What s New With Immunizations

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1 What s New With Immunizations 2018 Annual Update COURTNEY A. ROBERTSON, PHARMD, BCPS CLINICAL ASSISTANT PROFESSOR UNIVERSITY OF LOUISIANA AT MONROE COLLEGE OF PHARMACY Disclosures No financial disclosures to report 1

2 Learning Objectives Pharmacist Objectives: List important updates to most current vaccine recommendations for adults and children. Apply recent changes in adult and pediatric immunization schedules to pharmacy practice. Summarize information regarding newly available vaccines and those in development phases. Pharmacy Technician Objectives: Recognize current age-appropriate immunization schedules. List important updates to most current vaccine recommendations for adults and children. Summarize information regarding newly available vaccines and those in development phases. Vaccine-Preventable Diseases Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th ed.; May 2012 JAMA. 2007;298: MMWR. Weekly / February 10, 2017 /66(05) 2

3 CDC and ACIP Roles in Immunizations The Centers for Disease Control and Prevention (CDC) determine childhood and adult immunization schedules based on recommendations from the Advisory Committee on Immunization Practices (ACIP) ACIP recommendations consider multiple factors, including disease epidemiology, vaccine safety and efficacy, and economics Once approved by the CDC director, ACIP recommendations become agency guidelines on the date published in Morbidity and Mortality Weekly Report (MMWR) Working To Meet 2020 Goals 3

4 States Authorizing Pharmacists to Administer Influenza Vaccine & Pharmacists Trained to Administer Vaccines Updated December Pharmacists Making a Difference Five years after national implementation, we estimate that 6.2 million additional influenza immunizations and 3.5 million additional pneumococcal immunizations are attributable to pharmacy-delivered immunization services, each year 4

5 Recommended Adult Immunization Schedule years or older, by vaccine and age group 7/6/2018 Recommended Immunization Schedules for Persons Aged 0-18 Years

6 Recommended Adult Immunization Schedule years or older based on medical and other indications There s an App for That Free tool that allows users to identify correct vaccine, dosage, and timing with a few clicks Provides the most current version of Child and adolescent schedules with immunization Catch-up schedule for children Adult schedule, including recommendations for adults by age group and by medical condition Contraindications and precautions table, with all footnotes that apply to schedules Any changes in the schedules will be released through app updates Share content through social media sites 6

7 Childhood Schedule Changes Medical indications Information regarding HIV lab parameters and use of live vaccines included in HIV column Pneumococcal row clarified that in some situations an additional dose of vaccine may be recommended for children with heart disease/chronic lung disease, chronic liver disease, and diabetes MenHibrix no longer available; removed from the schedule Hepatitis B vaccine revised footnote information pertaining to infants weighing less than 2 g born to HBsAg-negative mothers Recommended birth dose of HepB vaccine at chronological age 1 month or at hospital discharge Childhood Schedule Changes Polio vaccine catch-up schedule modified to clarify recommendations for children 4 years and older and updated guidance for patients receiving oral polio vaccine during series Rotavirus vaccine maximum ages for providing first and last dose of series added to catch-up schedule Measles, Mumps, and Rubella vaccine updated footnote regarding use of a third dose during mumps outbreak Children 12 months of age and older who have received no more than two doses of mumpscontaining vaccine should receive another dose during outbreak 7

8 Adult Schedule Changes Measles, Mumps, and Rubella vaccine administer one dose to adults who previously received two doses or less of mumps-containing vaccine and are identified to be at increased risk during a mumps outbreak Zoster vaccines two vaccines now available; recombinant zoster vaccine (RZV; Shingrix ) and zoster vaccine live (ZVL; Zostavax ) ZVL has replaced the term HZV (herpes zoster vaccine) used in past schedules Meningococcal vaccine 4-valent meningococcal polysaccharide vaccine (MPSV4) is no longer available; removed from the adult immunization schedule 8

9 Influenza Vaccine Test Your Knowledge A patient walks into the pharmacy and would like you to administer the annual flu vaccine to her 10 year old daughter, Hannah. Hannah is healthy, has no chronic medical conditions, and is up to date on all of her childhood vaccinations. For the upcoming flu season , which is the most appropriate vaccine to use according to ACIP recommendations? A. Inactivated quadrivalent influenza vaccine (Fluzone ) B. Live attenuated influenza vaccine (Flumist nasal spray) C. Intradermal inactivated influenza vaccine (Fluzone Intradermal) D. A or B only E. Any of the above Influenza Season Key Facts Strongest season since the H1N1 pandemic of flu-related pediatric deaths this season 30,451 laboratory-confirmed influenza-associated hospitalizations reported through Influenza Hospitalization Network between 10/1/2017 and 4/30/2018 Data collected from 13 states and represent approximately 9% of the total U.S. population Cumulative overall rate of hospitalizations per 100,000 people in the United States 9

10 Influenza Season Peak Activity Influenza Vaccine Coverage 10

11 Influenza Recommendations Vaccination is recommended for all persons aged 6 months and older No preference stated for any influenza vaccine product Ideal to vaccinate before flu activity begins; CDC recommends vaccination before October 31 st Live attenuated influenza vaccine (Flumist nasal spray) was reinstated as one of the recommended vaccine options for season Effectiveness against Type A H1N1 viruses unknown 11

12 Influenza Vaccine Test Your Knowledge A patient walks into the pharmacy and would like you to administer the annual flu vaccine to her 10 year old daughter, Hannah. Hannah is healthy, has no chronic medical conditions, and is up to date on all of her childhood vaccinations. For the upcoming flu season , which is the most appropriate vaccine to use according to ACIP recommendations? A. Inactivated quadrivalent influenza vaccine (Fluzone ) B. Live attenuated influenza vaccine (Flumist nasal spray) C. Intradermal inactivated influenza vaccine (Fluzone Intradermal) D. A or B only E. Any of the above Herpes Zoster saintangelandcreative.com 12

