Administering Vaccines: Dose, Route, Site, and Needle Size

Transcription

1 Administering Vaccines: Dose, Route, Site, and Needle Size Vaccines Dose Route Injection Site and Needle Size Diphtheria, Tetanus, Pertussis (DTaP, DT, Tdap, Td) Haemophilus influenzae type b (Hib) Hepatitis A (HepA) 0.5 ml 0.5 ml <18 yrs: 0.5 ml >19 yrs: 1.0 ml <19 yrs: 0.5 ml* Hepatitis B (HepB) >20 yrs: 1.0 ml *Persons yrs may be given Recombivax HB (Merck) 1.0 ml adult formulation on a 2-dose schedule. Human papillomavirus (HPV) Influenza, live attenuated (LAIV) Influenza, trivalent inactivated (TIV) Measles, mumps, rubella (MMR) Meningococcal conjugate (MCV) IM IM IM IM 0.5 ml IM 0.2 ml 6 35 mos: 0.25 ml >3 yrs: 0.5 ml 0.5 ml Intranasal spray IM SC 0.5 ml IM Subcutaneous (SC) injection Use a gauge needle. Choose the injection site that is appropriate to the person s age and body mass. Age Infants (1 12 mos) Children 12 mos or older, adolescents, and adults Newborns (1 st 28 days) Infants (1 12 mos) Toddlers (1 2 yrs) Needle Length e" e" Needle Length e" * 1" 1 1¼" e 1"* Injection Site Fatty tissue over anterolateral thigh muscle Fatty tissue over anterolateral thigh muscle or fatty tissue over triceps Intramuscular (IM) injection Use a gauge needle. Choose the injection site and needle length appropriate to the person s age and body mass. Age Injection Site Anterolateral thigh muscle Anterolateral thigh muscle Anterolateral thigh muscle or deltoid muscle of arm Meningococcal polysaccharide (MPSV) 0.5 ml SC Children & teens e 1"* Deltoid muscle of arm or (3 18 years) 1 1¼" anterolateral thigh muscle Pneumococcal conjugate (PCV) 0.5 ml IM Adults 19 yrs or older Pneumococcal polysaccharide (PPSV) 0.5 ml IM or SC Male or female less than 130 lbs e 1"* Deltoid muscle of arm Polio, inactivated (IPV) 0.5 ml IM or SC Female lbs Male lbs 1 1½" Deltoid muscle of arm Rotavirus (RV) 2.0 ml Oral Varicella (Var) 0.5 ml SC Zoster (Zos) 0.65 ml SC Female 200+ lbs Male 260+ lbs 1½" Deltoid muscle of arm *A e" needle may be used only if the skin is stretched tight, subcutaneous tissue is not bunched, and injection is made at a 90-degree angle. Combination Vaccines Subcutaneous (SC) injection Intramuscular (IM) injection DTaP+HepB+IPV (Pediarix ) DTaP+Hib+IPV (Pentacel ) DTaP+Hib (Trihibit ) DTaP+IPV (Kinrix ) Hib+HepB (Comvax ) MMR+Var (ProQuad ) 0.5 ml <12 yrs: 0.5 ml IM SC 45 angle skin subcutaneous tissue muscle 90 angle skin subcutaneous tissue muscle HepA+HepB (Twinrix ) >18 yrs: 1.0 ml IM Please note: Always refer to the package insert included with each biologic for complete vaccine administration information. CDC s Advisory Committee on Immunization Practices (ACIP) recommendations for the particular vaccine should be reviewed as well. Technical content reviewed by the Centers for Disease Control and Prevention, February Item #P3085 (2/09) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

2 Checklist for Safe Vaccine Storage and Handling Here are the most important things you can do to safeguard your vaccine supply. Are you doing them all? Review this list to see where you might make improvements in your vaccine management practices. Fill in each box with either or. Establish Storage and Handling Policies 1. We have designated a primary vaccine coordinator and at least one back-up coordinator to be in charge of vaccine storage and handling at our facility. 2. Both the primary and back-up vaccine coordinator(s) have completely reviewed either CDC's online vaccine storage and handling guidance or equivalent training materials offered by our state health department's immunization program. 3. We have detailed, up-to-date, written policies for general vaccine management, including policies for routine activities and an emergency vaccine-retrieval-and-storage plan for power outages and other problems. Our policies are based on CDC's vaccine storage and handling guidance and/or on instruction from our state or local health department's immunization program. 4. We review these policies with all staff annually and with new staff, including temporary staff, when they are hired. Log In New Vaccine Shipments 5. We maintain a vaccine inventory log that we use to document the following: a. Vaccine name and number of doses received b. Date we received the vaccine c. Condition of vaccine when we received it d. Vaccine manufacturer and lot number e. Vaccine expiration date Use Proper Storage Equipment 6. We store vaccines in refrigerator and freezer units designed specifically for storing biologics, including vaccines. Alternatively, we keep frozen and refrigerated vaccines in separate, free-standing freezer and refrigerator units. At a minimum, we use a household-style unit with a separate exterior door for the freezer and separate thermostats for the freezer and refrigerator. We do T use a dormitory-style unit (a small combination freezer-refrigerator unit with a freezer compartment inside the refrigerator). 7. We use only calibrated thermometers with a Certificate of Traceability and Calibration* that are recalibrated as recommended by the manufacturer. 8. We have planned back-up storage unit(s) in the event of a power failure or other unforeseen event. We perform regular maintenance to assure optimal functioning. Ensure Optimal Operation of Storage Units 9. We have a "Do Not Unplug" sign next to the electrical outlets for the refrigerator and freezer and a "Do Not Stop Power" warning label by the circuit breaker for the electrical outlets. Both include emergency contact information. 10. We keep the storage unit clean, dusting the coils and cleaning beneath it every 3 6 months. Maintain Correct Temperatures 11. We always keep at least one accurate calibrated thermometer (+/-1ºC [+/-2ºF]) with the vaccines in the refrigerator; ideally, we have a continuous-temperature logger and/or temperature-sensitive alarm system. 12. We maintain the refrigerator temperature at 35 46ºF (2 8ºC), and we aim for 40ºF (5ºC). (Maintain Correct Temperatures continued on page 2) *Certificate of Traceability and Calibration with calibration measurements traceable to a testing laboratory accredited by the International Organization of Standardization, to the standards of the National Institute of Standards and Technology, or to another internationally recognized standards agency. Technical content reviewed by the Centers for Disease Control and Prevention, July Item #P3035 (7/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

3 Checklist for Safe Vaccine Storage and Handling (continued) (page 2 of 2) (Maintain Correct Temperatures continued from page 1) 13. We keep extra containers of water in the refrigerator (e.g., in the door, on the floor of the unit where the vegetable bins were located) to help maintain cool temperatures. 14. We always keep at least one accurate calibrated thermometer (+/-1ºC [+/-2ºF]) with vaccines in the freezer. 15. We maintain the average temperature in the freezer at +5ºF (-15ºC), preferably colder but no colder than -58ºF (-50ºC). 16. We keep ice packs or ice-filled containers in the freezer to help maintain cold temperatures. Store Vaccines Correctly 17. We post signs on the doors of the refrigerator and freezer that indicate which vaccines should be stored in the refrigerator and which in the freezer. 18. We do T store any food or drink in any vaccine storage unit. 19. We store vaccines in the middle of the refrigerator or freezer (never in the doors), with room for air to circulate. 20. We have removed all vegetable and deli bins from the storage unit. 21. If we are using a combination refrigerator-freezer unit, we do not store vaccines in front of the cold air outlet that leads from the freezer to the refrigerator (often near the top shelf). 22. We check vaccine expiration dates and rotate our supply of each type of vaccine so that we use the vaccines that will expire soonest. 23. We store vaccines in their original packaging in clearly labeled uncovered containers with slotted sides that allow air to circulate. Maintain Daily Temperature Logs 24. On days when our practice is open, we document refrigerator and freezer temperatures on the daily log twice a day first thing in the morning and right before our facility closes. 25. We consistently record temperatures on the log in either Fahrenheit or Celsius. We NEVER mix in any way how we record our temperatures. For example, if the log prompts us to insert an "x" by the temperature that's preprinted on the log, we do not attempt to write in the actual temperature. 26. The logs show whom to call if the temperature in the storage unit goes out of range. 27. When we change the thermostat setting, we document it in the daily log sheet's note section. 28. If out-of-range temperatures occur in the unit, we document in the daily log sheet's note section who responded and when. 29. Trained staff (other than staff designated to record the temperatures) review the logs weekly. 30. We keep the temperature logs on file for at least 3 years. Take Emergency Action As Needed 31. In the event that vaccines are exposed to improper storage conditions, we take the following steps: a. We restore proper storage conditions as quickly as possible; if necessary, we move the vaccine to our planned back-up storage unit. We address the storage unit s mechanical or electrical problems according to guidance from the manufacturer or repair service. b. In responding to improper storage conditions, we do T make frequent or large changes in thermostat settings. After changing the setting, we give the unit at least a day to stabilize its temperature. c. We temporarily label exposed vaccines Do not use and keep them separate from any unexposed vaccines. We do not use exposed vaccines until our state health department s immunization program or the vaccine manufacturer gives us approval. d. We document exactly what happened, noting the temperature in the storage unit and the amount of time the vaccines were out of proper storage conditions. We contact our state health department s immunization program or the vaccine manufacturer to determine how to handle the exposed vaccines. e. We follow the health department or manufacturer s instructions and keep a record detailing the event. Where applicable, we mark the exposed vials with a revised expiration date provided by the manufacturer. If we answer to all of the above, we give ourselves a pat on the back! If not, we assign someone to implement needed changes! Immunization Action Coalition Item #P3035 (7/11)

