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The Looming H1N1 Pandemic and
What it Means for You And Your Patients
Mary Andrawis, Pharm.D., M.P.H.
Director, Clinical Guidelines and Quality Improvement
The American Society of Health-System Pharmacists
State Affiliate Webinar
September 30, 2009
Objectives
1. Differentiate the appropriateness of H1N1
vaccination, oral prophylaxis, or treatment.
2. Identify steps that can be taken to prevent the
spread of influenza.
3. Describe the involvement of pharmacy personnel
in pandemic preparedness.
The H1N1 PANDEMIC
*Images from www.news4u.com, www.fox44.com, and www.javno.com
"About six out of ten Americans believe
there will be widespread swine flu cases
this fall or winter with people getting very
sick…but most are not worried it will strike
them or their family."
-Harvard School of Public Health Survey
June 2009
* Available from: http://www.wtop.com/?nid=220&sid=1719055
What is H1N1?
• A new highly contagious
reassorted flu virus
• First caused illness in
Mexico and the United
States in March 2009
• Spreads through:
– Coughs and sneezes
– Touching contaminated
surfaces (elevator buttons,
doorknobs, keyboards) and
then eyes, nose or mouth
What is H1N1?
• Incubation: 1 to 7 days; unknown
• Clinical Features:
– Fever
– Cough
– Sore throat
– Body aches
• Diagnosis:
– Headache
– Chills
– Fatigue
– Nausea, vomiting
and/or diarrhea
– Blood test (+ viral nucleoprotein antigen)
– Clinical suspicion
*Interim Guidance for Clinicians on Identifying and Caring for Patients with Swine-origin
Influenza A (H1N1) Virus Infection. Available at
http://www.cdc.gov/h1n1flu/identifyingpatients.htm
What is H1N1?
• Complications:
– Exacerbation of underlying chronic medical conditions
– Upper respiratory tract disease (sinusitis, otitis media,
croup)
– Lower respiratory tract disease (pneumonia,
bronchiolitis, status asthmaticus)
– Cardiac (myocarditis, pericarditis)
– Musculoskeletal (myositis, rhabdomyolysis)
– Neurologic (encephalopathy, encephalitis, febrile
seizures, status epilepticus)
– Sepsis
*Interim Guidance for Clinicians on Identifying and Caring for Patients with Swine-origin
Influenza A (H1N1) Virus Infection. Available at
http://www.cdc.gov/h1n1flu/identifyingpatients.htm
Who is at Risk for Complications?
• Pregnant women
• Those with chronic health disorders or
compromised immune systems
– Asthma, COPD, diabetes, heart disease, kidney
disease
– Morbid obesity
– Medications that cause suppression of the immune
system (e.g., chemotherapy, post-transplant)
– Compromised immune system (HIV patients)
• Children <5 years
*Interim Guidance for Clinicians on Identifying and Caring for Patients with Swine-origin
Influenza A (H1N1) Virus Infection. Available at
http://www.cdc.gov/h1n1flu/identifyingpatients.htm
Epidemiology
H1N1 Cases by Age Group (n=35,860*)
Rate / 100,000 Pop by Age Group
25
21.6
20
17.2
15
10
5.4
5
3
1.0
0
0-4 Yrs
5-24 Yrs
25-49 Yrs
50-64 Yrs
≥65 Yrs
Age Groups
*As of 09 July 2009. Rate / 100,000 by Single Year Age Groups: Denominator source: 2008 Census Estimates,
U.S. Census Bureau at: http://www.census.gov/popest/national/asrh/files/NC-EST2007-ALLDATA-R-File24.csv
Epidemiology
Hospitalizations per 100,000 Population in
Age Group
H1N1 Hospitalization Rate by Age Group (n=3,779)
4
3.8
3.5
3
n=799
2.5
2
1.7
1.5
n= 1417
1
0.5
1.2
0.8
0.9
n= 906
n=479
25-49 Yrs
50-64 Yrs
n= 178
0
0-4 Yrs
5-24 Yrs
≥65 Yrs
Age Group
*As of 09 July 2009. Rate / 100,000 by Single Year Age Groups: Denominator source: 2008 Census Estimates,
U.S. Census Bureau at: http://www.census.gov/popest/national/asrh/files/NC-EST2007-ALLDATA-R-File24.csv
For Comparison…
Hospitalizations Per 100,000 Person Years
Seasonal Influenza Hospitalization Rate By Age Group
600
500
400
300
200
100
0
0 - 4 Yrs
*Thompson WW, JAMA, 2004
5 - 49 Yrs
50 - 64 Yrs
Age Group
65+ Yrs
Where did “Swine Flu” Come From?
