Consultation Group: See relevant page in the PGD. Review Date: July 2016

Transcription

1 Patient Group Direction For The Administration Of Gardasil Vaccine Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed) By Nurses, Midwives and Health Visitors Working Within NHS Grampian Co-ordinators: PGD pharmacist Pharmacy and Medicines Directorate Consultation Group: See relevant page in the PGD Approver: Medicine Guidelines and Policies Group Signature: Signature: Identifier: NHSG/PGD/HPVG/ MGPG669 Review Date: July 2016 Date Approved: July 2014 A Patient Group Direction is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by Doctors, Pharmacists and other appropriate professionals, approved by the Employer and advised by the relevant professional advisory committees. In most cases, appropriate clinical care is provided on an individual basis by a specific prescriber to a specific individual patient. Patient Group Directions should only be considered where they offer a benefit to patient care without compromising patient safety in any way. Uncontrolled when printed Version 2.1 (Amended January 2016) This specimen Patient Group Direction was produced by Health Protection Scotland to assist NHS Boards This Patient Group Direction has been adapted by NHS Grampian in order to meet local clinical governance arrangements for Patient Group Directions.

2 Title: Patient Group Direction for the administration of Gardasil Vaccine Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed) by nurses, midwives and health visitors working within NHS Grampian Identifier: NHSG/PGD/HPVG/MGPG669, Version 2.1 Replaces: NHSG/PGD/HPVG/MGPG669, Version 2 Across NHS Boards Organisation Wide Directorate Clinical Service Sub Department Area Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Author: Subject Key word(s): Policy application: Purpose: Health Protection Scotland, adapted for NHSG by PGD pharmacist, Pharmacy and Medicines Directorate Patient Group Direction Patient Group direction PGD nurse HPV human papillomavirus gardasil NHS Grampian This Patient Group Direction (PGD) authorises appropriately qualified and trained nurses, midwives and health visitors to administer Gardasil vaccine to individuals without the requirement for a patient specific prescription written by a medical practitioner. Responsibilities for implementation: Organisational: Corporate: Departmental: Area: Hospital/Interface services: Operational Management Unit: Policy statement: Review: Chief Executive and Management Teams Senior Managers Heads of Service/Clinical Leads Line Managers Assistant General Managers and Group Clinical Directors Unit Operational Managers It is the responsibility of individual nurses and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. This policy will be reviewed at least every two years or sooner if current treatment recommendations change. UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG669 - i -

3 This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) or (01224) Responsible for review of this document: Responsible for ensuring Registration of this document on the NHS Grampian Information/ Document Silo: Physical location of the original of this document: Job/group title of those who have control over this document: Responsible for disseminating document as per distribution list: PGD pharmacist, Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate PGD pharmacist, Pharmacy and Medicines Directorate Revision History: Date of change Approval date of PGD that is being superseded Summary of Changes July 2014 July yearly update Section heading July 2014 July 2012 Removal of as no longer applicable Throughout January July 2014 Addition of Midwives and Health Visitors Throughout 2016 UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG669 - ii -

4 This Patient Group Direction (PGD) has been adapted from a specimen PGD template produced by Health Protection Scotland, July This PGD has been produced for NHS Grampian by Doctor Diana Webster Signature Pharmacist Judith Webster Signature Nurse Fiona Browning Signature Approved on behalf of NHS Grampian by Medical Director Roelf Dijkhuizen Signature Director of Pharmacy David Pfleger Signature Clinical Governance Lead Elinor Smith Signature Date Approved Effective from Review Date UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

