Patient Group Direction template Administration of shingles (herpes zoster) vaccine (live) Zostavax Version 7.0 updated for programme from September 2017 to August 2018 This specimen Patient Group Direction template has been produced by Health Protection Scotland to assist NHS boards NHS boards should amend/adapt this Patient Group Direction template and must ensure that the Patient Group Direction is considered and approved in line with local clinical governance arrangements for Patient Group Directions
PGD shingles (herpes zoster) vaccine (live) (Zostavax ) Authorisation This specimen Patient Group Direction (PGD) template has been produced by Health Protection Scotland to assist NHS boards. NHS boards should ensure that the final PGD is considered and approved in line with local clinical governance arrangements for PGDs. The qualified health professionals who may administer shingles (herpes zoster) vaccine (live) (Zostavax ) under this PGD can only do so as named individuals. It is the responsibility of each professional to practice within the bounds of their own competence and in accordance with their own Code of Professional Conduct and to ensure familiarity with the marketing authorisation holder s summary of product characteristics (SPC) for all vaccines administered in accordance with this PGD. NHS board governance arrangements will indicate how records of staff authorised to operate this PGD will be maintained. Under PGD legislation there can be no delegation. Administration of the vaccine has to be by the same practitioner who has assessed the patient under the PGD. This PGD has been produced for NHS (insert details) by Doctor Pharmacist Nurse Approved on behalf of NHS (insert details) by Medical Director Director of Pharmacy/Senior Pharmacist Clinical Governance Lead Date Approved Effective from 01/09/2017 Review Date 31/08/2018
Clinical Situation Indication Inclusion Criteria Prevention of shingles (herpes zoster) and herpes zoster-related post-herpetic neuralgia (PHN) in line with Scottish Government immunisation programme. Individuals included in age cohorts described by most current CMO letter. From September 2017 eligible individuals are: Those who were 70 years of age on 1 st September 2017 (i.e. born between 02/09/1946 and 01/09/1947). Those who were 76 years of age on 1 st September 2017 (i.e. born between 02/09/1940 and 01/09/1941). Individuals aged 71, 72, 73, 74, 77, 78, 79 years on 1 st September 2017 who were previously eligible for shingles vaccine under this programme who have not been vaccinated with shingles vaccine. Valid consent has been given to receive the vaccine. Exclusion Criteria Primary or acquired immunodeficiency states due to conditions such as: o current or previous treatment of malignant disease; o acute and chronic leukaemias; lymphoma (including Hodgkin s lymphoma); o those remaining under follow up for a chronic lymphoproliferative disorder including haematological malignancies such as indolent lymphoma, chronic lymphoid leukaemia, myeloma and other plasma cell dyscrasias (N.B: this list not exhaustive) o immunosuppression due to HIV/AIDS; o cellular immune deficiencies; o those who have received an allogenic stem cell transplant (cells from a donor) in the past 24 months; o those who have received an allogenic stem cell transplant more 24 months ago and have evidence of ongoing immunosuppression or graft versus host disease(gvhd); o those who have received an autologous (using their own stem cells) haematopoietic stem cell transplant in the past 24 months; o those who have received an autologous haematopoietic stem cell transplant more 24 months ago and are not in remission. Is on immunosuppressive or immunomodulating therapy including o those who are receiving or have received in the past 6 months immunosuppressive chemotherapy or radiotherapy for malignant disease or non-malignant
