Immunization Update for Health System Pharmacists Eric Crumbaugh, PharmD

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1 Immunization Update for Health System Pharmacists 2015 Eric Crumbaugh, PharmD

2 Financial Disclosures Eric Crumbaugh, PharmD Speaker s Bureau Merck Vaccines Pfizer Consultant Pfizer Novartis Merck

3 Objectives Review current US and Arkansas immunization rates. Discuss vaccines recently FDA approved and their role in preventing vaccine-preventable disease. Explain the current recommendations regarding prevention of pneumococcal disease in adult and elderly patients. Assess the immunization status of a patient with chronic conditions, and based on the Advisory Committee for Immunization Practices, recommend needed vaccines.

4 Achievements in Public Health Vaccine Development 1798 Smallpox 1881 Anthrax 1885 Rabies 1896 Cholera, Typhoid 1897 Plague 1923 Diphtheria 1926 Pertussis 1927 Tetanus 1936 Influenza 1955 IPV 1963 Trivalent OPV, Measles 1969 Rubella 1971 MMR 1982 Hepatitis B 1987 Hib 1995 Varicella, Hepatitis A 2005 Tdap 2006 Rotavirus, HPV, Zoster 4 CDC. MMWR. 1999;48(29):621-9.

5 Arkansas National Immunization Survey Series Rates and Rankings: 19 to 36 Months Vaccine Series and Rank / Year :3:1:3:3:1:4* 73.6± ± ± ± ±8.2 AR Rank *The series is 4 DTaP, 3 Polio, 1 MMR, >3 Hib, >3 Hep B, >1 Varicella, and >4 Pneumococcal Conjugate vaccines. 5

6 Arkansas Kindergartners CDC reported for school year, Arkansas had 3rd lowest rates for: 2 doses of MMR (86.5% vs 94.7%) 4 doses of DTaP (83.3% vs 95.0%) 2 doses of varicella (85.4% vs 93.3%) A full report on vaccination rates among children in kindergarten in the United States during the school year can be found at Stats from the Arkansas Department of Health. 6

7 Estimated Vaccination Coverage Among Children Enrolled in Kindergarten School Year

8 Measles Maculopapular rash Signs and Symptoms Fever up to 105 Malaise 3 C s: Cough, coryza, conjunctivitis Koplik spots: white spots that occur on the inside of cheeks early in the course of measles Highly contagious: approximately 9 out of 10 susceptible people with close contact will develop Incubation period is 7 to 21 days Rash usually appears about 14 days after exposure Contagious 4 days before to 4 days after rash appears Some immunocompromised patients do not develop a rash

9 United states Measles Outbreaks

10 Herd Immunity / Community Immunity school year AR vs US 2 doses of MMR (86.5% vs 94.7%) 92 to 95% of children need to have received 2 doses of the MMR vaccine to maintain herd immunity

11 Measles Vaccination (MMR) Live vaccine MMR vaccine is recommended for children 12 months of age and older One dose is approximately 93% effective at preventing measles, two doses increase to 97% effective Almost everyone who does not respond to measles component of first dose will respond to second dose.

12 MMR Vaccine Recommendations Children 1 st dose given at 12 through 15 months 2 nd dose given at 4 through 6 years of age Catch up is 2 doses separated by 28 days Students at post-high school educational institutions Evidence of immunity or 2 doses separated by 28 days Adults: people who are born after 1957 who do not have evidence of immunity should get at least 1 dose International Travelers: people 6 months of age or older / travelers born after 1957 should have two doses separated by a minimum of 28 days Healthcare Personnel: if born after 1957, should receive 2 doses separated by 28 days

13 2013 & 2014 NIS-Teen Survey For adolescents aged years For catch up vaccinations: 2 doses of MMR (88.6% vs 90.7%) (34th) 2 doses of varicella (68.7% vs 81.0%) (42nd) Arkansas: cases of cervical cancer 50 deaths American Cancer Society Stats from the 2014 / 2013 NIS and the Arkansas Department of Health. 13

