GG&C PGD ref no: 2016/1309 YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

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1 GG&C PGD ref no: 2016/1309 YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition Indication: Prevention of shingles (herpes zoster) and herpes zoster-related post-herpetic neuralgia (PHN) in line with Scottish Government Health Directorate immunisation programme. Inclusion criteria: Individuals 70 years and over included in age cohorts described by most current CMO letter at Valid consent has been given to receive the vaccine. Exclusion criteria: Primary and acquired immunodeficiency states due to conditions such as: current or previous treatment of malignant disease; acute and chronic leukaemias; lymphoma (including Hodgkin s lymphoma); 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) immunosuppression due to HIV/AIDS; cellular immune deficiencies; those who have received an allogenic stem cell transplant (cells from a donor) in the past 24 months; those who have received an allogenic stem cell transplant (cells from a donor) more than 24 months ago and have evidence of ongoing immunosuppression or graft versus host disease (GVHD); those who have received an autologous (using their own stem cells) haematopoietic stem cell transplant in the past 24 months; those who have received an autologous (using their own stem cells) haematopoietic stem cell transplant more than 24 months ago and are not in remission Is on immunosuppressive or immunomodulating therapy including those who: are receiving or have received in the past 6 months immunosuppressive chemotherapy or radiotherapy for malignant disease or non-malignant disorders. are receiving or have received in the past 6 months immunosuppressive therapy for a solid organ transplant are receiving or have received in the past 12 months biological therapy (e.g. anti-tnf therapy such as alemtuzumab, ofatumumab and rituximab) are receiving or have received in the past 3 months immunosuppressive therapy including Template Version: 2011 Page 1 of 10

2 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 currently have shingles or have had shingles in the last year should have vaccination delayed for one year after shingles. N.B. a history of shingles infection is not an exclusion. Individuals who currently have PHN (they 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) Active untreated tuberculosis infection Evolving neurological condition, immunisation should be deferred until resolved or stabilised. History of severe (i.e. anaphylactic reaction) to latex where vaccine is not latex free. Acute systemic or febrile illness postpone until patient has fully recovered. Cautions/Need for further advice/circumstances when further advice should be sought from the prescriber: 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. Use the HPS screening tool to aid identification of patients who are contraindicated for shingles vaccine. (Appendix 1.) 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. Template Version: 2011 Page 2 of 10

3 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 regimens. 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) The use of topical acyclovir is not an exclusion. Patients who have had two or more episodes of shingles in one year should have immunological investigation prior to vaccination. Apart from MMR vaccine where a four week gap between vaccinations should be observed, Zostavax can be administered at any time before or after other live vaccines. Known bleeding disorder administer subcutaneously Action if patient declines or is excluded: Refer to appropriate clinician e.g. GP, Travel Health Consultant, Sexual Health, GUM, ID Consultant. Referral arrangements for further advice / cautions: If declined advise regarding protective effect of immunisation and potential disease complications. Document advice given and refer to appropriate clinician. Temporary exclusion: In case of postponement due to acute severe illness, arrange a future date for immunisation. Temporary exclusion: In case of postponement due to current shingles or PHN arrange an appropriate future date for immunisation following cessation of symptoms. As above Template Version: 2011 Page 3 of 10

4 Drug Details Name, form & strength of medicine: Route/Method of administration: Dosage (include maximum dose if appropriate): Frequency: Duration of treatment: Maximum or minimum treatment period: Quantity to supply/administer: Additional Monitoring:* Legal Category: Is the use outwith the SPC:** Storage requirements: Shingles (herpes zoster) vaccine (live) Zostavax. Powder and solvent for suspension for injection in a pre-filled syringe Intramuscular Deep subcutaneous injection for individuals with a bleeding disorder (caution possibility of reduced immunogenicity with this route) 0.65ml Single dose n/a n/a 0.65ml Yes POM Yes The SPC states that Zostavax should not be administered at the same time as Pneumovax 2 (PPV) vaccine. However the Green Book supports concomitant administration. Store between 2 0 C-8 0 C in locked storage. NHS GG&C Immunisation and Best Practice Guidelines on Storage and Handling of vaccines should be observed deline%20and%20best%20practice%20document%20janaury% pdf Vaccine storage history e.g. temperature charts must be checked and deemed satisfactory before administration to patient. * The black triangle symbol has now been replaced by European additional monitoring ( ) ** Summary of Product Characteristics Template Version: 2011 Page 4 of 10