disorders o those who are receiving or have received in the past 6 months immunosuppressive therapy for a solid organ transplant o those who are receiving or have received in the past 12 months biological therapy (e.g. anti-tnf therapy such as alemtuzumab, ofatumumab and rituximab) o those who are receiving or have received in the past 3 months immunosuppressive therapy including i) short term high-dose corticosteroids (>40mg prednisolone per day for more than 1 week); ii) long term lower dose corticosteroids (>20mg prednisolone per day for more than 14 days) iii) non-biological oral immune modulating drugs e.g. methotrexate >25mg per week, azathioprine >3.0mg/kg/day or 6-mercaptopurine >1.5mg/kg/day Confirmed anaphylactic reaction to a previous dose of varicella vaccine. Confirmed anaphylactic reaction to any component of the vaccine, including neomycin or gelatin. Practitioners must check the marketing authorisation holder s summary of product characteristics (SPC) for details of vaccine components. Individuals who are acutely unwell postpone until patient has fully recovered. Individuals who currently have shingles or have had shingles in the last year should have vaccination delayed for one year after shingles. Individuals who currently have PHN should wait until symptoms have ceased before being considered for shingles immunisation. Individuals being currently treated or are within 48 hours of cessation of treatment with oral or intravenous antivirals (such as aciclovir) Cautions /Need for further advice/ Circumstances when further advice should be sought from a doctor Zostavax is a live attenuated vaccine. If there is any doubt of the individual s suitability for vaccine do not vaccinate and seek further advice. If the individual is under highly specialist care, and it is not possible to obtain full information on that individual s treatment history, then vaccination should not proceed until the advice of the specialist or a local immunologist has been sought. Specialists with responsibility for patients in the vaccine eligible cohorts should include a statement of their opinion on the patient s suitability for Zostavax in their correspondence with primary care. If primary healthcare professionals administering the vaccine have concerns about the nature of therapies (including biologicals) or the degree of
immunosuppression they should contact the relevant specialist for advice. Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. The use of topical aciclovir is not an exclusion. Humoral deficiencies affecting IgG or IgA antibodies are not of themselves a contra-indication unless associated with T cell deficiencies. If there is any doubt (e.g. common variable immune deficiency), immunological advice should be sought prior to administration. Many adults with chronic inflammatory diseases (e.g. rheumatoid arthritis, inflammatory bowel disease, psoriasis, glomerulonephritis) may be on stable long term low dose corticosteroid therapy (defined as 20mg prednisolone per day for more than 14 days) either alone or in combination with other immunosuppressive drugs including biological and non-biological therapies. Long term stable low dose corticosteroid therapy (defined as 20mg prednisolone per day for more than 14 days) either alone or in combination with low dose non-biological oral immune modulating drugs (e.g. methotrexate 25mg per week, azathioprine 3.0mg/kg/ day or 6-mercaptopurine 1.5mg/kg/day) are not considered sufficiently immunosuppressive and these patients can receive the vaccine. Specialist advice should be sought for other treatment regimes. The use of the vaccine is not excluded for use in individuals who are receiving topical/inhaled corticosteroids and in people who are receiving corticosteroids as replacement therapy (e.g. for adrenal insufficiency) Action if Excluded 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. Document in clinical records. Temporary exclusion: In case of postponement due to acute illness, arrange a future date for immunisation. Action if Patient Declines Temporary exclusion: In case of postponement due to current/recent shingles, PHN or current/recent treatment with antivirals arrange a future date for immunisation. Advise individual about the protective effects of the vaccine, the risks of infection and complications. Document advice given and decision reached. In GP practice setting, inform or refer to GP. Description of Treatment Name of Medicine Shingles (herpes zoster) vaccine (live) Zostavax. Form/Strength Powder and solvent for suspension for injection in a pre-filled syringe.
