The Quarterly Journal for Health Care Practice and Risk Management

continued on page 2

FEATURE STORIES1 Preparing Your Practice for the Fall Flu Season

2 What’s New with H1N1?

6 Rapid Flu Tests: When Timing is Everything

6 Vaccinations for Health Care Personnel

7 Anti-Viral Drugs Combat Flu Viruses

8 NYS Requires Flu Vaccines For Health Care Personnel

9 A Day in the Life of an ED During the H1N1 Outbreak

10 Prepare for the Onslaught: Flu Prevention and Control at Hospitals and Long-Term Care Facilities

12 The National Vaccine Injury Compensation Program (VICP)

ALSO IN THIS ISSUE14 Immunization Tips for Safe Storage and Handling

15 Drug-Resistant TB: New Tools to Fight Common Threat

Inside

FOJP SERVICECORPORATION

WWW.FOJP.COM VOluMe 12 |Fall 2009

A s the fall flu season approaches, this

issue of infocus takes a closer look at

prevention through immunization

for influenza and other communicable

diseases. We also highlight some of the

considerations that may be helpful for both office

practices and healthcare organizations.

During the initial pandemic H1N1 outbreak

in New York during the spring of 2009, many

outpatient facilities and emergency departments

experienced dramatic increases in the number of

patients presenting for care. This type of surge

in patient volume can have a substantial impact

on the ability of a medical practice to continue

operations and provide necessary services safely

and effectively. All hospitals, outpatient clinics

and private practices should develop strategies for

the upcoming flu season in order to ensure that

optimally safe and effective care can continue

to be provided even in the event of a substantial

surge in patient volume or an increase in employee

absenteeism due to illness. The Centers for Disease

Control and Prevention (CDC) has published

guidance to assist medical offices and outpatient

facilities in their planning efforts (www.cdc.gov/

h1n1flu/10steps.htm).

Communication with patients and employees is a

critical aspect of an influenza response plan.

Medical office or ED visits are not necessary for

most persons with mild influenza-like illness.

Communicating this information to patients prior

to and during influenza season and establishing an

effective phone triage and screening process may

help to limit the number of patients presenting for

evaluation unnecessarily (see “Telephone Triage

Protocol for Patients with Suspected Influenza

Infection”). This may reduce the potential for

exposure of other patients and personnel and

minimize the overcrowding that can delay evaluation

and treatment of those who do require medical care.

Patients with mild illness who are not at high

risk of influenza-related complications should be

Preparing Your Practice for the Fall Flu Season

Awareness of the critical importance of infectious disease prevention is growing.

The emergence of novel infectious organisms and resistant strains of illnesses

such as tuberculosis and the difficulty of maintaining reliable treatment and

prophylaxis regimens for them make the job of protecting patients and the

public increasingly complex. The frenzy that surrounded the H1N1 pandemic

this spring highlights the importance of communication, education and the en-

couragement of widespread use of preventive measures to thwart the spread

of infection and disease.

David P. Calfee, MDAssociate Professor, Medicine, Infectious DiseasesMount Sinai School of Medicine

2 FALL 2009

In June, the World Health Organization (WHO) declared the H1N1 influenza outbreak a global pandemic, the first flu pandemic in more than 40 years. Two months later, WHO reported that the confirmed flu cases had climbed to more than 162,000 worldwide, with 1,154 deaths.1 Closer to home, the Centers for Disease Control and Preven-tion (CDC) projects that as many as 40 percent of Americans could be infected or indirectly affected by H1N1 flu (such as those who stay home to care for sick family members). In early August, the CDC re-ported that the U.S. had seen more than 6,500 hospitalizations and 436 deaths resulting from H1N1.2 Because of this flu strain’s mild symptoms, the CDC estimates that a vast number of cases have gone unreported, putting the real infection rate closer to one million.3 Un-like other flu strains, the H1N1 virus has remained active throughout the summer, with outbreaks at summer camps and on college cam-puses across the country. As a result, health officials are bracing for the H1N1 virus to kick off an earlier start to this year’s flu season.

The H1N1 Flu SummitAt a federal government-sponsored H1N1 flu summit in July, the sec-retary of health and human services (HHS), Kathleen Sebelius, called for states to avoid complacency and challenged public officials to put definitive plans in place for dealing with the H1N1 flu pandemic.4 From policies for school closings and advice for businesses to health care worker guidelines and public service announcements, there is much work ahead. HHS has committed $884 million to boost its sup-

What’s New with H1N1?ply of critical vaccine ingredients (antigen and adjuvant). And to help with preparedness plans, the federal government has allocated $350 million in grants to aid state and local public health agencies with mass vaccination and treatment plans.5 The State of New York was granted $9.5 million for public health emergency response efforts and $3.3 million for hospital preparedness. New York City can expect $7 million and $2.4 million, respectively.6 HHS has also created www.flu.gov, a new Web site with a wealth of information on both H1N1 and seasonal flu.

Steps to PreparednessFor health care providers, preparedness is twofold: (1) dealing with patient treatment issues in a public pandemic and (2) developing and enforcing policies to keep workers in virtually every health care setting (hospitals, clinics, doctors’ offices, long-term care facilities, nursing homes, etc.) from getting sick and potentially infecting patients. These include a variety of safe practices for everything from hand-washing regimens to promoting vaccine campaigns (see “Vaccinations for Health Care Personnel”). Refer to “Prepare for the Onslaught: Flu Pre-vention and Control at Hospitals and Long-Term Care Facilities” for more on dealing with influenza infections.

Like its counterparts in other states, New York’s Department of Health (NYSDOH) has been reviewing plans for working with the Strategic National Stockpile (SNS) and the State Medical Emergency Response

2 FALL 2009

encouraged to stay home until at least 24 hours

after their symptoms have resolved. Clinical

judgment should be used to determine if persons

with underlying conditions that place them at

increased risk of complications need to be

evaluated in-person or if they can be managed

or treated at home. All patients should be

instructed to call their physician or to seek

medical attention immediately if they develop

more severe symptoms, such as difficulty

breathing, chest pain, dizziness or confusion.

Reducing the risk of unprotected exposure of

patients and personnel to influenza is a critical

component of any influenza response plan. This

can be accomplished through the implementation

of basic infection control practices:

• Screen all patients for symptoms of

influenza (e.g., fever, cough, sore throat) at

the time of arrival. Development of a

simple screening tool that can be used by

clinical or nonclinical personnel may be

helpful in the successful implementation of

a screening program.

• Provide surgical masks and tissues to all

patients with symptoms of influenza and

Preparing Your Practice for the Fall Flu Season continued from page 1

make hand hygiene products readily

available to patients and staff (see “How-

To’s for Clean Hands” and see “Hand

Hygiene 101,” infocus, Vol. 7, Spring 2008).

• Separate patients with influenza-like illness

from other patients. Strategies to do this

may include use of separate waiting areas,

designation of specific areas in the waiting

room for suspected influenza patients,

prioritizing symptomatic patients for

relocation to an exam room, and leaving

openings in the clinic schedule to

accommodate walk-in patients with

influenza-like illness in order to reduce

waiting time (see “A Day in the Life

of an ED”).

• Provide appropriate personal protective

equipment for health care personnel to use

when providing care to patients with

confirmed or suspected influenza

infection. The New York State Department

of Health (NYSDOH) and New York City

Department of Health and Mental Hygiene

(NYCDOHMH) currently recommend the

use of Standard Precautions and Droplet

Precautions (i.e., wearing a surgical face

mask) during routine care of patients with

confirmed or suspected influenza.

Additional precautions, including the use

of fit-tested N-95 respirators and eye

protection, are recommended when

aerosol-generated procedures (e.g.,

intubation, bronchoscopy, and open

suctioning) are being performed.

• Provide influenza vaccine to all health care

personnel. (Influenza vaccination is

discussed in more detail below.)

• Ensure that health care personnel who

develop influenza-like illness do not come

to work while ill and do not return to work

until at least 24 hours after symptoms have

resolved.

Finally, contingency plans should be developed

that will allow for continued operation of the

facility in the event of substantial personnel

absenteeism. Such preparation may include

cross-training of personnel so that they are

able to perform tasks that are not normally

part of their responsibilities, plans for

alteration of work schedules, and use of phone

answering services or systems to provide basic

3FALL 2009

Cache (MERC) to confirm supply, monitoring and distribution of antiviral drugs and N-95 masks to health care and pharmaceutical facilities across 51 counties. The state expects to receive 25 percent of these SNS supplies, the equivalent of about 3.1 million courses of treat-ment.7 The NYSDOH is also developing protocols for everything from school closures and interagency coordination to large-scale vaccination campaigns in anticipation of an H1N1 flu resurgence this fall.

For information and links to the latest local and national updates on the H1N1 flu, see “Additional Resources.”

1 Centers for Disease Control and Prevention, “Novel H1N1 Flu: International Situation Update,” accessed August 7, 2009, http://www.cdc.gov/h1n1flu/updates/international.

2 Centers for Disease Control and Prevention, “Novel H1N1 Flu: U.S. Situation Update,” accessed August 7, 2009, http://www.cdc.gov/h1n1flu/update.htm.

3 S. Reinberg, “Swine Flu Could Eventually Affect 40% of Americans: CDC,” U.S. News & World Report: Health Day News, July 24, 2009, http://health.usnews.com/articles/health/healthday/2009/07/24/swine-flu-could-eventually-affect-4037-of_print.htm.

4 Medline Plus, “Swine Flu Summit Focuses on Preparedness,” Health Day News, July 9, 2009, http://www.nlm.nih.gov/medlineplus/print/news/fullstory_86666.html.

5 J. Zigmond, “Getting Ready: HHS Increased Funding for H1N1 Preparedness,” Modern Healthcare, July 20, 2009, http://www.modernhealthcare.com/article/20090720/REG/907179994.

