Influenza and Adults: A Patient-Specific Approach to Universal Immunization

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Influenza and Adults A Patient-Specific Approach to Universal Immunization © Digital Vision/Getty Images

Dear Colleague: It’s an extraordinary concept, really. Despite the medical breakthroughs of the last century—advances in antimicrobial therapy, advances in immunization—influenza and pneumonia still rank among the top killers of adults in the United States. A seasonal influenza outbreak can put hundreds of thousands of people in the hospital and result in tens of thousands of deaths.

Those numbers are not acceptable.

The licensure of new influenza vaccines in recent years, with others in the pipeline, gives health professionals more tools to customize their approach to flu prevention in the context of a universal immunization recommendation. Vaccines geared toward select groups of adults (eg, those over 65 years of age), or administered other than intramuscularly, complement traditional influenza vaccines. Age, health status, and patient preferences should all be factored into the mix in vaccinating patients.

But getting vaccines from shelf to patient remains a challenge, one that you can help meet by implementing immunization strategies such as those presented in this newsletter. Beyond these practical strategies, it’s important that we impress upon our patients our determination to get everyone immunized. It should be crystal clear to your patients that you and your staff are passionate about protecting them against the flu.

Sincerely,

William Schaffner, MD FACULTY REVIEWER William Schaffner, MD Professor and Chair Department of Preventive Medicine, Vanderbilt University School of Medicine Nashville, Tennessee

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he Centers for Disease Control and Prevention (CDC) has endorsed universal influenza vaccination since 2010, when it expanded its recommendations for annual immunization to include everyone 6 months of age and older.1 Evidence supports the safety and effectiveness of influenza vaccination across all demographic groups, including healthy, nonpregnant adults 18-49 years of age, most of whom were previously excluded from recommendations for routine immunization.1 One analysis of the annual toll of seasonal influenza in the United States estimated that the disease was responsible for 5 million illnesses, 2.4 million outpatient visits, 32 000 hospitalizations, and 680 deaths among otherwise healthy adults 18-49 years of age.1 The burden of influenza, however, continues to fall disproportionately on older adults. Adults ≥65 years of age, along with children <2 years of age and people of any age who have an underlying medical condition that puts them at increased risk of influenza-related complications, have the highest rates of serious illness and death from the disease.1 During 1976-2007, the estimated annual number of influenza-related deaths from respiratory and circulatory causes ranged from 2344 to 43 727 among adults ≥65 years of age.2 Approximately 90% of all influenza-associated deaths occur among adults in this age group.2 This group is also more likely to have a reduced response to traditional influenza vaccines, due to immunosenescence—the gradual decline in immune function that accompanies aging.

Pregnant women are another vulnerable population. In their second or third trimester, they are 4 times more likely than their nonpregnant counterparts to be hospitalized for flu-related complications.3 During the pandemic of 2009-2010, 75 of 347 (22%) severely ill pregnant women died from H1N1 influenza; 272 (78%) were admitted

to an intensive care unit and survived.4 Some studies have linked maternal influenza to adverse birth outcomes, including fetal distress, preterm labor, and low birth weight.1,4 Maternal influenza vaccination has been associated with improved fetal and neonatal outcomes.5 Although seasonal influenza vaccination rates for pregnant women have risen substantially since the years prior to the 2009 H1N1 pandemic, it’s estimated that only 47% of pregnant women were immunized for the 2011-2012 flu season.6 Across all ages and risk groups, coverage rates fall well short of Healthy People 2020 goals for seasonal influenza immunization (Figure 1).7,8 Overall, the estimated immunization rate for adults ≥18 years of age for the 2011-2012 flu season was 39%.8 Rates among adults at high risk of influenza-related complications remain disappointingly low—37% in the 18- to 49-year age group for 2011-2012.8 Rates for adults ≥65 years of age have stagnated in the range of 65%-70% in recent years.1,8 Racial disparities in adult immunization have also endured. It’s estimated that 33% of non-Hispanic black adults and 29% of Hispanic adults were immunized against influenza during the 2011-2012 season, compared to 42% of non-Hispanic white adults.8 Among health care personnel, 1 in 3 did not receive the vaccine during the 2011-2012 flu season.9 Why aren’t more adults getting vaccinated?

