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PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF INFLUENZA VACCINE BY COMMUNITY PHARMACISTS Controls Assurance Statement The aim of this Patient Group Direction is to ensure that the supply and administration of medicines under a Patient Group Direction complies with the legal requirements and guidance set out in HSC2000/026 (i) Patient Group Directions (England Only). Failure to comply with the law could result in a criminal prosecution under the Medicines Act. Start date: September 2005 Expiry date: September 2006 Issued by: Primary Care Directorate GREENWICH TEACHING PRIMARY CARE TRUST PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF INFLUENZA VACCINE BY COMMUNITY PHARMACISTS 1. Clinical Condition 1.1 Define clinical situation Vaccination against influenza in accordance with the current national influenza vaccination programme. 1.2 Inclusion criteria Patients aged 65 and over. Patients from the age of 18 years who are at risk from serious illness from influenza who have: Chronic respiratory disease Chronic heart disease – including ischemic heart disease e.g. stroke. Chronic renal disease Chronic liver disease Diabetes Immunosuppression due to disease or treatment Patients in long stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality (this does not include prisons, young offenders institutions, university halls of residence etc.). People who are the main carer for an elderly or disabled person whose welfare may be at risk if the carer falls ill. 1.3 Exclusion Criteria Vaccinations will not be offered To patients who are acutely ill on the day of the scheduled vaccination Where there are contraindications: Hypersensitivity to eggs, chicken protein or any constituent of the vaccine such as neomycin, thiomersal or polymixin B. Previous severe reaction to influenza vaccination. Latex allergy To patients who are pregnant. To patients who are not registered with a Greenwich GP. If vaccine is withheld: Refer to general practitioner or reschedule as clinically indicated. If a patient has not been given the vaccination because of an acute illness, the patient will be offered the vaccination on recovery as soon as it is convenient. 1.4 Circumstances when to refer to a doctor Where there is doubt whether to give the influenza vaccination, refer the patient to their general practitioner. Patients under the age of 18 years who are at risk 2. Characteristics of practitioners authorised to supply and administer the influenza vaccine 2 Qualified pharmacists, currently registered with The Royal Pharmaceutical Society will administer the vaccinations. 2.1 Requirements for training and continuing education All pharmacists will have undergone both theory and practical training in immunisation and vaccination. (See appendix 1 for details of training). 3. Description of treatment within the PGD 3.1 Name, pharmaceutical form, strength: Influenza Vaccine. Suspension for injection containing split virus or surface antigen of Influenza A and Influenza B virus. The particular strains and strengths of the virus are recommended each year by the World Health Organisation. The strains of influenza virus recommended by WHO to be included in the components for the 2005-06 vaccine are: An A/New Caledonia/20/99(H1N1)-like virus An A/California/7/2004(HMN2)-like virus A B/Shanghai/361/2002-like virus 3.2 Dose and frequency 0.5ml dose for adults over the age of 18 years, given yearly. 3.3 Route of administration By intramuscular or deep subcutaneous injection 3.4 Maximum total dose Single dose per year 3.5 Minimum or maximum period over which the medicine should be administered Not applicable 3.6 Legal category Prescription Only Medicine 3.7 Storage and handling requirements 2°C – 8°C. Do not freeze. Allow vaccine to reach room temperature before administration. Shake gently before use. 4. Consent The patient will be asked to sign that they consent to be vaccinated and that they have received information about the influenza vaccine (appendix 2) 4.1 Action if the patient declines treatment Advice should be given about the complications of the disease. 5. Follow-up treatment Recipients of vaccines should be observed for adverse reaction and remain under observation until they are seen to be in good health. 3 If an adverse reaction occurs, such as anaphylaxis, give immediate treatment and inform the patient’s general practitioner as soon as possible. 6. Information to be given to the patient The pharmacist will give the patient an information leaflet (PIL) accompanying the vaccine, if available. The pharmacist will advise the patient as to the possible local and systematic adverse reactions and that these reaction will usually disappear within one or two days without treatment: Local reactions: redness, swelling, bruising, hardness at the site of injection. Systematic reactions: fever, feeling of being unwell, shivering, fatigue, headache, muscle ache. The patient must be advised that if there are other unusual severe reactions such as confusion or drowsiness, he or she should contact his or her general practitioner as soon as possible. 7. Treatment records 7.1 Names of pharmacists administering influenza vaccination As recorded in the pharmacist team record for each pharmacy or GP practice (appendix 3) if appropriate. 7.2 Patient identifiers Pharmacists administering influenza vaccine will maintain a list of patients who receives the vaccine. The list will have the patients name, date of birth, address, GP, date and time, brand name of vaccine and batch number (Appendix 4). 