PARTICIPANT HANDOUTS 2017 IMMUNIZATION UPDATE

Transcription

1 PARTICIPANT HANDOUTS 2017 IMMUNIZATION UPDATE Thank you for attending today s training. By doing so you are strengthening the ability of your community-based and patient-directed health center to deliver comprehensive, culturally competent, high-quality primary health care services. PRESENTER Donna Weaver, RN, MN, Nurse Educator, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC) LIVE BROADCAST DATE/TIME Tuesday, June 13, :30 AM 1:00 PM Mountain Time / 12:30 PM 2:00 PM Central Time TARGET AUDIENCE Clinical and clinical support staff at federally-funded health centers (FQHCs) in Region VIII including physicians, PAs, NPs, nurses, MAs, and other interested health care professionals. EVENT OVERVIEW The purpose of this presentation is to update healthcare personnel on the latest recommended immunization schedules and the most recent Advisory Committee on Immunization Practices (ACIP) immunization recommendations. LEARNING OBJECTIVES At the end of the session, participants will be able to: Describe at least one change made to the recommended childhood/adolescent immunization schedule for Explain the differences in the vaccination schedules for the two Meningococcal B vaccines. State which patients can receive the 2-dose HPV series. Explain the purpose of the third figure added to the child and adolescent immunization schedule. CONTENTS Page 2: Pages 3-48: Pages 49-56: Continuing Education Credit CHAMPS Archives Description of CHAMPS Speaker Biography Speaker Slides Additional Resources 1

2 CONTINUING EDUCATION CREDIT This Live activity, CHAMPS 2017 Immunization Update, with a beginning date of, has been reviewed and is acceptable for up to 1.50 Prescribed credit(s) by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. CHAMPS ARCHIVES This event will be archived online and on CD-ROM. The online version will be available within two weeks of the live event, and the CD will be available within two months. CHAMPS will all identified participants when these resources are ready for distribution. For more information, visit DESCRIPTION OF CHAMPS Community Health Association of Mountain/Plains States (CHAMPS) is a non-profit organization dedicated to supporting all Region VIII (CO, MT, ND, SD, UT, and WY) federally-designated Community, Migrant, and Homeless Health Centers so they can better serve their patients and communities. Currently, CHAMPS programs and services focus on education and training, collaboration and networking, workforce development, policy and funding communications, and the collection and dissemination of regional data. For more information about CHAMPS, and the benefits of CHAMPS Organizational Membership, please visit SPEAKER BIOGRAPHY Donna Weaver, RN, MN, is a Nurse Educator for the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention. She is responsible for the development and implementation of immunization education and training materials for vaccine providers in the United States, and frequently presents at conferences, meetings, and training sessions on vaccines and vaccine-preventable diseases. Donna is also the co-chair of the Nursing Continuing Education Committee at the CDC. Prior to coming to the CDC in April 2000, Donna was the Immunization Nurse Consultant at the South Carolina Department of Health and Environmental Control in Columbia, SC. She also worked on the nursing faculty at Central Carolina Technical College in Sumter, SC. Donna received her MN degree at the University of South Carolina in Nursing Administration, as well as her BSN degree in nursing. 2

3 Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Immunization Update 2017 Donna L. Weaver, RN, MN Nurse Educator Immunization Services Division Tuesday, June 13, :30 AM - 1:00 PM (MT) 12:30 PM - 2:00 PM (CT) Hosted By: This Live activity, CHAMPS 2016 Immunization Update, with a beginning date of, has been reviewed and is acceptable for up to 1.50 Prescribed credit(s) by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Interactive Poll What month do you usually begin your annual back to school immunization drive? May June July August Other 3

4 Interactive Question How many total people are watching this event at your computer (yourself included)? Disclosures Donna Weaver is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation The speaker will discuss the off-label use of Tdap and MenB vaccines The speaker will not discuss a vaccine not currently licensed by the FDA 4

5 Disclosures The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices (ACIP): - Composed of 15 non-government experts in clinical medicine and public health - Provides guidance on use of vaccines and other biologic products to DHHS, CDC, and the U.S. Public Health Service Next ACIP June 21-22, 2017 Meeting Draft Agenda - Votes: Hepatitis A updates to recommendations Influenza recommendations for season - Information and discussions Herpes zoster and varicella Anthrax, Dengue, Yellow Fever Mumps, HPV, Meningococcal VAERS and Evidence Based Recommendations Overview Recent ACIP Updates General Best Practices Guidelines for Immunization HepB Tdap MenB MenACWY HPV Polio Cholera Vaccine Updates 2vHPV and 4vHPV Hiberix MenHibrix 2017 Immunization Schedules Influenza Resources Vaccine Administration and Vaccine Errors 5

