1. I NFLUENZA V ACCINATION P OLICIES AND P ROCEDURES Indiana State Department of Health November 2009

2. G LOSSARY Multi dose Vial (MDV): 5mL vial contains at least 10.5mL doses of vaccine Prefilled Syringes (PFS): Syringes arrive prefilled with vaccine for either.25mL or.5mL dose Intranasal: Nasal spray vaccine Vaccine presentation: MDV, PFS or Intranasal 2

3. V ACCINE S TORAGE & H ANDLING 3

4. W HY S TORAGE & H ANDLING IS I MPORTANT Vaccine that is not stored correctly becomes nonviable and cannot be used Thousands of dollars in wasted vaccine If nonviable vaccine is used, people believe they are vaccinated when they are actually not immune 4

5. U NDERSTANDING THE C OLD C HAIN Begins with the manufacturer Continues to the distributor Then to the provider Until the vaccine has been properly administered to the patient Vital that proper storage has been maintained through the entire link Process is then extended anytime the vaccine is being transported to off-site clinics. If vaccine transportation is necessary for an off site clinic, it is critical that vaccine potency is protected by maintaining the cold chain at all time. 5

6. P ROPER S TORAGE U NIT Household or commercial –style refrigerator/freezer unit. Refrigerator and freezer compartments must each have a separate external door. 6

7. R EFRIGERATOR AND F REEZER P OLICY Refrigeration/Freezer Standards For Vaccine Storage Policy Number: II-02 (R3-2/2009) Refrigerators and freezers used for permanent storage of publicly provided vaccines must meet the following minimum standards: Have separate external doors, with separate gasket door seals for the refrigerator unit and the freezer unit. Refrigerators must maintain a temperature range from 2°C - 8°C, (35° F - 46° F) year-round. 7

8. R EFRIGERATOR AND F REEZER P OLICY CONT. Refrigerators must be dedicated to the storage of vaccines. Refrigerators must have enough room to store the largest anticipated vaccine inventory, while maintaining proper air circulation. 8

9. D O NOT USE DORM - SIZE REFRIGERATORS Dormitory type refrigerators have been shown to be unsuitable for the storage of vaccine and are not acceptable for use with CDC or ISDH except for the short term storage at a clinic site. 9

10. V ACCINE S PECIFIC C ONSIDERATIONS LAIV Refrigerator storage Prefilled syringes Once needle attached, must use same day All inactivated vaccines Do not freeze or expose to freezing temperatures 10

11. V ACCINE S TORAGE AT THE O FF SITE L OCATION The cold chain must be maintained once vaccine has been transported to the off site clinic. Ideally, vaccines should be transferred to and stored in a storage unit at the off site location. If off site storage units are utilized, prior temperature monitoring is required to ensure that the refrigerator and freezer compartments can maintain proper temperatures throughout the clinic day. Separate thermometers will be necessary to monitor temperatures 2-3 days prior to the off site clinic. If neither a full-size unit nor a dorm-style unit is available for use at the off site location, vaccines can be stored in portable refrigerators and/or in the Styrofoam containers used for transport. If vaccine must be maintained in an insulated cooler during an off site clinic, keep the cooler closed as much as possible. Limit the opening/closing of the cooler by taking out 5 doses at a time. A thermometer must be kept in the cooler with the vaccines, and temperatures should be checked and recorded periodically to ensure that the cold chain is not broken. 11

12. M ONITORING T EMPERATURES DURING O FF SITE C LINICS All vaccine storage units or containers must be monitored for temperatures throughout the clinic day. The refrigerator compartment must maintain a temperature range between 35° and 46°F (2° and 8°C). The temperature should never fall below 35° F (2° C) or rise above 46° F (8° C). It is best to set the temperature mid-range to achieve an average of 40° F (5° C). This temperature setting will provide the best safety margin. At a minimum, vaccine temperatures should be checked and recorded hourly. Assign a single staff person to monitor and record storage unit temperatures throughout the clinic day on an hourly basis. 12

13. I NACTIVATED V ACCINE (IV) OR L IVE A TTENUATED I NFLUENZA V ACCINE (LAIV) IV Inactivated vaccine flu shot IM administration Ages 6 months and older LAIV Live vaccine FluMist Nasal administration Ages 2-49 years and healthy and non pregnant. 13 Children age 9 and under must return for a second dose of either vaccine in 4 weeks. The time frame may be longer, but cannot be shorter than 4 weeks.

