Patient Group Drection (PGD) Number : Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil )

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1 Notice to all staff: The Patient Group Directions (PGDs) for the Hertfordshire and South Midlands Area Team 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 internet and use them straightaway. The PGDs are only on the 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. Page 1 of 11

2 Patient Group Direction (PGD) Number : Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil ) by Registered Nurses employed by GP Practices within the Hertfordshire and South Midlands Area Team and signatories to the PGD Approval of Patient Group Direction This Patient Group Direction has been approved on behalf of the Hertfordshire and South Midlands Area Team by: Authorising Officer for the Name: Health Moulder, Director of Nursing & Hertfordshire and South Midlands Quality Area Team Signature: Date: 28 th November 2013 Date of Issue November 2013 Issue Number PGD Date of Review November 2015 The Hertfordshire and South Midlands Area Team 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 undertaken by policy author Date: September 2013 This document is available electronically, in a larger font or an alternative format on request. Page 2 of 11

3 Document History: To replace: All previous PCT PGDs for the administration of Human Papillomavirus within the Hertfordshire and South Midlands Area Team Progress Lead Person Date V1 - First draft Carolyn Haselden September 2013 V2 - Final draft Including amendments from those circulated November 2013 Circulation List Barbara Hamill, Immunisation November 2013 Manager, Public Health England, Hertfordshire & South Midlands Area Team Cath Fenton, Consultant, Public Health England, Screening and Immunisation Lead, South Midlands and Hertfordshire Area Team Sarah Whiteman, Medical Director, Hertfordshire and South Midlands Area Team Heather Moulder, Director of Nursing & Quality, Hertfordshire and South Midlands Area Team Approved by the November 2013 Pharmaceutical Services Regulations Committee for the Hertfordshire and South Midlands Area Team Review Date November 2015 Date of Archiving Previous PCT PGDs for the administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil ) within the Hertfordshire and South Midlands Area Team November 2013 Table of Contents Page Front Sheet 4 1. Clinical Condition or Situation to which the Direction Applies 5 2. Description of Treatment 6 3. Adrenaline Management in the event of an anaphylactic reaction 9 4. Audit 9 5. Characteristics and qualification required of staff 9 6. References National/Local Policies or Guidelines 9 7. Management/authorisation of Patient Group Direction 11 Page 3 of 11

4 Patient Group Direction (PGD) Number : Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil ) by Registered Nurses employed by GP Practices within the Hertfordshire and South Midlands Area Team and signatories to the PGD Valid from: 1 st November 2013 Expiry (review) date: 1 st November 2015 After this date the direction is no longer valid. (Note: a review will be carried out sooner as a result of a critical incident, new safety or clinical information, changes in legislation or change in best practice.) Supersedes: All previous PCT 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 the Hertfordshire and South Midlands Area Team by: Name Signature Date Medical Director Sarah Whiteman 29/11/13 Pharmacist Director of Nursing & Quality Carolyn Haselden 12 th November 2013 Heather Moulder Page 4 of 11

5 1. Clinical condition or situation to which the direction applies: Indication Criteria for inclusion Criteria for exclusion Active immunisation against invasive cervical cancer caused by human papillomavirus (HPV) types 6, 11, 16 and 18. Informed consent obtained and documented 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 Routine Childhood Immunisation Schedule Where a female in the target cohort (aged over 12 and less than 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. 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. If a course has begun with Gardasil then the course should be completed with Gardasil. If a course has been started with Cervarix, the course should where possible be completed with Cervarix. In instances where this is not possible, or where the make of the initial vaccination is not known, then the vaccination course can be completed with Gardasil. There are very few individuals who cannot receive HPV vaccine. When there is doubt, appropriate advice should be sought from a GP, Paediatrician, Immunisation Co-ordinator or Consultant in Health Protection rather than withholding the vaccine. Cautions/Need for further advice from a doctor Consent refused and documented in the patient s medical notes Girls under the age of 12 years Girls who have commenced their HPV vaccination course with Cervarix (see above) 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 Gardasil may be given at the same time as other vaccines, but at a different injection site, preferably different limbs. If given in the same limb, it should be given at least 2.5cm apart. Ideally, and where possible, the same vaccine should be used for the whole primary course as there is currently no Page 5 of 11

