Swine Influenza Update #3. Triage, Assessment, and Care of Patients Presenting with Respiratory Symptoms

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1 Updated 12:00 p.m. April 30, 2009 Swine Influenza Update #3 Introduction: This document revises our last update which was sent April 28 th, The most important revisions include the following: 1. The duration of prophylaxis has been increased from 7 days to 10 days to be consistent with CDC guidelines. 2. The CDC has recently approved the use of Oseltamivir for treatment and prophylaxis for infants less than 1 year of age (See Appendix B). 3. Patients with severe symptoms should be considered for treatment with antiviral medications even if their illness has been longer than two days duration. 4. A separate document for the management of employees with potential exposure to influenza has also been developed. Triage, Assessment, and Care of Patients Presenting with Respiratory Symptoms I. Patient Treatment Guidelines (presentation from triage and during ED care) All patients presenting with flu like symptoms (fever PLUS cough or sore throat): 1. Patient and family members are immediately placed in a treatment area with isolation area capability if available or a sequestered waiting area. 2. Patient and family members wear a surgical mask. 3. Personnel wear N95 mask, gown, and gloves, and in addition goggles, if obtaining cultures or performing an invasive procedure. 4. At the present time, a probable case with swine influenza A (H1N1) virus (S-OIV) is defined as a person with acute febrile respiratory illness with onset: Within 7 days of close contact with a person who is a confirmed S-OIV infection, or Within 7 days of travel to community either within the United States or Internationally where there are one or more confirmed cases of S-OIV infection, or Resides in a community where there are one or more confirmed cases of S- OIV infection. 5. Case definition for infection with swine influenza A (H1N1) virus (S-OIV) Real-time RT-PCR Viral culture Clinical evaluation 1. Patients who have mild /moderate symptoms who are otherwise well need prompt physician evaluation to assess for rapid discharge. Most patients in this category require no diagnostic testing just rapid assessment and discharge (with appropriate discharge instructions). These patients also should NOT have a nasopharyngeal swab for influenza testing obtained. 2. Patients who have mild /moderate symptoms (and within the first 48 hours of onset of symptoms and not getting better) and who have comorbid conditions (see below) should be treated. These patients also should NOT have a nasopharyngeal swab for influenza testing obtained.

2 2 3. Patients with severe symptoms SHOULD have a nasopharyngeal swab for influenza testing obtained and also treated. This also includes all hospitalized patients with suspected Swine Influenza, as well as any hospitalized patient with severe febrile unexplained respiratory illness (including ARDS, pneumonia or respiratory distress) pending testing for Swine Influenza. These patients should be considered for treatment even if they have been symptomatic for more than two days. Note: Comorbid conditions include: Age less than two years or greater than 65 Chronic pulmonary, cardiovascular, renal, hepatic, hematological, or metabolic disorders (including diabetes mellitus) Immunosuppression Compromised respiratory function, including conditions which increase the risk for aspiration. Long-term aspirin therapy. Pregnancy (note: both neuraminidase inhibitors and adamantanes are Pregnancy Category C medications). Prophylaxis For patients with suspected*, probable or confirmed Swine Influenza, prophylaxis should be offered to any household members and close contacts who have a comorbid condition as listed above. Anti-viral medication should be prescribed for ten days. * A suspected case of Swine Influenza A virus infection is defined as a person with mildto-moderate symptoms of influenza who, during the seven days prior to symptom onset: Traveled to Mexico; Had close contact with an ill person associated with St. Francis Preparatory High School in Fresh Meadows, NY; Had close contact with a confirmed or probable case of Swine Influenza. Patients who are admitted should be preferentially admitted to isolation rooms with negative pressure or cohorted with similar patients, with airborne and contact precautions. For all patients discharged home, the following should be communicated: 1. Standard influenza precautions stay at home for 7 days after the onset of symptoms, or until hours after their symptoms resolve (whichever is longer). 2. Cover your cough with a tissue, perform hand washing (patient and family) and avoid contact with high risk household contacts. 3. Low risk contacts should seek assistance from their primary provider if they develop symptoms. 4. Patients should seek medical attention if short of breath, fever persisting beyond 72 hours or relapsing fever, signs of dehydration, mental status changes. II. Employees Exposure 1. An exposed healthcare worker is a HCW who came within 6 feet (2 meters) of a suspect, probable, or confirmed case of swine influenza without appropriate personal protective equipment. (at the minimum personal

