injecting the medication until the needle retracts automatically.
    • Dispose of the used syringe appropriately and monitor site for bleeding.
    • Person receiving vaccine is to wait for 15 minutes after the vaccination within the presence of a health professional to ensure signs of anaphylactic reaction do not occur.
    • See the Clinical Resource Intramuscular Injection for more information.
    Success
    Success
    Discontinue

    Management of Adverse Event Following Injection

    Additional Information

    Cold chain

    • It is essential to maintain cold chain while storing and transporting flu vaccines. Vaccines must be kept between +2°C and +8°C as they could otherwise become breached and not suitable for use.
    • The cold chain begins from the time the vaccine is manufactured, continues through to state or territory vaccine distribution centres and immunisation service providers, and ends when the vaccine is administered.
    • Purpose built vaccine refrigerators are specifically designed to store and transport vaccines safely.
    • Vaccine refrigerators should include a data logger to monitor the temperature in 5-minute intervals. Twice daily minimum and maximum temperatures must still be manually recorded as a timely alert to any breach in cold chain.

    Cold Chain Breach

    • A cold chain breach occurs when vaccine storage temperatures deviate outside the recommended range of +2°C to +8°C. The optimal storage temperature for vaccines is +5°C.
    • All vaccine temperatures recorded below +2°C or above +8°C must be reported to WA Department of Health.
      • This does not include temperature deviations or excursions in which the temperature reaches a maximum of up to +12°C for 15 minutes or less.
      • Any deviation below +2°C must be reported.

    What to do if there is a Cold Chain Breach

    • Immediately isolate the breached vaccines in temporary vaccine storage and label them ‘Do Not Use’.
    • Contact WA Health (or if purchased privately, the manufacturer) and advise them of the breach. Information to include:
      • Date and time of breach
      • Reason for breach and if it has rectified
      • Brand and size of refrigerator in which the vaccines are stored.
      • Information from the breach period that has been downloaded from the data logger
      • Maximum and minimum temperatures that the vaccines reached during the breach
      • Length of time refrigerator was outside of +2°C to +8°C range
      • Date of last refrigeration service and whether the fridge has had any maintenance issues recently
      • Type of vaccine, expiry date, and number of vaccines that were breached
      • Whether any vaccines have been pushed up against the cooling plate or a cold air outlet
      • Whether all vaccines are in their original packaging
      • Whether anybody has been vaccinated with potentially affected vaccines
      • Whether there is any visible damage to vaccines (eg wet or soggy packaging)
    • Do not use or discard vaccines until advised by WA Health or the manufacturer.

    References
    References

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