Barriers to Adult Immunizations Getting from “No!” to “Yes!”

1. Barriers to Adult Immunizations Getting from “No!” to “Yes!” Thomas G. Irons, MD Professor of Pediatrics The Brody School of Medicine at East Carolina University Greenville, North Carolina

2. Disclosures It is the policy of the AAFP that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflicts of interest. If conflicts are identified, they are resolved prior to confirmation of participation. Only participants who have no conflict of interest or who agree to an identified resolution process prior to their participation were involved in this CME activity. All faculty and staff in a position to control content for this activity have indicated they have no relevant financial relationships to disclose. This CME activity is funded by an educational grant to the AAFP from Merck.

3. Learning Objectives • Identify barriers to immunizations among adults • Use evidence-based recommendations and guidelines to establish standardized vaccine administration procedures, including standardized protocols to screen for immunizations during patient encounters • Identify available vaccine administration strategies and resources, available patient education resources, vaccine alert systems, current immunization schedules, and available education programs • Counsel patients using available patient education resources and motivational interviewing about vaccine safety and efficacy

4. Pre-Assessment Please complete your answers on the sheet provided in your syllabus.

5. Pre-Assessment Question #1 • Regarding adult immunizations, which of the following statements is true? • The Advisory Committee on Immunization Practice recommends HPV vaccine may be used in women up until age 26 and in men up until age 21. • The Advisory Committee on Immunization Practice currently recommends one dose of Zostavax at age 50. • The minimum recommended interval by the Advisory Committee on Immunization Practice to administer a Tdap after having had a Td is 24 months. • The Advisory Committee on Immunization Practice states that individuals who have experienced only hives after egg exposure should receive the Influenza Vaccine.

6. Pre-Assessment Question #2 • Each of the following individuals would receive a single dose of PCV 13 followed by a dose of PPSV 23 at least 8 weeks later EXCEPT: • Individual with a cochlear implant • Individual with functional asplenia • Individual with cirrhosis • Individual with a CSF leak

7. Pre-Assessment Question #3 • Key recommendations for practice in examining immunizations in adults include which one of the following? • Vaccinating adults against pertussis, especially those in high-risk groups, increases the risk of disease outbreaks • Annual influenza vaccination is recommended for only persons older than 24 months • The quadrivalent human papillomavirus vaccine may be considered in males and females to prevent genital warts and cervical and anal cancers • Vaccination against herpes zoster is most effective when given as early as possible after 50 years of age

8. Background • Vaccines are considered on of the greatest public health achievements of the last century for their role in - • Eradicating smallpox • Controlling polio, measles, mumps, rubella and other infectious diseases • Despite their effectiveness in preventing and eradicating disease, substantial gaps in vaccine uptake persist • Good News– Vaccination rates for young children are high • Bad News – Vaccination rates remain well below established Healthy People 2020 targets for many vaccines recommended for adolescents, adults, and pregnant women

9. Vaccination Coverage in Adults* CDC. Non-influenza vaccination coverage among adults: United States, 2012. MMWR Morb Mortal Wkly Rep. 2014;63 (5):95-102. *NOTE: Children’s vaccination coverage is about 90%.

10. Gaps in Vaccine Utilization and American Healthcare • Financial burden of vaccine-preventable diseases among adults – 10 billion annually • Public health burden is equally heavy • Annually on average, 50,000 adults die from vaccine-preventable diseases or their complications* • These figures would be greatly reduced with vaccinations * National Foundation for Infectious Disease. Facts about immunization. August 2009. Available at: http://www.nfid.org/publications/factsheets/adultfact.pdf

11. Background • Vaccines are considered on of the greatest public health achievements of the last century for their role in • Eradicating smallpox • Controlling polio, measles, mumps, rubella and other infectious diseases • Despite their effectiveness in preventing and eradicating disease, substantial gaps in vaccine uptake persist • Good News – Vaccination rates for young children are high • Bad News – Vaccination rates remain well below established Healthy People 2020 targets for many vaccines recommended for adolescents, adults, and pregnant women • Understanding why our patients respond with “No thanks!” rather than “Of course!” when we offer vaccinations and effectively communicating the risks and benefits of vaccination are important parts of this effort.

12. State of Adult Immunization • Twelve vaccines are available for adults, all of which should be considered when providing healthcare to adults • Universal vaccination among any group of people promotes a healthy society, increasing productivity and decreasing (worker) absenteeism • Vaccinating adults protects young children, those with immunodeficiencies, and those who cannot be vaccinated • Clinicians must educate themselves on applicable adult vaccines so they can make valid recommendations to patients

13. Who Most Influences Adults’ Decisions to Get Immunized? Source: National Foundation for Infectious Diseases. 2009 National Adult Immunization Consumer Survey. In: Landers SJ. Physicians asked to persuade adults to get immunized. American Medical News. 2009. Available at: http://amednews.com/article/20090803/profession/308039978/7/.