Adult immunization rates are suboptimal for all recommended vaccines. Barriers to immunization of adults include lack of patient knowledge about the risks of vaccine-preventable disease and concerns about vaccine safety and effectiveness.10,11 Barriers cited by health care professionals include the infrequency of adult well-visits, lack of systems for identifying

90 % of persons vaccinated

80 70

66.9%

64.9%

60 50 36.8%

40 30

47.0%

42.7%

28.6%

20 10 0

18-49 (All)

18-49 High-risk

50-64

≥65

Age (years)

Pregnant women

Health care personnel

Figure 1.

Influenza vaccination rates for 2011–2012 leave much room for improvement. Healthy People 2020 goals are 90% for adults 65 years of age and older, high-risk adults 18–64 years of age, long-term care residents, and health care personnel, and 80% for all others.

Source: CDC.6,8,9

patients in need of immunization and generating reminders, and lack of vaccination-related performance measures.10,11 In a 2006 survey of some 2000 adults, 61% of those who were aware of influenza immunization but did not receive it cited their belief that healthy people don’t need the vaccine (Table 1).11 Nearly 40% said they didn’t get the vaccine because a doctor “hasn’t told me I need it.”And 28% said they didn’t get the vaccine because they believe it “may not work well.”

Although more than 90% of 200 physicians, nurse practitioners (NPs), physician assistants (PAs), and registered nurses (RNs) surveyed said that all of their adult patients should be immunized, far fewer said they actively recommend influenza vaccine to all of their patients (39% of physicians; 59% of NPs, PAs, and RNs).11 Just 47% of physicians and 61% of the NP, PA, and RN group said they always talk to their adult patients about the consequences of missing influenza vaccine.11 The need for such discussions is supported by results of a 2011 CDC survey, which found that half of all

adults are unaware of the universal influenza vaccination recommendation.12 Influenza vaccine options for adults Vaccination is the best means available to help prevent influenza. Vaccines are 70%-90% effective in preventing illness in healthy recipients <65 years of age when vaccine components match the circulating strains.3 Traditional influenza vaccines are less successful at preventing the disease in adults ≥65 years of age than in younger adults. Although effectiveness in preventing influenza declines with old age, immunization remains critical in shielding older adults from flu-related hospitalization (50%60% effective) and death (80% effective).3 Influenza vaccines in the US are available as either inactivated influenza virus preparations or live attenuated influenza vaccine (LAIV).

Most vaccines are trivalent formulations, protecting against influenza strains A(H1N1), A(H3N2), and B. Adverse effects of influenza vaccination are generally mild, transient, and

Table 1.

2

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Top 10 reasons for not receiving influenza vaccine

Percentage of respondents

I’m healthy and don’t need it

61

Shortage, others may need it more

59

Concern about side effects

43

Doctor hasn’t told me I need it

38

Vaccine might be unavailable

29

I don’t visit doctor regularly

28

May not work well

28

Might get the disease

26

Don’t know when to get it

21

Could worsen current medical conditions

17

Influenza and Adults

A 2006 survey of adult consumers found that the most common reason for not receiving influenza vaccine is the erroneous belief that a healthy person does not need to be immunized.

Adapted from Johnson DR, et al.11

manageable, such as injection-site pain after receipt of intramuscular trivalent inactivated influenza virus vaccine (TIV) or rhinorrhea after LAIV, which is administered intranasally.1 TIV can be used in any person ≥6 months of age (age indication varies by product), including those with conditions that increase the risk of influenza-related complications. LAIV can be used in persons 2-49 years of age who are healthy and not pregnant.1 New influenza vaccines have been developed in recent years. In 2009, the US Food and Drug Administration (FDA) approved Fluzone® High-Dose, Influenza Virus Vaccine (Sanofi Pasteur, Swiftwater, PA) as a TIV for patients ≥65 years of age. Compared to the traditional Fluzone vaccine formulation, the high-dose vaccine contains 4 times as much antigen per strain and generates a more robust immune response.13 The fact that older people are disproportionately and severely affected by influenza and have an age-related reduced response to traditional influenza vaccines led to the accelerated approval of Fluzone HighDose vaccine by the FDA. Fluzone Intradermal vaccine (Sanofi Pasteur, Swiftwater, PA) was licensed in 2011 as an alternative to intramuscular TIV preparations for patients 18-64 years of age. The vaccine is administered via a single-dose, preservativefree, prefilled microinjection system.14 Vaccine is delivered just below the skin’s surface with a very small needle (1.5mm).

