PharMerica s Influenza and Adult Immunization Reference Guide

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1 PharMerica s Influenza and Adult Immunization Reference Guide 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. 1

3 Included in this Ready Reference: CMS Requires Flu/Pneumococcal Vaccinations for Nursing Homes 4 Seasonal Influenza 5 Primary Influenza Vaccination Changes and Updates to the 2013 Recommendations Influenza Vaccine General Information...7 Types of Vaccines Available...10 Ordering Influenza Vaccine...11 Needle Recommendations...12 Vaccine Side Effects...13 Key Facts about Influenza...14 Instructions for the Use of Vaccine Information Statements (VIS)...16 VIS: Inactivated (English and Spanish)...17 VIS: Live (English and Spanish)...21 Consent for Influenza Vaccine...25 Checklist for Contraindications to Inactivated Vaccine...26 Checklist for Contraindications to Live Intranasal Vaccine...28 Resident Immunization Record Sample...30 Standing Orders for Administering Seasonal Influenza to Adults...31 Declination of Influenza Vaccination...32 Take Time to Get a Flu Vaccine...33 No More Excuses Poster...35 Take 3 Actions to Fight the Flu...37 Pneumococcal Disease Updated Recommendations...40 VIS: Polysaccharide (English and Spanish)...43 VIS: Conjugate (English and Spanish)...47 Consent for Pneumococcal Vaccine...51 Meningococcal Disease 54 Meningococcal Questions and Answers...55 VIS: Meningococcal Vaccines (English and Spanish)...58 Standing Orders for Administering Meningococcal Vaccine to Adults...62 Herpes Zoster (Shingles) 63 Herpes Zoster Background...64 VIS: Shingles Vaccine (English and Spanish)...66 Shingles Fact Sheet...70 Consent for Herpes Zoster Vaccine...71 Pertussis (Whooping Cough) 73 Pertussis Background...74 VIS: DTaP (English and Spanish)...76 Standing Orders for Administering Tdap/Td to Adults...82 Standing Orders for Administering Tdap/Td to Children Ages 7 and Older...83 West Nile Virus Update...85 West Nile Virus Fact Sheet...86 Additional Information 88 Medicare Coverage of Vaccinations...89 Advisory Committee on Immunization Practices (ACIP) VIS Federal Law

4 CMS Requires Flu/Pneumococcal Vaccinations for Nursing Homes September, 2013 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 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: The use of standing orders by nursing homes and skilled nursing facilities, hospitals, and home health agencies ensures that vaccinations are offered. Generally, a standing orders program for influenza and pneumococcal 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 Changes and Updates in the Recommendations Routine annual influenza vaccination of all persons aged 6 months and older continues to be recommended U.S. trivalent influenza vaccines will contain an A/California/7/2009 (H1N1)-like virus, an H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011, and a B/Massachusetts/2/2012-like virus. Quadrivalent vaccines will include an additional vaccine virus, a B/Brisbane/60/2008-like virus. Several new, recently-licensed vaccines will be available for the season, and are acceptable alternatives to other licensed vaccines indicated for their respective age groups when otherwise appropriate: o A quadrivalent live attenuated influenza vaccine (LAIV4; Flumist Quadrivalent [MedImmune]) is expected to replace the trivalent (LAIV3) formulation. FluMist Quadrivalent is indicated for healthy, nonpregnant persons aged 2 through 49 years; o A quadrivalent inactivated influenza vaccine (IIV4; Fluarix Quadrivalent [GlaxoSmithKline]) will be available, in addition to the previous trivalent formulation. Fluarix Quadrivalent is indicated for persons aged 3 years and older; o A quadrivalent inactivated influenza vaccine (IIV4; Fluzone Quadrivalent [Sanofi Pasteur]) will be available in addition to the previous trivalent formulation. Fluzone Quadrivalent is indicated for persons aged 6 months and older; o A trivalent cell culture-based inactivated influenza vaccine (cciiv3; Flucelvax [Novartis]), which is indicated for persons aged 18 years and older; and o A recombinant hemagglutinin (HA) vaccine (RIV3; FluBlok [Protein Sciences]), which is indicated for persons aged 18 through 49 years. 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. This document includes revised abbreviations to refer to currently available influenza vaccines. The former abbreviation TIV (Trivalent Inactivated Influenza Vaccine, previously used for inactivated influenza vaccines) has been replaced with the new abbreviation IIV (Inactivated Influenza Vaccine). For , IIVs as a class will include: o egg-based and cell culture-based trivalent inactivated influenza vaccines (IIV3), and egg-based quadrivalent inactivated influenza vaccine (IIV4). o IV refers to recombinant hemagglutinin influenza vaccine, available as a trivalent formulation (RIV3) for ; o LAIV refers to live-attenuated influenza vaccine, available as a quadrivalent formulation (LAIV4) for o LAIV, IIV, and RIV denote vaccine categories; numeric suffix specifies the number of antigens in the vaccine. o Where necessary to refer specifically to cell culture-based vaccine, the prefix cc is used (e.g., cciiv3 ). 6

