This Patient Group Direction (PGD) must only be used by registered health professionals who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the PGD should be used. Patient Group Direction for the supply and administration of COMBINED HEPATITIS A and TYPHOID VACCINE (for the purpose of travel only) Brands - HEPATYRIX Vaccine ViATIM Vaccine by a registered Nurse for Adults and Adolescents aged 15 years and above (HEPATYRIX ) Adults and Adolescents aged 16 years and above (ViATIM ) PGD Version 6 Valid from 1 May 2015 Expiry Date 30 April 2017 Supersedes Combined Hepatitis A and Typhoid Vaccine PGD Version 5.0 Change history Version number Change details 6 Format update as per NICE guidance for PGDs. Content update in accordance with GB Chapter 17 (updated Dec 2013) and Chapter 33 (updated Oct 2014) and Summary of Product Characteristics revisions. MHRA revised advice for reporting Adverse Drug Reactions Date Expiry date: 30 April 2017 1
PGD development Developed and Produced by the Cheshire, Mersey & Greater Manchester Immunisation PGD Group: Organisation Professional group Current group member PHE Cheshire, Warrington & Wirral Screening & Immunisation Manager Lynn Simpson PHE Merseyside Immunisation Co-ordinator Michelle Falconer 5 Boroughs Partnership Governance Pharmacist Carol Humphries Liverpool Community Health Trust North West Commissioning Support Unit V&I Lead Nurse Senior Pharmacist Tracey Hart Helen Stubbs North West CSU Pharmacist Jo Bark-Jones PHE Cheshire & Merseyside PHE Cheshire & Merseyside PHE Merseyside Warrington CCG PHE Greater Manchester PHE Greater Manchester PHE Greater Manchester Deputy Director for Public Health Senior Health Protection Nurse Screening & Immunisation Manager Practice Nurse (for travel vaccines PGD review only) Screening & Immunisation Manager Screening and Immunisation Coordinator Screening and Immunisation Coordinator Dr S Ghebrehewet Gill Marsh Pauline Jones Angela Dickin Graham Munslow Catherine Hay Pam Southcombe Expiry date: 30 April 2017 2
PGD Signatories and Authorisation PGD Authorisation Organisational Authorisation by Name: Dr Philip Jennings Position: Deputy Medical Director NHS England (Cheshire & Merseyside) Optional local Signatory Signature: Date: 05/05/2015 Name: Position: Signature: Date: Expiry date: 30 April 2017 3
Training and competency of registered health professionals Qualifications and professional registration Requirements of registered health professionals working under the PGD Nurses currently registered with the Nursing and Midwifery Council (NMC) Initial training Received training to undertake supply and administration of medicines under Patient Group Directions. Competency assessment Ongoing training and competency Received appropriate training and updates on the administration of immunisations, in accordance with local policy and national PHE guidance, and can demonstrate competence in these areas. Received appropriate training and updates on resuscitation and management of anaphylaxis and demonstrates competence in this area. Received appropriate training and updates on the storage of vaccines, in accordance with the local cold chain policy, and can demonstrate competence in this area. The individual s competence to immunise should have been assessed in accordance with competency standards, for example, the RCN quality framework RCN 2013 (see reference), by an appropriate clinician/line manager before immunising under this PGD. Clinicians and line managers must ensure they assess the knowledge and competence of each staff member delivering vaccinations and keep a record of staff training requirements. Access annual training updates on resuscitation skills and the management of anaphylaxis in the community. Able to provide evidence of continued professional development i.e. meeting Post-Registration Education & Practice (PREP) requirements. Practitioners should be constantly alert to any subsequent recommendations from the Department of Health and Joint Committee on Vaccination and Immunisation, including tripartite letters, additional immunisation advice / campaigns, product updates and updates to the Department of Health Green Book. Practitioners are advised to register for the PHE Vaccine Update electronic newsletter via the www.gov.uk website, which will assist signposting to the latest information. Information in such documents supersedes information within the PGD and should be followed. However if this advice affects the inclusion /exclusion criteria, then the practitioner MUST seek a PSD until the PGD has been revised. Expiry date: 30 April 2017 4