5 Warnings including possible adverse reactions and management of these: Advice to patient/carer including written information provided: Monitoring (if applicable): Follow up: Please refer to current BNF, ebnf or SPC at for full details. Use the Yellow Card System to report adverse drug reactions directly to the CSM.CMS. Yellow Cards and guidance on their use are available at the back of the BNF or online at Explain treatment and course of action. Give patient a copy of relevant patient information leaflet., if appropriate. PIL available at Further Information available to patients at N/A See advice to patient/carer Template Version: 2011 Page 5 of 10

6 Staff Characteristics Professional Those registered health care professionals that are listed and approved in qualifications: legislation as able to operate under patient group directions and have current registration. Specialist competencies or qualifications: Continuing education & training: Has undertaken appropriate training and competence to undertake immunisation including recognition and treatment of anaphylaxis Has undertaken appropriate training for working under PGDs for the supply and administration of medicines All health care professionals working under the direction will be expected to maintain their competence as specified in hospital, local and national policies e.g. Nursing & Midwifery Council guidelines. The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development in all aspects of immunisation including recognition and treatment of anaphylaxis. Referral Arrangements and Audit Trail Referral As per local arrangements/national guidelines GP if required arrangements Records/audit Patient s name, address, date of birth and consent given; trail: Contact details of GP (if registered); Dose and form administered (batch details and expiry date); Advice given to patient (including side effects); Signature/name of staff who administered or supplied the medication, and also, if relevant, signature/name of staff who removed/discontinued the treatment; Details of any adverse drug reaction and actions taken including documentation in the patient s medical record; Referral arrangements (including self-care) Administration must be recorded on the GP record Template Version: 2011 Page 6 of 10

7 References/ Resources and comments: Notes: SPC Summary of Product Characteristics SEHD/CMO (2006)9 BNF British National Formulary NMC (2010) Standards for Medicines Management at NMC (2015) The NMC Code of Professional Conduct: standards for conduct, performance and ethics NHS GG&C Immunisation Resource Manual 0and%20Best%20Practice%20Document%20Janaury% pdf Immunisation against Infectious Diseases (2006). DOH (Green Book) always refer to on-line version Health Protection Scotland Immunisation and Vaccine Preventable Diseases website NHS HealthScotland website com/topics/health/immunisation/index.aspx Immunisation Scotland Template Version: 2011 Page 7 of 10

8 This Patient Group Direction must be agreed to and signed by all healthcare professionals involved in its use. The original signed copy will be held at PPSU, Queens Park House, Victoria Infirmary. The PGD must be easily accessible in the clinical setting. Organisation: NHS Greater Glasgow & Clyde drawing up PGD/Authors Name: Dr Syed Ahmed 30/10/2014 Designation and Contact Details Designation: Consultant in Public Health Medicine Public Health Protection Unit Westhouse, NHS GG&C address: Name: *Val Reilly 30/10/2014 Designation: Public Health Pharmacist Pharmaceutical Public Health Westhouse, NHS GG&C address: Name: Lyndsay Houston 30/10/2014 Designation: Health Protection Nurse Specialist Public Health Protection Unit Dalian House NHS GG&C address: * Lead Author Template Version: 2011 Page 8 of 10

9 AUTHORISATION: NHSGG&C PGD & Non-medical Prescribing Sub-Committee of ADTC Chairman in BLOCK CAPITALS Dr Craig Harrow 30/10/2014 Lead of the professional group to which this PGD refers: Name: in BLOCK CAPITALS Gavin Gorman 30/10/2014 Pharmacist representative of PGD & Non-Medical Sub-Committee of ADTC Name: in BLOCK CAPITALS Elaine Paton 30/10/2014 Antimicrobial use If the PGD relates to an antimicrobial agent, the use must be supported by the NHS GG&C Antimicrobial Management Team (AMT). A member of this team must sign the PGD on behalf of the AMT. Microbiology approval Name: Designation: (on behalf of NHS GG&C AMT) Template Version: 2011 Page 9 of 10

10 Local Authorisation: Service Area for which PGD is applicable: I authorise the supply/administer medicines in accordance with this PGD to patients cared for in this service area. Lead Clinician for the service area (Doctor) Name: Designation: contact address: I agree that only fully competent, qualified and trained professionals are authorised to operate under the PGD. Records of nominated individuals will be kept for audit purposes. Name (Lead Professional): Designation: contact address: Description of Audit arrangements: Frequency of checks: (Generally annually) Names of auditor(s): PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. 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 acknowledge that it is a legal document and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Date Template Version: 2011 Page 10 of 10