Patient Group Direction For the supply and administration of

Patient Group Direction For the supply and administration of Vi Capsular Polysaccharide Typhoid Vaccine(Ty2) Brands TYPHERIX Vaccine TYPHIM Vi Vaccine To adults and/or children over 2 years of age Or Oral Typhoid Vaccine (Ty21a) Brand VIVOTIF To Adults and Children over 6 years of age By Registered Nurse/Midwife/Health Visitor PGD Version Typhoid Vaccine PGD Version 5.0 Valid from February 2013 Review Date End January 2015 Supersedes Typhoid PGD V4 November 2010 1. Characteristics of staff Qualifications required Additional requirements Continued training requirements Registered Nurse / Midwife/ Health Visitor having valid registration with the Nursing and Midwifery Council (NMC). Received training to undertake supply and administration of medicines under Patient Group Directions. Received appropriate training and updates on the administration of immunisations, in accordance with local policy and national HPA 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. Annual attendance at update 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. Page 1 of 9

2. Clinical condition or situation Indication Criteria for inclusion Criteria for exclusion For active immunisation against invasive disease caused by Typhoid Fever. Adults and children aged 2 years and over (6 years and over for oral vaccine) in the following situations: Travellers to countries where sanitation and hygiene may be poor. Travellers to areas of high prevalence, especially if planned activities put them at higher risk, including travellers visiting friends and relatives, young children, long-term travellers and those exposed to conditions of poor sanitation. Occupational or lifestyle risk (e.g. laboratory workers who work with organisms or handle specimens from suspected cases). General exclusions to typhoid vaccines Current acute febrile illness A confirmed anaphylactic reaction to a previous dose of vaccine containing the same antigens a confirmed anaphylactic reaction to another component of the vaccine including gelatine found in the enteric coating of oral vaccine ( For previous severe hypersensitivity reactions see special precautions 9) Pregnant women (If high risk of infection see special precautions 1- will require a PSD). No Valid Consent Dose of injectable typhoid vaccine in the previous 3 years Specific exclusions for the live Oral Vaccine Immunosuppression ( see chapter 6 of the Green Book for more detail); Acute gastrointestinal illness (Vaccination should be postponed until after recovery). In children under 6 years of age Within 3 days of completing treatment with any antibacterial agents. (see also special precautions 3) Specific exclusion for the inactivated injectable vaccine Children under 2 years of age * Exclusion under this PGD does not necessarily mean contraindicated Page 2 of 9

2. Clinical condition or situation continued Action if excluded Action if patient declines treatment Advise when patient may receive vaccine. Advise regarding risks of Typhoid Fever and disease transmission, signs and symptoms. If travelling advise to take all necessary precautions to avoid contact with or ingestion of potentially contaminated water or food Immunise as soon as valid consent is obtained. Seek specialist advice if necessary. Document refusal and action taken in patient s record. Advise about the risks of Typhoid Fever, signs and symptoms, disease complications and transmission 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 Special precautions/additional information 1. Pregnancy and Breast feeding No data are available on the safety of Vi polysaccharide and Ty21a 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 (Plotkin and Orenstein, 2004). It is not known if Ty21a vaccine can cause foetal harm when administered to pregnant women or affect reproductive ability. If the risk of typhoid is high, vaccination should be considered- SEEK ADVICE a PSD will be required 2. Children under the age of 2 years may show sub-optimal response. 3. Children between the ages of 12 months and 2 years should be immunised if the risk of typhoid infection is considered high. (not covered by this PGD) 4. Vaccination with live Ty 21a vaccine (Vivotif ) should not commence within 3 days after completing treatment with any antibacterial agents as the growth of the vaccine organism may be inhibited by sulphonamides or antibiotics. It is also preferable that antibacterial therapy should not commence within 3 days after the last dose of Vivotif 5. Patient who are immunosuppressed due to disease, e.g. HIV, Hodgkins, or treatment e.g. corticosteroids therapy, when vaccinated by injection may not achieve an adequate immune response and may require additional doses. SEEK ADVICE. N.B. oral live vaccine contraindicated for use in these patients. 6. Current acute febrile illness immunisation should be postponed until recovered. Page 3 of 9

2. Clinical condition or situation continued Special 7. If malaria prophylaxis is also required the fixed precautions/additional combination of atovaquone and proguanil can be given information concomitantly with Vivotif. Doses of mefloquine and Vivotif should be separated by at least 12 hours. For other antimalarials, there should be an interval of at least 3 days between the last dose of Vivotif and the first of malaria prophylaxis. 8. The oral vaccines capsules should not be used if the blister packaging is not intact. 9. This vaccine only protects against Typhoid Fever caused by Salmonella Enterica serotype Typhi and does not protect against Paratyphoid Fever 10. Administer inactivated vaccine at least 2 weeks prior to risk of exposure to Typhoid. 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. 11. For live vaccination protection commences 7-10 days after the third dose 12. Seek specialist advice if necessary e.g. In the case of a previous severe reaction refer to the appropriate medical officer (Consultant or GP) NB severe reactions to a previous dose of non -Vi Typhoid vaccine does not contraindicate the subsequent use of a Vi- Typhoid containing vaccine. Most severe reactions to Typhoid vaccines will have been associated with the inactivated whole References to national/local policies or guidelines cell type. www.medicines.org.uk. Summary of Product Characteristics: Typherix (GSK) 26/02/12 accessed 28/01/13; Typhim Vi (Sanofi Pasteur MSD) 13/06/11 accessed 28/01/2013. Vivotif (Jannsen-Cilag) 06/04/12 accessed 28/01/2013 NMC (2010) Standards for Medicines Management NMC (2008) Code of Professional Conduct BNF64 September 2012 http://www.dh.gov.uk/ - Immunisation Against Infectious Disease The Green Book relevant updated Chapters to January2013 Health care professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary of Product Characteristics (SPC) for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and should be followed. Page 4 of 9

