Addressing the Challenges of Adult and Adolescent Vaccinations:

Transcription

1 Addressig the Challeges of Adult ad Adolescet Vacciatios: Improvig Cliical ad Ecoomic Outcomes i Immuizatios A CME/CNE Approved Activity This activity is supported by a educatioal grat from Merck & Co.

2 Addressig the Challeges of Adult ad Adolescet Vacciatios: Improvig Cliical ad Ecoomic Outcomes i Immuizatios Istructios for CME/CNE: Activity is valid from December 1, 2018 to November 30, A score of 70% must be achieved o the post-test to receive cotiuig educatio credits. Read the moograph, aswer the post-test, complete the evaluatio form, ad sed completed post-test ad evaluatio to: By Jeremy Williams at jwilliams@amcp.org By Fax: Jeremy Williams at By Mail: Jeremy Williams NAMCP CME Dept Waterfrot Drive, Suite 101 Gle Alle, VA Authors: Dr. Rachel N. Caskey, MD, MPP is a Associate Professor of Iteral Medicie ad Pediatrics at the Uiversity of Illiois at Chicago, Chicago, IL. Dr. David Jay Weber, MD, MPH, MHA is a Professor of Medicie i Pediatrics ad Epidemiology ad Associate Chief Medical Officer at UNC Health Care. He is also Medical Director of Hospital Epidemiology at the Uiversity of North Carolia i Chapel Hill, NC. Learig Objectives: 1. Describe adolescet vaccie-prevetable coditios. 2. Examie guidelies ad recommedatios about adolescet immuizatios. 3. Assess the latest cliical guidelies regardig the timig of HPV immuizatios i pretees ad tees. 4. Discuss the prevalece of HPV ifectio, the types of cacers it causes ad the ecoomic impact of HPV vacciatio. 5. Itegrate strategies to overcome perceived barriers to HPV vacciatio i the adolescet settig. 6. Describe commo barriers to effective immuizatio practices amog diverse patiet populatios. 7. Examie curret adult vacciatio recommedatios for the iflueza, peumococcal, tetaus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap), ad herpes zoster vaccies. 8. Provide recommedatios for vacciatios i adult immuocompromised patiets. 9. Employ the recommedatios for the iflueza vaccie to optimize immuizatio efforts ad decrease the cost burde of iflueza ad its complicatios. 10. Idetify strategies to address commo barriers ad misperceptios to effective immuizatio practices. Faculty Disclosure: Dr. Caskey has o fiacial relatioships to disclose. Dr. Weber serves o a advisory pael or group for Merck ad Pfizer ad as a cosultat for Merck ad Pfizer. He is o the Speaker s Bureau for Merck. All material has bee peer reviewed for bias. Plaig Committee Disclosure Bill Williams, MD; Jacquelie Cole, RN, CPHQ, CMCN; ad Jeremy Williams have o relevat fiacial relatioships to disclose. Accreditatio ad Desigatio The Natioal Associatio of Maaged Care Physicias (NAMCP) is accredited by the Accreditatio Coucil for Cotiuig Medical Educatio to provide cotiuig medical educatio for physicias. NAMCP desigates this edurig material for a maximum of 1 AMA PRA Category I credits. Each physicia should claim credit commesurate with the extet of their participatio i the activity. The America Associatio of Maaged Care Nurses is accredited as a provider of cotiuig ursig educatio by the America Nurses Credetialig Ceter s Commissio o Accreditatio. Nurses who complete this activity ad achieve a passig score will receive 1 hour i cotiuig ursig credit. This activity has bee approved by the America Board of Maaged Care Nursig for 1.0 cotact hours toward CMCN recertificatio requiremets. This activity is supported by a educatioal grat from Merck & Co.

3 Addressig the Challeges of Adult ad Adolescet Vacciatios: Improvig Cliical ad Ecoomic Outcomes i Immuizatios Post-Test Questios 1. What is the major reaso for the success of mass vacciatio i U.S.? a. ACIP recommedatios b. School-madates c. Medicare requiremets d. Cosumer educatio 2. Every dollar spet o childhood vacciatio results i i cost savigs. a $1 b. $5 C. $10 d. $50 3. Which of the followig groups provides the CDC with advice regardig immuizatios ad their fial recommedatios are official CDC recommedatios? a. Food ad Drug Admiistratio b. America Medical Associatio c. America Society of Pediatrics d. Advisory Committee o Immuizatio Practices 4. Which of the followig is NOT a accurate best practice guidelie? a. Missed dose(s) require a restart of a give vaccie series. b. Iactivated vaccies are safe for immuocompromised ad pregat persos. c. Iflueza ad Tdap are specifically idicated for pregat wome. d. Vaccie doses ca be provided at itervals beyod those recommeded but itervals caot be shorteed. 5. Optimally, whe should iflueza vacciatios start? a. Ed of September b. Ed of October c. Begiig of December d. Begiig of Jauary 6. Admiistratio of either PPSV23 or PCV13 is recommeded for adults greater tha 65 years of age. a. True b. False 7. Which of the followig is preferred i the guidelies for the prevetio of herpes zoster ad related complicatios i those 50 ad older? a. Shigrix b. Zostervax c. Varivax d. Varilrix 8. Which of the followig vaccies prevets certai types of cacer? a. Tdap b. Yellow fever c. HPV d. Rubella 9. Which of the followig is the best strategy for improvig HPV vacciatio rates i adolescets? a. Discuss the sexual trasmissio of the virus with parets b. Preset iformatio o the beefits of vacciatio ad low risk of adverse effects. c. Require HPV vacciatio for high school attedace. d. Give less iformatio rather tha more ad aouce that vacciatio will occur. 10. I geeral, which of the followig is effective for icreasig commuity demad for vacciatio? a. Fiacial icetives b. Feedback o prescriber performace c. Cliet remider systems d. Ehaced access at schools Activity Evaluatio ad Improvemet Process Please rate this activity o the followig scale: 4 - Excellet 3 - Good 2 - Fair 1 - Poor 1. Based o the cotet preseted, I am better able to: Describe adolescet vaccie-prevetable coditios. Examie guidelies ad recommedatios about adolescet immuizatios. Assess the latest cliical guidelies regardig the timig of HPV immuizatios i pretees ad tees. Discuss the prevalece of HPV ifectio, the types of cacers it causes ad the ecoomic impact of HPV vacciatio. Itegrate strategies to overcome perceived barriers to HPV vacciatio i the adolescet settig. Describe commo barriers to effective immuizatio practices amog diverse patiet populatios. Examie curret adult vacciatio recommedatios for the iflueza, peumococcal, tetaus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap), ad herpes zoster vaccies. Provide recommedatios for vacciatios i adult immuocompromised patiets. Employ the recommedatios for the iflueza vaccie to optimize immuizatio efforts ad decrease the cost burde of iflueza ad its complicatios. Idetify strategies to address commo barriers ad misperceptios to effective immuizatio practices. 2. The activity ad preseters were free of bias. 3. The activity was applicable to my positio. 4. How cofidet are you i maagig patiets based o this activity? (4 very cofidet - 1 ot cofidet) 5. Do you pla to chage maagemet strategies or patiet care i your orgaizatio or practice based o the cotet preseted? 0Yes D No 6. If yes, what chages do you pla to implemet i maagemet strategies or patiet care i your orgaizatio or practice? 7. Did the cotet of the activity help i meetig your above goal? 0Yes D No

