Transcript Budnick slides

Influenza Prevention for
Health Care Workers:
Mandate or Not Mandate?
Lawrence D. Budnick, MD
Director, Occupational Medicine Service
Associate Professor of Medicine & Preventive Medicine
Rutgers New Jersey Medical School
October 18, 2014
Disclaimer
 Conflicts of interest – None.
 Financial relations – In my wife’s dreams.
 No off-label recommendations.
 Any reference to trade names is in
NO WAY a personal endorsement.
Objectives
• To briefly review methods to prevent influenza transmission
and infection in health care facilities.
• To explain the different requirements and recommendations
concerning health care worker vaccination against influenza.
• To assess the current landscape of mandates for influenza
prevention among health care workers.
•
•
•
•
Respiratory droplets propel up to 3 feet through the air.
Can be infectious 1 day before symptoms.
Nasal-oral contact.
Environmental surfaces.
Environmental Exposure to
Respiratory Viruses
• Stationary and personal aerosol samplers
were used to collect airborne particles in an
urgent care medical clinic.
• Real time quantitative PCR testing
Virus
Per Cent Positive
Influenza A
17%
Influenza B
1%
Respiratory Syncytial Virus
38%
Lindsley et al. Clin Inf Dis 2010;50
Influenza Vaccines
US, 2013-14 Influenza Season
Vaccine
Dose
Route
Age Indication
Inactivated Influenza 0.25 mL Pediatric,
Vaccine, Trivalent
0.5 mL Adult
IIV3
IM
Pediatric 6-35
months
Adult >3 years
IIV3 Intradermal
0.1 mL
ID
18-64 years
IIV3 High Dose
0.5 mL
IM
>65 years
Inactivated Influenza 0.25 mL Pediatric,
Vaccine,
0.5 mL Adult
Quadrivalent IIV4
IM
Pediatric 6-35
months
Adult >3 years
Recombinant
Influenza Vaccine,
Trivalent RIV3
0.5 mL
IM
18-49 years
Live-attenuated
Influenza Vaccine,
Quadrivalent LAIV4
0.2 mL Prefilled
intranasal sprayer
IN
2-49 years
Influenza Vaccine Efficacy
1967-2011
Age
<7 years old
7-18 years old
18-59 year old
60-64 years old
65+ years old
Inactivated
Vaccine
“Inconsistent
evidence”
59%
“Paucity of
evidence”
Live Attenuated
Vaccine
83%
“Lack of evidence”
Not licensed for use.
“Inconsistent
evidence”
Osterholm MT, Kelley NS, Sommer A, Belongia EA. Efficacy and effectiveness of influenza
vaccines: a systematic review and meta-analysis. Lancet Infect Dis 2012;12:36-44.
Influenza A and B
Antiviral Medications
Oseltamivir
(Tamiflu)
Zanamivir
(Relenza)
Amantadine
(Symmetrel)
Treatment
Chemo Prevention
> 1 yo
> 1 yo
> 7 yo
> 5 yo
Not to be used for
Influenza A unless
evidence of
susceptibility has been
reestablished
No
Rimantidine
(Flumadine)
The emphasis is on early treatment as an alternative
to chemoprophylaxis after a suspected exposure
http://www.health.gov/hai/pdfs/hai-action-plan-hcp-flu.PDF
% Of Health Care Workers
Self-Reported Vaccinated
for Influenza, Internet
Panel Survey, US,
2010-11 through 2013-14
Influenza Seasons
CDC. MMWR 2014;63(37);805-11.
% Of Health Care Workers Reported Vaccinated for Influenza
by Reporting Acute Care Hospitals, National Healthcare
Safety Network, US, 2013-2014 Influenza Season
%
State
Employees
% LIP
Delaware
93.7
71.7
New Jersey
70.8
39.1
New York
85.9
66.3
Pennsylvania
86.2
62.8
US Overall
86.1
61.9
Range
69.0-97.6 33.8-93.6
No. of HCW
5.7
1.2
(millions)
% Adult
Students/
Volunteers
95.6
50.3
84.2
82.5
79.9
50.3-96.3
1.2
CDC. MMWR 2014;63(37);812-15.
% All
HCWs
92.1
62.4
83.3
82.1
81.8
62.4-96.4
8.0
Wodi AP et al. Influenza Vaccine: Immunization Rates, Knowledge, and Attitudes
of Resident Physicians in an Urban Teaching Hospital . Infect Control Hosp
Epidemiol. 2005; 26(11):867-873.
Wodi AP et al. Influenza Vaccine: Immunization Rates, Knowledge, and Attitudes
of Resident Physicians in an Urban Teaching Hospital . Infect Control Hosp
Epidemiol. 2005; 26(11):867-873.
