Immunization Toolkit. For Family Practice

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1 Immunization Toolkit For Family Practice October 2017

2 Thank you. To our partners thank you for your ongoing commitment of promoting immunization in Nova Scotia. Immunization programs have saved more lives in the last century than any other health intervention. Ongoing immunization programs with high vaccine coverage are needed to maintain low levels of vaccine-preventable diseases. We have created this provincial resource to help guide your safe and effective participation in our provincial immunization programs. We hope that you find this tool kit helpful in your day to day practice. Stacey Dunphy RN BScN MHSc Immunization Coordinator, Science and System Performance Public Health

3 Table of Contents Contacts...4 Storage and Handling of Vaccine General Information...6 Vaccine Fridges...7 Thermometers and Temperature Monitoring...8 Appendix A- Keep Vaccine Safe...10 Appendix B- Vaccine Temperature Log Day Appendix C- Vaccine Temperature Log Day Anticipating a Power Outage- Urgent Storage & Handling...13 Appendix D- Vaccine Management Emergency Event Recovery Plan...14 Appendix E- Inventory of Vaccine- Alternate Storage in Event of Power Outage...17 Management of Cold Chain Failure...18 Appendix F- Vaccine Cold Chain Failure Incident Report...19 Orde ring Vaccine and Inventory Procedures...21 Appendix G- Requisition for Publicly Funded Vaccine...22 Appendix H- Free Issue Request for High Risk Patients...23 Appendix -I - Requisition for Hospital/Community Agencies...24 Appendix -J - Requisition for Long Term Care Facilities...25 Appendix -K- Vaccine Returns from Service Providers...26 Reporting Require ments...27 Reciprocal Notification...28 Appendix L- Reciprocal Notification Form...29 Adve rse Events Following Immunization (AEFI)...30 Appendix M- It s the Law: Reporting Adverse events Following Immunization Poster 31 Appendix N- ARFI User Guide...32 Appendix O- AEFI Form...33 Urgent Issues in Immunization Appendix P- Tetanus Prophylaxis in Wound Management...37 Appendix Q- Rabies Fact Sheet...38 Appendix R- Rabies Letter to Physician...42 Appendix S- Rabies Immune Globulin Dosage...44 Resources for Health Care Professionals...45 Resources for Parents...46 Public Health, NSHA October 2017 Page 3

4 Please contact your local Public Health Office for: Immunization Records Vaccine Orders Questions related to Immunizations Report of an Adverse Event following Immunization Amherst Public Health Antigonish Public Health ex 4800 Bridg Sewater Public Health Central Zone Public Health New Glasgow Public Health Sydney Public Health Truro Public Health Wolfville Public Health Yarmouth Public Health Contacts Central Zone Public Health Switchboard...(902) Communicable Disease Prevention and Control Intake Line...(902) Immunization Records...(902) Vaccine Orders and Immunization Resources...(902) Family Practice Support for Vaccine Management...(902) Questions related to Immunizations for the following groups Children...(902) Adults and High Risk Clients...(902) Please contact Public Health before giving school based vaccines. Report of an Adverse Event Following Immunization (AEFI) CDC Intake Line (902) Fax (902) For Vaccine Orders Burnside Tel: (902) Fax: (902) Public Health, NSHA October 2017 Page 4

5 For Reporting Immunizations Given Send all Reciprocal Notification Forms or Immunization Records to the following address: Attention: Immunization Records Public Health, Capital Health 7 Mellor Avenue, Unit 5 Dartmouth, NS B3B 0E8 Stacey Dunphy, RN, BScN, MHSc Immunization Coordinator Science and System Performance, NSHA Public Health Tel: Stacey.dunphy@nshealth.ca Public Health, NSHA October 2017 Page 5

