SPECIMEN ENTER PCT NAME Protocol for the administration of 23-valent Pneumococcal Polysaccharide vaccine to adults by Health Care Assistants and Assistant Practitioners Purpose of Protocol To enable suitably trained Health Care Assistants and Assistant Practitioners working for or on behalf of ENTER PCT OR GP NAME who have undertaken relevant training (as outlined below), to administer pneumococcal vaccine to adults as a single dose, as a duty delegated by the General Practitioner (GP employee) or a registered nurse (PCT employee). Staff characteristics Staff group(s) Additional requirements Health Care Assistants and Assistant Practitioners Continuing training requirement Completion of HCA training course on administration of influenza and pneumococcal vaccines to adults Completion of period of supervised practice and assessment against NVQ unit CHS3 Administration of medication to individuals (Level 3) Training and competence in the correct procedure of administering medication via intra-muscular injection Knowledge of ENTER PCT NAME policy on management of Anaphylaxis in the community Access to and knowledge of the DH guidance ‘Immunisation against infectious disease’ Annual update in Basic Life Support and treatment of anaphylaxis. Demonstration of competence in relation to this medication within the PDP and appraisal process. Consent Refer to PCT policy on consent Pneumococcal vaccine template 26.06.06 1 SPECIMEN Clinical condition Clinical condition to be treated: All High-risk patients requiring pneumococcal vaccination Criteria for inclusion All patients aged 65 and over Any adult (over the age of 16 years) who has a confirmed diagnosis of one of the following diseases: Chronic heart / renal / respiratory disease, Diabetes, Chronic liver disease, Immunosuppression, Cochlear implants, CSF shunts Criteria for exclusion Patients with one of the following: Aged under 16 years Current acute illness Pregnancy/breastfeeding Previous severe reaction to any vaccine or vaccine component Unable to give informed consent Healthy adults under the age of 65 years Previous pneumococcal vaccination with the exception of those with absent or dysfunctional spleen or chronic renal disease Circumstances for further advice/action 1. Consent not given: Counsel with regards to the risks of pneumococcal infections and the protective effect of the vaccine 2. Severe reaction to any vaccine or pneumococcal polysaccharide vaccine or any vaccine component: Refer to GP 3. Immunocompromised patients; Refer to GP for individual assessment 4. Pregnancy or breast feeding: Refer to GP 5. Acute febrile illness: Re-arrange vaccination at appropriate date Recommended treatment, route and legal status Pneumococcal polysaccharide vaccine to be administered by intramuscular injection into the deltoid muscle ( may also be given subcutaneously) If administering influenza immunisation at the same time, use different site of injection Prescription Only Medicine (POM) Dosage & Criteria Adults 0..5ml Frequency of administration & Normally a once only injection Pneumococcal vaccine template 26.06.06 2 SPECIMEN maximum dosage Routine booster every 5 years for those with no spleen or splenic dysfunction or chronic renal disease Follow-up & advice Re-immunisation is not normally advised Side effects & their management Local side effects: Redness, swelling, hardness at injection site Systemic side effects: Low grade fever Treat with paracetamol Special considerations/Concurrent medication No drug interactions known The immune response to pneumococcal vaccination is reduced in those who are immunosuppressed or immunodeficient, including HIV patients. Patients should be individually assessed by the GP for the risk vs benefit of immunisation Immunosupressant therapy e.g. Corticosteroids, chemotherapy or radiotherapy may result in reduced antibody response. The benefits are such that immunisation should be considered. Refer to GP for advice. Clinical aspects The following will be required: 1. Patient specific direction – written by the General Practitioner 2. Patient identification – required prior to the administration of medication (confirmed by the patient declaring his or her name, date of birth and home address) 3. Consent – Informed consent must be obtained from the patient. Health Care Assistants and Assistant Practitioners are advised to familiarise themselves with the ENTER PCT NAME Consent Policy 4. Record Keeping – The following should be recorded in the patients notes or on the computer system according to the GP practice system o Name of drug, dose, route and site of administration o Date administered o Batch number and expiry date o Signature of person administering – written or electronic. o Checklist for influenza and pneumococcal immunisations o Patients assessed as not appropriate for vaccination and any alternative action taken o If the patient has declined the vaccination and any alternative action taken o Any reaction should be recorded in the clinical record Adverse reactions Pneumococcal vaccine template 26.06.06 3 SPECIMEN Health Care Assistants and Assistant Practitioners must ensure that Adrenaline 1:1000 or an Anaphylactic shock pack is available. If a general adverse reaction does occur: Record in patients notes Inform patients General Practitioner as soon as possible Local reactions should be seen by either the general Practitioner or practice nurse If anaphylactic reaction occurs: Give treatment in accordance with the PCT policy on the Management of Anaphylaxis in the community Record in patients notes Inform patients General Practitioner as soon as possible Relevant training 1. Health Care Assistants and Assistant Practitioners will undertake training covering the following aspects of the administration of the 23-valent pneumococcal polysaccharide vaccine Appropriate anatomy and physiology Correct procedure for the administration of the vaccine via intra-muscular injection Vaccine delivery, storage and stock control requirements, maintaining the cold chain Cautions and side effects related to the administration of Inactivated influenza vaccine. Documentation Legal aspects of drug administration 2. Health Care Assistants and Assistant Practitioners will have successfully completed NVQ unit CHS3 Administer medication to individuals (level 3) and Basic Life Support. The course includes assessment of competence at performing CPR and underpinning knowledge of consent issues 3. Health Care Assistants and Assistant Practitioners will undergo a period of supervised practice and assessment and will be directly