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  • ACOEM Responds to HHS Flu Action Plan

    October 11, 2010

    Department of Health and Human Services
    Office of Healthcare Quality
    200 Independence Ave., S.W., Room 719B
    Washington, D.C. 20201

    Attention: Draft Tier 2 Modules

    To Whom It May Concern:

    On behalf of the American College of Occupational and Environmental Medicine (ACOEM), we are pleased to submit the following comments on the plan outlined by the Department of Health and Human Services (HHS) to prevent health care-associated infections (HAIs) including a focus on influenza vaccination of health care personnel (HCP).

    The Action Plan includes a stated desire to engage stakeholders from professional organizations. ACOEM is the pre-eminent organization of physicians who champion the health and safety of workers, workplaces, and environments. Our members, particularly those in the Medical Center Occupational Health Section, oversee the occupational health/employee health programs through which HCP receive their flu vaccine, and therefore our members are vital to this conversation. We interact with HCP at the interface of policy and practice, on the front lines of medical center vaccination programs across the country. As such, we are major stakeholder in HCP vaccination policy, and appreciate inclusion in the dialogue.

    ACOEM has been a longstanding supporter of influenza vaccination programs for HCP, and has outlined 13 recommended elements of such programs in our guidance statement on Seasonal Influenza Prevention in Health Care Workers.i

    ACOEM applauds the stated Work Group Tasks:

    • Review available evidence for vaccination benefits, including improved health outcomes for HCP and patients.
    • Weigh benefits against costs and any possible harms. Identify the patient populations at highest risk of influenza-related mortality (e.g. infants, older persons, persons with respiratory illnesses) in whom vaccination of HCP would potentially provide the greatest benefit and review evidence for balance between benefits and harms for those specific populations.
    • Review available evidence on the factors that affect HCP vaccination as well as evidence-based strategies and best practices to increase vaccination rates. These include but not limited to recommendations or policies from medical and health organizations, state laws, improving access, educational efforts, employment mandates, declination forms, etc.
    • Identify gaps in current knowledge about reasons for HCP receiving and declining influenza vaccination, and approaches to fill these gaps.
    • Examine the potential impacts policy changes, such as mandating that influenza vaccination be offered or performed, may have on increasing influenza vaccination coverage for HCP.
    • Align data collection systems that track immunization rates across agencies.
    • Create and widely disseminate guidance, toolkits, and other materials for implementing evidence-based strategies to increase HCP vaccination rates.

    We agree with the need to standardize measurement of immunization rates. Given the seasonal nature of flu vaccine, HCP turnover between vaccination provision and flu season, and wide variability in organizational structure, current vaccination rates are an approximation at best. The Action Plan includes a pilot of four facilities using the National Quality Forum’s (NQF) influenza vaccination coverage measure to define nomenclature and standardize the numerator and denominator used to calculate vaccine rates. While technical and organizational challenges are inevitable, standardization is needed and the NQF definitions are a reasonable start.

    As outlined by HHS, the first task of the Interagency Working Group is to undertake a review of the available evidence regarding the impact of HCP vaccination on patient outcomes. ACOEM wishes to emphasize the importance of ensuring scientific integrity and full disclosure of financial conflicts in this area. We strongly urge the group to complete an unbiased literature review before proceeding with support for vaccine mandates. The current literature is far from conclusive on this topic.

    We do have concerns about the scientific underpinning of key assumptions in the document, especially in light of the potential consequences of a vaccine mandate. Given that some healthcare personnel are so fearful of vaccination that workplace conflict and loss of livelihood are very real considerations, the case for any HCP vaccine mandate must be scientifically sound and compelling. The Action Plan’s opening statement, that “influenza transmission to patients by HCP is well documented” cites eight references, some over 30 years old. These studies really document that transmission of influenza from HCP to patients is exceedingly difficult to verify. In just one case are HCP implicated as the most likely source of the transmission; in two cases transmission may have been from HCP, family members and/or visitors. In four case reports, the nosocomial influenza strain was not included in that year’s vaccine. Two review articles are also cited, and serve to further illustrate that although cases of nosocomial influenza have been well documented, the source of infection is almost never identified. These cases also highlight the importance of a multi-pronged infection control program, as the seasonal influenza vaccination may not match the circulating strain.

    The Action Plan states that HCP vaccination rates have remained low “despite the documented benefits of HCP influenza vaccination on patient outcomes,” citing two studies by Thompson et al,ii,iii to support this assertion. It concerns us that neither of the cited articles actually addresses HCP vaccination at all.

