This continuing education activity is co-sponsored by USF Health and by CME Outfitters, LLC.

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1 This continuing education activity is co-sponsored by USF Health and by CME Outfitters, LLC.

2 USF Health and CME Outfitters, LLC, gratefully acknowledge an educational grant from Pfizer Inc. in support of this CE activity.

3 Pneumococcal Disease in High-Risk Patients: Strategies for Appropriate Selection of Patients for Vaccination September 28, 2010

4 Moderator: Michael S. Niederman, MD, FACP, FCCP, FCCM Chairman, Department of Medicine Winthrop-University Hospital Mineola, NY Professor of Medicine Vice Chairman, Dept. of Medicine SUNY at Stony Brook Stony Brook, NY

5 Michael S. Niederman, MD, FACP, FCCP, FCCM Disclosures! " Research/Grants: Bayer Corp.! " Speakers Bureau: None! " Consultant: Bayer Corp.; Johnson & Johnson Pharmaceutical Research & Development; Merck & Co., Inc.; Pfizer Inc.! " Stockholder: None! " Other Financial Interest: Receives honoraria from Astellas Pharma Inc.; Johnson & Johnson Pharmaceutical Research & Development; Merck & Co. Inc.; Pfizer Inc.! " Advisory Board: Bayer Corp.; Johnson & Johnson Pharmaceutical Research & Development; Merck & Co., Inc.; Pfizer Inc.

6 Keith P. Klugman, MD, PhD William H. Foege Professor of Global Health Rollins School of Public Health Professor of Medicine Division of Infectious Diseases Emory University School of Medicine Atlanta, GA

7 Keith P. Klugman, MD, PhD Disclosures! " Research/Grants: Pfizer Inc.! " Speakers Bureau: None! " Consultant: Dow Pharmaceutical Sciences, Inc.; GlaxoSmithKline; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc.! " Stockholder: None! " Other Financial Interest: None! " Advisory Board: None

8 The faculty have been informed of their responsibility to disclose to the audience if they will be discussing offlabel or investigational uses (any use not approved by the FDA) of products or devices.

9 Learning Objectives! " Recognize the role of vaccination of highrisk populations in the prevention of pneumococcal disease! " Integrate established treatment guidelines into clinical practice to improve prevention and treatment of pneumococcal disease in high-risk patients! " Develop strategies to improve early recognition and diagnosis of pneumococcal disease

10 Learning Objectives Those applying for nursing credit should be able to:! " Recognize the role of vaccination of high-risk populations in the prevention of pneumococcal disease! " Identify established treatment guidelines to improve prevention and treatment of pneumococcal disease in high-risk patients! " Describe strategies to improve early recognition and diagnosis of pneumococcal disease

11 The course guide for this activity includes slides, disclosures of faculty financial relationships, and biographical profiles. For additional copies of these materials, please visit cmeoutfitters.com/500 or call 877.CME.PROS.

12 To receive CME/CE credits for this activity, participants must complete the post-test and evaluation online at cmeoutfitters.com/test

13 Pneumococcal Disease in High-Risk Patients: Strategies for Appropriate Selection of Patients for Vaccination September 28, 2010

14 Learning Objectives! " Recognize the role of vaccination of highrisk populations in the prevention of pneumococcal disease! " Integrate established treatment guidelines into clinical practice to improve prevention and treatment of pneumococcal disease in high-risk patients! " Develop strategies to improve early recognition and diagnosis of pneumococcal disease

15 Estimated Number of Cases of Invasive Pneumococcal Disease in the U.S., ,418 2,147 4,167 6,420 14,777 Age (Years) < 5 5 to to to & over Total = ~ 43,000 Moore MR. Presented at Infectious Disease Society of America (IDSA); October 29- November 1, 2009; Philadelphia, PA: Abstract 722.