6 Storage and Handling of Vaccine General Information Successful immunization programs are dependent upon proper handling, storage and rigorous cold chain management of vaccines. Cold chain is the process to maintain optimal conditions during the transport, storage, and handling of vaccines. This process begins at the vaccine manufacturer and ends with vaccine administration to the client. The optimum temperature for refrigerated vaccines is between +2 C and +8 C. Vaccines are subject to gradual loss of potency over time. Potency loss may happen more quickly if vaccines are transported or stored under sub optimal conditions. Biological products when maintained at the correct temperature are subject to gradual loss of potency. Vaccines may not be effective if exposed to excess light, heat or freezing. Products exposed to temperature or conditions outside of cold chain require further investigation before being used or disposed of. If your practice has a cold chain failure, complete a Cold Chain Failure Incident Report and send to Public Health. Public Health must be consulted to determine if exposed products are safe for use. Vaccines must be: Stored under refrigerated conditions between +2 C and +8 C. Used before the expiration date. Expiry is the last day of the month indicated on the product packaging. Transported between Public Health and other sites in a vaccine cooler with appropriate amount of packing equipment to maintain cold chain temperatures between +2 C and +8 C. Reconstituted with the diluent provided for the product. Reconstitution of vaccines should be done immediately prior to vaccine administration. Discard unused reconstituted vaccines. Quarantined if cold chain has been compromised. Vaccines must be stored in a fridge until consultation is made with Public Health. DO NOT dispose of products unless advised by Public Health. Public Health, NSHA October 2017 Page 6

7 Office Procedures for Storage and Temperature Monitoring All staff should be aware of office procedures for proper storage and handling of vaccine products. Offices should designate one staff and a back-up person to be responsible for vaccine ordering, storage and handling. Vaccine Fridges Offices must store biologicals in a dedicated vaccine refrigerator. Refrigerators should be selected carefully and used properly. Any refrigerator used for vaccine storage must be: Able to maintain vaccine storage temperatures (between +2ºC to +8ºC). Large enough to hold a month of inventory. Equipped with a thermometer or data logger. Dedicated to the storage of vaccines only. Bar fridges are unpredictable for maintaining proper vaccines temperatures. They are not approved for vaccine storage because of the high risk of products freezing. The fridge temperature becomes room temperature when the door is opened. When the door closes the fridge compressor is activated and often overcools the fridge causing freezing. Organizing the Vaccine Fridge Public Health, NSHA October 2017 Page 7

8 Here are some key tips for organizing the vaccine fridge to Keep Vaccine Safe. Stock vaccine on a first-in, first used basis to make sure products that expire first are used first. Store full bottles of water on shelves and the door to prevent temperature fluctuations. Do not store vaccines on door shelves as the temperature on the door fluctuates greatly. Thermometers and Temperature Monitoring Use thermometers and temperature recording devices that provide continuous recording or maximum-minimum thermometers. Place the thermometer probe in the center of the refrigerator. The Vaccine Temperature Day 1-15 and Day log is a tool to record the current temperature and the minimum and maximum fridge temperatures. Record the temperature at beginning and end of each work day. Place an X in the box that corresponds to the current temperature, record min/max readings. Record the time the reading was taken, the dial setting on the fridge, the ambient room temperature. If the temperature recorded is outside the recommended +2.0 C to +8.0 C range immediate action is necessary: Immediately report the incident to your designated staff person. Label vaccine exposed. Keep all exposed vaccines separate from non-exposed vaccines, in a functioning refrigerator. Complete a Cold Chain Failure Incident Report and send to Public Health. DO NOT USE the exposed vaccine until the vaccines have been assessed by Public Health and deemed fit for use. How to Read a Min/Max Thermometer The Min/Max thermometer has a digital readout and a wire probe that is long enough to remain permanently inserted in the fridge. The probe should be attached to a water bottle or Glycol solution or inside an empty vaccine box. The digital readout should be in an easy to read location (not in the fridge). Temperatures are checked twice a day. 1. Ensure that the In/Out switch is set to Out. This will give you the reading of the air from inside the fridge. 2. Record the current temperature. Public Health, NSHA October 2017 Page 8

9 3. Press the Min/Max button once to record the Min temperature. Once the temperature is read press clear. 4. Press the Min/Max button again and record the Max temperature. Once the temperature is read press clear. Recommended type Public Health recommends Canadian Scientific or another Min- Max thermometer that is calibrated to +/- 1 accuracy: We check our fridge temp twice a day. Appendix A Public Health, NSHA October 2017 Page 9