6 Comparison of 20 th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases Disease 20th Century 2016 Annual Morbidity Reported Cases National Center for Immunization & Respiratory Diseases Historical Comparisons of Vaccine-Preventable Disease Morbidity in the U.S. Percent Decrease Smallpox 29, % Diphtheria 21, % Measles 530, > 99% Mumps 162,344 5,311 97% Pertussis 200,752 15,737 92% Polio (paralytic) 16, % Rubella 47,745 5 > 99% Congenital Rubella Syndrome % Tetanus % Haemophilus influenzae 20,000 22* > 99% JAMA. 2007;298(18): CDC. MMWR January 6, 2017/ 65(52);ND-924 ND-941. (MMWR 2016 week 52 provisional data) * Haemophilus influenzae type b (Hib) < 5 years of age. An additional 11 cases of Hib are estimated to have occurred among the 222 reports of Hi (< 5 years of age) with unknown serotype. 1/11/2017 Comparison of Pre-Vaccine Era Estimated Annual Morbidity with Current Estimate: Vaccine-Preventable Diseases Disease Pre-Vaccine Era Annual Estimate 2014 Estimate (unless otherwise specified) Percent Decrease Hepatitis A 117,333 3,500 * 97% Hepatitis B (acute) 66,232 19,800 * 70% Pneumococcus (invasive) all ages 63,067 28,000 # 56% < 5 years of age 16,069 1,700 ## 89% Rotavirus (hospitalizations, < 3 years of age) 62,500 11,250 ### 82% Varicella 4,085, ,149 #### 96% JAMA. 2007;298(18): CDC. MMWR. February 6, 2009 / 58(RR02);1-25 * CDC. Viral Hepatitis Surveillance - United States, 2013 # CDC, Active Bacterial Core Surveillance Provisional Report; S. pneumoniae 2014 ## CDC. Unpublished, Active Bacterial Core Surveillance ### New Vaccine Surveillance Network 2015 data (unpublished); U.S. rotavirus disease now has biennial pattern #### CDC. Varicella Program 2014 data (unpublished) 2/12/2016 National Center for Immunization & Respiratory Diseases Historical Comparisons of Vaccine-Preventable Disease Morbidity in the U.S. 6

7 Advisory Committee on Immunization Practices (ACIP) Updates and MMWR Publications Posted April 20, Timing and Spacing of Immunobiologics Contraindications and Precautions Preventing and Managing Adverse Reactions Vaccine Administration Storage and Handling of Immunobiologics Altered Immunocompetence Special Situations Vaccination Records Vaccination Programs Vaccine Information Sources 10 7

8 Hepatitis B Vaccination HepB Hepatitis B Monovalent Hepatitis B vaccine should be administered within 24h of birth for medically stable infants weighing 2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers The recommendations for vaccination of infants <2,000 grams remain unchanged Preterm infants weighing <2,000 g born to HBsAg-negative mothers should receive the first dose of vaccine 1 month after birth or at hospital discharge The recommendation for infants born to HBsAg-positive mothers or mothers whose hepatitis B status is unknown also remain unchanged 8

9 Tetanus, diphtheria, and pertussis Vaccination Tdap Td Tdap Update For persons aged 7 through 10 years who receive a dose of Tdap as part of the catchup series, an adolescent Tdap vaccine dose may be given at age 11 through 12 years* In line with guidance of children for which Tdap is inadvertently administered *ACIP off-label recommendation 9

10 Tdap in Pregnancy Infants of Tdap vaccinated mothers were born with significantly higher anti-pertussis antibodies compared to infants of unvaccinated mothers Within the weeks administration window Concentration of anti-pertussis antibodies in infant cord blood were higher when mothers were vaccinated earlier Longer exposure to vaccine allows for higher vaccine induced antibody levels produced by mother and transferred to infant The tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap) footnote for vaccination of pregnant adolescents/adults between gestational weeks has been updated to reflect a preference for vaccination earlier during this period* *ACIP off-label recommendation Interactive Poll An 11-year-old patient received a dose of Tdap at 7 years of age. He also received a dose of Td 6 months later to finish a primary series of tetanus and diphtheria toxoid. Tdap is FDA approved for a single dose. Can he receive the adolescent dose of Tdap now? A. Yes B. No 10

11 Meningococcal Vaccination MenACWY MenB Meningococcal ACWY Recommendations for HIV-infected Persons Accumulating evidence indicates that HIV infection increases the risk of invasive meningococcal disease At the June 2016 meeting ACIP voted to recommend routine MenACWY vaccination for all HIV-infected persons age 2 months and older Number of doses depends on age 2-4 doses for children younger than 2 years Persons 2 years and older should receive 2 doses separated by 8 weeks MMWR 2016:65(43);

12 Use of 2- and 3-Dose Schedules of MenB-FHbp (Trumenba) Meningococcal Serogroup B Vaccine Current ACIP Recommendations for Serogroup B Meningococcal (MenB) Vaccines Certain persons aged 10 years* who are at increased risk for meningococcal disease should receive MenB vaccine (Category A) 1 A MenB vaccine series may be administered to adolescents and young adults aged years to provide short-term protection against most strains of serogroup B meningococcal disease (Category B) 2 *ACIP off-label recommendation 1 MMWR (22); MMWR (41); Use of 2- and 3-Dose Schedules of MenB-FHbp (Trumenba) Meningococcal Serogroup B Vaccine For persons at increased risk for meningococcal disease and for use during serogroup B outbreaks, 3 doses of MenB-FHbp should be administered at 0, 1-2, 6 months. However, if the second dose of MenB-FHbp is administered at an interval of >6 months, a third dose doses not need to be administered Persistent complement component deficiencies Anatomic or functional asplenia, including sickle cell disease Those who are present during outbreaks caused by serogroup B Those who have prolonged increased risk for exposure (such as microbiologists who routinely work with Neisseria meningitidis) 12

13 Use of 2- and 3-Dose Schedules of MenB-FHbp (Trumenba) Meningococcal Serogroup B Vaccine When given to healthy adolescents who are not at increased risk for meningococcal disease, 2 doses of MenB-FHbp should be administered at 0 and 6 months. If the second dose of MenB-FHbp is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose Human Papillomavirus Vaccination HPV 13

14 HPV 2-dose Schedule For persons initiating vaccination before age 15, the recommended immunization schedule is 2 doses of HPV vaccine at 0, 6-12 months For persons initiating vaccination at age 15 years or older, the recommended immunization schedule is 3 doses of HPV vaccine at 0, 1 2, 6 months Immunocompromised persons*, including those with human immunodeficiency virus (HIV) infection, should receive a 3-dose series at 0, 1 2, and 6 months, regardless of age at vaccine initiation *See MMWR December 16, 2016;65(49): , available at 9vHPV ACIP Recommendations ACIP has not made any recommendation regarding revaccination with 9vHPV for persons who already completed a series of 2vHPV or 4vHPV 14