14. What Are We Up Against? • Misinformation about vaccines • Falsehoods, once made public, are difficult to counter • Loudly stated misinformation overshadows complex, multisource scientific data in the minds of American people, and the information sticks • Research has documented public skepticism regarding vaccine safety

15. Barriers2011 AAFP Immunization Survey Practice level Patient level Safety (58%) Personal or religious beliefs (53%) Cost (51%) • Cost (51%) • Lack of insurance coverage • Patient acceptance (33%) • Fear of needles • Side effects • Supply (30%) American Academy of Family Physicians (AAFP). 2011 AAFP Immunization Survey Summary of findings. Leawod KS: AAFP; 2012.

16. Organizational Sociological Operational Barriers

17. Barriers • Organizational • Cost • Insurance coverage • Improving with healthcare reform • Competing demands • Sociological • Operational

18. Preventive Services in the Affordable Care Act (Organizational - Cost) • Address cost barriers • Ensure access to preventive healthcare • Law requires all new and non-grandfathered (plans created after 23 March 2010) private insurance plans to cover a wide range of preventive services WITHOUT copayments or other cost sharing requirements • August 2012

19. Some Services Covered Under the Law • All new health insurance plans must cover, without cost-sharing, preventive services derived from fours sets of expert recommendations • Services given an “A” or “B” recommendation by the USPSTF • All vaccinations recommended by the CDC ACIP • A set of evidence-based services for infants, children, and adolescents based on guidelines developed by the AAP and the DHHS • Evidence-based preventive services for women recommended by the IOM and supported by HRSA

20. Barrier(Organizational – Competing Demands) • Limited time during office visits to address medical problems and routine health maintenance • Forget (or choose not to discuss) immunizations during sick visits • Unlike childhood vaccinations (based primarily on age and vaccination history), decisions about adult vaccinations often must take into account comorbid medical conditions

21. Barriers • Organizational • Sociological • Socioeconomic disadvantage • Low patient health literacy • Understanding of vaccine safety and efficacy • Operational

22. Barrier(Sociological – Socioeconomic disadvantage) • Lack access to adequate resources • Lack access to adequate support • e.g., transportation

23. Barrier(Sociological – Low patient health literacy) • Poor communication can contribute to rejection of vaccinations and dissatisfaction with care • Such poor communication often results from a belief by the health professional that vaccine refusal arises from ignorance, which can simply be addressed by persuading or providing more information • Such an approach is counter-productive because it fails to account for the complexity of reasons underpinning vaccine refusal and may even result in a backfire effect Lewandowsky S, Ecker UKH, Seifer CM, Schwarz N, and Cook J. Misinformation and its correction: continued influence and successful debiasing. Psychological Science in the Public Interest. 2012; 13:106-131

24. Addressing Concerns About VaccinationCommunication Unhelpful Helpful Guiding style – “may I help you?” Care with body language Eliciting concerns Asking permission to discuss Acknowledging/listening/empathizing Determining readiness to change Informing about benefits and risks Giving or signposting appropriate resources • Directing style – “this is what you should do” • Righting reflex – using information and persuasion to achieve change • Missing cues • Using jargon • Discrediting information source • Overstating vaccine safety • Confrontation

25. Barrier(Sociological – Low patient health literacy) • Poor communication can contribute to rejection of vaccinations and dissatisfaction with care • Such poor communication often results from a belief by the health professional that vaccine refusal arises from ignorance, which can simply be addressed by persuading or providing more information • Such an approach is counter-productive because it fails to account for the complexity of reasons underpinning vaccine refusal and may even result in a backfire effect • Tailor messages on the basis of particular reasons for declination Lewandowsky S, Ecker UKH, Seifer CM, Schwarz N, and Cook J. Misinformation and its correction: continued influence and successful debiasing. Psychological Science in the Public Interest. 2012; 13:106-131

26. What Do We Hear?

27. What Do We Hear?

28. Barrier(Sociological – Safety and efficacy) • Safety • As the number of recommended immunizations has expanded across the population, so too have concerns about safety

29. Safety Safety of Vaccines Used for Routine Immunization in the United States — 2011 AHRQ Evidence Report/Technology Assessment No. 215 – July 2014www.ahrq/research/findings/evidence-based-reports/ptsafetyuptp.html • Systematic Review of the literature of safety of vaccines • 20,478 titles identified; 166 studies were accepted for abstraction • Conclusions • Evidence that some vaccines are associated with serious adverse events • Events are RARE and must be weighed against the protective benefits

30. Strength of Evidence AHRQ Evidence Report/Technology Assessment No. 215 (July 2014)

31. Barriers • Organizational • Sociological • Operational • Not stocking all recommended vaccines • Lack of standing orders • Lack of tracking systems (Immunization registries) • Leads to under- and over-vaccination

32. State Immunization Registry • Information available at the American Immunization Registry Association Web Site • http://www.immregistries.org/resources • Best possible scenario • National Immunization Registry

33. General PrinciplesSummary • Successful dialogue • Take time to LISTEN • Solicit and welcome questions • Keep the language simple and uniform • Clear cohesive voice of vaccine safety • Keep the conversation going • Every visit is an opportunity for primary prevention • Trust develops when patients identify both competence and caring in their physician

