Influenza, Pneumococcal and Herpes Zoster Vaccination

Transcription

1 Influenza, Pneumococcal and Herpes Zoster Vaccination Chris Campanile, MD, Ph.D Clinical Consultant, Healthcentric Advisors Clinical Associate Professor of Family Medicine, Brown University Alpert Medical School Family Practice Physician, Coastal Hillside Family Medicine This material was prepared by the New England Quality Innovation Network-Quality Improvement Organization (QIN-QIO), the Medicare Quality Improvement Organization for New England, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. CMSRIF

2 Conflict of Interest Statement Chris Campanile, MD, Ph.D has no financial relationships to disclose relating to the subject matter of this presentation 8/28/2018 2

3 Objectives Describe current trends in adult vaccination against influenza, shingles and pneumococcus infection Understand vaccine recommendations for PPSV23 and PCV13 and the new shingles vaccine Discuss innovative ways in which to improve immunization rates with your patients/residents/staff

4 Benefits of Vaccines Prevent symptoms and/or disease Reduce symptom severity/duration Reduce disease complications Reduce disease transmission Control and potentially eliminate or eradicate disease

5 Our Responsibilities Educate our patients Provide a strong recommendation for vaccination Know contraindications and precautions to vaccinations Provide vaccines in a timely fashion, based on most current recommendations Report adverse events related to vaccine administration

6 Influenza

7 Healthy People 2020: Goals and Progress for Influenza Vaccination Population (%) (%) (%) 2020 Goal 2 (%) Adults aged 65 years High-risk adults years HCP: All LTC Hospital Office , 2

8 Percentage of visits for ILI by season

9 Hospitalization Rate for Lab Confirmed Influenza by Season

10 Preventable Diseases Influenza and pneumococcal infection High morbidity and mortality and vaccine-preventable illnesses. The Gerontological Society of America. Comprehensive Report Of The 2013 National Adult Vaccination Program Summit: Developing Champions And Building A Roadmap For Action To Reach The Healthy People 2020 Goals For Adult Vaccination. NAVP; 2013:2-31.

11 Risks for Influenza Complications Age > 65 years Residents of long term care facilities People with chronic conditions chronic pulmonary, metabolic, or CV disorders renal dysfunction hemoglobinopathies immunosuppression, including HIV infection Pregnant women in second or third trimester during the influenza season American Indians and Alaskan Natives Children younger than 5 years and especially those younger than 2 years

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13 Influenza Vaccines-Types Several types Trivalent inactivated influenza vaccine (TIV) Inactivated formulation (IIV3) IM or intradermal 2009: new, higher-dose formulation for persons >65 yo (Fluzone High Dose) Recombinant formulation (RIV) IM only Quadrivalent Inactivated formulation (IIV4) IM only Live attenuated vaccine (LAIV) intranasal Contains NO thimerosal or other preservative Only RIV has no egg protein (safe for egg allergy) Single dose/preservative free syringes and multi-dose vials Kim D, Bridges C, Harriman K. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older: United States, 2015*. Annals of Internal Medicine. 2015;162(3):214.

14 For the U.S. Influenza Season, CDC and its Vaccines Advisory Committee (ACIP) recommend Providers use any licensed, ageappropriate influenza vaccine (Inactivated influenza vaccines (IIV), Recombinant influenza vaccine (RIV), or live attenuated influenza vaccine (LAIV4) with no preference expressed for one vaccine over another. (LAIV4 is again a recommended option for people for whom it is otherwise appropriate.)

15 >6 months old should be vaccinated Influenza vaccine indications If > 6 months and healthy, including pregnant women and those with hives-only allergy to eggs can give IIV If 2-49 yo, healthy, and without high-risk medical conditions LAIV can be given If > 18 yo can give RIV Contains NO egg protein; can be given to people with egg allergy of any severity Intradermal vaccination approved only for persons age High-dose IIV approved only for adults > 65 yo Health care personnel should get IIV or RIV If caring for immunocompromised, and LAIV given, avoid contact for 7 days post-vaccination *Children can shed virus for up to 3 weeks 1. Kim D, Bridges C, Harriman K. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older: United States, 2015*. Annals of Internal Medicine. 2015;162(3): (Footnotes)

16 Varies according to: Immunogenicity and Vaccine Efficacy Match between circulating and vaccine strains Remaining immunity from prior vaccine Antigenic drift Age Overall health of person GOOD match, 60-75% effective 2 in preventing clinical influenza in healthy individuals; less so with age > 65 yo, still, though: 50-60% reduction in influenza-related hospitalization in >65 yo 1 80% effective in preventing death from influenza in persons > 65 yo