6 B. Benson and G. Scott, “Flu Funding,” Crain’s Health Pulse, July 13, 2009, http://www.crainsnewyork.com/article/20090713/PULSE/907109953.

7 New York State Department of Health, “Novel H1N1 (Swine) Influenza Update,” New York State Hospital Review and Planning Council, June 4, 2009, http://www.hanys.org/public_health/h1n1/presentations/2009-06-04_novel_h1n1_influenza_update.pdf.

3FALL 2009

information to patients so that personnel can

focus on patient care.

Testing for InfluenzaHospitalized patients with acute febrile respira-

tory illness, including patients with pneumo-

nia and acute respiratory distress syndrome or

ARDS, should be tested for influenza. Diagnos-

tic testing for influenza is not routinely recom-

mended in the outpatient setting, especially for

otherwise healthy persons with mild illness.

These recommendations are based on several

factors. First, in the setting of known influ-

enza activity in the community, the accuracy

• Use a tissue to cover your mouth or nose when you cough or sneeze.

• Frequently wash hands or use alcohol-based rubs.

• Avoid touching your eyes, nose or mouth.

• Steer clear of close contact with sick people.

• Stay home if you are sick and limit contact with others—that means no office or no school (wait until symptom-free for 24 hours).

*Based on guidelines in Centers for Disease Control and Prevention, “Novel H1N1 Flu (Swine Flu) and You: Prevention & Treatment,” http://www.cdc.gov/H1N1flu/qa.htm.

Stay Flu-Free with Simple Safeguards*

http://www.cdc.gov/socialmedia/h1n1/

Health care professionals and consumers can get the latest CDC updates on the H1N1 flu pandemic via RSS feeds, mobile Web, Twitter and social networking sites such as Facebook and MySpace.

H1N1 Flu Meets Social Media

continued on page 4

of clinical diagnosis may be as high as 85 per-

cent.1 Clinical diagnosis may not be as accurate

among patients requiring hospital admission or

the elderly. Second, although office-based diag-

nostic tests for influenza infection are available,

these tests have a relatively low sensitivity for the

detection of influenza. For instance, rapid an-

tigen tests have been shown to have only 18–51

percent sensitivity in the detection of pandemic

H1N1 influenza A. The direct fluorescent anti-

gen test (DFA) has somewhat higher sensitivity,

but false-negative results do occur. Thus, a nega-

tive test result should not be considered to rule

out the possibility of influenza infection if clini-

cal suspicion is high. PCR-based (polymerase

chain reaction) testing has demonstrated higher

sensitivity for the detection of influenza virus

infection, including infection with pandemic

H1N1. PCR is available at the NYCDOHMH

Public Health Laboratory for testing in criti-

cally ill, hospitalized patients who test negative

for influenza A by rapid test or DFA. Specimens

must be submitted with a completed PHL vi-

ral identification submission form (available at

www.nyc.gov/html/doh/downloads/pdf/labs/

lab-forms-sflu.pdf). Providers in other areas of

New York should consult with their NYSDOH

regional epidemiologist if PCR testing is felt to

be necessary. In addition, the NYSDOH has giv-

en conditional approval to at least one commer-

cial reference laboratory to perform PCR testing

for influenza, including pandemic H1N1 in New

York. However, the turnaround time associated

with this test (greater than 24–48 hours) limits

its utility in the clinical management of patients,

especially ambulatory patients with mild or

moderate illness.

Treatment of Influenza InfectionAntiviral treatment of confirmed or suspected

influenza infection is currently recommended

for all persons hospitalized with influenza

infection and those with risk factors for compli-

cations of influenza (see “Antiviral Drugs Com-

bat Flu Viruses”). These persons include:

• Children younger than five years of age.

• Adults 65 years of age and older.

• Persons with the following conditions:

• chronic pulmonary (including asthma),

cardiovascular (except hypertension),

renal, hepatic, hematological (includ-

ing sickle cell disease), neurologic,

neuromuscular, or metabolic disorders

(including diabetes mellitus);

4 FALL 2009

• immunosuppression, including that

caused by medications or by HIV;

• pregnant women;

• persons younger than 19 years of age

who are receiving long-term aspirin

therapy; and

• residents of nursing homes and other

chronic-care facilities.

Treatment of other persons should be based

on clinical judgment. When treatment is being

considered, it should be initiated as early in the

course of illness as possible, preferably within

48 hours of symptom onset, in order to provide

benefit. However, treatment should not be with-

held from severely ill persons who present for

care more than 48 hours after illness onset.

Because of variable antiviral susceptibility

among the various circulating influenza virus-

es (see table), when treatment is being initiated

the antiviral agent(s) selected should be based

on currently circulating strains and known

resistance patterns. During the 2008–2009

season, recommended treatment regimens

included zanamivir (Relenza) monotherapy

or combination therapy with oseltamivir

(Tamiflu) and an adamantane (rimantadine

or amantadine). As of the end of June 2009,

over 95 percent of influenza isolates from New

York City patients were pandemic H1N1 2009,

and the remainder were seasonal H3N2. Thus,

at that time, monotherapy with a neuramini-

dase inhibitor (oseltamivir or zanamivir) was

considered to be sufficient. Treatment recom-

mendations are subject to change during the

fall influenza season when it is determined

which strains are circulating. Such informa-

tion will be provided by the CDC, NYSDOH,

and NYCDOHMH.

Oseltamivir is administered orally as either a

tablet or a suspension. Use of oseltamivir in

those less than one year of age was approved

under an Emergency Use Authorization by

the FDA in response to pandemic H1N1; thus,

Tamiflu can be used in persons of all ages. The

standard adult dose is 75 mg twice daily for

five days. Dose reductions are necessary for

patients with impaired renal function. Zana-

mivir is approved for use in persons seven years

of age or older. It is administered as an inhaled

powder, with a standard adult dose of two 5-mg

inhalations twice daily for five days. Zanamivir

should be used with caution in persons with un-

derlying airway disease due to the potential for

bronchospasm. The delivery device is different

Preparing Your Practice for the Fall Flu Season continued from page 3

from other commonly used inhaled medica-

tions, so care should be taken to make sure that

patients receive adequate instructions.

ChemoprophylaxisAntiviral chemoprophylaxis should be consid-

ered for exposed, nonimmune (unvaccinated)

persons at increased risk for complications of

influenza infections, health care workers ex-

posed to influenza without adequate personal

protective equipment, and in the control of

outbreaks in nursing homes and other long-

term care and congregate settings. Chemo-

prophylaxis is not currently recommended

for prevention of illness in healthy children or

adults. The typically recommended duration of

antiviral chemoprophylaxis is 10 days after the

last known exposure to influenza.

Influenza Vaccination Despite all of the attention recently given to

pandemic H1N1, clinicians and patients must

remember that the seasonal influenza vaccine

is still important. This vaccine will provide

protection against seasonal influenza A and

influenza B strains, which, in addition to pan-

demic H1N1, are likely to circulate during the

upcoming influenza season. In addition, pre-

vention of human infection with these viruses

may reduce the risk of reassortment between

pandemic H1N1 and seasonal influenza virus-

es in human hosts. Recommendations for the

use of the trivalent influenza vaccine have been

made by the ACIP. 2

In addition to the standard trivalent seasonal

influenza vaccine, a pandemic H1N1 influenza

vaccine is being produced for the 2009–2010

influenza season. Unlike the seasonal influen-

za vaccine, the pandemic H1N1 vaccine will

not be available from pharmaceutical distrib-

utors but will be procured, purchased and al-

located by the U.S. government through state

and local public health authorities. Although

it was initially anticipated that two doses of

this vaccine would be necessary, recent stud-

ies have suggested that a single dose may be

sufficient. Official recommendations will be

provided prior to distribution of the vaccine.

The first doses are expected to be delivered in

mid-October, with subsequent production of

enough vaccine for the entire U.S. population

over the following months. Because there will

not initially be a sufficient amount of vaccine

to allow for vaccination of the entire popu-

lation, the CDC’s Advisory Committee on

Immunization Practices (ACIP) has recom-

mended a number of target groups for whom

pandemic H1N1 vaccination will be priori-

tized. These groups were determined based

on risk factors for infection and for complica-

tions of infection observed during the initial

U.S. outbreak of pandemic H1N1 in the spring

of 2009. These groups include pregnant wom-

en, people who live with or care for children

less than six months of age, health care work-

ers and emergency services personnel, persons

six months to 24 years of age, and people be-

tween the ages of 25 and 64 who are at higher

risk for H1N1 infection and its complications

because of chronic health disorders or com-

promised immune systems. More information

on the distribution, administration and docu-

mentation requirements for the pandemic

H1N1 vaccine will be provided by NYSDOH

and NYCDOHMH as it becomes available.

5FALL 2009

INFLUENzA VIRUS

Antiviral agent Seasonal H1N1 influenza A Seasonal H3N2 influenza A Seasonal influenza B Pandemic H1N1 influenza A

Adamantanes (amantadine, rimantadine)

Susceptible Resistant No activity Resistant

Oseltamivir (Tamiflu) Resistant Susceptible Susceptible Susceptible

Zanamivir (Relenza)

Susceptible Susceptible Susceptible Susceptible

Antiviral Susceptibility of Recently Circulating Influenza Viruses

1. Has H1N1 influenza (swine flu) been documented in the community?

If no, do not use this protocol.

2. Is there a documented fever of 100ºF (37.8ºC) or higher?

If no, go to item 12.

3. Does the patient have symptoms of rhinorrhea/nasal congestion, cough, or a sore throat?

If no, go to item 12.

4. Did the illness start abruptly (e.g., going from feeling well to quite ill in a few hours)?

If no, go to item 12.

5. Is there any rash? If yes, go to item 11. There is an 80 percent

likelihood of influenza infection (when influenza is present in the community).

6. Is the patient between the ages of 5 and 49 years?

If no, go to item 11.

7. Has the illness been present for less than 36 hours?

If no, go to item 11.