    In studies that have attempted to evaluate the impact of HCP vaccination on patient outcomes in the most high-risk setting of long-term care,iv,v,vi,vii,viii the consistent conclusion is that HCP vaccination as an isolated intervention does not have significant impact on patients.ix Furthermore, recent evidence suggests that vaccine efficacy is much lower than previously thought.x,xi We urge HHS to approach the issue with scientific neutrality, remaining open to the null hypothesis that HCP vaccination may not significantly affect patient outcomes, especially in acute care settings. The working group may find that resources are best focused on vaccination of patients and multidisciplinary infection control programs, with voluntary vaccination of HCP strongly encouraged.

    For many HCP, the main reason they take vaccine is to prevent their own illnesses. Self-protection is a real, rational and powerful motivator promoting HCP vaccination. By focusing on potential but unproven benefits to others, we minimize a strong incentive for HCP to accept vaccination. HCP are not immune to the prevalent lay climate of distrust and skepticism regarding vaccines and vaccine manufacturers. To keep them engaged in a positive way, we must maintain open dialogue with a balanced appraisal of the available literature, and transparency regarding financial conflicts with vaccine manufacturers.

    It should also be noted that vaccine mandates have the potential to harm the employer-employee relationship – an important long-term consequence. Employer-mandated vaccinations are fraught with logical, ethical, and administrative pitfalls and constitute a false sense of security even though they may create the impression of strong action.

    Because current evidence regarding the benefit of influenza vaccination in HCP as a tool to protect patients is inadequate, on balance, the disadvantages of vaccine mandates may undercut their overall value.

    Summary
    As a major stakeholder in HCP vaccination, ACOEM applauds the HHS Action Plan’s stated aims to engage stakeholders, to conduct a rigorous review of the literature regarding influenza vaccine benefits, and to standardize the measurement of influenza vaccination rates. We believe that a thoughtful, dispassionate and scientifically neutral review process will recommend restraint regarding HCP vaccine mandates.

    ACOEM strongly supports influenza vaccination of healthcare personnel, and hopes that protection of HCP will remain foremost in any discussion regarding HCP vaccination. Resources expended to increase HCP vaccination rates should be proportional to the additional benefit of higher vaccination rates, and should not drain resources from other important programs to protect the health of workers.

    Finally, although exploring the potential benefits and shortcomings of the currently available seasonal influenza vaccine is a laudable and necessary process, we must not lose the forest for the trees. Because influenza vaccine is variably effective and subject to unpredictable interruptions in supply and delivery, a universal flu vaccine should be our primary goal in this field. A universal flu vaccine would change the paradigm of seasonal flu vaccine and provide year-round availability. And because influenza vaccine, even if perfectly effective and perfectly available, can only protect HCP and patients from influenza virus, other control measures such as source control and isolation, hand hygiene, respiratory etiquette and appropriate use of personal protective equipment are vital for protection against the legions of non-influenza respiratory viruses.

    Thank you for your consideration of these comments.

    Sincerely,

    Natalie P. Hartenbaum, MD, MPH, FACOEM
    President

    Melanie Swift, MD, FACOEM
    ACOEM Section on Medical Center Occupational Health

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    1. Seasonal Influenza Prevention in Health Care Worker, ACOEM Guidance Statement, 2008. Available at www.acoem.org/guidelines.aspx?id=5362.
    2. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA. 2004; 292:1333-40.
    3. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003; 289:179-86.
    4. Carman WF, Elder AG, Wallace LA, et al. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet. 2000;355(9198):93-7.
    5. Potter J, Stott DJ, Roberts MA, et al. Influenza vaccination of health care workers in long-term- care hospitals reduces the mortality of elderly patients. J Infectious Diseases. 1997;175(1):1-6.
    6. Hayward AC, Harling R, Wetten S, et al. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ. 2006; 333(7581):1229-30.
    7. Shugarman LR, Hales C, Setodji CM, Bardenheier B, Lynn J. The influence of staff and resident immunization rates on influenza-like outbreaks in nursing homes. J Am Med Directors Assoc. 2006;7:562-7.
    8. Lemaitre M, Meret T, Rothan-Tondeur M, et al. Effect of influenza vaccination of nursing home staff on mortality of residents: a cluster-randomized trial. J Am Geriatrics Society. 2009;57(9):1580-6.
    9. Thomas RE, Jefferson T, Lasserson TJ. Influenza vaccination for healthcare workers who work with the elderly. Cochrane Database of Systematic Reviews. 2010, Issue 2. Art. No.: CD005187.
    10. Kelly H, Carville K, Grant K, et al. Estimation of influenza vaccine effectiveness from routine surveillance data. PLoS. 2009;ONE 4(3): e5079. doi:10.1371/journal.pone.0005079.
    11. Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews. 2010, Issue 7. Art. No.: CD001269.