14 Potential Prevention with Increased Uptake of HPV Vaccine 26 million girls less than 13 years of age in US; 260,000 in Arkansas If none are vaccinated, then: 168,400 (US) and 1,680 (AR) will develop cervical cancer and 51,000 (US) and 541 (AR) will die of cervical cancer For each year, we are 30% vaccinated instead of achieving 80%, 4,400 future cases and 1,400 cancer deaths will occur 14

15 Australia 80% of school aged girls vaccinated High grade cervical lesions have declined in females less than 18 years of age Proportion of genital warts cases declined by 85% in 15 to 24 year old females Genital warts have declined by 71% among males of same age indicating herd immunity

16 HPV 9 Vaccine Recommended for use in young women 9 to 26 years of age and young men aged 9 to 21 years of age 3 dose schedule given at 0, 1 to 2, & 6 months (alternate dosing schedule currently being studied) Any available HPV vaccine product may be used to continue or complete the series Covers HPV types 6, 11, 16, 18, 31, 33, 45, 52, & 58 No recommendation to revaccinate anyone who had already received HPV 4

17 Presented as an optional vaccine since not required for school HPV vaccine is cancer prevention Focus groups find that this message resonates strongly with parents Frequency of vaginal HPV and the association of non-coital sexual behavior HPV was detected in 46% of women prior to first vaginal sex 70% of these women reported non-coital behaviors may in part explain genital transmission** Strong provider recommendation with main message of cancer prevention HPV Vaccination Coverage Among Adolescents, 2007 to **Shew, J J Infect Dis. 2012

18 Meningococcal Disease Caused by Neisseria meningitidis (meningococcus) Multiple serogroups that cause disease in US: B, C, Y, and W Quadrivalent meningococcal conjugate vaccine (MCV4) contains serotypes A, C, W, & Y Quadrivalent meningococcal polysaccharide vaccine (MPSV) also contains serotypes A, C, W, & Y Preferred vaccine for adults greater than 55 years of age Newly approved serogroup B meningococcal vaccine 10% of people have this bacteria in the nose or throat with no signs or symptoms called being a carrier Spread through the exchange of respiratory and throat secretions Signs and symptoms Nausea, vomiting, photophobia, confusion Develop within 3 to 7 days of exposure Can also cause septicemia or bacteremia Treatment must be started as soon as possible 10 to 15% death rate 11 to 19% will have long term disabilities such as loss of limbs, deafness, nervous system problems, or brain damage

19 Meningococcal Vaccination (MCV4) Recommendations Arkansas School Requirements regarding meningococcal vaccine 7 th graders must have one dose of MCV4 Second dose at age 16 (as of September 1 st ) with minimum interval of 8 weeks since 1 st dose

20 Meningococcal Serogroup B Outbreaks in US Ohio University: 7 cases (March 2010) Princeton University: infected 9 people and resulted in one death (March 2013 through 2014) University of California Santa Barbara: 4 cases (December 2014) University of Oregon: 6 cases confirmed ( )

21 Meningococcal B Vaccination Indicated for use in individuals 10 through 25 years old Suspension (shake before use) ACIP Category B recommendation (clinician s discretion) Do not use interchangeably Complement-mediated antibody-dependent killing of N. meningitidis Trumenba Three dose series given IM, 0, 2, and 6 months (same as HPV vaccine) Composed of two recombinant lipidated factor H binding protein (fhbp) Bexsero Two doses given 1 month apart NHBA, NadA, fhbp, and PorA are proteins on surface of meningococci and contribute to the ability of bacterium to cause disease Complement-mediated antibody-dependent killing of N. meningitidis Clinical trials studied concomitant administration with HPV4 vaccine Prescribing information for Tumenba and Bexsero ACIP Recommendation from February 2015 meeting

22 Age Restrictions for Administration of Medications Medication Patient Age Protocol or Rx Only Influenza vaccine 7 years and older Protocol or Rx All other immunizations / vaccinations (flu, zoster, tetanus, pertussis, etc.) 18 years and older Protocol or Rx All other immunizations 7 to 17 years old Rx only Other medications* 7 years and older Rx only *Other classes of medications Arkansas pharmacists can administer: Allergy medications Vitamins Minerals Antihyperglycemics Antinausea 22

