Influenza & Adult Immunization Guide

Transcripción

1 Influenza & Adult Immunization Guide Your Long Term Care Pharmacy Experts 1

2 Purpose for this Guide The purpose of this guide is for general educational purposes only. Please discuss individual patient conditions with the patients physician(s) prior to administration of any vaccine or pharmaceutical. Also refer to the product package insert for the full prescribing information of any vaccine or pharmaceutical listed. Acknowledgements The majority of the information provided here is available publicly through various government websites that are referenced throughout this guide. Primarily, the Centers for Disease Control and Prevention (CDC), the Department of the U.S. Health and Human Service Department (HHS), and the Centers for Medicaid and Medicare Services (CMS) were instrumental in our information gathering. The nature of drug information is that it is constantly evolving because of ongoing research and clinical experience and is often subject to interpretation. While great care has been taken to ensure the accuracy of the information presented, the reader is advised that the authors, editors, reviewers, contributors and publishers cannot be responsible for the continued currency of the information. All readers are advised that decisions regarding drug therapy and treatment must be based on the independent judgment of treating clinicians, changing information about a drug (e.g., as reflected in literature and manufacturer s most current product information), and changing medical practices. The editors are not responsible for any inaccuracy of quotations or for any false or misleading implication that may arise due to the text or formulas as used or due to the quotation of revisions no longer official. PharMerica Corporation does not represent or warrant the accuracy of the information provided in this manual and nothing in this manual is intended to replace the treatment by an established clinician. No official support or endorsement by any federal or state agency or pharmaceutical company is intended or inferred. 2

3 Contents CMS Requires Flu/Pneumococcal Vaccinations for Nursing Homes Seasonal Influenza Primary Influenza Vaccination Changes and Updates to the Recommendations Influenza Vaccine General Information... 7 Types of Vaccines Available Ordering Influenza Vaccine Needle Recommendations Vaccine Side Effects Key Facts about Influenza Influenza Management in Long-Term Care Facilities Instructions for the Use of Vaccine Information Statements (VIS) VIS: Inactivated (English & Spanish) VIS: Live (English & Spanish) Consent for Influenza Vaccine Checklist for Contraindications to Inactivated Vaccine Checklist for Contraindications to Live Intranasal Vaccine Resident Immunization Record Sample Standing Orders for Administering Seasonal Influenza to Adults Declination of Influenza Vaccination Take Time to Get a Flu Vaccine No More Excuses Poster Take 3 Actions to Fight the Flu Pneumococcal Disease Pneumococcal Questions and Answers Pneumococcal Updates VIS: Polysaccharide (English & Spanish).. 58 VIS: Conjugate (English & Spanish) Consent for Pneumococcal Vaccine Standing Orders for Administering Pneumococcal Vaccine to Adults Meningococcal Disease Meningococcal Questions and Answers VIS: Meningococcal Vaccines (English & Spanish) Standing Orders for Administering Meningococcal Vaccine to Adults Herpes Zoster (Shingles) Shingles Questions and Answers VIS: Shingles Vaccine (English & Spanish).. 82 Consent for Herpes Zoster Vaccine Standing Orders for Administering Zoster Vaccine to Adults Pertussis (Whooping Cough) Pertussis Questions & Answers VIS: Tdap (English & Spanish) VIS: Td (English & Spanish) Standing Orders for Administering Tdap/Td to Adults Additional Information Medicare Coverage of Vaccinations Recommended Adult Vaccine Schedule VIS Federal Law

4 CMS Requires Flu/Pneumococcal Vaccinations for Nursing Homes September 2014 The Centers for Medicare and Medicaid Services (CMS) requires nursing facilities participating in the Medicare and Medicaid programs to offer all residents influenza and pneumococcal vaccines and document the results. According to the requirements, each resident is to be vaccinated unless contraindicated medically, the resident or a legal representative refuses vaccination, or the vaccine is not available because of shortage. This information is to be reported in Section O of the CMS Minimum Data Set (MDS 3.0), which tracks nursing home health parameters. CMS uses this data in the Nursing Home Star Rating Program measuring the percent of both short-stay and long-stay residents assessed and given, appropriately, the seasonal influenza vaccine and the pneumococcal vaccine. Surveyors will assess each facility s vaccination policies and procedures for compliance during the annual survey. The full content of F-tag 334 can be viewed at: Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf The use of standing orders by nursing homes and skilled nursing facilities, hospitals, and home health agencies ensures that vaccination is offered. Generally, a standing orders program for influenza vaccinations would be conducted under the supervision of a licensed practitioner according to a physician-approved facility or agency policy by a Health Care Professional (HCP) trained to screen patients for contraindications to vaccination, administer vaccine, and monitor for adverse events. However, CMS has removed the physician signature requirement for the administration of influenza and pneumococcal vaccines to Medicare and Medicaid patients in hospitals, long-term care facilities, and home health agencies. To the extent allowed by local and state law, these facilities and agencies may implement standing orders for influenza and pneumococcal vaccination of Medicare and Medicaid-eligible patients. In its collaborative effort to improve quality of care, CMS is also encouraging nursing facilities to provide influenza vaccine to their healthcare workers. Immunizing nursing staff has been shown to reduce mortality rates among residents of long-term care facilities. 4