34. So getting to trust…

35. Physician Knowledge • Lack of knowledge of published preventive care guidelines • Recommend, explain, and order the service • Ambivalence • Scientific validity • Perception that service is clinically important

36. Current Adult Immunization Schedules • Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention – develops a vaccination schedule for adults that is approved annually by the AAFP and other professional organizations • Information about these schedules is available at http://cdc.gov/vaccines • Frequently monitor CDC websites for the most current recommendations • “CDC Vaccine Schedules” App • Optimized for tablets and useful on smartphones

37. 2014 ACIP Adult Immunization Schedule http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6305a7.htm?s_cid=mm6305a7_w

38. 2014 ACIP Adult Immunization Schedule

39. Immunization series do not need to be restarted • Breastfeeding is NOT a contraindication to vaccines Quadrivalent HPV Zostavax Tdap Influenza Pneumovax Vaccines

40. HPV • Most common STI in the United States • 20 million infected • 6.2 million newly infected annually • Increasing prevalence each year from ages 14 to 24, followed by a gradual decline through age 59 years.

42. Selected AgeACIP Recommendation (CDC) The recommendation for HPV vaccination for CHILDREN ages 11-12 is based on: Studies suggesting that HPV vaccines among adolescents will be safe and effective Can be started as young as 9 years of age The high antibody titers (persisting at least 5 years in initial clinical trials) achieved after vaccination at this age ACIP does not express a preference for either of the vaccine types Data on US HPV epidemiology and age of “sexual debut”

43. Cavazos-Rehg PA, et. al. Age of sexual debut among US adolescents. doi:10.1016/j.contraception.2009.02.014 Age of Sexual Debut Kaplan–Meier curves: probability of surviving free of sexual debut, according to race and gender.

44. Rationale for Vaccinating Men • Vaccinating women is effective • Vaccinating men (permissive use from ACIP 2009) • Herd immunity with reduced spread to women • Reduction of disease burden in men • Cancer • Anal • Oral • Penile • Genital warts

45. Annual Number of New Cases of HPV-Related Cancers in American Men American Cancer Society: Cancer Facts and Figures 2005 Kreimer AR, et al. Cancer Epidemiol Biomarkers Prev 2005;14(2):467 -75 Ryan DP, et al. N Engl J Med 2000: 342:792-800 Daling JR, et al. Int J Cancer 2005:116:606-616

46. Vaccinating Adolescent BoysACIP recommended 26 October 2011; CDC Approved 23 December 2011MMWR 60(50);1705-1708 • Routine use of quadrivalent HPV Vaccine in boys ages 11-12 • Catch-up dose for males ages 13-21 • Permissive use of vaccine ages 22-26 • Routine use in men ages 22-26 who have HIV infection or who have sex with men • Reason now routine: • Protect males from genital warts and certain cancers caused by HPV infection • Protect sexual partners from infection

47. Logistics of HPV Vaccination • 3-dose schedule; second dose 1-2 months after the first dose; third dose 6 months after first dose • Minimum interval between first and second doses - 4 weeks; between second and third dose -12 weeks; between first and third dose - 24 weeks • Whenever possible, the same HPV vaccine product should be used for all doses in the series

48. COST • $360 for 3 doses • Covered by Vaccine for Children Program • Cost prohibitive for uninsured adults • HPV-related diseases cost at least $4 billion in direct medical expenses

49. Vaccine-Type Human Papillomavirus and Evidence ofHerd Protection After Vaccine IntroductionKahn et al. Pediatrics 2012;130:1–8 http://pediatrics.aappublications.org/content/early/2012/07/03/peds.2011-3587.full.pdf+html • Objectives: • Compare prevalence rates of HPV in young women before and after HPV vaccine introduction to determine the following: (1) whether vaccine-type HPV infection decreased, (2) whether there was evidence of herd protection, and (3) whether there was evidence for type replacement (increased prevalence of nonvaccine-type HPV) • Results after propensity score weighting: • Prevalence rate for vaccine-type HPV decreased substantially (31.7%–13.4%, P < .0001) • Decrease in vaccine-type HPV not only occurred among vaccinated (31.8%–9.9%, P < .0001) but also among unvaccinated (30.2%–15.4%, P < .0001) postsurveillance study participants • Nonvaccine-type HPV increased (60.7%–75.9%, P <.0001) for vaccinated postsurveillance study participants

50. Vaccine-Type Human Papillomavirus and Evidence ofHerd Protection After Vaccine IntroductionKahn et al. Pediatrics 2012;130:1–8 http://pediatrics.aappublications.org/content/early/2012/07/03/peds.2011-3587.full.pdf+html • Conclusions • Four years after licensing of the quadrivalent HPV vaccine, there was: • a substantial decrease in vaccine-type HPV prevalence • evidence of herd protection in this community • Increase in nonvaccine-type HPV in vaccinated participants should be interpreted with caution but warrants further study