Clinical condition Clinical condition or situation to which this PGD applies Inclusion criteria Active immunisation against invasive disease caused by Hepatitis A and Typhoid Fever. Pre-exposure: Individuals who require protection against both typhoid and Hepatitis A who are Travelling to or going to reside in areas of moderate or high endemnicity for Hepatitis A, particularly where sanitation and food hygiene may be poor AND Travelling to typhoid endemic areas where planned activities put the individual at higher risk Exclusion criteria A confirmed anaphylactic reaction to a previous dose of vaccine containing the same antigens A confirmed anaphylactic reaction to any component of the vaccine (for previous severe hypersensitivity reactions to non-vi typhoid vaccine see Cautions) No Valid Consent Pregnancy - PSD will be required following a risk assessment) HEPATYRIX - Children under age of 15 years. ViATIM - Children under the age of 16 years. Received a dose of typhoid containing vaccine in the last 3 years Received a dose of Hepatitis containing vaccine in the last 6 months Under age 15 (Hepatyrix ) Under age 16 (Viatim ) NB. Exclusion under this PGD does not necessarily mean the vaccine is contraindicated. Expiry date: 30 April 2017 5
Cautions (including any relevant action to be taken) Cautions (including any relevant action to be taken) - continued Arrangements for referral for medical advice Current acute febrile illness immunisation should be postponed until recovered individuals with known hypersensitivity to neomycin (a residual of the manufacturing process) Breast feeding o No data are available on the safety of Vi polysaccharide typhoid vaccines in pregnancy or breast feeding. There is no evidence of risk from vaccinating pregnant women or those who are breast-feeding with inactivated viral or bacterial vaccines or toxoids. If the risk of typhoid is high, vaccination should be considered- a risk assessment should be carried out Individuals who are immunosuppressed due to disease, e.g. HIV, Hodgkins, or treatment e.g. corticosteroids therapy may not achieve an adequate immune response and may require additional doses - SEEK ADVICE This vaccine protects against Typhoid Fever caused by Salmonella Enterica serotype Typhi and does not protect against Paratyphoid Fever Administer inactivated vaccine at least 2 weeks prior to risk of exposure to Typhoid or hepatitis A. However if a patient presents for travel advice less than two weeks before travel they should still be offered vaccination. The importance of good personal, food and water hygiene must be emphasised to this group of patients as their vaccine response may not be maximal prior to departure NB severe reactions to a previous dose of non -Vi Typhoid vaccine does not contraindicate to the subsequent use of a Vi-Typhoid containing vaccine. Most severe reactions to Typhoid vaccines will have been associated with the inactivated whole cell type, which are no longer available in the UK. Refer to appropriate clinician in accordance with local arrangements e.g. GP, paediatrician Action to be taken if patient excluded Advise when patient may receive vaccine Advise regarding risks of Hepatitis A and Typhoid Fever and disease transmission, signs and symptoms Document exclusion in notes Immunise as soon as valid consent is obtained if appropriate Expiry date: 30 April 2017 6
Seek specialist advice if necessary. Action to be taken if patient declines treatment Document refusal and action taken in patient s record Advise regarding risks of Hepatitis A and Typhoid Fever and disease transmission signs and symptoms Advise on hygiene and avoiding hepatitis A and typhoid Provide information about protective effects of vaccine. If travelling advise to take all necessary precautions to avoid contact with or ingestion of potentially contaminated water or food Expiry date: 30 April 2017 7
Details of the medicine Name, form and strength of medicine Legal category Black triangle Indicate any off-label use (if relevant) Route/method of administration Dose and frequency Combined Hepatitis A and Typhoid Vaccine. ViATIM Hepatitis A adsorbed 160 antigen units and typhoid polysaccharide 25 micrograms vaccine. A dual chamber pre-filled syringe containing a cloudy white suspension and a clear colourless solution. Hepatyrix Hepatitis A adsorbed 1440 ELISA units and typhoid polysaccharide 25 micrograms vaccine is a slightly opaque white suspension in a pre-filled syringe. POM No Not applicable. Intramuscular injection. Individuals with a bleeding disorder may have vaccine by deep subcutaneous injection to reduce risk of bleeding (see SPC for detail) ViATIM Shake to ensure thorough mixing of the suspension. The contents of the two syringes are mixed immediately prior to administering. Hepatyrix should be shaken well before it is injected. Hepatyrix 1ml dose adults and adolescents aged 15 years and older ViATIM 1ml dose - adults and adolescents aged 16 years and older Primary vaccination Administer a single dose of vaccine at least 2 weeks prior to risk of exposure to Hepatitis A and Typhoid. If a patient presents for travel advice less than two weeks before travel they should still be offered vaccination. Reinforcing Doses Expiry date: 30 April 2017 8 A booster dose of an inactivated hepatitis A vaccine is recommended 6 to 12 months after a single dose of Hepatyrix or ViATIM, to provide long term protection against hepatitis A virus, (see single vaccine Hepatitis A PGD) 6 to 12 months after primary immunisation with Hepatitis A vaccine, Hepatyrix or ViATIM may be used to boost Hepatitis A in individuals who also require priming dose against Typhoid Fever. These boosters given 6 12 months after a primary dose will give immunity from Hepatitis A for up to 20 years.