Quadrivalent influenza vaccines—which include a second strain of influenza B to provide broader coverage—are expected to be available beginning with the 2013-2014 flu season. Both a quadrivalent LAIV (FluMist Quadrivalent [MedImmune]) and a quadrivalent inactivated vaccine (Fluarix Quadrivalent [GlaxoSmithKline]) were approved in 2012. A quadrivalent version of Fluzone vaccine (Sanofi Pasteur) has completed Phase III trials.

The growing number of vaccines from which to choose allows for a more patient-specific approach to prevention than in the past. (For tips on integrating new vaccines into a practice, see the box on page 3.) Health care providers, in addition to obtaining influenza vaccine appropriate for the age groups they plan to vaccinate,3 should consider patient risk factors, preferences, and contraindications in their selection. Offering more vaccine choices may increase patient and provider satisfaction and improve outcomes. For example, some adults might prefer the intradermal vaccine because of its small needle size; others might opt for intranasal administration. Elderly patients might elect to receive high-dose vaccine based on

the increased immune response it generates.

Within the indicated groups specified in the prescribing information for each vaccine, the CDC does not express a preference for one type of vaccine over another,14 leaving it to the provider to choose which specific vaccines to recommend.

Strategies to increase immunization rates Health care practices can employ a variety of strategies to maximize influenza vaccine uptake, with a shared aim of avoiding missed immunization opportunities and creating new ones.

Findings from the US Community Preventive Services Task Force have shown that multiple interventions implemented in combination are usually more effective at increasing vaccination rates in adults than any single strategy.15 Recommend vaccination. Surveys have shown that a health care provider’s recommendation is one of the most powerful predictors of vaccine uptake.16 In a recent study of more than 4000 adults, for example, those who received a provider recommendation for influenza vaccination were 14 to 32 percentage points more likely to be immunized than those who had not received any recommendation.17 It’s not sufficient to make a casual recommendation—clinicians need to advocate for immunization. A provider’s recommendation has been shown to have a more powerful effect on influenza vaccination acceptance than that of the patient’s own attitudes toward immunization, and a strong recommendation can result in vaccination even if a patient is negatively disposed toward being immunized.16 Educate staff. To convincingly recommend vaccination to patients, health care professionals must first recognize the importance of getting immunized themselves. One survey of physicians, including family physicians and geriatricians, found that a sizable minority did not strongly agree that influenza and its complications can be serious (19%) or that the benefits of vaccination outweigh the risk of side effects (26%).18 Low immunization rates among nurses and other employees in hospital settings also indicate the need for increased staff education. Key points to communicate include the prevalence and seriousness of influenza complications; the effectiveness of immunization in helping to prevent seasonal flu; and the vaccine’s ability to minimize absenteeism, influenza severity, and transmission to patients, co-workers, family members, and friends.19 Inform patients. In one study, 75% of patients who reported a high degree of worry about getting the flu said they intended to

Incorporating new influenza vaccines into your practice • Establish default vaccines for each age group (eg, high-dose vaccine for adults ≥65 years of age) and patient population (eg, a TIV product for pregnant women) • Combine standing orders for each influenza vaccine into a single order that includes all the vaccines offered • Use electronic health record technology to streamline and revise order sets • Educate staff about the side-effect profile of all default vaccines • Have on hand all appropriate Vaccine Information Statements and let patients know which type of influenza vaccine they have received • Be familiar with the Current Procedural Terminology (CPT®)a product code of each influenza vaccine to ensure correct reimbursement a

CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association.

be vaccinated, compared with less than half of those expressing a low degree of worry.10 Patients should be told that the CDC recommends influenza immunization for every adult because of the risk the disease poses to people of all ages, even healthy ones. Let patients know that the approval by the FDA of new vaccines offers more choices than in the past.

Vaccine Information Statements for influenza vaccine can help reassure patients about the benefits and safety of vaccination and correct misconceptions. The box below lists some

common myths about influenza vaccination and facts to rebut them. Waiting areas can be outfitted with fact sheets and brochures on influenza, immunization, and everyday preventive measures such as respiratory etiquette and hand hygiene. Look for materials that are culturally and linguistically appropriate to your patient population. The websites listed on page 4 offer a wealth of educational resources.

Identify an influenza vaccine champion.

Develop immunization champions throughout the office, but designate a staff member who

Refuting common myths about influenza vaccines1,20 Myth: The flu vaccine will give me the flu.

Fact: Influenza viruses contained in a flu shot are inactivated (killed), so they cannot cause infection. Viruses contained in the nasal vaccine are live but attenuated (weakened) to the point where they cannot cause the flu.

Myth: I’ll get sick even if I get a flu vaccine.

