Clinical Guidelines (Nursing)

RSV Immunoglobulin for at risk patients

  • Introduction

    Aim

    Definition of Terms

    Assessment

    Management

    Documentation

    Evidence Table

    References

    Introduction

    Respiratory Syncytial Virus (RSV) is one of the most common causes of lower respiratory tract infections in children at high risk of respiratory disease. It is associated with increased morbidity amongst preterm infants and babies born with chronic health conditions such as respiratory and/or cardiac complications. 

    RSV Immunoglobulin (Ig), provides passive immunity against RSV infection and has been shown to decrease hospitalisation for RSV related illness. For patients who have been admitted to hospital for RSV infection, the incidence of an ICU admission related to RSV infection is decreased in patients receiving 4 weekly RSV Ig. 

    The Royal Children’s Hospital (RCH) funds RSV Ig for selected cardiology patients and other at risk groups and administration is coordinated by the RCH Immunisation Service.  RSV Ig is given as a course of up to 5 intramuscular injections at 1 month intervals throughout the RSV season. The RSV program at RCH begins in May each year and concludes at the end of September.

    This guideline is intended for use by Medical and Pharmacy staff and nurse immunisers working in the Immunisation Drop in Centre (DIC) at RCH. The guideline applies to neonate/infants inpatient or outpatients attending RCH and can be administered by approved nurse immunisers in the DIC or ward with a DUC approved order on EMR. 
    RSV Ig can be given from birth. (Usually given in first year of life)

    Aim

    The aims of this guideline are:

    • To ensure that the nurse immunisers at RCH are providing safe and effective administration of the RSV Ig, according to the relevant legislation, Best Practice, the Australian Immunisation Handbook Guidelines and The Royal Children’s Hospital Clinical Practice Guidelines.
    • To ensure that parents receive consistent, accurate and reliable information about the procedure, including the potential risk and benefits, such as possible adverse events, how common they are and what they should do about them.To streamline current practices to minimise excessive wait times and potential exposure to further pathogens for high risk children.
    • To streamline current practices to minimise excessive wait times and potential exposure to further pathogens for high risk children.

    Definition of Terms 

    • Immunoglobulin – a protein extract from Plasma, also can be called ‘antibody’ an injection of immunoglobulin can provide temporary immunity against some infections.
    • Passive Immunity – can  occur naturally when maternal antibodies are transferred to fetus or can be artificially induced by the transfer of  readymade antibodies  such as administration of blood products.
    • Immunisation Nurse – Division 1 registered Nurse who has completed an approved immunisation course and has approval to administer scheduled vaccines under the secretary approval under regulation 5(3) Drugs, Poisons and Controlled Substances Regulations 2006. 
    • Cold Chain – cold chain is the process of transporting and storing vaccines within the temperature range of +2° - +8°. Maintenance of cold chain is essential to maintain vaccine potency and effectiveness.
    • Therapy Plan – Scheduled Order set that includes all doses for the season at the appropriate intervals.

    Assessment

    Eligibility for RSV Ig is determined by the consultant and reviewed by the Drug Usage Committee (DUC) on a case by case basis.  Criteria for use is established following consultation with relevant clinicians, and examples of approved patients include:

    • Preterm infants with or without chronic lung disease of prematurity or congenital heart disease
    • Infants with haemodynamically significant congenital heart disease
    • Children with anatomic pulmonary abnormalities or neuromuscular disorder
    • Immunocompromised children assessed on an individual basis

    Management 

    Dosage:

    • The recommended dose of RSV Ig is 15mg/kg IM and can be given from birth (See note below)
    • RSV Ig requires a Therapy Plan ordered on EMR by the treating team.
    • The child’s most recent weight must be recorded in EMR so that an accurate RSV Ig dose can be confirmed.
    • Parents are asked to call the immunisation service with the child’s current weight on the Monday of the week the child will receive the RSV Ig. The current weight of an inpatient should be documented on EMR.Note: Dose 2 is given 3 weeks after dose 1 and then 4 weekly for the remainder of RSV season. 

    Note: Dose 2 is given 3 weeks after dose 1 and then 4 weekly for the remainder of RSV season.  A total of 5 doses are given 

    Preparation:

    RSV Ig for injection is available as:

    • 50mg vial (0.5ml), (concentration 100mg/ml)
    • 100mg vial (1ml), (concentration 100mg/ml)

    Ensure the following steps are taken:

    • Ensure the RSV Ig vial is within expiry date and cold chain has been maintained
    • Perform hand hygiene
    • Clean trolley or work surface with detergent and water or wipe
    • Identify and collect the appropriate injection equipment for the RSV Ig to be administered
    • Perform hand hygiene
    • Peel open sterile equipment and protecting key parts draw up the Ig
      • Prepare patient and safely position, including distraction techniques
      • Provided the skin is visibly clean, there is no need to wipe it with an alcohol swab

        Note: RSV does not contain a preservative and should be administered immediately after drawing up the dose

        See also RCH Procedure document Multi-use of Pharmaceutical injection products, sealed vials and bags available at http://www.rch.org.au/policy/policies/Multi-use_of_pharmaceutical_injection_products,_sealed_vials_and_bags/

        Administration:

        • RSV Ig is given as an IM injection into the vastus lateralis muscle in the anterolateral thigh
        • Doses that are greater than 1 ml to be injected should be divided into 2 injectionsIntramuscular injection technique