8. Does the patient or patient’s parent or caregiver feel that the patient should be seen by a physician?

If yes, go to item 11.

9. Does the patient have an ongo-ing chronic illness, or is there any coexisting psychiatric illness or any indication of renal failure?

If yes, go to item 11.

10. This patient is a candidate for over-the-phone prescribing of antiviral therapy. Advise follow-up if condition worsens and routine follow-up two to three days after initiating therapy. Discuss the potential side effects.

11. This patient should be evaluated (interviewed and/or examined) by a physician.

12. The illness may be influenza or another respiratory virus. If signifi-cant concerns exist on the part of the patient, parent, or other person, consider scheduling a visit with a health care professional.

TELEPHONE TRIAGE PROTOCOL FOR PATIENTS WITH SUSPECTED INFLUENZA INFECTION (ANTIVIRAL MEDICATIONS)

Health care personnel are included on the

priority lists for both seasonal and pandemic

H1N1 influenza vaccination. Although vac-

cination of these persons has been strongly

recommended by the CDC, the Joint Com-

mission and other groups for several years,

vaccination rates among health care personnel

have remained dismally low (approximately

40–50 percent). New York state recently took

a major step toward protecting health care

personnel and their patients from influenza

infection by passing legislation that requires

many health care personnel to be vaccinated

against influenza (see “NYS Requires Flu Vac-

cines for Health Care Personnel”). Effective

August 13, 2009, health care facilities must

require that personnel be immunized against

influenza virus(es) as a precondition to em-

ployment and on an annual basis and must

provide or arrange for the vaccine at no cost to

their personnel. Health care facilities to which

this requirement applies include hospitals,

diagnostic and treatment centers, certified

home health agencies, long-term home health

care programs, AIDS home care programs, li-

censed home care services agencies, and hos-

pices. It is expected that during the 2009–2010

season this regulation will apply to both the

seasonal influenza vaccine and the H1N1 vac-

cine. For more information about this new re-

quirement, refer to http://www.nyhealth.gov/

regulations/emergency.

1 V. D. Hoeven, Infection 35, no. 2 (2007): 65–68.2 MMWR 58 (2009): 1–52 (early release).

INTERNET RESOURCESwww.health.state.ny.us/diseases/communicable/ influenza/h1n1www.nyc.gov/html/doh/html/imm/fluhome.shtmlwww.nyc.gov/html/doh/html/cd/cd-panflu.shtmlwww.pandemicflu.govwww.cdc.gov/flu Copyright © 2009 American Academy of Family Physicians. All Rights Reserved.

6 FALL 2009

Rapid Flu Tests: When Timing is Everything

Rapid diagnostic testing for influenza may be appropriate for office practices or other settings where a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory is not available. In such cases, however, a CLIA waiver is necessary.

The Centers for Disease Control and Prevention (CDC) mentions two situations where rapid testing for influenza may be appropriate:

• when individual patients exhibit flu-like signs and symptoms and clinical decisions hinge on the diagnosis; and

• in group settings such as nursing homes and long-term care facilities, to help rule out flu as a factor in large-scale outbreaks of respiratory illness.1

Generally, rapid flu test results are available within 15 to 30 minutes; however, these office-based tests’ sensitivity for detection of seasonal influenza A is described as low to moderate; sensitivity for influenza B is lower than that for A. In addition, test results cannot provide influenza subtype information and information on sensitivity for H1N1 is limited. False-positive and false-negative test results also can occur.

Whether to test and then treat a patient with suspected influenza is a clinical judgment based on multiple factors including: the presence of active influenza cases in the community; the existence of a plausible epidemiological link; clinical suspicion; and severity of illness and risk of complications. Additional factors to consider are related to the management of multiple cases and the likelihood of the spread of infection to others.

1 Centers for Disease Control and Pre-vention, “Rapid Diagnostic Testing for Influenza: Information for Health Care Professionals,” http://www.cdc.gov/flu/professionals/diagnosis/rapidclin.htm, or http://www.cdc.gov/h1n1flu/guid-ance/rapid_testing.htm.

According to the Centers for Disease

Control and Prevention (CDC), up to

20 percent of the U.S. population con-

tracts seasonal flu annually, more than

200,000 people are hospitalized, and 36,000 die

from influenza or related complications.1 Hence, it’s

no surprise that the CDC and the Advisory Com-

mittee on Immunization Practices (ACIP) recom-

mend flu immunizations for anyone who is eligible,

particularly health care personnel (HCP) who are

at increased risk of exposure. To help address influ-

enza and flu vaccine concerns, the CDC offers Web-

based Q&A targeted for HCP. This go-to resource

provides answers about vaccine efficacy, side effects,

the nasal spray versus flu shot decision, criteria for

who should or should not get a vaccine, detecting

flu symptoms, and what to do if infected.2

These recommendations on flu vaccines (particu-

larly the new H1N1 influenza vaccine) apply to all

personnel working in health care organizations,

from hospital surgeons and ED nurses to private-

practice staff and long-term care aides. Most lead-

ing health care groups, including the World Health

Organization (WHO) and the American Medical

Association (AMA), support this approach.

The Joint Commission Takes a LookWith all the endorsements, why are nearly 60 per-

cent of our nation’s HCP opting out of annual flu

immunizations? To find out, the Joint Commission

on Accreditation of Healthcare Organizations con-

ducted a 10-month project to examine the issues.

The resulting monograph, released in 2009, explores

current administrative considerations, issues sur-

rounding some HCP opposition to immunization,

and strategies for improving HCP vaccination rates.

It cites numerous studies showing that HCP immu-

nization can make a tremendous difference in re-

ducing influenza-related morbidity, mortality, staff

shortages and costs across health care institutions.

One study even equates vaccination among HCP in

long-term care facilities with saving lives by reducing

influenza-related infections and deaths. However,

the bottom line is that the current HCP vaccination

rate of around 40 percent would need to climb to 80

percent or better to provide the level of immu-

nity necessary to prevent health care-related flu

outbreaks.3

Flu Vaccines Help HCP Too It’s not just patients and institutions that benefit from

immunization. For HCP, getting the flu vaccine:

• is 70–90 percent effective at providing

infection protection in healthy adults;

• minimizes their risk of inadvertently

transmitting the flu to patients (and others);

• reduces absenteeism and incidences of

missing work due to flu infections; and

• reduces presenteeism or the tendency

(or need) to work through flu-like illnesses

without fully functioning.4

Why HCP Opt Not to Get Vaccinated The Joint Commission lists more than 10 reasons

HCP use to opt out of flu immunization. Certainly,

some HCP have cultural or medical reasons

for declining the flu vaccine. But typically, the

reasons focus more on fear of adverse reactions or

contracting the flu from the vaccine, the feeling it

is ineffective or unnecessary based on an HCP’s

built-up exposure resistance, the desire to avoid

medications, the view that the flu is a negligible

illness, and the lack of recommendations from

physicians and peers.5

Mandatory versus Voluntary Vaccine ProgramIn its monograph, the Joint Commission discusses

the pros and cons of mandatory versus voluntary flu

immunization for HCP, citing studies on both sides

of this issue. Among the arguments mandating

seasonal flu vaccines for HCP are the low vaccine

rate under voluntary measures, the infection

risk to HCP and their patients, the potential for

legislators to step in, and the fact that the measures

work (as evidenced by similar mandated vaccine

programs for school children). Others counter

that mandatory programs are coercive, invasive,

can degrade staff morale, and present potential

legal and liability challenges.6 Still, some hospitals,

such as Virginia Mason Medical Center in Seattle,

have mandated vaccination (with exemptions

for religious and medical reasons) with great

success. With HCPs, sales reps, vendors and even

volunteers participating, the center boasts a 99

percent compliance rate and has created a culture

where immunization is viewed as a key measure

Vaccinations for Health Care Personnel

FALL 2009 7

Antiviral Drugs Combat Flu Viruses

The frontline strategy for preventing influenza virus infections is still immunization with an annual flu shot or nasal-spray flu vaccine. However, antiviral drugs serve as the next line of defense for both prevention and treatment of influenza viruses, including the influenza A H1N1 virus.

Antiviral drugs are prescribed to prevent or cure a disease caused by a virus and work by interfering with the virus’s ability to replicate. According to the Centers for Disease Control and Prevention (CDC), administering antivirals as soon as possible after someone has been exposed to H1N1 is 70–90 percent effective in preventing the flu.

When it comes to treatment, antiviral drugs work best to minimize symptoms when given within 48 hours of the flu onset. However, the CDC recommends that physicians extend that 48-hour window for patients who are hospitalized or considered high-risk for flu-related complications such as young children and the elderly.1

Of the four antiviral drugs approved for use against flu in the U.S., the CDC recommends only two as effective in treating and preventing the H1N1 flu virus: oseltamivir and zanamivir, better known respectively as Tamiflu and Relenza.

In June 2009, the CDC’s Advisory Committee on Immunization Practices (ACIP) revised its overall recommendations for antiviral treatment (based on some viral resistance to oseltamivir) and now calls for:

• zanamivir or a combination of oseltamivir and rimantadine (or amantadine if rimantadine is not available) to treat seasonal influenza A (H1N1) virus infections; and

• oseltamivir or zanamivir to treat seasonal influenza A (H3N2), influenza B, or the novel influenza A H1N1 virus infections.