17 Recommendations for Patients Who Report Egg Allergy Can the person eat lightly cooked egg (eg, scrambled) without reaction? No After eating eggs or egg-containing foods, does the person experience ONLY hives? No Yes Yes Administer vaccine per usual protocol Administer RIV3 if patient is ages 18 through 49 y OR Administer IIV Observe for reaction for at least 30 minutes after vaccination After eating eggs or egg-containing foods, does the person experience symptoms of anaphylaxis? Yes CDC. MMWR. 2014;63: Slide borrowed and modified with permission from Dr. Stefan Gravenstein s presentation Targeting Influenza in Your Hospital: Who s At Risk, March 2015 Administer RIV3 if patient is ages 18 through 49 y OR If RIV3 is not available, or patient is age < 18 y or > 49 y, IIV should be administered by a physician with experience in the recognition and management of severe allergic conditions Observe for reaction for at least 30 minutes after vaccination

18 Cytokine Response Influenza infection is localized within the respiratory tract, but the release of cytokines produces a systemic response Systemic symptoms caused by cytokines include myalgia, malaise, and fever People with less cytokine are less symptomatic

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20 CDC Estimates of Influenza Mortality 8.5 % of all pneumonia and influenza deaths are estimated to be related to influenza 1 2.1% of all respiratory and circulatory deaths are estimated to be related to influenza 1 Majority of deaths occur in persons > 65 years and often as a complication of secondary infection or other comorbid conditions (ie. CHF, COPD) 1.

21 Adverse Effects Local injection-site reaction (15-20% 1 ) Malaise, fevers, chills, myalgias (occur at same rate as placebo) Allergic reaction (rare) Note thimerosol can potentiate hypersensitivity, but that this is usually a Type IV (delayed-type) hypersensitivity Guillain-Barre Syndrome Prevalence is 1-2 cases per 100,000 so estimation of risk is difficult Swine Flu vaccine is the one most commonly associated with GBS 1 Do not give if person has developed GBS within 6 weeks of prior vaccination Flu??? Inactivated virus -> cannot cause the flu

22 Vaccine Adverse Event Reporting System (VAERS) National Childhood Vaccine Injury Act (NCVIA) of 1986 Must provide patients with vaccine information statement (VIS) for indicated vaccines Report adverse events which may, or may not, be related to the vaccine

23 Pneumonia

24 Healthy People 2020: Goals and Progress for Pneumococcal Vaccination Population (%) (%) (%) 2020 Goal 2 (%) Adults aged 65 years High-risk adults years Table 75 from National Center for Health Statistics. Health, United States, 2014: With Special Feature on Adults Aged Hyattsville, MD

25 S. Pneumoniae How Common Is It? There is invasive and non-invasive pneumococcal disease Invasive (IPD): bacteremia, meningitis Up to 12,000 pneumococcal bacteremia hospitalizations annually 20% mortality (60% in elderly) ~ meningitis» 8% mortality kids» 22% mortality - adults Noninvasive: pneumonia, acute otitis media Up to 36% of adult CAP due to S. pneumoniae 100, ,000 hospitalizations annually due to pneumococcal pneumonia, with 5-7% mortality (higher in elderly) In patients yo with hematologic malignancies: 186/100,000 cases annually In patients yo with HIV: 173/100,000 cases annually

26 Polysaccharide vs. Conjugate Vaccines and Immunogenicity (Free) Polysaccharide vaccines induce a B-cell-dependent immunity Helps prevent bacteremia (60-70% effective against invasive disease) 1, less effective against pneumococcal pneumonia Conjugate vaccine gets B- and T-cell immunity memory response This involves mucosal surfaces, so helps with localized, nonbacteremic infection too (i.e., otitis media) PCV7 reduced invasive disease by 97%; reduced episodes of x-ray confirmed pneumonia, AOM, tympanostomy tube placement, and nasopharyngeal carriage Pletz M, et al.pneumococcal vaccines: mechanism of action, impact on epidemiology and adaption of the species. International Journal of Antimicrobial Agents. 2008;32(3):

