2015 Medical Assistant Immunization Update. Central Valley Immunization Coalition

Transcription

1 2015 Medical Assistant Immunization Update Central Valley Immunization Coalition

2 Angela Swanson RN IZ Coordinator Kings County Department of Public Health (559) Central Valley Immunization Coalition

3 1. Introductions 2. Disease Updates-Measles 3. Vaccine Administration- The Basics 4. Immunization School Law ACIP Recommendations, Children & Adults 6. Vaccine Management, Storage Equipment and Storage Equipment Maintenance/Calibration 7. Temperature Monitoring /Documentation 8. Questions 2015 MA Update Agenda

4 Disclosures Speakers have no financial conflict with manufacturers of any product named in this presentation. The use of trade names and commercial sources during this presentation is for identification only, and does not imply endorsement by the presenter, the Central Valley Immunization Coalition, Vaccines for Children, or the County of Fresno, Madera, Kings, or Tulare. Central Valley Immunization Coalition

5 So who s here? Central Valley Immunization Coalition

6 Disease Update Measles Stats as of 2/09/2015

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8 Confirmed measles cases since 12/17/14 CALIFORNIA 107 Alameda 6 Los Angeles 20 City of Long Beach* 2 City of Pasadena* 4 Marin 2 Orange 34 Riverside 5 San Bernardino 6 San Diego 13 San Mateo 3 Santa Clara 2 Solano 1 Ventura 9 *City health jurisdictions not included in county total

9 Table 2. Vaccination status among confirmed cases with known vaccination status Table 4. Number of confirmed measles cases by hospitalization status Unvaccinated Total* Percent 47 78% Vaccinated 1 dose 5 8% 2 doses 7 12% 3 doses 1 2% *16 cases self-report vaccination; 1 case had prior measles IgG positivity; 30 cases have unknown vaccination status Total* Percent Hospitalized 17 21% Not hospitalized 65 79% *25 have missing hospitalization data Table 3. Reason for not being vaccinated among unvaccinated cases Total* Percent Missed dose/alternative schedule PBE Too Young 2 5% 28 70% 10 25% *7 unvaccinated for unknown reasons Measles Cases-Stats

10 resources can be accessed on the EZIZ.org measles webpage.

11 Vaccine Administration- The Basics

12 Vaccine Information Statements Federal law requires that the VIS be provided before vaccine is administered to the patient

13 Vaccine Information Statements VIS s located at and

14 Be Organized!

15 Vaccine Administration Have an exact vaccine order in writing Order must be written Check and double check! Prepare vaccines carefully Stay focused and undisturbed; set it up as a quiet room Read labels and expiration dates Ask someone if you do not understand When using new vaccines all staff need education before using the vaccine

16 The Five Rights 1. Right Patient 2. Right Route 3. Right Dose 4. Right Time 5. Right Medication

17 PREVENT VIAL MIX-UPS!! Read your vials and syringes!

18 Injection Sites: IM DO NOT ASPIRATE! from EZIZ.org

19 Those underlined can be SQ or IM Injection Sites: SQ DO NOT ASPIRATE! from EZIZ.org

20 Oral (P.O.)-Rotavirus Other Routes

21 California Immunization School Law

22 State Immunization Requirements Immunization requirements for school and child care entry in the U.S. are state-specific In California, immunization requirements for school and child care are in the California Health and Safety Code and California Code of Regulations (rules) California Not all national immunization recommendations are requirements for school or child care entry

23 For Schools, Parents AND Providers

24 Required school vaccines PBE forms and info

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26 Personal Beliefs Exemptions Form can be signed up to 6 months before the first day of school Signature is only valid for 6 months If needed PBEs are used for the following. Children that are : Entering a child care facility/preschool Entering kindergarten Entering or advancing into the 7th grade Transferring from out-of state

27 Personal Beliefs Exemptions Those Authorized to Sign a PBE Form: 1. Licensed Medical Doctors (MD s) 2. Doctors of Osteopathic Medicine (DO S) 3. Nurse Practitioners (NP s) 4. Physician Assistants (PA s) 5. Naturopaths working under a licensed physician 6. Credentialed School Nurses Do NOT refer parents to the County Health Depts. to sign off PBEs as we will not be able to provide this service!

