Patient Group Direction PGD No /15 Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 - Gardasil

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1 Notice to all staff: This Patient Group Direction (PGD) may only be used by members of the healthcare professions named on the title page, and only if each professional has individually been listed by their manager as an authorised user meeting the competency and training requirements of that PGD. Each healthcare professional using a PGD must also have signed a copy of that PGD and have one available to refer to. Staff must not download PGDs from the intranet/internet and use them straightaway. The PGDs are only on the intranet/internet so that the appropriate GP/clinical manager can access them when they need to authorise their team members, or to check that their team is using the most recent version. The GP/clinical manager should also have signed the appropriate section of the PGD before use. Valid from: 1/7/15 Expiry date: 1/6/17 1

2 PGD Number 23 06/15 Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 - Gardasil by Registered Nurses employed by GP Practices within the Midlands & East (Central Midlands) Area and signatories to the PGD This Patient Group Direction has been approved on behalf of NHS England Midlands and East (Central Midlands) by: Authorising Officer for NHS England Midlands & East (Central Midlands) Signature: Date: Date of Issue 17/6/15 Issue Number PGD 23 06/15 Date of Review 1 st June 2017 NHS England is committed to being an organisation within which diversity, equality and human rights are valued. We will not discriminate either directly or indirectly and will not tolerate harassment or victimisation in relation to gender, marital status (including civil partnerships), gender reassignment, disability, race, age, sexual orientation, religion or belief, trade union membership, status as a fixed-term or part-time worker, socio-economic status and pregnancy or maternity leave status. Equality Impact Assessment (Level 1) undertaken by the author Date: July 2014 This document is available electronically or in a larger font or alternative format on request. Valid from: 1/7/15 Expiry date: 1/6/17 2

3 Document History Progress Lead Person & Contact Details Date V1 Jo Jenkins Senior Pharmacist Hertfordshire Community NHS Trust 10 th June 2015 Circulation List Barbara Hamill, Immunisation 10 th June 2015 Manager Cath Fenton, Immunisation Lead Review Date 1 st June 2017 Table of Contents Page Front Sheet 4 Clinical Condition or Situation to which the Direction Applies 5 Description of Treatment 6 Adrenaline management in the event of an anaphylactic reaction 9 Audit 9 Characteristics and qualification required of staff 9 References 10 Management/authorisation of Patient Group Direction 11 Valid from: 1/7/15 Expiry date: 1/6/17 3

4 PGD Number 23 06/15: Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 - Gardasil by Registered Nurses employed by GP Practices within the Central Midlands Area Team and signatories to the PGD Valid from: 1/7/2015 Expiry (review) date: 1 st June 2017 After this date the direction is no longer valid. (Note: a review will be carried out sooner as a result of any new safety information.) Supersedes: All previous PGDs for the administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil ) within the Hertfordshire and South Midlands Area Team Development of Patient Group Direction This Patient Group Direction has been developed on behalf of NHS England Midlands and East (Central Midlands) by: Name Signature Date Senior Pharmacist NHS E incoming CDAO Bhavisha Pattani Director of Nursing and quality Manjit Darby Authorising Doctor Dr. Aly Rashid Valid from: 1/7/15 Expiry date: 1/6/17 4

5 1. Clinical condition or situation to which the direction applies Indication Inclusion Criteria Active immunisation against invasive cervical cancer caused by human papillomavirus (HPV) types 6, 11, 16 and 18. Informed consent obtained and documented Two Dose Schedule: All girls aged 12 to 13 years (in school year 8), as a primary course of immunisation against human papillomavirus (HPV) types 6, 11, 16 and 18 as per the National Immunisation Schedule. The first dose to be given at any time during school year 8 as long as the girl is in the year age band Vaccination course to be initiated prior to 15 years of age (as long as vaccination is initiated prior to 15 years of age, the two dose schedule can be followed) The second dose may be given between six and up to 24 months after the first. Any gap between doses of between 6 and 24 months is clinically acceptable. However, timing of the second dose should comply with the locally agreed vaccination schedule Three Dose schedule: A 3-dose schedule should be followed if immunization is initiated after the girls 15th birthday (up to turning 18 years) A vaccination schedule of 0, 1, and 4-6 months is appropriate for girls commencing the course at age 15 years and above. All three doses should ideally be given within a 12-month period. Exclusion Criteria Females coming to the UK from overseas may not have been offered protection against HPV in their country of origin and should be offered vaccination where appropriate (course offered depending on age). There are very few individuals who cannot receive HPV vaccine. When there is doubt, appropriate advice should be sought from an Immunisation Co-ordinator or a Consultant in Health protection rather than withholding the vaccine. Consent refused Girls under the age of 12 years and who are 18 years or older (note: in girls over the age of 18 years who commence but do not complete vaccination before 18, it is reasonable Valid from: 1/7/15 Expiry date: 1/6/17 5

