REVAXIS v01 1/12 REVAXIS (DIPHTHERIA, TETANUS AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)) PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner (Nurse) Medicines Management Group Date issued 01/02/2013 Review date 31/01/2015 Clinical Publication Category Mandatory (RED) - No deviation from document permissible Clinical Requirements Competencies Continuing education Successful completion of a competency assessment in the use of this medicine for the indications stated; Completion of education in both the legal and professional aspects of PGD administration and the supply of medicines; Registered paramedics must have successfully completed a recognised Emergency Care Practitioner course; Registered nurses must be employed as Nurse Practitioners or have successfully completed a recognised Emergency Care Practitioner course. The clinician is responsible for keeping him/herself aware of any changes 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 own individual scope of practice.
REVAXIS v01 2/12 Clinical Situation Clinical situation Inclusion criteria Revaxis is indicated for active immunisation against tetanus as a result of an infected wound in adults and children aged 10 years of age and over. For immunisation against tetanus following any wounds in any adult or child aged 10 years and over where: The immunisation status of the patient is unknown (try to ascertain by phoning GP surgery when patient presents in hours ); There is an incomplete history of a primary course of tetanus. In these cases further doses of Revaxis will be needed to complete the schedule and these should be arranged via the patient s own GP surgery; The boosters are not up to date; The patient is an intravenous drug user; The wound is tetanus prone. This includes: Any wound or burn that requires surgical intervention that is delayed for more than 6 hours; Any wound or burn in patients who have systemic sepsis; Any wound or burn at any interval after injury that shows one or more of the following characteristics: a significant degree of devitalised tissue; a puncture type wound; contact with soil or manure; wounds containing foreign bodies; compound fractures. NB: The vaccine may be administered to breast feeding women if they fall under any of the above inclusion criteria.
REVAXIS v01 3/12 Exclusion criteria Cautions Primary immunisation; Children under 10 years; Legal consent has not been obtained; Previous dose of vaccine given within the last 28 days; If Guillain-Barres Syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid; Patients who have had a true anaphylactic reaction to a previous dose of diphtheria, tetanus and poliomyelitis; Patients who have had a true anaphylactic reaction to neomycin, streptomycin or polymixin B (vaccine may contain small amounts of these antibiotics); Hypersensitivity to any other component of the vaccine; Patients who may have reduced immunity such as: Patients on high dose steroids (e.g; prednisolone: adults at least 40mg daily for more than 1 week; children 2mg/kg daily for at least 1 week or 1mg/kg daily for 1 month); Patients receiving chemotherapy; Patients receiving generalised radiotherapy; If the patient has a fever or suffering from an acute severe systemic illness; Pregnant women. Bleeding may occur in patients with thrombocytopaenia or a bleeding disorder following an Intra-muscular injection. In these conditions Revaxis may be administered as a deep subcutaneous injection; Appropriate medical treatment should be readily available for immediate use in case of an anaphylactic reaction following vaccination.
REVAXIS v01 4/12 Very Common: Local Injection site pain, erythema, induration, oedema and occasionally injection site nodules. Onset is usually within 48 hours following vaccination and persists for 1-2 days. Common: Headache; Vertigo; Nausea/ vomiting; Pyrexia. Uncommon: Lymphadenopathy; Myalgia; Malaise. Side effects Rare: Arthralgia. Very Rare: Convulsions; Guillain-Barre Syndrome; Brachial Neuritis; Transient parasthesia; Hypothesia of the vaccinated limb; Vaso-vagal syncope; Abdominal pain/ diarrhoea; Urticaria, various types of rash and facial oedema; Pain in vaccinated limb; Anaphylactic reactions; Large injection site reactions (>50mm) including extensive limb swelling from the injection site beyond one or more joints.
REVAXIS v01 5/12 Action if excluded Action if patient declines If patient meets exclusion criteria refer to medical practitioner; Seek specialist advice from GP, A&E, Public Health or Health Protection Agency to evaluate the risk to the individual of not being immunised; Record in patient clinical record the reason for exclusion and any action taken. If patient declines treatment or advice, ensure the patient clinical record details: The advice given by the clinician; Details of any referral made; The intended actions of the patient (including parent or guardian).
REVAXIS v01 6/12 Description of Treatment Generic name Presentation Route Method Dose Frequency Duration of treatment Storage instructions Revaxis (Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content). Suspension for injection in a 0.5ml pre-filled syringe. The suspension has a cloudy white appearance. Intra-muscular injection into the deltoid muscle in the upper arm. Administration Supply Before administration check that the vaccine has been properly stored. This includes checking the refrigerator temperature records to ensure that the vaccine has been stored within the manufacturer s recommended temperature ranges. Vaccine which has not been stored correctly must not be used; Shake vaccine well immediately before use. Inspect the vaccine for extraneous particulate matter and discolouration prior to use. After agitation the vaccine is a slightly opaque, white solution. 0.5ml. A single booster dose to previously immunised adults and children aged 10 years and over; A single booster dose to adults and children 10 years and over with an incomplete history or no history of a primary course of tetanus. Advise patient to follow up with the GP practice to complete any further doses if required. Single dose. Store between +2C to +8C in a refrigerator; If vaccine has been frozen it should be discarded; Store in original package in order to protect from light.
REVAXIS v01 7/12 Follow Up Referral arrangements and safety netting Advice to patients Records Ensure that there is a communication to the patient s registered GP to inform him/her about the consultation, the outcomes of that consultation and any treatment given using local mechanisms. This information must also be available to other healthcare professionals who may be required to administer care to the patient following the consultation; The use of Revaxis was recommended by the Department of Health in recognition of a national shortage of tetanus immunoglobulin (TIG). Acute hospitals have limited supplies of TIG. However: Individuals with tetanus prone wounds and an unknown immunisation status, incomplete history of primary course of tetanus or if the boosters are not up to date, will require a tetanus immunoglobulin in addition to the tetanus booster and should be referred to the A&E Department for the Immunoglobulin; Individuals who are fully immunised and those whose primary immunisation is complete will require the immunoglobulin if the risk of infection is especially high such as contamination with soil or manure. Allergic reactions are always a rare possibility after receiving a vaccine and may include: difficulty in breathing; blue discolouration of the tongue or lips; swelling of the face or throat; low blood pressure (causing dizziness); fainting (collapse). When these signs or symptoms occur they usually develop very quickly after the injection is given and while the person affected is still in the clinic. If any of these symptoms occur after administering the injection, the patient must be advised to consult a doctor IMMEDIATELY. Dizziness (vertigo) has been reported after vaccination. If you feel dizzy after having the vaccine, you should not drive or operate machinery. Complete patient clinical record.
REVAXIS v01 8/12 References British National Formulary (BNF) 64, September 2012; Revaxis Summary of product characteristics (Accessed at http://www.emc.medicines.org.uk).
REVAXIS v01 9/12 Authorisation Chief Executive Officer Medical Director Pharmaceutical Advisor Name Ken Wenman Signature Date 01/02/2013 Name Dr Andy Smith Signature Date 01/02/2013 Name Sue Oakley Signature Date 01/02/2013 This must be signed by the Chief Executive Officer, Medical Director and Pharmaceutical Advisor to be legally valid.
REVAXIS v01 10/12 Individual Authorisation (Staff Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this document. 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. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.
REVAXIS v01 11/12 Individual Authorisation (Trust Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this document. 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. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.