5 Seasonal Influenza 5

6 Primary Influenza Vaccination Changes and Updates to the Recommendations Influenza Routine annual influenza vaccination of all persons aged 6 months and older continues to be recommended U.S.-licensed influenza vaccines will contain the same strains as those in the vaccine. Trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/California/7/2009 (H1N1)-like virus, an A/Texas/50/2012 (H3N2)-like virus, and a B/Massachusetts/2/2012-like (Yamagata lineage) virus. Quadrivalent influenza vaccines will contain these antigens, and also a B/Brisbane/60/2008-like (Victoria lineage) virus. Several vaccines will be available for the season, and are acceptable alternatives to other licensed vaccines indicated for their respective age groups when otherwise appropriate. Within approved indications and recommendations, no preferential recommendation is made for any type or brand of licensed influenza vaccine over another. Severely egg-allergic patients should be made aware that an egg-free flu vaccine is available. 6

7 Influenza Vaccine General Information Influenza A number of different manufacturers produce trivalent (three component) influenza vaccines for the U.S. market, including intramuscular (IM), intradermal, and nasal spray vaccines. Most of the flu vaccine offered for the season will be trivalent (three component). Some seasonal flu vaccines will be formulated to protect against four flu viruses (quadrivalent flu vaccines) and will be available as well according to manufacturers. All nasal spray vaccines are expected to be quadrivalent, however, this makes up only a small portion of total vaccine availability. Flu vaccines are designed to protect against three influenza viruses that experts predict will be the most common during the upcoming season. Three kinds of influenza viruses commonly circulate among people today: Influenza A (H1N1) viruses, influenza A (H3N2) viruses, and influenza B viruses,. Each year, one flu virus of each kind is used to produce seasonal influenza vaccine. The trivalent influenza vaccine is made from the following three viruses: an A/California/7/2009 (H1N1)pdm09-like virus an A/Texas/50/2012 (H3N2)-like virus a B/Massachusetts/2/2012-like virus. Quadrivalent influenza vaccines will contain these antigens, and also a B/Brisbane/60/2008-like virus Timing of Vaccination In general, health-care providers should begin offering vaccination soon after vaccine becomes available, and if possible, by October. Vaccination should be offered as long as influenza viruses are circulating. It takes about two weeks after vaccination for antibodies to develop in the body and provide protection against the flu. Although delaying vaccination might permit greater immunity later in the season, deferral might result in missed opportunities to vaccinate and difficulties in vaccinating a population within a limited time. Vaccination programs should balance maximizing likelihood of persistence of vaccine-induced protection through the season with avoiding missed opportunities to vaccinate or vaccinating after influenza virus circulation begins. Manufacturers have begun shipping flu vaccines for the U.S. season and have projected they will provide between million doses of vaccine for the US market. National Influenza Vaccination Week (NIVW) is a national observance that was established to highlight the importance of continuing influenza vaccination. NIVW is December 7-13,

8 Influenza Vaccine General Information, continued Influenza Persons at Risk for Medical Complications Due to Influenza Vaccination to prevent influenza is particularly important for persons who are at increased risk for severe complications from influenza, or at higher risk for influenza-related outpatient, emergency department, or hospital visits. When vaccine supply is limited, vaccination efforts should focus on delivering vaccination to the following persons (no hierarchy is implied by order of listing): All children aged 6 through 59 months; All persons aged 65 years; Adults and children who have chronic pulmonary (including asthma) or cardiovascular (except isolated hypertension), renal, hepatic, neurological, hematologic, or metabolic disorders (including diabetes mellitus); Persons who have immunosuppression (including immunosuppression caused by medications or by HIV infection); Women who are or will be pregnant during the influenza season; Children and adolescents (aged 6 months to 18 years) who are receiving long-term aspirin therapy and who might be at risk for experiencing Reye s syndrome after influenza virus infection; Residents of nursing homes and other long-term care facilities; American Indians/Alaska Natives; Persons who are morbidly obese (BMI 40). Persons Who Live With or Care for Persons at Higher Risk for Influenza-Related Complications All persons aged 6 months should be vaccinated annually. Continued emphasis should be placed on vaccination of persons who live with or care for persons at higher risk for influenza-related complications. When vaccine supply is limited, vaccination efforts should focus on delivering vaccination to persons at higher risk for influenza-related complications listed above, as well as these persons: Household contacts (including children) and caregivers of children aged 59 months (i.e., aged < 5 years) and adults aged 50 years, with particular emphasis on vaccinating contacts of children aged < 6 months; and Household contacts (including children) and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza. HCP and persons who are contacts of persons in these groups and who are not contacts of severely immunocompromised persons (those living in a protective environment) may receive any influenza vaccine which is otherwise indicated. Individuals who care for the severely immunocompromised should receive either IIV or RIV3. 8

