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Patient Group Direction (PGD) for the Administration of:

TETANUS, DIPHTHERIA (LOW DOSE) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED) Td/IPV (Revaxis)

POM Prescription Only Medicine

YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH THE DIRECTION APPLIES For active immunisation against tetanus, diphtheria and polio in adults Indication and young people from 10th birthday upwards.

Inclusion Criteria

Informed consent has been given, in accordance with current PCT guidelines, for the administration of the vaccine As a booster following primary immunisation. Ideally administered at age 13 to 18 as recommended in the national immunisation schedule (teenage booster). As a primary course in individuals previously unimmunised against tetanus, diphtheria and polio or where there is an unreliable history of vaccination To complete a primary course of immunisation against diphtheria, tetanus or poliomyelitis All the above are part of the national immunisation schedule Following a tetanus prone wound in line with current guidance. See latest Green Book chapter 30 for definition of tetanus prone wound. See Appendix 1 for guidance on when to vaccinate. Individuals requiring immunisation against tetanus diphtheria and polio prior to travel. See frequency section and refer to (NaTHNaC): http://www.nathnac.org/ for further details.

Exclusion Criteria

Informed consent has NOT been given for the administration of the vaccine Aged under 10 years. Any individual who has had a confirmed anaphylactic reaction to: (i) A previous dose of a vaccine containing diphtheria, tetanus, or inactivated polio. (ii) Any constituent of the vaccine (check the product leaflet). (iii) Neomycin, Polymyxin B, or Streptomycin (which may be present in trace amounts). Current acute febrile illness Individuals who have received a dose of a vaccine against tetanus, diphtheria or polio in the last month. Individuals who have completed a primary vaccination course or received a booster dose of vaccine against tetanus, diphtheria and polio within the last 5 years, except in circumstances described in frequency section.

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 1


Individuals who have received 5 doses of a tetanus containing vaccine at the recommended intervals, except in circumstances described in frequency section. Neurological Conditions Detailed guidance on the use of diphtheria containing vaccines in patients with neurological conditions, discussed as a precaution rather than a contraindication, is given on pages 118 to 120 of „Immunisation against Infectious Disease‟ (the Green Book). Pre-Existing Neurological Conditions o Where there is an unstable, evolving or deteriorating neurological abnormality, including poorly controlled epilepsy, immunisation should be deferred and patient should be referred to a paediatrician. See Green Book chapter 15 for details. o

Neurological Abnormalities Following Immunisation If a child experienced encephalopathy or encephalitis within 7 days of immunisation, OR a seizure associated with a fever within 72 hours of immunisation, further immunization should be deferred and the child referred to a paediatrician.* *NB – For children with a history of seizure associated with fever within 72 hours of immunization, if a cause is identified, or the child recovers within 24 hours, immunization should continue as recommended.

Cautions/Need for Further Advice

Please also see Cautions/Need for further advice section Previous severe reaction to vaccination – clarify nature of severe reaction and seek advice from a prescriber. Hypersensitivity to: (i) A previous dose of a vaccine containing diphtheria, tetanus, pertussis, inactivated polio or Hib., (ii) Any constituent of the vaccine (check the product leaflet). (iii) Neomycin, Polymyxin B, or Streptomycin (which may be present in trace amounts). Refer to a prescriber for further advice. Pre-existing neurological conditions. For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue Pregnancy and Breast feeding mothers – whilst this is not necessarily a contraindication, individuals working under this PGD must seek further clinical advice from an appropriate medical practitioner. (e.g. patient‟s GP) before the vaccine is administered.