15 Interactive Poll A healthy female received her first dose of HPV vaccine at 14 years of age, but she does not return for further HPV vaccination until 16 years of age. How many doses of HPV vaccine are needed to complete her HPV series? A. One B. Two C. Three Polio Vaccination IPV 15

16 Polio MMWRs published 1/13/17 and 2/17/17 provide additional guidance regarding assessment of poliovirus vaccination status and vaccination of children who have received poliovirus vaccine outside the U.S. If both OPV and IPV were administered as part of a series, the total number of doses needed to complete the series is the same as that recommended for the U.S. IPV schedule. A minimum interval of 4 weeks should separate doses in the series, with the final dose administered on or after the fourth birthday and at least 6 months after the previous dose If only OPV was administered, and all doses were given before age 4 years, 1 dose of IPV should be given at 4 years or older and at least 6 months after the last OPV dose Only trivalent OPV (topv) counts toward the U.S. vaccination requirements (topv was used for routine poliovirus vaccination in all OPV-using countries until April 1, 2016) MMWR 2017:66(01);23-25 MMWR 2017:66(7); Cholera Vaccination CVD 103-HgR 16

17 Cholera Recommendation: One dose of CVD 103-HgR for year-old travelers from U. S. to area of active cholera transmission. No recommendation for booster doses. If indicated, chloroquine should be started >10 days after the CVD 103-HgR. No data are available on concomitant administration with other vaccines, including oral Typhoid vaccine (Ty21a). Taking the first Ty21a dose >8 hours after ingesting CVD 103-HgR may decrease potential interference with Ty21a. Package insert states CVD 103-HgR should not be given if oral or parenteral antibiotics received in preceding 14 days. ACIP states a duration of fewer than 14 days between stopping antibiotics and giving CVD 103-HgR might be acceptable if travel cannot be avoided before 14 days after stopping antibiotics. Most (83%) vaccine recipients have antibody by 10 days after vaccination. Cholera Contraindications and Precautions History of severe allergic reaction, such as anaphylaxis, to any vaccine component or any cholera vaccine.no data on safety and effectiveness for vaccination in children and teens <18 years or >65 years No data available on use in pregnant or breastfeeding women Pregnant women at increased risk for poor outcomes from cholera infection Pregnant women and their clinicians should consider the risks associated with traveling to areas of active cholera transmission CVD 103-HgR not absorbed systemically; thus, maternal exposure to vaccine not expected to result in exposure of fetus or breastfed infant to vaccine. However, vaccine strain might be shed in stool for 7 days after vaccination, and theoretically, vaccine strain could be transmitted to infant during vaginal delivery No data on use of CVD 103-HgR in immunocompromised CVD 103-HgR may be shed in stool for >7 days 17

18 Vaccine Updates HPV Vaccines 2vHPV and 4vHPV vaccines are no longer being distributed in the United States. All available doses of 2vHPV expired at the end of 2016 All available doses of 4vHPV will expire in May

19 Hiberix Hiberix was first licensed in the US in August 2009 for use as a booster dose Hiberix is now FDA approved for a 3-dose infant primary vaccination series Safety and immunogenicity of Hiberix in infants is similar to ActHIB and Pentacel MenHibrix The vaccine manufacturer notified providers that it has decided to discontinue MenHibrix manufacturing All doses of MenHibrix will expire by mid September

20 2017 Immunization Schedules 20

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23 Introduction of High-risk Figure Demonstrates most children with medical conditions can (and should) be vaccinated according to the routine immunization schedule Indicates when a medical condition is a precaution or contraindication Indicates when additional doses of vaccines may be necessary secondary to the child s/adolescent s medical condition 23

24 Seasonal Influenza Vaccination IIV

25 Recommended composition of influenza virus vaccines for use in the northern hemisphere influenza season It is recommended that trivalent vaccines for use in the northern hemisphere influenza season contain the following: A/Michigan/45/2015 (H1N1)pdm09-like virus [NEW] A/Hong Kong/4801/2014 (H3N2)-like virus B/Brisbane/60/2008-like virus It is recommended that quadrivalent vaccines containing two influenza B viruses contain the above three viruses and: B/Phuket/3073/ Vaccine Supply for Influenza Season million doses of influenza vaccine anticipated NOTE: The amount of inactivated (injectable) vaccine that should be administered intramuscularly is based on the age of the patient and the vaccine product you are using For children 6 35 months of age, the correct dose is: 0.25 ml for Fluzone Quadrivalent 0.5 ml for FluLaval Quadrivalent For persons 3 years of age and older, the correct dose is 0.5 ml for all inactivated influenza vaccine products 25

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27 49 Mumps and MMR Vaccine Mumps outbreaks can occur any time of year A major factor contributing to outbreaks is being in a crowded environment, such as attending the same class, playing on the same sports team, or living in a dormitory with a person who has mumps Two doses of MMR are 88% effective at protecting against mumps (range: 66 to 95%) One dose is 78% effective (range: 49% to 92%) 27

28 Mumps Epidemiology Mumps vaccine has reduced disease by 97% Most recent cases are in fully vaccinated college students Mumps vaccine strain is effective against circulating mumps virus strain 2-dose schedule may be sufficient for general population Third doses may be offered in outbreaks Benefit of third dose in general population needs to be assessed Discussion at ACIP meeting, February 23, 2017 Preventing Vaccine Administration Errors 28