6 to complete their HPV vaccination course over the age of 18 years). Girls aged 15 years and over and up to 18 years are excluded from the two dose schedule - if vaccination is initiated after the girl s 15 th birthday (but before turning 18) a three dose schedule should be initiated (Refer to Section 2, Dose and frequency of administration) Girls who have already started a three dose schedule should complete the course as originally planned. Severe febrile illness - postpone. Minor infections without fever or systemic upset are not reasons to postpone immunisation A confirmed anaphylactic reaction to a previous dose of a HPV vaccine A confirmed anaphylactic reaction to any component of the vaccine Pregnancy. On a precautionary basis, HPV vaccine is not advised in pregnancy because of absence of data. Offering a full course of Gardasil following a previous partial or incomplete course of HPV vaccine is not recommended Cautions/Need for Gardasil may be given at the same time as other further advice from a vaccines, but at a different injection site, preferably doctor different limbs. If given in the same limb, it should be given at least 2.5cm apart. In patients with endogenous or iatrogenic immunosuppression including HIV, the HPV vaccine can be given but the response may be lower and further doses may be required seek Specialist advice from a GP, Community Paediatrician, an Immunisation Co-ordinator or a Consultant in Health protection. Where possible HPV vaccine should be administered at least 2 weeks before starting immunosuppressive treatment. Action if excluded Record in the patient s medical notes Specialist advice must be sought on the vaccines and circumstances under which they should be given. The risk to the individual of not being immunised must be taken into account. Action if patient declines treatment 2. Description of Treatment Name, strength and formulation of drug Legal status Method / Route Give advice about protective effects of the vaccine and the risks of infection and disease complications. Document advice given. Inform or refer to GP as appropriate. Gardasil human papillomavirus vaccine (HPV) types 6, 11, 16 and 18 (recombinant, adjuvanted, adsorbed) bivalent suspension for injection - pre-filled 0.5ml syringe POM (prescription only medicine) Shake gently; agitate immediately before use to obtain Valid from: 1/7/15 Expiry date: 1/6/17 6

7 uniform suspension. Intramuscular injection - deltoid area of the upper arm is the recommended site or the anterolateral area of the thigh The deep subcutaneous route may be used for patients with thrombocytopenia or individuals at risk of haemorrhage Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient's size and weight. Gardasil must not be administered either intravascularly or intradermally. Dose / Dose range 0.5ml dose Frequency of For girls aged less than 15 years, JVCI recommended a administration schedule of two doses of Gardasil vaccine given at 0, and 6-24 months. o First dose of 0.5ml; o The second dose of 0.5ml this should be administered at least six months and ideally not more than 24 months after the first dose. As long as the first dose was received before the age of 15 years, the two dose schedule can be followed If the course is interrupted, it should be resumed, but not repeated even if more than 24 months have elapsed since the first dose. For girls aged 15 years and over and under 18 years, the three dose schedule for Gardasil should be followed i.e. o First dose of 0.5ml o Second dose of 0.5ml at least one month after the first dose; o A third dose of 0.5ml at least three months after the second dose; o All 3 doses should be given within a 12 month period. o If the course is interrupted, it should be resumed but not repeated, ideally allowing the appropriate interval between the remaining doses. o In cases where the second dose of HPV vaccine is given late, the minimum interval between the second and third dose of Gardasil is 3 months. Note: Where a female in the target cohort (aged 12 and over and under 18 years) presents with an inadequate vaccination history, every effort should be made to clarify what doses they have had. A female (aged over 12 years and under 18 years) who has not completed the schedule should complete the vaccination course at the minimum interval where possible. Girls over the age of 18 years who commence but do not complete vaccination before 18, it is reasonable to Valid from: 1/7/15 Expiry date: 1/6/17 7

8 complete their HPV vaccination course over the age of 18 years. Duration See above Patient advice / Follow up treatment Adverse Reactions and their Management Reporting procedure of Adverse Reactions Provide suitable printed Patient Information Leaflet (PIL) as supplied with the vaccine or available via Give advice on the management of post-immunisation pyrexia Give advice on possible side effects and their management sore arm is a normal reaction to the injection Inform patient where applicable when subsequent doses are due. Advise that vaccination is not a substitute for routine cervical screening Appropriate medical equipment and drugs for the treatment of an anaphylactic event to be available (see local anaphylaxis guidelines or the current edition of the British National Formulary (BNF) The most common adverse reaction observed after HPV vaccine administration is mild to moderate short-lasting pain at the injection site. An immediate localised stinging sensation and redness at the injection site have also been reported. Other reactions commonly reported are headache and low grade fever. A detailed list of adverse reactions is available in the Summary of Product Characteristics (SPC) Consult GP if fever > 39.5 C, or other serious symptoms Refer to product SPC or the Immunisation against Infectious Disease Green Book, the British National Formulary or the Summary of Product Characteristics for full/further details. Green Book - Summary of Product Characteristics Initially via GP and documented in the patient s medical notes Report incident in line with the practice/local Incident Policy and Procedure All suspected adverse reactions to be reported to the Commission of Human Medicines (yellow card by the GP or Nurse. State brand and batch number. Drug Interactions None reported Additional Facilities Immediate access to epinephrine (adrenaline) 1 in 1000 injection Special Considerations Do not mix HPV vaccine with any other vaccines / Additional Information Arrangements for Store vaccine at 2 C to 8 C (in a refrigerator). Do not handling, security, freeze. Protect from light. storage and labelling If the vaccine has been frozen the vaccine must be Valid from: 1/7/15 Expiry date: 1/6/17 8