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 2


The benefits of administration should outweigh the risks. For further information see appropriate Green Book chapters. Thrombocytopenia, Haemophilia or any other problem that may stop blood from clotting properly, or patient taking anti coagulants. Where there is personal or family history of febrile seizures, there is an increased risk of these occurring after any fever, including that caused by immunisation. These children should be referred to a prescriber. Refer to Green Book chapter 15. The immunogenicity of the vaccine could be reduced in immunosuppressed patients. Consult with the individual‟s clinician to find out whether vaccination should be postponed until immune function has recovered. For individuals with chronic immunodeficiency, such as HIV, vaccination is recommended even if the antibody response might be limited. Some ointments and creams which are prescribed to treat eczema can affect the immune response. Tetanus, diphtheria (low dose) and poliomyelitis (inactivated) adsorbed vaccine should not be given during treatment with and for 14 days after stopping treatment with either Tacrolimus (Protopic) Ointment or Pimecrolimus (Elidel) cream, or similar preparations which may affect the immune response. Allergy to latex – Vial stoppers and syringe plunger stoppers are often made of this type of rubber and there is a risk of an allergic reaction to the vaccine because of this. However, for latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain latex can be administered. Refer to Green Book chapter 6. If an individual has a history of severe (i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered. For these individuals contact the manufacturer to confirm whether the vaccine to be administered contains latex.

Action if Patient Declines or is Excluded

Refer to supervising doctor if appropriate. Document findings and action taken in patient‟s record. Give information about risks of disease Give information about how to recognise signs and symptoms of the diseases. Give information about when the vaccine may be given

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 3


DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine

REVAXIS Tetanus, diphtheria (low dose) and poliomyelitis (inactivated) vaccine injection (adsorbed) in a pre-filled syringe - Td/IPV Td/IPV is thiomersal free

Route/Method

VACCINES MUST NOT BE GIVEN INTRAVENOUSLY

To be given by intramuscular injection into the deltoid region. For individuals with a bleeding disorder, however, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding. Upon storage, a white deposit may be present. Shake the pre-filled syringe well to re-suspend the deposit. This should give a homogeneous cloudy white suspension. If any particulate matter is present the syringe and contents should be discarded. Td/ IPV can be given at the same time as other vaccines including MMR, Men C and Hep B. Vaccines should be given at a separate site, preferably a separate limb. If given in the same limb, they should be given at least 2.5 cm apart. The site at which each vaccine was given should be noted in the individualâ€&#x;s record.

Dosage

0.5 ml

Frequency

Teenage Booster A single booster dose is administered as part of the national immunisation schedule to previously immunised young people aged 13 to 18 (teenage booster). Young people who have received a booster dose of tetanus or tetanus and diphtheria vaccine within the last five years, (e.g. following a tetanus prone wound), should still be given the booster dose of Revaxis to give protection against polio. (Single component polio vaccine is not available under the childhood scheme). Postpone immunisation if a booster dose of a tetanus containing vaccine has been given within the past month. Children and Adults aged 10 Years or Over with Unknown or Unimmunised/Incomplete Immunisation Status Td/IPV is used for primary vaccination for individuals aged 10 years or over who are previously unimmunised or where there is an unknown history of previous vaccination with diphtheria, tetanus and polio vaccines (i.e. a primary course of 3 doses at 1 month intervals; and booster doses preferably 5 years after completion of the primary course and again 5 to 10 years later) = 5 doses in total Where there is an incomplete vaccination history the primary course should be resumed but not repeated. Allow a one month interval

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 4


between remaining doses of the primary course. Boosters should be administered as detailed in the previous paragraph. Green Book chapter 30 advises individuals who have received a booster of a vaccine containing diphtheria and/or tetanus toxoid within the previous five years should still be given a booster of Td/IPV to provide protection against polio Tetanus Prone Wounds For use after tetanus prone wounds see Appendix 1 on page 10 of this PGD Travel For travellers to areas where medical attention may not be accessible should a tetanus prone injury occur and whose last dose of a tetanus containing vaccine was more than 10 years previously, a booster dose of REVAXIS should be given, even if the individual has received 5 doses of vaccine previously. This is a precautionary measure in case immunoglobulin is not available should a tetanus prone injury occur. Travellers requiring a booster dose of diphtheria or polio vaccine should be given a dose of Revaxis even if they are previously fully immunised against tetanus, as single component vaccines are not readily available in the UK. Allow a minimum one month gap after previous dose of a tetanus-containing vaccine.