5 Clinical Situation Indication Inclusion Criteria Active immunisation against disease caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18 in line with Scottish Government Health Directorate HPV immunisation programme. Females aged 11 to under 18 years. Gardasil is recommended in females from school year S1, aged around years, including those not in school. Females who do not commence HPV immunisation in S1 remain eligible until they reach 18 years of age. Exclusion Criteria Valid consent has been given to receive the vaccine. Confirmed anaphylactic reaction to a previous dose of HPV vaccine. Confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder s summary of product characteristics (SPC) for details of vaccine components. History of severe (i.e. anaphylactic) allergy to latex. Check against SPC or with Medicines Information at ARI (tel: ). Vaccination should be deferred until it can be ascertained that the vaccine to be used is latex-free. For latex allergies other than anaphylactic allergies (e.g. contact allergy to latex) vaccination may proceed as normal. Known pregnancy. No valid consent. Cautions /Need for further advice/ Circumstances when further advice should be sought from doctor Action if Excluded Acute systemic or febrile illness postpone immunisation until the individual has fully recovered. Arrange a future date for immunisation. Individuals with known bleeding disorders should receive the vaccine by deep subcutaneous route to reduce the risk of bleeding. (N. B. This is a Green Book recommendation and outwith the Gardasil product licence). Specialist advice must be sought on the vaccine and circumstances under which it could be given. The risk to the individual of not being immunised must be taken into account. Temporary exclusion: In case of postponement due to acute severe illness, arrange a future date for immunisation. Document in clinical records. UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

6 Action if Patient Declines Consent Advise individual about the protective effects of the vaccine, the risks of infection, diseases and complications. Document advice given and decision reached. In GP practice setting, inform or refer to GP. Prior to the administration of the drug, consent must be obtained, preferably written, either from the patient, parent, guardian or person with parental responsibility and documented either in the patient s medical records/notes or on an administration form. Consent must be in line with NHSG policy. See link below. MenuID=460& Description of Treatment Name of Medicine Form/Strength Gardasil Vaccine (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) Suspension for injection in a pre-filled syringe. During storage, a white precipitate may develop and the vaccine should be shaken before use to form a white cloudy liquid. Route of administration Intramuscular injection. Preferred site is deltoid area of upper arm. It can also be administered in the anterolateral area of the thigh. Individuals with known bleeding disorders should receive the vaccine by deep subcutaneous route to reduce the risk of bleeding. See above. Dosage Frequency 0.5mL The frequency depends on the age the individual receives their first dose and whether the individual is immunocompromised at the time of vaccination. Individuals aged below 15 years when receiving the first dose The course consists of two doses; First dose. Second dose at least six months after the first dose. Both doses should ideally be given with a 24 month period. If the course is interrupted, it should be resumed but not repeated. UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

7 Individuals aged 15 years or above receiving the first dose or individuals of any age who are known to be HIV positive (including those on antiretroviral therapy) or are immunocompromised at the time of vaccination The course consists of three doses; First dose. Second dose at least one month after the first dose. Third dose at least three months after the second dose. All three doses should be ideally 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. There are no clinical data on whether the interval between doses two and three can be reduced below three months. Where the second dose is given late and there is a high likelihood that the individual will not return for a third dose after three months or if, for practical reasons, it is not possible to schedule a third dose within this time-frame, then a third dose of HPV vaccine can be given at least one month after the second dose. Duration of treatment Maximum or minimum treatment period Quantity to supply/administer black triangle medicines Legal Category Is the use outwith the SPC Storage requirements See frequency section. See frequency section. Maximum three doses. No PoM Prescription-only Medicine. Yes, the SPC for Gardasil states the two dose schedule should be used in girls up to age 14 years. This is superseded by Scottish Government policy based on JCVI recommendation/advice in Green Book. Yes if administration is SC. Vaccine should be stored in the original packaging at a temperature of +2 to +8 C. If the vaccine has been frozen, it should be discarded. NHS board guidance on Storage and Handling of vaccines should be observed. Additional Information During storage, a white precipitate may develop and the vaccine should be shaken before use to form a white cloudy liquid. Gardasil vaccine can be given at the same time as other vaccines such as Td/IPV, MMR, influenza, MenC and UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

