PGD No Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 - Gardasil - September 2012

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1 Notice to all staff: NHS Hertfordshire Patient Group Directions (PGDs) 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 and use them. The PGDs are only on the intranet so that clinical managers can access them when they need to authorise their team members or to check that their team is using the most recent version. Managers should also have signed the appropriate section of the PGD. Valid from: 1 st September 2012 Expiry date: 1 st September

2 PGD Number Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 - Gardasil by registered nurses employed by NHS Hertfordshire or Hertfordshire GP Practices and signatories to the PGD This Patient Group Direction has been approved on behalf of NHS Hertfordshire by: Clinical Standards Committee Authorising Officer for NHS Signature: Hertfordshire Date: 1 st August 2012 Date of Issue September 2012 Issue Number PGD Date of Review September 2014 NHS Hertfordshire 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: April 2012 This document is available electronically or in a larger font or alternative format on request. Valid from: 1 st September 2012 Expiry date: 1 st September

3 Document History Progress Lead Person & Contact Date Number V1 First draft Jo Jenkins May 2012 V2 First revised draft Jo Jenkins May 2012 V3 Final draft Including CSC amendments July 2012 Circulation List Heather Gray Lead May 2012 Pharmacist NHS Hertfordshire Dr Mike Edwards NHS Hertfordshire Medical Director Heather Moulder, NHS Hertfordshire Executive Nurse Approved and ratified by 18 th July 2012 CSC Review Date September 2014 Date of Archiving PGD September 2012 Table of Contents Page Front Sheet 3 Clinical Condition or Situation to which the Direction Applies 4 Description of Treatment 5 Adrenaline management in the event of an anaphylactic reaction 7 Audit 7 Characteristics and qualification required of staff 8 References 8 Management/authorisation of Patient Group Direction 9 Valid from: 1 st September 2012 Expiry date: 1 st September

4 PGD Number Administration of Human Papillomavirus Vaccine (HPV) Types 6, 11, 16 and 18 - Gardasil by registered nurses employed by NHS Hertfordshire or Hertfordshire GP Practices and signatories to the PGD Valid from: 1 st September 2012 Expiry (review) date: 1 st September 2014 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: No previous PGD for Gardasil Development of Patient Group Direction This Patient Group Direction has been developed on behalf of HCT by: Name Signature Date NHS Hertfordshire Medical Director Dr Mike Edwards 18 th July 2012 NHS Hertfordshire Executive Nurse Heather Moulder 17 th May 2012 HCT Pharmacist Jo Jenkins 16 th May 2012 Valid from: 1 st September 2012 Expiry date: 1 st September

5 1. Clinical condition or situation to which the direction applies Indication Active immunisation against invasive cervical cancer caused by human papillomavirus (HPV) types 6, 11, 16 and 18. Criteria for inclusion 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 National 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 be completed with this see the Cervarix PGD. Criteria for exclusion There are very few individuals who cannot receive HPV vaccine. When there is doubt, appropriate advice should be sought from a GP rather than withholding the vaccine. Cautions/Need for further advice from a doctor Consent refused Girls under the age of 12 years Girls who have commenced their HPV vaccination course during academic year with Cervarix see PGD 15 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 the same vaccine should be used for the whole primary course as there is currently no 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. Where possible HPV vaccine should be administered at least 2 weeks before starting immunosuppressive treatment. Valid from: 1 st September 2012 Expiry date: 1 st September

6 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 Give advice about protective effects of the vaccine and declines treatment the risks of infection and disease complications. Document advice given. 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) Black triangle 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 Frequency of administration 0.5ml dose Primary course of three doses given at 0, 1 to 2 months 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 repeated, ideally allowing the appropriate interval between the remaining doses. Duration Patient advice / Follow up treatment 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 Where appropriate patient to remain on the premises for minutes following immunisation (i.e. if unlikely to be supervised within this time) Valid from: 1 st September 2012 Expiry date: 1 st September

7 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 Adverse Reactions and Appropriate medical equipment and drugs for the treatment their Management 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 38 C) 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 Reporting procedure of Adverse Reactions o o Syncope sometimes accompanied by tonic-clonic movements Hypersensitivity reactions including anaphylactic/anaphylactoid reactions Idiopathic thrombocytopenic purpura o Lymphadenopathy o Injection-site cellulitis See product s SPC or the Immunisation against Infectious Disease Green Book for full/further details. Initially via GP and documented in the patient s medical notes Complete an incident form All suspected adverse reactions to be reported to the Commission of Human Medicines (yellow card by the GP or Nurse who manages the anaphylaxis situation. State brand and batch number. Valid from: 1 st September 2012 Expiry date: 1 st September

8 Black triangle medication all adverse reactions (even if just suspected or minor) must be reported via the Yellow Card scheme. 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 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. For administration of vaccines a PIL should be offered or made available to the patient to read. 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) 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) Valid from: 1 st September 2012 Expiry date: 1 st September

9 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 NHS Hertfordshire Additional requirements Has undertaken appropriate training for working under PGDs for supply and administration of medicines Evidenced competency to undertake immunisations Evidenced up to date training in Cardiopulmonary Resuscitation skills (annually) and management of anaphylaxis (yearly) in line with NHS Hertfordshire s Mandatory Training Needs Framework Continued training requirements Attend training dates as required and keep up to date with changes The Registered Nurse 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 (2006) Immunisation against infectious disease (HMSO). Updated at Accessed 2 nd April Current edition of the British National Formulary (BNF) Accessed 2 nd April Most recent version of the Manufacturer s Summary of Product Characteristics (SPC) available at Accessed 2 nd April Immunisation website Accessed 2 nd April Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August Department of Health, CMO letters 7. NMC Standards for Medicines Management (2007) 8. NMC Code of Professional Conduct (2008) 9. Resuscitation Council (UK) Emergency Medical treatment of Anaphylactic Reactions by first medical responders and Community Nurses (updated January 2008) 10. Department of Health (6 th April 2001) Reference Guide to Consent for Examination or Treatment. Crown copyright. ( 11. 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 2011 Valid from: 1 st September 2012 Expiry date: 1 st September

10 7. Management of Patient Group Direction number Authorisation of GP/Clinical Lead for the administration of the named 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 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 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 it applies to. One copy should be given to each nurse with the original signed copy being easily accessible within the practice/clinical setting. Once fully signed a copy of this page only to be retained by the GP. 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 st September 2012 Expiry date: 1 st September