Expanding Practice of Pharmacist-Administered Immunizations for 2013

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1 Expanding Practice of Pharmacist-Administered Immunizations for 2013 Rupal Mansukhani, PharmD Clinical Assistant Professor Rutgers University Piscataway, NJ Faculty Information Presenter: Rupal Mansukhani, PharmD Clinical Assistant Professor Rutgers University Piscataway, NJ Moderator: David Heckard Senior Director of Education Pharmacy Times Office of CPE Plainsboro, NJ Disclosures Rupal Mansukhani, PharmD, has no financial relationships with commercial interests to disclose. Pharmacy Times Office of Continuing Professional Education Planning Staff Judy V. Lum, MPA, Elena Beyzarov, PharmD, David Heckard, and Donna W. Fausak have no financial relationships with commercial interests to disclose. PTOCPE uses an anonymous peer reviewer as part of content validation and conflict resolution. The peer reviewer has no relevant financial relationships with commercial interests to disclose. The contents of this webinar may include information regarding the use of products that may be inconsistent with or outside the approved labeling for these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult prescribing information for these products. 1

2 Please send all questions or comments concerning this webinar to: Or You can call and leave a message. All s and messages will be answered within 48-hours in the order that they are received. Learning Objectives Discuss morbidity and mortality associated with influenza, pneumococcal, herpes zoster, pertussis, and meningococcal disease Describe recent changes to ACIP recommendations for immunizations against various adult illnesses Interpret the most current immunization schedule Describe the signs and symptoms of adverse reactions that can occur after vaccination and understand emergency procedures for adverse-event management Expanding Practice of Pharmacist-Administered Immunizations for 2013 Rupal Mansukhani, PharmD Clinical Assistant Professor Rutgers University Piscataway, NJ 2

3 Live Vaccines Live attenuated vaccines Made from viruses or bacteria Must replicate to work Replication mimics natural infection, which stimulates immune response Which vaccines are live? Herpes zoster Live attenuated influenza Oral typhoid capsules Rotavirus Varicella Yellow fever Measles, mumps, rubella Inactivated Vaccines Inactivated vaccines Made from fractions and particles of viruses or bacteria Do not replicate because they are killed Antigen load stimulates immune response Which vaccines are inactivated? Diphtheria, Tetanus, Pertussis, Hepatitis A, Hepatitis B, Pneumococcal, Meningococcal, Human Papillomavirus, Rabies, Trivalent Inactive Influenza What s New With Vaccines in 2013? 3

4 2013 Immunization Schedules Finding the most updated schedule Updated annually Available from CDC website default.htm Published in the MMWR (a CDC publication) Childhood/Adolescent Schedule Update Adult Schedule Updates 4

5 Adult Schedule Updates New Vaccines Approved Meningococcal [groups A, C, Y and W- 135] oligosaccharide diphtheria CRM 197 conjugate (Menveo ) or MenACWY-CRM Approved February 19, 2010 Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) (Prevnar 13) or PCV-13 Approved February 24, 2010 New Vaccines Approved Fluzone High-Dose Indicated for age 65 years Approved May 9, 2011 Fluzone Intradermal Indicated for ages18-64 years Approved May 9, 2011 Quadrivalent influenza vaccine Flu Mist Quadrivalent: contains 4 strains of the influenza virus, 2 influenza A strains, and 2 influenza B strains Approved February 29,

6 Rates per 100,000 Cases Meningococcal Disease Caused by bacteria Neisseria meningitidis Transmitted through respiratory droplets Symptoms Meningitis (eg, pain, headache, neck stiffness) Bacteremia (eg, sepsis, rash) 16 Meningococcal Disease United States, Menactra approval (2005) Rates of Meningococcal Disease* by Age, United States, ABCs NETSS * Serogroups A/C/Y/W135 Age (yr) U.S. Rate 6

7 Meningococcal Disease Associated with high fatality rate 10%-14% of cases are fatal 11%-19% result in permanent disability (ie, limb loss, hearing loss, mental retardation) All vaccines cover Neisseria meningitidis Carried in 5%-10% of the population without causing disease Provide protection for ~5 years after vaccination Types of Meningococcal Vaccines Polysaccharide (MPSV) Tetravalent meningococcal polysaccharide vaccine Menomune (Sanofi Pasteur) Typically used in age Types of Meningococcal Vaccines Conjugate (MCV) Meningococcal polysaccharide diphtheria toxoid conjugate vaccine Menactra (sanofi Pasteur) Licensed in ages 2-55 years Licensed in infants ages 9-23 months as a 2- dose series separated by 3 months Meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine Menveo (Novartis) Indicated for ages 2-10 years; under FDA review for ages 2, 4, 6, and 12 months 7