9 Influenza Vaccine General Information, continued Influenza Vaccine Dose Considerations for Children 6 Months through 8 Years of Age Children aged 6 months through 8 years who are receiving influenza vaccine for the first time, and some in this age group who have previously been vaccinated, require two doses of vaccine administered 4 weeks apart. Influenza Vaccination for Pregnant Women Women who are or will be pregnant during influenza season should receive Inactivated Influenza Vaccine (IIV). Live attenuated influenza vaccine (LAIV) is not recommended for use during pregnancy. Postpartum women can receive either LAIV or IIV. Pregnant and postpartum women do not need to avoid contact with persons recently vaccinated with LAIV. Influenza vaccine can be given in any trimester. Influenza Vaccination of Persons with a History of Egg Allergy 1. Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive influenza vaccine. Because relatively little data are available for use of LAIV in this setting, IIV or RIV3 should be used. RIV is egg-free and may be used for persons aged years who have no other contraindications. However, IIV (egg- or cell-culture based) may also be used, with the following additional safety measures: Vaccine should be administered by a healthcare provider who is familiar with the potential manifestations of egg allergy; and Vaccine recipients should be observed for at least 30 minutes for signs of a reaction after administration of each vaccine dose. 2. Persons who report having had reactions to egg involving such symptoms as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention may receive RIV3 if aged 18 through 49 years and there are no other contraindications. If RIV3 is not available or the recipient is not within the indicated age range, IIV should be administered by a physician with experience in the recognition and management of severe allergic conditions. 3. All vaccines should be administered in settings in which personnel and equipment for rapid recognition and treatment of anaphylaxis are available. 9

10 Influenza Vaccine General Information, continued Influenza 4. Some persons who report allergy to egg might not be egg-allergic. Those who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic. Egg-allergic persons might tolerate egg in baked products (e.g., bread or cake). Tolerance to egg-containing foods does not exclude the possibility of egg allergy. Egg allergy can be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for immunoglobulin E antibodies to egg proteins. 5. For individuals who have no known history of exposure to egg, but who are suspected of being egg-allergic on the basis of previously performed allergy testing, consultation with a physician with expertise in the management of allergic conditions should be obtained prior to vaccination. Alternatively, RIV3 may be administered if the recipient is aged 18 through 49 years. 6. A previous severe allergic reaction to influenza vaccine, regardless of the component suspected to be responsible for the reaction, is a contraindication to future receipt of the vaccine. Influenza Vaccines and Use of Influenza Antiviral Medications Administration of IIV to persons receiving influenza antiviral drugs for treatment or chemoprophylaxis is acceptable. LAIV should not be administered until 48 hours after cessation of influenza antiviral therapy. If influenza antiviral medications are administered within 2 weeks after receipt of LAIV, the vaccine dose should be repeated 48 or more hours after the last dose of antiviral medication. Persons receiving antiviral drugs within the period 2 days before to 14 days after vaccination with LAIV should be revaccinated at a later date with any approved vaccine formulation. Concurrent Administration of Influenza Vaccine With Other Vaccines Inactivated vaccines do not interfere with the immune response to other inactivated vaccines or to live vaccines. Inactivated or live vaccines can be administered simultaneously with LAIV. However, after administration of a live vaccine, at least 4 weeks should pass before another live vaccine is administered. 10

11 Types of Influenza Vaccines Available in United States Influenza Vaccine PharMerica will be distributing Influenza Vaccine Trade name Manufacturer Presentation Mercury content from thimerosal (µg Hg/0.5 ml) Ovalbumin content (µg/0.5ml) Age indications Route Inactivated Influenza Vaccine, Quadrivalent (IIV4), Standard Dose Fluarix Quadrivalent GlaxoSmithKline 0.5 ml single-dose prefilled syringe yrs IM Inactivated Influenza Vaccine, Quadrivalent (IIV4), Standard Dose FluLaval Quadrivalent ID Biomedical Corporation of Quebec (distributed by GlaxoSmithKline) 0.5 ml single-dose prefilled syringe 5.0 ml multidose vial < yrs 3 yrs IM IM Inactivated Influenza Vaccine, Quadrivalent (IIV4), Standard Dose Fluzone Quadrivalent Sanofi Pasteur 0.25 ml single-dose prefilled syringe 0.5 ml single-dose prefilled syringe 6 35 mos 36 mos IM IM 0.5 ml single-dose vial 36 mos IM 5.0 ml multidose vial 25 6 mos IM Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Afluria biocsl 0.5 ml single-dose prefilled syringe 5.0 ml multidose vial 0.5 ml single-dose 24.5 <1 <1 9 yrs*** 9 yrs*** IM IM Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Fluarix GlaxoSmithKline prefilled syringe yrs IM Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose FluLaval ID Biomedical Corporation of Quebec (distributed by GlaxoSmithKline) 0.5 ml single-dose prefilled syringe 5.0 ml multidose vial < yrs 3 yrs IM IM Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Fluvirin Novartis Vaccines and Diagnostics 0.5 ml single-dose prefilled syringe 5.0 ml multidose vial yrs 4 yrs IM IM Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Fluzone Sanofi Pasteur 0.5 ml single-dose prefilled syringe 5.0 ml multidose vial mos 6 mos IM IM Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Fluzone Intradermal Sanofi Pasteur 0.1 ml prefilled microinjection system yrs ID** Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose, cell culture-based (cciiv3) Flucelvax Novartis Vaccines and Diagnostics 0.5 ml single-dose prefilled syringe 18 yrs IM Inactivated Influenza Vaccine, Trivalent (IIV3), High Dose Fluzone High-Dose Sanofi Pasteur 0.5 ml single-dose prefilled syringe 65 yrs IM Recombinant Influenza Vaccine, Trivalent (RIV3) FluBlok Protein Sciences 0.5 ml single-dose vial yrs IM Live attenuated influenza vaccine, quadrivalent (LAIV4) FluMist Quadrivalent MedImmune 0.2 ml single-dose prefilled intranasal sprayer <0.24 (per 0.2mL) 2 49 yrs IN 11