7.3 Treatment provided The following will be documented in the patient’s form: Brand name of vaccine, batch number and expiry date Method and route of administration of vaccine Injection site. The pharmacist will inform the GP of the above, by forwarding a copy of the patient form within 48 hours of administration, so that his patient’s records can be updated. 8. Reporting of adverse reactions Any serious adverse reactions, untoward incident/error will be reported to the general practitioner immediately and if necessary, the clinical governance leads and documented in the patients records. 9. Drug Alerts from the Medical Control Agency Pharmacists will be informed of Drug Alerts through the Contractor Services, Greenwich Teaching PCT. The pharmacists will co-ordinate the return of affected vaccines through their supplier. 4 10. Facilities provided at the site of care The following are required to be readily available: An in date anaphylactic kit A telephone must be available and working. Health and Safety policies must be adhered to regarding the disposable of sharps. 11. Professional accountability Each practitioner administering vaccines under this Group Direction is personally accountable for his/her own actions as laid down by the RPSGB Code of Ethics. 12. Indemnification The Trust will indemnify community pharmacists employed by the Trust against claims for negligence relating to injuries or loss caused by their actions provided the pharmacists have complied with the guidelines and requirements of this Patients Group Direction. The pharmacists’ employers will indemnify the pharmacists employed by them against claims for negligence relating to injuries or loss caused by their own actions provided the pharmacists have complied with the guidelines and requirements of this Patient Group Direction. 13. Management and monitoring of this Patient Group Direction 13.1 The authors of the Patient Group Direction are: Dr Clow Immunisation Lead Signature 5 Date Kuldeep Kaur Community services Pharmacist Denise Rabbette Head of Medicines Management Dr. John Livingstone PEC Chairman Signature Date Signature Date Signature Date 13.2 Authorised on behalf of Greenwich Teaching Primary Care Trust Hilary Shanahan Signature Chairman, Clinical Governance Subcommittee Date 13.3 The managers responsible for the implementation and monitoring of the Patient Group Directions are: Kuldeep Kaur Community Services Pharmacist Signature Date 14. References Immunisation against infectious diseases. Department of Health, HMSO (2004). London Influenza Immunisation Programme 2004/2005. From the Chief Medical Officer, the Chief Nursing Officer and the Chief Pharmacist PL/CMO/2005/2, PL/CNO/2005/2, PL/CPHO/2005/2.Department of Health, August 2005 Patient Group Directions (England Only) – HSC 2000 / 026, NHSE 9 August 2000 6 Code for Professional Practice. Nursing and Midwifery Council, 2002. Guidelines for the Administration of Medicines. Nursing and Midwifery Council, 2002. Guidelines for records and record keeping. Nursing and Midwifery council, 2002. Reference Guide of Consent for Examination or Treatment. Department of Health, July 2001. www.doh.gov.uk/consent Medicines, Ethics & Practice. A Guide for Pharmacists, July 2005, 29, RPSGB. APPENDIX 1 Training requirements Theory All pharmacists will be familiar with the summaries of the vaccines characteristics accompanying the influenza vaccines that they administer. All pharmacists will have knowledge of the book, Immunisations Against Infectious Diseases (DOH 2004) or subsequent editions, with particular reference to the chapter on influenza. 7 All pharmacists will have read and adhere to the Trust Policy on vaccine handling and storage with particular reference to the vaccine cold chain. All pharmacists will be familiar with this Patient Group Direction for the administration of influenza vaccine. Practical All pharmacists are accountable under the RPSGB guidelines to maintain safe practice. They will also have an annual peer review. See below. Requirements for training and continuing education All pharmacists will attend an annual update on anaphylaxis, vaccination and immunisation. All pharmacists will attend an annual update on resuscitation. All pharmacists will attend a yearly peer review of competent practice of vaccinations. APPENDIX 2 Greenwich Teaching Primary Care Trust Preliminary check Name ………………………………………………. Address…………………………………………….. Date of Birth……………………………………….. Are you feeling well today? Yes/No Have you had a reaction to the flu vaccine or any other injection before? Yes/No 8 Are you allergic to eggs or egg products? Yes/No Are you taking steroids? Yes/No Have you recently had chemotherapy or radiotherapy? Yes/No Whilst you may not receive full protection you should still receive the vaccination Are you pregnant? (For women under 55 years old) Yes/No Have you had a mastectomy? Yes/No (If the answer is yes, do not administer the injection on the arm on the same side) Are you on any of the following medicines? Antiepileptics Yes/No Warfarin or any other anticoagulants (If yes, give by subcutaneous, not intramuscular, injection) Yes/No Theophylline Yes/No If the answer to any of the above is ‘yes’, influenza vaccine is not contraindicated but please counsel patients according to information in ‘Interactions with influenza vaccine’. See appendix 6. Consent to have influenza vaccination The side effects of the vaccination have been explained to me I consent to receiving an influenza vaccination. Signature of patient……………………………………………. Date…………………………………………………………….. For Vaccines administered outside the surgery Name of patient’s GP………………………….. Brand name of vaccine……………………………Batch Number…………… Expiry Date ………………. Site of administration…………………………………………… Signature of pharmacist……………………………………………….. Print name……………………………………………………….. Appendix 3 PHARMACISTS TEAM RECORD This patient group direction is to be read and signed by all the pharmacists trained and competent to administer influenza vaccine. Pharmacy ……………………………………………………… We have read and understood the Patient Group Direction for the administration of the Influenza vaccine. We agree to comply with the conditions stated in it. 9 Staff name, designation and signature: Pharmacists ………………………………………….. ………………………………………….. ………………………………………….. ………………………………………….. ………………………………………….. ………………………………………….. ………………………………………….. ………………………………………….. Date ………………………………………….. 