13 Herpes Zoster Vaccines 2018 ACIP Recommendations Zoster vaccine recombinant (RZV) is recommended for the prevention of herpes zoster and related complications in immunocompetent adults aged 50 years RZV is recommended in immunocompetent adults who previously received zoster vaccine live (ZVL); RZV should not be administered <2 months after receipt of ZVL RZV is preferred over ZVL for the prevention of herpes zoster and related complications Special Populations History of herpes zoster, chronic medical conditions, immunocompromised, varicella zoster virus negative persons Shingrix Preferred Over Zostavax In October 2017, Shingrix, a recombinant lyophilized varicella zoster virus (RZV) glycoprotein E (ge) antigen vaccine, was approved by the FDA Development occurred due to concerns for long-term efficacy and increased incidence of herpes zoster Shown to reduce the occurrence of shingles by 96.6% in patients aged 50 to 59 years, 97.4% in patients aged 60 to 69 years, and 91.3% in patients aged 70 years compared to about 50% in patients aged 60 years with Zostavax Among those aged 50 years, vaccine efficacy against postherpetic neuralgia was 91.2% and 88.8% in those aged 70 years compared to only 39% with Zostavax

14 Warn Your Patients! Shingles Vaccines Shingrix shown to be very reactogenic with pain/swelling at injection site, malaise, aches, and symptoms interfering with daily activities Incidence much higher most likely due to adjuvant NEJM Journal Watch blog comment about Shingrix I got my first vaccine last week since I received the live vaccine 15 years ago. I thought the price would be the most painful component since it isn t covered by Medicare. I can t overemphasize how painful that shot was. I could perform most of my daily activities once I was able to put a shirt on. When it came to swimming my daily mile of freestyle which I rarely miss that was delayed for 3 days when I could finally raise my arm. Vaccine Administration Errors Involving Recombinant Zoster Vaccine United States, MMWR Weekly / May 25, 2018 / 67(20); During the first four months of monitoring, VAERS received 155 reports involving Shingrix (RZV) 13 administration errors (SQ instead of IM) Inappropriate age Incorrect VIS Incorrect storage Administration of only adjuvant component without reconstitution with vaccine antigen Shingrix should be given intramuscularly in two doses The second dose should be administered 2 to 6 months after the first Zostavax (ZVL) should be given subcutaneously in one dose

15 Key Differences between Herpes Zoster Vaccines Shingrix Demand Outpaces Supply May 1, 2018 CDC states providers should expect ordering limits and shipping delays through end of June GSK is working to make more doses available Shingrix vaccination recommendations remain the same regardless of shortages CDC Update June 2018 Due to high levels of demand for GSK s Shingrix vaccine, GSK has implemented order limits and providers have experienced shipping delays. It is anticipated these order limits and shipping delays will continue throughout In response, GSK has increased the US supply available for 2018 and plans to release doses to all customer types on a consistent and predictable schedule for the rest of Overall, the supply of Shingrix during 2018 is sufficient to support the vaccination of more patients during 2018 than were vaccinated against shingles during

16 A patient was inadvertently given RZV by the subcutaneous rather than the intramuscular route. Does the dose need to be repeated? RZV has been shown to be immunogenic when given by the subcutaneous route. A dose erroneously given by this route does not need to be repeated. Hepatitis B Vaccine 11/09/2017: FDA approved HEPLISAV-B, a recombinant adjuvanted Hepatitis B vaccine for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults 16

17 CHIP 7/6/2018 Mumps and New Recommendations Mumps outbreaks still occur in highly vaccinated US communities, especially in close contact settings Recent increase from 229 cases in 2012 to 6,366 cases in doses of mumps vaccine = 88% effective at preventing disease; 1 dose = 78% effective Studies have shown 78% lower risk of mumps with 3-dose regimen ACIP recommends third dose to all persons previously vaccinated with 2-dose series at increased risk due to an outbreak EBOLA ZIKA C DIFF PATCH CANCER Developing one vaccine is estimated to cost $200 million and at least 10 years Innovators are thinking outside the syringe for new ways of developing, shipping, storing, and administering vaccines In the last 20 years, over 21 million hospitalizations and 732,000 deaths could have been saved by existing vaccines in the US alone

18 Immunization for the Ages IN LOUISIANA Influenza vaccine: -may be administered without a Rx to anyone 7 years -may be administered with a Rx to anyone 3 years ANY vaccine: -may be administered without a Rx to anyone 17 years THINGS TO REMEMBER Documentation is required for ALL vaccines administered, update BLS every 2 years and send to LABP, 1 hour Immunization-related CE per year, OSHA/Bloodborne Pathogen training, sign up for LINKS From 2010 to 2016 influenza seasons, there were shoulder injury reports in 130 million doses Best strategy to minimize injury = maintain same level as patient and target lower two-thirds of the deltoid muscle

19 Document in LINKS and VAERS In-depth demonstration of the two methods for submitting VAERS report electronically /watch?v=9ivczqfohew References Centers for Disease Control and Prevention Vaccines and Immunizations - ACIP Vaccine-Specific Recommendations - Immunization Schedules for Health Care Professionals - Vaccination Coverage Rates and Data/NIS - American Pharmacists Association APhA Pharmacy-Based Immunization Delivery Certificate Training Program, 14th edition - Mospan, C. New Vaccines and Immunization Schedule Changes. 19

20 Questions 20

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