10 Public Health, NSHA October 2017 Page 10

11 APPENDIX B - Vaccine Temperature Log Day 1-15 APPENDIX C - Vaccine Temperature Log Day Public Health, NSHA October 2017 Page 11

12 Anticipating a Power Outage - Urgent Vaccine Storage & Handling When providers have cause to believe weather conditions or emergencies might affect vaccine storage, urgent procedures should be implemented in advance of the event to minimize vaccine wastage. Providers should have a Vaccine Management Emergency Recovery Plan. Agencies/practices are encouraged to arrange a back-up plan with local pharmacies or other providers with a back-up generator. Do I have a back-up plan? Local pharmacy Uninterrupted power supply (UPS) PH Bio De pot In the absence of a back-up plan Public Health Biologicals Depot could be designated as the alternate vaccine storage facility for your agency/practice. Make advance arrangements with the Public Health Biologicals Depot to have the Depot designated as the back-up or alternate storage facility for your agency/practice. Contact us Monday Friday 8:30am to 4:30pm. Provide the following: Devel op protocol Packing requirements are met Arrangements with courier Name of practice/agency, and hours of operation. Address and contact information, including name of primary vaccine contact person and back-up person for your practice. Name and contact info for courier that will be used. What you need to do: Develop a protocol for vaccine transport to and from the Public Health Biological Depot. Designate staff to pack vaccine to maintain cold chain temperatures (+2.0 C to +8.0 C). Have packing materials on hand (e.g. vaccine cooler, refrigerated and frozen gel packs). Record the inventory by lot number, amount of doses, and pack in a clear plastic bag with the inventory list visible as the packing list. Use the form: Inventory of Vaccine Alternate Storage in Event of Power Outage. Make advance arrangements with a courier service or staff to transport vaccine. Public Health, NSHA October 2017 Page 12

13 APPENDIX D - Vaccine Management Emergency Event Recovery Plan Vaccine Management Emergency Event Recovery Plan PHS office: Date Person completing form: This plan offers guidance for developing a vaccine emergency event recovery plan. Included are steps to follow when your refrigerator fails. Fill in the contact information for the emergency service providers identified on this form. In advance of an event, all providers should identify an alternative storage facility with backup power where the vaccine can be properly stored and monitored for the interim ensure the availability of staff to pack and move the vaccine maintain the appropriate packing/insulating materials ensure a means of transportation for the vaccine to the alternative storage facility train staff and post information about these emergency procedures Note: Whenever possible, suspend immunization activities BEFORE the onset of the emergency event to allow sufficient time for packing and transporting of vaccines. Written instructions for entering your facility and vaccine storage spaces in an emergency if the building is closed or it is after hours. These instructions should include the building security and after-hours access procedure and location of the following: doors flashlights spare batteries light switches keys locks alarms packing materials Public Health, NSHA October 2017 Page 13

14 Emergency Procedures A. Emergency phone numbers, companies, and points of contact List the designated person(s) responsible for monitoring the operation of the vaccine storage equipment and systems daily tracking inclement weather conditions assuring the appropriate handling of the vaccine during the emergency event Name of employee Title of employee Work phone Home phone Determine if your refrigerator is having a mechanical failure or if the building has lost electrical power. Check with the building maintenance to ensure that the generator is operational and has been activated. Building maintenance Point of contact Work phone Emergency phone Contact the designated company responsible for restoring power to the location in the event of a power failure. Power company Point of contact Work phone Emergency phone Contact the designated company responsible for repair where the compressor or the refrigeration equipment has been destroyed or you need emergency maintenance. Repair company Point of contact Telephone number If a time frame for the restoration cannot be determined, implement the following procedures for transferring the vaccines to an alternative storage facility with backup power. Public Health, NSHA October 2017 Page 14

15 B. List emergency phone numbe rs and points of contact for location with a backup generator This may be the local hospital, LTCF, etc. Make arrangements with the site to store your vaccine there when weather predictions call for inclement weather or when your vaccine storage equipment cannot be fixed or the power cannot be restored within 6 hours. Before moving your vaccine, call the location to ensure that their backup generator is working. Alte rnative facility Point of contact Work phone Emergency phone C. Describe how to enter the building and vaccine storage spaces in an emergency if closed or after hours. Include a floor diagram and the locations of the following Item Location(s) Doors Flashlights Spare batteries Light switches Keys Locks Alarms Packing/insulating materials D. Conduct an inventory before you move the vaccine. E. Package the vaccine as per packing instructions. F. Move vaccine to backup storage according to prearranged plans. Public Health, NSHA October 2017 Page 15