Duration of Treatment

See Frequency

Maximum or Minimum Treatment Period Quantity to Supply/Administer Side Effects

See Frequency 0.5ml Reactions are usually mild and confined to first few days after immunisation. Local and allergic reactions may be more severe if an individual receives more than five doses of a tetanus containing vaccine. Common side effects include: Local reactions (injection site pain, erythema, induration, oedema and injection site nodule), pyrexia, vertigo, nausea/vomiting, headache. Guillain-BarrĂŠ-Syndrome has been reported after vaccination with tetanus-toxoid containing vaccines. Anaphylactic reactions to vaccines are extremely rare but have the potential to be fatal. Onset is rapid, usually within minutes but can occur within hours of vaccine administration. It is not possible to define a particular time period in which an individual should be observed following immunisation. See Green Book Chapter 8 (latest edition).

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 5


Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it. Yellow cards and guidance on their use are also available at the back of the BNF.

Additional Facilities

Immediate access to Adrenaline/Epinephrine for treatment of Anaphylaxis. Access to a telephone Vaccines must be stored and transported according to manufacturers‟ guidelines and PCT Cold Chain policy.

Special Considerations / Additional information

Vaccine and solvent should be stored in the original packaging at a temperature of 2 to 8º C. If the vaccine has been frozen, it should be discarded. Healthcare professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary 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. Green Book recommendations are reflected in this PGD which in some instances could result in an unlicensed use of a licensed product.

Advice to Patient/Carer/ Parent/Guardian

Explain procedure and further action if required Give a copy of the manufacturer‟s patient information leaflet and discuss as required. Advice on the management of fever and other common/uncommon post-vaccination adverse effects. Management of local/general reactions. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash. Vertigo has been reported following vaccination. If affected advise patient not to drive or operate machinery. Advise patient if further boosters will be required at a later date

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 6


Follow Up

See frequency section for information on boosters

REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

If patient is excluded from this PGD refer to GP or other appropriate clinician. Any health professional administering a vaccination must be able to identify and contact an appropriate clinician, e.g. GP, or the NHS Kirklees Immunisation Coordinator, as necessary, e.g. in the case of a child with an allergy to components of the vaccine.

Records/Audit Trail

Self referral to GP practice or A&E department if appropriate (post immunisation). The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary. Patient‟s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose administered and route. Site of injection. Batch details, expiry date, manufacturer, supplier and brand name Advice given to patient (including side effects). Date administered Signature and name of staff who administered the vaccine. For paperless practices the electronic record should identify the name of the nurse administering the vaccine and should ideally have an electronic signature. Scanned paper records are acceptable Details of any subsequent adverse drug reaction and actions taken including referral arrangements. (This MUST be documented in the patient‟s medical record). For all vaccines administered to children or young people up to age 16 or still in full time education. The following records must also be completed. Computerised records and data collection held by Child Health Information Services (CHIS) The Personal Health Child Record (PHCR –red book) (manual records) should be completed if available. Failure to present this is not a reason to refuse to administer vaccination. If the red book is not available vaccination may proceed as long as there is clear information in respect of which vaccinations the child is due to receive. Every effort should be made to complete the red book at the earliest opportunity and the importance of providing it at subsequent vaccination appointments should be communicated to the parent/guardian.

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 7


If applicable to the vaccine given Travel destination Liaison with HPA

STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Continuing Training & Education

Registered nurse with current registration working within Kirklees PCT Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD – e.g. annual updates in Immunisation and Vaccination. Has undertaken training and is competent in all aspects of immunisation including contraindications and the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. 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 and to work within the limitations of their scope of practice. Attends compulsory annual updates in Immunisation and Vaccination. Undertakes mandatory annual updates on Anaphylaxis and Resuscitation. Practitioner should have access to product leaflet, current BNF and green book chapters, and to updated DH advice where appropriate.