3 3 protective equipment must include a surgical mask) These employees should be given antiviral prophylaxis for 10 days as per the current CDC guidelines. 2. If the employee develops symptoms of influenza illness they should contact their Department Director or call Employee Health Service for recommendations for evaluation and follow-up. Symptomatic Employees 1. Any employee displaying symptoms of influenza illness should refrain from work and seek medical evaluation as needed from their personal physician. 2. Any employee who presents to work with symptoms of influenza should be sent immediately to the emergency department. All of these employees should have a nasopharyngeal swab for influenza obtained. If a potential source of exposure to a patient with swine influenza is identified, they should be treated with anti-viral medication. For all other employees the above guidelines should apply. *For additional information regarding employees, please see Employee Health Service document number 1, (Management of Employees with Potential/Symptoms of Influenza). III. Personal Protective Equipment Patient/Visitors 1. The patient should wear a surgical mask when outside of the patient room, and should be encouraged to wash hands frequently and follow respiratory hygiene practices. All visitors should also wear a surgical mask. Personnel 2. Personnel should wear N95 respirators when entering the patient room, and should don disposable gown and gloves. In addition, if a culture is obtained staff should also wear goggles. 3. For suctioning, bronchoscopy, or intubation, use a procedure room with negative pressure air handling. Personnel should wear N95 respirators, gowns, gloves, and goggles for the procedure. IV. Antiviral Therapy 1. Either oral oseltamivir (Tamiflu) pills or suspension or zanamivir (Relenza) oral inhalation are acceptable for either treatment or prophylaxis. *Refer to Appendix A for treatment guidelines and specific recommendations. 2. The Food and Drug Administration (FDA) has recently issued an emergency use authorization for the use of oseltamivir for treatment and prophylaxis of patients less then on year of age. *Refer to Appendix B for treatment guidelines for children less than 1 year of age.

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5 APPENDIX A 5 Recommended Daily Dosage of Seasonal Influenza Antiviral Medications for Treatment and Chemoprophylaxis for the Season United States Zanamivir* Oseltamivir Antiviral agent Treatment, Chemoprophylaxis, Treatment, Chemoprophylaxis, Duration of Treatment Treatment Chemoprophylaxi s Age group (yrs) and older N/A Ages 1-4 N/A weight weight Ages 5-9 weight weight weight weight 75 mg twice daily 75 mg 75 mg/day 75 mg/day Recommended duration for antiviral treatment is 5 days. Recommended duration is 10 days after the last known exposure. For control of outbreaks in long-term care facilities and hospitals, CDC recommends antiviral chemoprophylaxis for a minimum of two weeks, and up to one week after the last known case was identified. NOTE: Zanamivir is manufactured by GlaxoSmithKline (Relenza inhaled powder). Zanamivir is approved for treatment of persons aged 7 years and older and approved for chemoprophylaxis of persons aged 5 years and older. Oseltamivir is manufactured by Roche Pharmaceuticals (Tamiflu tablet). Until recently Oseltamivir was approved for treatment or chemoprophylaxis of persons aged 1 year and older only. The Food and Drug Administration (FDA) has recently issued an emergency use authorization for the use of oseltamivir for treatment and prophylaxis of patients less then on year of age. This information is based on data published by the Food and Drug Administration (FDA). * Zanamivir is administered through oral inhalation by using a plastic device included in the medication package. Patients will benefit from instruction and demonstration of the correct use of the device. Zanamivir is not recommended for those persons with underlying airway disease. A reduction in the dose of oseltamivir is recommended for persons with creatinine clearance less than 30 ml/min. The treatment dosing recommendation for children who weigh 15 kg or less is 30 mg twice a day. For children who weigh more than 15 kg and up to 23 kg, the dose is 45 mg twice a day. For children who weigh more than 23 kg and up to 40 kg, the dose is 60 mg twice a day. For children who weigh more than 40 kg, the dose is 75 mg twice a day. The chemoprophylaxis dosing recommendation for children who weigh less than 15 kg is 30 mg once a day. For who weigh more than 15 kg and up to 23 kg, the dose is 45 mg once a day. For children who weigh more than 23 kg and up to 40 kg, the dose is 60 mg once a day. For children who weigh more than 40 kg, the dose is 75 mg once a day. $Rimantadine is approved by FDA for treatment among adults. However, certain specialists in the management of influenza consider rimantadine appropriate for treatment among children. Studies evaluating the efficacy of amantadine and rimantadine in children are limited, but they indicate that treatment with either drug diminishes the severity of influenza A infection when administered within 48 hours of illness onset. Pregnant women: BOTH RELENZA AND TAMIFLU ARE CATEGORY C