27 ACIP MMWR :34 Percentage of Invasive Pneumococcal Disease Caused by Serotypes in 3 Pneumococcal Vaccines

28 In 2010, PCV13 replaced PCV7 Efficacy of Pneumococcal 7 serotypes of PCV7 + 6 more Conjugate Vaccine Good for IPD against those 13 serotypes; and OM against 7 serotypes common to PCV7 There has been decreased penicillin resistance as well! 1 Compared with PCV7 alone, IPD in children < 5 years declined by 64% 2 IPD caused by PCV13 (excluding PCV7) serotypes decreased by 93% by summer In adults, IPD overall decreased by 12-32% and PCV13-PCV7 serotypes IPD decreased by 58-72% (depending on age) ~30,000 cases of IPD and 3000 deaths prevented 2 1. Pilishvili T, Noggle B, Moore M. Chapter 11: Pneumococcal Disease. In: Roush S, Baldy L, ed. Manual For The Surveillance Of Vaccine-Preventable Disease. 5th ed. Atlanta, GA: Centers for Disease Control and Prevention; Moore M, et al. The Lancet Infectious Diseases. 2015;15(3):

29 Pneumococcal Vaccine Timing Flow Chart (age 65+ and high-risk adults)

30 Shingles

31 What is Shingles? (aka Herpes Zoster) Shingles is caused by Varicella Zoster Virus (VZV) Primary infection with VZV causes highly contagious Chicken Pox Reactivation causes Shingles VZV can reactivate later in a person s life and cause Shingles or Herpes Zoster Shingles rash Chicken Pox rash 31

32 Symptoms First: localized pain- burning, throbbing or stabbing Before rash appears days to weeks later Then, rash: painful maculopapular vesicular Along nerve pathways Typically, unilateral: face or trunk Vesicles dry and heal in 2-4 weeks Fever Headache Photophobia Nausea Source: CDC/John Noble, Jr., M.D. 32

33 Complications Postherpetic Neuralgia (PHN) Risk factors include Age 50 Severe pain at any time It can begin before or after onset of rash Extensive rash Trigeminal or ophthalmic distribution of rash Herpes Zoster Ophthalmicus ~15% of HZ cases Involves ophthalmic division of trigeminal nerve Untreated 50-70% acute ocular complications Can chronic ocular complications, blindness CDC. Prevention of Herpes Zoster. MMWR (RR-5): p. 1-30

34 Complications Neurologic complications Myelitis Encephalitis, Meningoencephalitis, Ventriculitis Cranial nerve palsies Ischemic stroke syndrome VZV viremia Cutaneous dissemination (bilateral) Pneumonia, hepatitis Disseminated intravascular coagulation Dermatologic complications Secondary rash infections Permanent scarring and changes in pigmentation CDC. Prevention of Herpes Zoster. MMWR (RR-5): p. 1-30

35 Complications: PHN Pain 30 days: in 18-30% of zoster cases Mild to excruciating pain after rash cleared Constant, intermittent, or with trivial stimuli May persist weeks, months or even years Can cause Sleep, mood, work disruption Activities of daily living impairment Social withdrawal and depression CDC. Prevention of Herpes Zoster. MMWR (RR-5): p. 1-30

36 Shingles Vaccine Options

37 Zostavax (ZVL) ZVL (Zostavax) A live attenuated virus vaccine Single sub-cutaneous (SQ) dose

38 Shingrix (RZV) RZV (Shingrix) Recombinant zoster vaccine 2-dose intramuscular (IM) series 2 nd dose 2-6 months after the first 38

39 Vaccine: Storage and Durability ZVL (Zostavax) Storage: Freezer (between - 58 and +5 F) for powder containing vial Diluent stored at room temperature (between 68 and 77 F) or refrigerator (between 36 and 46 F) Do not freeze diluent Protect vials from light RZV (Shingrix) Storage: Refrigerator (between 36 and 46 F) Store both vials together in refrigerator before reconstitution protect vials from light DO NOT FREEZE Discard if vaccine has been frozen Source: CDC website (accessed Feb 5, 2018); Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines ; Refer to product package inserts for further.

40 Side Effects ZVL (Zostavax) Injection site reactions In rare instances Disseminated rash Herpes Zoster in immunocompetent recipients Life threatening and fatal complications in immune compromised recipients RZV (Shingrix) A sore arm with mild or moderate pain Redness and swelling at site of injection ~1 out of 6 experience Grade 3 side effects preventing them doing regular activities. Symptoms resolve on their own in about 2-3 days Side effects were more common in younger people Patients might have a reaction to either or both doses Source: CDC website (accessed Feb 5, 2018); Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines ; Refer to product package inserts for further.