12 Types of Influenza Vaccines Available in United States , cont. Influenza Footnotes to Chart IIV=Inactivated Influenza Vaccine; IIV3=Inactivated Influenza Vaccine, Trivalent; IIV4=Inactivated Influenza Vaccine, Quadrivalent; RIV=Recombinant Influenza Vaccine LAIV=Live-Attenuated Influenza Vaccine; IM=intramuscular; ID=intradermal; IN=intranasal. * Immunization providers should check Food and Drug Administration approved prescribing information for influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available athttp:// vaccines/approvedproducts/ucm htm. For adults and older children, the recommended site of vaccination is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP s General Recommendations on Immunization (available at preview/mmwrhtml/rr6002a1.htm). Trivalent inactivated vaccine, intradermal: A 0.1-mL dose contains 9 µg of each vaccine antigen (27 µg total). ** The preferred site is over the deltoid muscle. Fluzone Intradermal is administered using the delivery system included with the vaccine. Trivalent inactivated vaccine, high-dose: A 0.5-mL dose contains 60 µg of each vaccine antigen (180 µg total). FluMist is shipped refrigerated and stored in the refrigerator at 35 F 46 F (2 C 8 C) after arrival in the vaccination clinic. The dose is 0.2 ml divided equally between each nostril. Health care providers should consult the medical record, when available, to identify children aged 2 through 4 years with asthma or recurrent wheezing that might indicate asthma. In addition, to identify children who might be at greater risk for asthma and possibly at increased risk for wheezing after receiving LAIV, parents or caregivers of children aged 2 through 4 years should be asked, In the past 12 months, has a health care provider ever told you that your child had wheezing or asthma? Children whose parents or caregivers answer yes to this question and children who have asthma or who had a wheezing episode noted in the medical record within the past 12 months should not receive FluMist. *** Age indication per package insert is 5 years; however, ACIP recommends Afluria not be used in children aged 6 months through 8 years because of increased risk for febrile reactions noted in this age group with biocsl s 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5 through 8 years who has a medical condition that increases the child s risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of influenza vaccination with Afluria before administering this vaccine. Afluria may be used in persons aged 9 years. Information not included in package insert. Estimated to contain <50 femtograms (5x10-8 µg) of total egg protein (of which ovalbumin is a fraction) per 0.5 ml dose of Flucelvax. Available upon request from Sanofi Pasteur (telephone: ; mis. s@sanofipasteur.com). Ordering Influenza Vaccine Much of the influenza vaccine was pre-booked early this year. Providers should contact their local PharMerica pharmacy about remaining supply. 12

13 Needle Recommendations Influenza What Type of Safety Needle Should Be Used to Administer the Flu Vaccine? What Type of Safety Needle Should Be Used to Administer the Flu Vaccine? For the influenza season PharMerica recommends using the BD Eclipse 23g x For the influenza season PharMerica recommends using the BD Eclipse 23g x 1 Safety Needle with 1 Safety Needle with syringe or BD 23 g x 1 Safetyglide Needle. The flu shot is an syringe intramuscular or BD 23 g x 1 (IM) Safetyglide injection Needle. and you The should flu shot use is a an 1 intramuscular or longer needle. (IM) injection A 1" inch and needle you should use a 1 or longer works needle. well for A most 1 inch patients. needle works well for most patients. Instructions for the needle are as follows: Instructions for the needle are as follows: Firmly attach needle onto a Luer Lock syringe with a push and clockwise twist Pull back on Firmly the safety attach cover needle toward onto the a syringe Luer Lock and syringe away from with the a push needle and clockwise twist Grasp the syringe Pull back with on one the hand safety and cover with the toward other the pull syringe the clear and needle away shield from the straight needle off Draw up medication Grasp the as syringe per your with usual one technique hand and - Note: with if the changing other pull needles, the clear activate needle safety shield cover prior to removing the straight needle off from the syringe Inject according Draw to up protocol medication as per your usual technique - Note: if changing needles, For user convenience, activate safety the needle cover prior bevel-up to removing position the is oriented needle to from the the safety syringe cover After injection, Inject immediately according activate to protocol safety cover as follows: Using For the same user convenience, hand holding the syringe, needle center bevel- up thumb position or forefinger is oriented on the finger to the pad safety area of the cover safety cover Push the After cover injection, forward immediately over the needle activate until safety you hear cover and/or as follows: feel it lock Visually confirm o Using that the same needle hand tip is holding covered the syringe, center thumb or forefinger on After activation, discard the finger immediately pad area into of an the approved safety cover sharps container o Push the cover forward over the needle until you hear and/or feel it lock Things to remember: o Visually confirm that the needle tip is covered After activation, discard immediately into an approved sharps container Aseptic technique and proper skin preparation of the site are essential Follow Things your to institutions remember: policy for safe disposal of all medical waste These instructions are not for use with luer slip syringes Aseptic technique and proper skin preparation of the site are essential Follow your institutions policy for safe disposal of all medical waste These instructions are not for use with luer slip syringes 13