29 Advisory Committee on Immunization Practices General Recommendations on Immunization Failure to adhere to recommendations for storage and handling of immunobiologics can reduce or destroy their potency, resulting in inadequate or no immune response in the recipient Routes of administration are recommended by the manufacturer for each immunobiologic. Deviation from the recommended route of administration might reduce vaccine efficacy or increase the risk for local adverse reactions Vaccination Error Reports 1 to VAERS 3,Number and Percentage 2 by Year, ,585 total vaccination error reports, primary U.S. VAERS, Percentage of vaccination error reports among all primary U.S. VAERS reports by year 3 311,185 total primary U.S. VAERS reports,

30 Number of VAERS Reports by Error Group, Vaccination Error Group 1 N % 1. Inappropriate schedule 5,947 27% 2. Storage and handling 4,983 23% 3. Wrong vaccine 3,372 15% General error 2,526 12% Incorrect dose 2,002 9% Administration error 1,951 9% Accidental exposure 373 2% Product quality 239 1% Contraindication 215 1% Equipment 205 1% Product labeling/packaging 30 <1% Total errors 2 21,843 1 Some groupings contain more than 1 Medical Dictionary for Regulator Activities (MedDRA) Code; error groups are not mutually exclusive 2 Total primary reports with errors = 20,585; an individual report may be associated with more than one vaccination error or error group depending on assigned MedDRA terms Top 3 Vaccination Error Reports 1. Inappropriate schedule 27% of VAERS error reports 1 Inappropriate schedule errors included Wrong age Wrong timing/spacing between doses in a series Wrong age errors were most common for children 0-18 years (57%) 53% of these errors were reported in children younger than 1 year of age Wrong timing errors were most common in: Quadrivalent human papillomavirus vaccine 3rd dose given too soon (12 week minimum interval) Rotavirus vaccine First dose given after 15 weeks 1 Last dose given after 32 weeks 1 1 Based on 5% random sample review of reports wrong age inappropriate schedule ( n=297) Hibbs et al. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, Vaccine. 2015;33:

31 Top 3 Vaccination Error Reports 2. Storage and handling 23% of VAERS error reports 1 Storage and handling errors reported included: Expired vaccine (55%) Live, attenuated influenza vaccine most common Vaccines exposed to inappropriate temperatures (44%) Vaccines kept outside of proper storage temperatures commonly reported (88%) 1 55% of these reports vaccine exposed to temperatures below recommended storage temperature 1 Based on 5% random sample review of reports Hibbs et al. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, Vaccine. 2015;33: Top 3 Vaccination Error Reports 3. Wrong vaccine administered 15% of VAERS administration error reports 1 Occurred among vaccines with similar names, acronyms, antigens Varicella Diphtheria, tetanus, and pertussis (DTaP) Trivalent inactivated influenza vaccine (IIV) Pneumococcal conjugate Hepatitis A Common Vaccine Mix-ups 1 with Herpes zoster with Tetanus, diphtheria, and pertussis (Tdap) with Another IIV with different age indications with Pneumococcal polysaccharide with Hepatitis B 1 Vaccine mix ups can be either combination (e.g. varicella vaccine instead of herpes zoster vaccine or herpes zoster vaccine instead of varicella vaccine) 31

32 Vaccine Administration Error Reports: Adverse Health Events and Errors Most common adverse health events (AHEs) included: Injection site erythema (13%) Injection site pain (11%) Pyrexia (11%) All serious reports 1 were clinically reviewed and reports included: Injection site reactions (25%) Musculoskeletal (e.g., shoulder pain) (13%) Neurological (e.g., headache) (12%) Error groups and reported AHEs Administration errors ( e.g., wrong site, wrong technique, incorrect route) had the highest percentage of AHEs for its group (1,176 of 1,951 error reports; 60%) 1 Based on the Code of Federal Regulations, a report is classified as serious if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability Preventing Medication Errors Institute of Medicine recommends implementing proven medication safety practices, including: - Reducing reliance on memory - Standardization - Protocols and checklists - Differentiating look-alike and sound-alike products - Monitoring error frequencies and correcting system problems associated with errors 32

33 Strategies to Prevent Vaccination Errors Knowledgeable Staff Before administering vaccines, all personnel who will administer vaccines should: - Receive competency-based training - Have knowledge and skills validated Integrate competency-based training into: - New staff orientation - Annual education requirements Skills Checklist for Immunization Immunization Action Coalition: Skills Checklist for Immunization Strategies to Prevent Vaccination Errors Knowledgeable Staff Ongoing education: - Whenever vaccine administration recommendations are updated - When new vaccines are added to inventory Don t forget to assess vaccine administration skills of temporary staff Skills Checklist for Immunization Immunization Action Coalition: Skills Checklist for Immunization 33

34 Infection Control Perform hand hygiene: Before preparing and administering vaccines Between patients Anytime hands become soiled Gloves are not required to be worn when administering vaccines unless the person administering the vaccine is likely to come into contact with potentially infectious body fluids or has open lesions on hands: If gloves are worn, they should be changed between patients Perform hand hygiene between patients even if wearing gloves MMWR 2011;60(2):17 Infection Control Maintain proper infection control practices while preparing and administering vaccines: Draw up and prepare vaccines in a clean medication preparation area Equipment disposal: Puncture-proof biohazard container Empty or expired vaccine vials are medical waste MMWR 2011;60(2):17 34

