immunization in healthcare providers: recommendations ... · immunization in healthcare providers:...

Immunization in Healthcare Providers: Recommendations,

Evidence and Controversy

Shelly A. McNeil, MD, FRCPCProfessor of Medicine, Division of Infectious Diseases

Clinician Scientist, Canadian Center for Vaccinology

Dalhousie University, Halifax NS

Disclosures

In the past 2 years I have been an employee of:

In the past 2 years I have been a consultant of:

In the past 2 years I have held investments in the following pharmaceutical organizations, medical devices companies or communications firms:

In the past 2 years I have been a member of the Scientific advisory board of:

Sanofi Pasteur, Roche, Pfizer

In the past 2 years I have been a speaker for:

In the past 2 years I have received research support (grants) from:

GSK, Pfizer, Sanofi Pasteur

In the past 2 years I have received honoraria from:

I agree to disclose approved and non-approved indications for medications in this presentation:

YES

I agree to use generic names of medications in this presentation:

YES

Acknowledgements

Dr. Paul Van Buynder, CMOH Fraser Health, BC

Dr. Allison McGeer,Mount Sinai Hospital

Objectives

� To review current recommendations for immunization of healthcare workers

� To discuss evidence supporting recommendations for influenza immunization of healthcare workers

� To review strengths and limitations of policies requiring influenza vaccination as a condition of employment for healthcare providers

Current immunization recommendations

Vaccine Schedule Indication Notes

Hepatitis B 3 doses; 0, 1, 6 All HCP Serology 1-6mos post dose 3 to confirm immunity

MMR 2 doses; 4 weeks apart

Non-immune HCP regardless of age

Immunity= proof of vaccine X2, lab confirmed infection, serology

Td Q 10 yrs All HCP

Tdap 1 adult dose All HCP Even if vaccinated in school

Varicella 2 doses; 4 weeks apart

Non-immune HCP Immunity= HCP diagnosis of VZV, proof of vaccine X2, serology

Vaccine Schedule Indication Notes

Influenza (TIV/LAIV)

Annually All HCP TIV preferred in HCP of IC pts; TIV if egg allergic, comorbidity, >59y

Quadrivalentconjugate meningococcal

Q 5 years Lab personnel at risk of exposure

Even if prior MenC-C

Vaccine coverage in Canadian HCP

0

10

20

30

40

50

60

70

Influenza Hepatitis B Tetanus Varicella Pertussis

% H

CP

vaccin

ate

d

2006

2008

http://resources.cpha.ca/CCIAP/data/544e.pdf

Innocence vs Ignorance

N. Wong, Dal Med 2006

When should a public health intervention be mandatory ?

� When the burden of disease is significant

� When there is clear medical value of the intervention to the individual

� When there is clear medical value of the intervention to public health

� When there is no other means to obtain the public health benefit

Wynia Am J Bioethics 2007;7:2-6

Mandates for vaccines

� Entry into countries

� Yellow fever vaccine

� Meningococcal vaccine – Saudi Arabia for the Hajj

� School entry

� Childhood vaccines and public schools

� HepB, MMR, Varicella, TdaP - medical and nursing schools

� Occupational licensure

� Paramedics, some physicians

What do we mean by mandatory in public health?

� A mandate requires that

� Opting out requires more than just saying “no”

� There is an enforcement method, and a consequence


Enforcement of “mandates”

� None

� Moral suasion

� Signed declination

� Stated philosophical or religious objection

� bureaucratic complexity

� requirement for notarization

� restrictions on religion/philosophy

� Medical contraindications only

Estimates of Canadian influenza mortality burden

Mortality rate/

100,000 pop/yr

# Deaths/y, Canada

Methods

CDC – P&I1976-2007

2.4 700Serfling model, adjusted for influenza and other viral activity

CDC – all1976-2007

9.0 2600Serfling model, adjusted for influenza and other viral activity

Canada1990-1999

13 4000Poisson regression, adjusting for season, viral activity

ONBOIDS2006

2.2 700Epidemiologic studies to estimate contribution of influenza to respiratory infection syndromes

TIBDN2005-2011

1.1 370Laboratory confirmed, hospitalized cases; in-hospital mortality

Thompson MMWR 2010;59:1058; Schanzer Epidemiol Infect 2007;135:1109-16Kwong J www.ices.on.ca/file/ONBOIDS_FullReport_intra.pdf; TIBDN, unpublished

Ontario Burden of Infectious Diseases Study

0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000

Gonorrhea

Adenovirus

Chlamydia

Legionella

Tuberculosis

Haemophilus influenzae

Group A streptococcus

Group B streptococcus

Parainfluenza virus

Respiratory syncytial virus

Rhinovirus

Clostridium difficile

Influenza

Staphylococcus aureus

HIV/AIDS

Escherichia coli

Hepatitis B virus

Human papillomavirus

Streptococcus pneumoniae

Hepatitis C virus

HALYs

YLL

YERF

http://www.oahpp.ca/resources/documents/reports/onboid/ONBoID_ICES_Report_ma18.pdf

Traditional measures of influenza BOD

Glezen WP, Keitel WA, Taber LH, et al.