16 IPD in Adults Risk Factors! " Age > 65 years! " Smoking! " COPD and asthma! " Chronic disease! " Impaired immunity! " Immunosuppressive therapy! " Hyposplenia! " HIV/AIDS! " Cytotoxic therapy, radiation therapy! " Alcoholism! " Cancers! " Male! " American Indian, Alaskan native, African-American in the United States! " Children in daycare IPD = invasive pneumococcal disease

17 Adults with Chronic Medical Diseases Significantly Increased Risk for IPD 1 Disease Increase Cases per 100,000 In a separate study, asthma increased IPD by 2.4 ( ) 2 1. Kyaw MH, et al. J Infect Dis 2005;192; Talbot TR, et al. N Engl J Med 2005;352:

18 Smoking: Strongest Risk Factor for IPD Immune-Competent Non-Elderly Adults 2! " 50% of adults < 65 with severe IPD 1! " Dose-response 2! " Current # cigarettes/day! " Pack years! " Time since quitting! " Impairs 3! " Humoral & cellular immunity! " Mechanical clearance! " Enhances bacterial adherence and nasopharyngeal colonization 3 Invasive Pneumococcal Disease and Cigarette Smoking 2 Status Odds Ratio (95% CI) 1. Green CM, et al. Clin Infect Dis 2006;43: ; 2. Nuorti JP, et al. N Engl J Med 2000;342: ; 3. Feldman C, et al. Respirology 2009;14:

19 Multiple Factors Contribute to the Increased Risk of IPD in COPD 1,2! " Smoking and smoking history! " Corticosteroid use! " Chronic airway inflammation! " Impaired mucocilliary clearance! " Increased mucous production! " Malnutrition S. pneumoniae accounts for 10-15% of exacerbations 3,4 IPD = invasive pneumococcal disease; COPD = chronic obstructive pulmonary disorder 1. Nuorti P. CDC Accessed at PPSV_ACIP_Update.ppt; 2. Lynch J, Zhanel J. Curr Opin Pulm Med 2010;16: ; 3. Sethi S, et al. N Engl J Med 2002;347: ; 4. Sethi S, et al. N Engl J Med 2008;359:

20 2010 CDC Recommended Adult Immunization Schedule Vaccine Age Group (Years) ! 65 1 or 2 doses 1 dose For all persons in this category who meet the age requirements and who lack evidence of immunity Recommended if some other risk factor is present PCV = pneumococcal conjugate vaccine; IPD = invasive pneumococcal disease CDC. Accessed June 2010.

21 Pneumococcal Polysaccharide Vaccine (PPV23*)! "Vaccination recommended for:! "All! 65 years! "2-64 years: chronic CV disease, chronic pulmonary disease, diabetes, alcoholism, chronic liver disease, CSF leaks, asplenia, cochlear implants! "> 2 years and immunocompromised! "Asthmatics and smokers age years * Approved for use in! 2 yrs with certain chronic conditions or in special environments or social settings and adults 50 years of age or older CDC. Accessed June 2010.

22 Benefits of Pneumococcal Vaccine! " Healthy adults: Prevents bacteremic pneumonia! " Elderly and chronically ill! " Probably prevents pneumonia, but best shown by case control methodology and not in a prospective randomized VA trial! " Up to 61% effective in immune competent with case control study 1! " Limited efficacy in indirect cohort method among those with alcoholism, cirrhosis, sickle cell, CRF, hematologic malignancy; effective in COPD, CHF, and other chronic illness 2 1. Shapiro ED, et al. N Engl J Med 1991;325: Butler JC, et al. JAMA 1993;270:

23 Benefits of Prior Pneumococcal Vaccination In-Hospital Survival (%) Time Since Admission (Days)! " 7.6% died of all causes - vaccinated with OR mortality of 0.29 vs. non-vaccinated and 0.56 vs. unknown status! " Vaccination reduced risk of respiratory failure, ARDS, tracheotomy, renal failure, sepsis, cardiac arrest! " Vaccination reduced LOS (5.5 vs. 6.5 days, p <.001) LOS = length of stay Fisman DN, et al. Clin Infect Dis 2006;42:

24 Benefits of Prior Pneumococcal Vaccination: PORT Scores Case-Fatality Rate (%) All Classes Vaccinated No Record of Vaccination I II III IV V PORT Class Benefit of vaccine applied to all PORT scores (ex Class I) Fisman DN, et al. Clin Infect Dis 2006;42:

25 Kaplan-Meier Curves Nursing Home Patients Without Pneumonia* Cumulative Proportion of Participants Without Pneumococcal Pneumonia Vaccine (PPV23) (n = 399) Placebo (n = 387) Time (Days) * In Vaccine and Placebo Groups; Hazard ratio (95% CI to 0.680); p =.0009 Maruyama T, et al. Br Med J 2010;340:c1004.