Pigs = Good breeding grounds for viruses
– Pigs can harbor several flu viruses, may mix and
create a new viral strain
Viruses easily pass from:
BIRD  PIG  PIG  HUMAN  HUMAN
– By breathing infected particles (NOT by consuming
pork, chicken, etc)
History of H1N1
Confirmed and Probable Novel H1N1 Cases
40000
36000
32000
24000
20000
16000
12000
8000
4000
Week Ending Date
*www.cdc.gov/H1N1
3Ju
l
10
-J
ul
24
-J
un
16
-J
un
6Ju
n
10
-J
un
ay
30
-M
ay
23
-M
ay
16
-M
9M
ay
11
-A
pr
18
-A
pr
25
-A
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2M
ay
4Ap
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ar
0
28
-M
Cases
28000
H1N1 Becomes Pandemic
• June 11, 2009: World Health Organization raises
worldwide pandemic alert level to Phase 6
– More than 70 countries had reported cases; since
then, double
– Based on spread of the virus
What is a Pandemic?
*Available from: http://www.who.int/csr/disease/influenza/GIPA3AideMemoire.pdf
History of Pandemics
• 1918: Spanish Flu
– High severity
– Highest death rate: adults 20 to 50 years old
– 675,000 deaths in the U.S.
– 20 to 40 percent of the worldwide population
became ill; over 50 million people died
*Pandemics and Pandemic Threats since 1900
Available from: http://www.pandemicflu.gov/general/historicaloverview.html
History of Pandemics
• 1957: Asian Flu
– Highest death rate: the elderly
– 69,800 deaths in the U.S.
– Identified in February, vaccine was available
by August
– In fall, spread increased; infection rates
highest among school children, young adults,
and pregnant women
– Most deaths occurred between September
and March
*Pandemics and Pandemic Threats since 1900
Available from: http://www.pandemicflu.gov/general/historicaloverview.html
History of Pandemics
• 1968: Hong Kong Flu
– Mild severity
• Possible immunity from earlier infections
• Peaked during winter break; lower rate of infection
among schoolchildren and families
• Improved medical care and antibiotics for
secondary bacterial infections
– Highest death rate: the elderly
– Detected September; deaths peaked
December, January 1969
– 33,800 deaths in the U.S.
*Pandemics and Pandemic Threats since 1900
Available from: http://www.pandemicflu.gov/general/historicaloverview.html
Prevention of H1N1 Infection
H1N1 Vaccine
• Currently in development by five manufacturers
(four approved as of 9/25/09)
• Purchased by the U.S. government; will be
available to vaccinators at no cost, assumption
that health plans will provide reimbursement for
administration
• Children < 10 years old likely to require two
doses of vaccine about 3 weeks apart
• Adults and children > 10 years old only need one
dose
*Available from: http://www.cdc.gov/h1n1flu/vaccination/provider/preparing.htm
H1N1 Vaccine Supply
• Estimated shipping to start mid-October
– 10 to 20 million doses to be available each week
after first week in October
– Total of 250 million doses
----------------------------------------------------------• Inactivated subunit (TIV)
– Intramuscular injection
– Includes multi-use vials (contains thimerosal) and
single-dose (preservative-free)
• Live attenuated vaccine (LAIV)
– Intranasal spray
– NOT for pregnant patients or <2 years old
Who Should Get the Vaccine (First)?
