Attacking The Flu Bug The Pharmacist s s Pro-Active Role in Preventing & Treating Influenza

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Attacking The Flu Bug The Pharmacist s s Pro-Active Role in Preventing & Treating Influenza Catherine E. Cooke, PharmD, BCPS, PAHM This program has been brought to you by PharmCon

Attacking The Flu Bug The Pharmacist s s Pro-Active Role in Preventing & Treating Influenza Speaker: Catherine Cooke attained her Bachelor in Pharmacy from the University of Iowa and then went on to receive her Pharm.D. from the Medical University of South Carolina. Subsequently, she completed a specialty residency in Ambulatory Care/Managed Care through the Philadelphia College of Pharmacy and Science. After post-graduate training, Dr. Cooke served as a full-time Assistant Professor at the University of Maryland School of Pharmacy where she became a Board Certified Pharmacotherapy Specialist. Currently, she is an Independent Consultant working in health care quality and research. In addition, she provides clinical pharmacy services such as hypertension, dyslipidemia and smoking cessation management to patients in Maryland. Her main research interests are in the areas of cardiovascular pharmacotherapeutics and pharmacy services in the managed care environment with specific interest in discrepancies in health care based on sex or ethnicity. Speaker Disclosure: Dr. Cooke has no actual or potential conflicts of interest in relation to this program. This program has been brought to you by PharmCon PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

Attacking The Flu Bug The Pharmacist s s Pro-Active Role in Preventing & Treating Influenza Accreditation: Pharmacists-798-000-080-073-L01-P Technicians- 798-000-080-073-L01-T Target Audience: Pharmacists & Technicians CE Credits: 1.0 Credit hour or 0.1 CEU for pharmacists/technicians Expiration Date: 9/17/2011 Program Overview: Pharmacists can play a pro-active role in the treatment of influenza and must understand the various delivery options. This program for pharmacists will enhance their knowledge about the flu and currently available vaccine delivery options and information needed to educate and treat patients. Objectives: 1.Describe the signs, symptoms, and diagnosis of current strains of influenza, distinguishing flu from the common cold. 2. Review the various pharmaceutical options for the prevention and treatment of influenza to include ease of use, comparative efficacy, pharmacokinetics and contraindications of vaccines. 3. Explain the pharmacist s role in the prevention and treatment of Influenza. This program has been brought to you by PharmCon

Learning Objectives DESCRIBE the signs, symptoms, and diagnosis of current strains of o influenza, distinguishing flu from the common cold REVIEW the various pharmaceutical options for the prevention and treatment of influenza EXPLAIN the pharmacist s s role in the prevention and treatment of Influenza Reference: Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NS; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR Recomm Rep. 2008 Aug 8;57(RR- 7):1-60.

Flu prevention Strategies Wash your hands Scrub hands vigorously for at least 15 seconds, rinse well and turn off the faucet with a paper towel. OR Use 60% alcohol-based hand gel Eat right, sleep tight Fresh fruits and vegetables, whole grains, and small amounts of lean protein Adults - 7-88 hours/night Older children and teens 9-10 hours/night Exercise regularly Avoid crowds during flu season

Human Influenza Contagious respiratory illness caused by influenza virus Yearly winter epidemics Peak activity usually in January and February Sporadic, unpredictable pandemics

Influenza Virus Type of nuclear material Hemagglutinin Neuraminidase A/Fujian/411/2002 (H3N2) Virus type Geographic origin Strain number Year of isolation Virus subtype

Influenza Clinical Features Incubation period 2 days (range 1-41 4 days) Common signs and symptoms of the flu: Fever over 101 F (38 C) in adults, and often as high as 103 to 105 F (39.5 C to 40.5 C) in children Chills and sweats Headache Dry cough Muscular aches and pains, especially in your back, arms and legs Fatigue and weakness Nasal congestion Loss of appetite Diarrhea and vomiting in children Severity of illness depends on prior experience with related variants

Influenza Complications Pneumonia Primary influenza viral Secondary bacterial Reye s s syndrome Myocarditis Death 0.5-1 1 per 1,000 cases

Influenza-Associated Hospitalizations By Age Group (Thompson, JAMA, 2004) Hospitalizations Per 100,000 Person Years 600 500 400 300 200 100 0 472 115 90 22 0-4 Yrs 5-49 Yrs 50-64 Yrs > 65 Yrs Age Group

Influenza-Associated Deaths By Age Group, 1990-2001 (Thompson, JAMA 2003) 120 R&C Deaths Per 100,000 Person Years 100 80 60 40 20 0 98.3 7.5 0.6 0.4 0.5 < 1 Yrs 1-4 Yrs 5-49 Yrs 50-64 Yrs 65+ Yrs Age Group