4 Tape this edge after foldig ad before mailig. Fold o this crease secod Place Stamp Here Natioal Associatio of Maaged Care Physicias CME Departmet Attetio: Jeremy Williams 4435 Waterfrot Drive, Suite 101, Gle Alle, VA Fold o this crease first Name: Credetials: Mailig Address: City, State, Zip: Phoe: Sed my certificate by: G U.S. Mail G

5 JMCM JOURNAL OF MANAGED CARE MEDICINE 4435 Waterfrot Drive, Suite 101 Gle Alle, VA (804) fax (804) EDITOR-IN-CHIEF J. Roald Hut, MD PUBLISHER Jeremy Williams Joural of Maaged Care Medicie The Official Joural of the NAMCP MEDICAL DIRECTORS INSTITUTE A Peer-Reviewed Publicatio TABLE OF CONTENTS Immuizatios Moograph Istructios for CME/CNE... 2 JOURNAL MANAGEMENT Douglas Murphy Commuicatios Ic. P.O. Box Richmod, VA (804) fax (703) MANAGING EDITOR Barry Barum barry.barum@douglasmurphy.com Post-Test Questios... 3 Activity Evaluatio ad Improvemet Process... 3 Addressig the Challeges of Adult ad Adolescet Vacciatios: Improvig Cliical ad Ecoomic Outcomes i Immuizatios Rachel N. Caskey, MD, MPP; David Jay Weber, MD, MPH... 6 GRAPHIC DESIGN Douglas Murphy Commuicatios, Ic. Custom Article Reprits High quality reprits of idividual articles are available i prit ad electroic formats. Cotact Jeremy Williams, jwilliams@amcp.org, for reprits. ISSN: The Joural of Maaged Care Medicie is published by NAMCP Medical Directors Istitute. Corporate ad Circulatio offices: 4435 Waterfrot Drive, Suite 101, Gle Alle, VA 23060; Tel (804) ; Fax (804) Editorial ad Productio offices: P.O. Box 71895, Richmod, VA ; Tel (804) ; Fax (703) Advertisig offices: Sloae Reed, 4435 Waterfrot Drive Ste 101, Gle Alle, VA Tel (804) , Fax (804) All rights reserved. Copyright No part of this publicatio may be reproduced or trasmitted i ay form or by ay meas, electroic or mechaical, icludig photocopy, recordig, or ay iformatio storage or retrieval system, without writte coset from the publisher. The publisher does ot guaratee, either expressly or by implicatio, the factual accuracy of the articles ad descriptios herei, or does the publisher guaratee the accuracy of ay views or opiios offered by the authors of said articles or descriptios. POSTMASTER: Sed address chages to The Joural of Maaged Care Medicie, 4435 Waterfrot Drive, Suite 101, Gle Alle, VA Immuizatios Moograph Joural of Maaged Care Medicie 5

6 Addressig the Challeges of Adult ad Adolescet Vacciatios: Improvig Cliical ad Ecoomic Outcomes i Immuizatios Rachel N. Caskey, MD, MPP; David Jay Weber, MD, MPH, MHA Vacciatio programs are amog the most widely used ad cost-effective public health itervetios i the Uited States (U.S.). Vacciatios were amed the umber oe greatest public health achievemet i both periods 1900 to 1998 ad 2001 to 2010 by the Ceters for Disease Cotrol ad Prevetio (CDC). 1,2 Mass vacciatio has led to cotrol of multiple ifectious diseases. Exhibit 1 illustrates the dramatic decrease i vaccie-prevetable diseases i the U.S. 3 The major reaso for the success of mass vacciatio i the U.S. stems from school madates; there is ow a growig tred toward workplace madates, which should help improve adult vacciatio rates. Vaccies are ot oly effective i reducig morbidity ad mortality, they are also cost effective. I a aalysis of a birth cohort of 4.2 millio childre, routie childhood immuizatio preveted 20 millio vaccie-prevetable diseases ad 42,000 deaths due to vaccie-prevetable disease. 4 Vacciatig these 4.2 millio childre cost approximately $7.5 billio; however, the savigs are estimated to be over $76 billio (direct ad idirect costs). 4 Importatly, every dollar spet o childhood vacciatio results i $10 i cost savigs (a beefit to cost savigs of 10 to 1). Few other medical itervetios have this degree of beefit to cost savigs. Adult ad adolescet vaccie programs have also bee show to be cost savig. The ideal vaccie is potet, iexpesive to produce, stable at room temperature, ad safe. Ideally, vaccies would have few or o systemic adverse effects, a log shelf life, ad would be safe for use i pregat wome. Other factors that would make a ideal vaccie are a kow correlate of immuity, a easily measured correlate of immuity, log-lived immuity with o eed for boosters ad efficacy ot affected by circulatig immuity. Lastly, a oral vaccie, rather tha a itramuscular or subcutaeous route of admiistratio, would be desirable. Ufortuately, there are o ideal vaccies; however, some of them are close. Exhibit 2 lists the may goals of vacciatio ad a sigle vaccie ca have multiple goals. For example, measles vaccie ca prevet disease pre-exposure ad post-exposure, provide herd protectio, ad elimiate or eradicate disease. Aother example is iflueza vaccie. I a give seaso, the vaccie might be 50 percet effective i prevetig ifectio, but 70 percet effective for reducig severity (i.e., prevetig hospitalizatio ad death). I the U.S., the FDA approves vaccies based o data submitted by maufacturers after review of efficacy ad safety. The Advisory Committee o Immuizatio Practices (ACIP) is the committee that provides the CDC with advice regardig immuizatios; fial recommedatios from the ACIP are official CDC recommedatios. The committee has 15 members, who meet three times aually, ad icludes liaisos from govermet agecies (e.g., Health ad Huma Services, Departmet of Defese) ad professioal orgaizatios (e.g., America Medical Associatio). FDA approval is required prior to ACIP recommedatios ad the ACIP is ot boud by the approved FDA label. The Affordable Care Act icluded a stipulatio that ACIP recommedatios trump FDA label with regard to isurace coverage. The ACIP recommedatios are published i the Morbidity ad Mortality Weekly Report (MMWR). ACIP recommedatios are ow developed usig a explicit evidece-based method based o the Gradig of Recommedatios, Assessmet, Developmet ad Evaluatio (GRADE) approach. Category A recommedatios are made for all persos i a age- or risk-factor-based group. Category B recommedatios are made for idividual cliical decisio makig. The GRADE approach relies o radomized cotrolled trials ad observatioal studies oly ad cosiders stregths (stregth of study, doserespose) ad weakesses (risk of bias, icosistecy, idirectess, imprecisio ad publicatio bias) of each study. The ACIP, ulike the FDA, also relies o costbeefit aalyses i makig recommedatios. The ACIP publishes best practice guidelies for immuizatio. 5 Some key recommedatios are provided i these guidelies which are summarized here. Iactivated vaccies are safe for immuocompromised ad pregat persos; 6 Joural of Maaged Care Medicie Immuizatios Moograph