Increased Risk of Noninfluenza Respiratory
Virus Infection Associated with Receipt of
Inactivated Influenza Vaccine
Cowling BJ et al. Clin Inf Dis 2012;54:1778-83.
Ahmed F et al. Clin Infect Dis. 2014;58:50-57
Ahmed F et al. Clin Infect Dis. 2014;58:50-57
Ahmed F et al. Clin Infect Dis. 2014;58:50-57
Influenza Vaccination Effectiveness
in Health Care Settings
Cochrane Collaboration Database Analysis
• 4 cluster-RCTs (C-RCTs) (n = 7558) and one cohort (n = 12742) of
influenza vaccination for HCWs caring for individuals >/= 60 in LTCFs.
• Pooled data from three C-RCTs showed no effect on specific
outcomes: laboratory-proven influenza, pneumonia or deaths from
pneumonia.
• For non-specific outcomes pooled data from three C-RCTs showed
HCW vaccination reduced ILI; data from one C-RCT that HCW
vaccination reduced GP consultations for ILI; and pooled data from
three C-RCTs showed reduced all-cause mortality in individuals >/= 60.
• Non-specific outcomes are difficult to interpret because ILI includes
many pathogens, and winter influenza contributes < 10% to all-cause
mortality in individuals >/= 60.
Thomas RE, Jefferson T, Lasserson TJ. Influenza vaccination for healthcare workers who
care for people aged 60 or older living in long-term care institutions. Cochrane Database Syst
Rev 2013;7:CD005187.
Editorial Commentary: Influenza Vaccination of
Healthcare Workers: Making the Grade for Action
Marie R. Griffin
“Since Ahmed et al's meta-analysis was submitted, the Cochrane metaanalysis on this same topic was updated and concluded that there was
no evidence to mandate compulsory vaccination of healthcare workers
[11].
It is disconcerting when meta-analyses come to different conclusions.
Unlike the previous iteration of this Cochrane meta-analysis [12] and that
of Ahmed et al discussed above, the recent one [11] eliminated influenzalike illness and all-cause mortality as outcomes of interest because they
are nonspecific and thus excluded the study of Hayward et al.
Nevertheless, for the more specific outcomes, prevention of laboratoryconfirmed influenza illness and acute respiratory hospitalizations, there
was agreement between these 2 meta-analyses on the lack of evidence
for protection.”
Clin Infect Dis 2014;58:50-7.
From Vanderbilt. Grant support from MedImmune.
Editorial Commentary: Influenza Vaccination of
Healthcare Workers: Making the Grade for Action
Marie R. Griffin
“Given the dire consequences that outbreaks of influenza can
have in institutional settings, the known safety and efficacy of
current influenza vaccines, and the strong evidence that
vaccinating a segment of the population can protect
unvaccinated persons who are in contact with vaccinees, the
meta-analysis by Ahmed et al offers additional reassurance that
the threshold for action has been reached or surpassed.
Vaccination of healthcare workers to protect vulnerable patients
and residents of long-term care facilities should be viewed as
an evidence-based recommendation.”
Clin Infect Dis 2014;58:50-7.
From Vanderbilt. Grant support from MedImmune.
Physical Interventions to Interrupt or
Reduce the Spread of Respiratory Viruses
Cochrane Collaboration Conclusions
Odds Ratio
95% CI
Number Needed
to Treat
95% CI
Washing hands
>10 times daily
0.45
0.45-0.57
4
3.65-5.52
Wearing masks
0.32
0.25-0.40
6
4.54-8.03
Wearing N95
respirators
0.09
0.03-0.30
3
Wearing gloves
0.43
0.29-0.65
5
4.15-15.41
Wearing gowns
0.23
0.14-0.37
5
3.37-7.12
Handwashing,
masks, gloves, and
gowns combined
0.09
0.02-0.35
3
2.66-4.97
2.37-4.06
Jefferson T, Del Mar CB, et al. Physical Interventions to Interrupt or Reduce the Spread of
Respiratory Viruses. Cochrane Database Syst Rev 2011:CD006207.
Physical Interventions to Interrupt or
Reduce the Spread of Respiratory Viruses
Cochrane Collaboration Database Analysis
• 67 Studies, but risk of bias for RCTs was high.
• Implementing barriers to transmission, isolation, and hygienic
measures are effective and relatively cheap interventions to contain
epidemics of respiratory viruses, such as SARS, with estimates of
effect ranging from 55% to 91%.
• Surgical masks or N95 respirators were the most consistent and
comprehensive supportive measures.