Am J Epidemiol. 1991 Copyright Elsevier

Catastrophic disability

� Defined as a loss of independence in ≥ 3 ADL

� 72% who experience catastrophic disability have been hospitalized

� Leading causes of catastrophic disability

1. Stroke

2. CHF

3. Pneumonia and influenza

4. Ischemic heart disease

5. Cancer

6. Hip fracture

Ferrucci et al. JAMA 277:728, 1997Barker et al. Arch Int Med 158:645, 1998Falsey et al. N Engl J Med. 2005;352:1749

Vaccine Preventable Disability

Impact of influenza on Frailty McNeil, SOS Network, CIC 2012

Influenza Cases

Mean (SD)

Controls

Mean (SD)P value

Baseline 0.24 (.15) 0.24 (.14) 0.98

On admission

0.29 (.16) 0.31 (.16) 0.39

30d post discharge

0.30 (.15) 0.26 (.14) 0.06

Change from baseline

0.06 0.02

- Cases (flu) are left more frail at 30d than controls (increase of .06 or 2.3 new deficits vs 0.02 or 0.8 new deficits)

Acute care hospital-acquired influenza

Incidence3 / 1000 admissions8 / 1000 admissions6 / 1000 admissions

California, 1987Virginia, 1988-94Houston, 1988

Case fatality rate

7 % (0-60%)

Cost/ case$7,545$ 4,050$ 3,622

US, 1990US, 1993US, 2000

Weingarten AIM1988;148:113; Glezen CJIC 1991;6:65; Adal ICHE 1996;17:641; Serwint PIDJ 1993;12:200; Evans AJIC 1997;25:357; Salgado LancetID 2002;2:145

Passive surveillance in TIBDN for acute care hospital-acquired, lab-confirmed influenza, 2005-2011

0

1

2

3

4

5

6

7

8

9

10

2004/5 2005/6 2006/7 2007/8 2008/9 2009/10 2010/11

no

so

co

mia

l L

CI

per

1000 a

dm

issio

ns (

No

v-A

pr)

Season

307 cases & 52 deaths / 7 years~ 30% associated with outbreaks

TPH: 17 ACH outbreaks in 5 years

Efficacy of influenza vaccinehealthy adults

� 59% reduction in PCR confirmed, symptomatic influenza infection

� “breakthrough” illness less severe

Osterholm Lancet ID 2012;12:36

Reduction in illness associated with influenza vaccination, healthy adults� Episodes of ILI: 3-10 per 100 vaccinated

� Sick days: 21-52 per 100 vaccinated

� Antibiotic scripts: ~0.7 per 100 vaccinated

� (with associated adverse events, allergies, CDAD)

� Hospitalization: 1 per 100,000

� ICU admission: 1.2 per 1,00,000

� Death due to influenza: 1 per 3 M annually

� Guillian-Barré syndrome: Nichol NEJM 1995;333: 889-93; Saxen PIDJ 1999;18:779; Wilde JAMA

1999;281:908; Nichol JAMA 1999;282:137;

Influenza, vaccination and GBS

� Sivadon (GBS registry)

� GBS without known etiology occurs predominantly in winter, and preceded by ILI

� 14/234 documented influenza

� Risk GBS post vaccine and ILI, GPRD

Sivadon EID 2006;12:188; Sivadon CID 2009;48:48; Stowe Am J Epi 2009;169:382; Tam PlosOne 2009;e344

Study Odds ratio (95% CI) for GBS

After vaccine After ILI After ARI

Stowes 0.76 (0.41, 1.4) 18.6 (7.5, 46) -

Tam 0.16 (0.02, 1.3) 7.4 (4.4, 13) 5.2 (3.5, 7.6)

Risks of influenza vaccine:healthy adults

� Common

� Sore arm (40%): in 2 missed work days/100 vaccinees

� Less common

� ORS (~1/10,000): ~15% with a MD visit

� Allergic reaction (~1/20,000)