7 Exhibit 1: Impact of Vaccies i the U.S. 3 Disease Maximum Cases per Year 2015 Cases Percetage Reductio Diphtheria 206,939 (1921) 0 100% Ivasive Hib (< 5 yrs) 20,000 (1984) % Measles^ 894,135 (1941) % Mumps 152,209 (1968) 1, % Meigococcal ACWY 330 (2008) % Pertussis 265,269 (1934) 20, % Polio 21,269 (1952) 0 100% Rubella 57,686 (1969) % Rubella (cogeital) 20,000 ( ) % Tetaus 601 (1948) % ^Idigeous 162, Imported 26 Hib = Hemophilus iflueza type B vaccie ACWY = Serogroups A, C, W, ad Y Exhibit 2: Goals of Vacciatio Prevet coloizatio u Cojugate vaccies for H. iflueza, meigococci, peumococci Prevetio ifectio (pre-exposure) u Live-atteuated polio vaccie Ihaled iflueza vaccie Prevet disease (pre-exposure) u Hepatitis A ad B, tetaus, measles, mumps, rabies, rubella, others Prevet disease (post-exposure) u Measles, varicella, smallpox, hepatitis A & B, tetaus, rabies Reduce disease severity u Iflueza, peumococcal, varicella Prevet reactivatio u Zoster Provide herd protectio u Measles, mumps, rubella, varicella, polio, peumococcal, others Disease elimiatio (Icidece of 0 i a selected area) u Polio (Americas), measles (US) Disease eradicatio (Worldwide eradicatio) u Smallpox, type 2 ad 3 polio virus Reduce icidece of ifectios due to multi drug resistat pathoges (MRSA, Group A strep) u Iflueza, peumococcal, varicella/zoster Prevet cacer u Hepatitis B (liver), HPV (cervical, aal, vagial, vulvar, oral) however, the huma papillomavirus (HPV) vaccie is ot recommeded for use i pregat wome. Iflueza ad tetaus/diphtheria/acellular pertussis (Tdap) are specifically idicated for pregat wome. Live-atteuated vaccies are cotraidicated i immuocompromised ad pregat idividuals, but there are exceptios for mild immuocompromisig states. Breastfeedig is oly a cotraidicatio for smallpox ad yellow fever vacciatio. The guidelies state that vaccie doses ca be provided at itervals beyod those recommeded, but itervals caot be shorteed. I the case of missed dose(s) i a vaccie series, there is ever a eed to restart the series; cliicias should just provide additioal vaccies as per the series recommedatios. Simultaeous admiistratio of vaccies is acceptable i most cases; there are a few exceptios which are detailed i the guidelies. Household cotacts ad other close cotacts of idividuals with altered immue competece should receive all age- ad exposureappropriate vaccies, with the exceptio of the smallpox vaccie. Whe assessig a patiet s vaccie Immuizatios Moograph Joural of Maaged Care Medicie 7