7 Influenza Vaccine General Information 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(H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011; a B/Massachusetts/2/2012-like virus. It is recommended that quadrivalent vaccines containing two influenza B viruses contain the above three viruses and 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. Manufacturers have begun shipping flu vaccines for the U.S. season. Between 135 million and 139 million doses of vaccine are being produced. While some vaccine will be available in August, ample supplies should be available by September and October. Everyone 6 months of age and older should get their yearly flu vaccine, ideally by October. National Influenza Vaccination Week (NIVW) is a national observance that was established to highlight the importance of continuing influenza vaccination. NIVW is December 8-14, 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 50 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 to18 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; 7 American Indians/Alaska Natives; Persons who are morbidly obese (BMI 40).

8 Influenza Vaccine General Information 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: Healthcare personnel (HCP); 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. 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 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 RIV 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 receipient is not within the indicated age range, such persons should be referred to a physician with expertise in the management of allergic conditions for further risk assessment before receipt of vaccine. 3. All vaccines should be administered in settings in which personnel and equipment for rapid recognition and treatment of anaphylaxis are available. 8

9 Influenza Vaccine General Information 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. 9

10 Influenza Vaccines Available Highlighted are those Influenza Vaccines that PharMerica will be distributing. Vaccine Trade name Manufacturer Presentation Mercury Ovalbumin Age Route content content Indications (µg Hg per (µg per 0.5 ml dose) 0.5mL dose) Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose -0.5 ml single-dose 0.0 prefilled syringe Afluria CSL Limited 1 9 yrs. IM -5.0 ml multi-dose vial 24.5 Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Fluarix GlaxoSmithKline 0.5 ml single-dose yrs. IM prefilled syringe Flucelvax Novartis Vaccines 0.5 ml single-dose yrs. IM prefilled syringe ID Biomedical FluLaval < yrs. IM Corporation of Quebec 5.0 ml multi-dose vial (distributed by GlaxoSmithKline) Fluvirin Novartis Vaccines -0.5 ml single-dose 1 1 4yrs. IM prefilled syringe -5.0 ml multi-dose vial -0.25mL single-dose 0.0 **** Fluzone Sanofi Pasteur 6 35 prefilled syringe IM months -0.5mL single-dose prefilled syringe -0.5mL single-dose vial -5.0mL multi-dose vial **** **** **** 36 months 36 months 6 months Fluzone Sanofi Pasteur 0.1 ml pre-filled 0.0 **** yrs. D Intradermal microinjection system Inactivated Influenza Vaccine, Trivalent (IIV3), Standard Dose Inactivated Influenza Vaccine, Trivalent (IIV3), High Dose Inactivated Influenza Vaccine, Quadrivalent (IIV4), Standard Dose Recombinant Influenza Vaccine, Trivalent (RIV3) Live-attenuated Influenza Vaccine, Quadrivalent (LAIV4) Fluzone Sanofi Pasteur 0.5 ml single-dose 0.0 **** 65 years IM High-Dose prefilled syringe Fluarix Quadrivalent GlaxoSmithKline 0.5 ml single-dose prefilled syringe yrs. IM Fluzone ml single-dose 6-35 yrs. Quadrivalent Sanofi Pasteur prefilled syringe 0.0 **** IM -0.5 ml single-dose 36 yrs. prefilled syringe 36 mos 00.5 ml single-dose vial FluBlok Protein Sciences 0.5 ml single-dose vial yrs. IM 10 Quadrivalent MedImmune 0.0 (per 0.2 ml) < yrs.*** IN FluMist 0.2 ml prefilled intranasal sprayer (per 0.2 ml)

