Global Immunization Measures and Healthcare Worker Vaccination

1. Global Immunization Measures and Healthcare Worker Vaccination Dale W. Bratzler, DO, MPH Professor and Associate Dean, College of Public Health Professor of Medicine, College of Medicine Chief Quality Officer – OU Physicians Group University of Oklahoma Health Sciences Center September 25, 2012

2. Outline • Burden of disease • Rationale for hospital-based vaccination • From disease-specific to “global” measures • New challenges with pneumococcal vaccine • Healthcare worker vaccination

3. Influenza • 5-20% of the population is infected annually • Widely varying estimates of mortality (3,000 to 49,000) • > 200,000 hospitalizations annually • During annual epidemics – • rates of infection are highest among children • rates of serious illness and death are highest among persons aged ≥65 years, children aged <2 years, and persons of any age who have medical conditions that place them at increased risk for complications from influenza • Infected patients at greater risk of post-influenza pneumonia, acute myocardial infarction, and stroke 1. http://www.cdc.gov/flu/about/qa/disease.htm 2. Nichol KL, et al. Influenza vaccination and reduction in hospitalizations for cardiac disease and stroke among the elderly. N Engl J Med. 2003; 348:1322-32.

4. Hospitalization Due to Influenza http://www.cdc.gov/mmwr/pdf/rr/rr5908.pdf

6. Transmission of Influenza • The virus can be transmitted by both symptomatic and asymptomatic people —hence, simply “staying home from work” is an insufficient strategy for preventing transmission of influenza. • Viral shedding can occur for a day or two before a person has any symptoms LaForce FM, Nichol KL, Cox NJ. Influenza: virology, epidemiology, disease, and prevention. Am J PrevMed 1994;10:31–44.

7. Pneumococcal Disease • Streptococcus pneumoniae (pneumococcus) remains a leading cause of serious illness, including bacteremia, meningitis, and pneumonia among children and adults worldwide. It is also a major cause of sinusitis and acute otitis media. • Estimated 5000 deaths annually • Young children, the elderly, and patients with serious underlying disease are at greatest risk 1. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm?s_cid=rr5911a1_e 2. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5934a3.htm

8. Benefits of Pneumococcal Vaccinations 1 Sisk J. JAMA 1997; 278: 1333. 2 Nichol KL. Arch Intern Med 1999; 159: 2437. Studies consistently show a 50-75% reduction in the risk of bacteremia.

9. Effectiveness of Pneumococcal Vaccination in Older Adults:The VSD Cohort Study • 3 year cohort study of 47,365 members of Group Health Coop (Seattle) • PPV was associated with lower rates of bacteremia: • HR 0.56 (95% CI 0.33 – 0.93) • PPV was not associated with lower rates of community acquired pneumonia • HR 1.07 (95% CI 0.99 – 1.14) HR = hazard ratio. Jackson LA, et al. NEJM 2003; 348: 1747.

10. EurRespir J. 2005;26:1086-1091.

11. Pneumococcal Vaccination Reduces Disease Severity • Prospective cohort of 11,241 patients > 65 years of age in Spain: • “Pneumococcal vaccination did not alter the risk of hospitalisation from pneumonia ….or overall pneumonia, but the vaccine was associated with considerable reductions of death risk from pneumonia (HR: 0.28; 95% CI: 0.09–0.83).” Vila-Corcoles A, et al. Protective effect of pneumococcal vaccine against death by pneumonia in elderly subjects. EurRespir J. 2005:26;1086-1091

12. Clin Infect Dis. 2006; 42:1093–101.

13. Pneumococcal Vaccination Reduces Disease Severity • 62,918 consecutive adults (> 18 years) hospitalized with community-acquired pneumonia at 109 community and teaching hospitals in the United States: • “Prior vaccination against pneumococcus is associated with improved survival, decreased chance of respiratory failure or other complications, and decreased length of stay among hospitalized patients with community-acquired pneumonia.” Fisman DN, et al. Prior pneumococcal vaccination is associated with reduced death, complications, and length of stay among hospitalized adults with community-acquired pneumonia.Clin Infect Dis. 2006; 42:1093–101.

15. Pneumococcal Vaccination Reduces Disease Severity • Prospective study of 3,415 adults hospitalized in Canada with community-acquired pneumonia: • “Patients with CAP who had prior PPV had about a 40% lower rate of mortality or ICU admission compared with those who were not vaccinated.” Johnstone J, et al. Effects of pneumococcal vaccination in hospitalized adults with community-acquired pneumonia. Arch Intern Med. 2007:167;1938-1943.

16. Introduction of the Conjugate Vaccine Musher DM. Clin Infect Dis. 2012;55:265-267

17. Rationale for Hospital-based Vaccination • Patients sick enough to be hospitalized are often at greater risk of subsequent influenza or pneumococcal infections • Hospital patients may represent an under-vaccinated population • Many uninsured or underinsured patients utilize the hospital setting for much of their primary care Fedson DS, Houck P, Bratzler D. [Editorial] Hospital-based influenza and pneumococcal vaccination: Sutton's Law applied to prevention. Infect Control HospEpidemiol. 2000; 21:692-9.