6 Action if excluded Action if patient declines treatment evidence on the interchangeability of the two HPV vaccine products. 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 advice from GP, Paediatrician, Immunisation Co-ordinator or Consultant in Health Protection. Where possible HPV vaccine should be administered at least 2 weeks before starting immunosuppressive treatment. Record in the patient s medical notes If medically unwell at the time of immunisation, advise as to when the vaccine may be given. Specialist advice (from GP, Paediatrician, Consultant in Health protection/immunisation Facilitator) 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. Give advice about protective effects of the vaccine and the risks of infection and disease complications. Document advice given in the patient s medical notes. Inform or refer to GP as appropriate. 2. Description of Treatment Name, strength and Gardasil - human papillomavirus vaccine (HPV) types 6, 11, formulation of drug 16 and 18 (recombinant, adjuvanted, adsorbed) bivalent suspension for injection - pre-filled 0.5ml syringe Legal status POM (prescription only medicine) Method / Route Shake gently; agitate immediately before use to obtain uniform suspension. Intramuscular injection (deltoid area of the upper arm is the recommended site) 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 Primary course of three doses given at 0, 1 to 2 months administration and 6 months The second dose should be administered one to two months after the first dose and the third dose at least 6 months after the first dose All 3 doses should be given within a 12 month period. If the course is interrupted, it should be resumed but not Page 6 of 11

7 repeated, ideally allowing the appropriate interval between the remaining doses. Duration Patient advice / Follow up treatment Adverse Reactions and their Management 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. See above 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) Local reaction at injection site see GP if severe (see product s Summary of Product Characteristics (SPC)) Consult GP if fever > 39.5 C, or other serious symptoms Very common ( 1/10) o Headache o At the injection site: erythema, pain, swelling o Common ( 1/100 to <1/10) o Pyrexia (fever over 38C) o At the injection site: hematoma, pruritis o Pain in extremity o Nausea Rare ( 1/10,000 to <1/1,000) o Urticaria Very rare (<1/10,000) o Bronchospasm Other adverse effect (unknown frequency of occurrence) o Injection-site cellulitis o Asthenia o Chills o Fatigue o Malaise o Arthralgia o Myalgia o Vomiting o Dizziness o Guillain-Barré syndrome o Syncope sometimes accompanied by tonic-clonic movements o Hypersensitivity reactions including anaphylactic/anaphylactoid reactions Idiopathic thrombocytopenic purpura Page 7 of 11

8 o Lymphadenopathy o Injection-site cellulitis See product s SPC or the Immunisation against Infectious Disease Green Book at for further details. Reporting procedure of Initially GP and documented in the patient s medical notes Adverse Reactions Report incident in line with local Incident Policy and Procedure All suspected adverse reactions to be reported to the Commission on Human Medicines via the yellow card system (copies of the yellow card are available at the back of the BNF or via 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. If the vaccine has been frozen the storage and labelling vaccine must be discarded. Before use, nurses should satisfy themselves that the vaccine has been properly stored and that the cold chain has not been broken. Shake well before use Disposal Equipment used for vaccination should be disposed of at the end of a session by sealing in a proper, puncture-resistant sharps box (UN-approved, BS 7320) 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 In all cases manual records including personal Child Health Record (PCHR- red book), computerised records (depending on location) and data collection for Child Health Information Services (CHIS) should be completed immediately, be legible, clear, accurate and include: Patient s name, NHS number, address, date of birth, consent given and GP (if registered) Vaccine name, product name, batch number and expiry date Dose and route and site of administration Date immunisation(s) were given Name and signature of vaccinator Advice given to patient Detail of any adverse reaction and action taken Page 8 of 11

9 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) 6 12 years 0.3ml (300 micrograms) 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 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 5. Characteristics of Staff: Qualifications required Registered nurse with current Nursing & Midwifery Council (NMC) registration employed by GP practices within the Hertfordshire and South Midlands Area Team Additional requirements Has undertaken appropriate training for working under PGDs for supply and administration of medicines Evidenced competency to undertake injections/immunisations Evidenced up to date training in Cardiopulmonary Resuscitation skills (annually) and management of anaphylaxis (annually). Continued training Attend training dates as required and keep up to date with requirements changes The Registered Nurse mu st act at all times in accordance with the Nursing and Midwifery Council (NMC) code of professional conduct and Standards for the medicines management, 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 Green Book. Updated at Accessed September Current edition of the British National Formulary (BNF) Accessed October Most recent version of the Manufacturer s Summary of Product Characteristics (SPC) available at Accessed September Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August 2000 Page 9 of 11

10 5. Department of Health, CMO letters 6. NMC Standards for Medicines Management (Feb NMC The Code: Standards of conduct, performance and ethics for nurses and midwives (May 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 PCT PGD for the administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 (Gardasil ) Page 10 of 11

11 7. Management of Patient Group Direction (PGD) Number : Authorisation of GP (on behalf of the practice) for the administration of this vaccine 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 to administer the above named vaccine 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 vaccine as described in this direction and in accordance with this PGD and the current Department of Health Guidelines (HMSO immunisation against Infectious Diseases). Signed Date Practice Address: This Patient Group Direction is to be read, agreed to and signed by all registered nurses it applies to. One copy should be given to each nurse with the original signed copy being easily accessible within the practice setting. Once fully signed a copy of this page only to be kept by the GP 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 Page 11 of 11