28 Medical Exemptions Permanent Parent must present a written and signed statement from a doctor at school registration Note must state the medical condition and which immunization(s) the child cannot receive Temporary Same as above AND doctor must specify how long to postpone immunizations

29 The Vaccine Recommendations

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32 Catch-up schedule

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34 General Rules re: Timing/Spacing 1. There is no need to restart a vaccine series even if pt. is returning mos. or yrs. later. Just pick up where the series left off. (i.e. Hep B, HPV, etc.). 2. Vaccine doses administered up to 4 days before the minimum interval or age can be counted as valid ( grace period )

35 General Rules re: Timing/Spacing (cont.) 3. Live-virus vaccines (MMR, Varicella, MMRV, LAIV, Zoster) must be separated by at least 28 days-no grace period 4. Live virus vaccines can interfere with the response to TB skin tests. If a L.V. vaccine is given on a day prior to the TST- the TST should be deferred least 28 days. But the L.V. vaccines can be given on the same day as TST placement or placed after the TST reading.

36 Hepatitis B Vaccine Routine vaccination for the prevention of infection caused by hepatitis B virus Hepatitis B can lead to hospitalization, cirrhosis, hepatocellular carcinoma, and death.

37 Hepatitis B Vaccine Recommended: 3 doses birth, 1-2 months, and 6 months 4 doses permissible Birth dose plus DTaP-IPV-HepB at 2, 4 and 6 months Minimum intervals: Dose 1 to Dose 2 = 4 weeks Dose 2 to Dose 3 = 8 weeks Minimum age for final dose (3 or 4) is 24 weeks of age, and at least 16 weeks after the first dose

38 Rotavirus Routine vaccination for the prevention of rotavirus gastroenteritis in infants and children Virus that causes diarrhea (sometimes severe), mostly in babies and young children Often accompanied by vomiting and fever, and can lead to dehydration and electrolyte imbalance

39 RotaTeq (Merck) - RV5 Rotavirus Vaccine 3 dose series, given orally 2, 4, and 6 months Rotarix (GSK) RV1 2 dose series, given orally 2 and 4 months If any dose in the series was RotaTeq or unknown, then give a total of 3 doses 4 week minimum interval between doses

40 Diphtheria, Pertussis, & Tetanus

41 Diphtheria, Tetanus and Acellular Pertussis (DTaP) Vaccine Routine vaccination for the prevention against diphtheria, tetanus, and whooping cough (pertussis) Routine vaccination (5 doses, intramuscular injection): 2, 4, and 6 months Minimum age of 6 weeks for 1 st dose; 4 week min interval 4 th dose at months May be given as early as 12 months if at least 6 months since 3 rd dose 5 th dose at 4-6 years 5 th dose is not needed if 4 th dose given on or after 4 years of age; 6 month minimum interval since 4 th dose.

42 Combination Vaccines with DTaP DTaP-IPV-Hep B (Pediarix ) Licensed for 6 weeks through 6 years 3 dose series: 2, 4, and 6 months DTaP-IPV/Hib (Pentacel ) Licensed for 6 weeks through 4 years 4 dose series: 2, 4, 6, and months DTaP-IPV (Kinrix ) Licensed for 4-6 years For the 5 th dose of DTaP and 4 th dose of IPV

43 Haemophilus influenzae, type B Severe bacterial Infection, esp. among infants Most common types of invasive disease: Meningitis, epiglottitis, pneumonia, septic arthritis, cellulitis, purulent pericarditis, and bacteremia Approximately 4% of cases were fatal Hearing impairment or other neurologic sequelae in 15-30% of Hib meningitis survivors 2/3 of children had meningitis

44 Hib Vaccine Routine vaccination : 3-dose primary series plus booster (ActHIB, MenHibrix *, Pentacel # ) 3 doses 2, 4, 6, and 12 through 15 months 2-dose primary series plus booster (PedvaxHib or Comvax ) 4 doses 2, 4, and 12 through 15 months Minimum intervals: Minimum age 6 weeks Dose 1 to 2, and Dose 2 to 3 = 4 weeks Dose 3 to 4 = 8 weeks

45 Hib Vaccine Generally not recommended for those older than 5 years; however 1 dose should be given to those unvaccinated or partially vaccinated with certain high-risk medical conditions See ACIP recommendations for catch-up, minimum intervals and high-risk recommendations *MenHibrix protection against invasive Hib disease and meningococcal serogroups C and Y (Hib-MenCY) # Pentacel --DTaP-IPV/Hib Comvax--Hib-HepB- Discontinued as of Dec. 31,