References/Resources SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ and Comments BNF chapter 14 http://www.bnf.org/bnf/ DH Immunisation Against Infectious Disease (The Green Book) chapters 15, 26, 30. These can be accessed at: http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Gr eenBook/fs/en (Chapters 15 & 26 updated November 2009 and chapter 30 updated August 2009)

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health Green Book Chapter. This will result in an unlicensed use of a licensed product following current DH guidance. PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 8


This PGD is an amended version of the Kirklees PCT PGD No 8v3, ‘Tetanus, Low Dose Diphtheria and Poliomyelitis (inactivated) Vaccine (adsorbed) –Td/IPV’. It was updated for use in Kirklees Primary Care Trust by the individuals listed below: Name Dr Ebere Okereke Julie Bulmer Jane O‟Donnell Lucianne Ricketts Deborah Mitchell Karen Gillings Sally Wright Lisa Meeks

Position

Date

Consultant in Communicable Disease Control (West Yorkshire Health Protection Agency) School Nurse Team Leader

9th November 2010

Deputy Director Infection Control

9th November 2010

Senior Medicines Management Adviser - Strategy and Operational Development. GP Practice Nurse

9th November 2010

GP Practice Nurse

9th November 2010

Immunisation Nurse Team Leader

9th November 2010

Specialist Technician – Community and Support Services

9th November 2010

9th November 2010

9th November 2010

Refer to Revision Proforma (over-leaf) for list of amendments made to original document. Reason(s) for amendment Date of amendment List of persons/groups involved in amending PGD

Operational issues highlighted with regards to pre-existing stable neurological conditions. Risk assessed and wording reviewed. April 2011 Lisa Meeks – Specialist Technician, Community & Support Services

(including job title) List of persons involved in

PGD Review Group members

consultation process (including job title) PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 9


REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 8 version 3 SECTION Inclusion Criteria Exclusion Criteria

CHANGES MADE Wording “school leavers booster” amended to read “teenage booster” Following bullet removed: o

Cautions/Need for Further Advice

For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue. However these patients are not covered under this PGD – refer to a prescriber.

Following bullet added: Pre-existing neurological conditions. For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue.

Frequency

Wording “school leavers booster” amended to read “teenage booster”

.

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 10


Individual Authorisation for the Administration of Diphtheria, Tetanus and Poliomyelitis (inactivated) Vaccine (adsorbed) – REVAXIS, by Nurses Employed Either by the PCT/KCHS or GP Practices Within Kirklees PCT. THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF. 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 I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the nurse is willing to be professionally accountable for this work as defined in the NMC Code of Professional Conduct 2008. Name of Professional Signature Authorising Manager and Date signature

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Practice Staff this will be the GP. For PCT staff this will be the team leader, or relevant clinical manager (see PGD policy) Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may give vaccinations away from the base should have an individual copy of the relevant signed PGD with them when administering the vaccine.

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 11


APPENDIX 1 IMMUNISATION STATUS

CLEAN WOUND Vaccine

Fully immunised, i.e. None required has received a total of five doses of vaccine at appropriate intervals

TETANUS-PRONE WOUND Vaccine

Human tetanus immunoglobulin

None required

Only if high risk. See Green Book chapter 30

Primary immunisation None required (unless None required (unless Only if high risk. See complete, boosters next dose due soon and next dose due soon and Green Book chapter incomplete but up to convenient to give now ) convenient to give now ) 30 date

Primary immunisation A reinforcing dose of incomplete or boosters vaccine and further not up to date doses as required to complete the recommended schedule (To ensure future immunity) Not immunised or An immediate dose of immunisation status not vaccine followed, if known or uncertain records confirm this is needed, by completion of a full 5 dose course to ensure future immunity.

A reinforcing dose of vaccine and further doses as required to complete the recommended schedule. (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.

Yes: one dose of human tetanus immunoglobulin in a different site.

Green Book Chapter 30 Table 30.1 - Immunisation recommendations for clean and tetanus-prone wounds.

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 12


AUTHORISATION This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting

Organisation

Kirklees Primary Care Trust

Director of Patient Care & Professions

Name: Sheila Dilks

Signature: Assistant Director of Medicines Management & Prescribing

Date:

Name: Neill McDonald

Signature: Medical Director

Date:

Name: Dr Judith Hooper

Signature: CEC Chair

Date:

Name: Dr David Anderson

Signature:

Date:

PGD No 8 v4 Tetanus, low dose Diphtheria and Poliomyelitis (inactivated Vaccine (adsorbed) Td/IPV vaccine - REVAXIS Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 13


/P  

http://www.kirklees.nhs.uk/fileadmin/documents/New/Public_Information/med_mgt/PGDs/Updated_July_11/PGD_No_8_v4_Revaxis.pdf

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