18. Why the shift from a disease-specific (pneumonia) performance measure, to the “global” immunization measures? • Approximately 4 years ago when the Pneumonia core measures on influenza and pneumococcal vaccination were submitted to the National Quality Forum (NQF) for re-endorsement, the NQF committees felt it made no sense to limit the hospital-based immunization measures to just pneumonia patients • They “de-endorsed” the pneumonia measures • Recommended harmonization of immunization measures for all patients across ambulatory, hospital, and nursing home care http://www.qualityforum.org/Projects/i-m/Influenza_and_Pneumococcal_Immunizations/Influenza_and_Pneumococcal_Immunizations.aspx

19. Global Immunization Measures www.qualitynet.org

20. Measures Construct • Measures largely follow the Advisory Committee on Immunization Practices recommendations • Defines denominator for the measures • Patients are placed in the numerator for the measures if – • They receive the vaccine in the hospital prior to discharge • They were vaccinated prior to the admission • They had a documented contraindication (rare) • They refuse vaccination

21. Myths abound…… ..but in reality • It is safe and effective to vaccinate hospitalized patients (there are few side effects and the patients do develop antibodies) • Contraindications are very rare • Surgical patients are NOT excluded • Fever is uncommon in adults AND children • Multiple studies have shown that unvaccinated patients who don’t receive these vaccines in the hospital, usually don’t receive them after discharge

22. Implementation - Influenza • Denominator – all patients aged > 6 months discharged between October 1 and March 31 • Vaccine specific notes: • Egg allergy (see flowchart) • History of Guillain-Barre Syndrome within 6 weeks of the influenza vaccine • Bone marrow transplantation within the past 6 months • (Anaphylactic latex allergy) • Organ transplant during the current hospital stay • Expired in the hospital

23. J Infect Dis 2011; 204:1475–82

24. Clin Infect Dis 2010; 51:1355–61.

25. Implementation - Influenza http://www.cdc.gov/mmwr/pdf/wk/mm6132.pdf

26. Implementation - Influenza http://www.cdc.gov/mmwr/pdf/wk/mm6132.pdf

27. When do you vaccinate? “Routine annual influenza vaccination is recommended for all persons aged ≥6 months. To permit time for production of protective antibody levels, vaccination optimally should occur before onset of influenza activity in the community. Therefore, vaccination providers should offer vaccination as soon as vaccine is available. Vaccination should be offered throughout the influenza season (i.e., as long as influenza viruses are circulating in the community).” http://www.cdc.gov/mmwr/pdf/wk/mm6132.pdf

29. Recommendations for Pneumococcal Polysaccharide Vaccine Administration* • Immunocompetent persons • Persons aged > 65 years • Persons aged 2–64 years with chronic cardiovascular disease (including congestive heart failure and cardiomyopathies), chronic pulmonary disease (including chronic obstructive pulmonary disease and emphysema), or diabetes mellitus • Persons aged 2–64 years with alcoholism, chronic liver disease (including cirrhosis), or cerebrospinal fluid leaks • Persons aged 2–64 years with functional or anatomic asplenia (including sickle cell disease and splenectomy) • Persons aged 2–64 years living in special environments or social settings (including Alaskan Natives and certain American Indian populations). *Based on ACIP Recommendations for the Prevention of Pneumococcal Disease. MMWR 1997; 46 (No. RR-8):1-24.

30. Recommendations for Pneumococcal Polysaccharide Vaccine Administration • Immunocompromised persons • Immunocompromised persons aged > 2 years, including those with HIV infection, leukemia, lymphoma, Hodgkins disease, multiple myeloma, generalized malignancy, chronic renal failure, or nephritic syndrome; those receiving immunosuppressive chemotherapy (including corticosteroids); and those who have received an organ or bone marrow transplant. If earlier vaccination status is unknown, patients in immunocompetent or immunocompromised groups should be administered pneumococcal polysaccharide vaccine

31. Updated ACIP Recommendations for Use of Pneumococcal Vaccines*October 2008 • Persons aged 19 through 64 years who smoke cigarettes should receive a single dose of PPSV23 and smoking cessation counseling. • “Persons aged 19 through 64 years who have asthma should receive a single dose of PPSV23.” • “A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for persons aged >2 years who are immunocompromised, have sickle cell disease, or functional or anatomic asplenia.” http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-Oct-2008-508.pdf

32. Implementation - Pneumococcal • Denominator – all patients aged > 65 years, and patients at high risk of invasive pneumococcal disease ages 6 – 64 years • Vaccine specific notes: • Vaccine allergy (rare) • Bone marrow transplantation within the past 12 months • Chemotherapy or radiation therapy during this admission or less than 2 weeks prior • Organ transplant during the current hospital stay • [Received the Herpes zoster (Zostavax) with the last 4 weeks] • Expired in the hospital • Patients who are pregnant

33. For the purposes of the global pneumococcal immunization measure, “high-risk” patients are defined as patients with: diabetes, nephrotic syndrome, ESRD, heart failure, COPD, HIV or asplenia.