16 APPENDIX E - Inventory of Vaccine Alternate Storage in Event of Power Outage Public Health, NSHA October 2017 Page 16

17 Management of Cold Chain Failure A temperature reading outside +2.0 C to +8.0 C range means the vaccine products have been exposed to wrong temperatures and could be compromised. Follow this procedure: Check if the thermometer is working correctly; the battery may need to be changed. Record the date, time, and refrigerator temperatures as per log sheet. Reset the thermometer. Adjust the refrigerator setting to +2.0 C to +8.0 C. Clearly label exposed vaccine Do Not Use Cold Chain Failure and mark the date and time. Place exposed products in a working refrigerator. Keep exposed vaccines separated from non-exposed vaccines. Complete the Vaccine Cold Chain Failure Incident Report and consult with Public Health to determine whether vaccines can still be used. Monitor the temperature of the affected fridge twice daily for 3 days prior to returning product to the fridge, ensuring all readings have been between +2.0 C to +8.0 C. Record readings on the Vaccine Temperature Log and submit to Public Health. After Consulting with Public Health Clearly label biological products that have had an initial cold chain breach, but were deemed safe for use. This is important information for Public Health to have if the practice has a second cold chain break. Consult with Public Health regarding the temperature readings of the fridge prior to returning any vaccine to the affected fridge. Dispose of any products only upon direction of Public Health. Public Health, NSHA October 2017 Page 17

18 APPENDIX F - Vaccine Cold Chain Failure Incident Report Public Health, NSHA October 2017 Page 18

19 Public Health, NSHA October 2017 Page 19

20 Ordering Vaccine and Inventory Procedures A MONTH S WORTH Order enough vaccine for a month supply for your practice. MONTHLY AUDIT Audit biological products inventory once a month. Check for expired products. Return expired products to Public Health Biologicals Depot. Please complete the Vaccine Returns from Service Providers, (Appendix K) form. FOR ROUTINE VACCINE REQUESTS Complete a Requisition for Publicly Funded Vaccine, (Appendix G) and submit to the Public Health Biological Depot at the Public Health Services Main Office by fax to (902) , or by contacting your local Public Health office. FOR NON-ROUTINE VACCINE REQUESTS (HIGH RISK) Complete a Vaccine Request for High Risk Patients (Appendix H) and fax to the Biological Depot. Publicly funded vaccines are provided for individuals at high-risk of vaccine-preventable disease as outlined by The Department of Health and Wellness. Consult the NS Immunization Manual high risk policy for eligibility requirements. After hours/weekend requests should be directed to the Medical Officer of Health through Capital Health locating (902) Public Health, NSHA October 2017 Page 20

21 Appendix G Requisition for Publicly Funded Vaccine Public Health, NSHA October 2017 Page 21

22 APPENDIX H Vaccine Request for High Risk Patients Public Health, NSHA October 2017 Page 22

23 Appendix I - Requisition for Hospital /Community Agencies Public Health, NSHA October 2017 Page 23

24 Appendix J Requisition for Long Term Care Facilities Public Health, NSHA October 2017 Page 24

25 Appendix K Vaccine Returns from Service Provide rs Public Health, NSHA October 2017 Page 25

26 Reporting Requirements Records Each person receiving an immunization should receive an individual record. A personal immunization card is provided to all newborn infants in the information package at the IWK Health Centre. Additional copies may be requested from Public Health. Each practice or agency should develop protocols for documentation of immunization in accordance to professional documentation standards. The following information is required for documentation: Name DOB Health Card Number Vaccine Given Lot Number Date Given (Day, Month, Year) Site Route Dose Professional signature and designation Public Health, NSHA October 2017 Page 26