14 Vaccine Side Effects (What to Expect) Influenza Different side effects can be associated with the flu shot and LAIV. The flu shot The viruses in the flu shot are killed (inactivated), so you cannot get the flu from a flu shot. Some minor side effects that could occur are: Soreness, redness, or swelling where the shot was given Hoarseness; sore, red or itchy eyes; cough Fever (low grade) Aches If these problems occur, they begin soon after the shot and usually last 1 to 2 days. Almost all people who receive influenza vaccine have no serious problems from it. However, on rare occasions, flu vaccination can cause serious problems, such as severe allergic reactions. As of July 1, 2005, people who think that they have been injured by the flu shot can file a claim for compensation from the National Vaccine Injury Compensation Program (VICP). A guide to filing a claim through the VICP can be found here: vaccinecompensation/fileclaim.html The nasal spray (also called LAIV4 or FluMist Quadrivalent ): The viruses in the nasal-spray vaccine are weakened and do not cause severe symptoms often associated with influenza illness. (In clinical studies, transmission of vaccine viruses to close contacts has occurred only rarely.) In children, side effects from LAIV4 (FluMist Quadrivalent ) can include: runny nose wheezing headache vomiting muscle aches fever In adults, side effects from LAIV4 (FluMis Quadrivalent ) can include: runny nose headache sore throat cough Additional Resources Relevant Morbidity and Mortality Weekly Reports (MMWRs) on the topic of Influenza can be found at this location: The most recent influenza vaccination recommendations can be found at: Vaccine information from the World Health Organization (WHO) can be found at: Information about Medicare vaccine coverage can be found at: index.html?redirect=/immunizations/ Information about the H3N2 variant strain of influenza can be found here: html# Information about H5N1 (avian/bird) influenza is available here: 14

15 Key Facts about Influenza Influenza The flu is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness, and at times can lead to death. The best way to prevent the flu is by getting a flu vaccine each year. People who have the flu often feel some or all of these symptoms: fever* or feeling feverish/chills cough sore throat runny or stuffy nose muscle or body aches headaches fatigue (very tired) Some people may have vomiting and diarrhea, though this is more common in children than adults *It is important to note that not everyone with flu will have a fever. Most experts believe that flu viruses spread mainly by droplets made when people with flu cough, sneeze or talk. These droplets can land in the mouths or noses of people who are nearby. Less often, a person might also get the flu by touching a surface or object that has flu virus on it and then touching their own mouth, eyes or nose. You may be able to pass on the flu to someone else before you know you are sick, as well as while you are sick. Most healthy adults may be able to infect others beginning 1 day before symptoms develop and up to 5-7 days after becoming sick. Some people, especially children and people with weakened immune systems, might be able to infect others for an even longer time. It takes about two weeks after vaccination for antibodies to develop in the body and provide protection against influenza virus infection. In the meantime, you are still at risk for getting the flu. That s why it s better to get vaccinated early in the fall, before the flu season really gets under way. Certain people are at greater risk for serious complications if they get the flu. This includes older people, young children, pregnant women, and people with certain health conditions (such as asthma, diabetes, or heart disease). Complications of flu can include bacterial pneumonia, ear infections, sinus infections, dehydration, and worsening of chronic medical conditions, such as congestive heart failure, asthma, or diabetes. During , a new and very different flu virus (called 2009 H1N1) spread worldwide causing the first flu pandemic in more than 40 years. It is estimated that the 2009 H1N1 pandemic resulted in more than 12,000 flu-related deaths in the US. In contrast to seasonal flu, nearly 90 percent of the H1N1 related deaths occurred among people younger than 65 years of age. Clinical Signs and Symptoms of Influenza Influenza viruses are spread from person to person in respiratory droplets, primarily through the coughing and sneezing of infected persons. The typical incubation period for influenza is 1 4 days, with an average of 2 days. Adults can be infectious from the day before symptoms begin through approximately 5 days after illness onset. Children can be infectious for > 10 days, and young children can shed virus for several days before their illness onset. Severely immunocompromised persons can shed virus for weeks or months. 15