• N95 respirators were noninferior to simple surgical masks but more
expensive, uncomfortable and irritating to skin.
Jefferson T, Del Mar CB, et al. Physical Interventions to Interrupt or Reduce the Spread of
Respiratory Viruses. Cochrane Database Syst Rev 2011:CD006207.
US Supreme Court and
Immunizations
• Jacobson v. Commonwealth of
Massachusetts, 1905
– Police powers of the state under the Tenth
Amendment authorize them to impose restrictions
on private rights for the sake of public welfare,
including the requirement for immunizations.
• Zucht v. King, 1922
– Endorsed immunization requirement for school
entry, finding that they convey not arbitrary power,
but only that broad discretion required to protect
public health.
Community–wide protection outweighs
individual right to refuse immunization
US Constitution
Fourteenth Amendment
Section 1. All persons born or naturalized in the United
States, and subject to the jurisdiction thereof, are citizens
of the United States and of the State wherein they reside.
No State shall make or enforce any law which shall
abridge the privileges or immunities of citizens of the
United States; nor shall any State deprive any person of
life, liberty, or property, without due process of law; nor
deny to any person within its jurisdiction the equal
protection of the laws.
Competent adults have the right to bodily
autonomy and to refuse medical treatment.
2008 ADA Amendments
Amended to focus on discrimination
• Was an alleged discriminatory action taken because
of disability, rather than on whether the person has a
disability?
• Cases to be decided on whether the employer could
accommodate
• Employer cannot take into account mitigating
measures when determining whether an impairment
is substantially limiting
– Is diabetes substantially limiting, regardless of use
of insulin?
– Is lack of immunity substantially limiting regardless
of the use of vaccine?
OSHA
Healthcare employers need to use a combination of controls
to protect workers and help reduce the transmission of the
seasonal flu virus, to include:
• Promote, administer and make readily accessible the annual flu
vaccine to all workers
• Encourage sick workers to stay at home
• Emphasize hand hygiene and cough etiquette
• Use airborne infection isolation rooms
• Ensure proper functioning of the HVAC system in patient rooms,
procedure rooms, and examination rooms
• Limit the transport of infectious patients throughout the facility
• Limit the number of healthcare staff in contact with flu patients
• Give proper personal protective equipment (PPE) (gloves, gowns,
surgical masks, respirators) to healthcare staff and ensure that it is
used and discarded correctly
https://www.osha.gov/dts/guidance/flu/healthcare.html
OSHA
• For seasonal flu, HHS/CDC recommends that
workers wear a fit tested N95 disposable
respirator while performing high-risk, aerosolgenerating procedures on flu patients
• Employers who require workers to wear
respirators (N95 disposable respirators or better)
must have a complete respiratory protection
program in place that meets the requirements in
the OSHA standard, 29 CFR 1910.134
• Employers are responsible for making sure that
workers are trained to use and discard PPE
correctly, including respirators
https://www.osha.gov/dts/guidance/flu/healthcare.html
Strategies for Improving Health Care
Personnel Influenza Vaccination Rates
•
•
•
•
•
Education and campaigns
Role models
Improved access
Measurement and feedback
Legislation and regulation
– 9 states have offer
State Immunization Laws for Healthcare
Workers: Administration Requirements For
Influenza, September 24, 2014
Ensure
Offer
AL
CO
NH
CA
GA
IL
MA
MD
ME
NE
NY
OK
RI
TN
No Law Specific
to Influenza
DC
NV
OR
VA
No Law
All Others
Including
DE
NJ
PA
http://www2a.cdc.gov/vaccines/statevaccsApp/Administrationb
yVaccine.asp?Vaccinetmp=Influenza.
State Immunization Laws for Healthcare
Workers: Assessment Requirements For
Influenza, September 24, 2014
Yes
No Law
CA
NY
All Others
Including
DE
NJ
PA
http://www2a.cdc.gov/vaccines/statevaccsApp/Administrationb
yVaccine.asp?Vaccinetmp=Influenza.
New York State Flu Mandate for
Health Care Workers:
Vaccinate or Mask
• Unvaccinated health care personnel in regulated settings must wear a
surgical mask in areas where patients or residents may be present.
• These settings include hospitals, nursing homes, diagnostic and
treatment centers, home care agencies and hospices.
• HCFs must report the number of personnel who have been vaccinated
and supervise unvaccinated staff to ensure the appropriate use of
masks.
• Personnel who fail to comply are subject to the same institutional
disciplinary procedures imposed on workers who do not follow other
infection control procedures.
• The State may cite a facility for failure to comply with these regulations
if these requirements are not met.