4 Form Decision to Not Vaccinate My Child I am the parent/guardian of the child named at the bottom of this form. My healthcare provider has recommended that my child be vaccinated against the diseases indicated below. I have been given a copy of the Vaccine Information Statement (VIS) that explains the benefits and risks of receiving each of the vaccines recommended for my child. I have carefully reviewed and considered all of the information given to me. However, I have decided not to have my child vaccinated at this time. I have read and acknowledge the following: I understand that some vaccine-preventable diseases (e.g., measles, mumps, pertussis [whooping cough]) are infecting unvaccinated U.S. children, resulting in many hospitalizations and even deaths. I understand that though vaccination has led to a dramatic decline in the number of U.S. cases of the diseases listed below, some of these diseases are quite common in other countries and can be brought to the U.S. by international travelers. My child, if unvaccinated, could easily get one of these diseases while traveling or from a traveler. I understand that my unvaccinated child could spread disease to another child who is too young to be vaccinated or whose medical condition (e.g., leukemia, other forms of cancer, immune system problems) prevents them from being vaccinated. This could result in long-term complications and even death for the other child. I understand that if every parent exempted their child from vaccination, these diseases would return to our community in full force. I understand that my child may not be protected by herd or community immunity (i.e., the degree of protection that is the result of having most people in a population vaccinated against a disease). I understand that some vaccine-preventable diseases such as measles and pertussis are extremely infectious and have been known to infect even the very few unvaccinated people living in highly vaccinated populations. I understand that if my child is not vaccinated and consequently becomes infected, he or she could experience serious consequences, such as amputation, pneumonia, hospitalization, brain damage, paralysis, meningitis, seizures, deafness, and death. Many children left intentionally unvaccinated have suffered severe health consequences from their parents decision not to vaccinate them. I understand that my child may be excluded from his or her child care facility, school, sports events, or other organized activities during disease outbreaks. This means that I could miss many days of work to stay home with my child. I understand that the American Academy of Pediatrics, the American Academy of Family Physicians, and the Centers for Disease Control and Prevention all clearly support preventing diseases through vaccination. Vaccine / Disease VIS given ( ) Vaccine recommended by doctor or nurse (Dr./Nurse initials) I decline this vaccine (Initials of parent/ guardian) Vaccine / Disease VIS given ( ) Vaccine recommended by doctor or nurse (Dr./Nurse initials) I decline this vaccine (Initials of parent/ guardian) Diphtheria-tetanus-pertussis (DTaP) Meningococcal (MCV) Haemophilus influenzae type b (Hib) Varicella (Var) Hepatitis A (HepA) Pneumococcal conjugate (PCV) Hepatitis B (HepB) Polio, inactivated (IPV) Human papillomavirus (HPV) Rotavirus (RV) Influenza Tetanus-diphtheria (Td) Measles-mumps-rubella (MMR) Tetanus-diphtheria-pertussis (Tdap) In signing this form, I acknowledge I am refusing to have my child vaccinated against one or more diseases listed above; I have placed my initials in the column titled I decline this vaccine to indicate the vaccine(s) I am declining. I understand that at any time in the future, I can change my mind and vaccinate my child. Child s name: Parent/guardian signature: Doctor/nurse signature: Date of birth: Date: Date: Item #P4059 (11/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

5 Additional information for healthcare professionals about IAC s Decision to Not Vaccinate My Child form Unfortunately, some parents will decide not to give their child some or all vaccines. For healthcare providers who want to assure that these parents fully understand the consequences of their decision, the Immunization Action Coalition (IAC) has produced a new form titled Decision to Not Vaccinate My Child. IAC s form, which accompanies this page of additional information, facilitates and documents the discussion that a healthcare professional can have with parents about the risks of not having their child immunized before the child leaves the medical setting. Your use of IAC s form demonstrates the importance you place on timely and complete vaccination, focuses the parents attention on the unnecessary risk for which they are accepting responsibility, and may encourage a vaccine-hesitant parent to accept your recommendations. According to an American Academy of Pediatrics (AAP) survey on immunization practices, almost all pediatricians reported that when faced with parents who refuse vaccination they attempt to educate parents regarding the importance of immunization and document the refusal in the patient s medical record. 1 Recommendations from the child s healthcare provider about a vaccine can strongly influence parents final vaccination decision. 2 Most parents trust their children s doctor for vaccine-safety information (76% endorsed a lot of trust ), according to researchers from the University of Michigan. 3 Simi- larly, analyses of the 2009 HealthStyles Survey found that the vast majority of parents (81.7%) name their child s doctor or nurse as the most important source that helped them make decisions about vaccinating their child. 4 Gust and colleagues found that the advice of their children s healthcare provider was the main factor in changing the minds of parents who had been reluctant to vaccinate their children or who had delayed their children s vaccinations. 5 Vaccine-hesitant parents who felt satisfied with their pediatricians discussion of vaccination most often chose vaccination for their child. 6 All parents and patients should be informed about the risks and benefits of vaccination. This can be facilitated by providing the appropriate Vaccine Information Statement (VIS) for each vaccine to the parent or legal representative, which is a requirement under federal law when vaccines are to be given. When parents refuse one or more recommended immunizations, document that you provided the VIS(s), and have the parent initial and sign the vaccine refusal form. Keep the form in the patient s medical record. Revisit the immunization discussion at each subsequent appointment. Some healthcare providers may want to flag the charts of unimmunized or partially immunized children to be reminded to revisit the immunization discussion. Flagging also alerts the provider about missed immunizations when evaluating illness in children, especially in young children with fever of unknown origin. What do others say about documentation of parental refusal to vaccinate? American Academy of Pediatrics (AAP): Pediatricians need to explain the risks of not vaccinating and should have (parents) sign an informed refusal document at each visit during which vaccination is declined. A sample AAP Refusal to Vaccinate form is available at org/immunization. 7 Association of State and Territorial Health Officials (ASTHO): To address the risk of VPD, states should consider adopting more rigorous standards for non-medical vaccine exemptions that require parents to demonstrate that they have made a conscious, concerted, and informed decision in requesting these exemptions for their children. An example of such a standard might include a requirement for parents to complete a form that explicitly states the grounds for the exemption and requires them to acknowledge awareness of the disease-specific risks associated with not vaccinating their child(ren). 8 National Association of County & City Health Officials (NACCHO): School systems and childcare facilities (where appropriate) should use an exemption application form that requires a parental signature acknowledging their understanding that their decision not to immunize places their child and other children at risk for diseases and ensuing complications. The form should also state that in the event of an exposure to a vaccine-preventable illness, their child would be removed from school and all school-related activities for the appropriate two incubation periods beyond the date of onset of the last case, which is standard public health practice. 9 Pediatric Infectious Diseases Society (PIDS): PIDS opposes any legislation or regulation that would allow children to be exempted from mandatory immunizations based simply on their parents, or, in the case of adolescents, their own, secular personal beliefs. PIDS further recognizes that many states have or are considering adopting legislation or regulation that would allow for personal belief exemptions and outlines specific provisions to minimize use of exemptions as the path of least resistance. One of the provisions reads as follows: Before a child is granted an exemption, the parents or guardians must sign a statement that delineates the basis, strength, and duration of their belief; their understanding of the risks that refusal to immunize has on their child s health and the health of others (including the potential for serious illness or death); and their acknowledgement that they are making the decision not to vaccinate on behalf of their child. 10 References 1. Diekema DS, and the Committee on Bioethics. Responding to parental refusals of immunization of children. Pediatrics. 2005;115: org/cgi/content/full/pediatrics;115/5/ Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med Aug-Sep;45[2-3]: pubmed/ Freed GL, Clark SJ, Butchart AT, Singer DC, Davis MM. Sources and perceived credibility of vaccine-safety information for parents. Pediatrics May;127 Suppl 1:S www. ncbi.nlm.nih.gov/pubmed/ Kennedy A, Basket M, Sheedy K. Vaccine attitudes, concerns, and information sources reported by parents of young children: results from the 2009 HealthStyles survey. Pediatrics. 2011; 127 Suppl 1:S Gust DA, Darling N, Kennedy A, Schwartz B. Parents with doubts about vaccines: which vaccines and reasons why. Pediatrics. 2008;122: pubmed/ Benin AL, Wisler-Scher DJ, Colson E, Shapiro ED, Holmboe ES. Qualitative analysis of mothers decision-making about vaccines for infants: the importance of trust. Pediatrics. 2006;117[5]: AAP. Communicating with Families, accessed on Oct. 17, 2011 on AAP website at www. aap.org/immunization/pediatricians/pdf/improvevaccineliabilityprotection.pdf. 8. ASTHO. Permissive State Exemption Laws Contribute to Increased Spread of Disease. 21 May Accessed on Oct. 17, 2011 on ASTHO website at Programs/Immunization/ASTHO%20Vaccine%20Refusal%20Brief.pdf 9. NACCHO. Eliminating Personal Belief Exemptions from Immunization Requirements for Child Care and School Attendance. July Accessed on Oct. 17, 2011 on NACCHO website at PIDS. A Statement Regarding Personal Belief Exemption from Immunization Mandates. March Accessed on Oct. 17, 2011 on PIDS website at pdf/pids-pbe-statement.pdf Item #P4059 (11/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