observed administering intramuscular injections of the 23-valent pneumococcal polysaccharide vaccine by the general practitioner or practice nurse and an occupationally competent NVQ assessor. Assessment of competence Assessment of competence will be undertaken during the period of supervised practice on 2 separate occasions. Supervised practice will be provided by the practice nurse or general practitioner and assessment will be performed by an occupationally competent NVQ assessor. Competence will be assessed by direct observation and questioning of the Health Care Assistants and Assistant Practitioners ability to: Prepare the patient for the procedure Safely administer the medication (including choice of site, needle size and injection technique) and observation of the patient post procedure Pneumococcal vaccine template 26.06.06 4 SPECIMEN Correct disposal of clinical waste Correct documentation Correct procedure followed for delivery, storage and stock control of the vaccine The Health Care Assistant and Assistant Practitioner will also be assessed, by oral questioning, on issues relating to the therapeutics of inactivated influenza vaccine Significant events Any significant event which occurs during or as a result of administration of medication must be reported to the Practice Manager / General Practitioner (GP employee) or the Registered Nurse / Manager (PCT employee), and the incident reported via the PCT significant event reporting framework. Audit: Health Care Assistants and Assistant Practitioners will be expected to participate in audit in relation to patient outcomes and the development of this role. Health Care Assistants and Assistant Practitioners must be familiar with the following documents: ENTER PCT DOCUMENTS AS APPROPRIATE e.g. Medicines Policy Consent Policy Documentation Policy Significant Event Reporting Policy Clinical Nursing Procedures NMC Guidelines for the Administration of Medication 2004 NMC Guidelines for Records and Record Keeping 2004 This protocol has been devised by: Pneumococcal vaccine template 26.06.06 5 SPECIMEN Signature: Date: Signature: Date: This protocol has been accepted by ENTER PCT NAME Medicines Management Group: Signature Date: Review: It is the responsibility of the lead of the staff groups to whom this protocol applies to ensure the review process takes place. This protocol becomes valid on ENTER DATE and becomes due for review on ENTER DATE Protocol for 23-valent Pneumococcal Polysaccharide Vaccine Pneumococcal vaccine template 26.06.06 6 SPECIMEN Agreement for Health Care Assistants and Assistant Practitioners within ENTER PCT NAME This protocol is to be read, agreed and signed by all Health Care Professionals it applies to: Approved base: ………………………………………………………………….. Staff name: …………………………………………………………………… Designation: …………………………………………………………………… Signature: ……………………………………………………………………. Date: …………………………………………………………………….. Managers signature: ……………………………………………………………… Date: ……………………………………………………………………. The Health Care Professional should retain a copy of the document after signing and the original be retained in their personal file. General Guidance for the Administration of Vaccines Pneumococcal vaccine template 26.06.06 7 SPECIMEN General 1. The identity of the vaccine must be checked to ensure the right product is used in the appropriate way on every occasion 2. The expiry date must be noted. Vaccines must not be used after the expiry date on the label. 3. The date of immunisation, title of vaccine and batch number must be recorded on the recipients record. When two vaccines are given at the same time, the relevant sites should be recorded to allow any reactions to be related to the causative site. It may be considered good practice to record all sites of administration 4. The recommended storage conditions must have been observed Reconstitution of vaccines 1. Freeze dried vaccines must be reconstituted with the diluent supplied and used within the recommended period after reconstitution 2. The diluent must be added slowly to avoid frothing, a sterile syringe and 21G needle should be used for reconstituting the vaccine and a smaller gauge needle for injection, unless only one needle is supplied with a prefilled syringe 3. Vaccines must not be mixed before administration. Exceptions are vaccines pre-mixed by the manufacturer Cleaning of skin If skin cleansing is required, soap and water are adequate. If spirit swabs are used, the skin should be allowed to dry before the vaccine is administered. This is essential for live vaccines, which may be inactivated by alcohol. Route of administration Most vaccines are given by intramuscular or deep subcutaneous route. The deltoid muscle is the preferred choice in adults Recommended choice of needle lengths Children Women < 90kg Women > 90kg Men 60 – 118 kg = = = = 25mm needle 25mm needle 38mm needle 25mm needle Pneumococcal vaccine template 26.06.06 8 SPECIMEN ENTER PCT NAME CHECKLIST FOR INFLUENZA AND PNEUMOCOCCAL IMMUNISATIONS Individual organisations may wish to use an alternative consent form or may record the outcome of the discussion with the patient on consent directly onto the clinical system To be completed by the patient and/or nurse Name of patient ………………………………………………………M/F………… Address………………………………………………………………………………. Date of Birth…………………………………………………………………………. Name of GP ………………………………………………………………………… Do you feel unwell today? YES/NO *Have you ever had the pneumococcal vaccine before?……………YES/NO Did you have a reaction to pneumococcal vaccine or have you had a reaction to any other vaccine?…………………………………….YES/NO Are you pregnant or breast feeding?……………………………………..YES/NO **Do you have lowered immunity due to disease or treatment, for example steroids?…………………………………………………… YES/NO If you have answered YES to any of the above questions – speak to the nurse before you are given your immunisation Have the advantages/disadvantages of this immunisation been discussed with you?……………………………………………… YES/NO Have you had advice about side effects, temperature control? YES/NO Has a patient information leaflet been provided? YES/NO Signature of patient for consent to immunisation *Revaccination is only recommended in patients with no spleen or dysfunctional spleen or chronic renal disease. Children under 5 who had the conjugate pneumococcal vaccine for children will need 1 dose of the vaccine for older children and adults. **Lowered immunity may result in reduced vaccine response. The benefits of immunisatiom are such that they usually outweigh any risks. Check with GP. Pneumococcal vaccine template 26.06.06 9