Fact: If you’re exposed to the flu virus before vaccination or for 2 weeks afterward, it is possible to get the flu. You may also become sick from flulike viruses or if the influenza strain circulating does not match the vaccine strain. Compared to younger, immunocompetent persons, older people and people with weakened immunity are more likely to get the flu despite immunization, but the flu vaccine can still help make the illness less severe. The bottom line is that flu vaccine provides the best protection possible against influenza.

Myth: If I get vaccinated early in the flu season, I won’t be protected throughout the entire season.

Fact: Seasonal flu vaccination will protect you for the entire flu season, and only 1 dose is needed for adults.

Myth: After November, it’s too late to get vaccinated.

Fact: As long as flu viruses are circulating, it’s not too late to get vaccinated. The illness usually peaks in January or February but can occur as late as May. Myth: People who are sick should not receive flu vaccine.

Fact: The vaccine can be given to patients who have mild illnesses with or without fever. Vaccination is especially important for people with chronic medical conditions, such as asthma, diabetes, and heart disease, because these individuals are at increased risk for influenza-related complications.

Influenza and Adults

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will have primary responsibility for ensuring that employees and patients are vaccinated.

That person should set and assess annual seasonal influenza vaccination campaign goals and help enact and apply proper procedures for the administration of all influenza vaccines. The champion should be familiar with the practice’s patient profile to help determine which influenza vaccines are the most appropriate choices for the practice to purchase.

Influenza Resources American Public Health Association www.getreadyforflu.org/ preparedness/influenza_main.htm CDC, www.cdc.gov/flu Faces of Influenza www.facesofinfluenza.org

Immunize throughout influenza season. Start vaccinating as early as September

Immunization Action Coalition www.immunize.org/influenza

to avoid missed opportunities, and continue vaccination efforts—talk about it, recommend it—throughout the entire influenza season.

Influenza can continue to circulate as late as May, yet significant drop-off in immunization occurs as the season progresses.1,12 Publicize the fact that it is not too late to be immunized.

National Council on Aging www.ncoa.org/flu

Make vaccination convenient and accessible. Because adults tend not to visit a health

care provider regularly, influenza vaccination should be offered during acute care visits for mild illness or injury as well as routine visits.

To accommodate busy schedules and working adults, make immunization visits available during evenings and weekends, if possible. Consider establishing walk-in vaccination days.

Cultivate enthusiasm. Look for creative ways to generate interest in immunization. One pediatric practice in California shuts down its office one afternoon a year to hold a fall harvest party in its parking lot, during which immunizations are administered to parents.

Also consider partnering with your local health department or health care institutions in your community. In 2011,Vanderbilt University and Medical Center conducted a mass vaccination event called “Flulapalooza,” in Nashville, Tennessee, setting a Guinness World Record for the number of flu immunizations delivered in an 8-hour period—more than 12 000!

Implement standing orders. Standing orders, which enable nonphysician staff to assess each patient’s immunization status and administer vaccines, are one of the most effective tools for increasing adult vaccination rates, yet they are underutilized. A 2009 survey of primary care physicians found that fewer than half (42%) use standing orders for influenza vaccination, a figure that has improved little in the past decade.21 Standing-order protocols and training materials are available at www. immunizationed.org/standingorders and www. immunize.org/standing-orders.

Use reminders. Strong evidence supports the effectiveness of patient reminders (eg, tele-

National Foundation for Infectious Diseases www.nfid.org/influenza National Influenza Vaccine Summit www.preventinfluenza.org Society of Teachers of Family Medicine Group on Immunization Education www.immunizationed.org US Department of Health and Human Services, www.flu.gov

phone, postcards, e-mails) and provider reminders (eg, flagged charts, electronic medical record reminders) in improving vaccination coverage in adults.17,22-24 A mass patient reminder can be delivered to callers to the practice through use of a pre-recorded message about making an appointment to get vaccinated. Provider reminder systems can be as simple and lowcost as a stamp reading “No Influenza Vaccine on Record” or a clip marked “Immunization Due” that is affixed to a patient’s chart.24 Whatever interventions are used to help increase uptake of influenza vaccine, measure how successful they are at achieving the practice’s immunization goal. One study found that only 33% of providers had ever evaluated their adult immunization rates through chart review or another objective means.11 Knowing what percentage of patients in a practice are being immunized against influenza allows improvements to be made where needed. Attainment of a high immunization rate demonstrates the office’s commitment to disease prevention and is a statistic worth communicating—in jump-on-the-bandwagon fashion—to that practice’s patients.