6 Don t Be Guilty of These Errors in Vaccine Storage and Handling The following are frequently reported errors in vaccine storage and handling. Some of these errors are much more serious than others, but none of them should occur. Be sure your clinic or practice is not making errors such as these. Error #1: Designating only one person, rather than at least two, to be responsible for storage and handling of vaccines Since vaccines are both expensive and fragile, everyone in the office should know the basics of vaccine handling, including what to do when a shipment arrives and what to do in the event of an equipment failure or power outage. It s very important to train at least one back-up person in all aspects of proper storage and handling of vaccines. The back-up and primary persons should be equally familiar with all aspects of vaccine storage and handling, including knowing how to handle vaccines when they arrive, how to properly record refrigerator and freezer temperatures, and should be prepared to lead the response to an equipment problem or power outage. Error #2: Refrigerating vaccine in a manner that could jeopardize its quality The temperature in the vegetable bins, on the floor, next to the walls, in the door, and near the cold air outlet from the freezer may differ significantly from the temperature in the body of the refrigerator: do not store your vaccines or place thermometers in these locations. Always store vaccines in their original packaging in the body of the refrigerator away from these locations, and place your thermometer with the vaccines. Place vaccine packages in such a way that air can circulate around the compartment. Never overpack a refrigerator compartment. Error #3: Storing food and drinks in the vaccine refrigerator Frequent opening of the refrigerator door to retrieve food items can adversely affect the internal temperature of the unit and damage vaccines. Error #4: Inadvertently leaving the refrigerator or freezer door open or having inadequate seals Remind staff to close the unit doors tightly each time they open them. Also, check the seals on the doors on a regular schedule, and if there is any indication the door seal may be cracked or not sealing properly, have it replaced. Replacing a seal is much less costly than replacing a box of pneumococcal conjugate or varicella vaccine. Error #5: Storing vaccine in a dorm-style refrigerator All vaccines should be stored in a refrigerator and/or freezer unit that is designed specifically for the storage of biologics or, alternatively, in a separate free-standing unit. A dorm-style combination refrigerator-freezer unit with just one exterior door has been shown to be unacceptable no matter where the vaccine was placed inside the unit. Small stand-alone refrigerator or freezer units are best for short-term storage needs. Error #6: Recording temperatures only once per day Temperatures fluctuate throughout the day. Temperatures in the refrigertor and freezer should be checked at the beginning and end of the day to determine if the unit is getting too cold or too warm. Ideally, you should have continuous thermometers that record temperatures all day and all night; those with alarms can alert you when temperatures go out of range. A less expensive alternative is to purchase maximum/minimum thermometers. Only thermometers with a Current Certificate of Traceability and Calibration* should be used for vaccine storage. It s also a good idea to record the room temperature on your temperature log in case there is a problem with the storage unit. This information may *A calibrated thermometer with a Certificate of Traceability and Calibration with calibration measurements traceable to a testing laboratory accredited by the International Organization of Standardization, to the Standards of the National Institute of Standards and Technology, or to another internationally recognized standards agency. be helpful to the vaccine manufacturer and/or state immunization program in determining whether your vaccine is still usable. Error #7: Recording temperatures for only the refrigerator or freezer, rather than both It is essential to monitor and record temperatures in all refrigerators and freezers used to store vaccine. At all times you should have calibrated thermometers in the refrigerators as well as the freezers. Assure that your storage temperature monitoring is accurate by purchasing thermometers that have a Certificate of Traceability and Calibration* and recalibrate them according to the manufacturer s instructions. Your state immunization program may be able to provide more information on calibrated thermometers. Error #8: Documenting out-of-range temperatures on vaccine temperature logs but not taking action Documenting temperatures is not enough. Acting on the information is essential! So, what should you do? Notify your supervisor whenever you have an out-of-range temperature. Sometimes the solution is as simple as shutting a door left ajar or re-checking a freezer temperature that is slightly elevated as it goes through a normal, brief defrost cycle. Check the condition of the unit for problems. Are the seals on the door tight? Is there excessive lint or dust on the coils? After you have made any adjustment, document the date, time, temperature, the nature of the problem, the action you took, and the results of your action. Recheck the temperature every two hours. Call maintenance or a repair person if the temperature is still out of range. If the solution is not quick and easy, you will need to safeguard your vaccines by moving them to another storage unit that is functioning at the proper temperature. Label the affected vaccines Do not use and contact your state immunization program or vaccine manufacturer to find out if the affected vaccine is still usable. Be sure to notify your state s VFC Program Coordinator if VFC vaccine was involved. Error #9: Discarding temperature logs at the end of every month It s important that you keep your temperature logs for at least three years. As your refrigerator or freezer ages, you can track recurring problems. If out-ofrange temperatures have been documented, you can determine how long and how often this has been happening and take appropriate action. It s also a great way to demonstrate why you need a new refrigerator or freezer. Error #10: Discarding multi-dose vials 30 days after they are opened Don t discard your multi-dose vials of vaccines prematurely. Almost all multidose vaccine vials contain a preservative and can be used until the expiration date on the vial unless there is actual contamination or the vials are not stored under appropriate temperatures. However, you must discard multi-dose vials of reconstituted vaccine (e.g., meningococcal polysaccharide, yellow fever) if they are not used within a defined period after reconstitution. Refer to the vaccine package inserts for detailed information. Error #11: Not having emergency plans for a power outage or natural disaster Every clinic should have a written Emergency Response Plan that identifies a refrigerator and freezer in another location (ideally, a storage unit with a back-up generator) in which to store vaccine in the event of a power outage or natural disaster. Consider arranging in advance for a local hospital or similar facility to be your back-up location if you should need it. Be sure back-up location staff understand vaccine storage and will allow you to supervise placement and verify storage temperatures so vaccine is not damaged. Technical content reviewed by the Centers for Disease Control and Prevention, April Item #P3036 (4/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

