PGD for Td/IPV. Version number: 1.1

Transcription

1 Patient Group Direction (PGD) for the Administration of Combined Diphtheria (low dose), Tetanus, and Inactivated Poliomyelitis Vaccine (Td/IPV REVAXIS ) 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, who have been named and authorised to practice under it. Version number: 1.1 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 Change details Date number 1.0 First version December Revision of content March 2014 Reference Number: NHSE(LR)/PGD/Td/IPV Page 1 of 7

2 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 Jonathan Mason Pharmacist and Lead Author Henrietta Hughes Doctor Eileen Bryant Nurse reviewer Nicola Pratelli Nurse Reviewer Thara Raj Public Health Specialist Nick Beavon Raana Ali Pauline Taylor Helen Tsang Dee Vadukul Seema Buckley Job title and organisation Clinical Adviser (Medicines) Medical Director North Central and East London Area Team Primary Care Nurse Adviser Population Health Practitioner Manager Immunisation South London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) Chief Pharmacist Wandsworth Clinical Commissioning Group Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit Head of Medicines Management Haringey Clinical Commissioning Group Practice Link Pharmacist North West London Commissioning Support Unit Senior Practice Pharmacist Richmond Clinical Commissioning Group Chief Pharmacist NHS Kingston Clinical Commissioning Group References: SmPC References for Revaxis (accessed March 2014): Green Book chapters on Diphtheria, Polio, and Tetanus (accessed March 2014): Reference Number: NHSE(LR)/PGD/Td/IPV Page 2 of 7

3 PGD for Td/IPV Reference Number: NHSE(LR)/PGD/Td/IPV st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016 Page 3 of 7

4 Patient Group Direction for the Administration of Combined Diphtheria (low dose), Tetanus, and Inactivated Poliomyelitis Vaccine (Td/IPV REVAXIS ) Clinical condition or situation to which this PGD applies Inclusion criteria Active immunisation against diphtheria, tetanus and poliomyelitis in children and adults aged 10 years and over Any child aged 10 years and over, or adult: Where there is either no history, or an incomplete history of a primary course of diphtheria, tetanus or poliomyelitis; For whom a booster is required following a primary course of immunisation against diphtheria, tetanus and poliomyelitis. Note that this vaccine is usually offered to pupils in school at 13 to 18 years of age, unless the course has already been completed; Who is travelling to, or will be residing in epidemic or endemic areas where tetanus, diphtheria or polio protection is required and the final dose of relevant antigen was received more than 10 years ago; Who is travelling to an area where medical attention may not be accessible should a tetanus prone wound occur, even if the individual has received 5 doses of tetanus containing vaccine previously; Following a tetanus prone wound when: o Primary immunisation is incomplete or o Boosters not up to date or o Individual has not been immunised or o Immune status is not known or is uncertain Refer to Appendix 1; Intravenous drug users are at greater risk of tetanus, booster doses should be given if there is any doubt about their immunisation status; For laboratory and healthcare workers if not previously immunised. Exclusion criteria As per the general exclusion criteria stated in the Core PGD, plus: Any individual who has had a confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, or polio containing vaccine. This includes any conjugate vaccines where diphtheria or tetanus toxoid is used in the conjugate; Child aged under 10 years; Individuals who have experienced encephalopathy or encephalitis occurring within 7 days following previous vaccination with diphtheria, tetanus or poliomyelitis; Vaccination of cases, contacts or carriers of diphtheria. Reference Number: NHSE(LR)/PGD/Td/IPV Page 4 of 7

5 These cases should be referred to a specialist for consideration on an individual basis; First booster dose given within the last 12 months, or second booster dose within the last 5 years. Action if excluded/special considerations/ additional information Details of the medicine Name, form and strength of medicine Dose Frequency If aged under 10 years refer to the PGD for Pediacel ; First booster dose given within the last 12 months, or second booster dose within the last 5 years defer until appropriate interval. Adsorbed diphtheria (low dose), tetanus, and inactivated poliomyelitis vaccine (Td/IPV - Revaxis ) is presented as a suspension for injection in a pre-filled syringe. 0.5ml As a primary course of 3 doses administered at 4 weekly intervals in previously unimmunised individuals, or where there is no history of a primary course of diphtheria, tetanus and polio vaccination; To complete a course where there is an incomplete history of a primary course of diphtheria, tetanus and polio vaccination: A single booster dose should be administered to previously immunised children aged over 10 years of age and adults, at least one year after the primary course; A second booster should be given 5 to 10 years after the first booster, if less than 5 doses of diphtheria and tetanus and polio vaccine are documented. Travellers, following a tetanus-prone wound, IV drug users, laboratory and healthcare workers: A single booster dose Quantity Adverse effects 1 x 0.5ml per dose As detailed in the core PGD, plus: common: vertigo Refer to SmPC for complete list. Reference Number: NHSE(LR)/PGD/Td/IPV Page 5 of 7

6 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. Reference Number: NHSE(LR)/PGD/Td/IPV Page 6 of 7

7 Appendix 1 Immunisation recommendations for clean and tetanus-prone wounds Tetanus prone wounds include: Wounds or burns that require surgical intervention that is delayed for more than six hours; Wounds or burns that show a significant degree of devitalised tissue or a puncture-type injury, particularly where there has been contact with soil or manure; Wounds containing foreign bodies; Compound fractures; Wounds or burns in patients who have systemic sepsis. IMMUNISATION STATUS CLEAN WOUND TETANUS-PRONE WOUND Vaccine Vaccine Human tetanus immunoglobulin Fully immunised, i.e. has received a total of five doses of vaccine at appropriate intervals None required None required Only if high risk (see Green book section above Primary immunisation complete, boosters incomplete but up to date None required (unless next dose due soon and convenient to give now) None required (unless next dose due soon and convenient to give now) Only if high risk (see Green book section above Primary immunisation incomplete or boosters not up to date A reinforcing dose of vaccine and further doses as required to complete the recommended schedule (to ensure future immunity) A reinforcing dose of vaccine and further doses as required to complete the recommended schedule (to ensure future immunity) Yes: one dose of human tetanus immunoglobulin in a different site Not immunised or immunisation status not known or uncertain An immediate dose of vaccine followed, if records confirm this is needed, by completion of a full 5-dose course to ensure future immunity An immediate dose of vaccine followed, if records confirm this is needed, by completion of a full 5-dose course to ensure future immunity Yes: one dose of human tetanus immunoglobulin in a different site Reference Number: NHSE(LR)/PGD/Td/IPV Page 7 of 7