        Intramuscular injection technique 

        • For IM injection, use a 23 gauge 25 mm needle
        • Position the limb so as to relax the muscle into which the RSV Ig will be injected
        • Pierce the skin at an angle of 90° to the skin, so the needle can be safely inserted to the hub
        • It is not necessary to draw back on the syringe plunger before injecting the RSV Ig

        Intramuscular injection technique

        Photo courtesy Lloyd Ellis, The Royal Children’s Hospital, Victoria (pg. 80 of Australian Immunisation Handbook, 10th ed. 2013)

        Position for infants < 12 months

        Position the infant in a semi-recumbent position on the lap of the parent/carer (see figure below) this position is also suitable for young children.
        Position for infants

        Photo courtesy Dr Joanne Molloy, Victoria (pg 75 of Australian Immunisation handbook, 10th ed. 2013)

        Procedural Pain Management

        Injections can result in distress and anxiety for infants, children and their parents. It is important that effective pain management strategies are used during injection procedures. Some strategies that are recommended during administration of the Injection include:

        • Oral sucrose (infants)
        • Breastfeeding
        • Shaking a noisy toy
        • Topical anaesthetic agents, such as AnGel or EMLA cream can also be used.

        See also RCH nursing clinical guideline document available at http://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Procedural_Pain_Management/

        Post Vaccination

        Immediate after care

        • Dispose of Clinical and sharps waste 
        • Cover the injection site with cotton wool and tape as needed
        • Gently apply pressure for 1-2 minutes (do not rub injection site, as it may lead to localised irritation)
        • As with any IM injection, caution should be used when administering RSV to patients with thrombocytopenia or anticoagulation.  Firm pressure should be applied for approximately 5-10 minutes.
        • After procedure perform hand hygiene
        • Inform parent to remain in the hospital with the child for at least 15 minutes after receiving the RSV Ig (to observe for any immediate adverse event)

        Adverse Events 

        • An adverse event is any untoward medical occurrence that follows medication administration and does not necessarily have a causal relationship with the usage of the Ig.
        • The most serious adverse event is anaphylaxis. Nursing staff must be aware of anaphylaxis management.
        • Any adverse event should be reported to the Immunisation service and can be contacted on 1300 882 924 (Option 2). 

        RSV Ig Adverse reactions:

        • Common (>1%)
          Fever, rash, rhinitis, wheeze, cough, diarrhoea, injection site reaction
        • Infrequent (.01-1%)
          Anaemia, elevated liver enzymes
        • Rare (<0.1%)
          Hypersensitivity, (including anaphylaxis)

        Documentation requirements

        • The RSV Ig Therapy plan will be documented on the neonates/infants EMR. Details which should be recorded includ
        • After the dose has been given the order will need to be completed and signed off on EMR then recorded in the Infants Child Health record book.
        • Details which should be recorded include
          • Medication given (Including brand name, batch number, dose number
          • Date and time of injection
          • Site of administration
          • Name of the person who administered the injection.

        Evidence Table

        The evidence table for this guideline can be found here. 

        References

        • American Academy of Pediatrics 2014, Updated Guidance for Palivizumab Prophylaxis Among
          Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection accessed 16/07/18
          <http://pediatrics.aappublications.org/content/pediatrics/134/2/415.full.pdf
        • Australian Medicines Handbook Pty Ltd 2018, Palivizumab – Australian Medicines Handbook (online), accessed 16/07/18
          https://amhonline.amh.net.au.acs.hcn.com.au/chapters/anti-infectives/antivirals/other-antivirals/palivizumab
        • Children’s health Queensland Hospital and health Service 2017, Palivizumab for RSV prophylaxis in high risk paediatric patients Document ID CHQ-GDL -01071 version no. 3
        • Department of Health Victoria 2018, Mims online, accessed 16/07/18 
          https://www.mimsonline.com.au/Search/FullPI.aspx?ModuleName=Product Info&searchKeyword=Palivizumab&PreviousPage=~/Search/QuickSearch.aspx&SearchType=&ID=4849000
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        • Elia,S (2016) Immunisation Service – RSV Immunoglobulin Report – November 2016 The Royal Children’s Hospital Melbourne
        • MedImmune 2018, Synagis Palivizumab, accessed 16/07/18 < https://www.synagis.com/>   
        • National Health and Medical Research Council 2017, The Australian Immunisation Handbook, accessed16/07/18<http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home~handbook10part5~handbook10-5-1>
        • The Royal Childrens Hospital Melbourne n.d, Respiratory syncytial Virus RSV, accessed 16/07/18 <http://www.rch.org.au/washup/for_health_professionals/Respiratory_Syncytial_Virus_RSV/>
        • The Royal Children’s Hospital Melbourne 2018, Multi-Use of pharmaceutical injection products, sealed vials and bags, accessed 16/08/18 <http://www.rch.org.au/policy/policies/Multi-use_of_pharmaceutical_injection_products,_sealed_vials_and_bags/>
        • The Royal Children’s Hospital Melbourne 2018, Paediatric Injectable Guidelines, accessed 16/07/18 <http://www.rch.org.au/pig/>
        • The Victorian Government Melbourne 2012, Secretary Approval Nurse Immuniser accessed 16/07/18 <https://www2.health.vic.gov.au/about/publications/factsheets/Secretary%20Approval%20-%20Nurse%20Immuniser>

        Please remember to read the disclaimer

        The development of this nursing guideline was coordinated by Nadine Henare, Nurse Coordinator Immunisation, and approved by the Nursing Clinical Effectiveness Committee. Updated August 2018.