11 Influenza Vaccines Available Footnotes 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, and precautions. Package inserts for US-licensed vaccines are available at 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 may be found in the ACIP General Recommendations on Immunization [4]. The preferred site is over the deltoid muscle. Fluzone Intradermal is administered using the delivery system included with the vaccine. ** Inactivated influenza vaccine, high-dose: A 0.5-mL dose contains 60 μg of each vaccine antigen (180 μg total). Inactivated influenza vaccine, intradermal: A 0.1-mL dose contains 9 μg of each vaccine antigen (27 μg total). It is anticipated that the quadrivalent formulation of FluMist will replace the trivalent formulation for the season. 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--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--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. *** Flumist is indicated for healthy, non-pregnant persons aged 2-49 years. Individuals who care for severely immunosuppressed persons who require a protective environment should not receive FluMist given the theoretical risk of transmission of the live attenuated vaccine virus. Age indication per package insert is 5 years; however, the ACIP recommends Afluria not be used in children aged 6 months through 8 years because of increased risk of febrile reactions noted in this age group with CSL s 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5--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 (5). Information not included in package insert. The total egg protein is estimated to be less than 50 femtograms (5x10-14 grams) total egg protein, of which a fraction is ovalbumin, per 0.5 ml dose of Flucelvax. **** Available upon request from upon request from Sanofi Pasteur, by telephone, , or , Ordering Influenza Vaccine Much of the influenza vaccine was pre-booked early this year. Providers should contact their local PharMerica pharmacy about remaining supply. 11

12 Needle Reccomendations 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 1 Safety Needle with syringe or BD 23 g x 1 Safetyglide Needle. The flu shot is an intramuscular (IM) injection and you should use a 1 or longer needle. A 1 inch needle works well for most patients. Instructions for the needle are as follows: Firmly attach needle onto a Luer Lock syringe with a push and clockwise twist Pull back on the safety cover toward the syringe and away from the needle Grasp the syringe with one hand and with the other pull the clear needle shield straight off Draw up medication as per your usual technique - Note: if changing needles, activate safety cover prior to removing the needle from the syringe Inject according to protocol For user convenience, the needle bevel-up position is oriented to the safety cover After injection, immediately activate safety cover as follows: Using the same hand holding the syringe, center thumb or forefinger on the finger pad area of the safety cover Push the cover forward over the needle until you hear and/or feel it lock Visually confirm that the needle tip is covered After activation, discard immediately into an approved sharps container Things to remember: 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 12

13 Vaccine Side Effects Vaccine Side Effects (What to Expect) 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: The nasal spray (also called LAIV or FluMist ): 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 LAIV (FluMist ) can include: runny nose wheezing headache vomiting muscle aches fever In adults, side effects from LAIV (FluMist ) 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: Immunizations/index.html?redirect=/Immunizations/ Information about the H3N2 variant strain of influenza can be found here: Information about H5N1 (avian/bird) influenza is available here: 13

14 Key Facts Key Facts About 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 is why it is 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. 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. 14

15 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: 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 Cold Flu Viral Infection Yes Yes Severe Symptoms No Yes Fever No Yes Body Aches No Yes Extreme Tiredness No Yes Dry Cough Unlikely More Likely Runny Nose Less Intense More Intense Stuffy Nose More Likely Less Likely Can Result in Pneumonia, Bacterial Infections or Hospitalization Unlikely More Likely 15