These revised recommendations are subject to change as more information becomes available.2 In late September, the CDC updated its interim recommendations on the use of antivirals for flu treatment and prevention.3

What About Pregnancy and H1N1 Flu Antivirals? Women who are pregnant, especially during their last trimester, are categorized as high risk for flu-related complications. With this in mind, a recent medical review in the Canadian Medical Association Journal examined available literature on the safety of using either oseltamivir or zanamivir antivirals to treat H1N1 flu infections in women who are pregnant or breast-feeding. This comprehensive review also relied on information from Japan, which has a longer history of using these antivirals in treating flu. Both drugs appear to be compatible with breast-feeding and are not thought to result in significant drug exposure to the infant. In fact, women are advised to continue nursing infants because of the anti-infective benefits of breast milk. However, during pregnancy, oseltamivir is the preferred antiviral to use, primarily because more data is available regarding exposure and safety.4 The CDC’s Web site also contains information on pregnant women and the influenza vaccine.5

1 Centers for Disease Control and Prevention, “An-tiviral Drugs and H1N1 Flu (Swine Flu),” April 29, 2009, http://www.cdc.gov/H1N1flu/antiviral.htm.

2 D. Mitchell, “CDC’s Advisory Committee Gives Thumbs-Up to New Antiviral Recs,” AAFP News Now, July 1, 2009, http://www.aafp.org/online/en/home/publications/news/news-now/clinical-care-research/20090701acip-h1n1.html.

3 CDC, “Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010

Season,” September 22, 2009, http://www.cdc.gov/H1N1flu/recommendations.htm.

4 T. Tanaka, K. Nakajima et al., “Safety of Neuraminidase Inhibitors against Novel Influenza A (H1N1) in Pregnant and Breastfeed-ing Women,” Canadian Medical Association Journal, July 7, 2009, 55–58.

5 CDC, “2009 H1N1 Influenza Vaccine and Pregnant Women,” Sept. 1, 2009, http://www.cdc.gov/H1N1flu/vaccination/pregnant_qa.htm.

for protecting patients.7 And while voluntary

programs have proven largely ineffective,

some studies tout the hepatitis B vaccine

program as a model for success. This voluntary

program combines targeted education, free

immunizations, and informed declinations,

resulting in a 75 percent immunization rate

among HCP.8

Five Steps to Improve Vaccination RatesThe CDC recommends taking a five-step ap-

proach to improving annual influenza vaccine

rates among HCP, which includes providing:

• multifaceted HCP education and

marketing campaigns;

• free flu vaccines for eligible HCP;

• convenient access at the work site (all

shifts) with role-model support and a

team approach;

• declination forms for HCP who decline the

vaccine for nonmedical reasons; and

• HCP vaccination levels as part of an

institution’s patient safety measurements.

Will this approach work? The Joint Commis-

sion findings show that organizations need to

adapt these steps and develop a multifaceted

strategy to fit their particular needs and HCP

audience. It also cites the importance of regu-

lar promotion as well as availability. For exam-

ple, simply offering the vaccine might yield a

5 to 19 percent acceptance. Add some promo-

tion and boost acceptance to 26 to 54 percent.

Now add an annual promotional campaign

and acceptance rates climb as high as 61 to 97

percent.9 Whatever the approach, it’s clear that

measures need to be adopted to boost immuni-

zation rates among HCPs.

1 Centers for Disease Control and Prevention, “Influenza and Influenza Vaccine Information for Healthcare Per-sonnel, October 31, 2008, http://www.cdc.gov/ncidod/dhqp/id_influenza_vaccine.html.

2 Ibid. 3 Joint Commission on Accreditation of Healthcare

Organizations, Providing a Safer Environment for Health Care Personnel and Patients through Influenza Vaccination: Strategies from Research and Practice, 2009, http://www.jointcommission.org/PatientSafety/InfectionControl/flu_monograph.htm.

4 Ibid. 5 Ibid. 6 Ibid. 7 Red Orbit, “Many Health Care Workers Refuse Annual

Flu Shots,” October 16, 2008, http://www.redorbit.com/news/health/1589244/many_health_care_work-ers_refuse_annual_flu_shots/#.

8 Joint Commission, Providing a Safer Environment. 9 Ibid.

8 FALL 2009

The National Vaccine Program Office

(NVPO), established by the De-

partment of Health and Human

Services (HHS), oversees and co-

ordinates activities related to vaccines, from

research, development and testing to procure-

ment, distribution and funding. Another key

area of NVPO responsibility is the evaluation

of vaccine effectiveness and adverse effects.

To address these tasks, the NVPO issued a

National Vaccine Plan in 1994 that aimed

to develop and improve vaccines, work to

ensure safety and effectiveness, provide

comprehensive education on the benefits

and risks, and better use vaccines to prevent

illness and save lives. Some specific goals

included tackling the childhood immuniza-

tion portfolio, seeking new vaccines for HIV

and STDs, and looking at new approaches for

vaccine safety and delivery.

For years, the Centers for Disease Con-

trol and Prevention (CDC) and the

World Health Organization (WHO)

have urged health care workers to

get annual flu shots. The reasoning is obvi-

ous: health care workers are typically on

the front lines of exposure during influenza

outbreaks, which can put them (and the pa-

tients they treat) at risk for infection. In fact,

studies at health care institutions, from hos-

pitals to long-term care facilities, show that

many health care personnel do contract the

flu. Based on New York State Department of

Health (NYSDOH) data, over a seven-year

period more than 5,000 workers and 19,000

patients at hospitals and nursing homes had

suspected or confirmed cases of the flu.1

Despite the recommendations, few health

care personnel get an annual flu shot or nasal-

spray vaccine. In New York and around the

country, the average participation rate in vol-

untary inoculation programs hovers around

40 percent.2 With this in mind and the H1N1

flu again looming, the State Hospital Review

and Planning Council (SHRPC) and the

Commissioner of Health adopted an emer-

gency regulation in August.3 The regulation

mandates that all state health care workers be

NYS Requires Flu Vaccines for Health Care Personnel

Watch for an Updated National Vaccine PlanIt has been years since that initial plan was

created, and much has changed. As a result, in

2008, the NVPO, along with the Centers for

Disease Control and Prevention (CDC), the

Institute of Medicine (IOM) and other federal

agencies, evaluated the 1994 plan goals and ac-

complishments. The review committee then

drafted a new plan.

This year, following a “reality check” review

by the National Vaccine Advisory Committee

(NVAC), the IOM has conducted five break-

out sessions to gather recommendations on

the 2008 draft plan from national stakehold-

ers in medicine, public health, industry and

vaccinology. Public collaboration has also

been sought from advocacy groups, global

partners, health associations and individuals.

The result of all this analysis promises to be

a new plan with priority actions for address-

ing the changing face of vaccines over the next

five years. Expect to see details on this updat-

ed plan released later this year.1

1 See Department of Health and Human Services, “National Vaccine Program Office: U.S. National Vaccine Plan,” http://www.hhs.gov/nvpo/vacc_plan; and R. A. Strikas, “Update of the National Vaccine Plan,” National Vaccine Program Office presenta-tion, http://www.iom.edu/Object.File/Master/52/354/ Strikas,%20v2.pdf.

immunized for the current influenza strains

by November 30 each year. (If fully-licensed

later this year as expected, the H1N1 flu vac-

cine will be included in the requirements.)

Health care facilities must also cover the cost

for the mandated vaccines, document admin-

istration of shots, and report on the status of

the program by May 1 of the following year.

This regulation applies to:

• all personnel who directly interact with

patients, including employees, contract

workers, students and volunteers (except

for those with valid medical reasons);

and

• everyone working in hospitals, diag-

nostic and treatment centers, certified

home health agencies, long-term home

health care programs, AIDS home care

programs, licensed home care services

agencies, and hospices.

The mandate does not apply to long-term

care facilities, nursing homes, adult day care

centers, etc., which fall under Public Health

Law Article 21A. These organizations are

only required to offer vaccines to employees

each year.

At least one group expressed concern about

the implications of the mandate. In an on-

line media release (July 23, 2009) following

the initial ruling, the New York State Nurses

Association “strongly opposed” the mandatory

measure. Calling it an “onerous mandate,” the

group cited the flu vaccine’s variable effective-

ness year to year, the lack of exemptions for

cultural and religious preferences, and the re-

sulting “serious threat” to the shrinking avail-

ability of nurses.

New York is the first state to enact free, man-

datory inoculations for health care personnel

while other states are considering regulations

of their own.

1 B. Benson, “Flu Shots on Tap for Health Care Workers,” Crain’s New York Business.com, May 22, 2009, http://www.crainsnewyork.com/article/20090522/FREE/905229982.

2 Ibid.3 New York Department of Health, “Health Care

Personnel Influenza Immunization Requirements,” September 2009, http://www.nyhealth.gov/diseases/communicable/influenza/seasonal/providers/health_care personnel_influenza_immunization_requirements.htm.

4 S. Sloan, “Fighting the Flu: States Suggest Health Care Workers Get Vaccine,” Council of State Governments: State News, October 2006, http://www.csg.org/pubs/Documents/sn0610FightingtheFlu.pdf.

Immunization SchedulesThe Centers for Disease Control and Prevention provides immunization schedules for children (including a catch-up schedule), adolescents and adults. The schedules are available on the centers’ Web site at http://www.cdc.gov/vaccines/recs/schedules/

Recommended Immunization Schedule for Persons Aged 0 Through 6 Years—United States • 2009For those who fall behind or start late, see the catch-up schedule

Certain high-risk groups

Range of recommended ages

This schedule indicates the recommended ages for routine administration of currently licensed vaccines, as of December 1, 2008, for children aged 0 through 6 years. Any dose not administered at the recommended age should be administered at a subsequent visit, when indicated and feasible. Licensed combination vaccines may be used whenever any component of the combination is indicated and other components are not contraindicated and if approved by the Food and Drug Administration for that dose of

the series. Providers should consult the relevant Advisory Committee on Immunization Practices statement for detailed recommendations, including high-risk conditions: http://www.cdc.gov/vaccines/pubs/acip-list.htm. Clinically significant adverse events that follow immunization should be reported to the Vaccine Adverse Event Reporting System (VAERS). Guidance about how to obtain and complete a VAERS form is available at http://www.vaers.hhs.gov or by telephone, 800-822-7967.