14. L IVE A TTENUATED I NFLUENZA V ACCINE C ONTRAINDICATIONS AND P RECAUTIONS These persons should receive only inactivated influenza vaccine Immunosuppression from any cause Pregnant women Children younger than 2 years of age Persons 50 years of age or older Persons with chronic medical condition, including asthma Children and adolescents receiving long-term aspirin therapy Children younger than 5 years with recurrent wheezing http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/Slides/Influenza10.ppt 14

15. I NFLUENZA V ACCINE C ONTRAINDICATIONS AND P RECAUTIONS Severe (anaphylactic) allergy to egg or other vaccine components History of Guillian-Barré syndrome within 2 months of previous flu vaccine Moderate or severe acute illness http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/Slides/Influenza10.ppt 15

16. H1N1 V ACCINE P RIORITY G ROUPS Pregnant women Household contacts of babies under 6 months of age Healthcare and emergency medical services (EMS) workers Children and young people aged 6 months through 24 years People between 25 and 64 years who have chronic medical conditions 16

17. N EXT ON THE L IST 17 Healthy people age 25 to 64 And finally: Anyone age 65 and over regardless of the presence of chronic health conditions

18. V ACCINE ADMINISTRATION 18

19. S CREENING The key to preventing the majority of serious adverse reactions is screening Every person who administers vaccines should screen every patient for contraindications and precautions before giving the vaccine dose Each local health department may have their own screening document Any questions should be directed to the nurse or physician in charge of the clinic 19

20. T YPICAL S CREENING Q UESTIONS Is your child or are you sick today? Allergies to food or medications? Any problems after previous flu shots? Problems with the immune system? Pregnant? Any shots or nasal mist in the last 4 weeks? Each local health department will incorporate these and perhaps other questions into their own screening form 20

21. P REPARATION Keep vaccine refrigerated until time to reconstitute and/or administer Inspect the vaccine vial Never use expired vaccine Label all vaccines that are drawn up No pre-filling syringes 21

22. I NFECTION C ONTROL Hand hygiene Single, most effective disease prevention activity Hands should be washed thoroughly with soap and water or cleansed with an alcohol based antiseptic Gloves are not mandatory unless: During vaccine administration there is potential for exposure to blood/bodily fluids Provider has open lesions on the hands May be facility mandated policy 22

23. I NTRANASAL A DMINISTRATION LAIV is supplied in a prefilled, single-use sprayer containing 0.2 mL of vaccine. An attached dose-divider clip is removed from the sprayer after administration in one side to administer the second half of the dose into the other nostril. Administer 0.1 ml per nostril If patient sneezes or has nasal discharge, do not repeat dose. Source: HealthSoft, Inc. 23

24. S IMULTANEOUS A DMINISTRATION There is no contraindication to the simultaneous administration of any injectable vaccines. 24

25. S PACING OF V ACCINE C OMBINATIONS N OT G IVEN S IMULTANEOUSLY Combination Minimum Interval Two live intranasal influenza vaccines MMR or Varicella and LAIV All other injectable vaccines 4 weeks None http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/Slides/Gen%20Recs10.ppt 25

26. R OUTES OF A DMINISTRATION 26 Deliver vaccine by recommended route Promotes optimal vaccine effectiveness Decreases the risk of local adverse reactions Injection technique Aspiration before injection To aspirate or not to aspiratethere is no evidence for or against aspirating with vaccinations ¤

27. I NTRAMUSCULAR (IM) I NJECTIONS Needle should be at a 90 degree angle. Patient AgeSiteNeedle Size Young children (6 to 36 mos. of age) Vastus lateralis until deltoid muscle is adequate 5/8 to 1 ¼ needle 23 - 25 gauge Older children (>36 mos. of age) & adults Thickest portion of deltoid muscle 1 to 1 ½ needle 23 - 25 gauge Females over 200 lbs. Males over 260 lbs. Thickest portion of deltoid muscle 1 ½ needle 23 - 25 gauge 27

28. I NTRAMUSCULAR I NJECTIONS 28

29. I NTRAMUSCULAR S ITES 29

30. C OMFORTING R ESTRAINT AND P OSITIONING Accommodate for patients comfort, safety, and age Encourage the parent/guardian to hold the child 30

31. C OMFORTING R ESTRAINTS 31