by registered nurses employed by NHS Hertfordshire or Hertfordshire GP Practices and signatories to the PGD

Transcription

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 16 and 18 - Cervarix in girls who began their HPV vaccination schedule with Cervarix during the 2011/12 academic year only 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: May 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 To replace PGD No. 15: Administration of Human Papillomavirus Vaccine (HPV) Types 16 and 18 - Cervarix September 2010 September 2012 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 9 Audit 9 Characteristics and qualification required of staff 9 References 9 Management/authorisation of Patient Group Direction 11 Valid from: 1 st September 2012 Expiry date: 1 st September

4 PGD Number Administration of Human Papillomavirus Vaccine (HPV) Types 16 and 18 - Cervarix in girls who began their HPV vaccination schedule with Cervarix during the 2011/12 academic year only 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 2013 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: PGD No. 15: Administration of Human Papillomavirus Vaccine (HPV) Types 16 and 18 - Cervarix September 2010 September 2012 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 16 and 18 in girls who have already received at least one dose of Cervarix vaccine during the academic year but who did not complete the three dose course these girls should complete their vaccination course with Cervarix. The Department of Health has stated that all Cervarix courses should be completed April 2013 as the majority of UK Cervarix stock expires at this time. Criteria for inclusion Informed consent obtained and documented Any girl, aged 12 years or over who has already received at least one dose of Cervarix vaccine during the academic year but who did not complete the three dose course these girls should complete their vaccination course with Cervarix. Criteria for exclusion Cautions/Need for further advice from a doctor In exceptional circumstances if an individual has started a course of Gardasil but the course cannot be completed with Gardasil the vaccine course can be completed with Cervarix to three doses in total (e.g. one Gardasil and two Cervarix etc) following the normal vaccination schedule of 0, 1-2 months, 6 months. In exceptional circumstances 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 and of what preparation (brand). A female who presents with an incomplete course of Cervarix (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 who have not previously received a dose of HPV vaccine they should have a complete course of Gardasil (see PGD 62). Consent refused Girls under the age of 12 years 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 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. Cervarix 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 Valid from: 1 st September 2012 Expiry date: 1 st September

6 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 exceptional circumstances if an individual has started a course of Gardasil but the course cannot be completed with Gardasil the vaccine course can be completed with Cervarix to three doses in total (e.g. one Gardasil and two Cervarix etc) following the normal vaccination schedule of 0, 1-2 months, 6 months. 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 Community paediatrician, patients GP or immunisation coordinator. Where possible HPV vaccine should be administered at least 2 weeks before starting immunosuppressive treatment. HPV vaccine should only be administered to breast feeding mothers if the possible advantages outweigh possible risks. Action if excluded Record in the patient s medical notes Action if patient declines treatment Specialist advice must be sought on the vaccines from a Community paediatrician, patients GP or immunisation co-ordinator 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. Inform or refer to GP as appropriate. 2. Description of Treatment Name, strength and Cervarix human papillomavirus vaccine (HPV) types 16 and formulation of drug 18 (recombinant, adjuvanted, adsorbed) bivalent suspension for injection - pre-filled 0.5ml syringe Legal status Method / Route Dose / Dose range Frequency of administration POM (prescription only medicine) 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 Cervarix must not be administered either intravascularly or intradermally. 0.5ml dose Standard practice: Primary course of three doses given at 0, 1 to 2 months Valid from: 1 st September 2012 Expiry date: 1 st September

7 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. Duration Patient advice / Follow up treatment Adverse Reactions and their Management 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. If the second dose of HPV is given late: In cases where the second dose of HPV vaccine is given late, the minimum interval between the second and third dose of Cervarix is 3 months. If there is a high likelihood of dose three not being attended for: There is no clinical data on whether the interval between doses 2 and 3 can be reduced below 3 months. Where there is a high likelihood that the individual will not return for a third dose after this length of time or if for practical reasons it is not possible to schedule a third dose within this time-frame, then a third dose of Cervarix can be given at least one month after the second dose. 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) 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 mild side effects: o mild to moderate short lasting pain, discomfort, redness or swelling at the injection site o headache o aching muscles o muscle tenderness or weakness o fatigue Valid from: 1 st September 2012 Expiry date: 1 st September

8 Common side effects: o gastrointestinal symptoms (including nausea, vomiting, diarrhoea and abdominal pain) o itching o rash o urticaria o joint pain o fever over 38C Uncommon side effects: o upper respiratory tract infection o dizziness o other injection site reactions See product s SPC or the Immunisation against Infectious Reporting procedure of Adverse Reactions Disease Green Book for 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. 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 handling, security, storage and labelling Records Store vaccine at 2 C to 8 C (in a refrigerator). Do not freeze. Protect from light. 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. 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 Valid from: 1 st September 2012 Expiry date: 1 st September

9 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) 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. Valid from: 1 st September 2012 Expiry date: 1 st September

10 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 Guidance for the 2010/11 HPV programme Letter from the DoH Director of Immunisations 17 th March Department of Health Vaccine Update Issue 187 March Accessed 2 nd April 2012 Valid from: 1 st September 2012 Expiry date: 1 st September

11 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