8 Exhibit 3: Recommeded Adult Immuizatio Schedule, Vaccie years years years years > 65 years Iflueza Tdap or Td MMR VAR 1 dose aually 1 dose Tdap the Td booster every 10 years 1 or 2 doses depedig o idicatio (if bor i 1957 or later) 2 doses RZV or ZVL (preferred) 2 doses RZV (preferred) or 1 dose ZVL HPV - Female 2 or 3 doses depedig o age at series iitiatio HPV - Male 2 or 3 doses depedig o age at series iitiatio PCV13 1 dose PPSV23 1 or 2 doses depedig o idicatio 1 dose HepA HepB MeACWY MeB Hib 2 or 3 doses depedig o vaccie 3 doses 1 or 2 doses depedig o idicatio, the booster every 5 years if risk remais 2 or 3 doses depedig o vaccie 1 or 3 doses depedig o idicatio Recommeded for adults who meet the age requiremet, lack documetatio of vacciatio, or lack evidece of past ifectio. Recommeded for adults with other idicatios No recommedatios Tdap = tetaus toxoid, reduced diphtheria toxoid, ad acellular pertussis vaccie Td = tetaus ad diphtheria toxoids MMR = measles, mumps, ad rubella vaccie VAR = varicella vaccie RZV = recombiat zoster vaccie ZVL = zoster vaccie live HPV vaccie = huma papillomavirus vaccie PCV13 = 13-valet peumococcal cojugate vaccie PPSV23 = 23-valet peumococcal polysaccharide vaccie HepA = hepatitis A vaccie HepB = hepatitis B vaccie MeACWY = serogroups A, C, W, ad Y meigococcal vaccie MeB, serogroup B meigococcal vaccie Hib, Haemophilus ifluezae type b vaccie history, self-report is acceptable for iflueza ad peumococcal but ot ay other vacciatios. Documeted immuizatio for measles/mumps/ rubella (MMR) ad varicella trumps serology because serology values are ot perfect. Fially, immuized idividuals should be observed for 15 miutes after admiistratio; the most commo adverse effect is faitig. Adult Immuizatio Exhibit 3 shows the 2018 recommedatios for adult immuizatio. 6 Iformatio to ote o selected vacciatios is covered below. The guidelies cotai additioal specific recommedatios for pregacy, HIV ifected, immuocompromised, aspleia, complemet deficiecies, ed-stage real disease o hemodialysis, heart disease, lug disease, liver disease, alcoholism, diabetes, health care persoel, ad me who have sex with me. Iflueza Optimally, iflueza vacciatio should occur before the oset of iflueza activity i the commuity. Health care persoel should offer vacciatio by the ed of October, if possible. Available iflueza vaccies iclude trivalet ad quadrivalet iactivated (IIV3 ad IIV4), cell culture-based quadrivalet (cciiv4), adjuvated trivalet (aiiv3), high dose trivalet iactivated (HD-IIV3), itradermal quadrivalet (ID4), recombiat quadrivalet (RIV4), ad live 8 Joural of Maaged Care Medicie Immuizatios Moograph

9 Exhibit 4: Adult Peumococcal Vaccie Timig 6 Age 65 Years ad Older *If PCV13 was give before age 65, o additioal PCV13 is eeded No history of peumococcal vaccie PCV13 Prevar 13 1 Year (8 weeks for groups B ad C as defied below) PPSV Peumovax 23 Received PPSV23 before age 65 1 year PCV13 1 Year (8 weeks for groups B ad C as defied below) ad 5 years after prior dose of PPSV23 PPSV23 Received PPSV23 at age 65 or older 1 year PCV13 Age years with Uderlyig Medical Coditio(s) *Prior doses cout towards doses recommeded below ad do ot eed to be repeated. * If PPSV23 was give previously: (1) Wait oe year before givig PCV13. (2) For group B, wait at least five years before givig a secod dose of PPSV23. *No more tha two doses of PPSV23 recommeded before 65th birthday ad oe dose thereafter. A. Smoker, log-term facility residet, or chroic coditios: Heart Disease (excludig hypertesio) Lug Disease (icludig Asthma) Liver Disease (icludig cirrhosis) Diabetes Alcoholism PPSV23 B. Immuocompromised HIV Ifectio Chroic Real Failure Nephrotic Sydrome Aspleia PCV13 8 Weeks PPSV23 5 Years PPSV23 C. CSF Leaks or Cochlear Implats PCV13 8 Weeks PPSV23 For further iformatio, see: vaccies/vpd-vac/peumo/ default.htm atteuated itraasal quadrivalet (LAIV4). Trivalet iflueza vaccie is beig replaced by quadrivalet vaccies. RIV, which does ot cotai ay egg protei, may be admiistered to persos aged 18 years ad older with egg allergy of ay severity. IIV may be used with additioal safety measures for persos with hives-oly allergy to eggs. For the 2018 to 2019 iflueza seaso, providers may choose to admiister ay licesed, age-appropriate iflueza vaccie (IIV, RIV4, or LAIV4). No preferece is expressed for ay iflueza product i the ACIP guidelies. Some studies, but ot all, have show that high-dose IIV3 is better at reducig illess rates i the elderly, compared with stadard-dose IIV3, but adverse effects are higher with the higher dose Peumococcus Two peumococcal vaccies are available: 23-valet peumococcal polysaccharide vaccie (PPSV23) ad 13-valet peumococcal cojugate vaccie (PCV13). The additioal strais covered by PPSV23 provide coverage for a additioal 20 to 30 percet of ifectig orgaisms. Both vaccies work to prevet ivasive disease. The cojugate vaccie prevets peumoia better, ad the polysaccharide vaccie helps prevet meigitis better. The PCV13 has oe strai 6A which is ot icluded i PPSV23. The differeces i the vaccie beefits are why givig both vaccies is recommeded i certai cases (Exhibit 4). 6 Admiistratio of both PPSV23 ad PCV13 are recommeded for adults greater tha 65 Immuizatios Moograph Joural of Maaged Care Medicie 9