Caplan AL, Shah NR. Managing the human toll caused by seasonal influenza. JAMA 2013;310:1797.
New Jersey
Senate Bill No. 1464
Introduced February 6, 2012
Sponsored by Senator Joseph F. Vitale
• Requires certain health care facilities
to offer annual influenza vaccination.
• Requires that each health care worker at
the facility receive an influenza vaccination
or sign a written declination statement.
http://www.njspotlight.com/stories/13/11/04/hospitals-try-to-fend-off-flu-byrequiring-workers-to-get-shotshospitals-try-to-fend-off-flu-by-requiringworkers-to-get-shots/
Joint Commission
Standard IC.02.04.01
• Approved September 2011
• Establish an influenza vaccination program
for staff and licensed independent
practitioners (LIPs).
• Include in Infection Control Plan the goal of
improving influenza vaccination rates.
• Set incremental goals for meeting the 90%
target in 2020.
• Measure and improve influenza vaccination
rates for staff and LIPs.
Joint Commission
Standard IC.02.04.01
• Collect and review the reasons given by staff
and LIPs for declining the influenza
vaccination at least annually
– Does not require that a declination form be signed.
• Does not mandate influenza vaccinations for
staff and LIPs as a condition of Joint
Commission accreditation.
• Does not mandate that accredited
organizations pay for the influenza
vaccination for staff and LIPs.
ACIP Recommended Vaccines
for Healthcare Workers
•
•
•
•
•
•
Hepatitis B
Influenza
MMR = Measles, Mumps, Rubella
Varicella
Tdap = Tetanus, Diphtheria, Pertussis
Meningococcal
http://www.cdc.gov/vaccines/adults/rec-vac/hcw.html
American Medical Association
American Medical Association
Physicians have an obligation to
• (a) accept immunization absent a recognized
medical, religious, or philosophical reason to
not be immunized and
• (b) Accept a decision of the medical staff
leadership of health care institution or other
appropriate authority to adjust practice
activities if not immunized.
American College of Physicians
October 3, 2007
http://www.acponline.org/pressroom/hcw.htm
IDSA, SHEA, PIDS
Mandatory Immunizations for HCPs
December 10, 2013
• Immunization of HCP against vaccine-preventable
diseases protects patients as well as HCP from morbidity
and mortality related to these diseases.
• HCP immunization also reduces work absence during
outbreaks, which would further compromise patient care.
• HCPs continue to have low vaccination rates for ACIPrecommended vaccines, despite recent outbreaks of
measles and influenza among patients.
• When voluntary programs are insufficient to maintain
adequate HCP vaccination rates, mandatory vaccination
programs are needed.
Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America,
and the Pediatric Infectious Diseases Society
IDSA, SHEA, PIDS
Mandatory Immunizations for HCWs
• The safety, efficacy, and cost-effectiveness of ACIPrecommended vaccines are well documented and proven.
• Although educational campaigns improve HCP compliance
with immunization programs, they are inconsistent in
effecting adequate vaccine coverage levels when used
alone.
• Providing free vaccinations in the occupational setting
improves HCP immunization compliance.
• On the basis of the Hippocratic Oath, physicians and other
HCPs have an ethical moral obligation to prevent
transmission of infectious diseases to their patients,
because they have pledged "to do good or to do no harm."
http://www.idsociety.org/uploadedFiles/IDSA/Policy_and_Advocacy/Current_Topics_and_
Issues/Immunizations_and_Vaccines/Health_Care_Worker_Immunization/Statements/ID
SA_SHEA_PIDS%20Policy%20on%20Mandatory%20Immunization%20of%20HCP.pdf
Seasonal Influenza Prevention in
Health Care Workers
ACOEM Guidance Statement, Nov 17, 2008
• HCFs must employ a comprehensive approach to
reduce the risk of influenza transmission in the
workplace, encompassing education, vaccination, and
infection control practices.
• Education and adherence to infection control practices
should be mandatory.
• Immunization is safe but variably effective and is not a
panacea for respiratory virus transmission in the health
care setting.
• Immunization against influenza should be strongly
encouraged and employers should provide vaccine at
no charge to the worker.
Seasonal Influenza Prevention in
Health Care Workers
ACOEM Guidance Statement, Nov 17, 2008
• Current evidence regarding the benefit of influenza
vaccination in HCW as a tool to protect patients is
inadequate to override the worker’s autonomy to refuse
vaccination.
• Declination statements should only be implemented if they
do not divert resources from vaccination and education or
create an adversarial atmosphere in the workplace.