7 Emergency Response Worksheet What to do in case of a power failure or another event that results in vaccine storage outside of the recommended temperature range Follow these procedures: 1. Close the door tightly and/or plug in the refrigerator/freezer. 2. Ensure the vaccine is kept at appropriate temperatures. Make sure the refrigerator/freezer is working properly or move the vaccines to a unit that is. Do not discard the affected vaccines. Mark the vaccines so that the potentially compromised vaccines can be easily identified. 3. Notify the local or state health department or call the manufacturer (see manufacturers phone numbers below). 4. Record action taken. Record this information*: 1. Temperature of refrigerator: current max. min. 2. Temperature of freezer: current max. min. 3. Air temperature of room where refrigerator is located: 4. Estimated amount of time the unit s temperature was outside normal range: refrigerator freezer 5. Vaccines in the refrigerator/freezer during the event (use the table below) * Using a recording thermometer is the most effective method of tracking the refrigerator and freezer temperatures over time. Visually checking thermometers twice a day is an effective method to identify inconsistent or fluctuating temperatures in a refrigerator and freezer. Vaccines Stored in Refrigerator Vaccine, manufacturer, and lot # Expiration date # of doses # of affected vials Action taken Vaccines Stored in Freezer Vaccine, manufacturer, and lot # Expiration date # of doses # of affected vials Action taken Other Conditions 1. Prior to this event, was the vaccine exposed to temperatures outside the recommended range? Y N 2. Were water bottles in the refrigerator and ice packs in the freezer at the time of this event? Y N 3. Other: Manufacturers Crucell Vaccines Inc. (800) CSL Biotherapies, Inc. (888) GlaxoSmithKline (888) MedImmune, Inc. (877) Merck & Co., Inc. (800) Novartis Vaccines (800) Pfizer Inc. (800) sanofi pasteur (800) Other Resources Local health department phone number State health department phone number Adapted by the Immunization Action Coalition, courtesy of the Michigan Department of Community Health Technical content reviewed by the Centers for Disease Control and Prevention, October Item #P3051 (10/10) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

8 Guide to Contraindications and Precautions 1 to Commonly Used Vaccines in Adults* Vaccine Contraindications Precautions 1 Tetanus, diphtheria, pertussis (Tdap) Tetanus, diphtheria (Td) Human papillomavirus (HPV) Measles, mumps, rubella (MMR) 2 Varicella (Var) 2 Influenza, injectable trivalent (TIV) Influenza, live attenuated (LAIV) 2 Pneumococcal polysaccharide (PPSV) Hepatitis A (HepA) Hepatitis B (HepB) Meningococcal, conjugate (MCV4) Meningococcal, polysaccharide (MPSV4) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component For Tdap only: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP, DTaP, or Tdap Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Pregnancy Known severe immunodeficiency (e.g., from hematologic and solid tumors; receiving chemotherapy; congenital immunodeficiency; longterm immunosuppressive therapy 3 ; or patients with HIV infection who are severely immunocompromised) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receiving chemotherapy, congenital immunodeficiency or longterm immunosuppressive therapy 3 or patients with HIV infection who are severely immunocompromised) Pregnancy Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component, including egg protein Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component, including egg protein Pregnancy Immunosuppression Certain chronic medical conditions 6 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of tetanus toxoid-containing vaccine History of arthus-type hypersensitivity reactions following a previous dose of tetanus toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus toxoid-containing vaccine For Tdap only: Progressive or unstable neurologic disorder, uncontrolled seizures, or progressive encephalopathy; defer vaccination with Tdap until a treatment regimen has been established and the condition has stabilized Pregnancy Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product 4 ) History of thrombocytopenia or thrombocytopenic purpura Need for tuberculin skin testing 5 Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product 4 ) Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination, if possible; delay resumption of these antiviral drugs for 14 days after vaccination History of GBS within 6 wks of previous influenza vaccine History of GBS within 6 wks of previous influenza vaccine Receipt of specific antivirals (i.e., amantadine, rimantadine, zanamivir, or oseltamivir) 48 hours before vaccination; avoid use of these antiviral drugs for 14 days after vaccination Pregnancy Zoster (Zos) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Substantial suppression of cellular immunity Pregnancy Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination, if possible; delay resumption of these antiviral drugs for 14 days after vaccination Footnotes 1. Events or conditions listed as precautions should be reviewed carefully. Benefits of and risks for administering a specific vaccine to a person under these circumstances should be considered. If the risk from the vaccine is believed to outweigh the benefit, the vaccine should not be administered. If the benefit of vaccination is believed to outweigh the risk, the vaccine should be administered. 2. LAIV, MMR, and varicella vaccines can be administered on the same day. If not administered on the same day, these vaccines should be separated by at least 28 days. 3. Substantially immunosuppressive steroid dose is considered to be 2 weeks or more of daily receipt of 20 mg (or 2 mg/kg body weight) of prednisone or equivalent. 4. Vaccine should be deferred for the appropriate interval if replacement immune globulin products are being administered (see Table 5 in CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices [ACIP] at 5. Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine can be administered on the same day as tuberculin skin testing. If testing cannot be performed until after the day of MMR vaccination, the test should be postponed for at least 4 weeks after the vaccination. If an urgent need exists to skin test, do so with the understanding that reactivity might be reduced by the vaccine. 6. For details, see CDC. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010 at *Adapted from Table 6. Contraindications and Precautions to Commonly Used Vaccines, found in: CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2011; 60(No. RR-2), p Technical content reviewed by the Centers for Disease Control and Prevention, February Item #P3072 (2/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

9 Guide to Contraindications and Precautions 1 to Commonly Used Vaccines* (Page 1 of 2) Vaccine Contraindications Precautions 1 Hepatitis B (HepB) Rotavirus (RV5 [RotaTeq], RV1 [Rotarix]) Diphtheria, tetanus, pertussis (DTaP) Tetanus, diphtheria, pertussis (Tdap) Tetanus, diphtheria (DT, Td) Haemophilus influenzae type b (Hib) Inactivated poliovirus vaccine (IPV) Pneumococcal (PCV or PPSV) Measles, mumps, rubella (MMR) 4 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe combined immunodeficiency (SCID) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) not attributable to another identifiable cause within 7 days of administration of previous dose of DTP or DTaP (for DTaP); or of previous dose of DTP, DTaP, or Tdap (for Tdap) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Age younger than 6 weeks Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component For PCV13, severe allergic reaction (e.g., anaphylaxis) after a previous dose (of PCV7, PCV13, or any diphtheria toxoid-containing vaccine) or to a vaccine component (of PCV7, PCV13, or any diphtheria toxoid-containing vaccine) For PPSV, severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Pregnancy Known severe immunodeficiency (e.g., from hematologic and solid tumors; receiving chemotherapy; congenital immunodeficiency; or long-term immunosuppressive therapy 5 ; or patients with HIV infection who are severely immunocompromised) 6 Infant weighing less than 2000 grams (4 lbs, 6.4 oz) 2 Altered immunocompetence other than SCID History of intussusception Chronic gastrointestinal disease 3 Spina bifida or bladder exstrophy 3 Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of tetanus toxoid-containing vaccine History of arthus-type hypersensitivity reactions after a previous dose of tetanus toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid containing vaccine Progressive or unstable neurologic disorder (including infantile spasms for DTaP), uncontrolled seizures, or progressive encephalopathy: defer vaccination with DTaP or Tdap until a treatment regimen has been established and the condition has stabilized For DTaP only: Temperature of 105 F or higher (40.5 C or higher) within 48 hours after vaccination with a previous dose of DTP/DTaP Collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours after receiving a previous dose of DTP/DTaP Seizure within 3 days after receiving a previous dose of DTP/DTaP Persistent, inconsolable crying lasting 3 or more hours within 48 hours after receiving a previous dose of DTP/DTaP GBS within 6 weeks after a previous dose of tetanus toxoidcontaining vaccine History of arthus-type hypersensitivity reactions after a previous dose of tetanus toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid containing vaccine Pregnancy Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product) 7 History of thrombocytopenia or thrombocytopenic purpura Need for tuberculin skin testing 8 Technical content reviewed by the Centers for Disease Control and Prevention, February Item #P3072a (2/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