6 6 APPENDIX B Children Younger than 1 Year of Age Children less than one year of age are at higher risk for complications associated with seasonal human influenza virus infections compared to older children, and the risk of influenza complications is especially high for children less than 6 months of age. The characteristics of human infections with S-OIV are still being studied, and it is not known whether infants are at higher risk for complications associated with S-OIV infection compared to older children. However, children less than 1 year old are known to be at increased risk of complications from seasonal influenza infection and during previous pandemics. Limited safety data on the use of oseltamivir (or zanamivir) is available from children less than one year of age, and oseltamivir is not licensed for use in children less than 1 year old. Available data comes from use of oseltamivir for treatment of seasonal influenza. However, these data suggest that severe adverse events are rare, and the Infectious Diseases Society of America recently noted that limited retrospective data on the safety and efficacy of oseltamivir in this young age group have not demonstrated age-specific drug-attributable toxicities to date.. Because infants typically have higher rates of morbidity and mortality from influenza compared to healthy older children, infants with S-OIV infections may benefit from treatment using oseltamivir. Oseltamivir use for children less than 1 year old was recently approved by the FDA under an Emergency Use Authorization (EUA), and dosing for these children is age-based. (Table 2). Table 2. Recommended doses of oseltamivir antiviral medication for the treatment of S-OIV influenza for children less than 1 year of age. Age Recommended treatment dose for 5 days <3 months 12 mg 3-5 months 20mg 6-11 months 25 mg Use of fever-reducing medications in children Aspirin or aspirin-containing products (e.g. bismuth subsalicylate Pepto Bismol) should not be administered to any confirmed or suspected ill case of swine influenza A (H1N1) virus infection aged 18 years old and younger due to the risk of Reye syndrome. For relief of fever, other antipyretic medications are recommended such as acetaminophen or non steroidal anti-inflammatory drugs. Antiviral Chemoprophylaxis For antiviral chemoprophylaxis of S-OIV infection, either oseltamivir or zanamivir are recommended for children 1 year of age or older (Table 1). Oseltamivir can be used for chemoprophylaxis under the EUA for children less than 1 year-old (Table 3). Under this EUA, chemoprophylaxis is not recommended for infants less than 3 months old unless the situation is judged to be critical. Duration of antiviral chemoprophylaxis post-exposure is 10 days after the last known exposure to an ill confirmed case of swine influenza A (H1N1) virus infection. For pre-exposure protection, chemoprophylaxis should be given during the potential exposure period and continued for 10 days after the last known exposure to an ill confirmed case of swine influenza A (H1N1) virus infection.

7 7 Table 3. Recommended doses of oseltamivir antiviral medication for the prevention of swine influenza for children less than 1 year of age. TABLE 3 HERE Age Recommended prophylaxis dose for 10 days <3 months Not recommended unless situation judged critical 3-5 months 20mg 6-11 months 25 mg