Influenza Diagnosis Clinical and epidemiological characteristics Isolation of influenza virus from clinical specimen (e.g., nasopharynx, throat, sputum) Significant rise in influenza IgG by serologic assay Direct antigen testing for type A virus

Month of Peak Influenza Activity United States, 1976-2006 Percent 50 45 40 35 30 25 20 15 10 5 0 45% 19% 13% 13% 3% 3% Dec Jan Feb Mar Apr May MMWR 2007;55(RR-6):5

Preventing the Flu #1 Prevention Strategy Influenza Vaccines

Composition of the 2008-2009 2009 Influenza Vaccine* A/Brisbane/59/2007 (H1N1) A/Brisbane/10/2007 (H3N2) B/Florida/4/2006 *manufacturers may use strains that are antigenically identical to the selected strains

Influenza vaccination recommendations Adults 2008

Influenza vaccination recommendations Children and adolescents, 6 months to 18 years 2008

Inactivated flu vaccine IM injection

Inactivated Influenza Vaccine Efficacy 70%-90% effective among healthy persons younger than 65 years of age 30%-40% effective among frail elderly persons 50%-60% effective in preventing hospitalization 80% effective in preventing death

Influenza and Complications Among Nursing Home Residents Vaccinated* Unvaccinated Percent 40 35 30 25 20 15 10 5 0 RR=1.9 Illness Percent 10 8 6 4 2 0 RR=2.5 RR=2.0 RR=4.2 Hosp Pneu Death *Inactivated influenza vaccine. Genesee County, MI, 1982-1983

Inactivated Influenza Vaccine Schedule Age Group 6-35 mos 3-8 yrs >9 yrs Dose 0.25 ml 0.50 ml 0.50 ml No. Doses 1* or 2 1* or 2 1 *Only one dose is needed if the child received 2 doses of influenza vaccine during the previous influenza season

Influenza Vaccination of Children 6 Months Through 8 Years Of Age* Previous vaccination One dose last year Vaccine THIS year Two doses One dose in each of the last 2 years One dose 3 years ago One dose in each of the last 3 years One dose One dose One dose *children 9 years and older should receive only one dose of influenza vaccine per year regardless of the number of doses in previous years

Inactivated Influenza Vaccine Adverse Reactions Local reactions 15%-20% Fever, malaise not common Allergic reactions rare Neurological very rare reactions

Inactivated Influenza Vaccine Contraindications and Precautions Severe allergic reaction to a vaccine component (e.g., egg) or following a prior dose of vaccine Moderate or severe acute illness History of Guillian Barre syndrome within 6 weeks following a previous dose of TIV (precaution)

Percentage of children fully vaccinated (i.e., 1 or 2 doses as appropriate) against influenza among children 24-59 months of age, IIS Sentinel Site Project, 2006-07 07 & 2007-08 08 influenza seasons Preliminary Data 100 80 Fully vaccinated, 2006-7 Fully vaccinated, 2007-8 Percent (%) 60 40 20 0 OR MI AZ IIS Sentinel Site *Note: OR sentinel site expanded from Washington County in 2004-5 through 2006-7 seasons to include Multnomah county in 2007-8 season. Michigan added one county to its sentinel site region in 2007-8 season.

Live attenuated vaccine (LAIV) intranasal administration

LAIV Efficacy in Healthy Children 87% effective against culture-confirmed confirmed influenza in children 5-75 7 years old 27% reduction in febrile otitis media (OM) 28% reduction in OM with accompanying antibiotic use Decreased fever and OM in vaccine recipients who developed influenza

LAIV Efficacy in Healthy Adults 20% fewer severe febrile illness episodes 24% fewer febrile upper respiratory illness episodes 27% fewer lost work days due to febrile upper respiratory illness 18%-37% fewer days of healthcare provider visits due to febrile illness 41%-45% 45% fewer days of antibiotic use

Live Attenuated Influenza Vaccine Schedule Age Group 2-8 years, no previous influenza vaccine Number of Doses 2 (separated by 4 weeks) 2-8 years, previous influenza vaccine * 9-49 years 1 1 * LAIV or inactivated vaccine

Live Attenuated Influenza Vaccine Indications Healthy*, nonpregnant persons 2-492 years of age healthy children healthcare personnel persons in close contact with high-risk groups persons who want to reduce their risk of influenza *Persons who do not have medical conditions that increase their risk for complications of influenza