41 ACIP Recommendations 1) RZV is recommended for the prevention of HZ and its complications for immunocompetent adults aged 50 yo 2) RZV is recommended for prevention of HZ and its complications for immunocompetent adults who previously got live zoster vaccine (ZVL) 3) RZV is preferred over ZVL for the prevention of HZ and complications

42 Data Supporting Recommendations

43 RZV Grade 3 events Grade 3 Reactions severe enough to prevent normal activities Grade 3 injection-site reactions Pain, redness, swelling 9.4% RZV vs 0.3% placebo recipients Solicited systemic events (myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms) 10.8% RZV vs 2.4% placebo Similar proportion local grade 3 between 1 st and 2 nd dose More systemic grade 3 after 2 nd dose Most common solicited adverse reactions (grade 1 3) were pain (78%), myalgia (45%), and fatigue (45%) Lal H, et al. ; ZOE-50 Study Group. N Engl J Med 2015;372: Cunningham AL, et al. ; ZOE-70 Study Group. N Engl J Med 2016;375: ACIP GRADE RZV and ZVL; 2017.

44 Summary Two shingles vaccines: one killed, one live. A new option for immunocompromised patients who cannot take a live vaccine RZV received preferred recommendation from ACIP Best Practice- Integrate specific training into your practice on the new Shingrix vaccine (storage and AEs) Make a firm yet positive vaccine recommendation Advanced discussion of side effects can help prepare patients in the event they occur

45 Key takeaways

46 Provider-oriented Reasons Indications based on environment, lifestyle, and chronic medial conditions are overlooked Missed opportunities Incorrect contraindications No system to identify people due for vaccination No standing orders Patient-oriented Reasons Patients don t know they are due Fear of adverse events, needles Lack of routine appointment Low Vaccination Rates System Reasons Shortage Lack of vaccine tracking systems Reimbursement issues (<65 yo) Access difficulties Adapted from

47 How Can WE Improve Vaccination Rates? Protocol to screen patient and standing orders to vaccinate Use coding systems to ID patients who need vaccine based on age and high-risk conditions Devise a reminder system (for patient and EMR alert or chart sticker) Incorporate vaccination discussion into routine office intake Maintain accurate documentation of vaccination history and help patient keep vaccination list which they can keep updated Develop a QI initiative for performance feedback, competition Improve access: reimbursements, health-care coverage, multiple sites, home visits for home-bound, call less-literate reserving your flu shot, no appointment necessary Improve provider access to records: vaccine registries Adapted from

48 How Can You Improve Vaccination Rates? Patient education, dispelling myths, staff vaccination rates Adapted from

49 Aligning Quality Reporting Meaningful Use electronic Clinical Quality Measures (e- CQMs/Medicaid) MIPS/MACRA Preventative Care and Screening: Influenza (110) Pneumonia Vaccination Status for Older Adults (111) Patient Centered Medical Homes ACO Shared Savings Programs

50 Aligning MIPS Quality Reporting IA_PM_5: Population Management Take steps to improve health status of communities, such as collaborating with key partners and stakeholders to implement evidence-based practices to improve a specific chronic condition. Cardiac Health Healthcentric Advisors helps health care providers improve the Controlling High Blood Pressure outcome measure and other related Million Hearts measures. Improving Adult Immunization Rates Healthcentric Advisors helps healthcare providers improve Influenza and Pneumonia measures. Diabetes Health- Healthcentric Advisors coordinates the Everyone with Diabetes Counts (EDC) program.

51 Aligning MIPS Quality Reporting IA_PM_6: Population Management Take steps to improve healthcare disparities, such as Population Health toolkit or other resources identified by CMS, the Learning Action Network, Quality Innovation Network, or National Coordinating Center. Improve Health Status of Communities. Healthcentric Advisors supports health care providers with the Quality Payment Program. We collaborate with local communities, health care providers, partners and stakeholders to provide education and resources to improve healthcare disparities and the health of our communities and strive to increase awareness of racial and ethnic disparities in health care among health care providers and key stakeholders.

52 Summary None of the current adult vaccines have uptake anywhere near the Healthy People 2020 goals of 90% Influenza and pneumococal vaccines reduce or prevent disease, and are covered by insurance Older adults present differently, and have consequences affecting cardiovascular outcomes, too Develop systematic approach to getting vaccination status tracked, reminders, and standing orders to meet HP2020 goals and align with meaningful use

53 Standing Orders Vaccine Information Statements Resources ACIP Recommendations 703a5_w Vaccine Adverse Event Reporting System (VAERS) Institute for Safe Medication Practices Vaccine Error Reporting Program (VERP)

54 Q+A If you have any questions after the conclusion of today s presentation please reach out to: Jennifer Ricci at jricci@healthcentricadvisors.org

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