Influenza Vaccination Policies and Procedures

1. Influenza Vaccination Policies and Procedures Indiana State Department of Health November 2009

2. Glossary 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

3. Vaccine Storage & Handling

4. Why Storage & Handling is Important • 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

5. Understanding the Cold Chain • 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.

6. Proper Storage Unit • Household or commercial –style refrigerator/freezer unit. • Refrigerator and freezer compartments must each have a separate external door.

7. Refrigerator and Freezer Policy • 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.

8. Refrigerator and Freezer Policy 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.

9. Do 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.

10. Vaccine Specific Considerations • LAIV • Refrigerator storage • Prefilled syringes • Once needle attached, must use same day • All inactivated vaccines • Do not freeze or expose to freezing temperatures

11. Vaccine Storage at the Off site Location • 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.

12.  Monitoring Temperatures during Off site Clinics • 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.

13. Inactivated Vaccine (IV) or Live Attenuated Influenza Vaccine (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. 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. Live Attenuated Influenza VaccineContraindications and Precautions • 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

15. Influenza VaccineContraindications and Precautions • 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

16. H1N1 Vaccine Priority Groups • 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

17. Next on the List • Healthy people age 25 to 64 And finally: • Anyone age 65 and over regardless of the presence of chronic health conditions

18. Vaccine administration

19. Screening • 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

20. Typical Screening Questions • 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

21. Preparation • 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

22. Infection Control • 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

23. Intranasal Administration • 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.

24. Simultaneous Administration • There is no contraindication to the simultaneous administration of any injectable vaccines.

25. Spacing of Vaccine Combinations Not Given Simultaneously Combination Minimum Interval • Two live intranasal influenza vaccines • MMR or Varicella and LAIV • All other injectable vaccines • 4 weeks • 4 weeks • None http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/Slides/Gen%20Recs10.ppt

26. Routes of Administration • 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 aspirate—there is no evidence for or against aspirating with vaccinations ¤

27. Intramuscular (IM) Injections • Needle should be at a 90 degree angle.

28. Intramuscular Injections

29. Intramuscular Sites

30. Comforting Restraint and Positioning • Accommodate for patient’s comfort, safety, and age • Encourage the parent/guardian to hold the child

31. Comforting Restraints