16 Key Facts about Influenza, continued Influenza Uncomplicated influenza illness is characterized by the abrupt onset of constitutional and respiratory signs and symptoms (e.g., fever, myalgia, headache, malaise, nonproductive cough, sore throat, and rhinitis). Among children, otitis media, nausea, and vomiting are also commonly reported with influenza illness. Respiratory illness caused by influenza is difficult to distinguish from illness caused by other respiratory pathogens on the basis of symptoms alone. Reported sensitivities and specificities of clinical definitions for influenza-like illness in studies primarily among adults that include fever and cough have ranged from 63% to 78% and 55% to 71%, respectively, compared with viral culture. (Sensitivity and predictive value of clinical definitions can vary, depending on the degree of co-circulation of other respiratory pathogens and the level of influenza activity). A study among older nonhospitalized patients determined that symptoms of fever, cough, and acute onset had a positive predictive value of 30% for influenza, whereas a study of hospitalized older patients with chronic cardiopulmonary disease determined that a combination of fever, cough, and illness of <7 days was 78% sensitive and 73% specific for influenza). However, a study among vaccinated older persons with chronic lung disease reported that cough was not predictive of influenza infection, although having a fever or feverishness was 68% sensitive and 54% specific for influenza infection. Influenza illness typically resolves after 3-7 days for the majority of persons, although cough and malaise can persist for >2 weeks. Among certain persons, influenza can exacerbate underlying medical conditions (e.g., pulmonary or cardiac disease), lead to secondary bacterial pneumonia or primary influenza viral pneumonia, or occur as part of a coinfection with other viral or bacterial pathogens. Young children with influenza infection can have initial symptoms mimicking bacterial sepsis with high fevers, and < 20% of children hospitalized with influenza have febrile seizures. Influenza infection has also been associated with encephalopathy, transverse myelitis, REYE s syndrome, myositis, myocarditis, and pericarditis. Symptoms of Flu include: fever headache extreme tiredness dry cough sore throat runny or stuffy nose muscle aches Stomach symptoms, such as nausea, vomiting, and diarrhea, also can occur but are more common in children than adults Cold Versus Flu: Characteristics Viral Infection Severe Symptoms Fever Body Aches Extreme Tiredness Dry Cough Runny Nose Stuffy Nose Can Result in Pneumonia, Bacterial Infections or Hospitalization Cold Yes No No No No Unlikely Less Intense More Likely Unlikely Flu Yes Yes Yes Yes Yes More Likely More Intense Less Likely More Likely 16

17 Influenza Management in Long-Term Care Facilities Influenza Influenza vaccination should be provided routinely to all residents and health care workers of long-term care facilities. Residents If possible, all residents should receive trivalent inactivated influenza vaccine (TIV) annually before influenza season. In the majority of seasons, TIV will become available to long-term care facilities beginning in September, and influenza vaccination should commence as soon as vaccine is available. Informed consent is required to implement a standing order for vaccination, but this does not necessarily mean a signed consent must be present. In the event that a new patient or resident is admitted after the influenza vaccination program has concluded in the facility, the benefits of vaccination should be discussed, educational materials should be provided, and an opportunity for vaccination should be offered to the new resident as soon as possible after admission to the facility. Since October 2005, the Centers for Medicare and Medicaid Services (CMS) has required nursing homes participating in Medicare and Medicaid programs to offer all residents influenza and pneumococcal vaccines and to document the results. According to requirements, each resident is to be vaccinated unless contraindicated medically, the resident or legal representative refuses vaccination, or the vaccine is not available because of storage. This information is to be reported as part of the CMS Minimum Data Set, which tracks nursing home health parameters. Health Care Personnel CDC and the Advisory Committee on Immunization Practices (ACIP), recommend that all U.S. health care personnel get vaccinated annually against influenza. Health care personnel who get vaccinated help to reduce the following: Transmission of influenza Staff illness and absenteeism Influenza-related illness and death, especially among people at increased risk for severe influenza illness Higher vaccination levels among personnel have been associated with a lower risk of health care facilityassociated influenza cases. Influenza outbreaks in hospitals and long-term care facilities have been attributed to low influenza vaccination coverage among health care personnel. Higher influenza vaccination levels among health care personnel can reduce influenza-related illness, and even deaths, in settings like nursing homes. 17

18 Influenza Management in Long-Term Care Facilities, continued Influenza Surveillance When there is influenza activity in the local community, active daily surveillance (defined below) for influenza illness should be conducted among all new and current residents, staff, and visitors of long-term care facilities, and continued until the end of influenza season. Ill residents, personnel, and visitors should be excluded from the facility until illness has resolved. Testing Even if it s not influenza season, influenza testing should occur when any resident has signs and symptoms of influenza-like illness. More information about testing is included below. When there is a confirmed or suspected influenza outbreak (2 or more ill residents) If there is one laboratory-confirmed influenza positive case along with other cases of respiratory infection in a unit of a long-term care facility, an influenza outbreak might be occurring. While unusual, an influenza outbreak can occur outside of the normal influenza season; therefore, testing for influenza should be added to testing for other respiratory pathogens during non-influenza season periods. Even if it s not influenza season, influenza testing should occur when any resident has signs and symptoms that could be due to influenza *, and especially when two residents or more develop respiratory illness within 72 hours of each other. Determine if influenza virus is the causative agent by performing influenza testing on respiratory specimens (i.e. nasal swabs, throat swabs, nasopharyngeal swab, or nasopharyngeal or nasal aspirates) of ill residents with recent onset of signs and symptoms suggestive of influenza. In order of priority, the following influenza tests are recommended: reverse transcription polymerase chain reaction (RT-PCR); immunofluorescence; rapid influenza diagnostic tests. Because of the possibility of false negative results during influenza season, if influenza is suspected and immunofluorescence or rapid influenza diagnostic test results are negative, perform confirmatory testing using RT-PCR or viral culture. Information on influenza diagnostic testing is available online or by contacting your state public health laboratory. Because of the possibility of false positive results, especially outside of influenza season, perform confirmatory testing using RT-PCR or viral culture if immunofluorescence or rapid influenza diagnostic test results are positive. 18