Vaccine Age Birth1

month2

months4

months6

months12

months15

months18

months19–23

months2–3

years4–6

years

Hepatitis B1 HepB see footnote1

Rotavirus2 RV RV RV2

Diphtheria, Tetanus, Pertussis3 DTaP DTaP DTaP see footnote3

Haemophilus influenzae type b4 Hib Hib Hib4

Pneumococcal5 PCV PCV PCV

Inactivated Poliovirus IPV IPV

Influenza6

Measles, Mumps, Rubella7

Varicella8

Hepatitis A9

Meningococcal10

HepBHepB

DTaP DTaP

Hib

IPVIPV

MMR

VaricellaVaricella

MMR

see footnote8

see footnote7

PCV

HepA (2 doses) HepA Series

MCV

Influenza (Yearly)

PPSV

1. Hepatitis B vaccine (HepB). (Minimum age: birth) At birth: •AdministermonovalentHepBtoallnewbornsbeforehospitaldischarge. •IfmotherishepatitisBsurfaceantigen(HBsAg)-positive,administerHepB

and0.5mLofhepatitisBimmuneglobulin(HBIG)within12hoursofbirth. •Ifmother’sHBsAgstatusisunknown,administerHepBwithin12hoursof

birth.Determinemother’sHBsAgstatusassoonaspossibleand,if HBsAg-positive,administerHBIG(nolaterthanage1week).

After the birth dose: •TheHepBseriesshouldbecompletedwitheithermonovalentHepBora

combinationvaccinecontainingHepB.Theseconddoseshouldbe administered at age 1 or 2 months. The final dose should be administered no earlier than age 24 weeks.

•InfantsborntoHBsAg-positivemothersshouldbetestedforHBsAgandantibodytoHBsAg(anti-HBs)aftercompletionofatleast3dosesoftheHepBseries,atage9through18months(generallyatthenextwell-childvisit).

4-month dose: •Administrationof4dosesofHepBtoinfantsispermissiblewhencombination

vaccinescontainingHepBareadministeredafterthebirthdose.

2. Rotavirus vaccine (RV). (Minimum age: 6 weeks) •Administerthefirstdoseatage6through14weeks(maximumage:

14 weeks 6 days). Vaccination should not be initiated for infants aged 15 weeks or older (i.e., 15 weeks 0 days or older).

•Administerthefinaldoseintheseriesbyage8months0days. •IfRotarix® is administered at ages 2 and 4 months, a dose at 6 months is

not indicated.

3. Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP). (Minimum age: 6 weeks)

•Thefourthdosemaybeadministeredasearlyasage12months,providedat least 6 months have elapsed since the third dose.

•Administerthefinaldoseintheseriesatage4through6years.

4. Haemophilus influenzae type b conjugate vaccine (Hib). (Minimum age: 6 weeks)

•IfPRP-OMP(PedvaxHIB®orComvax®[HepB-Hib])isadministeredatages 2 and 4 months, a dose at age 6 months is not indicated.

•TriHiBit®(DTaP/Hib)shouldnotbeusedfordosesatages2,4,or6monthsbut can be used as the final dose in children aged 12 months or older.

5. Pneumococcal vaccine. (Minimum age: 6 weeks for pneumococcal conjugate vaccine [PCV]; 2 years for pneumococcal polysaccharide vaccine [PPSV])

•PCVisrecommendedforallchildrenagedyoungerthan5years.Administer 1 dose of PCV to all healthy children aged 24 through 59 months who are not completely vaccinated for their age.

•AdministerPPSVtochildrenaged2yearsorolderwithcertainunderlyingmedical conditions (see MMWR2000;49[No.RR-9]),includingacochlearimplant.

6. Influenza vaccine. (Minimum age: 6 months for trivalent inactivated influenza vaccine [TIV]; 2 years for live, attenuated influenza vaccine [LAIV])

•Administerannuallytochildrenaged6monthsthrough18years. •Forhealthynonpregnantpersons(i.e.,thosewhodonothaveunderlying

medical conditions that predispose them to influenza complications) aged 2 through 49 years, either LAIV or TIV may be used.

•ChildrenreceivingTIVshouldreceive0.25mLifaged6through35monthsor0.5mLifaged3yearsorolder.

•Administer 2 doses (separated by at least 4 weeks) to children aged younger than 9 years who are receiving influenza vaccine for the first time or who were vaccinated for the first time during the previous influenza season but only received 1 dose.

7. Measles, mumps, and rubella vaccine (MMR). (Minimum age: 12 months) •Administertheseconddoseatage4through6years.However,thesecond

dose may be administered before age 4, provided at least 28 days have elapsed since the first dose.

8. Varicella vaccine. (Minimum age: 12 months) •Administertheseconddoseatage4through6years.However,thesecond

dosemaybeadministeredbeforeage4,providedatleast3monthshaveelapsed since the first dose.

•Forchildrenaged12monthsthrough12yearstheminimumintervalbetweendosesis3months.However,iftheseconddosewasadministered at least 28 days after the first dose, it can be accepted as valid.

9. Hepatitis A vaccine (HepA). (Minimum age: 12 months) •Administertoallchildrenaged1year(i.e.,aged12through23months).

Administer 2 doses at least 6 months apart. •Childrennotfullyvaccinatedbyage2yearscanbevaccinatedat

subsequent visits. •HepAalsoisrecommendedforchildrenolderthan1yearwholiveinareas

where vaccination programs target older children or who are at increased risk of infection. See MMWR 2006;55(No. RR-7).

10. Meningococcal vaccine. (Minimum age: 2 years for meningococcal conjugate vaccine [MCV] and for meningococcal polysaccharide vaccine [MPSV])

•AdministerMCVtochildrenaged2through10yearswithterminalcomplement component deficiency, anatomic or functional asplenia, and certain other high-risk groups. See MMWR 2005;54(No. RR-7).

•PersonswhoreceivedMPSV3ormoreyearspreviouslyandwhoremainatincreasedriskformeningococcaldiseaseshouldberevaccinatedwithMCV.

The Recommended Immunization Schedules for Persons Aged 0 Through 18 Years are approved by the Advisory Committee on Immunization Practices (www.cdc.gov/vaccines/recs/acip),the American Academy of Pediatrics (http://www.aap.org), and the American Academy of Family Physicians (http://www.aafp.org). C

S103164

Department of Health and Human Services • Centers for Disease Control and Prevention

*detail of immunization schedule for 0-6 years

FALL 2009 9

A fter more than 30 years as a hospital emergency department physician, Diane Sixsmith, MD, chairman of the Department

of Emergency Medicine at The New York Hospital Medical Center of Queens, calls the spring 2009 H1N1 influenza outbreak one of the most difficult experiences of her career.

Due to the media attention surrounding the outbreak as well as the mayor and office-based physicians urging residents to visit hospital emergency rooms if they or a family member felt ill, in May “we went from zero to 60 almost overnight,” Dr. Sixsmith recalled. “We were seeing an extra 200 to 300 children a day.” At peak times, the ED treated as many as 40 to 50 patients per hour, she said. And no one had any idea when the deluge would end.

ED volume jumped 31 percent in May, the hospital reported. During the outbreak, from May through June, the ED saw about 10,000 additional patients, Dr. Sixsmith said. The great-est flow of patients came in the evening around dinner time and then again between 8 pm to 9 pm after working parents came home and started bringing their children to the hospital.

Luckily, Dr. Sixsmith noted, the vast majority of ED visitors did not need emergency medical care.

Mixed messages from the Centers for Disease Control and Prevention (CDC) and the New York City Department of Health and Mental Hygiene (NYCDOHMH) made the early days of the outbreak confusing. Initially, the hospital was told to swab everyone and to liberally dispense treatment and prophylactic medication. A few days later, as the volume of patients increased and it became apparent that not everyone with mild symptoms required testing and emergency department treatment and that it would be impossible to provide those services to everyone, the hospital began informing visitors that it would not be testing or dispensing antivirals to everyone—only to those who were very ill. It also urged those who were not severely ill to stay at home.

The hospital soon developed a system: Information brochures and posters available at all entrances alerted visitors to hospital policy regarding the outbreak. The information, now on the hospital Web site, provided answers to questions frequently asked by visitors to the ED. This included whether the hospital would provide testing and medication and when ill residents should seek medical attention or go to the hospital. Hand wipes and sanitizer were located throughout the hospital and ED. Visitors to the ED were met by volunteer “greeters” who wore masks and had received training on how to ask questions to help quickly identify those with flu-like symptoms. These patients were then given masks and sent to a separate waiting room where a nurse was assigned to triage patients and manage patient flow. Generally, ED staff did not wear masks during the outbreak—“we felt it was more important to mask the patients”—to stem the spread of the illness Dr. Sixsmith explained. However, employees with young children did wear them. Also, pregnant employees were reassigned to work in other areas.

As ED staff began working 12-hour days and coming into contact with sick patients, some did become ill, Dr. Sixsmith said. But all were required to follow hospital policy that directed sick employees to stay home. Due to the closure of three other Queens hospitals just months before the outbreak, “we found we couldn’t receive as much assistance as we would have liked from other hospital departments, because many already were strained by increased workloads, she said.

The hospital has made plans for the fall flu season. Things that worked well in the spring, such as the greeter assistance with patient screening and separate waiting room, will be in place again. In addition, the hospital will conduct education sessions and distribute information to local schools, businesses and nursing homes. Staff physicians will receive information on the various resources available from the hospital and agencies such as the CDC and NYCDOHMH to assist them in advising and treating patients. Existing hospital-affiliated

clinics and ambulatory care centers may also be made available during extended hours to help manage the influx of flu patients.

During the spring outbreak, six to eight additional employees were needed at all times to cover the ED. Hence, staff is already being asked to volunteer for the possibility of scheduled overtime during the peak flu months. In addition, everyone will be asked to get a flu shot and compliance will be monitored closely.