• Pregnant women
• Live with or care for children younger than
6 months of age
• Healthcare and emergency medical
services personnel
• Anyone 6 months to 24 years of age
• Anyone 25 to 64 years of age with chronic
health disorders or compromised immune
systems
*Available from: http://www.cdc.gov/h1n1flu/vaccination/provider/preparing.htm
Who Should Not Get the Vaccine?
• Persons who have:
– Allergy to eggs
– Had a severe reaction or developed GuillianBarré syndrome after an influenza vaccination
in the past
– Moderate or severe illness with a fever
(should wait until symptoms lessen)
• Children less than 6 months of age
*Available from: http://www.cdc.gov/h1n1flu/vaccination/provider/preparing.htm
Preventing the Spread
• Ask yourself daily before coming to work:
–
–
–
–
–
Do I have a fever?
Do I have a sore throat?
Am I coughing?
Do my muscles ache?
Do I feel ill?
• If you answered “yes” to any of the questions
above:
– Do not report to work; stay at home
– Notify your supervisor as soon as possible
– Seek medical guidance
Preventing the Spread
1. Cough/Sneeze ‘Etiquette’
– Cover mouth and nose with tissue;
trash
– If tissues not available, use
elbow/shoulder, not hands
2. Hand Washing
–
Soap and water for 20 seconds (hum
“Happy Birthday”)
– If not available, hand sanitizer
•
•
•
Before and after preparing food or eating
After using the restroom
Before and after touching nose, eyes, or
mouth
*Available from: http://www.cdc.gov/h1n1flu/antiviral.htm
Preventing the Spread
• Facemasks and respirators:
– generally not recommended for non-healthcare
workers
• Unless increased risk of severe illness
• May choose to wear on voluntary basis
• If work activities include contact, workers
should:
– Maintain distance of 6 feet or more
– Keep interactions as brief as possible
– Ask ill person to follow good cough etiquette,
hand hygiene and to wear facemask
*CDC Recommendations for Facemask and Respirator Use: http://www.cdc.gov/h1n1flu/masks.htm
Preventing the Spread
• Provide:
– Flexible leave policies to encourage sick to stay home
– Written guidance on H1N1 flu
– Facilities for hand washing, alcohol-based hand
sanitizers in common workplace areas
– Disinfectants, disposable towels for cleaning work
surfaces
• Disinfect hard surfaces such as keyboards,
doorknobs
• Display posters about hand washing and
cough etiquette (free posters at:
http://www.cdc.gov/germstopper/materials.htm)
Preventing the Spread
• “Social distancing”
– No handshakes and no crowded elevators
– Spread out – offices, cubicles, conference
rooms
– Email and phones for conversations
– Staggered shifts or schedules
Antivirals for Prophylaxis
• CDC: ‘reserved for persons at higher risk for
complications … early treatment is an
emphasized alternative to prophylaxis after a
suspected exposure’
• 70% to 90% effective
– Tamiflu® (oseltamivir)
– Relenza® (zanamivir)
• Contagious?