34. Implementation - Pneumococcal • New challenges – there are two pneumococcal vaccines • PCV 13 – conjugate vaccine (licensed in 2010) • PPSV 23 – polysaccharide vaccine • ACIP recommends • In a child that is 6-18 years old who has never received the PCV 13, that child should receive a single dose of PCV 13 first, followed by PPSV 23 at least 8 weeks later

35. Pneumococcal Vaccination Challenges • FDA has approved PCV 13 for adults aged 50 years and over • No study has shown reduced rates of pneumonia or invasive pneumococcal disease • ACIP does not recommend PCV 13 for all adults 50 years and older • On June 20, 2012, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV 13 for adults 19 years and older with immunocompromisingconditions, functional or anatomic asplenia, cerebrospinal fluid (CSF) leaks, or cochlear implants. • Not FDA approved in this age group

36. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-adults-ic.pdfhttp://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-adults-ic.pdf

37. And, to make it more complicated… • If the patient receives PCV 13 first, it is recommended to wait 8 weeks to give PPSV 23 • If the patient receives PPSV 23, it is recommended to wait one year before giving PCV 13 http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-adults-ic.pdf

38. Implementation - Pneumococcal • How can you implement the measure???: • Those patients 65 years of age and over – all were eligible for PPSV 23 • But if you follow FDA, you could give PCV 13 if the patient has never received it • Patients aged 19 – 64 years – eligible for PPSV 23 if they have diabetes, nephrotic syndrome, ESRD, heart failure, COPD, HIV or asplenia (better to follow ACIP recommendations which are more comprehensive) • ACIP now recommends PCV 13 for some of these patients

39. Implementation - Pneumococcal • How can you implement the measure (cont): • Those patients aged 6 – 18 years will pass if they receive either PCV 13 or PPSV 23 • How do you decide?

40. Implementation - Pneumococcal • How can you implement the measure (cont): • Those patients aged 6 – 18 years will pass if they receive either PCV 13 or PPSV 23 • How do you decide?

41. More to come… • Working with representatives of our Technical Expert Panel, CDC representatives, the Pediatric Infectious Diseases Society, and the Children’s Hospital Association the pneumococcal vaccination measure is being re-evaluated • We know there are missed opportunities for childhood vaccination!

42. Healthcare Worker Influenza Vaccination

43. What do we know about vaccination of healthcare workers? • Vaccination of health-care workers (HCWs) has been shown to reduce influenza infection and absenteeism among HCWs, prevent mortality in their patients, and result in financial savings to sponsoring health institutions.

45. The “Seven Truths” • Influenza infection is a serious illness causing significant morbidity and mortality adversely affecting the public health on an annual basis. • Influenza-infected health care workers can transmit this deadly virus to their vulnerable patients Vaccine2005; 23:2251–5.

46. Multiple studies have shown that health care workers continue to work despite being ill with influenza, increasing exposure of patients and coworkers. • In an influenza A, outbreak in a neonatal intensive care unit in 1998, 19 of the 54 patients on the ward tested positive for influenza A.Of these 19, 6 were symptomatic and 1 died. In a survey of the 150 medical staff involved during the outbreak, only 15% had received the influenza vaccination including 67% of physicians and 9% of nurses. Only 29% of staff with symptomatic influenza took time off from work. • Another outbreak in a bone marrow transplant unit resulted in 25 confirmed cases of nosocomial pneumonia in the hospital, 40% were in the BMT ward, 2 of which died. Surveys during this outbreak revealed a 12% vaccination rate among health care workers on the unit. Vaccine2005; 23:2251–5.

47. Influenza vaccination of healthcare workers saves money for employees and employers and prevents workplace disruption. • Influenza vaccination of healthcare workers is already recommended by the CDC and is the standard of care. • Immunization requirements are effective and work in increasing vaccination rates. • Health care workers and healthcare systems have an ethical and moral duty to protect vulnerable patients from transmissible diseases. • The healthcare system will either lead or be lambasted. Vaccine2005; 23:2251–5.

48. Final IPPS Rule – FY 2012 • The Centers for Medicare &Medicaid Services (CMS) published a final rule in the Federal Register on August 18, 2011 that included healthcare personnel (HCP) influenza vaccination summary reporting from acute care hospitals via the Centers for Disease Control and Prevention’s (CDC’s) NHSN in the CMS Hospital Inpatient Quality Reporting (IQR) Program requirements for calendar year 2013. More specifically, the rule announced a requirement for acute care hospitals to report HCP influenza vaccination summary data beginning on January 1, 2013.

49. http://www.cdc.gov/nhsn/hps_Vacc.html

50. NHSN Module Requirements • Facilities must report vaccination data for three categories of HCP: • employees on payroll; • licensed independent practitioners (who are physicians, advanced practice nurses, and physician assistants affiliated with the hospital but not on payroll); and • students, trainees, and volunteers aged 18 or older. • Only HCP physically working in the facility for at least 30 days between October 1 and March 31 should be counted. • Data on vaccinations received at the facility, vaccinations received outside of the facility, medical contraindications, and declinations are reported for the three categories of HCP.