23 Arkansas Immunization Information System Online database of immunizations received by Arkansans Helps keep track of immunizations given and vaccine inventory Required by law to report any vaccine given to any person 21 years of age or younger Voluntary reporting for any vaccine given to any person 22 years of age or older Application for access to registry can be found at Webinars to train pharmacists on the registry are available 23

24 Insurance Coverage of Pharmacist-Administered Immunizations Insurer Vaccine Copay Admin Fee Special Criteria Medicare Part B Influenza 0 n/a Including high dose Pneumonia 0 n/a 2 (PCV13 and PPSV23) after age of 65 years Hep B Pharmacy not able to bill High Risk Only PCV13 and PPSV23 must be separated by 1 year to be paid by Medicare Part B Influenza (Advantage Plan) 0 n/a Including high dose Medicare Part D Pneumonia (Advantage Plan) 0 n/a Tdap Yes Yes Zoster Yes Yes All ACIP-recommended immunizations Yes Yes CMS requires Medicare Part D plans to pay administration fees on all vaccines; usually there will be a copay to the patient Arkansas Medicaid Flu and Pneumonia 0 No Only patients over 19 years old Billed to medical plan Only pays a total of $12.06 for flu and $12.38 for PPSV23 Blue Cross Blue Shield Federal Influenza 0 n/a Zoster HPV All ACIP-recommended and FDAapproved 0 Yes* immunizations *Admin fee paid when given by a Preferred retail pharmacy that participates in their vaccine network 24

25 Insurance Coverage of Pharmacist-Administered Immunizations (continued) QualChoice Influenza 0 Yes Zoster 0 Yes Over 60 years old Arkansas Blue Cross Blue Shield Private / Commercial Plans All ACIP- recommended and FDA-approved immunizations 0 Yes Billed through pharmacy dispensing software Pharmacist can bill medical plan through AHIN; must be credentialed for medical network Arkansas State Employees Influenza 0 n/a Zoster 0 Yes Over 50 years old HPV 0 Yes All ACIP- recommended and FDA-approved immunizations 0 Yes Tricare Influenza 0 n/a Pneumonia 0 n/a Zoster 0 Yes All ACIP- recommended immunizations 0 Yes 25

26 Updates to Immunization Recommendations Use of pneumococcal conjugate vaccine (PCV13) in adults Immunization indications for patients with diabetes Immunizations during pregnancy Influenza vaccine recommendations for

27 Pneumococcal Pneumonia Vaccination Pneumococcal Polysaccharide Vaccine (PPSV) FDA approved for adults 50 years of age and older and people greater than or equal to 2 years of age at increased risk for pneumococcal disease ACIP All people 65 years and older People years old who smoke People years old who have asthma People at least 2 years old with chronic illness Contains 11 serotypes not found in PCV13 More efficacious against bacteremia than pneumonia Not adequately effective in children younger than 2 years Pneumococcal Conjugate Vaccine (PCV) FDA approved for adults 50 years and older and children 6 weeks through 17 years of age Approval based upon serology ACIP recommends one dose for all patients 65 years of age and older in addition to PPSV23 Give PCV13 first, then 6 to 12 months later give PPSV23 Both PPSV23 and PCV13 Recommended for patients greater than 19 years of age who are at highest risk of pneumococcal disease such as patients Immunocompromising conditions (including immunosuppressive drug therapies) Functional or anatomical asplenia CSF leaks Cochlear implants Kidney or liver disease

28 Three Groups of Patients for Pneumococcal Immunization Recommendation All people 65 years and older HIGH RISK Adults younger than 65 years old with Chronic lung disease (COPD, emphysema, asthma) Chronic cardiovascular disease Diabetes Chronic renal or liver failure Alcoholism Smokers Residents of nursing home or long-term care facilities HIGHEST RISK Adults younger than 65 years old with Cochlear Implants, cerebrospinal al fluid leaks, immunocompromising condition, functional or anatomic asplenia (sickle cell) 28

29 Revaccination With PPSV23 Revaccinate these people: People older than 65 years who received initial dose(s) at least 5 years ago and when younger than 65 years People 2 64 years at highest risk of death (e.g., asplenia, immunosuppression, sickle cell disease), who received initial dose at least 5 years ago 29