– Beginning one day before symptoms to up to 7 days
after illness
Antivirals for Prophylaxis
Adult
Oseltamivir: 75-mg
PO once per day x 10
days
OR
Zanamivir: Two 5-mg
inhalations once per
day x 10 days
Pediatric
Oseltamivir: < 12 months old
(once per day)
<15 kg
16-23 kg
24-40 kg
>40 kg
30 mg
45 mg
60 mg
75 mg
OR
Zanamivir: > 7 years old
Two 5-mg inhalations
once per day x 10 days
Antivirals Post-Exposure for Prophylaxis
• Given daily for 10 days
• Close contacts of people who are
contagious (confirmed, probable, or
suspected)
*At high-risk for complications
*Health care personnel, public health workers,
or first responders
Antivirals Pre-Exposure for Prophylaxis
• Given daily during potential exposure
period and continued for 10 days after last
known exposure
• Close contacts of people who are
contagious (confirmed, probable, or
suspected)
*At high-risk for complications
*Health care personnel, public health workers,
or first responders
Antiviral Supply
• Reserved for high-risk and hospitalized
patients
• Issues with oseltamivir liquid
– Graduations in mg
– Availability (need for compounding)
Treatment of H1N1 Infection
Antivirals for Treatment
• CDC: ‘recommended for persons at higher risk for
complications … and influenza requiring
hospitalization’
• Maximum efficacy when started soon (within 48
hours) after getting sick
– Tamiflu® (oseltamivir)
– Relenza® (zanamivir)
• Emergency Use Authorizations issued by FDA
allows use not previously approved
*CDC Definitions. Available at http://www.emergency.cdc.gov/agent/agentlistcategory.asp#catdef
Antivirals for Treatment
Adult
Oseltamivir: 75-mg
PO twice per day x 5
days
OR
Zanamivir: Two 5-mg
inhalations twice per
day x 5 days
Pediatric
Oseltamivir: < 12 months old
(divided into 2 doses)
<15 kg
16-23 kg
24-40 kg
>40 kg
60 mg/day
90 mg/day
120 mg/day
150 mg/day
OR
Zanamivir: > 7 years old
Two 5-mg inhalations
twice per day x 5 days
Antivirals for Treatment
• Given daily for 5 days to people with
suspected or confirmed H1N1 infection, with
priority for:
Hospitalized patients
Those at high risk for complications
*CDC Treatment Recommendations: http://www.cdc.gov/h1n1flu/recommendations.htm
When to Return to Work?
• Non-healthcare settings:
– After fever (100° F) or signs of a fever is gone
for at least 24 hours
• Without use of fever-reducing medications
• Healthcare or high-risk settings*:
– 7 days from symptom onset, or until resolution
of symptoms (whichever longer)
*High number of high-risk persons, e.g. nursery
*Available from: http://www.cdc.gov/h1n1flu/guidance/exclusion.htm
Applications: Practices and
Resources
What is a Disaster?
“Something that disrupts the environment of
care; disrupts care and treatment; changes or
increases demand” (The Joint Commission)
An event that exceeds the capabilities of
response: NEED exceeds RESOURCES
*G7 Sommet de Lyon 1996. Declaration on Terrorism. Lyon, France; June 27, 1996.
Role of Pharmacy
• According to ASHP, pharmacists should:
– Have a key role in planning and execution of:
• Appropriate deployment of emergency supplies of
pharmaceuticals
• Distribution (ensure proper packaging, storage,
handling, labeling, dispensing, and counseling)
– Consider volunteering to assist in distribution,
dispensing
*ASHP Statement on the Role of Health-System Pharmacists in Emergency Preparedness. Am
J Health-Syst Pharm. 2003; 60: 1993-5.
Role of Pharmacy
• (Continued) pharmacists should:
– Become informed of local and institutional plans
for preparedness especially related to distribution,
control, and use of pharmaceuticals;
– Share with colleagues/patients evidence-based
information on pharmaceuticals used to respond;
– Act assertively to prevent and allay panic
*ASHP Statement on the Role of Health-System Pharmacists in Emergency Preparedness. Am
J Health-Syst Pharm. 2003; 60: 1993-5.
Resources
• CDC H1N1 Flu Page
– www.cdc.gov/h1n1flu/
• H1N1 Flu Resource Center
– www.ashp.org/h1n1
• ASHP Connect
– www.ashp.org/ashpconnect
• Pandemic Readiness and Emergency
Preparedness Resource Center
– www.pharmacyready.org
Conclusion
• Pandemic influenza is here this season –
readiness without panic is important
• Must be prepared both on individual and
institutional levels
• Major opportunity for pharmacists to
contribute to public health
The Looming H1N1 Pandemic
and What it Means for You And Your Patients
Mary Andrawis, Pharm.D., M.P.H.
Director, Clinical Guidelines and Quality Improvement
The American Society of Health-System Pharmacists
EMAIL: [email protected]