PANDEMIC (H1N1) 2009 VACCINATION INFORMATION & GUIDELINES

Transcription

1 PANDEMIC (H1N1) 2009 VACCINATION INFORMATION & GUIDELINES September 2009

2 Contents Pandemic (H1N1) 2009 (swine influenza) Vaccination Program... 3 The vaccine Panvax... 3 Who is eligible for Panvax?... 3 Pre-vaccination Procedures... 4 Vaccination Packs ( Vac Packs )... 4 Other resources included with vaccine delivery... 4 Information for providers and patients... 5 Planning and Preparation What practices can do now... 5 Planning and Preparation Conducting a vaccination clinic... 6 APPENDIX A: Priority Groups... 7 APPENDIX B: Protocol for immunisation using multi dose vials... 8 APPENDIX C: Qld Health Panvax order form... 9 APPENDIX D: Qld Health Panvax wastage form APPENDIX E: Qld Health Panvax data collection form APPENDIX F: Influenza H1N1 vaccination clinic checklist APPENDIX G: Influenza H1N1 vaccination clinic attendance tally sheet APPENDIX H: Patient invitation letter APPENDIX I: Panvax Product Information APPENDIX J: Consumer Medicines Information APPENDIX K: Entering Panvax in medical software Page 2 of 24

3 Pandemic (H1N1) 2009 (swine influenza) Vaccination Program The Commonwealth government has announced that a program of vaccination will be initiated across Australia in response to the influenza H1N swine flu pandemic. The Commonwealth has purchased 21 million doses of the vaccine to be rolled out through all state and territory health departments. General practice will be able to provide the influenza H1N vaccine to their patients once it is released. As this vaccine is additional to the usual immunisation program, it will probably mean an increased workload for general practice and in many cases will need extra time or a variation on normal practice programs. The pandemic influenza H1N vaccine (Panvax ) will be available from 30 September The vaccine Panvax Panvax is an inactivated (killed) monovalent vaccine produced by CSL Biotherapies in the same way as the yearly seasonal flu. There is an extensive body of safety data associated with this flu vaccine and in effect, Panvax is simply the seasonal flu vaccine with a different new strain. It is a clear liquid provided in multi dose vials with a latex free rubber bung and contains thiomersal as a preservative. The vaccine will be presented in multi dose vials in 3 pack sizes. 18 doses/vial x 50 vials 900 doses/pack 18 doses/vial x 10 vials 180 doses/pack 10 doses/vial x 10 vials 100 doses/pack It is envisaged that the 10 vials x 10 doses/vial will be distributed to general practice. The 10 dose vials have a red label and the 18 dose vials have a blue label. The dose to be administered is 15 µg/0.5ml. The vaccine must be stored between +2 C and +8 C in your vaccine dedicated refrigerator. A paediatric formulation of the vaccine will be available at a later date and will be provided in a prefilled syringe. Practices will need to ensure that clinical staff are familiar with and competent in the drawing up of doses from multi dose vials. Refer to Appendix A for a protocol for immunisation using multi dose vials. Refer to New England Journal of Medicine, 10 September 2009 article describing the efficacy of the monovalent vaccine. Access at Refer to Appendix I Panvax Product Information. Who is eligible for Panvax? The vaccination program will be focused on vaccinating certain priority groups at higher risk of developing complications from influenza. The vaccine is provided free of charge. It is not available for purchase on the private market. The first priority group includes anyone from the below groups and aged 10 years and above: All health care workers Aboriginal and Torres Strait Islander people Pregnant women (all trimesters) Adults and children (aged 10 years and above) with underlying chronic conditions. See Appendix A for a complete list of priority groups. Page 3 of 24

4 Important: The Commonwealth Government has advised that these priority groups are indicative categories only and that the vaccine can be provided to anyone who expresses an interest in being vaccinated. Vaccination of children aged 10 years and under will commence at a later date once safety data for this age group is available. Anyone who had a confirmed case of influenza H1N1 does not require vaccination. Vaccination of people with a previous influenza-like illness and not confirmed as H1N1 infection will be up to the clinical judgement of the doctor. Pre-vaccination Procedures Section 1.3 (page 8) in The Australian Immunisation Handbook 9 th edition 2008 provides information on: Preparing an anaphylaxis response kit Effective cold chain management Valid consent Pre-vaccination screening Vaccination Packs ( Vac Packs ) The Commonwealth Government is providing practices with the consumables necessary for immunisation to take place. These Vac Packs will include: Drawing up needles 19 g x 38 mm (2 boxes x 44 needles) Drawing up needles 23g x 38 mm (3 boxes x 40 needles) Injection needles 23g x 25 mm (1 box x 220 needles) 1ml syringes 1 box x 220 syringes The Vac Packs will be distributed by CSL Biotherapies and will be delivered separately to the vaccine. Other resources included with vaccine delivery Queensland Health will include in the vaccine delivery: Qld Health Panvax order form* Qld Health vaccine wastage form* Qld Health data collection sheet* Commonwealth FAQs for providers Commonwealth consent form CSL Product Information Practices can contact Queensland Health Immunisation Program on to request the resources marked with an asterisk Page 4 of 24