26 Kaplan-Meier Curves Nursing Home Patients Without All-Cause Pneumonia* Cumulative Proportion of Participants Without All-Cause Pneumonia Vaccine (PPV23) (n = 350) Placebo (n = 320) Time (Days) * In Vaccine and Placebo Groups; Hazard ratio (95% CI to 0.802); p =.0007 Maruyama T, et al. Br Med J 2010;340:c1004.

27 PCV13* Conjugated Vaccine Under Investigation in Adults! "PCV13 conjugate vaccine to be evaluated in randomized, PBOcontrolled trial! "N = 85,000 adults! 65 years, no prior vaccination! "Primary endpoint: Efficacy of PCV13 to prevent first episode of vaccineserotype-specific pneumococcal CAP * Not approved by the FDA for immunization in adults Hak E, et al. Netherlands J Med 2008;66:

28 Rates of IPD Caused by All Serotypes Among Adults! 18 Years Old, ABCs Cases per 100, PCV7 introduction 2008 vs. baseline 65+: -42% (-37, -47) 50-64: -20% (-10, -28) 18-49: -58% (-54, -62) Year Moore MR. Presented at Infectious Disease Society of America (IDSA); October 29-November 1, 2009; Philadelphia, PA: Abstract 722.

29 Rates of IPD Caused by PCV7* Serotypes Among Adults! 18 Years Old, ABCs Cases per 100, PCV7 introduction 2008 vs. baseline 65+: -93% (-91, -95) 50-64: -90% (-86, -93) 18-49: -92% (-92, -95) Year * PCV7 is indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine Moore MR. Presented at Infectious Disease Society of America (IDSA); October 29-November 1, 2009; Philadelphia, PA: Abstract 722.

30 Rates of IPD Caused by Serotype 19A Among Adults! 18 Years Old, ABCs Cases per 100, Year Age (Years) Percent Change (95% CI) Rate Difference Moore MR. Presented at Infectious Disease Society of America (IDSA); October 29-November 1, 2009; Philadelphia, PA: Abstract 722.

31 IPD Caused by PCV7 & Non-PCV7 Serotypes Among Adults Aged Years with HIV/AIDS IPD Cases with HIV per 100,000 Persons with AIDS All Serotypes Nonvaccine Serotypes 0 Conjugate Vaccine Serotypes Vaccine-Related Serotypes Serotype Replacement Year Cohen AL, et al. AIDS 2010;24:

32 Estimated IPD Cases Prevented All Ages, U.S., Cases Prevented 40,000 30,000 20,000 10,000 0 Age! 5 Age < 5 210,000 cases & 14,000 deaths prevented Year Pilishvili T, et al. J Infect Dis 2010;201:32-41.

33 ABC Incidence of Pneumococcal Meningitis All Ages by PCV7* ST Group Over Time PCV7 STs PCV7-Related STs Non-PCV7 STs Meningitis Cases/ 100,000 Persons ! " The increase in non-pcv7 ST disease was seen primarily in children < 2 years of age! " The absolute increase in this population (2.11 cases/100,000) was small relative to decrease in PCV7 ST disease (7.60 cases/100,000) * Indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine ABC = active bacterial core; PCV = pneumococcal conjugate vaccine; ST = serotype Hsu HE, et al. N Engl J Med 2009;360:

34 Case Discussion - Joseph! " A 78-year-old male is admitted to the hospital! " Fever to F! " Chills and cough! " Found to have a R lower lobe infiltrate! " Blood cultures are Neg! " Sputum culture grows normal flora! " He is treated for community-acquired pneumonia (CAP) with a core-measure compliant regimen and recovers rapidly

35 Case Discussion - Joseph! " Patient history! " Previous smoker! " History of COPD, CHF, and stroke! " Previous admission for pneumonia 1 year ago at another hospital! " Both he and the family are uncertain if he has ever received pneumococcal vaccination, but they are willing for him to receive before discharge, if recommended! " Your hospital has had a 78% pneumococcal vaccination rate for CAP patients! " Note: Hospital is below the desired rate and the rate of surrounding hospitals; there is a desire to improve immunization rates

36 Questions to Consider 1." Should this patient receive a pneumococcal vaccination? 2." Would you give the vaccine if you could not establish a history of previous vaccination? 3." Would you give the vaccine if you knew he previously received at age 62? 4." Is it safe to give the vaccine if he has previously received vaccination during his hospitalization 1 year ago? 5." Do you need patient consent to give pneumococcal vaccine?