8 hepatitis B. The vaccines should be given at a separate site, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual s records. Warnings including possible adverse reactions and management of these 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 has also been reported. Redness has also been reported at the injection site. Other reactions commonly reported are headache, myalgia, fatigue and low grade fever. For full details/information on possible side effects, refer to the marketing authorisation holder s SPC. Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should this occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. (Refer to Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals). In the event of severe adverse reaction individual should be advised to seek medical advice. Syncope (vasovagal reaction) or fainting can occur during any vaccination, most commonly amongst adolescents. Some individuals may also experience panic attacks before vaccination. The clinical features of fainting and panic attacks are described in Chapter 8 of the Green Book. Fainting and panic attacks before or very shortly after vaccination are not usually direct side effects (adverse reactions) of the vaccine but events associated with the injection process itself. Reporting procedure for adverse reactions Advice to Patient/carer including written information As with all vaccines, healthcare professionals and parents/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on Any serious adverse reaction to the vaccine should be documented in an individual s record. GP should also be informed. Supply marketing authorisation holder s patient information leaflet (PIL) provided with vaccine. Inform of possible side effects and their management. Give advice regarding normal reaction to the injection e.g. sore arm is possible. Give advice on the management if individual becomes UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

9 Monitoring Follow-up feverish. Advise individual to seek medical advice in case of severe adverse reaction. Advise individual when subsequent doses are due when applicable. Following immunisation individual to remain under observation in line with NHS Board policy. Advise individual when subsequent doses are due when applicable. Additional Facilities Immediate access to Epinephrine (Adrenaline) 1 in 1000 injection. Access to telephone. Characteristics of staff authorised under the PGD Professional qualifications Specialist competencies or qualifications Continuing education and training Nurses, Midwives and Health Visitors currently registered with the Nursing and Midwifery Council (NMC). Approved by the organisation as competent: to undertake immunisation and discuss issues related to immunisation, to assess the person s capacity to understand the nature and purpose of the immunisation in order to give or refuse consent, to work with this patient group direction, in the recognition and management of anaphylaxis. The practitioner must be familiar with the marketing authorisation holder s SPC for all vaccines administered in accordance with this PGD. It is the responsibility of the individual to keep up to date with all aspects of immunisation and in the recognition and management of anaphylaxis. Audit Trail Record/Audit Trail The approved practitioner must ensure maintenance of records for each vaccine administered and may be required to share information with appropriate parties in line with confidentiality protocols. The information relating to immunisation of each individual must include as a minimum: Individual s name and date of birth, Dose, Site and route of injection, Brand, batch number and expiry date of vaccine, Date given and by whom. All records must be clear and legible and, ideally, in an easily retrievable format. Depending on the clinical setting where immunisation is UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

10 undertaken, the information should be recorded manually or electronically, in one (or more) of the following systems, as appropriate: Consent forms, Child Health Information Services, Individual s GP records. Additional references Practitioners operating the PGD must be familiar with: Department of Health (2006): Immunisation against Infectious Disease [Green Book] Immunisation against Infectious Disease [Green Book] chapter 18a HPV Current edition of British National Formulary Marketing authorisation holder s Summary of Product Characteristics All relevant Scottish Government Health Directorate advice including the relevant CMO letter(s) NMC (2008) The code: Standards of conduct, performance and ethics for nurses and midwives NMC (2010) Standards for Medicines Management Authorising Body Scottish Government Health Department Consultative Group Elaine Allan Fiona Browning Gillian Flett Linda Juroszek Liz Kemp Pamela Molyneaux Diana Webster Lead Nurse for school nursing Health Protection Nurse Specialist Consultant, Family Planning CHP Lead Pharmacist Principal Pharmacist Pharmaceutical Services Consultant Virologist Consultant in Public Health Medicine & Immunisation Coordinator UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

11 Appendix 1 Health Care Professional Agreement To Administer Medicines Under Patient Group Direction I: (Insert name) Working within: e.g. CHP, Practice Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Administration Of Gardasil Vaccine Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed) By Nurses, Midwives and Health Visitors Working Within NHS Grampian I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor outwith the recommendations of the Patient Group Direction. Signed: Print Name: Date: Professional Registration No: UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG

12 Appendix 2 Certificate Of Authorisation To Administer Medicines Under Patient Group Direction This authorises: Working within: e.g. CHP, Practice To administer medicines under the following Patient Group Direction Patient Group Direction For The Administration Of Gardasil Vaccine Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed) By Nurses, Midwives and Health Visitors Working Within NHS Grampian The above named person has satisfied the training requirements and is authorised to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed: Authorising Manager/Doctor Print Name: Date: UNCONTROLLED WHEN PRINTED Review Date: 31/07/16 Identifier: NHSG/PGD/HPVG/MGPG