5 Information for providers and patients The Commonwealth Government has provided a web-based resource on Questions & Answers on the pandemic vaccine for providers and their patients. The information is divided into sections relating to information on: getting vaccinated priority groups specific groups vaccine safety Planning and Preparation What practices can do now The following points will assist practices prior to vaccine delivery: Plan to conduct vaccination clinics if required. Refer to Appendix H for a letter template to invite patients to attend Promote the availability of the vaccine in your waiting room to priority groups. Create list of priority groups from medical software. Recall patients from priority groups using normal practice recall/reminder systems (letter or phone call) Ensure staff are shown how to record Panvax in medical software. Refer to Appendix K for instructions Access the Commonwealth Government s Q & As for providers at to assist with addressing questions from patients. Add message about the availability of the influenza H1N vaccine to on hold telephone messages Purchase or organise additional equipment i. Extra sharps containers ii. Lightproof container/s to store drawn up vaccine doses in Discard 2009 seasonal influenza vaccine to maximise storage space in your vaccine fridge Consider the layout of the practice and arrange as necessary to allow for additional people in the waiting room, area for vaccination to occur and waiting area following vaccination. Consider staff training/updating on use of multi-dose vial, drawing up of doses and vaccine administration depending on the requirements of your practice. Further information on using multi-dose vials can be accessed via the Royal College of General Practitioners (RACGP) website at Page 5 of 24

6 Planning and Preparation Conducting a vaccination clinic Estimate the number of patients eligible to attend and book the number of sessions required. Set dates and times for influenza vaccination clinic. Adjust appointment book accordingly. Book time with the doctor and nurse. Allow time for vaccines and Vac Packs to arrive If your practice intends to invite patients to attend an influenza vaccination clinic, send patients a letter. Refer to Appendix H for a letter template to invite patients to attend Ensure appropriate arrangements for the storage of additional vaccines are made Order the vaccine and ensure necessary supplies are available. Instruct receptionists to make appointments for 5-10 minutes Rehearse with all staff involved in vaccination clinic what you will say to patients and ensure all staff are familiar with the support materials available. Refer to Q & As on pandemic vaccine at and Appendix J Consumer Medicines Information. Ensure all staff administering and/or managing vaccine storage are trained and familiar with use and storage of multi-dose vials. Refer to Appendix B. Prepare information about the vaccine, its risks and benefits for patients, to be handed out on arrival at the clinic. Refer to Appendix J Consumer Medicines Information. Have your anaphylaxis kit and treatment guide to hand. Refer to back cover of The Australian Immunisation Handbook, 9th edition Refer to the vaccination clinic checklist at Appendix F. Page 6 of 24

7 APPENDIX A: Priority Groups Target group Pregnant women Adults & children (aged 10 years and above) with underlying chronic medical conditions: Chronic respiratory conditions Immuno-suppression Cancer Diabetes mellitus Chronic renal disease Cardiac disease Chronic metabolic diseases Haemoglobinopathies Chronic neurological diseases Definition All trimesters Requires clinical judgement. Includes asthma & chronic obstructive pulmonary disease HIV/AIDS infection, use of immunosuppressive drugs Only malignant cancers Not including simple hypertension Individuals with moderate to severe obesity BMI > 35 Health care & community care workers (includes volunteers and students) Indigenous people, remote and isolated communities with vulnerable people Children (aged 10 years and above) in special schools Parents & guardians of children aged 0 6 months Health care worker: a person who has direct contact with patients, either in the community or hospital setting, in both public and private practice settings, focusing on the following: All staff within or working with Aboriginal Medical Services, general practice, remote or community health clinics, and ambulance services. All hospital and outpatient staff focusing on those who have direct patient contact. All staff working in acute care clinics/satellite clinics that provide care, limited to diabetic clinics, alcohol and drug rehabilitation, dialysis and oncology services and perinatal care. Community and residential care workers: Aged care and disability services workers who have direct patient contact while providing community and residential services to vulnerable groups. Self identification of indigenous status. Includes the Australian Antarctic Territory and subantarctic islands (vaccination to be provided prior to departure). Children (aged 10 years and above) in schools and institutions that are exclusively special needs based. Excludes mainstream schools with special needs programs. Primary carers of children aged 0 6 months