3. Description of treatment Name, strength & Vi capsular polysaccharide Typhoid vaccine 25 formulation of drug micrograms / 0.5ml Typherix and Typhim Vi are presented in pre-filled syringes Oral typhoid vaccine Vivotif contains a live attenuated strain of S typhi. Vivotif is presented in a blister pack of 3 enteric-coated capsules Legal status Black Triangle POM No Dose/Dose range Typherix and Typhim Vi. A single dose of 0.5ml for adults and children 2 years of age and older. Vivotif A 3 dose regimen,at 0,2 and 4 days for both adults and children 6 years of age and older. Route/method Typherix and Typhim Vi Intramuscular injection, the preferred site is the deltoid muscle. Individuals with a bleeding disorder or on oral anticoagulants should have vaccine by deep subcutaneous injection to reduce risk of bleeding Frequency of administration Vivotif Oral. The capsules should be taken about 1 hour before a meal with cold or lukewarm drink (temperature not to exceed 37ºC). It must not be chewed and should be swallowed as quickly as possible. Inactivated Intramuscular Vaccine Priming Single Dose. Page 5 of 9 Reinforcing Dose Patients who remain at risk of Typhoid Fever should be revaccinated using a single dose of Vi polysaccharide Typhoid vaccine every 3 years (different brands can used interchangeably). Live Oral Vaccine Priming Course of 3 vaccines Reinforcing Dose In the case of travel from a non-endemic area to an area where typhoid is endemic, an annual booster consisting of three doses is recommended. *see Vivotif SPC for full details of reinforcing doses.

3. Description of treatment continued Identification & Management of Adverse Reactions Common adverse effects may include injection site reactions (e.g. erythema, induration, swelling, pain tenderness); headache, fever and malaise mostly within 48 hrs after vaccination. Oral immunisation may also include abdominal pain and diarrhoea. Any serious adverse events in adults and all adverse events in children should be reported via yellow card system. www.yellowcard.gov.uk Additional Facilities Immediate access to Adrenaline 1 in 1000 injection. Patient advice Inform of possible side effects and their management. Emphasise good personal, food and water hygiene. The vaccine does not protect against Paratyphoid Fever. Follow up Specific Product Information Not applicable Not applicable Records Record fully in Trust clinical record / GP records and as required in parent held records and forward immunisation records to the Child Health Information System (CHIS) / Department. Patient name and date of birth Dose, site and route of injection 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. State if immunisation was given as scheduled or unscheduled. 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 Page 6 of 9

4. PGD Development Developed and Produced by Cheshire and Merseyside Childhood Immunisation PGD subgroup: PCT Represented Organisation Professional group Current group member Central & Eastern Cheshire PCT Halton & St Helens Knowsley Knowsley Liverpool Central & Eastern Cheshire PCT NHS Halton & St Helens 5 Boroughs Partnership 5 Boroughs Partnership Liverpool Community Health Primary Care Immunisation Facilitator Immunisation Co-ordinator Immunisation Co-ordinator Pharmacist V&I training Lead Cath Lilley Michelle Falconer Pauline Jones Carol Humphries Pauline Morris Sefton Sefton PCT Pharmaceutical Adviser Helen Stubbs in Public Health Warrington Warrington PCT Public Health Consultant Marioth Manche Warrington Western Cheshire Bridgewater Community Healthcare NHS Community Care Western Cheshire Immunisation Co-ordinator Lead Pharmacist Wirral NHS Wirral Immunisation Co-ordinator Wirral & Cheshire & Merseyside HPU Cheshire & Merseyside HPU Health Protection Agency Health Protection Agency CCDC & Unit Director Senior Health Protection Nurse Tracie Duffy John Hickey Claire Elliot Dr S Ghebrehewet Gill Marsh (chair) Page 7 of 9

5. PGD Authorisations Patient Group Direction Authorisation Lead Doctor Name: Dr Sam Ghebrehewet Position: Unit Director and Consultant in Communicable Disease Control, C&MHPU Lead Pharmacist Name: Helen Stubbs Position: Pharmaceutical Adviser in Public Health, Sefton PCT Lead Nurse Name: Gill Marsh Position: Senior Health Protection Nurse Practitioner, C&MHPU PGD Authorised on Behalf of NHS Wirral by: Governance Lead Name: Dr Phil Jennings Position: Wirral CCG Chair PGD Authorised for use in GP Practice by: Senior Partner (or delegate) for GP employed nurses only Name: Position: Page 8 of 9

6. Declaration Practitioner I have read the contents of this Patient Group Direction and will work within this remit. Name Signature Date Employer/ Line Manager Name I give authorisation on behalf of for the named Health Care Professional who has signed this PGD to administer those vaccines as prescribed within this direction and in accordance with the current Department of Health guidelines (The Green Book - Immunisation against Infectious Disease, HMSO 2006 and relevant updated chapters). Organisation Signature Date Page 9 of 9