Patient Group Direction for the Administration of Human Papilloma Virus (HPV) Vaccine (Gardasil and Cervarix )

Transcription

1 Patient Group Direction for the Administration of Human Papilloma Virus (HPV) Vaccine (Gardasil and Cervarix ) This PGD must be read in conjunction with the core PGD (Reference: NHSE(LR)/PGD/Core PGD for Immunisations), which details information that is common to all of the immunisation PGDs. This PGD must only be used by registered healthcare professionals, working within, who have been named and authorised to practice under it. Version number: 1.1 The master copy for this PGD is held N:\2.0 Medical\Clinical Adviser Medicines\Patient Group Directions\Final Signed PGDs\Immunisation PGDs 2014 Change history Version Change details Date number 1.0 First version December Revision of content March 2014 Reference Number: NHSE(LR)/PGD/HPV v1.1 Page 1 of 6

2 PGD Development and Clinical Approval PGD Working Group This PGD was developed by a working group involving pharmacists from a number of Clinical Commissioning Groups across London, plus nurse representatives. Name and role Jonathan Mason Pharmacist and Lead Author Henrietta Hughes Doctor Eileen Bryant Nurse reviewer Nicola Pratelli Nurse Reviewer Thara Raj Public Health Specialist Nick Beavon Raana Ali Pauline Taylor Helen Tsang Dee Vadukul Seema Buckley Job title and organisation Clinical Adviser (Medicines) Medical Director North Central and East London Area Team Primary Care Nurse Adviser Population Health Practitioner Manager Immunisation South London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) Chief Pharmacist Wandsworth Clinical Commissioning Group Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit Head of Medicines Management Haringey Clinical Commissioning Group Practice Link Pharmacist North West London Commissioning Support Unit Senior Practice Pharmacist Richmond Clinical Commissioning Group Chief Pharmacist NHS Kingston Clinical Commissioning Group References: SmPC References for Gardasil and Cervarix. Latest versions on emc (accessed March 2014): Green Book chapter on Human Papilloma VIrus vaccines (accessed March 2014): Reference Number: NHSE(LR)/PGD/HPV v1.1 Page 2 of 6

3 PGD for HPV Reference Number: NHSE(LR)/PGD/HPV v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016 Page 3 of 6

4 Patient Group Direction for the Administration of Human Papilloma Virus (HPV) Vaccine (Gardasil and Cervarix ) Clinical condition or situation to which this PGD applies Active immunisation against premalignant genital lesions (cervical, vulvar and vaginal) and invasive cervical cancer caused by human papillomavirus (HPV). Note: Gardasil is the vaccine recommended for the national immunisation programme. Inclusion criteria Exclusion criteria Cautions/special considerations/ additional information Female patients over 9 years of age and under 18 years of age. As per the general exclusion criteria stated in the Core PGD, plus: Female patients under 9 years of age; Female patients over 18 years of age; Male patients; Known pregnancy; The US data sheet for Cervarix ( states that the tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals. This information is not included in the European SmPC. If the patient finds out she is pregnant after starting a course of HPV vaccine, she should complete her pregnancy before finishing the three-dose schedule; The two vaccine products are not routinely interchangeable and, ideally, one vaccine product should be used for the entire course; Yeast allergy is not a contraindication to the HPV vaccine. Even though Gardasil is grown in yeast cells, the final vaccine product does not contain any yeast. Details of the medicine Name, form and strength of medicine Human Papillomavirus Vaccine (Gardasil ) [types 6,11, 16,18] (recombinant, adsorbed) quadrivalent vaccine; Human Papillomavirus Vaccine (Cervarix ) [types 16, 18] (recombinant, adsorbed) bivalent vaccine; The vaccine comes as a turbid white suspension in a single dose (0.5mL) prefilled syringe with a plunger stopper. N.B. Shake vaccine gently immediately before administration to produce a white cloudy Reference Number: NHSE(LR)/PGD/HPV v1.1 Page 4 of 6

5 liquid. Dose Frequency 0.5ml Dose 1: 0 month; Dose 2: one month after the first dose; Dose 3: four to six months after the first dose AND preferably at least 3 months after the second dose. All three doses should be given within a 12-month period. In cases where the second dose of HPV vaccine is given late, the minimum interval between the second and third dose of vaccine is three months. Use outside terms of SmPC Quantity Adverse effects The dosing schedules stated in the SmPCs for the two vaccines are different from those stated above. The Green Book states that HPV vaccine should be administered at 0, 1, and 4 to 6 months. 3 doses of 0.5ml As detailed in the core PGD, plus: Common: An immediate localised stinging sensation at the injection site has been reported; Aching muscles, muscle tenderness or weakness; Low-grade fever. Refer to SmPC for complete list. Follow-up If appropriate (e.g. depending on age) explain that immunisation is not a substitute for cervical screening. Reference Number: NHSE(LR)/PGD/HPV v1.1 Page 5 of 6

6 Healthcare Professional s Agreement to Practise and Practice/Pharmacy/Local Organisation Authorisation PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE AND IN ACCORDANCE WITH THEIR OWN CODE OF PROFESSIONAL CONDUCT. DECLARATION by healthcare professional: I have read and understand this PGD; I have been appropriately trained to understand the criteria listed, and the techniques and record-keeping required to administer the vaccine in accordance with this PGD; The training has included both the theoretical and practical aspects of the techniques required to administer vaccines by the following routes (please tick as appropriate): Intramuscular injection Subcutaneous injection I confirm that I have been assessed for my knowledge and clinical competency, and EITHER am experienced in administering vaccines in the past 12 months, OR I have been observed administering vaccines in practice; I confirm that I am competent to undertake administration of this vaccine; I confirm that I will ensure that I remain up to date in all aspects of the administration of this vaccine. Healthcare Professional s Name:. Registration Number:. Expiry Date:. Signature:.... Date:. Declaration by Authorising Manager * : Managers should only authorise staff who have received the required training and are competent to work to this PGD. Each authorised member of staff should be provided with an individual copy of the PGD, which they should also sign to declare themselves competent. A copy of the signed document should be kept by the individual staff member. The authorising manager should retain a copy of the signed individual authorisation page. I have read and understood the PGD and authorise the staff member named above to operate in accordance with this PGD. Authorising Manager s Name:.. Signature:.... Date:. * The term manager refers to the person taking responsibility for authorising healthcare professionals to operate under the terms of this PGD, and includes lead GPs, nurse managers, pharmacy managers etc. Reference Number: NHSE(LR)/PGD/HPV v1.1 Page 6 of 6