10 Pharmacy Influenza Vaccination Scheme Name (BLOCK CAPITALS) GP Surgery Address DOB dd/mm/yy Today’s Date dd/mm/yy Reason for vaccination, please tick; Aged 65 or over At risk medical condition Private - £12 Do you suffer from the following? Yes No Panic attacks? Fainting? Product Details Vaccination dose & brand Batch Number Site Expiry Date dd/mm/yy Pharmacists’ Name (BLOCK CAPITALS) Pharmacists’ Signature Pharmacy Stamp White Copy – Pharmacy Yellow Copy – GP Consent form completed and on file at Pharmacy Office use only Cost Centre Cost Code Voucher number: APPENDIX 5 Pink Copy – PCT Greenwich Teaching Primary Care Trust Medical Direction for the Administration of Influenza Vaccine without a Prescription for a Named Individual I………………………….General Practitioner give authorisation on behalf of the group practice for the named health care professionals who have signed this protocol, to administer influenza vaccine in accordance with current Department of Health guidelines to the patients registered with this practice. Signed………………………………………. Practice Stamp Appendix 6 Interactions with influenza vaccine 12 Date……………………….. The following interactions are not included in the manufacturers’ summaries of products characteristics and thought not to be significant in clinical practice. There is no contradiction to giving influenza vaccine to patients on the following medicines mentioned. However, it is well to be aware of possible changes to the effects of the medicines on patients because of the influenza vaccine. 1. Influenza vaccine with anticonvulsants Influenza vaccine is thought to inhibit liver enzymes, which can reduce the metabolism of phenobarbitone and increase its serum level. Influenza vaccine can reduce, raise or have no effect on the levels of phenytoin. Studies have shown that there is no effect of influenza vaccine on cabamazepine levels in patients. It is prudent to advise patients to see their GP if there is any change in their epilepsy control or if they feel unusually drowsy or agitated or have insomnia. 2. Influenza vaccine with warfarin or any other anticoagulants Administer the vaccine by subcutaneous, not intramuscular, injection. Influenza vaccination in patients treated with warfarin is usually safe and uneventful. There have been a very few reports of bleeding occurring unpredictably. The mechanism of the interaction is not fully understood but it is to do with an alteration in the synthesis of blood clotting factors. Advise patients to report to their GPs if there is unusually easy bruising or bleeding say, from the nose or when brushing teeth. 3. Influenza vaccine with theophylline Influenza vaccination in patients on theophylline is usually very safe with no adverse reactions. There have been a few reports of raised theophylline levels, possible due to liver enzyme inhibition. One proposal may be due to the impurities in the vaccine but with the purer vaccines now used; interactions will be very rare. Advise patient to see their GP if they experience palpitations, tachycardie, nausea or gastrointestinal upsets or headaches. 4. Influenza vaccine with steroids Influenza vaccination in patients on steroids is usually very safe with no adverse reactions. However, some immunocompromised patients may have a sub-optimal response to the vaccine. General Practitioners should report any adverse reactions and suspected interactions to the MCA using the yellow forms at the back of the BNF Reference Stockley I, Drug interactions 4th Edition, Pharmaceutical Press, 1996 13 Appendix 7 Patients who fall within the ‘risk- groups’ category. Chronic respiratory Disease, including asthma This includes chronic obstructive pulmonary disease including chronic bronchitis and emphysema, bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis, asthma requiring continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission. Chronic Heart Disease This includes chronic ischaemic heart disease, congenital heart disease and hypertensive heart disease requiring regular medication and follow up (but excluding uncomplicated controlled hypertension), and chronic heart failure. Chronic Renal Disease Including nephritic syndrome, chronic renal failure, and renal transplantation. Diabetes Diabetes Mellitus requiring insulin or oral hypoglycaemic drugs. Immunosuppression Due to disease or treatment, including asplenia or splenic dysfunction, and also including systemic steroids equivalent to 20 mg prednisolone daily for more than 2 weeks. However, please note that some immunocompromised patients may have a sub- optimal immunological response to the vaccine. Vaccines covered under this PGD All vaccines may have been exposed to latex in the manufacturing process so patients who are allergic to latex should be referred to the GP. Inactivated Influenza vaccine (Split Virion) Aventis Pasteur Special warnings and precautions for use: Not to be administered intravascularly. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. Can be used after the second trimester in pregnancy and during lactation. Contraindications- hypersensitivity to the active substances, to any of the excipients, to eggs, chicken protein, neomycin, formaldehyde and octoxinol 9 14