37 Controversies in Adult Pneumococcal Vaccination Presumptive pneumococcal pneumonia All trials Double-blind Other Adequate concealment of allocation Other Pneumonia from all causes All trials Double-blind Other Adequate concealment of allocation Other Death from all causes All trials Double-blind Other Adequate concealment of allocation Decreased risk of clinical outcome Increased risk of clinical outcome Relative Risk (95% CI) Meta-analysis that included 22 trials and 101,507 individuals Huss A, et al. Can Med Assoc J 2009;180:45-58.

38 Revaccination with PPSV! "For adults < 65! "Single vaccination after 5 years for persons with chronic renal failure, asplenia, and immunocompromised conditions! "For persons aged! 65 years! "Vaccinated! 5 years previously and were aged < 65 years at the time of primary vaccination CDC. Accessed June 2010.

39 Safety of Repeat Pneumococcal Vaccination! "179 patients who received at least 3 pneumococcal vaccinations, compared to 181 with 1 or 2 doses! "Only 1 with adverse reaction (tachycardia and arm redness)! "No more reaction than those with 1-2 doses! "54.6% of all re-vaccinations in less than 6 years Walker FJ, et al. Clin Infect Dis 2005;40:

40 Rationale for Hospital-Based Immunization! " In those < 65, only 10% eligible pts receive vaccine! " Up to 28% of those > 65 were vaccinated by 1993! " Repeat in 5 years if likely to have rapid decline in antibody titer! " Consider hospitalized-based immunization! " 60% of all CAP patients hospitalized in preceding 4 years Fedson DS, et al. JAMA 1994;272:

41 Medicare Quality Indicators in CAP Pneumonia Core Measures Set! " First dose of antibiotics within 6 hours of arrival at hospital! " Oxygenation assessment within 24 hours of admittance! " Correct antibiotic for admitted patients (HCAP patients exempt)! " Non-ICU! " ICU! " Includes NO MONOTHERAPY with quinolones Joint Commission. Pneumonia Core Measures Set. In: Specification Manual for National Hospital Quality Measures

42 Medicare Quality Indicators in CAP Pneumonia Core Measures Set! " Blood cultures within 24 hours for all patients admitted to ICU! " Blood cultures before antibiotics for those drawn in ED! " Smoking cessation advice! " Evaluation and offer of pneumococcal and influenza vaccines Joint Commission. Pneumonia Core Measures Set. In: Specification Manual for National Hospital Quality Measures

43 Is Signed Consent Needed for Vaccination???! " Argue that it is NOT needed! " Should not be used to prevent the implementation of vaccination guidelines! " Simply use a Vaccine Information Statement (VIS) that is given to patient! " Risks of vaccine are low, side effects rare, and that risk of NOT vaccinating is quite high! " MORE LIABILITY by not vaccinating Kissam S, et al. Arch Intern Med 2004;162:13-16.

44 Clinical Connections! " Vaccine preventable infections in adults continues to be a significant source of morbidity and mortality! " Be vigilant for common risk factors (e.g., age, smoking, COPD) and classic presentations of IPD (e.g., pneumonia, sinusitis)! " Maintain awareness of current vaccination schedules! " Implement guidelines into clinical practice! " ACIP, Medicare, IDSA, Joint Commission, BTS! " Consent for vaccination should not be used to prevent the implementation of vaccination guidelines! " Risks of vaccine are low, side effects rare, and risk of NOT vaccinating is quite high

45 IPD Guidelines & Recommendations! " AHRQ recommended adult immunization schedule: United States, 2010! " " Advisory Committee on Immunization Practices (ACIP) provisional recommendations for use of pneumococcal vaccines! " Oct pdf! " Centers for Disease Control and Prevention summary of recommendations for adult immunization! " " Immunization Action Coalition (IAC)! " " Joint Commission pneumonia core measures set! " PerformanceMeasurement/Current+NHQM+Manual.htm

46 Additional Resources

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