Right now, the hospital does not plan to implement a telephone triage system to screen patients, Dr. Sixsmith said, explaining that the hospital did not have the manpower to screen a huge volume of calls and “we don’t want to discourage people who might need care” from coming into the hospital. But such a process could be a viable one for physicians’ offices, she added.

One thing the spring flu outbreak brought to light is that “there isn’t a lot of extra give in our system to deal with disaster situations.” Dr. Sixsmith said. Her hope is that many local residents will have built up immunity to H1N1 and fewer cases will present in the fall. “I don’t want to go through what we went through in the spring.” She emphasized, “the number one lesson I learned was to plan ahead. The second lesson is that it was important for department leaders to meet every day to review policies and what we were doing; to have a good communication process and ensure that we had all the resources (including masks, linens, etc.) we needed and knew how well we would be staffed.” Such preparations should help the ED successfully manage the fall flu season.

A Day in the Life of an ED During the H1N1 OutbreakA doctor at the epicenter of the H1N1 influenza outbreak in New York City shares her story.

Diane Sixsmith, MD

10 FALL 2009

available at the CDC’s Flu Gallery Web site.

These materials include everything from

traditional posters, buttons and handouts to

e-cards, videos and podcasts. (For more, visit

ht t p : //w w w.cdc .gov/f lu /profes s iona l s /

flugallery/index.htm.)

INFLUENZA TESTINGIt is vital that hospitals and long-term care

facilities institute procedures for performing

both rapid and cultured influenza testing

whenever clusters of respiratory illness are

detected, or where influenza infection is

suspected in an individual (patient, resident,

or health care worker). Because rapid flu tests

such as the rapid diagnostic test or

immunofluorescence are moderately sensitive,

the CDC recommends verifying negative

results with a viral culture or polymerase chain

reaction (PCR) test.

USING ANTIVIRALSDuring flu outbreaks, use antiviral drugs to

treat patients and residents and make these

drugs available to health care personnel as

needed. In the case of long-term care, residents

should be treated for at least two weeks (and

possibly as long as one week after the last case

of infection). The CDC also stresses the

importance of monitoring for potential side

effects and for virus strains that may be

resistant to these medications. Detailed, up-to-

date antiviral recommendations can be found

at the CDC Web site (www.cdc.gov/flu/

professionals/antivirals).

COMMON SENSE PROGRAMSWhat the CDC calls “Respiratory Hygiene/

Cough Etiquette” programs closely resemble

those common sense precautions reiterated by

caregivers and teachers for years. These include

providing the necessary supplies to keep hands

clean; supplying tissues or masks to cover one’s

nose and mouth for coughs and sneezes;

distancing coughing persons (3–6 feet) from

others; and encouraging patients, residents

and visitors to alert health care personnel to

any respiratory symptoms they may have. For

health care personnel, contact with potentially

infected persons is unavoidable; however, safe

Despite many differences in

both the patient base and the

range of care, the challenges of

controlling infections at hospitals

and long-term care facilities are surprisingly

similar. A look at facility-based guidelines

and recommendations issued by the Centers

for Disease Control and Prevention (CDC)

confirms this commonality. The guides for

each facility present a nine-step strategy

for preventing and controlling influenza

infections and transmissions.1 Overall, this

strategy focuses on basic infection control

measures to help protect health care workers

and the patients they treat. Measures include

everything from the use of vaccination and

antiviral medications to active surveillance and

droplet precautions. Following is a countdown

of the CDC’s recommendations for both long-

term care and acute care facilities:

Annual VaccinationsAccording to the CDC, getting an annual flu

vaccine is the top measure for controlling and

preventing flu outbreaks. While there are very

specific criteria and conditions for which type

to select, either the inactivated influenza

vaccine or the live attenuated vaccine is

effective at limiting infection and transmission.

Annual flu vaccines (nasal or intramuscular)

are recommended for all eligible, high-risk

patients/residents and health care personnel

(see “Vaccinations for Health Care Personnel”).

ACTIVE SURVEILLANCEDespite vaccinations and other precautions,

outbreaks of influenza can still occur (even

among those who have been vaccinated).

Coupling vigilant monitoring of respiratory

illness with quick detection and prompt control

measures is essential to prevent the flu from

spreading in these facilities.

THOROUGH EDUCATIONDon’t underestimate the importance of

educating health care personnel and patients/

residents (as appropriate) on effective control

measures, flu signs and symptoms, and ways to

get tested. A wide range of free educational

materials on flu control and prevention are

Prepare for the Onslaught: Flu Prevention and Control at Hospitals and Long-Term Care Facilities

11FALL 2009FALL 2009 11

hygiene practices can help prevent various

infections from traveling through the facility.

STANDARD PRECAUTIONSThese precautions outline basic guidelines for

health care personnel on what to wear (gloves,

gowns), how to clean up (alcohol-based

rubs and hand washing) and when to

decontaminate to prevent transmission of

respiratory infections within the facility. Most

of this should be familiar to health care

personnel as part of standard infection

isolation procedures for their facilities. Details

can be found on the CDC’s Infection Control

Guidelines page at www.cdc.gov/ncidod/dhqp/

guidelines.html.

DROPLET PRECAUTIONSWhen residents or patients have influenza, they

can transmit the virus to others through virus-

laden droplets generated when they cough or

sneeze. Thus droplet precautions are a vital

part of infection control and should be followed

for five days after the onset of illness. These

include isolating a flu-infected patient or

resident in a private room or with others who

are infected. Health care personnel should be

masked to enter the room and then should

remove and properly dispose of masks as they

leave. If possible, infected patients and residents

should also wear masks when being moved or

transported.

ILLNESS RESTRICTIONSWhen influenza is prevalent in the surrounding

community, long-term care facilities and

hospitals should institute restrictions to protect

residents and patients from ill visitors and

health care workers. This includes notifying

adults with respiratory symptoms not to visit

such a facility for 5 days (10 days for children)

after the onset of symptoms. Facilities should

post notices regarding these restrictions.

Health care personnel, especially those around

high-risk patients or residents, should also be

monitored for symptoms of respiratory

infections and immediately flu-tested. If

influenza is confirmed, they should be removed

from direct patient care for five days following

the onset of symptoms, if possible.

Outbreaks Happen— What’s Next?Even with the best precautions, influenza can

and does surface at health care institutions.

According to the CDC, long-term care facilities

need to be especially vigilant for both clusters,

three or more cases of acute febrile respiratory

illness (AFRI) within two to three days, and

actual outbreaks, characterized by a sudden,

abnormal increase of AFRI cases or a single

confirmed case of influenza. When an outbreak

occurs, quickly implementing these infection

control measures for rapid testing, diagnosis,

treatment and isolation, combined with

vigilant monitoring, can impact the level and

severity of infection. Hospitals and long-term

care facilities must also observe any state and

local requirements for outbreak notification

and viral testing (often within 24 hours).

What about the H1N1 Pandemic?When the World Health Organization (WHO)

declared the H1N1 influenza virus a pandemic,

it triggered a wide range of responses from

community, government, and health care

groups for infection planning and control. For

example, the American College of Emergency

Physicians (ACEP) released a national strategic

plan to help first responders and hospital

emergency departments (EDs) manage the

anticipated flood of H1N1 cases. Recognizing

that these health care personnel are on the

front lines of a pandemic medical response,

this comprehensive 16-page plan offers a

management strategy based on the Department

of Homeland Security’s directive for handling

biological threats.2

The ACEP plan addresses the following

strategic areas: providing situational awareness,

protecting ED infrastructure and personnel,

preventing disruptions to service delivery,

enabling organized, timely medical response,

and ensuring return to normal (steady state)

conditions. It assesses the current H1N1 flu

threat, rates our vulnerability based on prior

pandemics and current patterns, and offers a

potential scenario of what to expect this fall.

Based on this information, it presents planning

assumptions, determines current ED response

capabilities, and identifies some critical actions

that need to be performed. To further assist

hospital EDs, this plan provides a

comprehensive checklist of 26 categories

outlining the actions, roles and responsibilities

necessary to manage outbreaks in this flu

pandemic.

The CDC has also issued additional flu

pandemic planning and response guidelines

geared for the health care community—

including medical offices, outpatient facilities

and clinicians—as well as the community at

large, from day care centers and camps to

colleges and businesses. These guidelines are

available through the CDC’s H1N1 flu Web site

at http://www.cdc.gov/h1n1flu/

Is Your Institution Ready for Pandemic Influenza?By now, most health care institutions are

probably gearing up for the predicted surge

in H1N1 cases this fall. In addition to some of

the guidelines described previously, the CDC

has developed a series of planning checklists

to assist health care management personnel in

evaluating and improving their preparedness

and response to pandemic influenza. These tools

can be used in conjunction with requirements

from state and local health departments, federal

regulations, and accreditation standards such

as the Joint Commission on Accreditation of

Healthcare Organizations (JCAHO). Separate

checklists are available to help hospitals,

long-term care facilities, emergency medical

services, physician practices, clinics and home

health care providers effectively prepare for the

potential onslaught of flu infections.3

1 See Centers for Disease Control and Prevention, “Infection Control Measures for Preventing and Controlling Influenza Transmission in Long-Term Care Facilities,” Influenza (Flu) Guidelines and Recommen-dations, November 15, 2007, http://www.cdc.gov/flu/professionals/infectioncontrol/longtermcare.htm; and Centers for Disease Control and Prevention, “Infec-tion Control Measures for Preventing and Controlling Influenza Transmission in Acute-Care Facilities,” Influenza (Flu) Guidelines and Recommendations, November 15, 2007, http://www.cdc.gov/flu/profes-sionals/infectioncontrol/healthcarefacilities.htm.

2 See American College of Emergency Physicians, “National Strategic Plan for Emergency Department Management of Outbreaks of Novel H1N1 Influenza,” July 2009, http://www.acep.org/WorkArea/Downloa-dAsset.aspx?id=45781.