46 Pneumococcal Disease Presents as pneumonia, bacteremia, and meningitis Can result in meningitis, sepsis, brain damage, ear and sinus infections Some strains are antibiotic resistant

47 Pneumococcal Conjugate Vaccine (PCV13) Routine vaccination: 4-dose series via intramuscular injection 2, 4, 6, and months See full ACIP Recommendations for catch-up guidance by age and specific high-risk condition

48 Pneumococcal Vaccine 250 < 1 yr 1 yr yrs cases per 100,000 population yrs yrs yrs yrs 65+ yrs

49 Pneumococcal Polysaccharide Vaccine (PPSV23) Recommended for certain high-risk populations ages 2 years and older See full ACIP recommendations for details and 2 nd dose recommendations (timing and specific populations) If no prior doses of PPSV23, administer PPSV23 at least 8 weeks after the most recent dose of PCV13

50 Poliomyelitis Poliovirus enters the body through the mouth and replication occurs in the pharynx and GI tract Up to 95% are asymptomatic carriers

51 Polio Vaccine (IPV) Recommended: 4 doses 2, 4, 6-18 months, and 4-6 years Minimum intervals: Dose 1 to 2, and Dose 2 to 3 = 4 weeks Dose 3 to 4 = 6 months Last dose should be given on/after 4 th birthday and at least 6 months after previous dose A fourth dose is not necessary if dose #3 was administered at age 4 years or older and at least 6 months after the previous dose If 4 doses given prior to age 4 years, 5th dose should be given at 4-6 years

52 Mumps and Rubella

53 Measles Virus transmitted through coughing, sneezing, or talking Do not even have to be in the same the same time to catch/transmit the disease Causes rash, cough, runny nose, eye irritation, and fever Can lead to ear infection, pneumonia, seizures, brain damage, and death

54 MMR Vaccine Routine vaccination: 2 dose series Live virus vaccine Administered subcutaneously 1st dose: months 2 nd dose: 4-6 years Minimum interval of 4 weeks between doses Ensure all school-aged children and adolescents have had 2 doses of MMR vaccine

55 MMR Prior to International Travel One dose of MMR vaccine to infants aged 6 through 11 months before departure for international travel These children should still receive two doses administered on or after 12 months 4 week minimum interval between doses Two doses to children ages 12 months and older before departure 2 nd dose at least 4 weeks after 1 st dose

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57 Varicella (Chickenpox) Virus spread from person to person through the air, or by contact with fluid from blisters Causes a rash, itching, fever, and tiredness Can lead to severe skin infection, scars, pneumonia, brain damage or death Usually mild but can be serious in young infants and adults

58 Varicella Vaccine Routine 2-dose series, given subcutaneously 1 st dose given months 2 nd dose given 4-6 years Minimum interval: Ages 1 through 12 years: 3 months 2 nd dose valid if at least 4 weeks after the 1 st dose Ages 13 years and older: 4 weeks Ensure all persons without evidence of immunity to chickenpox have received 2 doses of the varicella vaccine

59 MMRV Vaccine The CDC and ACIP recommends that the first dose of MMR and varicella given at months of age (can be given through 47 months) be administered separately using MMR and varicella vaccines due to an increased risk for febrile seizures following dose #1 of ProQuad The second dose should be administered at 4-6 years of age (up to 12 years) and ProQuad (MMRV) vaccine may be used if a combination vaccine is preferred over separate injections

60 Hepatitis A Virus that affects the liver Transmitted via the fecal-oral route Usually spread by close personal contact and sometimes by eating food or drinking water containing hepatitis A virus Can cause flu-like illness, jaundice, severe stomach pains and diarrhea (in children)

61 Hepatitis A Vaccine 2-dose series at months Minimum interval of 6 months Catch-up immunization through age 18 years with 2 doses May be given to anyone who wishes immunity to hepatitis A See full ACIP recommendations for high-risk and post-exposure prophylaxis recommendations

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64 Tdap Vaccine Routine vaccination with 1 dose to all adolescents aged years Regardless of interval since last tetanuscontaining vaccine May be given as early as 7 years for catch-up See ACIP recommendations for catch-up schedule.