8 APPENDIX B: Protocol for immunisation using multi dose vials Practices can contact their local division of general practice to request a copy. Further information on using multi-dose vials can be accessed via the Royal College of General Practitioners (RACGP) website at

9 APPENDIX C: Qld Health Panvax order form Page 9 of 24

10 APPENDIX D: Qld Health Panvax wastage form Page 10 of 24

11 APPENDIX E: Qld Health Panvax data collection form Page 11 of 24

12 APPENDIX F: Influenza H1N1 vaccination clinic checklist Photocopy this checklist for each vaccination clinic that you hold. On Arrival Use your practice appointment system to record arrival of patients Give each patient the patient information leaflet. Refer to Appendix J for Consumer Medicines Information. Consultation and history Go through the pre-vaccination screening checklist (refer to The Australian Immunisation Handbook 9 th edition 2008 on page 16) Check for and document all patient allergies (including egg allergy) Explain the risks and benefits of the vaccine, including possible side effects as per the patient information leaflet Consent is obtained and recorded Document vaccine encounter on tally sheet (optional) or enter into medical software. Include vaccine batch number and if necessary priority group patient is from. Refer to Appendix K for instruction on entering Panvax in medical software. Vaccine Service Provider Have vaccine prepared as per the Protocol for Immunisation using Multi Dose Vials Ensure patient has the vaccine information sheet Request that the patient wait for 15 minutes following the immunisation Record keeping Record attendance and vaccination details in patient records. Refer to Appendix K for instruction on entering Panvax in medical software. Complete Qld Health vaccine wastage sheet if required Complete Qld Health data collection sheet General Practice Queensland acknowledges the work of Central Highlands Division of General Practice and Impetus for materials used to produce this guide. (Please do not remove this acknowledgement) Page 12 of 24

13 APPENDIX G: Influenza H1N1 vaccination clinic attendance tally sheet Doctor: Nurse Date Name Vaccine batch number Consent Given Entered onto patient notes Total attended

14 APPENDIX H: Patient invitation letter Print on practice letterhead paper, sign and print name of sender. Dear insert patient name, The Australian Government in response to the H1N1 pandemic is funding a national H1N1 vaccination program to protect certain vulnerable people. For the majority of people, H1N1 influenza (commonly known as swine flu) is a relatively mild illness causing discomfort that may require some bedrest. However, for certain vulnerable groups of people there is an increased risk of more serious complications from influenza. The Australian Government Department of Health & Ageing have determined that people in the following groups are at greater risk: all pregnant women indigenous people chronic neurological diseases chronic respiratory conditions (including asthma & chronic obstructive pulmonary disease) diabetes mellitus haemoglobinopathies cardiac disease individuals who are obese (BMI>35) chronic renal disease immuno-suppression (including malignant cancers, HIV/AIDS, drugs) chronic metabolic diseases health care workers (including front line practice staff) The vaccine will provide protection against the H1N1 influenza virus. The vaccination may have some side effects in some people, but these are minor compared to the flu itself. The vaccine cannot give you the flu'. Please discuss any concerns you may have with your doctor. As you meet the criteria to receive the free vaccination, we would like to invite you to attend a special influenza flu vaccination clinic which will be held at this practice on: insert date Please phone insert telephone number as soon as possible to book your appointment. When you arrive at the clinic you will be given an information leaflet and consent form to read prior to seeing the nurse/doctor. You will also be asked to wait for 15 minutes following vaccination so please ensure you leave sufficient time for the appointment. Yours sincerely Doctor s Name

15 APPENDIX I: Panvax Product Information Available from the CSL website: Page 15 of 24

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22 APPENDIX J: Consumer Medicines Information Available from the CSL website Page 22 of 24

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24 APPENDIX K: Entering Panvax in medical software Open patient file Click on Immunisation tab Click on red cross Vaccination Window appears (as shown on right) In Type box, free text Panvax Add priority group (if applicable) in Comments box Click Save Vaccination encounter appears in patient record as shown below: Page 24 of 24