35 Safe Injection Practices To ensure vaccination is as safe and effective as possible, incorporate: - Professional standards for medication administration - Manufacturer s vaccine-specific guidelines - Evidence-based safe medication administration practices, including proper injection practices CDC Injection Safety website CDC Injection Safety Injection Safety Best Practices Prepare and administer vaccines using aseptic technique: - Use a new needle and syringe for every injection - Disinfect the medication vial by rubbing the diaphragm with a sterile alcohol wipe Use a single-dose vial for a SINGLE patient for a SINGLE procedure or injection: - Discard after entering the vial, even if there is leftover vaccine CDC Injection Safety website CDC Injection Safety website 35

36 Additional Safe Injection Practice Resources One and Only Coalition materials Checklist of Best Practices for Vaccination Clinics Held at Satellite, Temporary, or Off-site Locations One and Only Campaign NAIIS: Checklist of Best Practices for Vaccination Clinics Held at Satellite, Temporary, or Off-site Locations Vaccination-Clinic-Checklist_ FINAL.pdf Strategies to Prevent Vaccination Errors: Schedule and Timing Keep current reference materials available for staff, including: - Recommended childhood and adult schedules - Minimum age and interval table (Table 1) Educate staff administering vaccines about vaccines in the facility s inventory Educate staff to schedule immunization appointments AFTER the child s birthday Assess for indicated vaccines using your state s immunization information system ACIP General Recommendations on Immunization, Table 1 ACIP Immunization Schedules for Children and Adults Immunization Information Systems ACIP General Recommendations: Table 1 36

37 Strategies to Prevent Vaccination Errors: Wrong Vaccine Store some vaccines on separate shelves: - Pediatric and adult formulations of the same vaccine - Sound-alike and look-alike vaccines Label vaccines with type, age, and gender (if applicable): - Color coding labels can help CDC vaccine labels CDC vaccine label examples Strategies to Prevent Vaccination Errors: Wrong Vaccine Only administer vaccines you have prepared and triple-checked ACIP vaccine abbreviations Use standardized ACIP vaccine abbreviations Consider using standing orders ACIP vaccine abbreviations Immunization Action Coalition: standing orders templates IAC standing orders template 37

38 Strategies to Prevent Vaccination Errors: Storage and Handling Monitor the vaccine storage unit temperature: - Read temperature monitoring devices in storage units a minimum of 2 times each workday in the morning and at the end of the workday - Record temperature readings on temperature log, along with time of the reading and initials of person recording data - Review electronic temperature data at least 1 time each week Take immediate action and isolate vaccine(s) exposed to improper temperatures CDC Vaccine Storage and Handling Toolkit CDC Vaccine Storage and Handling Toolkit Strategies to Prevent Vaccination Errors Storage and Handling Check expiration dates weekly and promptly remove expired vaccines from the storage unit Designate a primary vaccine coordinator for your facility - Choose a second staff member to act as an alternate vaccine coordinator Use a continuous temperature monitoring device - CDC recommends using digital data loggers CDC You Call the Shots CDC You Call the Shots web-based education program: Storage and Handling 38

39 Multidose Vials and Expiration Dates A multidose vial (MDV) that has been stored and handled properly may be used more than once Double-check the manufacturer s package insert (PI) for information on beyond-use date or dose limits (if applicable) IPV MDV may be used through the expiration date if stored and handled correctly and not contaminated Some IIV products have a beyond-use-date and should be used within a certain number of days after being entered Fluzone inactivated influenza vaccine PI indicates only 10 doses may be withdrawn from a MDV After the maximum number of doses has been withdrawn from the MDV, the vial should be discarded, even if the expiration date has not been reached or there is vaccine left in the vial IAC Food and Drug Administration (FDA) Product Approval: Vaccine index Strategies to Prevent Vaccination Errors: Adverse Health Events Use standing orders Comprehensive standing order includes: - Who should be vaccinated - Indications, contraindications, and precautions - Procedures for administering the vaccine - Federal requirements (e.g., Vaccine Information Statement) - Documentation in the patient record - Protocol for the management of any medical emergency related to the administration of the vaccine - Reporting possible adverse events occurring after vaccination IAC Standing Orders IAC. Standing Orders 39

40 Strategies to Prevent Vaccination Errors Adverse Health Events Screen for contraindications and precautions every time vaccines are needed Use a standardized form Integrate into office procedures and flow IAC Screening Checklist for Contraindications and Precautions to Vaccines for Adults IAC Screening Checklist for Contraindications and Precautions to Vaccines for Children and Teens IAC Screening Checklist for Contraindications and Precautions Strategies to Prevent Vaccination Errors Adverse Health Events Administer injectable vaccines in the correct site based on the age, muscle mass and size of the patient Identify IM injection site using anatomical landmarks Vastus lateralis muscle (anterolateral thigh) Deltoid muscle (upper arm) IAC How to Administer Intramuscular and Subcutaneous Vaccine Injections IAC How to Administer Intramuscular and Subcutaneous Vaccine Injections 40

41 Reporting Vaccine Administration Errors First step: - Establish an environment that values reporting and investigating errors as part of risk management and quality improvement What if a vaccination error occurs? Next steps:: - Inform the patient/parent of the error - Determine the status of the patient - Know how to correct the error Contact your local health department, the vaccine manufacturer, or nipinfo@cdc.gov for guidance Not all errors require revaccination! - Explain any needed next steps to the patient/parent - Record the vaccination as it was given on the medical record - Contact the immunization information system (IIS) for additional information as needed - Follow the policies and procedures of your facility for medication errors 41

42 Reporting Vaccination Errors to VAERS Report all significant adverse events that occur after vaccination of adults and children VAERS accepts all reports, including reports of vaccination errors Providers are encouraged to report vaccination errors without health events if they believe the error may pose a safety risk There are 3 ways to report to VAERS online, fax, or mail Vaccine Adverse Event Reporting System Take Home Messages Vaccination error reports comprised 6-15% of all reports to VAERS The number and percentage of vaccination error reports have increased significantly in VAERS during the period Approximately 75% of vaccination error reports have no reported adverse health event However, errors can affect cost, convenience, effectiveness, and confidence in vaccination programs Comprehensive skills-based education is needed for all staff that administer vaccines Integrate best practice strategies into clinical procedures and office flow Use immunization job aids and resource materials to keep staff on the same page Report administration errors to VAERS 42

43 Resources CDC Resources for Staff Education Competency-based education for staff is critical Multiple education products available free through the CDC website: - Immunization courses (webcasts and online selfstudy) - Netconferences - You Call the Shots self-study modules Continuing education credits available 43

44 You Call the Shots (Several Modules Added or Updated) Now Available The Pink Book, 13th Edition Supplement (2017) Supplemental information regarding: Human Papillomavirus Meningococcal Disease Pneumococcal Disease

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46 CDC Vaccine and Immunization Resources Questions? CDC - Providers nipinfo@cdc.gov - Parents and patients Website Twitter Influenza Vaccine Safety Additional Resources State Immunization Program And local public health immunization programs, too! Immunization Action Coalition Vaccine Education Center American Academy of Pediatrics (AAP) National Foundation for Infectious Diseases (NFID)

47 Thank You! Candice Robinson, MD, MPH Medical Officer, NCIRD/CDC JoEllen Wolicki, RN, BSN Nurse Educator, NCRID/CDC Ginger Redmon, MA Writer-Editor, NCIRD/CDC 47

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49 Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2017 This schedule includes recommendations in effect as of January 1, Any dose not administered at the recommended age should be administered at a subsequent visit, when indicated and feasible. The use of a combination vaccine generally is preferred over separate injections of its equivalent component vaccines. Vaccination providers should consult the relevant Advisory Committee on Immunization Practices (ACIP) statement for detailed recommendations, available online at Clinically significant adverse events that follow vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS) online ( or by telephone ( ). Suspected cases of vaccinepreventable diseases should be reported to the state or local health department. Additional information, including precautions and contraindications for vaccination, is available from CDC online ( contraindications.html) or by telephone (800-CDC-INFO [ ]). The Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger are approved by the Advisory Committee on Immunization Practices ( American Academy of Pediatrics ( American Academy of Family Physicians ( American College of Obstetricians and Gynecologists ( U.S. Department of Health and Human Services Centers for Disease Control and Prevention 49

50 Figure 1. Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger United States, (FOR THOSE WHO FALL BEHIND OR START LATE, SEE THE CATCH-UP SCHEDULE [FIGURE 2]). These recommendations must be read with the footnotes that follow. For those who fall behind or start late, provide catch-up vaccination at the earliest opportunity as indicated by the green bars in Figure 1. To determine minimum intervals between doses, see the catch-up schedule (Figure 2). School entry and adolescent vaccine age groups are shaded in gray. Vaccine Birth 1 mo 2 mos 4 mos 6 mos 9 mos 12 mos 15 mos 18 mos mos CHAMPS 2017 Immunization Update 2-3 yrs 4-6 yrs 7-10 yrs yrs yrs 16 yrs yrs Hepatitis B 1 (HepB) 1 st dose 2 nd dose 3 rd dose Rotavirus 2 (RV) RV1 (2-dose series); RV5 (3-dose series) 1 st dose 2 nd dose See footnote 2 Diphtheria, tetanus, & acellular pertussis 3 (DTaP: <7 yrs) 1 st dose 2 nd dose 3 rd dose 4 th dose 5 th dose Haemophilus influenzae type b 4 (Hib) 1 st dose 2 nd dose See footnote 4 3 rd or 4 th dose, See footnote 4 Pneumococcal conjugate 5 (PCV13) 1 st dose 2 nd dose 3 rd dose 4 th dose Inactivated poliovirus 6 (IPV: <18 yrs) 1 st dose 2 nd dose 3 rd dose 4 th dose Influenza 7 (IIV) Annual vaccination (IIV) 1 or 2 doses Annual vaccination (IIV) 1 dose only Measles, mumps, rubella 8 (MMR) See footnote 8 1 st dose 2 nd dose Varicella 9 (VAR) 1 st dose 2 nd dose Hepatitis A 10 (HepA) 2-dose series, See footnote 10 Meningococcal 11 (Hib-MenCY >6 weeks; MenACWY-D >9 mos; MenACWY-CRM 2 mos) See footnote 11 1 st dose 2 nd dose Tetanus, diphtheria, & acellular pertussis 12 (Tdap: >7 yrs) Tdap Human papillomavirus 13 (HPV) See footnote 13 Meningococcal B 11 See footnote 11 Pneumococcal polysaccharide 5 (PPSV23) See footnote 5 Range of recommended ages for all children Range of recommended ages for catch-up immunization Range of recommended ages for certain high-risk groups NOTE: The above recommendations must be read along with the footnotes of this schedule. Range of recommended ages for non-high-risk groups that may receive vaccine, subject to individual clinical decision making No recommendation 50