19 Influenza Management in Long-Term Care Facilities, continued Influenza Viral culture should be performed if additional information on influenza viruses, such as influenza A virus subtype, antigenic characterization to compare with vaccine strains, or antiviral resistance data, are needed. Additionally, viral culture can be used to confirm results from rapid diagnostic testing (as mentioned above) Determining influenza virus type or subtype of influenza A virus can help inform antiviral therapy decisions. Test for other respiratory pathogens as well if it s not influenza season. Once an outbreak has been identified, outbreak prevention and control measures should be implemented immediately. Implement daily active surveillance for respiratory illness among ill residents, health care personnel and visitors to the facility. During an outbreak, once a single laboratory-confirmed case of influenza has been identified, it is likely there are other cases among exposed persons. Conduct daily active surveillance until at least 1 week after the last confirmed influenza case occurred. Test for influenza in the following: Ill persons who are in the affected unit as well as previously unaffected units in the facility Persons who develop acute respiratory illness symptoms more than 72 hours after beginning antiviral chemoprophylaxis Note that elderly persons and other long-term care residents, including those who are medically fragile and those with neurological or neurocognitive conditions, may manifest atypical signs and symptoms with influenza virus infection, and may not have fever. Ensure that the laboratory performing the tests notifies the facility of tests results promptly. The local health and state health departments should be notified of every suspected or confirmed influenza outbreak in a long-term care facility, especially if a resident develops influenza while on or after receiving antiviral chemoprophylaxis. Implement Standard and Droplet Precautions for all residents with suspected or confirmed influenza. CDC s guidance titled Prevention Strategies for Seasonal Influenza in Healthcare Settings contains details on the prevention strategies for all health care settings. Specific recommendations are highlighted below. Standard Precautions are intended to be applied to the care of all patients in all health care settings, regardless of the suspected or confirmed presence of an infectious agent. Implementation of Standard Precautions constitutes the primary strategy for the prevention of healthcare-associated transmission of infectious agents among patients and health care personnel. 19

20 Influenza Management in Long-Term Care Facilities, continued Influenza Examples of standard precautions include: Wearing gloves if hand contact with respiratory secretions or potentially contaminated surfaces is anticipated. Wearing a gown if soiling of clothes with a resident s respiratory secretions is anticipated. Changing gloves and gowns after each resident encounter and performing hand hygiene Perform hand hygiene before and after touching the resident, after touching the resident s environment, or after touching the resident s respiratory secretions, whether or not gloves are worn. Gloves do not replace the need for performing hand hygiene. Droplet Precautions are intended to prevent transmission of pathogens spread through close respiratory or mucous membrane contact with respiratory secretions. Droplet Precautions should be implemented for residents with suspected or confirmed influenza for 7 days after illness onset or until 24 hours after the resolution of fever and respiratory symptoms, whichever is longer, while a resident is in a health care facility. Examples of Droplet Precautions include: Placing ill residents in a private room. If a private room is not available, place (cohort) residents suspected of having influenza residents with one another; Wear a facemask (e.g., surgical or procedure mask) upon entering the resident s room. Remove the facemask when leaving the resident s room and dispose of the facemask in a waste container. If resident movement or transport is necessary, have the resident wear a facemask (e.g., surgical or procedure mask), if possible. Communicate information about patients with suspected, probable, or confirmed influenza to appropriate personnel before transferring them to other departments. These Precautions are part of the overall infection control strategy to protect against influenza in health care settings and should be used along with other infection control measures, such as isolation or cohorting of ill residents, screening employees and visitors for illness, furloughing ill health care personnel, and discouraging ill visitors from entering the facility. In some cases, facilities may choose to apply Standard Precautions and Droplet Precautions for longer periods based on clinical judgment, such as in the case of young children or severely immunocompromised residents, who may shed influenza virus for longer periods of time. Because residents with influenza may continue to shed influenza viruses while on antiviral treatment, infection control measures to reduce transmission, including following Standard and Droplet Precautions, should continue while the resident is taking antiviral therapy. This will also reduce transmission of viruses that may have become resistant to antiviral drugs during therapy. 20