� Uncommon

� Anaphylaxis (1/500,000)

� Guillain Barré Syndrome (1/1,000,000)Nichol NEJM 1995;333: 889-93; Saxen PIDJ 1999;18:779; Wilde JAMA 1999;281:908; Nichol JAMA 1999;282:137; Smith Cochrane 2004, CD000245; Aroll,Keally Cochrane 2005, CD000247; De Serres, personal communication; Skowronski CID 2003;36:705; Price BMJ 2009;339:b3577

Comparison of risks

Vaccine� 9 minutes missed work

� 40% chance of sore arm

� 1 in 5000 chance of allergic reaction

� 1 in 1,000,000 risk of hospitalization (allergy/GBS)

� 1 in 50 million risk of death

No vaccine� 135 minutes missed work

� 33% chance of ARI

� 2 in 100 chance of illness needing antibiotics

� 1 in 100,000 risk of hospitalization due to influenza

� 1 in 3 million risk of death

Nichol et al. JAMA 1999;282:137; Smith et al. Cochrane 2004, CD000245;

Aroll,Keally Cochrane 2005, CD000247; McGeer CID 2007; TIBDN unpublished

information

Neuzil JAMA 1999;281:907

Rates of symptomatic influenza in unvaccinated HCWs

0 5 10 15 20

Keitel

Wakdman

Kumplainen

Feery

Sirivichayakul

Coleman

Total infection rate (ILI, ARI + asymptomatic) : 8-26%

Proportion of LTCF reporting an influenza outbreak by percentage of residents/staff vaccinated

0

20

40

60

<70% 70-90% >90%

Per

cen

t o

f L

TC

Fs

rep

ort

ing i

nfl

uen

za

ou

tbre

ak

Percent of residents vaccinated

P=0.11, Chi-sq for trend

Stevenson CG, et al. CMAJ 2001;164:1413-9

0

10

20

30

40

50

<25% 25-50% 50-75% >75%

Per

cen

t o

f L

TC

Fs

rep

ort

ing

infl

uen

za o

utb

rea

k

Percent of staff vaccinated

Impact of HCP vaccination on patient outcomes (LTCF)� 4 RCTs in long term care facilities

� Potter. J Infect Dis 1997

� 44% ↓ mortality (p<.01)

� Carman. Lancet 2000

� 42% ↓ mortality (p<.01)

� Hayward. BMJ 2006

� 27% ↓ mortality (p<.001)

� Lemaitre. J Am Geriatr Soc 2009

� 20% ↓ mortality (p=.02)

Results, Cochrane review of impact of HCW vaccination on resident outcomes Thomas, Cochrane Database Syst Rev. 2010;(2):CD005187

Outcome Pooled OR (95% CI)

All cause mortality 0.68 (0.55, 0.84)*

ILI 0.71 (0.58, 0.98)*

GP consultation for ILI 0.48 (0.33, 0.69)*

Influenza 0.87 (0.38, 1.99)

*Pneumonia 0.71 (0.29, 1.71)

Hospital admission 0.90 (0.66, 1.21)

Death due to ILI 0.72 (0.31, 1.70)

*Death due to pneumonia

0.87 (0.47, 1.64)Pooled data…found no effect on the outcomes of direct interest. We conclude that there is no evidence from this research that vaccinating healthcare workers against influenza protects elderly people in their care.

*See Dolan et al EID, Aug 2012

What about acute care?

Risk of ILI in ACH during seasonal influenza epidemics, Edouard Herriot Hospital, 2004/5-2006/7 Arch Intern Med 2011; Jan 24

Salgado ICHE 2005;11:923

Influenza vaccination of healthcare workers in acute-care hospitals: effect on hospital-acquired influenza among patients

� Nested case-control study

� Cases: patients with laboratory confirmed influenza with onset ≥72 hours after admission

� Controls: patients with HA-ILI, negative for influenza

� 4 controls: case, matched by season

Benet BMCID 2012;12:30

Multivariable analysis

Characteristic Adjusted OR (95% CI)

Age, per year older 1.03 (0.99-1.07)

Potential influenza source on unit 5.22 (1.08-25.2)

Proportion of HCW vaccinated ≥35%

0.07 (0.005-0.98)

Benet BMCID 2012;12:30

Vaccine 2009;27:6261

Improving HCW vaccination ratesHospital Program % vaccinated

Pre Post

Cadena, 2011, 1 hospital

QI methodology: PDSA cycle, with weekly meetings, force-field analysis, cause and effect diagrams, process flow charts, Gantt charts