Dose and frequency continued Either Hepatyrix or ViATIM may be used as a reinforcing dose when protection from both hepatitis A and typhoid is required Subjects who remain at risk of typhoid fever should be revaccinated using a single dose of Vi polysaccharide vaccine every 3 years (see single vaccine Typhoid PGD). Quantity to be administered and/or supplied Maximum or minimum treatment period Adverse effects Additional Facilities Storage and Disposal Delayed administration of the booster dose Ideally, the manufacturers recommended timing for the administration of the booster dose of hepatitis A vaccine should be followed. In practice, and particularly in infrequent travellers, there may be a delay in accessing this injection. Studies have shown that successful boosting can occur even when the second dose is delayed for several years so a course does not need to be re-started. Refer to dose and frequency section above. Not applicable Adverse reactions are usually mild and confined to the first few days. Most common reactions are mild transient soreness, erythema, and induration at injection site. This list is not exhaustive refer to current BNF and SPC for complete list. All suspected ADRs that are serious or result in harm should be reported via yellow card system. https://yellowcard.mhra.gov.uk Serious reactions are those that are fatal, lifethreatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason Immediate access to Adrenaline 1 in 1000 injection. The vaccine should be maintained at a temperature of +2ºC to +8ºC and protected from light. Freezing may cause loss of potency rendering the vaccine non effective. It can also cause hairline cracks in the container, leading to contamination of the contents. If there is a potential that the vaccine has been frozen it should be discarded as special waste. Disposal should be by incineration - as per the local waste policy. In the event of any vaccines being stored outside of the recommended +2ºC to +8ºC, this should be reported Expiry date: 30 April 2017 9
Storage and disposal continued Records to be kept and actions taken according to the local Cold Chain policy. These vaccines cannot be given using this PGD. Record fully in Trust clinical record / GP records and as required in parent held records. Patient name and date of birth. Dose, site and route of administration. Antigen(s) given, brand, batch and expiry date of vaccine. Date and time given and by whom. Consent obtained. Stage of immunisation (if appropriate) and if/when next dose is due. An indication that the vaccine has been administered under a PGD. Advice given. Immuniser s signature on appropriate record/ password controlled immunisers record on patient e-records. An electronic or manual record of all individuals receiving immunisation under this PGD should be kept for audit purposes. Patient information Written and verbal information to be given to patient or carer Follow-up advice to be given to patient or carer Inform of possible side effects and their management. Supply Patient Information Leaflet. Emphasise good personal, food and water hygiene; Advise to take all necessary precautions to avoid contact with or ingestion of potentially contaminated water or food. Use the opportunity to provide advice on other preventative measures or to arrange referral to appropriate specialist services. Inform of timings of subsequent vaccines if appropriate. Expiry date: 30 April 2017 10
Appendices Appendix A - Key References 1. NMC (2010) Standards for Medicines Management 2. NMC (2015) The Code of Professional Conduct 3. RCN (2013) Supporting the delivery of immunisation education. A quality framework to support the implementation of national standards and guidelines on immunisation training 4. ebnf at https://www.medicinescomplete.com 5. www.medicines.org.uk Summary of Product Characteristics a. Hepatyrix 16 March 2015 (accessed 17 April 2015) b. ViATIM 2 March 2015 (accessed 17 April 2015) 6. https://www.gov.uk/government/collections/immunisation-against-infectiousdisease-the-green-book Immunisation Against Infectious Disease The Green Book including updated Chapter 17 (accessed 17.4.15) and Chapter 33 (accessed 17.4.15) 7. RCN 2013 Supporting the delivery of immunisation education. A quality framework to support the implementation of national standards and guidelines on immunisation training 8. NICE Competency Framework for Health Professionals using PGDs (Jan 2014). Expiry date: 30 April 2017 11
Appendix B - Health Professionals Agreement to Practise Both the Health Professional and the Senior Representative must be familiar with the NICE competency framework for Health Professionals using PGDs (Jan 2014) before signing this agreement. Health Professional Name I have read and understood the Patient Group Direction and agree to supply and/or administer this medicine only in accordance with this PGD Signature Date Senior Representative (Clinical) Name I give authorisation on behalf of the NHS organisation / Group Practice for the named Health Professional who has signed this PGD to administer the vaccine as prescribed within this direction and in accordance with the local governance policy for PGDs, and current Public Health guidance (The Green Book - Immunisation against Infectious Disease) available at www.gov.uk Signature Date Expiry date: 30 April 2017 12