REFERENCES 1. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommenda-

tions of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR. 2010;59(RR-8):1-62.

2. CDC. Estimates of deaths associated with seasonal influenza—United States, 1976–2007. MMWR. 2010;59(33):10571062.

3. CDC. Influenza. In: Epidemiology and Prevention of VaccinePreventable Diseases. (The Pink Book). Atkinson W, Wolfe S, Hamborsky J, eds. 12th edition. Washington, DC: Public Health Foundation, 2012:151-172.

4. CDC. Maternal and infant outcomes among severely ill pregnant and postpartum women with 2009 pandemic influenza A (H1N1)—United States, April 2009–August 2010. MMWR. 2011;60(35):1193-1196.

5. Fell DB, Sprague AE, Liu N, et al. H1N1 influenza vaccination during pregnancy and fetal and neonatal outcomes. Am J Public Health. 2012;102(6):e33–e40.

6. CDC. Influenza vaccination coverage among pregnant women—2011-12 influenza season, United States. MMWR. 2012;61(38):758-763.

7. US Department of Health and Human Services. Healthy People 2020. http://www.healthypeople.gov/2020/ topicsobjectives2020/objectiveslist.aspx?topicid=23.

Accessed January 2, 2013.

8. CDC. Flu vaccination coverage, United States, 2011-12 influenza season. http://www.cdc.gov/flu/professionals/ vaccination/coverage_1112estimates.htm. Accessed October 1, 2012.

9. CDC. Influenza vaccination coverage among health-care personnel—2011-12 influenza season, United States. MMWR. 2012;61(38):753-757.

10. Harris KM, Uscher-Pines L, Mattke S, Kellerman AL. A Blueprint for Improving the Promotion and Delivery of Adult Vaccination in the United States. Santa Monica, CA:Rand Corporation, 2012.

11. Johnson DR, Nichol KL, Lipczynski K. Barriers to adult immunization. Am J Med. 2008;121(7B):S28–S35.

12. Kennedy ED, Santibanez TA, Bridges CB, Singleton JA. National flu survey: national mid-season flu vaccination coverage, United States, 2011-12 influenza season. http://www. cdc.gov/flu/pdf/professionals/vaccination/1112-nationalflu-survey.pdf. Accessed January 2, 2013.

13. Falsey AR, Treanor JJ, Tornieporth N, et al. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009;200(2):172-180.

14. CDC. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2012-13 influenza season.

MMWR. 2012;61(32):613-618.

15. Community Preventive Services Task Force. Universally recommended vaccinations: health care system-based interventions implemented in combination. http://www. thecommunityguide.org/vaccines/universally/ healthsysteminterventions.html. Accessed January 2, 2013.

16. Nichol KL. Improving influenza vaccination rates among adults. Cleve Clin J Med. 2006;73(11):1009-1015.

17. Maurer J, Harris KM. Contact and communication with healthcare providers regarding influenza vaccination during the 2009–2010 H1N1 pandemic. Prev Med. 2011;52(6):459-464.

18. Cowan AE, Winston CA, Davis MM, et al. Influenza vaccination status and influenza-related perspectives and practices among US physicians. Am J Infect Control. 2006;34(4):164-169.

19. Department of Veterans Affairs. VA Influenza Manual 2010/2011. Washington, DC: US Department of Veterans Affairs, 2010.

20. CDC. Misconceptions about seasonal influenza and influenza vaccines. http://www.cdc.gov/flu/about/qa/ misconceptions.htm. Accessed January 2, 2013.

21. Zimmerman RK, Albert SM, Nowalk MP, et al. Use of standing orders for adult influenza vaccination: a national survey of primary care physicians. Am J Prev Med. 2011;40(2):144-148.

22. Loo TS, Davis RB, Lipsitz LA, et al. Electronic medical record reminders and panel management to improve primary care of elderly patients. Arch Intern Med. 2011;171(17):1552-1558.

23. Community Preventive Services Task Force. Increasing appropriate vaccination: universally recommended vaccinations. Task force recommendations and findings. http:// www.thecommunityguide.org/vaccines/universally/index. html. Accessed January 2, 2013.

24. CDC. Immunization strategies for healthcare practices and providers. In: Epidemiology and Prevention of VaccinePreventable Diseases. (The Pink Book). Atkinson W, Wolfe S, Hamborsky J, eds. 12th edition. Washington, DC: Public Health Foundation, 2012:31-44.

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