51 FIGURE 2. Catch-up immunization schedule for persons aged 4 months through 18 years who start late or who are more than 1 month behind United States, The figure below provides catch-up schedules and minimum intervals between doses for children whose vaccinations have been delayed. A vaccine series does not need to be restarted, regardless of the time that has elapsed between doses. Use the section appropriate for the child s age. Always use this table in conjunction with Figure 1 and the footnotes that follow. Children age 4 months through 6 years Vaccine Minimum Minimum Interval Between Doses Age for Dose 1 Dose 1 to Dose 2 Dose 2 to Dose 3 Dose 3 to Dose 4 Dose 4 to Dose 5 Hepatitis B 1 Birth 4 weeks 8 weeks and at least 16 weeks after first dose. Minimum age for the final dose is 24 weeks. Rotavirus 2 6 weeks 4 weeks 4 weeks 2 Diphtheria, tetanus, and acellular pertussis 3 6 weeks 4 weeks 4 weeks 6 months 6 months 3 Haemophilus influenzae type b 4 Pneumococcal 5 6 weeks 6 weeks 4 weeks if first dose was administered before the 1 st birthday. 8 weeks (as final dose) if first dose was administered at age 12 through 14 months. No further doses needed if first dose was administered at age 15 months or older. 4 weeks if first dose administered before the 1 st birthday. 8 weeks (as final dose for healthy children) if first dose was administered at the 1 st birthday or after. No further doses needed for healthy children if first dose was administered at age 24 months or older. 4 weeks 4 if current age is younger than 12 months and first dose was administered at younger than age 7 months, and at least 1 previous dose was PRP-T (ActHib, Pentacel, Hiberix) or unknown. 8 weeks and age 12 through 59 months (as final dose) 4 if current age is younger than 12 months and first dose was administered at age 7 through 11 months; OR if current age is 12 through 59 months and first dose was administered before the 1 st birthday, and second dose administered at younger than 15 months; OR if both doses were PRP-OMP (PedvaxHIB; Comvax) and were administered before the 1 st birthday. No further doses needed if previous dose was administered at age 15 months or older. 4 weeks if current age is younger than 12 months and previous dose given at <7 months old. 8 weeks (as final dose for healthy children) if previous dose given between 7-11 months (wait until at least 12 months old); OR if current age is 12 months or older and at least 1 dose was given before age 12 months. No further doses needed for healthy children if previous dose administered at age 24 months or older. 8 weeks (as final dose) This dose only necessary for children age 12 through 59 months who received 3 doses before the 1 st birthday. 8 weeks (as final dose) This dose only necessary for children aged 12 through 59 months who received 3 doses before age 12 months or for children at high risk who received 3 doses at any age. Inactivated poliovirus 6 6 weeks 4 weeks 6 4 weeks 6 6 months 6 (minimum age 4 years for final dose). Measles, mumps, rubella 8 12 months 4 weeks Varicella 9 12 months 3 months Hepatitis A months 6 months Meningococcal 11 (Hib-MenCY 6 weeks; MenACWY-D 9 mos; 6 weeks 8 weeks 11 See footnote 11 See footnote 11 MenACWY-CRM 2 mos) Children and adolescents age 7 through 18 years Meningococcal 11 (MenACWY-D 9 mos; MenACWY-CRM 2 mos) Not Applicable (N/A) 8 weeks 11 Tetanus, diphtheria; tetanus, diphtheria, and 7 years 12 4 weeks acellular pertussis 12 4 weeks if first dose of DTaP/DT was administered before the 1 st birthday. 6 months (as final dose) if first dose of DTaP/DT or Tdap/Td was administered at or after the 1 st birthday. Human papillomavirus 13 9 years Routine dosing intervals are recommended. 13 Hepatitis A 10 N/A 6 months Hepatitis B 1 N/A 4 weeks 8 weeks and at least 16 weeks after first dose. Inactivated poliovirus 6 N/A 4 weeks 4 weeks 6 6 months 6 Measles, mumps, rubella 8 N/A 4 weeks Varicella 9 N/A 3 months if younger than age 13 years. 4 weeks if age 13 years or older. 6 months if first dose of DTaP/DT was administered before the 1 st birthday. NOTE: The above recommendations must be read along with the footnotes of this schedule. 51

52 Figure 3. Vaccines that might be indicated for children and adolescents aged 18 years or younger based on medical indications VACCINE INDICATION Pregnancy Hepatitis B 1 Immunocompromised status (excluding HIV infection) HIV infection CD4+ count (cells/μl) <15% of total CD4 cell count 15% of total CD4 cell count Kidney failure, endstage renal disease, on hemodialysis Heart disease, chronic lung disease CSF leaks/ cochlear implants Asplenia and persistent complement component deficiencies Chronic liver disease Diabetes Rotavirus 2 SCID* Diphtheria, tetanus, & acellular pertussis 3 (DTaP) Haemophilus influenzae type b 4 Pneumococcal conjugate 5 Inactivated poliovirus 6 Influenza 7 Measles, mumps, rubella 8 Varicella 9 Hepatitis A 10 Meningococcal ACWY 11 Tetanus, diphtheria, & acellular pertussis 1 2 (Tdap) Human papillomavirus 13 Meningococcal B 11 Pneumococcal polysaccharide 5 Vaccination according to the routine schedule recommended Recommended for persons with an additional risk factor for which the vaccine would be indicated Vaccination is recommended, and additional doses may be necessary based on medical condition. See footnotes. *Severe Combined Immunodeficiency NOTE: The above recommendations must be read along with the footnotes of this schedule. No recommendation Contraindicated Precaution for vaccination 52