10 years of age ad for selected adults 19 to 64 years of age with immuocompromised states, cochlear implats, ad cerebrospial fluid leaks. PPSV23 aloe is recommeded for adults 19 to 64 years of age with certai chroic diseases (heart or lug disease, diabetes mellitus, alcoholism, liver disease, smokig). Booster doses are ot recommeded for PCV13; however, for PPSV23, up to three total doses may be provided per ACIP guidelies. Pertussis The majority of serious cases of pertussis are i ifats ad youg childre. There has bee a icrease i cases of pertussis i the U.S. sice Ifats aged less tha 12 moths accouted for 145 (93%) of 156 pertussis-related deaths reported to the CDC for 2000 to To protect ifats util they are old eough to have immuizatios, pregat wome should receive a dose of Tdap vaccie durig each pregacy (preferably durig weeks gestatio) regardless of the iterval sice the prior Td or Tdap vacciatio. Tdap immuizatio of pregat wome has bee show to trasfer pertussis atibodies to the ewbor ad to be very effective i reducig cases of pertussis from birth to 18 moths of age Idividuals aged 11 ad older who have ot received Tdap vaccie, or for whom vaccie status is ukow, should receive a dose of Tdap followed by tetaus ad diphtheria toxoids (Td) booster doses every 10 years thereafter. Tdap ca be admiistered regardless of the iterval sice the most recet tetaus or diphtheria toxoid-cotaiig vaccie. I cases of wouds, Tdap or Td should be provided as prophylaxis. Zoster Zostavax is a live atteuated vaccie idicated to prevet herpes zoster was origially licesed i the U.S. i It has bee recommeded for all adults over 60 years of age. I 2017, a ew recombiat vaccie, Shigrix, was approved; it is recommeded for the prevetio of herpes zoster ad related complicatios for immuocompetet adults aged 50 years ad older. Shigrix is recommeded for the prevetio of herpes zoster ad related complicatios for immuocompetet adults who previously received Zostavax two moths or loger ago. Screeig for a history of varicella (either verbally or via laboratory serology) before vacciatio for herpes zoster is ot recommeded. Adults with a history of herpes zoster should receive Shigrix. Although ot specifically idicated i immuocompromised patiets, the recombiat vaccie is safe to use i those patiets. Shigrix has a higher efficacy rate (90-97% vs 51-64%), but it causes a higher rate of severe ijectio site reactios ad systemic reactios tha Zostavax. Overall, Shigrix is preferred over Zostavax for the prevetio of herpes zoster ad related complicatios. Meigococcus There are two differet vaccie types to prevet meigococcal ifectios meigococcal serogroups A, C, Y, W (MeACWY, Meactra, Meveo ) ad meigococcal serogroup B vaccies (MeB). Meactra is recommeded for ages 9 moths to 55 years ad Meveo for ages 2 to 55 years. Meigococcal polysaccharide vaccie (MPSV4, Meomue ) is recommeded for ages 56 ad older. Meigococcal serogroup B vaccies (MeB) vaccies iclude Trumeba, idicated for ages 10 to 25 years (give at 0, 6 moths or 0, 1 2, 6 moths) ad Bexsero, idicated for ages 10 to 25 years (2 doses at least 1 moth apart). MeB vacciatio is a Category B recommedatio for adolescets because icidece of meigococcal disease is decreasig, meigococcus serogroup B disease is ucommo i adolescets ad adults, ad the duratio of protectio is ukow. However, outbreaks cotiue to occur ad there is substatial morbidity ad mortality with meigococcal disease. Hepatitis B The rate of hepatitis B virus (HBV) ifectio has dramatically declied sice the itroductio of the vaccie. Strategies to elimiate HBV trasmissio i the U.S. iclude screeig of all pregat wome, prophylaxis (HBV vaccie ad hepatitis B immue globuli) for ifats bor to hepatitis B surface atige (HBs-Ag) positive wome, uiversal vacciatio of ifats begiig at birth, ad routie vacciatio of previously uvacciated childre less tha 19 years of age. Vacciatio of at-risk adults is recommeded i those with itraveous drug use, idividuals who have uprotected sex, household cotacts of persos with chroic HBV, health care persoel, hemodialysis patiets, hepatitis C viruspositive patiets, persos with chroic liver disease, HIV-positive idividuals, diabetics, ad travelers to edemic coutries. HBV vaccies (Egerix-B, Recombivax-HB ) are give o a 0, 1, ad 6 moth schedule. A high-dose formulatio is available for hemodialysis patiets. Post-exposure prophylaxis is give to childre bor to HBV-positive wome, health care providers exposed to blood or potetially ifectious material, ad i cases of sexual assault. Heplisav-B is a yeast-derived vaccie prepared with a ovel adjuvat ad admiistered as a twodose series (0, 1 moth) for persos aged 18 ad older. It was approved by the FDA i 2017 ad 10 Joural of Maaged Care Medicie Immuizatios Moograph

11 Exhibit 5: Adolescet Immuizatios 6 Tdap (tetaus, diphtheria, acellular pertussis) u First dose at years old, the every 10 years HPV (Gardasil9) u Two doses, 6+ moths apart, if started before age 15 u Three doses (0, 2, 6 moths) if started 15+ years old Meigitis u Meigitis cojugate (MeACWY) v First dose years old v Booster dose at 16 years old u Meigitis B vaccie v Dose at years old Iflueza (aually) recommeded by the ACIP i It ca be used for revacciatio of health care providers, i immuocompromised persos, ad for patiets o hemodialysis. I a compariso trial, two doses of this vaccie achieved seroprotective ati-hepatitis B levels i 90 to 100 percet of subjects, compared with 70.5 to 90.2 percet of subjects receivig three doses of Egerix-B. 16 Similar rates of adverse effects were see with each vaccie. Multiple outbreaks of HBV associated with blood glucose moitorig plus iadequate ifectio cotrol practices i health care settigs have occurred. 17 Thus, HBV vacciatio should be admiistered to uvacciated adults with diabetes who are aged 19 through 59 years (Category A recommedatio) ad may be admiistered at the discretio of the treatig cliicia to uvacciated adults with diabetes who are 60 years of age or older (Category B). Immuocompromised Patiets All recommeded vaccies should be provided as early i the course of immuosuppressive disease as possible. Vaccies give prior to immuosuppressive therapy result i immuologic memory ad patiets do ot require revacciatio (except whe stem cell trasplatatio occurs). Certai types of corticosteroid therapies are ot a cotraidicatio to live virus vaccie. This icludes short-term regimes (i.e., < 14 days); chroic low- to moderate-dose regimes (< 20 mg predisoe or equivalet per day); log-term, alterative-day therapy with short-actig preparatios; maiteace physiologic doses (replacemet therapy); ad topical, ihaled, or by itra-articular, bursal, or tedo ijectio regimes. All iactivated vaccies (killed whole cell, recombiat, subuit, toxoid, ad polysaccharide) ca be admiistered safely, regardless of immue compromise. Live vaccies should ot be admiistered for at least three moths after immuosuppressive therapy has bee discotiued. Patiets vacciated withi 14 days before startig immuosuppressive therapy should be cosidered uimmuized ad should be revacciated at least three moths after therapy is discotiued, if immue competece has bee restored. Childhood Immuizatio For ifats ad childre, the U.S. primarily has a culture of vacciatio. Providers expect to admiister vaccies ad parets expect their childre to receive vaccies. Except for the small portio of the populatio that refuses vacciatio for their childre, for the most part vaccies are part of pediatric care across the coutry. The ACIP guidelies provide recommedatios for childhood immuizatio. 18 Adolescet Immuizatio The culture of immuizatio is ot as prevalet i adolescet care. For may years, families have cosidered vacciatio as somethig that started i ifacy ad eded at school age. The umber of recommeded vaccies for adolescets has icreased from oe (Td booster) to four [Tdap, HPV, meigitis, iflueza] betwee 2000 ad 2010 (Exhibit 5). 6 Today s parets of adolescets did ot receive these vaccies as teeagers ad may are ot aware of the eed for vacciatio. As show i Exhibit 6, the rates of Tdap ad meigitis vacciatio i 2016 were much higher tha those for HPV. 19 This data shows that school madates work; i may states Tdap ad meigitis are madated for school erollmet i sixth grade or ith grade, but HPV is ot. Access does ot appear to be the issue with the low HPV rates because most isurace plas cover its use. It appears likely to be a combiatio of providers ot recommedig the HPV vacciatio, ad families choosig oly to have state madated vacciatios. HPV Cliicias ad maaged care eed to work to icrease HPV vacciatio rates because it is the most Immuizatios Moograph Joural of Maaged Care Medicie 11