16 Instructions for the Use of Vaccine Information Statements (VIS) Instructions for the Use of Vaccine Information Statements Required Use 1. Provide a Vaccine Information Statement (VIS) when a vaccination is given. As required under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), all health care providers in the United States who administer, to any child or adult, any of the following vaccines diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), trivalent influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC): to the parent or legal representative 1 of any child to whom the provider intends to administer such vaccine, or to any adult 2 to whom the provider intends to administer such vaccine. If there is not a single VIS for a combination vaccine, use the VISs for all component vaccines. VISs should be supplemented with visual presentations or oral explanations as appropriate. 2. Record information for each VIS provided. 1 Legal representative is defined as a parent or other individual who is qualified under State law to consent to the immunization of a minor child or incompetent adult. 2 In the case of an incompetent adult, relevant VISs shall be provided to the individual s legal representative. If the incompetent adult is living in a long-term care facility, all relevant VISs may be provided at the time of admission, or at the time of consent if later than admission, rather than prior to each vaccination. Health care providers shall make a notation in each patient s permanent medical record at the time vaccine information materials are provided, indicating: (1) the edition date of the Vaccine Information Statement distributed, and (2) the date the VIS was provided. This recordkeeping requirement supplements the requirement of 42 U.S.C. 300aa-25 that all health care providers administering these vaccines must record in the patient s permanent medical record (or in a permanent office log): (3) the name, address and title of the individual who administers the vaccine, (4) the date of administration, and (5) the vaccine manufacturer and lot number of the vaccine used. Applicability of State Law Health care providers should consult their legal counsel to determine additional State requirements pertaining to immunization. The Federal requirement to provide the vaccine information materials supplements any applicable State laws. Availability of Copies Copies are available in English and many other languages from CDC s website at Single camera-ready copies may also be available from State health departments. Current VIS Editions DTaP/DT: 5/17/07 Meningococcal: 10/14/11 Hib: 12/16/98 Pneumococcal (PCV13): 2/27/13 Hepatitis A: 10/25/11 Polio: 11/8/11 Hepatitis B: 2/2/12 Rotavirus: 12/6/10 HPV (Cervarix): 5/3/11 Tdap/Td: 1/24/12 HPV (Gardasil): 5/17/13 Tdap: 5/9/13 Influenza (inactivated): 7/2/12 Varicella: 3/13/08 Influenza (live): 7/2/12 Multi-Vaccine*: 11/16/12 MMR: 4/20/12 MMRV: 5/21/10 Interim Reference 42 U.S.C. 300aa-26 June 1, 2013 *An optional alternative when two or more routine childhood vaccines (i.e., DTaP, hepatitis B, Hib, pneumococcal, polio, or rotavirus) are administered at the same visit. 16