Live Attenuated Influenza Vaccine Adverse Reactions Children no significant increase in URI symptoms, fever, or other systemic symptoms significantly increased risk of asthma or reactive airways disease in children 12-59 months of age Adults significantly increased rate of cough, runny nose, nasal congestion, sore throat, and chills reported among vaccine recipients no increase in the occurrence of fever No serious adverse reactions identified

Live Attenuated Influenza Vaccine Contraindications and Precautions Children < 2 years* Persons > 50 years* Persons with chronic medical conditions* Children and adolescents receiving long- term aspirin therapy* *These persons should receive inactivated influenza vaccine

Live Attenuated Influenza Vaccine Contraindications and Precautions cont. Immunosuppression from any cause* Pregnant women* Severe (anaphylactic) allergy to egg or other vaccine components History of Guillain-Barr Barré syndrome Children < 5 years w/ recurrent wheezing* Moderate or severe acute illness *These persons should receive inactivated influenza vaccine

Influenza Vaccine Storage and Handling Both types of influenza vaccine must be stored at refrigerator temperature (35-46 F, 2-8 C) 2 Neither vaccine should be frozen If LAIV is inadvertently frozen the vaccine should be placed at refrigerator temperature and used as soon as possible

Antiviral Medication Recommendations

Influenza Antiviral Medications Two classes Adamantanes rimatadine and amantadine Currently not recommended for use due to high level of resistance among circulating influenza A viruses Neuraminidase inhibitors Oseltamivir and zanamivir Used for both prevention and for treatment

Neuraminidase Inhibitors Oseltamivir (Tamiflu - Roche) and Zanamivir (Relenza - GSK) Used for the treatment and prevention of seasonal influenza A and B virus infections Treatment should begin as soon as possible after symptom onset Ideally within first 2 days of illness 41

Neuraminidase Inhibitors Reduces duration of influenza symptoms by average of 1-1.51 1.5 days when administered within 2 days of illness onset Recent observational study by McGeer, et al showed benefit even when treatment started >48 hours after onset* Reduces lower respiratory tract complications, pneumonia, and hospitalization in some studies McGeer study also suggests oseltamivir reduces mortality among hospitalized patients with lab- confirmed seasonal influenza A* Effective in preventing seasonal influenza 70-90% effectiveness when started within 48 hours of exposure in RCT *McGeer et al. Clin Infect Dis 2007

Oseltamivir - Tamiflu Available as a capsule or suspension administered by mouth Approved in the U.S. for treatment or prevention of influenza in persons aged 1 year Treatment for 5 days Prevention regimen typically for 10 days after exposure Pediatric dosage depends on age and weight For treatment of seasonal influenza, administered BID x 5 days Side effects: nausea, vomiting in some persons Reports of delirium in pediatric patients (adolescents, most reports from from Japan) Warning added to label in 2007

Zanamivir - Relenza Orally inhaled powder administered by mouth via special device Approved in the U.S. for Treatment of seasonal influenza (aged > 7 years) Prevention of seasonal influenza (aged > 5 years) Treatment dosage: two puffs in the morning and two at night for 5 days Prevention dosage: 2 puffs QD (typically for 10 days after exposure) Side effects Wheezing, and breathing problems Precautions Persons with chronic respiratory disease Pregnant women Resistance rare

Improving Vaccination Rates

Coverage Level (%) Self-Reported Influenza Vaccination Coverage Levels Among Selected Priority U.S. Adult Populations, 1989-2007*, National Health Interview Survey 100 90 80 70 60 50 40 30 20 10 Source: CDC, NHIS. http://www.cdc.gov/flu/professionals/vaccination/pdf/vaccinetrend.pdf *Preliminary data from 2006-07 influenza season 0 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 Year 2000 2001 2002 2003 2004 2005 2006 2007* >=65 yrs Healthy 50-64 yrs Pregnant women Health-care workers Vaccine shortage: 2004-05 season

Conclusions Influenza causes substantial morbidity and mortality yearly in US Recommended annually for persons 6 months through 18 years > 50 years 18-49 with high risk conditions Close contact with high risk Household members Health care workers

Conclusions Vaccine is primary prevention tool Live, intranasal spray vaccine for healthy persons 2-49 years No asthma or recurrent wheezing in 2-42 4 year olds Inactivated, injectable vaccine for persons 6 months and older Oseltamivir and zanamivir are currently recommended influenza antiviral medications

Resources for Vaccines and Immunizations Local County Health Department CDC: Telephone 800-CDC CDC-INFO nipinfo@cdc.gov Email Website www.cdc.gov/vaccines

References Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NS; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR Recomm Rep. 2008 Aug 8;57(RR-7):1-60.