Route of administration Intramuscular injection preferably in the deltoid region of the upper arm. The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder. Intramuscular administration is preferred due to comparable immune response and less frequent injection site adverse reactions than subcutaneous administration. Dosage Frequency 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 Additional Information 0.65ml Single dose. Not applicable. Not applicable. Not applicable. No Prescription Only Medicine The SPC states that Zostavax and 23-valent pneumococcal polysaccharide vaccine (PPV) should not be given concomitantly. This is superseded by the Green Book recommendation that the two vaccines may be given at the same time. Vaccine should be stored 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. Zostavax is available as a vial containing an off-white compact crystalline plug of powder and a prefilled syringe of clear and colourless diluent. To reconstitute the vaccine, use the solvent provided. Inject the entire content of the pre-filled syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into a syringe for injection. When reconstituted, Zostavax is a semi-hazy to translucent, offwhite to pale yellow liquid. The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the vaccine differs from that described above. It is recommended that the vaccine be administered immediately after reconstitution, to minimize loss of potency. Discard reconstituted vaccine if it is not used within 30 minutes. Zostavax can be given at the same time as inactivated influenza vaccinations.
Zostavax can be given at the same time as the 23-valent pneumococcal polysaccharide vaccine (PPV). Zostavax and MMR vaccine if not administered on the same day, then a four week minimum interval period should be observed. Zostavax and Yellow Fever vaccine if not administered on the same day, then a four week minimum interval period should be observed. Apart from MMR vaccine where a 4 week gap between vaccinations should be observed, Zostavax may be administered at any time before or after other live vaccines Apart from the above two combinations Zostavax can be administered at any time before or after other live vaccines. If given at the same time as other vaccinations, care should be taken to ensure that the appropriate route of injection is used for all the vaccinations. 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 commonly reported side effects for Zostavax, occurring in at least one in ten people were injection site reactions including erythema (redness), pain, swelling, and pruritus (itching). Other common reactions reported in at least one in 100 people were haematoma, induration and warmth at the injection site, pain in arm or leg and headache. For full details/information on possible side effects, refer to the marketing authorisation holder s SPC. As with all vaccines there is a very small possibility of anaphylaxis and facilities for its management must be available. In the event of severe adverse reaction individual should be advised to seek medical advice. Reporting procedure for adverse reactions Advice to Patient/carer including written information Any adverse events that may be attributable to Zostavax vaccine should be reported using the yellow card system on http://yellowcard.mhra.gov.uk/ 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
Monitoring Follow-up Additional Facilities is possible. Advise individual that if they develop a varicella-like rash after vaccination, they should avoid direct contact with a susceptible (chickenpox naïve) person until the rash is dry and crusted. Advise individual to seek medical advice in case of severe adverse reaction. Following immunisation patients remain under observation in line with NHS board policy. Not applicable. Immediate access to Epinephrine (Adrenaline) 1 in 1000 injection. Access to telephone. Characteristics of staff authorised under the PGD Professional Those registered health care professionals that are listed and qualifications approved in legislation as able to operate under patient group directions. Specialist competencies or qualifications Continuing education and training Audit Trail Record/Audit Trail 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 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. The approved practitioner must ensure maintenance of records for each supply 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: Patient 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
undertaken, the information should be recorded manually or electronically, in one (or more) of the following systems, as appropriate: GP practice computer, Individuals GP records. Additional references Practitioners operating the PGD must be familiar with: Immunisation against Infectious Disease [Green Book] https://www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book Immunisation against Infectious Disease [Green Book] chapter 28a shingles (herpes zoster) https://www.gov.uk/government/publications/shingles-herpeszoster-the-green-book-chapter-28a 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 (2015) Code of Professional Conduct. NMC (2010) Standards for Medicines Management.
PGD for administration of shingles (herpes zoster) vaccine (live) (Zostavax ) Authorisation This PGD does not remove professional obligations and accountability. It is the responsibility of each professional to practice with the bounds of their own competence and in accordance with their Code of Professional Conduct and to ensure familiarity with the manufacturer s summary of product characteristics for all vaccines administered in accordance with this PGD. Note to Authorising Managers Authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction. I agree to administer shingles (herpes zoster) vaccine (live) (Zostavax ) only in accordance with this PGD. Name of Professional Date I agree that the professionals listed above are authorised to supply/administer medicines in accordance with this PGD to patients cared for in this service area. Lead Clinician for the service area (Doctor) Name: : Date: