Version Number: 02. Patient Group Direction drawn up by: Jayne Bruce - Deputy Director of Nursing Standards and Safety Sussex

Transcription

1 PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF INFLUENZA VACCINE BY REGISTERED NURSES (PEER VACCINATORS) TO STAFF WORKING FOR SUSSEX PARTNERSHIP NHS FOUNDATION TRUST Version Number: 02 Patient Group Direction drawn up by: Name & title Jayne Bruce - Deputy Director of Nursing Standards and Safety Sussex Signature Ray Lyon Chief Pharmacist - Strategy Dr Samantha Phillips Occupational Health Consultant Group direction authorised by: Medical Director On behalf of the organisation Chief Pharmacist Director of Nursing Dr Tim Ojo Ray Lyon Diane Hull Date Protocol agreed November 2016 Proposed review date August 2019 Date Protocol expires November

2 PLAN OF CARE Aim(s) of treatment or care Information for staff Symptom(s)/clinical criteria under which the patient will be eligible for treatment under the PGD Exclusion criteria Actions to be taken for staff who after attending the session do not wish to receive the vaccine Follow-up treatment and actions Active immunization against influenza virus in staff employed by Sussex Partnership NHS Trust who consent to treatment. Prior to obtaining consent, staff must be given an information card to read covering the main side-effects. A product information leaflet must also be offered to staff as it provides more detailed information. All staff who do not meet the exclusion criteria below. Staff must give informed consent to vaccination (see page 8 for sample), and should be informed of its effectiveness. (In 2012, a study of trivalent vaccines suggested an overall effectiveness against confirmed disease of 59% in adults aged 18 to 65 years). A confirmed anaphylactic reaction to previous dose of the vaccine. A confirmed anaphylactic reaction or hypersensitivity to any active substances or components of the vaccine or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate. (Confirmed anaphylaxis is rare) Has already received a flu vaccination this season from their GP or other source. Member of staff to be counselled regarding the risks associated with contracting infection and the potential sources of infection. Advise on symptoms and complications of the disease. Document administration on the Influenza vaccine consent form MEDICINE Generic name and form(s) Mode of action Storage of vaccine Legal status of medicine Special precautions for disposal and other handling Seasonal inactivated influenza vaccine (split virion) BP suspension for injection in prefilled syringe. By stimulating production of antibodies and other components of the immune mechanism. Store in a refrigerator (2-8 C). Do not freeze. Keep syringe in the outer carton in order to protect from light. Prescription Only Medicine (POM) The vaccine should be allowed to reach room temperature before use. Shake before use. Inspect visually prior to administration. The vaccine should not be used if foreign particles are present in the suspension. Any unused product or waste material should be disposed of in accordance with local requirements. If a spillage occurs see the Trust s COSHH data sheet on handling vaccines - Adverse Reactions Very common Irritability*, myalgia, injection site pain and fatigue** 2

3 Common: Headache*, sweating*, arthralgia*, fever, malaise, shivering, appetite loss*, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain) and local reactions; redness, swelling, ecchymosis, induration*. *These reactions usually disappear within 1-2 days without treatment. Uncommon, rare and very rare adverse reactions: Blood and lymphatic system disorders: Transient thrombocytopenia, transient lymphadenopathy Immune system disorders: Allergic reactions, in rare cases leading to shock, angioedema Nervous system disorders: Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis & Guillain Barré syndrome Vascular disorders: Vasculitis associated in very rare cases with transient renal involvement Skin and subcutaneous tissue disorders: Generalized skin reactions including pruritus, hematoma, urticaria or non-specific rash Drug interactions Method or route of administration Dose Frequency of administration There are no significant drug interactions, but the vaccine may possibly enhance the anticoagulant effect of warfarin. Those immunocompromised from medication may have a suboptimal immunological response to the vaccine. Intramuscular or deep subcutaneous injection. Intramuscular injection preferably into the upper arm. Individuals with bleeding disorders should be given vaccine by deep subcutaneous injection to reduce the risk of bleeding. One dose of 0.5ml Influenza vaccine should be administered annually each season, ideally between September and early November. Influenza activity is not usually significant before mid-november. Antibody levels may be achieved within 14 days of the vaccination. Prior to treatment the patient should be given the abbreviated Patient Information Leaflet (PIL) provided by the Occupational Health Team. Confirmation should then be sought that they have read and understood the PIL and they consent to treatment. Written / verbal advice to be given to the patient on the identification and management of significant potential side effects Advise of the very common and common side effects and how these can be managed. It is recommended that the patient is observed for 10 minutes after vaccination, for any immediate adverse reactions e.g. urticaria, angiooedema, bronchospasm and anaphylaxis. Tell the member of staff to inform their doctor if they get any of the following unwanted effects: Nerve pain (neuralgia, numbness / pins and needles, possibly with fever. Convulsions. Unexpected or easy bruising. Skin rash. Urinary symptoms. Myalgia (muscle pain) and/ or arthralgia (joint pain) for longer 3

4 than 48 hours. Other severe symptoms. Indications for follow up and actions to be taken As vaccine is administered intramuscularly (or occasionally subcutaneously), the time of onset of anaphylaxis is variable and onset may be delayed for up to 72 hours. Patients should be advised to seek urgent medical attention if they develop symptoms such as breathlessness, swelling and/or a rash. AUDIT TRAIL Records required for a documented audit trail Influenza vaccine consent form (Supplied each year by the Sussex Community NHS Trust s Occupational Health Team) Trust Incident Form To be completed for each member of staff and sent to occupational health. To be completed in the event of a suspected serious adverse drug reaction. The incident must be reported immediately once the emergency has been dealt with. Report on suspected Adverse Drug Reactions (Yellow form in back of the BNF) To be completed for a significant adverse event by the doctor or pharmacist. REFERENCES 1. BNF September Inactivated influenza vaccine (split virion) BP, suspension for injection in prefilled syringe. Influenza vaccine (split virion, inactivated). Summary of Product Characteristics. Available from: Accessed; October Immunisation against infectious diseases The Green Book. Chapter 19 - Influenza (2 September 2014 update). Available from: Accessed; October

5 COMPETENCY Designation NMC Registered Nurse Competency/Qualifications (tick when checked) Professional qualification: NMC Registered Nurse Has been signed off as competent to administer influenza vaccines by the Sussex Community NHS Trust s Occupational Health Team or completed the Public Health England online immunization training. Evidence of training in basic life support and anaphylaxis, and to remain updated annually Has demonstrated they can find the Flu Plan and access The Green Book Immunisation against infectious disease, (Chapter 19) which is updated regularly and sometimes this update can occur during a flu season. (Both accessed via Has successfully completed the 'Key topics of pharmacy' questionnaire for influenza vaccine. Evidence checked by: Name: Designation: Signature: Review of competency Competency expires 21 months or following a significant change in the Patient Group Direction. Two years or following a significant change in the Patient Group Direction. 5

6 AUTHORISATION OF PROFESSIONAL TO USE THE PATIENT GROUP DIRECTION: Administration of Influenza Vaccine to Staff as a Peer Vaccinator Name: I confirm that I; understand the PGD have received the necessary education and training am of the opinion I am competent to implement the PGD effectively agree to work within the PGD Signature: Date: Competency review date: Competency expiry date: SIGNATURE OF AUTHORIZING NURSE. Name: Date: Designation: 6

7 KEY ASPECTS OF PHARMACY QUESTIONNAIRE (To be completed without access to the PGD, text books or internet) Key aspects of pharmacy for influenza vaccine Professional's name: Job Title: 1. Symptoms / criteria under which the patient will be eligible for treatment under the PGD 2. Forms and strengths available 3. Mode of action 4. Exclusion criteria 5. Dose 6. Route of administration 7. What potentially significant side effects and drug interactions are there? 8. What written/verbal advice must be given to the patient on the identification and management of significant potential side effects? I confirm that at the time of completion the answers provided showed an acceptable level knowledge. Name: Designation: Signature: Date: 7

8 Influenza Vaccine Consent form 2017/18 A/Michigan (HIN1) (A/Singapore), A/Hong Kong (H3N2), B/Brisbane Surname Forename DOB Trust Area Place of Work Town Job category Please circle as appropriate or add in free text box Registered Nurse Non-Registered Nurse Doctor/Dentist/ Psychologist Registered Therapists Unregistered Therapists Admin/Clerical Estates and Facilities Volunteer Other Clinical Other Non Clinical Declaration I hereby consent to influenza vaccination. I have been offered a copy of the patient information leaflet to read and I have read the list of possible side effects as detailed by the manufacturer. I have also read the list of exclusions detailed below and to the best of my knowledge none of the exclusions apply. Signature.. Date. NB. Also may be present in traces, potassium chloride, potassium dihydrogen phosphate disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections. Exclusion criteria: Allergy to hens eggs, egg products or chicken proteins. Previous severe reaction to any vaccine. Already vaccinated against influenza this season. Known hypersensitivity to influenza vaccine or any component of the vaccine (including cetyltrimethylammonium bromide, polysorbate 80 formaldehyde and gentamicin) Acute febrile illness (raised temperature) or acutely unwell (vaccination to be postponed). Confirmed anaphylactic reaction to a previous dose of the vaccine. Interacting medication. Further information is available at request from the nurse. Manufacturer and brand name: Influvac, Mylan Products Limited Date Dose & batch number/expiry date Time Route Site Venue Adverse Reaction Signature 8