8 Populations Who Should Receive the Meningitis Vaccine Military basic training personnel College students living in dormitories Patients with asplenia (anatomic or functional) Travelers to meningitis belt of Africa or Saudi Arabia for Islamic Hajj pilgrimage Protection during outbreaks; work with health department What are the ACIP Meningitis Vaccine Recommendations? Vaccination All adolescents ages years Preferred at ages years Catch-up: ages years if no record of vaccine Ages years: routine vaccination not recommended unless patient is at high risk for infection Revaccination Revaccinate with MCV after 5 years for adults who remain at increased risk for infection ACIP Statement Routine vaccination before age 10 not recommended If a child receives Menveo prior to 10 th birthday, should still receive a dose at ages years & 16 years, as recommended on adolescent schedule 8

9 Pneumococcal Disease Pneumococcal Disease Bacterial infection caused by a type of Streptococcus pneumoniae Causes pneumonia if bacteria invades lungs Can cause blood infection (sepsis) or infection of tissues and fluid surrounding brain or spinal cord (meningitis) Spread by coughing, sneezing, or contact with respiratory secretions Approximately 4500 Americans die from invasive pneumococcal disease annually Symptoms of Pneumococcal Disease Pneumonia Fever Cough Shortness of breath Chest Pain Meningitis Stiff neck Fever Confusion or disorientation Sensitivity to light Blood infection Same as pneumonia and meningitis Joint pain and chills 9

10 Types of Pneumococcal Vaccines valent polysaccharide (PPV23) Pneumovax 23 (Merck) valent polysaccharide conjugate (PCV7) Prevnar (Wyeth/Pfizer) valent polysaccharide conjugate (PCV13) Prevnar 13 (Wyeth/Pfizer) What s the Difference? Polysaccharide (PPV23) Purified antigen from 23 different types of pneumococcus Protects against ~80% of serotypes known to cause invasive disease More efficacious against bacteremia than pneumonia Ineffective for children under age 2 years PPSV23 Indications People age 65 years People with chronic illness People with asthma Smokers 10

11 PPSV23 Can give any time of year Can give at same time as influenza vaccine Usually administered in opposite arm Schedule Change Patients with certain medical conditions can receive 2 doses of PPSV23 before age 65 years Patients can receive 1 dose at age 65 as long as 5 years after most recent dose Pneumococcal Polysaccharide Vaccine (PPSV) Recommendations Everyone age 65 years People ages years who smoke cigarettes or have asthma (updated 2010) People who have problems with their lungs, liver, heart, or kidneys People with health problems such as diabetes, sickle cell disease, alcoholism, or HIV/AIDS People with reduced resistance to infection Undergoing chemotherapy or x-ray therapy for cancer 11

12 What s the Difference? Conjugate vaccines (PCV7 and PCV 13) Effective for infants and children Indicated for children ages 6 weeks to 5 years Routine schedule: 2, 4, 6 months Booster at months For children ages months with incomplete schedule Catch-up schedule is complicated Providers should refer to up-to-date ACIP recommendations to schedule missed doses PCV 13 FDA approval in adults age > 50 years Based on noninferior immunogenicity compared to PPSV23 Evidence not available until study in Netherlands is published in 2013 PCV 13 Recommended for immunocompromising conditions, functional or anatomical asplenia, cerebrospinal fluid leaks, or cochlear implants Those not previously vaccinated should receive PCV13, followed by a dose of PPSV 23 at least 8 weeks later Those vaccinated with PPSV23 should be vaccinated with PCV13 1 year later 12

13 What Are the Side Effects? ~ ½ of people who get the pneumococcal vaccine have mild reaction Redness or pain where shot is given Less than 1% develop fever, muscle aches, or more severe local reactions Risk of vaccine causing serious reaction or death extremely small How Often Does a Patient Need to Get Immunized? Most people need only ONE shot Protects them for lifetime Some people might need booster shot after age 65 if received dose before that age Usually maximum of 3 doses total: 2 before age 65 and 1 after age 65 Influenza 13

14 What Is Influenza? Highly contagious viral infection of the nose, throat, and lungs that can cause severe illness Spreads easily from person to person by respiratory droplets Sneezing, coughing, and talking passes virus into the air Breathed in by anyone nearby Influenza Statistics In the US each year, influenza and its complications cause an average of 36,000 deaths More than 220,000 hospitalizations Highest rates of complications and hospitalization among young children and persons age 65 years Symptoms of Influenza Sudden onset of high fever and chills Fatigue Cough Headache Runny nose Sore throat Muscle and joint pain 14

15 Why Get Vaccinated? Influenza vaccine can reduce the chances of getting the flu by 70% to 90% in healthy adults If patient gets vaccinated and still contracts the flu, may be a less severe case Who Should Get Vaccinated? Everyone 6 months of age or older! Especially Anyone over age 50 years Anyone wishing to reduce the risk of becoming sick with influenza Anyone with chronic medical conditions (eg, diabetes, asthma, heart disease) Residents of nursing homes or other nursing facilities Pregnant women When to Get Vaccinated? As soon as vaccine is available Can be as early as August or September Usually early October Takes 2 weeks for protection to develop after the shot Vaccination should continue until the winter and spring, even until April or May 15