3 Centers for Disease Control and Prevention, “Hospital Pandemic Influenza Planning Checklist,” version 1, June 2007, http://www.pandemicflu.gov/plan/health-care/hospitalchecklist.pdf; and Centers for Disease Control and Prevention, “Long-Term Care and Other Residential Facilities Pandemic Influenza Planning Checklist,” version 1, May 1, 2006. http://www.flu.gov/professional/hospital/longtermcarechecklist.html.

For health care personnel, contact with potentially infected persons is unavoidable; however, safe

hygiene practices can help prevent various infections from traveling through your facility.

12 FALL 2009

Immunization programs in the U.S. have had a successful history of combating and virtually eradicating serious diseases such as polio. But in the 1980s, reports of potential DTP (diphtheria, tetanus, pertussis) vaccine-related side effects cast doubt on vaccine safety, prompting a flurry of lawsuits. As childhood immunization rates plummeted and more manufacturers stopped production, the U.S. faced a health care crisis with vaccines in short supply.

A coalition of concerned leaders from government, the health care industry and the business sector responded by enacting the National Childhood Vaccine Injury Act of 1986, which led to the National Vaccine Injury Compensation Program (VICP) in 1988. The VICP was Congress’s attempt to stabilize the vaccine supply and costs by offering “a no-fault alternative to the traditional tort system for resolving vaccine injury claims,” with compensation in rare cases where injury did occur.1 By compensating consumers and shielding vaccine makers and health care providers from liability, this program has also helped promote development of new, safer vaccines. Statistics through 2007 reveal about 7,000 claims had been filed (for adverse effects other than autism), 2,000 were settled, with average settlements of $850,000, and 700 claims were still outstanding.2

How VICP WorksAnyone claiming vaccine-related injury (or death) can seek compensation from the Vaccine Trust Fund by filing their claim in the U.S. Court of Federal Claims and naming the Secretary of Health and Human Services (HHS) as the respondent. To qualify for compensation, a claim must meet at least one of three eligibility requirements. It must:

• demonstrate that the injury occurred and is included on the Vaccine Injury Table;

• prove the vaccine significantly aggravated a pre-existing condition; or

• show that the vaccine caused the condition.3

The Vaccine Injury Table, maintained by HHS, currently includes 12 vaccines and an open category covering a number of newer vaccines that have been recommended by the Centers for Disease Control and Prevention (CDC) for routine administration to children. The latest to be added include hepatitis A, trivalent influenza (all annual flu vaccines), meningococcal, and human papillomavirus (HPV) vaccines.4

Issues of Autism Since 2001, more than 5,000 families have filed with the VICP claiming that the MMR (measles, mumps and rubella) vaccine caused autism in their children. Many claims cite thimerosal (a mercury-containing preservative formerly used in the MMR vaccine) as the culprit. With a backlog of these cases, the VICP convened a special vaccine court (part of the U.S. Court of Federal Claims) to examine causation and to rule on the issues. In its February 2009 ruling on a number of these cases, the court found no links between MMR vaccines and thimerosal, alone or combined, and autism. This ruling was upheld on appeal in July 2009, with several appeals still pending.5

In its statement on thimerosal and autism, the CDC also supports this view. While acknowledging the evident increase in childhood autism rates and indicating a commitment to understanding the causes, the CDC clearly dismisses any causation factors related to the MMR vaccine and thimerosal. As proof, it cites a number of studies and a 2004 Institute of Medicine (IOM) scientific review supporting this view.6

Although a number of families have tried to bypass the VICP process by issuing direct suits against makers of the vaccine and thimerosal, and some have filed class action suits, prevailing research on the subject appears to enforce the court’s 2009 decisions. In fact, one of the key studies (Lancet, 1998) linking the MMR vaccine (not thimerosal) to autism was found to be seriously flawed. The lead physicians involved in this study are currently under investigation in England for questionable research practices.7 1 National Vaccine Program Office, “National Vaccine Injury

Compensation Program,” http://www.hhs.gov/nvpo/fact-sheets/fs_tableIV_doc1.htm.

2 S. Sugarman, “Cases in Vaccine Court: Legal Battles over Vaccines and Autism,” New England Journal of Medicine 357, no. 13 (September 27, 2007).

3 National Vaccine Program Office, “National Vaccine Injury Compensation Program.”

4 U.S. Department of Health and Human Services Health Re-sources and Services Administration, “Vaccine Injury Table,” http://www.hrsa.gov/Vaccinecompensation/table.htm#b.

5 S. Barrett, “Omnibus Court Rules against Autism-Vaccine Link,” Autism Watch, July 28, 2009, http://www.autism-watch.org/omnibus/overview.shtml.

6 Centers for Disease Control and Prevention, “Mercury and Vaccines (Thimerosal),” February 8, 2008, http://www.cdc.gov/vaccinesafety/updates/thimerosal.htm.

7 B. Deer, “MMR Doctor Andrew Wakefield Fixed Data on Autism,” Times Online, February 8, 2009, http://www.time-sonline.co.uk/tol/life_and_style/health/article5683671.ece.

The National Vaccine Injury Compensation Program (VICP)

Created by Congress in 1988, this program has helped promote the development of new, safer vaccines.

13FALL 2009

Additional Resources

LOCAL LINKS

For more information, refer to the following resources:

http://www.health.state.ny.us

NYS Department of Health (DOH) home pageImmunization and infection control for health care professionals, facilities and consumers

http://www.ny.gov/h1n1/index.html

NYS H1N1 Influenza Update pageState updates on H1N1 pandemic

http://www.health.state.ny.us/dis-eases/communicable/influenza

NYS DOH influenza pageInfluenza and H1N1 resources

https://apps.nyhealth.gov/vms/appmanager/vms/public?_nfpb=true&_pageLabel=homepage

NYS DOH ServNY home pageA registry of health care and mental health professionals who wish to volunteer during an emergency or major disaster

http://www.nysl.nysed.gov/ reference/swineflu.htm

NYS LibrarySelected H1N1 Web sites

http://www.nyc.gov/html/doh/html/imm/fluhome.shtml

NYC Department of Health and Mental Hygiene flu pageInformation on flu, immunizations, and other resources

http://www.preventinfluenza.org

Prevent Flu Now! site (National Influenza Vaccine Summit)Flu prevention and control tips for patients and health care professionals

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5808a1.htm

Centers for Disease Control and Prevention (CDC) MMWR siteInfluenza vaccine recommendations from the Advisory Committee on Immunization Practices (ACIP), July 31, 2009

http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm#printable

CDC vaccines and immunizations siteVaccine and immunization schedules for children, adolescents and adults

http://www.cdc.gov/h1n1flu

CDC novel H1N1 siteNational/global information and situational updates on swine flu pandemic

http://www.flu.gov

Flu.gov siteU.S. government information on H1N1, avian and pandemic influenza

http://www3.niaid.nih.gov/topics/Flu

National Institute of Allergies and Infectious Diseases (NIAID) flu pageCurrent flu information and research, including 2009 H1N1, seasonal, avian and pandemic

http://www.aafp.org/online/en/home/clinical/disasterprep/swine-flu.html

American Academy of Family Physicians (AAFP) H1N1 siteH1N1 Web links and resources for physicians, including Checklist to Prepare Doctors’ Offices for Pandemic Influenza

http://www.ahcancal.org/facility_operations/clinical_practice/Pages/ SwineFlu.aspx

American Health Care Association (AHCA) flu pageH1N1 flu update and resources for long-term care providers

http://www.aha.org/aha_app/issues/Emergency-Readiness/index.jsp

American Hospital Association (AHA) emergency readiness pageInformation for hospitals on emergency readiness for A/H1N1 flu outbreaks

NATIONAL LINKS

With the myriad of childhood immunizations, shots for travelers, or annual influenza shots and nasal-spray vaccines, safe storage, handling and administering are top concerns for health care professionals.

Storage SafetyEnsuring the safety of immunization vials entails the obvious: following manufacturers’ recommendations as well as practical steps related to inventory stocking and rotation. Most vaccines must be stored in a temperature-controlled environment; some are light sensitive; others exist in different forms, dictating different storage requirements.

To protect cold storage vaccine supplies, the Centers for Disease Control and Prevention (CDC) endorses these tips from the Immunization Action Coalition:

• Store in a certified refrigerator or freezer dedicated for that use only. Do not store food in the same unit.

• Continuously monitor and log temperatures to ensure they remain within allowable ranges.

• Take action if the temperature is out of range by notifying a supervisor, moving the vials, and assessing their usability.

• Be careful when retrieving vials to make sure the door is not open too long and that it reseals when closing.

• Stock and rotate vials by expiration date so that the older supplies are in the front and can be used first.

• Post a “Do Not Unplug” sign by the electrical outlet for the refrigerator or freezer.

• Have a backup power source readily available in the event of a power outage.

• Prepare a backup plan should the refrigerator or freezer fail. 1

Handling Multi-dose versus Single-dose Vials Most multi-dose vials contain a preservative that, if the vials are stored properly, allows them to be opened and reused until their expiration date (unless contamination is detected). The exception is multi-dose vials that are reconstituted, such as meningococcal. These must be dated and used according to the manufacturer’s defined time frame. Single-dose vials, on the other hand, are intended for one-time use only. However, as it is difficult to determine when rubber seals have been punctured, these vials should not be opened until ready to draw up and administer.2

Administering VaccinesIn 2007, a number of high-profile outbreaks of hepatitis infections at ambulatory care facilities led the CDC to establish clearer guidelines for safe injection practices. These guidelines are designed to prevent health care personnel from reinserting used needles into multi-dose vials and to keep them from reusing a single needle or syringe to inject multiple persons. Instead, the CDC advised that health care institutions train all personnel in “the use of a sterile, single-use, disposable needle and syringe for each injection given and prevention of contamination of injection equipment and medication.”3

The CDC’s Vaccine Handling and Storage Toolkit offers a wealth of resources related to immunization safety (www2a.cdc.gov/vaccines/ed/shtoolkit). 1 Immunization Action Coalition, “Don’t Be Guilty of These

Errors in Vaccine Storage and Handling” (technical content reviewed by the Centers for Disease Control and Prevention, June 2008), http://immunize.org/catg.d/p3036.pdf.