10 Guide to Contraindications and Precautions 1 to Commonly Used Vaccines* (continued) (Page 2 of 2) Vaccine Contraindications Precautions 1 Varicella (Var) 4 Hepatitis A (HepA) Influenza, injectable trivalent (TIV) Influenza, live attenuated (LAIV) 4 Human papillomavirus (HPV) Meningococcal, conjugate (MCV4) Meningococcal, polysaccharide (MPSV4) Zoster (Zos) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receiving chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy 5 or patients with HIV infection who are severely immunocompromised) 6 Pregnancy Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component, including egg protein Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component, including egg protein Possible reactive airways disease in a child age 2 through 4 years (e.g., history of recurrent wheezing or a recent wheezing episode) Pregnancy Immunosuppression Certain chronic medical conditions 9 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Substantial suppression of cellular immunity Pregnancy Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product) 7 Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination, if possible; delay resumption of these antiviral drugs for 14 days after vaccination. Pregnancy History of GBS within 6 weeks of previous influenza vaccine History of GBS within 6 weeks of previous influenza vaccine Receipt of specific antivirals (i.e., amantadine, rimantadine, zanamivir, or oseltamivir) 48 hours before vaccination. Avoid use of these antiviral drugs for 14 days after vaccination. Pregnancy Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination, if possible; delay resumption of these antiviral drugs for 14 days after vaccination. Footnotes 1. Events or conditions listed as precautions should be reviewed carefully. Benefits of and risks for administering a specific vaccine to a person under these circumstances should be considered. If the risk from the vaccine is believed to outweigh the benefit, the vaccine should not be administered. If the benefit of vaccination is believed to outweigh the risk, the vaccine should be administered. Whether and when to administer DTaP to children with proven or suspected underlying neurologic disorders should be decided on a case-by-case basis. 2. Hepatitis B vaccination should be deferred for preterm infants and infants weighing less than 2000 g if the mother is documented to be hepatitis B surface antigen (HBsAg)-negative at the time of the infant s birth. Vaccination can commence at chronological age 1 month or at hospital discharge. For infants born to women who are HBsAg-positive, hepatitis B immunoglobulin and hepatitis B vaccine should be administered within 12 hours of birth, regardless of weight. 3. For details, see CDC. Prevention of Rotavirus Gastroenteritis among Infants and Children: Recommendations of the Advisory Committee on Immunization Practices. (ACIP) MMWR 2009;58(No. RR 2) at 4. LAIV, MMR, and varicella vaccines can be administered on the same day. If not administered on the same day, these vaccines should be separated by at least 28 days. 5. Substantially immunosuppressive steroid dose is considered to be 2 weeks or more of daily receipt of 20 mg (or 2 mg/kg body weight) of prednisone or equivalent. 6. HIV-infected children may receive varicella and measles vaccine if CD4+ T-lymphocyte count is >15%. (Source: Adapted from American Academy of Pediatrics. Passive Immunization. In: Pickering LK, ed. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics: 2009.) 7. Vaccine should be deferred for the appropriate interval if replacement immune globulin products are being administered (see Table 5 in CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) at 8. Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine can be administered on the same day as tuberculin skin testing. If testing cannot be performed until after the day of MMR vaccination, the test should be postponed for at least 4 weeks after the vaccination. If an urgent need exists to skin test, do so with the understanding that reactivity might be reduced by the vaccine. 9. For details, see CDC. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010 at *Adapted from Table 6. Contraindications and Precautions to Commonly Used Vaccines found in: CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60(No. RR-2), p

11 How to Administer Intramuscular (IM) Vaccine Injections Administer these vaccines by the intramuscular (IM) route: Diphtheria-tetanus (DT, Td) with pertussis (DTaP, Tdap); Haemophilus influenzae type b (Hib); hepatitis A (HepA); hepatitis B (HepB); human papillomavirus (HPV); inactivated influenza (TIV); quadrivalent meningococcal conjugate (MCV4); and pneumococcal conjugate (PCV). Administer inactivated polio (IPV) and pneumococcal polysaccharide (PPSV23) either IM or SC. Patient age Injection site Needle size Needle insertion Newborn (0 28 days) Infant (1 12 months) Anterolateral thigh muscle Anterolateral thigh muscle ⅝"* (22 25 gauge) 1" (22 25 gauge) Use a needle long enough to reach deep into the muscle. Toddler (1 2 years) Children (3 18 years) Adults 19 years and older Anterolateral thigh muscle Alternate site: Deltoid muscle of arm if muscle mass is adequate Deltoid muscle (upper arm) Alternate site: Anterolateral thigh muscle Deltoid muscle (upper arm) Alternate site: Anterolateral thigh muscle 1 1¼" (22 25 gauge) ⅝ 1"* (22 25 gauge) ⅝ 1"* (22 25 gauge) 1 1¼" (22 25 gauge) 1 1½"* (22 25 gauge) 1 1½" (22 25 gauge) Insert needle at a 90 angle to the skin with a quick thrust. (Before administering an injection of vaccine, it is not necessary to aspirate, i.e., to pull back on the syringe plunger after needle insertion. ) Multiple injections given in the same extremity should be separated by a minimum of 1", if possible. 90 angle skin subcutaneous tissue muscle *A ⅝" needle may be used only if the skin is stretched tight, the subcutaneous tissue is not bunched, and injection is made at a 90 angle. A ⅝" needle is sufficient in adults weighing <130 lbs (<60 kg); a 1" needle is sufficient in adults weighing lbs (60 70 kg); a 1 1½" needle is recommended in women weighing lbs (70 90 kg) and men weighing lbs ( kg); a 1½" needle is recommended in women weighing >200 lbs (>90 kg) or men weighing >260 lbs (>118 kg). CDC. ACIP General Recommendations on Immunization at IM site for infants and toddlers IM site for children and adults level of axilla (armpit) acromion IM injection site (shaded area) IM injection site (shaded area) elbow Insert needle at a 90 angle into the anterolateral thigh muscle. Technical content reviewed by the Centers for Disease Control and Prevention, November Insert needle at a 90 angle into thickest portion of deltoid muscle above the level of the axilla and below the acromion. Item #P2020 (11/10) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) admin@immunize.org

12 Administer these vaccines by the subcutaneous (SC) route: measles, mumps, and rubella (MMR), varicella (VAR), meningococcal polysaccharide (MPSV4), and zoster (shingles [ZOS]). Administer inactivated polio (IPV) and pneumococcal polysaccharide (PPSV23) vaccines either SC or IM. Patient age How to Administer Subcutaneous (SC) Vaccine Injections Injection site Needle size Needle insertion Birth to 12 mos. 12 mos. and older Fatty tissue over the anterolateral thigh muscle Fatty tissue over anterolateral thigh or fatty tissue over triceps ⅝" needle, gauge ⅝" needle, gauge Pinch up on subcutaneous (SC) tissue to prevent injection into muscle. Insert needle at 45 angle to the skin. (Before administering an injection of vaccine, it is not necessary to aspirate, i.e., to pull back on the syringe plunger after needle insertion.*) Multiple injections given in the same extremity should be separated by a minimum of 1". *CDC. ACIP General Recommendations on Immunization at skin subcutaneous tissue muscle 45 angle SC site for infants SC site for children (after the 1st birthday) and adults acromion SC injection site (shaded area) SC injection site (shaded area) elbow Insert needle at a 45 angle into fatty tissue of the anterolateral thigh. Make sure you pinch up on SC tissue to prevent injection into the muscle. Insert needle at a 45 angle into the fatty tissue over the triceps muscle. Make sure you pinch up on the SC tissue to prevent injection into the muscle. Technical content reviewed by the Centers for Disease Control and Prevention, November Item #P2020 (11/10) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) admin@immunize.org