9 discarded. Shake well before use All medicines supplied to a patient under a PGD must comply with the European Commission (EC) labelling and leaflet directive i.e. must be fully labelled and an appropriate Patient Information Leaflet (PIL) supplied. Records The following information should be recorded accurately: vaccine name, product name, batch number and expiry date site(s) used including, clear description of which injection was administered in each site, especially where two injections were administered in the same limb date immunisation(s) were given dose administered name and signature of vaccinator. advice given to patient detail of any adverse reaction and action taken This information should be recorded in: patient-held record or Personal Child Health Record (PCHR, the Red Book) for children patient s GP record or other patient record, depending on location Child Health Information System Practice computer system 3. Adrenaline (Epinephrine) Management in the Event of an Anaphylactic Reaction Adrenaline (epinephrine) 1:1000 (1mg/ml) Intramuscular injection Subcutaneous route (not generally recommended) Age of Patient Volume of adrenaline (epinephrine) 1:1000 (1mg/1ml) Adults and adolescents over 12 years 0.5ml (500 micrograms) (0.3ml (300 micrograms) if the child is small or pre-pubertal) These doses may be repeated if necessary at 5 minute intervals according to blood pressure, pulse and respiratory function with urgency of hospital transfer * Use suitable syringe for measuring small volumes 4. Audit Stock Reconciliation Stock Storage 5. Characteristics of Staff Qualifications required Stock balances should be reconcilable with receipts, administration records and disposals on an individual patient basis. Product should be stored in accordance with the specifications of the PGD and Summary of Product Characteristics relating to the vaccine Registered nurse with current Nursing & Midwifery Council (NMC) registration employed by GP practices within the Valid from: 1/7/15 Expiry date: 1/6/17 9

10 Central Midlands Area Team Additional requirements Has undertaken appropriate training for working under PGDs for supply and administration of vaccines Continued training Evidenced competency to undertake injections/immunisations requirements The Registered Nurse/Midwife must act at all times in accordance with the Nursing and Midwifery Council (NMC) code of professional conduct and Standards for the Administration of Medicines, and must at all times acknowledge any limitations in their knowledge or competence. 6. References - National / Local Policies or Guidelines 1. Department of Health Immunisation against infectious disease (HMSO). Updated at Accessed 3 rd June Current edition of the British National Formulary (BNF) Accessed June Most recent version of the Manufacturer s Summary of Product Characteristics (SPC) available at Accessed 3rd June Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August Department of Health, CMO letters 6. NMC Standards for Medicines Management (2008) 7. NMC Code of Professional Conduct (2008) 8. Resuscitation Council (UK) Emergency Medical treatment of Anaphylactic Reactions by first medical responders and Community Nurses (updated January 2008) 9. Department of Health (6 th April 2001) Reference Guide to Consent for Examination or Treatment. Crown copyright. ( 10. Introduction of Human Papillomavirus vaccine into the National immunisation Programme CMO letters dated 2 nd May 2008, 15 th May 2008 & 19 th June HPV immunisation programme change of supply to Gardasil from September 2012 Letter from the DoH Director of Immunisations 25 th November Previous PGD for the administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil ) Valid from: 1/7/15 Expiry date: 1/6/17 10

11 7. Management of Patient Group Direction number 23 06/15 Authorisation of GP (on behalf of the practice) for the administration of Gardasil without a prescription by the named nurse(s) below I,. (name and designation), confirm that the named nurse(s) who has/have signed this Patient Group Direction is/are competent to operate under the PGD and fulfil the criteria set out in the Characteristics of Staff section. I give authorisation for the named nurse(s) who has/have signed this Patient Group Direction to administer the above named preparation as described in this direction and in accordance with this PGD. Signed Date Practice address: This Patient Group Direction is to be read, agreed to and signed by all registered nurses/midwives it applies to. One copy should be given to each nurse/midwife with the original signed copy being easily accessible within the practice/clinical setting. Once fully signed a copy of this page only to be kept by the Practice. By completing the section below I confirm that I have read and understood the content of this Patient Group Direction and that I fulfil the criteria set out in the Characteristics of Staff section and I am willing, competent and authorised to work under it within my professional code of conduct. Name and designation of Authorised Nurse Signature of Authorised Nurse Date Valid from: 1/7/15 Expiry date: 1/6/17 11