65 Human papillomavirus (HPV) Most common sexually transmitted virus in US Infects both males and females Most HPV infections asymptomatic Transmitted via sexual contact Can cause cervical cancer, vaginal and vulvar cancers, anal and oropharyngeal cancers (in both men and women), and genital warts and warts in the throat

66 HPV Vaccine 3-dose series recommended routinely to all adolescents (females and males) aged years Given over a period of 6 months: 0, 1-2 months, and 6 months Minimum intervals between: dose 1 and 2 is 4 weeks; dose 2 and 3 is 16 weeks; dose 1 and 3 is 24 weeks. May be started as young as 9 years of age See full ACIP recommendations for catch-up and high-risk recommendations

67 HPV Vaccines Gardasil (HPV4) 4 strains Males and Females Cervarix (HPV2) 2 strains Females only

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69 Meningococcal Disease Bacteria that is the leading cause of bacterial meningitis in children 2-18 years old in US Also causes blood infections Children with anatomical or functional asplenia are at higher risk Transmitted through the airborne droplets or direct contact with secretions from the nasopharynx

70 Invasive Meningococcal Disease Cases with Known Serogroup by Serogroup* California, 2013 (n=105)

71 ACIP Recommendations: Meningococcal Conjugate Vaccines Routinely recommended for all adolescents at age years of age and a booster at age 16 years Protects against serogroups A, C, Y, and W-135 Newly licensed Meningococcal Vaccine for serogroup B (1/2015) from Novartis- see next slide See current ACIP recommendations for catch-up and high-risk recommendations (2 months and older) Note: adolescents aged 11 through 18 years who are HIV+ should receive a 2-dose primary series with at least 8 weeks between doses

72 rmen (type B) Novartis-Licensed for ages 10-25yrs. -2 dose series MCV (types C & Y) + Hib GSK- Licensed for ages 6 through 18mo. -4 dose series Meningococcal Vaccines on the Market- Not on VFC

73 Influenza Update Routine vaccination annually for all persons age 6 months and older Children aged 6 months through 8 years 2 doses of influenza vaccine (administered a minimum of 4 weeks apart) during their first season of vaccination to optimize immune response

74 Algorithm for Children 6 Months through 8 Years ACIP, Influenza Season *Minimum interval 4 weeks If history before July 1, 2010 known: Child who received at least 2 seasonal influenza vaccines during any prior season and at least 1 dose of 2009 H1N1- containing vaccine (monovalent H1N1 or seasonal flu , , ) then they need only one dose this season.

75 Live Attenuated Influenza Vaccine Inactivated Influenza Vaccine LAIV Quadrivalent For healthy 2 year through 49 year olds Multiple Manufacturers Trivalent and Quadrivalent Formulations Check label for age indications

76 Abbreviations IIV3=Inactivated influenza vaccine, trivalent IIV4=Inactivated influenza vaccine, quadrivalent LAIV, LAIV4=Live-attenuated intranasal influenza vaccine, quadrivalent Available for adults only for (non-vfc): cciiv3=trivalent, cell culture-based inactivated influenza vaccine RIV, RIV3=recombinant hemagglutinin influenza vaccine

77 2015 ACIP ADULT SCHEDULE-Age Indications

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79 Annual influenza vaccine Tdap Adult Schedule Pneumococcal 2013 footnotes changed regarding PCV13 and PPSV23 for persons with certain medical and immunocompromising conditions Hepatitis A and/or Hepatitis B Shingles (Zoster) ACIP recommends vaccination for all beginning at age 60 Vaccines for foreign travel-typhoid, Yellow Fever, etc. Meningococcal and Hib may also be recommended for persons with asplenia or other immune compromise

80 Tdap Vaccine Recommended during the 3 rd Trimester of EACH Pregnancy Tdap should be administered during each pregnancy, irrespective of the patient s prior history of receiving Tdap. To maximize maternal antibody response and passive antibody transfer to the infant, optimal timing for Tdap administration is between 27 and 36 weeks gestation. If not given during pregnancy can be given postpartum but this is considered sub-optimal.