12 Exhibit 6: U.S. HPV Vacciatio Rates Females Males Tdap Meigitis (MeACWY) >1 HPV 3 doses HPV >1 HPV 3 doses HPV commo sexually trasmitted ifectio i the U.S., with more tha 6.2 millio ew geital ifectios every year. 20 Nearly three-quarters of ew ifectios are i the 15 to 24-year-old age group. By 50 years of age, greater tha 80 percet of Americas will have acquired at least oe geital HPV ifectio. Although the peak age of ifectio is 20 to 24 years of age, wome still have a sigificat risk of HPV ifectio throughout their lifetime. 21 The peak age for me to have high-risk HPV (more likely to cause cacer) is 30 to 34 years ad, as with wome, risk for ifectio cotiues throughout their lifetime. 22 HPV is resposible for over 90 percet of cervical, 70 percet of oropharygeal, 91 percet of aal, 75 percet of vagial, 69 percet of vulvar, ad 63 percet of peile cacers. 23 Some researchers believe that all aogeital cacers are caused by HPV, but that has ot yet bee prove. Overall, most ifected people will ot go o to develop HPV-related cacer, but because it is such a prevalet ifectio ad there is the risk of cacer, vacciatio is importat. HPV is ow a recogized cause of oropharygeal cacer (OPC). The icidece of HPV-related OPC is icreasig, particularly amog males. From 1988 to 2004, there was a 225 percet icrease i HPVrelated OPC i the U.S. 24 By 2030, half of all head ad eck cacer cases will be HPV related. Tobacco ad alcohol use remai major risk factors for OPC; however, the icrease i OPC has occurred, despite a decrease i tobacco use. May HPV-positive cacers occur amog ever smokers. If the tred cotiues, HPV-related OPC will exceed the icidece of cervical cacer i comig years; there are already more me with HPV-related cacer tha wome Ufortuately, from a public health perspective, callig HPV ifectio a sexually trasmitted disease (STD) is a issue because the term STD is fraught with stigma ad judgmet. This virus is so prevalet that the mode of trasmissio becomes irrelevat. HPV is trasmitted by ay surface to surface cotact, which is why it is so prevalet. It ca be trasmitted by figer to geital cotact, ad codoms are oly partially effective prevetio (~70%). Some adolescets have tested positive for vagial HPV prior to their first vagial sexual itercourse. 28 Additioally, the virus ca spread across the aogeital regio. For example, this ca icrease risk of aal cacer i someoe who has oly had vagial itercourse. The HPV vaccie has bee available for over 10 years ad has bee demostrated to be safe ad effective. Greater tha 350 millio doses have bee give worldwide. The most commo adverse effects with this vaccie are arm soreess ad myalgias. The safety of HPV vaccie is similar to the safety of all 12 Joural of Maaged Care Medicie Immuizatios Moograph

13 Exhibit 7: Techical ad Admiistrative Barriers to Vaccie Admiistratio Multiple vaccies recommeded for childre, adolescets ad adults Multiple doses of a vaccie may be required u Therefore, trackig required for follow-up doses (both specific vaccie ad timig) u Patiet icoveiece: Multiple visits required Need to store may vaccies i refrigerator or freezer (i.e., may be difficult i office situatio) Iadequate reimbursemet to provider Cost to patiet (although isurace must cover ACIP recommeded vaccies) Patiet cocers about efficacy ad/or safety Lack of physicia support Lack of ifrastructure i U.S. other adolescet vaccies. Withi six years of vaccie approval i the U.S., there was a 89 percet reductio i HPV 6, 11, 16, ad 18 ifectios i females 14 to 24 years of age who received oe or more doses, compared to uvacciated females. 29 Iterestigly, there was a 17 to 49 percet reductio of HPV ifectio i uvacciated females, which is potetially a idicator of herd immuity. A 72 percet declie i HPV 16 ad 18 precacerous cervical lesios was see four years after vacciatio i wome give oe or more doses. Because it ca take may years to develop some of the cacers from HPV (such as OPC), the full cacer prevetio beefit of this vaccie will ot be see for decades. I terms of givig the HPV vaccie, oly the 9 strai vaccie (Gardasil9 ) is curretly marketed i the U.S. The 2 ad 4 strai products have bee discotiued. The two or three doses (depedig o age at start) should be give at least six moths apart, but the iterval ca be as log as oe year. Delayig the time betwee doses delays full immuity; however, the vaccie series does ot have to be restarted if the patiet is late gettig a dose. Uder spacig is more of a cocer tha over spacig. As of today, there is o recommedatio for booster ijectios of HPV vaccie. It will take time to fully uderstad how log immuity lasts from the iitial vaccie series. Strategies to Icrease HPV Vacciatio Specifically for HPV vacciatio, there are challeges to vacciatig adolescets. Parets do ot wat to thik about their childre beig sexually active, but vaccies ca oly prevet disease to which you have ot yet bee exposed. It is importat to immuize before exposure to HPV, but most parets do ot kow how immuizatios work. May cliicias iitially took the wrog approach whe talkig with parets about this vaccie by focusig o sexual trasmissio, ad they scared parets with too much iformatio. The approach to cosider is less iformatio is more. Cliicias ca just state that the patiet will be gettig routie vaccies which iclude HPV. This is how cliicias approach vacciatio for ifats. HPV vaccie eeds to be treated just like all other vaccies, with a aoucemet that vacciatio will occur rather tha a coversatio about whether to vacciate A example would be Today your so is due for three routie vaccies which iclude HPV, meigitis vaccie, ad Tdap (which is tetaus), diphtheria, ad whoopig cough. Someoe will be right i to admiister those vaccies, ad I look forward to seeig you ext year. If questios arise about the HPV vaccie, cliicias ca focus their discussio o why we have a HPV vaccie (cacer prevetio) ad ot the mode of trasmissio. Example statemets ca iclude We ca reduce the chaces of your so havig a cacer experiece. Do you wat to reduce the chaces of your so havig cacer? Parets may ot be thikig about cacer i their adolescets. The media age of cervical cacer diagosis is 47; more tha 14 percet occur before age The oropharyx cacer media age of diagosis is 62 years, but 30 percet occur before age 50. HPV-related OPC typically occurs i those 50 or youger. 34,35 The media age for aal cacer is 60 years, ad more tha 30 percet of cases occur before the age of Overall, HPV is a life course ifectio. It requires prevetio durig adolescece, ca cause disease durig adulthood, ad importatly ifectio ca occur throughout the lifetime. HPV disease prevetio requires a all-out effort by everyoe ivolved. A cliicia s recommedatio is most effective for vacciatio to occur. Overcomig Barriers to Vacciatio I additio to the issues related to HPV vacciatio i adolescets discussed previously, there are umerous other barriers to vacciatio i geeral (Exhibit 7). I oe study, the most commo physicia explaatios for why adults did ot receive peumococcal vaccie Immuizatios Moograph Joural of Maaged Care Medicie 13