27 Reciprocal Notification Public Health enters all immunization records of vaccines administered within the district into a provincial database called Application for Notifiable Disease Surveillance (ANDS). Providers MUST supply immunization records to Public Health for each vaccine administered. Providers can either mail/fax the record using the Reciprocal Notification (Appendix L) form or send a copy of the electronic records (PHIM, Nightingale, or other). Submit immunization records monthly to Public Health. The following data elements are required to be entered into ANDS: Name DOB Health Card Number Vaccine Given Lot Number Date Given (Day, Month, Year) Site Route Dose This will ensure up to date records can be provided on request of the client or health care provider, and can be used in calculating immunization coverage rates. All vaccine provide rs must provide a record of immunizations given to be entered into the provincial immunization registry. Public Health, NSHA October 2017 Page 27

28 APPENDIX L - Reciprocal Notification Form Public Health, NSHA October 2017 Page 28

29 Adverse Events Following Immunization (AEFI) Under the Nova Scotia Health Protection Act, Adverse Events Following Immunization (AEFI) must be reported to public health. If a patient experiences an adverse event following immunization, please complete the AEFI FORM and contact your local public health office. These AEFI instructions can assist you to complete this form. Visit chapter 8 of the NS Immunization Manual for further information on AEFI reporting Public Health Agency of Canada collects case reports on adverse events following immunization from provincial and territorial health departments, health care professionals and the pharmaceutical industry. The data is stored in the Canadian Adverse Events Following Immunization (CAEFI) database and is used to signal adverse events that may require more in-depth investigation. Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) monitors AEFIs to ensure the safety of vaccines on the Canadian market. Public Health, NSHA October 2017 Page 29

30 APPENDIX M - It's the Law: Reporting Adverse events Following Immunization Poster Public Health, NSHA October 2017 Page 30

31 APPENDIX N - AEFI User Guide To download the AEFI User Guide please visit ug-gueng.pdf Public Health, NSHA October 2017 Page 31

32 APPENDIX O - AEFI Form Public Health, NSHA October 2017 Page 32

33 Public Health, NSHA October 2017 Page 33

34 Public Health, NSHA October 2017 Page 34

35 Public Health, NSHA October 2017 Page 35

36 Urgent Issues in Immunization APPENDIX P - Tetanus Prophylaxis in Wound Management: Tetanus Poster Public Health, NSHA October 2017 Page 36

37 APPENDIX Q - Rabies: Fact sheet Detailed information about rabies in the province can be found in NS Rabies Response Plan. This Rabies Poster can help health care providers assess concerns about animal bites and rabies exposure. Further information about rabies can be found in chapter 9 of the NS Communicable Disease Prevention and Control Manual Public Health, NSHA October 2017 Page 37

38 Public Health, NSHA October 2017 Page 38

39 Public Health, NSHA October 2017 Page 39

40 Public Health, NSHA October 2017 Page 40

41 APPENDIX R - Rabies letter to Physicians post exposure prophylaxis Public Health, NSHA October 2017 Page 41

42 Public Health, NSHA October 2017 Page 42

43 APPENDIX S - Rabies Immune Globulin Dosage Public Health, NSHA October 2017 Page 43

44 Resources for Health Care Professionals Canadian Immunization Guide Evergreen Version Department of Health and Wellness Information for Professionals site Immunize Canada Immunization Competencies for Health Professionals Public Health Agency of Canada Keeping Vaccine Safe National Advisory Committee on Immunization Nova Scotia Communicable Disease Prevention and Control Manual Nova Scotia Immunization Manual Nova Scotia Rabies Response Plan Nova Scotia Routine Childhood Immunization Schedule Nova Scotia Immunization Schedule for Adults Nova Scotia School Immunization Schedule Pain Management Public Health Agency of Canada Vaccine Preventable Diseases and Immunization Public Health, NSHA October 2017 Page 44

45 Vaccine Shoppe Vaccine Storage and Handling Guidelines for Physicians, Pharmacists and Other Immunization Providers V1.pdf Vaccine Tear Sheets for Childhood Immunizations Resources for Parents Canadian Pediatric Society Immunization Action Coalition It s Time to Immunize Vaccinate Your Baby Your Childs Best Shot Public Health, NSHA October 2017 Page 45

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