81 New Recommendations Re: Pneumococcal Vaccine

82 Vaccine Management, Storage Equipment and Equipment Maintenance/Calibration

83 EZIZ: One EZ Stop for IZ Resources!

84 Routine and Emergency Management Plans VFC Requirements: Maintain updated plans Reviewed annually & document review Update as needed

85 Vaccine Management Plans

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87 USE APPROPRIATE STORAGE UNITS FOR YOUR PRACTICE

88 Store Vaccines According to Best Practice Standards

89 Thermometers & VFC VFC providers must have VFC-compliant thermometers in the practice s vaccine storage units at all times. A primary thermometer must be centrally located in each vaccine storage unit in proximity with vaccines. Practices with multiple vaccine storage units may need more than one back-up thermometer. A minimum of one back-up thermometer, located in an easily accessible area of the practice, must be available for use when primary thermometers are being calibrated or fails.

90 Need to buy a thermometer for your clinic? You ll need to: 1. Become familiar with VFC s Vaccine Thermometer Specifications 2. Do an on-line search 3. Purchase a thermometer

91 Thermometer Specifications Display current, minimum and maximum temperatures. Temperature reset button Be within +/-0.5 C (+/-1 F) accuracy. External digital display to monitor temperatures without opening unit Have an alarm biosafe glycolencased probe (or similar buffered solution).

92 Are these therms OK?

93 It depends..check specifications!

94 Thermometer Calibration & Certification Every thermometer (primary and back-up) must be calibrated annually (or every other year when the manufacturer recommends calibration done in a period that is longer than two years). When sending your thermometers for calibration make sure to share items in the Calibration checklist with the calibration lab! Each must have a valid Certificate of Traceability and Calibration Testing, also known as a Certification of Calibration. A valid Certification of Calibration must be kept on file Calibration should be conducted by an accredited laboratory. (ILAC/ MRA see next slide) Thermometers not accurate to within +/-1 F (+/-0.5 C) must be replaced.

95 Calibration Services Thermometer calibration must be done by a laboratory with accreditation from an International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body. Follow links for listings of accredited laboratories: The American Association for Laboratory Accreditation (A2LA) Laboratory Accreditation Bureau (L-A-B) ANSI-ASQ National Accreditation Board (ACLASS) International Accreditation Service (IAS) Perry Johnson Laboratory Accreditation, Inc.( PJLA)

96 thermometer identification Technician Info Calibration date and next date due Calibration Data Accredited Laboratory Name

97 Temperature Monitoring and Documentation

98 Temperature Monitoring & Documentation Issues Inconsistent documentation Untrained personnel Incorrect logging Inappropriate units Temperature Monitoring Issues Lack of action Unit cycling Lack of QA

99 Monitor Temps Twice Daily Record current, MIN, MAX for each unit Use the VFC-provided logs Clear all temps after each reading Keep all logs for 3 yrs. (will be reviewed during site visits)

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101 REFRIGERATOR FREEZER F (2-8 C) Most vaccines stored in fridge MMR may be stored in fridge or freezer AIM FOR F (-15 C) or colder Varicella, MMR(recommended), MMRV, Zostavax stored here AIM FOR BELOW 5

102 Managing a Cold Chain Failure Definition- Storage temps outside the recommended temperature range- Also called an excursion Still store questionable temp Label vaccine DO NOT USE Notify VFC program ASAP after discovery Follow guidance on documentation & reporting to the vaccine manufacturers for resolution

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104 Future Policy Changes? Sunset of combination units Pharmacy Grade units vs. Household grade units (Standalone) Digital Data Loggers (DDLs) New Enrollments, Providers with limited hours Vaccine Losses Multiple incidents Temperature Monitoring QA (Practice level) Temperature monitoring lessons (expanded to additional roles in the clinic) Field Visits: Practice-based scenarios for Temp monitoring/skill verification

105 Available Resources Central Valley Immunization Coalition Vaccines for Children (EZIZ) Immunization Action Coalition Shots for Schools Shot By Shot The Pink Book online (CDC) Central Valley Immunization Coalition

106 Central Valley Immunization Coalition

107 Sincere Thanks To: Anthem Blue Cross CDPH CAIR Team CDPH Immunization Branch / Vaccines for Children (VFC) Fresno County Department of Public Health CHDP Program Fresno County Department of Public Health Immunization Program Health Net / Cal Viva Kings County Immunization Program Madera County Immunization Program Madera County Department of Social Services MedImmune Novartis Sanofi-Pasteur Tulare County Immunization Program Tulare County Immunization Program - HHSA Tulare County Professional Development Center West Fresno Regional Center United Health Center Central Valley Immunization Coalition

108 THANKS FOR COMING! Central Valley Immunization Coalition