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31 Immunocompromised Patients 19 to 64 Years ACIP Recommendations (HIGHEST RISK) It is possible that these patients could receive 3 doses of PPSV23 in their lifetime. ACIP. MMWR. 2012;61(40):

32 Sequential Administration and Intervals for PCV13 and PPSV23 Minimum interval between PCV13 and PPSV 23 is 8 weeks

33 Medicare Coverage of Pneumococcal Immunizations Medicare Part B will cover 2 pneumococcal pneumonia vaccinations after 65 years of age PCV13 and PPSV23 CMS has updated their coverage retroactive to October 1, 2014 Doses must be separated by a minimum of 11 months For more information from CMS please go to: Guidance/Guidance/Transmittals/Downloads/R3159CP.pdf

34 Diabetes

35 Hepatitis B and Diabetes CDC Recommendations Persons with diabetes younger than age 60 years as soon as feasible after diagnosis Persons with diabetes who are age 60 years or older at the discretion of the treating clinician Need for assisted blood glucose monitoring in long-term care facilities Likelihood of acquiring hepatitis B infection and complications Likelihood of immune response to vaccination Recommendations from Advisory Committee on Immunization Practices (ACIP)

36 Why vaccinate? MMWR Dec 23, 2011 noted 29 outbreaks of hepatitis B in one or more long term care facility 25 involved adults with diabetes Concluded that persons aged 23 to 59 with no other hepatitis B risk factors were 2.1 times more likely to develop hepatitis B 60 years and older were 1.5 times more likely Case fatality rate from hepatitis B with diabetes vs without (5% vs 2%) Outbreaks resulted from exposure to hepatitis B from blood glucose testing devices Inadequate cleaning Using lancing devices for multiple patients Hepatitis B vaccination strongly recommended for younger adults with diabetes August 1, 2012 Pharmacy Today

37 Pregnancy

38 Pregnancy Influenza Case reports and limited studies suggest that pregnancy increases the risk of serious complications from influenza infection Give in 2 nd or 3 rd trimester Tetanus / diphtheria / acellular pertussis Given during each pregnancy between 27 and 36 weeks If not given during pregnancy give immediately postpartum Indicated to protect unborn child Live vaccines are contraindicated

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41 Seasonal Influenza United States 141 pediatric deaths Hospitalization rate for people 65 years and older was per 100,000 (highest since data collection started in season) Arkansas 74 deaths 56 among adults 65 and older 4 pediatric H3N2 predominated season 2/3 rd s of strains analyzed at CDC had drifted CDC reminded clinicians about the importance of early antiviral medications for treatment of flu Updated June 3, 2015

42 Influenza Vaccine Recommendations for Continue universal recommendations. All people aged 6 months and older be vaccinated annually against influenza. Did NOT renew the preference for using LAIV instead of IIV in healthy children 2 to 8 years of age. Influenza vaccine strain for season A/California/7/2009 (H1N1) A/Switzerland/2013 (H3N2) B/Phuket/2013 (Yamagata lineage) Quadrivalent will include B/Brisbane/60/2008-like virus

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44 Patient Case Family of 3 with a son getting ready to go off to college presents to pharmacy for needed vaccinations for admission to college Son is 17 years old

45 Vaccination history Last Tdap when he was 12 years old Meningococcal at 12 years 2 dose of hepatitis A 3 doses of hepatitis B 4 doses of polio 1 dose of MMR before kindergarten 1 dose of varicella in kindergarten

46 Arkansas College / University Immunization Requirements

47 Mom Mom is 45 years old with no chronic conditions Up-to-date on childhood immunizations Only vaccine she has had as an adult was a flu shot several years ago, but it made her sick

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49 Dad Dad is 50 year old with rheumatoid arthritis What do we need to know about dad?

50 Dad s Medical History Medications include adalimumab and ibuprofen Up-to-date on childhood immunizations Received a pneumonia vaccine 10 years ago

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52 Become Part of the Immunization Neighborhood Collaboration, coordination, and communication among immunization stakeholders dedicated to meeting the immunization needs of the patient and protecting communities from vaccine-preventabledisease Pharmacists role in immunizations: Advocate Facilitate Vaccinate