16 What s New with Flu? Summary of Influenza Activity for Season Strains Trivalent influenza vaccine: A/California/7/2009 (H1N1)pdm09-like virus; A(H3N2) virus antigenically like the cellpropagated prototype virus A/Victoria/361/2011; B/Massachusetts/2/2012-like virus. Quadrivalent influenza vaccine: B/Brisbane/60/2008-like virus. 16

17 Abbreviation Change Influenza vaccination is now abbreviated IIV (inactivated influenza vaccine) vs TIV (trivalent inactivated vaccine) What Are the Different Types of Vaccines? Most common vaccine is trivalent inactivated influenza vaccine (IIV) Given as an 0.5 ml IM injection into the deltoid muscle Flu shot Live attenuated influenza vaccine (LAIV) also available Given as two 0.1 ml sprays into each nostril Only for people from age 2-49 years TIV and QIV Fluzone High-Dose Manufactured by Sanofi Pasteur Contains 4 times the amount of influenza virus antigen compared with other inactive influenza vaccines Indicated for patients age > 65 years No preference expressed by ACIP for any TIV for use in persons age > 65 years 17

18 Intradermal Flu Vaccine Fluzone Intradermal Received FDA approval on May 10, 2011 Novel microinjection system works by depositing vaccine antigen into dermal layer of skin Approved for use during flu season Intradermal Injection Technique Intradermal Injection Technique 18

19 What Are the Side Effects? Mild problems Soreness, redness, or swelling where shot was given Hoarseness; sore, red, itchy eyes; cough Fever or aches Usually begin soon after the shot and last for 1-2 days after Intradermal Side Effects Fluzone Intradermal Injection Site 89% 60% Reaction Erythema 76% 13% Induration 58% 10% Swelling 57% 8% Pain 51% 54% Fluzone Intramuscular 0-7 days post-vaccination; Sanofi-Pasteur, 2011 Package Insert Contraindications to IIV Administration Contraindications Severe (life-threatening) allergies To eggs To any vaccine component To a previous dose of influenza vaccine Precautions Patients suffering from moderate or severe acute illness (with or without fever) History of Guillain-Barré Syndrome 19

20 Egg Allergy Algorithm Herpes Zoster Herpes Zoster (Shingles) Occurs when latent varicella zoster virus reactivates and causes recurrent disease Not well understood why this happens in some people and not others Risk factors Increasing age Immunosuppression Taking immunosuppressive drugs 20

21 Who Should Get Vaccinated? Single-dose of zoster vaccine recommended for Adults aged 60 years Regardless of prior episode of herpes zoster Patients with chronic medical conditions Unless condition constitutes contraindication to vaccination When to Get Vaccinated? Can be given any time of year Can be given at same time as influenza and pneumococcal vaccines Usually administered in opposite arm What Are the Side Effects? Mild adverse effects Redness, soreness, swelling, or itching at injection site Headache Moderate or severe reactions Risk of vaccine causing serious reaction or death extremely small Monitor for signs and symptoms of anaphylaxis 21

22 Vaccie Efficacy on HZ (%) Herpes Zoster Vaccine Updates ACIP guidelines recommend for adults age 60 years Manufacturer s product labeling recently updated to reflect indication in adults age 50 years Insurance coverage issue? Zostavax Efficacy and Safety Trial N=22,439 between the ages of years Mean follow-up 1.3 years Vaccine effectiveness at preventing herpes zoster 69.8% V Duration of Protection: VE HZV Duration of Protection 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Vaccine Efficacy on Incidence of HZ Pooled SPS and STPS Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Schmader, IDSA 2008 Year Post-Vaccination 22

23 Tetanus-Diphtheriaaccellular Pertussis (Tdap) How to Receive Credit for Live CE Webinars To be eligible for CE credit, each participant must use a computer to log-onto the webinar using the assigned link sent to them in their confirmation . All participants must view the webinar in its entirety.. After completion of the live webinar, please allow at least 24 hours, and then: Log into your CE account from Go to View Course History on the left menu bar Click on the Statement of Credit link Complete the evaluation form Download and/or print your certificate or Wait for an from Pharmacy Times Office of CPE containing a link to the evaluation form and certificate Tetanus-Diphtheria- Acellular Pertussis FDA-approved age indications DTaP age <7 years Tdap Boostrix (GSK) age >10 years Adacel (Sanofi Pasteur) ages years ACIP Feb 2012 Extended recommendations to all 65 years Boostrix preferred because has FDA approval If Adacel used, not necessary to redose 23

24 Schedule Change ACIP recommends pregnant women receive Tdap vaccination during later pregnancy (>20 weeks gestation) Pertussis in pregnancy- no increased morbidity or mortality Contraindications and Precautions Tdap contraindicated with serous allergic reaction to any component of the vaccine Encephalopathy (eg, coma, prolonged seizures) not attributed to identifiable cause within 7 days of pertussiscontaining vaccine Staying Current

25 Thank You! 25