13 How to administer intramuscular, intradermal, and intranasal influenza vaccines Intramuscular injection Trivalent Inactivated Influenza Vaccines (TIV) Intradermal administration Trivalent Inactivated Influenza Vaccine (TIV) Intranasal administration Live Attenuated Influenza Vaccine (LAIV) 1. Use a needle long enough to reach deep into the muscle. Infants age 6 through 11 mos: 1"; 1 through 2 yrs: 1 13"; children and adults 3 yrs and older: 1 1½". 2. With your left hand*, bunch up the muscle. 3. With your right hand*, insert the needle at a 90 angle to the skin with a quick thrust. 4. Push down on the plunger and inject the entire contents of the syringe. There is no need to aspirate. 5. Remove the needle and simultaneously apply pressure to the injection site with a dry cotton ball or gauze. Hold in place for several seconds. 6. If there is any bleeding, cover the injection site with a bandage. 7. Put the used syringe in a sharps container. *Use the opposite hand if you are left-handed. 1. Gently shake the microinjection system before administering the vaccine. 2. Hold the system by placing the thumb and middle finger on the finger pads; the index finger should remain free. 3. Insert the needle perpendicular to the skin, in the region of the deltoid, in a short, quick movement. 4. Once the needle has been inserted, maintain light pressure on the surface of the skin and inject using the index finger to push on the plunger. Do not aspirate. 5. Remove the needle from the skin. With the needle directed away from you and others, push very firmly with the thumb on the plunger to activate the needle shield. You will hear a click when the shield extends to cover the needle. 6. Dispose of the applicator in a sharps container. 1. FluMist (LAIV) is for intranasal administration only. Do not inject FluMist. 2. Remove rubber tip protector. Do not remove dosedivider clip at the other end of the sprayer. 3. With the patient in an upright position (i.e., head not tilted back), place the tip just inside the nostril to ensure LAIV is delivered into the nose. The patient should breathe normally. 4. With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further. 5. Pinch and remove the dose-divider clip from the plunger. 6. Place the tip just inside the other nostril, and with a single motion, depress plunger as rapidly as possible to deliver the remaining vaccine. 7. Dispose of the applicator in a sharps container. dose-divider clip 90 angle skin subcutaneous tissue muscle Technical content reviewed by the Centers for Disease Control and Prevention, October Item #P2024 (10/11) Immunization Action Coalition 1573 Selby Avenue Saint Paul, MN (651) admin@immunize.org

14 Medical Management of Vaccine Reactions in Children and Teens All vaccines have the potential to cause an adverse reaction. To minimize adverse reactions, patients should be carefully screened for precautions and contraindications before vaccine is administered. Even with careful screening, reactions can occur. These reactions can vary from trivial and inconvenient (e.g., soreness, itching) to severe and life threatening (e.g., anaphylaxis). If reactions occur, staff should be prepared with procedures for their management. The table below describes procedures to follow if various reactions occur. Reaction Symptoms Management Localized Psychological fright and syncope (fainting) Anaphylaxis Soreness, redness, itching, or swelling at the injection site Slight bleeding Continuous bleeding Fright before injection is given Extreme paleness, sweating, coldness of the hands and feet, nausea, light-headedness, dizziness, weakness, or visual disturbances Fall, without loss of consciousness Loss of consciousness Sudden or gradual onset of generalized itching, erythema (redness), or urticaria (hives); angioedema (swelling of the lips, face, or throat); severe bronchospasm (wheezing); shortness of breath; shock; abdominal cramping; or cardiovascular collapse Apply a cold compress to the injection site. Consider giving an analgesic (pain reliever) or antipruritic (antiitch) medication. Apply an adhesive compress over the injection site. Place thick layer of gauze pads over site and maintain direct and firm pressure; raise the bleeding injection site (e.g., arm) above the level of the patient s heart. Have patient sit or lie down for the vaccination. Have patient lie flat or sit with head between knees for several minutes. Loosen any tight clothing and maintain an open airway. Apply cool, damp cloths to patient s face and neck. Examine the patient to determine if injury is present before attempting to move the patient. Place patient flat on back with feet elevated. Check the patient to determine if injury is present before attempting to move the patient. Place patient flat on back with feet elevated. Call 911 if patient does not recover immediately. See Emergency Medical Protocol for Management of Anaphylactic Reactions in Children and Teens on the next page for detailed steps to follow in treating anaphylaxis. (page 1 of 3) Technical content reviewed by the Centers for Disease Control and Prevention, July Item #P3082a (7/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

15 Medical Management of Vaccine Reactions in Children and Teens (continued) (page 2 of 3) Supplies you may need at a community immunization clinic First-line treatment: Aqueous epinephrine 1:1000 dilution, in ampules, vials of solution, or prefilled syringes, including epinephrine autoinjectors (e.g., EpiPen). If EpiPens are to be stocked, both EpiPen Jr. (0.15 mg) and adult EpiPens (0.30 mg) should be available. Secondary treatment option: Diphenhydramine (Benadryl) injectable (50 mg/ml solution) or oral (12.5 mg/5 ml liquid, 25 or 50 mg capsules/tablets) Syringes: 1 and 3 cc, 22 25g, 1", 1½", and 2" needles for epinephrine and diphenhydramine (Benadryl) Alcohol wipes Tourniquet Pediatric & adult airways (small, medium, and large) Pediatric & adult size pocket masks with one-way valve Oxygen (if available) Stethoscope Sphygmomanometer (blood pressure measuring device) child, adult and extra-large cuffs) Tongue depressors Flashlight with extra batteries (for examination of mouth and throat) Wrist watch with ability to count seconds Cell phone or access to an onsite phone Emergency medical protocol for management of anaphylactic reactions in children and teens 1. If itching and swelling are confined to the injection site where the vaccination was given, observe patient closely for the development of generalized symptoms. 2. If symptoms are generalized, activate the emergency medical system (EMS; e.g., call 911) and notify the on-call physician. This should be done by a second person, while the primary nurse assesses the airway, breathing, circulation, and level of consciousness of the patient. 3. Drug Dosing Information: a. First-line treatment: Administer aqueous epinephrine 1:1000 dilution (i.e., 1 mg/ml) intramuscularly; the standard dose is 0.01 mg/kg body weight, up to 0.3 mg maximum single dose in children and 0.5 mg maximum in adolescents (see chart on next page). b. Secondary treatment option: For hives or itching, you may also administer diphenhydramine either orally or by intramuscular injection; the standard dose is 1 2 mg/kg body weight, up to 30 mg maximum dose in children and 50 mg maximum dose in adolescents (see chart on next page). 4. Monitor the patient closely until EMS arrives. Perform cardiopulmonary resuscitation (CPR), if necessary, and maintain airway. Keep patient in supine position (flat on back) unless he or she is having breathing difficulty. If breathing is difficult, patient s head may be elevated, provided blood pressure is adequate to prevent loss of consciousness. If blood pressure is low, elevate legs. Monitor blood pressure and pulse every 5 minutes. 5. If EMS has not arrived and symptoms are still present, repeat dose of epinephrine every 5 15 minutes for up to 3 doses, depending on patient s response. 6 Record all vital signs, medications administered to the patient, including the time, dosage, response, and the name of the medical personnel who administered the medication, and other relevant clinical information. 7. Notify the patient s primary care physician. (page 2 of 3) Item #P3082a (7/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

16 Medical Management of Vaccine Reactions in Children and Teens (continued) (page 3 of 3) For your convenience, approximate dosages based on weight and age are provided in the charts below. Please confirm that you are administering the correct dose for your patient. First-Line Treatment: Epinephrine (the recommended dose for epinephrine is 0.01 mg/kg body weight) Infants and Children Teens Epinephrine Dose Note: If body weight is known, then dosing by weight is preferred. If weight is not known or not readily available, dosing by age is appropriate. *Rounded weight at the 50th percentile for each age range Maximum dose for children Maximum dose for teens Age Group Range of weight (lb) Range of weight (kg)* 1 mg/ml injectable (1:1000 dilution) intramuscular Minimum dose: 0.05 ml 1 6 months 9 19 lb kg 0.05 ml (or mg) off label 7 36 months lb kg 0.1 ml (or mg) off label months lb kg 0.15 ml (or mg) 0.15 mg 5 7 years lb kg ml (or mg) 0.15 mg 8 10 years lb kg ml (or mg) 0.15 mg or 0.3 mg years lb kg ml (or mg) 0.3 mg 13 years & older 100+ lb 46+ kg 0.5 ml (or mg) 0.3 mg EpiPen (Dey, L.P.) Epinephrine auto-injector 0.15 mg or 0.3 mg Secondary Treatment Option: Diphenyhydramine (the recommended dose for diphenhydramine [Benadryl] is 1 2 mg/kg body weight) Age Group Range of weight (lb) Range of weight (kg)* Diphenhydramine Dose 12.5 mg/5 ml liquid 25 mg or 50 mg tablets 50 mg/ml injectable (IV or IM) Infants and Children 7 36 months lb kg 10 mg 20 mg months lb kg 15 mg 30 mg 5 7 years lb kg 20 mg 30 mg Teens 8 12 years lb kg 30 mg 13 years & older 100+ lb 46+ kg 50 mg Note: If body weight is known, then dosing by weight is preferred. If weight is not known or not readily available, dosing by age is appropriate. *Rounded weight at the 50th percentile for each age range Maximum dose for children Maximum dose for teens Sources Boyce JA, Assa ad A, Burks AW, et al. Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-Sponsored Expert Panel. Allergy Clin Immunol 2010; 126(6):S1 S57. Simons FE, Camargo CA. Anaphylaxis: Rapid recognition and treatment. In: UpToDate, Bochnew BS (Ed). UpToDate: Waltham, MA, These standing orders for the medical management of vaccine reactions in child and teenage patients shall remain in effect for patients of the until rescinded or until. name of clinic date Medical Director s signature Effective date Item #P3082a (7/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