2 Immunization Action Coalition, “Checklist for Safe Vaccine Handling and Storage” (technical content reviewed by the Centers for Disease Control and Prevention, July 2008), http://www.immunize.org/catg.d/p3035.pdf.

3 Centers for Disease Control and Prevention, “Safe Injection Practices to Prevent Transmission of Infections to Patients,” March, 28, 2008, http://www.cdc.gov/ncidod/dhqp/injec-tionSafetyPractices.html.

Immunization Tips for Safe Storage and Handling

14 FALL 200914 FALL 2009

How-To’s for Clean Hands*

• Wet hands with clean running water (warm if available).

• Apply soap, rub hands together to lather and scrub all surfaces.

• Continue rubbing hands for 20 seconds (the time it takes to sing “Happy Birthday” twice).

• Rinse hands well under running water.

• Use paper towel or dryer to dry hands (use towel to turn off faucet, open doors, etc.)

• If soap and water are not available, apply 60 percent alcohol-based gel (alcohol-based handrub) to palm, rub hands together and continue rubbing all over hands and fingers till dry.

*Based on the CDC’s Clean Hands Save Lives site, http://www.cdc.gov/cleanhands/

The U.S. may be focused on the H1N1 influenza pandemic, but to other countries, drug-resistant tuberculosis is a far more pervasive threat. According to the World Health Organization (WHO), there were 9.27 million incident TB cases and 13.7 million prevalent cases of TB worldwide in 2007. WHO likens the situation to a “time bomb” with an explosion of multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB) strains circulating among global populations. Based on 2007 data, WHO puts worldwide estimates at 500,000 infected with MDR-TB and 50,000 with XDR-TB. It notes that 85 percent of all cases were confined to 27 countries; the top four being India (131K), China (112K) and the Russian Federation and South Africa (16K each).1

By comparison, TB and its more virulent strains have been far from the limelight in the U.S. (with the exception of the XDR-TB infected U.S. airline traveler who ignited a media frenzy two years ago). In that same year, the U.S. reported more than 13,000 TB cases, 98 MDR-TB cases, and just two XDR-TB cases. There is one key indicator to note for 2007: the TB rate among foreign-born persons was 9.7 times higher than for those born in the U.S.2

The evolution of drug-resistant TB is well-documented and results from inadequate controls and improper use of TB drug treatment regimens. Although WHO has led efforts to address these issues through its DOTS, Stop TB, and other programs, it estimates that 37 percent of TB cases and up to 96 percent of MDR-TB cases continue to be treated improperly.3

New Alternatives on the HorizonThe good news is that there have been a number of recent breakthroughs in this area. For example,

international screening programs in high-risk countries combined with a new technique for more sensitive detection may help stem TB rates among new immigrants to the U.S.4 On the treatment front, some new drugs are showing promise in fighting drug-resistant TB:

• Drugs used for Parkinson’s disease have been identified by computer models and lab tests to offer potential against XDR-TB. The drugs, entacapone (Comtan) and tolcapone (Tasmar), block the brain chemical COMT and target the TB enzyme inhA. Of the two, Comtan is more suitable, as it does not damage the liver. Further studies are required to pursue this finding.5

• TMC207, a new drug from Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson, attacks the activity of the enzyme ATP synthase, but only in TB bacteria. The drug has shown success in the first of several planned trials.6

• The Albert Einstein College of Medicine and the National Institute of Allergy and Infectious Diseases (NIAID) teamed up to test a combination of old school beta-lactam antibiotics, meropenem and clavulanate in the lab. They found the drugs work in tandem to inhibit both TB and 13 strains of XDR-TB. These initial findings have generated excitement and plans for subsequent trials with TB patients in South Korea and South Africa.7

1 World Health Organization, Global Tuberculosis Control: Epidemiology, Strategy, Financing, http://www.who.int/tb/publications/global_report/2009/pdf/full_report.pdf.

2 Centers for Disease Control and Prevention, “Trends in Tuberculosis—United States, 2007,” MMWR Weekly 57, no. 11 (March 21, 2008): 281–85, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5711a2.htm.

3 WHO, Global Tuberculosis Control.

4 E. Edelson, “Two Ways to Tackle Tuberculosis: International Screening Program and New Drug Show Promise in Stud-ies,” U.S. News & World Report: Health Day News, July 28, 2009, http://health.usnews.com/articles/health/health-day/2009/06/03/two-ways-to-tackle-tuberculosis.html.

5 University of California–San Diego, “Existing Parkinson’s Disease Drug May Fight Drug-Resistant TB,” Science-Daily, July 4, 2009, http://www.sciencedaily.com/releas-es/2009/07/090703065218.htm.

6 Edelson, “Two Ways to Tackle Tuberculosis.”

7 Albert Einstein College of Medicine, “Antibiotic Combina-tion Defeats Extensively Drug-Resistant TB,” ScienceDaily, February 27, 2009, http://www.sciencedaily.com/releas-es/2009/02/090226141112.htm.

Drug-Resistant TB: New Tools to Fight Common Threat

15FALL 2009

The Quarterly Journal for Health Care Practice and Risk Management

© 2009 by FOJP Service Corporation

Editor-in-ChiefMark A. Callahan, MD

Managing EditorSharon R. King

Senior WriterDiane Desaulniers

ContributorsAnne BurnsChristine Chang Irene KasselAngela L. Laurio Don Parker-BurgardGlenn Slavin

Editorial BoardHarold JacobowitzPatricia KischakSteven MacalusoLoreto J. RuzzoRobert Stanyon

Risk Management Advisory BoardSue Cannavo, RN, ARMLouis I. Schenkel, MS, JDSheila Namm, RN, MA, JD, CS

Voluntary AttendingPhysicians (VAP) ProgramAll questions concerning coverageshould be directed to Alice Walsh,AVP, Underwriting & PhysicianServices, Hospitals InsuranceCompany, Inc. at 800.982.7101.

Recommendations contained ininfocus are intended to exemplifythe application of risk managementand quality of care principles.They are not intended as standardsfor, or requirements of, clinicalpractice. For specific legal advice,consult an attorney.

infocus is published by:FOJP Service Corporation28 East 28th StreetNew York, NY 10016.

FOJP Service CorporationRisk Management Advisorsto the Health Care andSocial Services Community

Light micrograph of a section through a lymph node in tuberculosis (TB).

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This is not the first time that the swine flu has dominated the public health scene. A form of the virus kicked off the Spanish flu pandemic in 1918, emerging with a virulence that killed more than 40 million people worldwide.1 So when the swine flu virus reappeared in 1976, the U.S. government was determined to act quickly and deal with what it viewed as a major threat to the American public. Amid predictions that one million U.S. citizens might die in the 1976 pandemic, President Gerald Ford enacted the National Influenza Immunization Program (NIIP), with the goal of mass immunization of more than 80 percent of the population. Though production of that year’s flu vaccine had just been completed and the vaccine was not yet tested, the government moved forward with its aggressive immunization plans.2

Within 10 weeks, 45 million people were immunized. But problems began to appear in the form of paralysis and death related to Guillain-Barre syndrome. Although there was no real proof that the vaccine had caused these serious reactions, the damage was done.3 Two months later, the public program ended, the anticipated flu pandemic never transpired, and only 33 percent of the population had been immunized.4 However, the outbreak did result in many future improvements in influenza vaccines.

As the fall flu season commences, many of those immunized during the 1976 outbreak are expected to show immunity to today’s novel H1N1 influenza virus.5 In addition, continued safe protocols for vaccine testing and administration should ensure that we continue to benefit from the lessons learned during the 1976 influenza outbreak.

1 J. K. Taubengerger and D. M. Morens, “1918 Influenza: The Mother of All Pandemics,” Emerging Infectious Diseases 12, no. 1 (January 2006): 15-22,

2 http://www.cdc.gov/ncidod/eid/vol12no01/pdfs/05-0979.pdf

3 P. Di Justo, “The Last Great Swine Flu Epidemic,” Salon.com, April 28, 2009, http://www.salon.com/env/ feature/2009/04/28/1976_swine_flu.

4 D. J. Sencer and J. D. Millar, “Reflections on the 1976 Swine Flu Vaccination Program,” Emerging Infectious Diseases 12, no. 1 (January 2006): 29–33, http://www.cdc.gov/ncidod/eid/vol12no01/05-1007.htm.

5 C. Soares, “Single Vaccine Dose, Even One from 1976, Could Protect Against the H1N1 Swine Flu,” Scientific American Features, September 11, 2009, http://www.scientificamerican.com/article.cfm?id=single-vaccine-dose-even&print=true.

Pandemic Flu Déjà VuA look back at the 1976 influenza outbreak

AMA Brochures Offer Pandemic Flu Guidance The American Medical Association (AMA) has put out a series of brochures designed to educate consumers, businesses and health care professionals on what to do in cases of pandemic flu. With the World Health Organization (WHO) categorizing the novel H1N1 influenza outbreak as a pandemic and predicting widespread resurgence this fall, these brochures could prove to be useful tools in the fight against the flu. Each It’s Not Flu as Usual brochure provides a handy table illustrating the key differences between seasonal and pandemic flu, as well as next steps and safe practices for infection prevention and control. To download a free copy, visit http://healthyamericans.org/reports/flu/brochures/.

It’s Not FluAs UsualWHAT HEALTH CARE PROFESSIONALSNEED TO KNOW ABOUT PANDEMIC FLU

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It’s Not FluAs UsualWHAT INDIVIDUALS AND FAMILIES NEEDTO KNOW ABOUT PANDEMIC FLU

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