17 English VIS: Inactivated Influenza Vaccine What You Need to Know VACCINE INFORMATION STATEMENT (Flu Vaccine, Inactivated) Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 Why get vaccinated? Influenza ( flu ) is a contagious disease that spreads around the United States every winter, usually between October and May. Flu is caused by the influenza virus, and can be spread by coughing, sneezing, and close contact. Anyone can get flu, but the risk of getting flu is highest among children. Symptoms come on suddenly and may last several days. They can include: fever/chills sore throat muscle aches fatigue cough headache runny or stuffy nose Flu can make some people much sicker than others. These people include young children, people 65 and older, pregnant women, and people with certain health conditions such as heart, lung or kidney disease, or a weakened immune system. Flu vaccine is especially important for these people, and anyone in close contact with them. Flu can also lead to pneumonia, and make existing medical conditions worse. It can cause diarrhea and seizures in children. Each year thousands of people in the United States die from flu, and many more are hospitalized. Flu vaccine is the best protection we have from flu and its complications. Flu vaccine also helps prevent spreading flu from person to person. 2 Inactivated flu vaccine There are two types of influenza vaccine: You are getting an inactivated flu vaccine, which does not contain any live influenza virus. It is given by injection with a needle, and often called the flu shot. A different, live, attenuated (weakened) influenza vaccine is sprayed into the nostrils. This vaccine is described in a separate Vaccine Information Statement. Flu vaccine is recommended every year. Children 6 months through 8 years of age should get two doses the first year they get vaccinated. Flu viruses are always changing. Each year s flu vaccine is made to protect from viruses that are most likely to cause disease that year. While flu vaccine cannot prevent all cases of flu, it is our best defense against the disease. Inactivated flu vaccine protects against 3 or 4 different influenza viruses. It takes about 2 weeks for protection to develop after the vaccination, and protection lasts several months to a year. Some illnesses that are not caused by influenza virus are often mistaken for flu. Flu vaccine will not prevent these illnesses. It can only prevent influenza. A high-dose flu vaccine is available for people 65 years of age and older. The person giving you the vaccine can tell you more about it. Some inactivated flu vaccine contains a very small amount of a mercury-based preservative called thimerosal. Studies have shown that thimerosal in vaccines is not harmful, but flu vaccines that do not contain a preservative are available. 3 Some people should not get this vaccine Tell the person who gives you the vaccine: If you have any severe (life-threatening) allergies, including an allergy to eggs. If you ever had a lifethreatening allergic reaction after a dose of flu vaccine, or have a severe allergy to any part of this vaccine, you may be advised not to get a dose. If you ever had Guillain-Barré Syndrome (a severe paralyzing illness, also called GBS). Some people with a history of GBS should not get this vaccine. This should be discussed with your doctor. If you are not feeling well. They might suggest waiting until you feel better. But you should come back. 17

18 English VIS: Inactivated 4 Risks of a vaccine reaction With a vaccine, like any medicine, there is a chance of side effects. These are usually mild and go away on their own. Serious side effects are also possible, but are very rare. Inactivated flu vaccine does not contain live flu virus, so getting flu from this vaccine is not possible. Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. Tell your doctor if you feel dizzy or light-headed, or have vision changes or ringing in the ears. Mild problems following inactivated flu vaccine: soreness, redness, or swelling where the shot was given hoarseness; sore, red or itchy eyes; cough fever aches headache itching fatigue If these problems occur, they usually begin soon after the shot and last 1 or 2 days. Moderate problems following inactivated flu vaccine: Young children who get inactivated flu vaccine and pneumococcal vaccine (PCV13) at the same time may be at increased risk for seizures caused by fever. Ask your doctor for more information. Tell your doctor if a child who is getting flu vaccine has ever had a seizure. Severe problems following inactivated flu vaccine: A severe allergic reaction could occur after any vaccine (estimated less than 1 in a million doses). There is a small possibility that inactivated flu vaccine could be associated with Guillain-Barré Syndrome (GBS), no more than 1 or 2 cases per million people vaccinated. This is much lower than the risk of severe complications from flu, which can be prevented by flu vaccine. The safety of vaccines is always being monitored. For more information, visit: 5 What if there is a serious reaction? What should I look for? Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or behavior changes. Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would start a few minutes to a few hours after the vaccination. What should I do? If you think it is a severe allergic reaction or other emergency that can t wait, call or get the person to the nearest hospital. Otherwise, call your doctor. Afterward, the reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor might file this report, or you can do it yourself through the VAERS web site at or by calling VAERS is only for reporting reactions. They do not give medical advice. 6 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines. Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 7 How can I learn more? Ask your doctor. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Inactivated Influenza Vaccine 07/26/ U.S.C. 300aa-26 Office Use Only 18