17 Quick Chart of Vaccine-Preventable Disease Terms in Multiple Languages (Page 1 of 2) Eastern European Languages English Bosnian Croatian Polish Romanian Russian Serbian Slovak Ukrainian DTP Detepe Detepe Di-Te-Per АКДС Detepe DiTePe Diphtheria difterija difterije przeciwko błonicy difteriei дифтерия дифтерије záškrt дифтерії Haemophilus influenzae type b Hepatitis A Hepatitis B Human papillomavirus Hemofili na influenca tipa B utica A, Hepatitis A utica B, Hepatitis B Ljudski papiloma virus Haemophilus influenzae tipa b utica A, hepatitisa A utica B, hepatitisa B papilomavirusi čovjeka Haemophilus influenzae typu b wirusowemu zapaleniu wątroby typu A wirusowemu zapaleniu wątroby typu B wirus brodawczaka ludzkiego Haemophilus influenzae tip b boala гемофільной инфекции типа B Хаемопхилус инфлуензае тип Б болести Haemophilus influenzae typ b ochorenia гемофільної інфекції типу B захворювань hepatita A гепатит А хепатитиса A hepatitída A гепатиту S hepatita B гепатит B хепатитиса Б hepatitída B гепатиту В papilomavirus uman вирус папилломы человека људски папилома вирус ľudský papillomavírus Influenza gripa gripe grypa gripa грипп грип chrípka грипу MMR MMR ΜMR Measles rubeola ospice odra pojarul коpь Μале бοгиње morbilli, osýpky Meningococcal conjugate meningokoknog konjugirati meningokokom sprzężenia conjugate meningococice менингококковая сопряженных менингококне коњуговано meningokokove j konjugovanou Mumps zauške zaušnjaci swinka oreionul, oreion свинка, ларотит Эаушκе parotitis кір вірус папіломи людини менінгококова сполучених Pertussis veliki kašalj kašalj hripavac krztuścowi tusei convulsive коклюша великог кашља čierny kašeľ кашлюку Poliomyelitis dje ja paraliza dječje paralize polio poliomielita пoлиомиелит дечје парализе detská obrna поліомієліту Pneumococcal conjugate upala plu a pneumokoka konjugirano skoniugowanej szczepionki pneumokokowej pneumococic conjugat пневмококковоя конъюгированной Пнеумоцоццал коњунговане konjugovaná pneumokoková пневмококковой конъюгированной Rotavirus Rotavirus rotavirusa rotavirusy rotavirus ротавірусной рота-вируса Ροтавирус ротавірусної Rubella male boginje rubeola r ycka Shingles (Herpes zoster) šindra półpasiec rubeola, rubeolei, pojar German Herpes zoster (zona zoster) краснуха Ρубеοла rubeola опоясывающий лишай херпес зостер (појасни херпес) Smallpox veliki boginje veliki boginje ospa variola, variolei оспа veliki boginje kiahne pásového oparu (pásový opar) Tetanus tetanus tetanusa tężcowi tetanosului столбняк тетануса tetanus правця оперізуючий герпес (оперізуючий лишай) Tuberculosis tuberkuloza tuberkuloza gruzlica tuberculozei туберкулеѕ Tuberkuloza tuberkulóza Varicella (chickenpox) ospice varicella (vodene kozice) ospy wietrznej (ospa wietrzna) şi varicelă (varicelă) ветряная оспа (вітрянка) Варицелла (цхицкен богиње) ovčím kiahňam (ovčie kiahne) вітряної віспи (вітрянка) Immunization Action Coalition 1573 Selby Avenue St. Paul, MN (651) admin@immunize.org

18 Quick Chart of Vaccine-Preventable Disease Terms in Multiple Languages (Page 2 of 2) Western European Languages English Dutch French German Italian Norwegian Portuguese Spanish Swedish DTP DKTP DT Coq, DTC Tríplice trippel Diphtheria difterie diphtérie diphtherie difterite difteri difteria Difteria difteri Haemophilus influenzae type b Haemophilus influenzae b Haemophilus influenzae de type b Haemophilus influenzae type b Haemophilus influenzae b Haemophilus influenzae tipe b doenca Haemophilus influenzae tipo b Hemófilo tipo b, Haemophilus influenzae tipo b Haemophilus influenzae typ b Hepatitis A hepatitis A hepatite A hepatitis A epatite A hepatitt A hepatite A hepatitis A hepatit A Hepatitis B hepatitis B hepatite B hepatitis B epatite B hepatitt B hepatite B hepatitis B hepatit B Human papillomavirus humaan papillovirus papillovirus humaines humanen papillovirus il papillovirus umano humant papillomavirus virus do papiloma humano Virus del papiloma humano mänskliga papillovirus Influenza ( flu ) influenza (griep) grippe influenza (grippe) l nfluenzae influensa influenza (gripe) influenza (gripe) influensa MMR BMR ROR MMR MPR SPR SRP MPR Measles mazelen rougeole masern morbillo meslinger sarampo Meningococcal conjugate meningokokken conjugaat conjugué contre le méningocoque meningokokken konjugatimpfstoff coniugato meningococcico meningokokksykdom konjugert meningocóccica conjugada sarampión, sarampión comun meningococo conjugada mässling meningokockinfektion konjugatet Mumps bof oreillons ziegenpeter parotite kusma caçhumba paperas, parotiditis påssjuka Pertussis (Whooping cough) kinkhoest coqueluche keuchhusten pertosse (tosse asinina) Poliomyelitis poliomyelitis poliomyélite kinderlähmung poliomielite poliomyelitt Pneumococcal conjugate pneumokokken conjugaat antipneumococcique conjugué pneumokokken konjugat pneumococcico coniugato kikhoste coqueluche coqueluche (tos ferina) pneumokokk komjugatvaksine poliomielite, paralisia Infantil pneumocócica conjugada polio, poliomielitis antineumocócica conjugada kikhosta poliomyelitis konjugerat pneumokock Rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavírus rotavirus rotavirus Rubella rode hond - rubéole - rubéola röteln rosolia røde hunder rubéola (sarampo alamão) rubéola, sarampión aleman röda hund Shingles (Herpes zoster) gordelroos (herpes zoster) zona (l herpès zoster) gürtelrose (herpes zoster) fuoco di Sant Antonion (l herpes zoster) helvetesild (herpes zoster) zona (herpes zoster) zona de matojos (herpes) bältros (herpes zoste) Smallpox pokken variole pocken vaioloso kopper varíola viruela smittkopper Tetanus tetanus tétanos wundstarrkrampf tetano stivkrampe tétano, tetânica tétanos, tetánica, tétano stelkramp Tuberculosis tering tuberculose tuberkulose tubercolosi tuberkulose tuberculose tuberculínica tuberkulos Varicella (chickenpox) varicella (waterpokken) varicelle varizellen (windpocken) varicella vannkopper (vannkopper) varicella (catapora) varicela vattkopper Immunization Action Coalition 1573 Selby Avenue St. Paul, MN (651) admin@immunize.org