53 Footnotes Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2017 For further guidance on the use of the vaccines mentioned below, see: For vaccine recommendations for persons 19 years of age and older, see the Adult Immunization Schedule. Additional information For information on contraindications and precautions for the use of a vaccine and for additional information regarding that vaccine, vaccination providers should consult the ACIP General Recommendations on Immunization and the relevant ACIP statement, available online at For purposes of calculating intervals between doses, 4 weeks = 28 days. Intervals of 4 months or greater are determined by calendar months. Vaccine doses administered 4 days before the minimum interval are considered valid. Doses of any vaccine administered 5 days earlier than the minimum interval or minimum age should not be counted as valid doses and should be repeated as age-appropriate. The repeat dose should be spaced after the invalid dose by the recommended minimum interval. For further details, see Table 1, Recommended and minimum ages and intervals between vaccine doses, in MMWR, General Recommendations on Immunization and Reports / Vol. 60 / No. 2, available online at mmwr/pdf/rr/rr6002.pdf. Information on travel vaccine requirements and recommendations is available at wwwnc.cdc.gov/travel/. For vaccination of persons with primary and secondary immunodeficiencies, see Table 13, Vaccination of persons with primary and secondary immunodeficiencies, in General Recommendations on Immunization (ACIP), available at and Immunization in Special Clinical Circumstances, (American Academy of Pedatrics). In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2015 report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics, 2015: The National Vaccine Injury Compensation Program (VICP) is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions. Created by the National Childhood Vaccine Injury Act of 1986, it provides compensation to people found to be injured by certain vaccines. All vaccines within the recommended childhood immunization schedule are covered by VICP except for pneumococcal polysaccharide vaccine (PPSV23). For more information; see 1. Hepatitis B (HepB) vaccine. (Minimum age: birth) Routine vaccination: At birth: Administer monovalent HepB vaccine to all newborns within 24 hours of birth. For infants born to hepatitis B surface antigen (HBsAg)- positive mothers, administer HepB vaccine and 0.5 ml of hepatitis B immune globulin (HBIG) within 12 hours of birth. These infants should be tested for HBsAg and antibody to HBsAg (anti-hbs) at age 9 through 12 months (preferably at the next well-child visit) or 1 to 2 months after completion of the HepB series if the series was delayed. If mother s HBsAg status is unknown, within 12 hours of birth, administer HepB vaccine regardless of birth weight. For infants weighing less than 2,000 grams, administer HBIG in addition to HepB vaccine within 12 hours of birth. Determine mother s HBsAg status as soon as possible and, if mother is HBsAg-positive, also administer HBIG to infants weighing 2,000 grams or more as soon as possible, but no later than age 7 days. Doses following the birth dose: The second dose should be administered at age 1 or 2 months. Monovalent HepB vaccine should be used for doses administered before age 6 weeks. Infants who did not receive a birth dose should receive 3 doses of a HepB-containing vaccine on a schedule of 0, 1 to 2 months, and 6 months, starting as soon as feasible (see figure 2). Administer the second dose 1 to 2 months after the first dose (minimum interval of 4 weeks); administer the third dose at least 8 weeks after the second dose AND at least 16 weeks after the first dose. The final (third or fourth) dose in the HepB vaccine series should be administered no earlier than age 24 weeks. Administration of a total of 4 doses of HepB vaccine is permitted when a combination vaccine containing HepB is administered after the birth dose. Catch-up vaccination: Unvaccinated persons should complete a 3-dose series. A 2-dose series (doses separated by at least 4 months) of adult formulation Recombivax HB is licensed for use in children aged 11 through 15 years. For other catch-up guidance, see Figure Rotavirus (RV) vaccines. (Minimum age: 6 weeks for both RV1 [Rotarix] and RV5 [RotaTeq]) Routine vaccination: Administer a series of RV vaccine to all infants as follows: 1. If Rotarix is used, administer a 2-dose series at ages 2 and 4 months. 2. If RotaTeq is used, administer a 3-dose series at ages 2, 4, and 6 months. 3. If any dose in the series was RotaTeq or vaccine product is unknown for any dose in the series, a total of 3 doses of RV vaccine should be administered. Catch-up vaccination: The maximum age for the first dose in the series is 14 weeks, 6 days; vaccination should not be initiated for infants aged 15 weeks, 0 days, or older. The maximum age for the final dose in the series is 8 months, 0 days. For other catch-up guidance, see Figure Diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. (Minimum age: 6 weeks. Exception: DTaP- IPV [Kinrix, Quadracel]: 4 years) Routine vaccination: Administer a 5-dose series of DTaP vaccine at ages 2, 4, 6, 15 through 18 months, and 4 through 6 years. The fourth dose may be administered as early as age 12 months, provided at least 6 months have elapsed since the third dose. Inadvertent administration of fourth DTaP dose early: If the fourth dose of DTaP was administered at least 4 months after the third dose of DTaP and the child was 12 months of age or older, it does not need to be repeated. Catch-up vaccination: The fifth dose of DTaP vaccine is not necessary if the fourth dose was administered at age 4 years or older. For other catch-up guidance, see Figure Haemophilus influenzae type b (Hib) conjugate vaccine. (Minimum age: 6 weeks for PRP-T [ActHIB, DTaP-IPV/Hib (Pentacel), Hiberix, and Hib-MenCY (MenHibrix)], PRP- OMP [PedvaxHIB]) Routine vaccination: Administer a 2- or 3-dose Hib vaccine primary series and a booster dose (dose 3 or 4, depending on vaccine used in primary series) at age 12 through 15 months to complete a full Hib vaccine series. The primary series with ActHIB, MenHibrix, Hiberix, or Pentacel consists of 3 doses and should be administered at ages 2, 4, and 6 months. The primary series with PedvaxHIB consists of 2 doses and should be administered at ages 2 and 4 months; a dose at age 6 months is not indicated. One booster dose (dose 3 or 4, depending on vaccine used in primary series) of any Hib vaccine should be administered at age 12 through 15 months. For recommendations on the use of MenHibrix in patients at increased risk for meningococcal disease, refer to the meningococcal vaccine footnotes and also to MMWR February 28, 2014 / 63(RR01):1-13, available at gov/mmwr/pdf/rr/rr6301.pdf. 53