59 77

Ribner, 20081 hospital

task force, senior management visible support, weekly feedback to managers, T-shirt given out to vaccinees, declination form required

43 67

Rakita, 20111 hospital

Task force, education, on-line modules, champions, incentives

38 54

Ajenjo, 2010Multiple

Education, communication, incentives, feedback, leadership involvement, prizes, competitions, declination forms

45 72

Zimmerman, 2009multiple

Education, communication, incentives, accessibility

32 39

Lopes, 20081 hospital

Education, communication, incentives, accessibility, leadership involvement

6 49

Influenza vaccination rates in participating members of the UHC benchmarking project, 2007

Immunization program elements associated with higher uptake

Component

No. (%) of facilities

with component

(n = 47)

Vaccination rate, mean ± SD, %

P

At facilities with

component

At facilities without

component

Weekend avail 37 (79) 58.8 ± 12.0 43.9 ± 14.9 .01

Train‐the‐trainer programs 33 (70) 59.5 ± 12.5 46.5 ± 13.2 .005

Feedback of vaccination rates provided to administration 10 (21) 63.9 ± 9.7 53.4 ± 14.1 .01

Letter from administration emphasizing importance 33 (70) 59.3 ± 11.9 47.0 ± 15.0 .01

How do you increase staff vaccination rates?

So… does “mandatory” immunization work?

Virginia Mason Medical Center

Rakita ICHE 2010;31:881

VMMC program (cont’d)

� 5 employees resigned, 2 terminated (2005/6)

� 2007-2010: 2 additional employees have left

� Sick leave 7.1 hrs/HCW v. 6.6 hrs/HCW (P=.43)

BJC HealthCare annual influenza vaccination rates (percentage of total employees).

Babcock H M et al. Clin Infect Dis. 2010;50:459-464

Other published experience

� HCA Inc (163 hospitals)

� Septimus JAMA 2011;305:999

� MedStar (9 hospitals)

� Karanfil ICHE 2011;32:375

� GHS (2 hospitals)

� Esolen ICHE 2011;32:703

� CHOP (1 hospital)

� Feemster Vaccine 2011;29:1762

Broad endorsement of immunization as a condition of employment

Distribution of institutional requirements for influenza vaccination, US hospitals, 2010/11 season

359, 46%

246, 32%

29, 4%

143, 18%

0, 0%

Vaccination not required

Vaccination required, noconsequences

Vaccination required(termination

Vaccination required,mask

Vaccination required,other

Proportion of hospitals with requirements and consequences for vaccine refusal increased from 5% (N=37) in 2007/8 to 25% (N=183) in 2010/11

Miller CID 2011;53:1051; Miller Vaccine2011;29:9398

Change in vaccination rate associated with institutional requirement, by consequences associated with refusal, US hospitals, 2007-11

0

10

20

30

40

50

60

70

80

90

100

Termination Other consequence No consequence

Percent HCW vaccinated

Pre

Post

What is happening in Canada?

Mandatory Influenza Immunization of HCWPosition paper 2012

Annual influenza immunization should be required as a condition of new and on-

going employment or appointment for all workers who spend time in areas where patient care is provided and/or patients

are present.

Annual influenza vaccination should be a condition of continued employment in, or appointment to, health care organizations.

HCW with medical contraindications should be accommodated by

reassignment, or other methods used to protect patients and staff (eg masks)

during influenza season.

Best Practices for Infection Prevention and Control Programs in Ontario, Third Revision, May 2012

British Columbia

� Fall 2012 HCW in BC must be vaccinated

against influenza as a condition of service

� If unable/unwilling must wear a mask

� throughout influenza season

� while in facilities where patient care is given

� includes physicians, RNs, students, volunteers

and contracted workers

� regardless of reason for not immunizing

BC so far….

� Policy implemented Fall 2012

� Nov. 30, 2012 MOH announced that no discipline would be enforced this year to allow further consultation

� Despite this, coverage of 73% of FT staff achieved by Nov. 30

Words of wisdom…..

“The American experience with mandatory (flu vaccination) is that it is not a hill you die on. It's a hill

that actually vanishes when you

start climbing it.”

-A. McGeer, Canadian Press 3/25/13

“There are risks and costs to a program of action. But they are far less than the long-range risks and costs of

comfortable inaction.”- John F. Kennedy

Why vaccinate healthcare providers?

immunization in healthcare providers: recommendations ... · immunization in healthcare providers:...

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