19 Spanish VIS: Inactivated Vacuna contra la gripe Lo que usted necesita saber HOJA DE INFORMACIÓN SOBRE VACUNAS (Vacuna contra la gripe inactivada) Muchas de las declaraciones informativas sobre vacunas están disponibles en español y otros idiomas. Consulte Las hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite 1 Por qué es necesario vacunarse? La gripe o influenza es una enfermedad contagiosa que se transmite entre la población de los Estados Unidos durante el invierno, generalmente entre octubre y mayo. La gripe es causada por el virus de la influenza y se puede transmitir al toser, estornudar y tener contacto cercano. Todas las personas pueden contraer gripe, pero el riesgo es mayor en los niños. Los síntomas se presentan de forma repentina y pueden durar varios días. Estos pueden incluir los siguientes: fiebre/escalofríos dolor de garganta dolores musculares fatiga tos dolor de cabeza rinorrea o congestión nasal La gripe puede afectar a algunas personas más que a otras. Entre estas se incluyen los niños pequeños, las personas mayores de 65 años, las mujeres embarazadas y las personas con ciertas afecciones de salud, como enfermedades cardíacas, pulmonares o renales, o con un sistema inmunitario debilitado. La vacuna contra la gripe es especialmente importante para estas personas y para todas las que estén en contacto cercano con ellas. La gripe también puede provocar neumonía y empeorar las afecciones médicas existentes. En los niños, puede causar diarrea y convulsiones. Cada año, miles de personas mueren por gripe en los Estados Unidos, y muchas más son hospitalizadas. La vacuna contra la gripe es la mejor protección que tenemos contra la gripe y sus complicaciones. Esta vacuna también previene el contagio de la gripe de persona a persona. 2 Vacuna contra la gripe inactivada Existen dos tipos de vacuna contra la gripe: Usted recibirá la vacuna contra la gripe inactivada, que no contiene virus de influenza vivos. Esta se administra mediante una inyección. Existe otro tipo de vacuna contra la gripe viva, atenuada (debilitada) que se administra a través de las fosas nasales en forma de aerosol. Esta vacuna se describe en una Hoja de información sobre vacunas por separado. Se recomienda vacunarse contra la gripe todos los años. Los niños de 6 meses a 8 años de edad deben recibir dos dosis el primer año que se vacunan. Los virus de la gripe cambian constantemente. La vacuna contra la gripe de cada año se fabrica para proteger contra los virus que tienen mayor probabilidad de causar la enfermedad ese año. Si bien la vacuna no puede prevenir todos los casos de gripe, es nuestra mejor defensa contra esta enfermedad. La vacuna contra la gripe inactivada protege contra 3 o 4 virus diferentes de la influenza. Luego de la vacunación, la protección demora unas dos semanas en desarrollarse y dura entre varios meses y un año. Algunas enfermedades que no son causadas por el virus de la influenza suelen confundirse con la gripe. La vacuna contra la gripe no previene ese tipo de enfermedades. Solo puede prevenir la gripe. Para personas mayores de 65 años, existe una vacuna contra la gripe en dosis alta. La persona que le administre la vacuna puede informarle más al respecto. Algunas vacunas contra la gripe inactivadas contienen una cantidad muy pequeña de timerosal, un conservante hecho a base de mercurio. Los estudios han demostrado que el timerosal presente en las vacunas no es perjudicial, pero existen vacunas contra la gripe que no contienen conservantes. 3 Algunas personas no deben aplicarse esta vacuna Informe lo siguiente a la persona que le aplique la vacuna: Si tiene alguna alergia severa (que represente un riesgo para la vida). Si alguna vez tuvo una reacción alérgica que representa un riesgo para la vida después de haber recibido una dosis de la vacuna contra la gripe, o si tiene una alergia severa a cualquier parte de esta vacuna, es posible que le recomienden no aplicarse la vacuna. La mayoría de los tipos de vacunas contra la gripe, pero no todos, contienen una cantidad pequeña de huevo. Si alguna vez tuvo el síndrome de Guillain-Barré (Guillain-Barré Syndrome, GBS) (una enfermedad grave que causa parálisis). Algunas personas con antecedentes de GBS no deben recibir esta vacuna. Esto debe ser analizado con el médico. Si no se siente bien. Pueden recomendarle que espere hasta sentirse mejor, pero debe regresar para vacunarse. Influenza (inactivated) VIS - Spanish (7/26/13) 19