14 Exhibit 8: Patiet Barriers to Vacciatio ad Solutios Geeral cocers about vaccie effectiveess or safety u Strog recommedatio by healthcare provider Afraid of ijectio u Use ID4 or LAIV4 for iflueza, use oral typhoid vaccie Cocered about ijectio pai u Distractio (look away, music) u Pretreatmet (30-60 mi) with 5% topical lidocaie (does ot iterfere with immue respose) u Topical refrigerat (vapocoolat) Did kow vaccie was idicated or whe to get it u Automatic remiders based o age or existig medical coditios Might get disease from the vaccie u Educatio Cost ot covered by isurace u Fiacial couselor Icoveiece u Use of pharmacists or pharmacy-based urse practitioers to provide vaccies were lack of well visits, cocer about adverse effects, lack of kowledge, ad fear of eedles. 36 Patiets said that they were healthy ad did ot eed the vaccie, their doctor had ot recommeded it, or they were worried about adverse effects. To help icrease vacciatio rates i all populatios, health care providers ad systems eed to make vacciatios available, assess a patiet s vaccie status at every visit, educate patiets about the risks ad beefits of vacciatio, admiister ad documet vacciatios properly, ad develop procedures for vacciatios. Strategies to improve vacciatio rates ca iclude patiet remiders, ad health systems ad providers parterig with the commuity for educatio ad vacciatio programs. Cliet remider systems, multicompoet itervetios icludig educatio, ad requiremets for etry to schools, childcare facilities, ad colleges are all prove itervetios for icreasig commuity demad for vacciatio. 5 All types of remiders (postcards, letters, ad telephoe or autodialed calls) are effective; telephoe calls are most effective, but are most costly. 37 Recommeded strategies to ehace access to vaccie services iclude reducig out-of-pocket costs; ehacig access through the U.S. Departmet of Agriculture Wome, Ifats, ad Childre program; home visits, outreach, ad case maagemet; ad ehaced access at schools. 5 Strogly recommeded strategies to help providers improve their vacciatio rates iclude automated recall/remider systems, assessmet ad feedback o performace, ad stadig orders. 5 Exhibit 8 lists some patiet-related barriers ad solutios to overcome those barriers. Coclusio Overall, vaccies reduce morbidity ad mortality ad are cost effective. Icreasig rates of HPV vacciatio amog adolescets ad cotiuig to push for improvemets i adult vacciatio rates should both be missios for providers, health systems, ad maaged care. Although there are barriers to vacciatio i all patiet populatios, these ca be overcome with prove strategies. Author Bios Rachel N. Caskey, MD, MPP is a Associate Professor of Iteral Medicie ad Pediatrics at the Uiversity of Illiois at Chicago. David Jay Weber, MD, MPH, MHA is a Professor of Medicie i Pediatrics ad Epidemiology ad Associate Chief Medical Officer at UNC Health Care. He is also Medical Director of Hospital Epidemiology at the Uiversity of North Carolia i Chapel Hill, NC. Refereces 1. Ceters for Disease Cotrol ad Prevetio (CDC). Te great public health achievemets Uited States, MMWR Morb Mortal Wkly Rep. 2011;60(19): Ceters for Disease Cotrol ad Prevetio (CDC). Te great public health achievemets Uited States, MMWR Morb Mortal Wkly Rep. 1999;48(12): Adams DA, Thomas KR, Jajosky RA, et al. Summary of Notifiable Ifectious Diseases ad Coditios - Uited States, MMWR Morb Mortal Wkly Rep. 2017;64(53): Zhou F, Shefer A, Weger J, et al. Ecoomic evaluatio of the routie childhood immuizatio program i the Uited States, Pediatrics. 2014;133(4): Kroger AT, Sumaya CV, Pickerig LK, Atkiso WL. Geeral Recommedatios o Immuizatio Recommedatios of the Advisory Committee o Immuizatio Practices (ACIP). MMWR. 2011;60(RR- 2): Joural of Maaged Care Medicie Immuizatios Moograph