21 Influenza Management in Long-Term Care Facilities, continued Influenza Administer influenza antiviral treatment and chemoprophylaxis to residents and health care personnel according to current recommendations. All long-term care facility residents who have confirmed or suspected influenza should receive antiviral treatment immediately. Treatment should not wait for laboratory confirmation of influenza. Antiviral treatment works best when started within the first 2 days of symptoms. However, these medications can still help when given after 48 hours to those that are very sick, such as those who are hospitalized, or those who have progressive illness. Two influenza antiviral drugs are currently recommended for use against circulating influenza viruses. These are oseltamivir, available as a pill or suspension, and zanamivir, available as an inhaled powder using a disk inhaler device. It should be noted that some long-term care residents may have difficulty using the inhaled device. Amantadine and rimantadine are NOT recommended for use because of high levels of antiviral resistance among circulating influenza A viruses. The recommended dosing and duration of antiviral treatment is twice daily for 5 days. Longer treatment courses for patients who remain severely ill after 5 days of treatment can be considered. Dosage adjustment may be required for children and persons with certain underlying conditions. Clinicians should consult the manufacturers package insert for recommended drug dosing adjustments and contraindications. Having preapproved orders from physicians or plans to obtain orders for antiviral medications on short notice can substantially expedite administration of antiviral medications. For more information on the antiviral agents see Recommended Dosage and Duration of Treatment or Chemoprophylaxis for Influenza Antiviral Medications. 21

22 Influenza Management in Long-Term Care Facilities, continued Influenza All eligible residents in the entire long-term care facility (not just currently impacted wards) should receive antiviral chemoprophylaxis as soon as an influenza outbreak is determined. When at least 2 patients are ill within 72 hours of each other and at least one resident has laboratory-confirmed influenza, the facility should promptly initiate antiviral chemoprophylaxis to all non-ill residents, regardless of whether they received influenza vaccination during the previous fall. Priority should be given to residents living in the same unit or floor as an ill resident. However, since staff and residents may spread influenza to residents on other units, floors, or buildings of the same facility, all non-ill residents are recommended to receive antiviral chemoprophylaxis to control influenza outbreaks. Antiviral chemoprophylaxis is recommended for all non-ill residents, regardless of their influenza vaccination status, in long-term care facilities that are experiencing outbreaks. Antiviral chemoprophylaxis is meant for patients and residents who are not exhibiting influenza-like illness but who may be exposed or who may have been exposed to an ill person with influenza, to prevent transmission. Use of antiviral drugs for chemoprophylaxis of influenza is a key component of influenza outbreak control in institutions that house residents at higher risk of influenza complications. While highly effective, antiviral chemoprophylaxis is not 100% effective in preventing influenza illness. CDC recommends antiviral chemoprophylaxis for a minimum of 2 weeks, and continuing for at least 7-10 days after the last known case was identified. Persons whose need for chemoprophylaxis is attributed to potential exposure to a person with laboratoryconfirmed 2009 H1N1, influenza A (H3N2), or influenza B should receive oseltamivir or zanamivir. Zanamivir should be used when persons require chemoprophylaxis as a result of exposure to influenza virus strains that are suspected of being oseltamivir-resistant. (For more information see Recommended Dosage and Duration of Treatment or Chemoprophylaxis for Influenza Antiviral Medications or the IDSA guidelines) 22

23 Influenza Management in Long-Term Care Facilities, continued Influenza Antiviral chemoprophylaxis can be considered or offered to unvaccinated personnel who provide care to persons at high risk of complications. While CDC recommends judicious use of antiviral medications for chemoprophylaxis to reduce the possibility of development and spread of antiviral resistant influenza viruses, chemoprophylaxis may be considered for all employees, regardless of their influenza vaccination status, if the outbreak is caused by a strain of influenza virus that is not well matched by the vaccine. Antiviral chemoprophylaxis should also be considered in personnel for whom influenza vaccine is contraindicated. An emphasis on early treatment is an alternative to chemoprophylaxis in managing certain persons who have had a suspected exposure to influenza virus. Health care personnel who have occupational exposures can be counseled about the early signs and symptoms of influenza and advised to contact their health-care provider immediately for evaluation and possible early treatment if clinical signs or symptoms develop. For newly vaccinated staff, antiviral chemoprophylaxis can be administered up to 2 weeks following influenza vaccination with TIV. Persons receiving antiviral chemoprophylaxis should not receive live attenuated influenza virus vaccine (LAIV), and persons receiving LAIV should not receive antiviral treatment or chemoprophylaxis until 14 days after LAIV administration. The latest CDC antiviral recommendations are available on CDC s influenza antiviral drugs page for health professionals. Be Aware of the Possibility of a Drug-Resistant Virus Residents receiving antiviral medications who do not respond to treatment or who become sick with influenza after starting chemoprophylaxis might have an infection with an antiviral-resistant influenza virus. To limit the potential transmission of antiviral drug-resistant influenza virus, whether in chronic or acute-care settings or other closed settings, measures should be taken to reduce contact between ill persons taking antiviral drugs for treatment and other persons, including those receiving antiviral chemoprophylaxis. Infection-control mea sures are especially important for patients who are immunocompromised to reduce the risk for transmission of oseltamivir-resistant viruses. Notify the health department if a resident develops influenza while on or after receiving antiviral chemoprophylaxis. 23