PGD for Typhoid

Reference Number: NHSE(LR)/Typhoid v1.1 Page 1 of 6 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

Patient Group Direction for the Administration of Typhoid Vaccine (Typherix®, or

TYPHIM Vi®)

This PGD must be read in conjunction with the core PGD (Reference:

NHSE(LR)/PGD/Core PGD for Immunisations), which details information that is common to all of the immunisation PGDs.

This PGD must only be used by registered healthcare professionals, working within NHS England (London Region), who have been named and authorised to practice

under it.

Version number: 1.1

Expiry date: 31st March 2016 The master copy for this PGD is held N:\2.0 Medical\Clinical Adviser Medicines\Patient Group Directions\Final Signed PGDs\Immunisation PGDs 2014 Change history Version number

Change details Date

1.0 First version December 2013 1.1 Revision of content March 2014

PGD for Typhoid

Reference Number: NHSE(LR)/Typhoid v1.1 Page 2 of 6 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

PGD Development and Clinical Approval PGD Working Group This PGD was developed by a working group involving pharmacists from a number of Clinical Commissioning Groups across London, plus nurse representatives. Name and role Job title and organisation Jonathan Mason Pharmacist and Lead Author

Clinical Adviser (Medicines) NHS England (London Region)

Henrietta Hughes Doctor

Medical Director North Central and East London Area Team NHS England (London Region)

Eileen Bryant Nurse reviewer

Primary Care Nurse Adviser NHS England (London Region)

Nicola Pratelli Nurse Reviewer

Population Health Practitioner Manager Immunisation South NHS England (London Region)

Thara Raj Public Health Specialist

London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) NHS England (London Region)

Nick Beavon Pharmacist Reviewer

Chief Pharmacist Wandsworth Clinical Commissioning Group

Raana Ali Pharmacist Reviewer

Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit

Pauline Taylor Pharmacist Reviewer

Head of Medicines Management Haringey Clinical Commissioning Group

Helen Tsang Pharmacist Reviewer

Practice Link Pharmacist North West London Commissioning Support Unit

Dee Vadukul Pharmacist Reviewer

Senior Practice Pharmacist Richmond Clinical Commissioning Group

Seema Buckley Pharmacist Reviewer

Chief Pharmacist NHS Kingston Clinical Commissioning Group

References: • SmPC References for Typherix® and TYPHIM Vi®. Latest versions on eMC

(accessed March 2014): http://www.medicines.org.uk/emcmobile/medicine/2063/spc http://www.medicines.org.uk/emcmobile/medicine/6186/spc

• Green Book chapter on Typhoid vaccines (accessed March 2014): https://www.gov.uk/government/publications/typhoid-the-green-book-chapter-33

• NaTHNaC factsheet on Typhoid: http://www.nathnac.org/pro/factsheets/typhoid.htm

PGD for Typhoid

Reference Number: NHSE(LR)/Typhoid v1.1 Page 3 of 6 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

PGD for Typhoid

Reference Number: NHSE(LR)/Typhoid v1.1 Page 4 of 6 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

Patient Group Direction for the Administration of Typhoid Vaccine (Typherix® and TYPHIM Vi®)

Clinical condition or situation to which this PGD applies

Active immunisation against infection caused by the gram-negative bacterium Salmonella typhi.

Inclusion criteria Patient over 2 years of age: • Travelling to countries where typhoid is endemic (e.g.

South Asia, parts of South-East Asia, the Middle East, Central and South America, and Africa), especially if staying with or visiting the local population;

• Travelling to endemic areas (see above) with frequent and/or prolonged exposure to conditions where sanitation and food hygiene are likely to be poor;

• Laboratory personnel who may handle S. typhi in the course of their work.

Exclusion criteria As per the general exclusions stated in the Core PGD, plus: • Patient under 2 years of age; • Known hypersensitivity to components of the vaccine in

particular: o Formaldehyde - TYPHIM Vi®; o Phenol - Typherix®.

Special considerations/ additional information

• No protection is given against paratyphoid fever; • When given for travel purposes, the patient should be

given general travel advice, including good personal, food and water hygiene;

• Refer to the NATHNAC website and factsheet on typhoid for advice: http://www.nathnac.org/pro/factsheets/typhoid.htm

Details of the medicine Name, form and strength of medicine

Typhoid Polysaccharide vaccine in a pre-filled syringe (Typherix® and TYPHIM Vi®)

Dose 0.5ml

Frequency Primary course: single dose Booster: • Patients who remain at risk of typhoid fever should be

revaccinated using a single dose of Typhoid polysaccharide vaccine every 3 years;

• For information about boosting for or with Typhoid/ Hepatitis A combinations please refer to the PGD for the

PGD for Typhoid

Reference Number: NHSE(LR)/Typhoid v1.1 Page 5 of 6 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

combined vaccines, and the SmPC for the specific vaccine.

Quantity 1 x 0.5ml

Adverse effects As detailed in the core PGD, plus common: itching. Refer to SmPC for complete list.

PGD for Typhoid

Reference Number: NHSE(LR)/Typhoid v1.1 Page 6 of 6 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

Healthcare Professional’s Agreement to Practise and Practice/Pharmacy/Local Organisation Authorisation

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR

ACCOUNTABILITY. IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE AND IN

ACCORDANCE WITH THEIR OWN CODE OF PROFESSIONAL CONDUCT. DECLARATION by healthcare professional: • I have read and understand this PGD; • I have been appropriately trained to understand the criteria listed, and the

techniques and record-keeping required to administer the vaccine in accordance with this PGD;

• The training has included both the theoretical and practical aspects of the techniques required to administer vaccines by the following routes (please tick as appropriate): Intramuscular injection □ Subcutaneous injection □

• I confirm that I have been assessed for my knowledge and clinical competency, and EITHER am experienced in administering vaccines in the past 12 months, OR I have been observed administering vaccines in practice;

• I confirm that I am competent to undertake administration of this vaccine; • I confirm that I will ensure that I remain up to date in all aspects of the

administration of this vaccine. Healthcare Professional’s Name:……………………………. Registration Number:………………………. Expiry Date: ………………………. Signature: …..………………….. Date: ………………………. Declaration by Authorising Manager*: Managers should only authorise staff who have received the required training and are competent to work to this PGD. Each authorised member of staff should be provided with an individual copy of the PGD, which they should also sign to declare themselves competent. A copy of the signed document should be kept by the individual staff member. The authorising manager should retain a copy of the signed individual authorisation page. I have read and understood the PGD and authorise the staff member named above to operate in accordance with this PGD. Authorising Manager’s Name:…………………………….. Signature: …..………………….. Date: ……………………….

*The term manager refers to the person taking responsibility for authorising healthcare professionals to operate under the terms of this PGD, and includes lead GPs, nurse managers, pharmacy managers etc.