19 Sample Vaccine Policy Statement Ready for you to adapt for your practice Use the vaccine policy statement below as is, or modify it to reflect your practice s own strong statement of support for the vital role vaccination plays in safeguarding the health of children. Your practice s clearly expressed commitment to immunization can be powerfully persuasive with parents who are hesitant to have their child vaccinated because of scientifically invalid information they have encountered on the Internet or through the news media. The policy statement below was developed by clinicians at All Star Pediatrics in Lionville, Penn., where it is posted in every exam room and given to parents at the prenatal meet and greet and newborn visit. The results have been that parents new to All Star Pediatrics know exactly where their doctors stand on immunization, and the families of established patients feel supported in the choice they ve made to immunize their children. The following statement was originally published as a letter to the editor in AAP News, May 2008, by Bradley J. Dyer, MD, FAAP, and his colleagues at All Star Pediatrics. [Your practice name here] Vaccine Policy Statement We firmly believe in the effectiveness of vaccines to prevent serious illness and to save lives. We firmly believe in the safety of our vaccines. We firmly believe that all children and young adults should receive all of the recommended vaccines according to the schedule published by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. We firmly believe, based on all available literature, evidence, and current studies, that vaccines do not cause autism or other developmental disabilities. We firmly believe that thimerosal, a preservative that has been in vaccines for decades and remains in some vaccines, does not cause autism or other developmental disabilities. We firmly believe that vaccinating children and young adults may be the single most important health-promoting intervention we perform as health care providers, and that you can perform as parents/ caregivers. The recommended vaccines and their schedule given are the results of years and years of scientific study and data gathering on millions of children by thousands of our brightest scientists and physicians. These things being said, we recognize that there has always been and will likely always be controversy surrounding vaccination. Indeed, Benjamin Franklin, persuaded by his brother, was opposed to smallpox vaccine until scientific data convinced him otherwise. Tragically, he had delayed inoculating his favorite son Franky, who contracted smallpox and died at the age of 4, leaving Ben with a lifetime of guilt and remorse. Quoting Mr. Franklin s autobiography: In 1736, I lost one of my sons, a fine boy of four years old, by the smallpox... I long regretted bitterly, and still regret that I had not given it to him by inoculation. This I mention for the sake of parents who omit that operation, on the supposition that they should never forgive themselves if a child died under it, my example showing that the regret may be the same either way, and that, therefore, the safer should be chosen. The vaccine campaign is truly a victim of its own success. It is precisely because vaccines are so effective at preventing illness that we are even discussing whether or not they should be given. Because of vaccines, many of you have never seen a child with polio, tetanus, whooping cough, bacterial meningitis, or even chickenpox, or known a friend or family member whose child died of one of these diseases. Such success can make us complacent or even lazy about vaccinating. But such an attitude, if it becomes widespread, can only lead to tragic results. After publication of an unfounded accusation (later retracted) that MMR vaccine caused autism in 1998, many people in Europe chose not to vaccinate their children. As a result of underimmunization, there were large outbreaks of measles, with several deaths from complications of the disease. In 2010 there were more than 3000 cases of whooping cough in California, with nine deaths in children less than six months of age. Again, many of those who contracted the illness (and then passed it on to the infants, who were too young to have been fully vaccinated) had made a conscious decision not to vaccinate. Furthermore, by not vaccinating your child you are taking selfish advantage of thousands of others who do vaccinate their children, which decreases the likelihood that your child will contract one of these diseases. We feel such an attitude to be self-centered and unacceptable. We are making you aware of these facts not to scare you or coerce you, but to emphasize the importance of vaccinating your child. We recognize that the choice may be a very emotional one for some parents. We will do everything we can to convince you that vaccinating according to the schedule is the right thing to do. However, should you have doubts, please discuss these with your health care provider in advance of your visit. In some cases, we may alter the schedule to accommodate parental concerns or reservations. Please be advised, however, that delaying or breaking up the vaccines to give one or two at a time over two or more visits goes against expert recommendations, and can put your child at risk for serious illness (or even death) and goes against our medical advice as providers at [Your practice name here]. Such additional visits will require additional co-pays on your part. Furthermore, please realize that you will be required to sign a Refusal to Vaccinate acknowledgement in the event of lengthy delays. All patients in the practice are required to receive a minimum of DTaP, Hib, polio, and pneumococcal vaccines by three months of age, all AAP-recommended immunizations by two years of age, and meningococcal vaccine and booster doses of Tdap and varicella vaccines by age 12 years. Finally, if you should absolutely refuse to vaccinate your child despite all our efforts, we will ask you to find another health care provider who shares your views. We do not keep a list of such providers, nor would we recommend any such physician. Please recognize that by not vaccinating you are putting your child at unnecessary risk for life-threatening illness and disability, and even death. As medical professionals, we feel very strongly that vaccinating children on schedule with currently available vaccines is absolutely the right thing to do for all children and young adults. Thank you for your time in reading this policy, and please feel free to discuss any questions or concerns you may have about vaccines with any one of us. Item #P2067 (1/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

20 IMM-694B (9/01) Skills Checklist for Immunization The DVD Immunization Techniques: Best Practices with Infants, Children, and Adults ensures that staff administer vaccines correctly. Order online at The Skills Checklist is is a self-assessment tool tool for for health care care staff staff who who administer immuniza- immunizations. To complete To complete it, review it, review the the competency areas areas below below and and the the clinical clinical skills, skills, techniques tech- to vide several immunizations patients and to score several in the patients Supervisor and score Review in the columns. Supervisor If improvement Review columns. is needed, If score portunity themselves to score in advance. themselves Next in observe advance. their Next, performance observe their as they performance provide immunizations as they pro- and niques, procedures and procedures outlined outlined for each for of them. each of Score them. yourself Score yourself in the Self-Assessment in the Self-Assessment column. If meet improvement with them is to needed, develop meet a Plan with of Action them to (over) develop that will a Plan help of them Action achieve (p. 2) the that level will of competence them achieve you expect; the level circle of desired competence actions you or write expect; in circle others. desired In 30 actions days, observe or write their in others. perfor- help you column. check If Need you check to Improve Need you to Improve, indicate further you indicate study, further practice study, or change practice, is needed. or change When is you needed. check When Meets you or Exceeds check Meets you indicate or Exceeds, you believe you indicate you are you performing believe at you the are expected performing at the expected level of competence, or higher. them level mance again. When all competency areas meet expectations, file the Skills Checklist in their of competence, or higher. personnel The DVD folder. Immunization At the end of Techniques: the probationary Best Practices period and with annually Infants, thereafter, Children, observe and Adults again ensures and that complete staff administer the Skills Checklist. vaccines correctly. Order online at Supervisors: Use the Skills Checklist to to clarify responsibilities and and expectations for for staff staff who administer who administer vaccines. vaccines. When When you use you it for use performance it performance reviews, reviews, give staff give the opportunity staff the op-to Self-Assessment Competency Clinical Skills,Techniques, and Procedures Need to Improve Meets or Exceeds Need to Improve Supervisor Review Meets or Plan of Action* Exceeds A. Patient/Parent Education 1. Welcomes patient/family, establishes rapport, and answers any questions. 2. Explains what vaccines will be given and which type(s) of injection will be done. 3. Accommodates language or literacy barriers and special needs of patient/parents to help make them feel comfortable and informed about the procedure. 4. Verifies patient/parents received the Vaccine Information Statements for indicated vaccines and had time to read them and ask questions. 5. Screens for contraindications. (MA: score NA not applicable if this is MD function.) B. Medical Protocols 6. Reviews comfort measures and after care instructions with patient/parents, inviting questions. 1. Identifies the location of the medical protocols (i.e. immunization protocol, emergency protocol, reference material). 2. Identifies the location of the epinephrine, its administration technique, and clinical situations where its use would be indicated. 3. Maintains up-to-date CPR certification. C. Vaccine Handling 4. Understands the need to report any needlestick injury and to maintain a sharps injury log. 1. Checks vial expiration date. Double-checks vial label and contents prior to drawing up. 2. Maintains aseptic technique throughout. 3. Selects the correct needle size. for 1"-1IM 1 /2" and for SC. IM (DTaP, Td, Hib, HepA, HepB, Pneumo Conj., Flu); 5 /8" for SC (MMR, Var); IPV and Pneumo Poly depends on route to be used. 4. Shakes vaccine vial and/or reconstitutes and mixes using the diluent supplied. Inverts vial and draws up correct dose of vaccine. Rechecks vial label. 5. Labels each filled syringe or uses labeled tray to keep them identified. 6. Demonstrates knowledge of proper vaccine handling, e.g. protects MMR from light, logs refrigerator temperature. Adapted from California Department of Public Health Immunization Branch Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) Item #P7010 (8/11) page 1 of 2