15 6. Ceters for Disease Cotrol. Recommeded Immuizatio Schedule for Adults Aged 19 Years or Older, Uited States, Available at gov/vaccies/schedules/dowloads/adult/adult-combied-schedule.pdf. Accessed 10/17/ Falsey AR, Treaor JJ, Torieporth N, et al. Radomized, double-blid cotrolled phase 3 trial comparig the immuogeicity of high-dose ad stadard-dose iflueza vaccie i adults 65 years of age ad older. J Ifect Dis. 2009;200(2): Izurieta HS, Thadai N, Shay DK, et al. Comparative effectiveess of highdose versus stadard-dose iflueza vaccies i U.S. residets aged 65 years ad older from 2012 to 2013 usig Medicare data: a retrospective cohort aalysis. Lacet Ifect Dis. 2015;15(3): Richardso DM, Medvedeva EL, Roberts CB, et al. Comparative effectiveess of high-dose versus stadard-dose iflueza vacciatio i commuity-dwellig veteras. Cli Ifect Dis. 2015;61(2): DiazGraados CA, Duig AJ, Kimmel M, et al. Efficacy of high-dose versus stadard-dose iflueza vaccie i older adults. N Egl J Med. 2014;371(7): DiazGraados CA, Duig AJ, Jordaov E, et al. High-dose trivalet iflueza vaccie compared to stadard dose vaccie i elderly adults: safety, immuogeicity ad relative efficacy durig the seaso. Vaccie. 2013;31(6): Rohai P, Drake JM. The declie ad resurgece of pertussis i the U.S, Epidemics. 2011;3(3-4): Ceters for Disease Cotrol ad Prevetio (CDC). Updated recommedatios for use of tetaus toxoid, reduced diphtheria toxoid, ad acellular pertussis vaccie (Tdap) i pregat wome Advisory Committee o Immuizatio Practices (ACIP), MMWR Morb Mortal Wkly Rep. 2013;62(7): Vilajeliu A, Gocé A, López M, et al. Combied tetaus-diphtheria ad pertussis vaccie durig pregacy: trasfer of materal pertussis atibodies to the ewbor. Vaccie. 2015;33(8): Becker-Dreps S, Butler AM, McGrath LJ, et al. Effectiveess of Preatal Tetaus, Diphtheria, Acellular Pertussis Vacciatio i the Prevetio of Ifat Pertussis i the U.S. Am J Prev Med. 2018;55(2): Schillie S, Harris A, Lik-Gelles R, Romero J, Ward J, Nelso N. Recommedatios of the advisory committee o immuizatio practices for use of a hepatitis b vaccie with a ovel adjuvat. MMWR Morb Mortal Wkly Rep. 2018;67: Thompso ND, Schaefer MK. Never evets : hepatitis B outbreaks ad patiet otificatios resultig from usafe practices durig assisted moitorig of blood glucose, J Diabetes Sci Techol. 2011;5(6): U.S. Departmet of Health ad Huma Services Ceters for Disease Cotrol. Recommeded Immuizatio Schedule for Childre ad Adolescets Aged 18 Years or Youger, UNITED STATES, Available at Accessed 10/16/ Walker TY, Elam-Evas LD, Sigleto JA, et al. Natioal, regioal, state, ad selected local area vacciatio coverage amog adolescets aged years Uited States, MMWR Morb Mortal Wkly Rep. 2017;66: Due EF, Uger ER, Sterberg M, et al. Prevalece of HPV ifectio amog females i the Uited States. JAMA. 2007;297(8): Due EF, Sterberg M, Markowitz LE, et al. Huma papillomavirus (HPV) 6, 11, 16, ad 18 prevalece amog females i the Uited States Natioal Health Ad Nutritio Examiatio Survey, : opportuity to measure HPV vaccie impact? J Ifect Dis. 2011; 204(4): Giuliao AR, Lazcao-Poce E, Villa LL, et al. The huma papillomavirus ifectio i me study: huma papillomavirus prevalece ad type distributio amog me residig i Brazil, Mexico, ad the Uited States. Cacer Epidemiol Biomarkers Prev. 2008;17(8): Bailey HH, Chuag LT, dupot NC, et al. America Society of Cliical Ocology statemet: Huma papillomavirus vacciatio for cacer prevetio. J Cli Ocol. 2016;34(15): America Cacer Society. Cacer Facts & Figures Available at Accessed 10/16/ Chaturvedi AK, Egels EA, Aderso WF, Gilliso ML. Icidece treds for huma papillomavirus-related ad -urelated oral squamous cell carciomas i the Uited States. J Cli Ocol. 2008;26(4): Jemal A, Ward EM, Johso CJ, et al. Aual report to the atio o the status of cacer, , featurig survival. J Natl Cacer Ist. 2017;109(9). 27. Habbous S, Chu KP, Lau H, et al. Huma papillomavirus i oropharygeal cacer i Caada: aalysis of 5 comprehesive cacer cetres usig multiple imputatio. CMAJ. 2017;189(32):E1030-E Shew ML, Weaver B, Tu W, et al. High frequecy of huma papillomavirus detectio i the vagia before first vagial itercourse amog females erolled i a logitudial cohort study. J Ifect Dis. 2013;207(6): Garlad SM, Kjaer SK, Muñoz N, et al. Impact ad effectiveess of the quadrivalet huma papillomavirus vaccie: A systematic review of 10 years of real-world experiece. Cli Ifect Dis. 2016;63(4): Caskey R, Ades S, Walto SM. HPV vaccie: Less is more. Vaccie. 2016;34(16): Clegg W, Caskey R, Morita J. A 9-Valet HPV Vaccie i Wome. N Egl J Med. 2015;372(26): Brewer NT, Hall ME, Malo TL, et al. Aoucemets versus coversatios to improve HPV vacciatio coverage: a radomized trial. Pediatrics. 2017;139(1). pii: e Natioal Cacer Istitute. Surveillace, Epidemiology, ad Ed Results Program. Accessed 10/16/ Marur S, D Souza G, Westra WH, Forastiere AA. HPV-associated head ad eck cacer: a virus-related cacer epidemic. Lacet Ocol. 2010;11(8): Giuliao AR, Nyitray AG, Kreimer AR, et al. EUROGIN 2014 roadmap: differeces i huma papillomavirus ifectio atural history, trasmissio ad huma papillomavirus-related cacer icidece by geder ad aatomic site of ifectio. It J Cacer. 2015;136(12): Johso DR, Nichol KL, Lipczyski K. Barriers to adult immuizatio. Am J Med. 2008;121(7 Suppl 2):S Szilagyi P, Va J, Bordley C, et al. Itervetios aimed at improvig immuizatio rates. Cochrae Database Syst Rev. 2002;(4):CD Immuizatios Moograph Joural of Maaged Care Medicie 15

16 Notes 16 Joural of Maaged Care Medicie Immuizatios Moograph

17 Immuizatios Moograph Joural of Maaged Care Medicie 17

18 Immuizatios Moograph