20 Spanish VIS: Inactivated Las personas moderadamente o muy enfermas por lo general deben esperar hasta recuperarse antes de vacunarse contra la influenza. Si está enfermo, hable con su doctor sobre si debe cambiar la cita para vacunarse. Las personas con una enfermedad leve por lo general se pueden vacunar. 5 Cuáles son los riesgos de la vacuna desactivada contra la influenza? Las vacunas, como cualquier medicamento, pueden causar problemas serios, como reacciones alérgicas graves. El riesgo de que la vacuna cause un daño serio, o la muerte, es sumamente pequeño. Problemas serios de la vacuna desactivada contra la influenza ocurren muy rara vez. Los virus en la vacuna desactivada están muertos o sea que no se puede enfermar de influenza mediante la vacuna. Problemas leves: molestia, hinchazón o enrojecimiento o en el lugar donde lo vacunaron ronquera; dolor, enrojecimiento y picazón en los ojos; tos fiebre dolores dolor de cabeza picazón cansancio Si estos problemas ocurren, en general comienzan poco tiempo después de vacunarse y duran 1 ó 2 días. Problemas moderados: Los niños pequeños que reciben la vacuna contra la influenza desactivada y la vacuna antineumocócica (PCV13) durante la misma cita parecen correr mayor riego de tener convulsiones por causa de fiebre. Consulte a su doctor para más información. Diga a su doctor si el niño que está recibiendo la vacuna contra la influenza ha tenido una convulsión. Problemas graves: Las reacciones alérgicas que amenazan la vida ocurren muy rara vez después de la vacunación. Si ocurren, por lo general es a los pocos minutos o a las pocas horas de haberse vacunado. En 1976, un tipo de la vacuna desactivada contra la influenza (gripe porcina) estuvo asociado al síndrome de Guillain-Barré (GBS). Desde entonces, las vacunas contra la influenza no se han asociado claramente al GBS. Sin embargo, si hay un riesgo de GBS por las vacunas contra la influenza que se usan actualmente, no debe ser de más de 1 ó 2 casos por millón de personas vacunadas. Eso es mucho menor que el riesgo de tener una influenza fuerte, que se puede prevenir con vacunación. Una marca de la vacuna desactivada contra la influenza, llamada Afluria, no se debe dar a niños menores de 8 años de edad, con la excepción de circunstancias especiales. En Australia una vacuna relacionada estuvo asociada a fiebre y convulsiones febriles en niños pequeños. Su doctor le puede proporcionar más información. Siempre se seguirá prestando atención a la seguridad de las vacunas. Para más información visite: y 6 Qué pasa si hay una reacción grave? A qué debo prestar atención? A cualquier condición fuera de lo común, como fiebre alta o cambios en el comportamiento. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o sibilancias, ronchas, palidez, debilidad, latidos rápidos del corazón o mareos. Qué debo hacer? Llame a un doctor o lleve a la persona inmediatamente a un doctor. Diga a su doctor lo que ocurrió, la fecha y la hora en que ocurrió, y cuando recibió la vacuna. Pida a su doctor que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (VAERS).O puede presentar este informe mediante el sitio Web de VAERS, en:www.vaers.hhs.gov, o llamando al: VAERS no proporciona consejos médicos. 7 8 Programa Nacional de Compensación por Lesiones Causadas por las Vacunas El Programa Nacional de Compensación por Lesiones Causadas por las Vacunas (VICP) fue creado en Las personas que piensan haber sido lesionadas por alguna vacuna pueden aprender acerca del programa y cómo presentar una reclamación llamando al: , o visitando el sitio Web de VICP en Cómo puedo obtener más información? Consulte a su doctor. Le pueden dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al (1-800-CDC-INFO) - Visite el sitio Web de los CDC en DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Inactivated Influenza Vaccine Vaccine - Spanish (7/26/11) (7/2/12) 42 U.S.C. 300aa-26 Translation provided by the California Department of Public Health 20

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