• HCFs should measure and track vaccination rates among
workers and patients, staff education completion rates and
influenza transmission rates.
http://www.acoem.org/SeasonalInfluenzaPrevention_HealthCareWorkers.aspx
Mandate Influenza Vaccination
for Health Care Workers?
Yes
AAFP
AAP
ACP
AHA
APhA
APHA
APIC
IDSA
PIDS
SHEA

No
AMA
CDC
JC
ACOEM
OSHA
USDHHS
Guidelines in Disrepute:
A Case Study of Influenza Vaccination
of Healthcare Workers
Street JM, Delany TN. Aust NZ J Public Health 2012;36(4):357-363
Institutional requirements for influenza
vaccination of healthcare personnel: results
from a nationally representative survey of
acute care hospitals--United States, 2011.
• Of responding hospitals (n = 808 of 998; 81.0%), 440
(55.6%) reported institutional requirements for
influenza vaccination.
• Employees were uniformly subject to requirements,
nonemployees often were not.
• 44.4% of requirements included consequences for
vaccine
– 69.3% included allowance for nonmedical exemptions
– 74.2% included wearing a mask, which was the most
common consequence
– 29 hospitals - 14.4% - terminated unvaccinated HCP
Miller BL, et al. Clin Infect Dis 2011 Dec;53(11):1051-9.
Institutional requirements for influenza
vaccination of healthcare personnel: results
from a nationally representative survey of
acute care hospitals--United States, 2011.
• Significantly associated with requirements
– Location in a state requiring HCP to receive or decline
influenza vaccine.
– Caring for inpatients that are potentially vulnerable to
influenza
– Use of ≥9 ACIP-recommended, evidence-based influenza
vaccination campaign strategies.
– For-profit ownership.
• Influenza vaccination requirements were prevalent
among hospitals of varying size and location.
• Few policies were as stringent or as comprehensive
as those endorsed by
Miller BL, et al. Clin Infect Dis 2011 Dec;53(11):1051-9.
Mandatory Flu Vaccination
OR Masking Examples
Must Vaccinate
Must Vaccinate
or Mask Within
6 Feet of
Patients
Must Vaccinate
or Mask in
Patient Care
Areas
Must Caccinate
or Mask In
Entire Facility
Virginia Mason
Medical Center,
VA
Memorial
Hospital at
Gulfport, MS
UCLA Health
System, CA
University
Hospital of
Newark, NJ
BJC HealthCare,
MO
Eastern Idaho
Regional Medical
Center, ID
Includes selected responses from MCOH-EH List Serve Survey, September 2014
Virginia Mason Medical Center
• In Seattle, Washington.
• In 2004, first hospital to make annual
influenza vaccination a “fitness-for
duty” requirement for every employee.
• Medical and religious accommodations
 must wear surgical mask.
• 54.0% vaccination in 2003-04 
97.6% in 2005-06  98.9% in 2009-10.
Rakita RM et al. Mandatory influenza vaccination of healthcare workers: a five-year
study. Infect Control Hosp Epidemiol 2010;31:881-888.
Influenza Vaccine Mandate for
All Health Care Workers?
Yes
No
Consumers/ Professionals and
Patients
Workers
Societal and
Employers
• Influenza is
serious for
certain groups.
• Patient
protection?
• 60% Vaccine efficacy.
• Herd immunity.
• Ethical.
• Some epidemiologic
support in long term care
facilities
• Savings?
• Patient
protection?
• Police power
of state.
• False
security.
• Influenza
<10% of viral
URIs.
• 40% Vaccine not effective.
• Herd immunity (?>35%).
• Lack of epidemiologic
support.
• Adverse effects.
• Potentially harmful?
• 14th amendment rights.
• Costs
(>Savings?).
• Wisest use of
resources?
Thanks to Drs Gwen Brachman and Carolina Mangura
Mask Mandate for Clinical
Health Care Workers?
Yes
No
Consumers/
Patients
Professionals and
Workers
Societal and
Employers
• Influenza is
serious for
certain groups.
• Patient
protection for
multiple
pathogens.
• Ethical.
• Some epidemiologic
support.
• Personal protective
equipment.
• Savings?
• Patient
protection.
• Police power of
state.
• Consistent with
OSHA.
• False security.
• Message of
unsafe
environment 
fear.
• Decreased
communication.
• Decreased work ability.
• Adverse effects.
• Costs
(>Savings?).
• Enforcement
difficulty.
• Wisest use of
resources?
Thanks to Drs Gwen Brachman and Carolina Mangura
Who Has the Power to Decide?
• State legislature
• State health department
(executive)
• Court
• Individual hospital
• OSHA
But NOT
• Joint Commission
• Professional Societies