Immunization Update for Health System Pharmacists 2015

Eric Crumbaugh, PharmD

Financial Disclosures• Eric Crumbaugh, PharmD

• Speaker’s Bureau• Merck Vaccines

• Pfizer

• Consultant• Pfizer

• Novartis

• Merck

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.

Achievements in Public Health

Vaccine Development1798 Smallpox1881 Anthrax1885 Rabies1896 Cholera, Typhoid1897 Plague1923 Diphtheria1926 Pertussis1927 Tetanus1936 Influenza 1955 IPV1963 Trivalent OPV, Measles1969 Rubella1971 MMR1982 Hepatitis B1987 Hib1995 Varicella, Hepatitis A2005 Tdap2006 Rotavirus, HPV, Zoster

4CDC. MMWR. 1999;48(29):621-9.

Arkansas National Immunization Survey Series Rates and Rankings: 19 to 36 Months

Vaccine Series

and Rank / Year2010 2011 2012 2013 2014

4:3:1:3:3:1:4* 73.6±6.1 66.0±7.5 66.4±7.6 60.6±8.8 66.0±8.2

AR Rank 22 34 36 50 44

5*The series is 4 DTaP, 3 Polio, 1 MMR, >3 Hib, >3 Hep B, >1 Varicella, and >4 Pneumococcal Conjugate vaccines.

Arkansas Kindergartners•CDC reported for 2013-14 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 2013-14 school year can be found at www.cdc.gov/mmwr/preview/mmwrhtml/mm6341a1.htm

Stats from the Arkansas Department of Health.6

Estimated Vaccination Coverage Among Children Enrolled in Kindergarten 2014-15 School Year

Measles

Koplik spots: white spots that occur on the inside of cheeks early in the course of measles

Signs and SymptomsFever up to 105Malaise3 C’s: Cough, coryza, conjunctivitis

Maculopapular rash

• 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 rashhttp://www.cdc.gov/measles/hcp/index.html

United states Measles Outbreaks

Herd Immunity / Community Immunity

2013 – 2014 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

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.

MMR Vaccine Recommendations

Children

• 1st dose given at 12 through 15 months

• 2nd 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

2013 & 2014 NIS-Teen Survey

• For adolescents aged 13-17 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)

Stats from the 2014 / 2013 NIS and the Arkansas Department of Health. 13

Arkansas: 2013• 150 cases of cervical cancer• 50 deaths

American Cancer Society

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

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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

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

HPV Vaccination Coverage Among Adolescents, 2007 to 2013http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6329a3.htm**Shew, J J Infect Dis. 2012

• 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

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

Arkansas School Requirements regarding meningococcal vaccine• 7th graders must have one dose of

MCV4• Second dose at age 16 (as of

September 1st) with minimum interval of 8 weeks since 1st dose

Meningococcal Vaccination (MCV4) Recommendations

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 (3-20-15)

Meningococcal B Vaccination

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)

• Complement-mediated antibody-dependent killing of N. meningitidis

• Clinical trials studied concomitant administration with HPV4 vaccine

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

• 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

Prescribing information for Tumenba and BexseroACIP Recommendation from February 2015 meeting

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

• Allergy medications• Vitamins• Minerals

• Antihyperglycemics• Antinausea

*Other classes of medications Arkansas pharmacists can administer:

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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 www.arrx.org/immunizations

• Webinars to train pharmacists on the registry are available

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Insurance Coverage of Pharmacist-Administered ImmunizationsInsurer 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 OnlyPCV13 and PPSV23 must be separated by 1 year to be paid by Medicare Part B

Medicare Part D

Influenza (Advantage Plan) 0 n/a Including high dose

Pneumonia (Advantage Plan) 0 n/a

Tdap Yes Yes

CMS requires Medicare Part D plans to pay administration fees on all vaccines; usually there

will be a copay to the patient

Zoster Yes Yes

All ACIP-recommended immunizations

Yes Yes

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/aZoster

0 Yes**Admin fee paid when given by a Preferred retail

pharmacy that participates in their vaccine network

HPV

All ACIP-recommended and FDA-approved immunizations

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Insurance Coverage of Pharmacist-Administered Immunizations (continued)

QualChoiceInfluenza 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 Yes25

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 2015 -2016

Pneumococcal Pneumonia VaccinationPneumococcal Polysaccharide Vaccine (PPSV)

• FDA approved for adults 50 years and older and children 6 weeks through 17 years of ageApproval 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

Pneumococcal Conjugate Vaccine (PCV)

• 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 19 – 64 years old who smoke

– People 19 – 64 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

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

Three Groups of Patients for Pneumococcal Immunization Recommendation• All people 65 years and older

• HIGH RISKAdults 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 RISKAdults younger than 65 years old with

• Cochlear Implants, cerebrospinal al fluid leaks, immunocompromising condition, functional or anatomic asplenia (sickle cell)28

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

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Immunocompromised Patients 19 to 64 Years—ACIP Recommendations (HIGHEST RISK)

31

It is possible that these patients could receive 3 doses of PPSV23 in their lifetime.

ACIP. MMWR. 2012;61(40):816-9.

Sequential Administration and Intervals for PCV13 and PPSV23

Minimum interval between PCV13 and PPSV 23 is 8 weeks

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:

http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3159CP.pdf

Diabetes

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)

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

Pregnancy

Pregnancy• Influenza

• Case reports and limited studies suggest that pregnancy increases the risk of serious complications from influenza infection

• Give in 2nd or 3rd 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

Seasonal Influenza 2014 - 2015

United States• 141 pediatric deaths

• Hospitalization rate for people 65 years and older was 319.2 per 100,000 (highest since data collection started in 2005-06 season)

Arkansas• 74 deaths

• 56 among adults 65 and older

• 4 pediatric

• H3N2 predominated season• 2/3rd’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

Influenza Vaccine Recommendations for 2015 - 2016

• Continue universal recommendations. All people aged 6 months and older be vaccinated annually against influenza.

• Did NOT renew the 2014 – 2015 preference for using LAIV instead of IIV in healthy children 2 to 8 years of age.

• Influenza vaccine strain for 2015 – 2016 season• A/California/7/2009 (H1N1)

• A/Switzerland/2013 (H3N2)

• B/Phuket/2013 (Yamagata lineage)

• Quadrivalent will include B/Brisbane/60/2008-like virus

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

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

Arkansas College / University Immunization Requirements

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

Dad

• Dad is 50 year old with rheumatoid arthritis

What do we need to know about dad?

Dad’s Medical History

• Medications include adalimumab and ibuprofen

• Up-to-date on childhood immunizations

• Received a pneumonia vaccine 10 years ago

Become Part of the Immunization Neighborhood

www.pharmacist.com/cdc-hhs-urge-more-vaccination-coverage

• Collaboration, coordination, and communication among immunization stakeholders dedicated to meeting the immunization needs of the patient and protecting communities from vaccine-preventable-disease

• Pharmacists’ role in immunizations:• Advocate• Facilitate• Vaccinate