IMMUNIZATION UPDATE: 2015 Patti Fabel, PharmD Clinical Assistant Professor SC College of Pharmacy USC Campus

Transcription

1 IMMUNIZATION UPDATE: 2015 Patti Fabel, PharmD Clinical Assistant Professor SC College of Pharmacy USC Campus Learning Objectives - Pharmacists Advocate for patients receiving all recommended immunizations Apply updates to national immunization recommendations to patient cases Evaluate recently published vaccine-efficacy studies Compare and contrast available influenza vaccine products Define proper vaccine administration techniques Learning Objectives - Technicians Advocate for patients receiving all recommended immunizations. Explain the technician s role in providing immunizations Summarize updates to national immunization recommendations List available influenza vaccine products Review proper vaccine storage and handling 1

2 Healthy People Influenza Patient Population Goal May 2013 May months-17 years 80% 56.6% years 80% 41.5% 65 years 90% 64.9% Influenza Vaccination Rates Children Adults Healthy People Zoster Overall White Black Asian Hispanic % 16.6% 4.5% 12.7% 4.4% % 17.6% 7.9% 14.0% 8.0% % 22.8% 8.8% 16.9% 8.7% 2013 Herpes Zoster Goal 30% MMWR 2013; 62(04);66-72 MMWR 2014; 63(05);

3 Healthy People Pneumococcal Pneumococcal 65 years & older 90% years, high risk 60% Pneumococcal Vaccination Rates 2011 Subgroup Overall White NH Black NH Hispanic 65 years 62.3% 66.5% 47.6% 43.1% years, high risk 2012 What about 2013?? 20.1% 20.1% 22.8% 18.3% Subgroup Overall White NH Black NH Hispanic 65 years 59.9% 64.0% 46.1% 43.4% years, high risk 20.0% 21.4% 19.7% 13.8% MMWR 2013; 62(04);66-72 Tdap Vaccination Rates years 65+ years with infant % No data 21.5% % 16.8% 25.9% 2013 MMWR 2013; 62(04);66-72 MMWR 2014; 63(5);

4 DHEC received some grant monies to increase the immunization rates in South Carolina. They decide to hold a stakeholder meeting to determine the best approach. You were asked to attend this meeting to represent pharmacy. A lot of ideas are mentioned and there is great discussion. However in the middle of the discussion, the person leading the conversation turns to you and asks, And what is pharmacy s role in all of this? How would you respond? Pharmacists Roles Advocate for vaccination Facilitate the administration of vaccines Immunize patients against vaccine preventable diseases Technicians Role Technicians cannot administer medications Technical tasks to help free up the pharmacist to administer the vaccine Ordering Ensuring proper storage Advocating for vaccination / Marketing Patient screening form Prescription processing / Billing Drawing up doses 4

5 Student Pharmacists Students must be Certified to administer immunizations Up-to-date on immunizations (HepB) Directly supervised by a immunization-certified pharmacist CPR or BLS for HCP certified Check with state s Board of Pharmacy SC: Senate bill 413 signed into law June 2015! Check employer s policy CDC and HHS Request Help from Pharmacists Increase Awareness Ensure patients know their vaccination needs Offer Tdap Inform pregnant women about Tdap recommendations Offer flu vaccine to everyone Offer zoster vaccine to adults 60 years + Offer PPSV to adults 65 years + Recommend and offer vaccinations to high risk populations Enter vaccinations into registries and notify PCP Collaborate with local/state stakeholders D=28710&template=/CM/ContentDisplay.cfm Place of Influenza Vaccination Children (6mos-17rs) 18 years MDs office 64.9% 38.4% Hospital 4.2% 7.6% Clinic 18.3% 8.4% Health Department 3.6% 2.5% Pharmacy 2.9% 20.1% School/College 4.4% 1.1% Workplace n/a 17.6% MMWR.2013;62(SS#4):

6 How can we increase immunization rates? Recommend the vaccine Patients likely to follow recommendation of the provider Remind the Patients notification that immunizations are due soon Recall their Attention notification that immunizations are past due Reduce Missed Opportunities Standing orders/protocols Provider education Provider reminder/recall systems Mandates Schools, day cares, term of employment, etc. Increasing Appropriate Vaccination in Health Care Systems Community Preventative Services Task Force recommends At least one intervention to increase client demand Reminder and recall systems Clinic-based client education Manual outreach AND at least one intervention to address either (or both) Enhance Access Expanded access in all health care settings Reduced client out-of-pocket costs Home visits Vaccination Providers Education Provider reminders Standing orders Provider assessment and feedback CDC Letter to Pharmacists Thanks us for our efforts to improve adult vaccination rates Addresses concerns regarding differences between FDA-approved indications and ACIP recommendations Zoster Tdap Discusses ACIP s process in developing recommendations ANSWER: Follow ACIP s recommendation ACIP recommendations are supported by federal laws and resources. 6

7 Senate Bill 413 Signed into Law!! June 2015 Immediate changes: RPh s can administer ANY vaccine to ANY patient REGARDLESS of age as long as we have a valid prescription Student Pharmacists, meeting eligibility requirements, can administer vaccines Requires Joint Pharmacist Administered Immunization Committee recommendation and then Board of Medical Examiners approval: Influenza to patients 12 years Additional vaccines without a prescription to patients 18 years DRAFT Changes Current as of September 11 th, 2015 needs final vote from committee and approval by BME Updated language regarding: Screening questions CPR and BLS for HCP courses Emergency kit (need a mat and a log) Vaccination Record Cards Documentation signatures of intern/supervising RPh Administer any FDA-approved formulation of vaccines contained within protocol Hib, HepA/HepB, HPV, Meningococcal (excludes MenB), Pneumococcal, Td/Tdap, Varicella, Zoster Pharmacist responsibility to adhere to most current ACIP recommendations & dosing/administration guidelines provided in package inserts and by ACIP 7

8 Influenza Vaccine WHO Recommendations A/California/7/2009 (H1N1) A/Texas/50/2012 (H3N2) B/Massachusetts/2/2012 Quadrivalent vaccines above three viruses plus: B/Brisbane/60/ Flu Vaccine Efficacy for year Early estimates (Nov Jan) Based on 2321 children and adults Overall effectiveness at preventing medically attended acute respiratory illness is 23% Recommend antivirals to patients at high risk for complications Continue vaccinating may lesson severity MMWR 2015;64(1): Influenza Vaccine WHO Recommendations: A/California/7/2009 (H1N1) A/Switzerland/ /2013 (H3N2) B/Phuket/3073/2013 Quadrivalent vaccines contain the above three viruses plus: B/Brisbane/60/2008 MMWR. 2015:64(21) 8

9 Influenza Vaccine Available Doses Manufacturer Projected Supply in Doses Medimmune (Flumist) 16 million biocsl (Aflura) 18 million GSK (Fluarix)* million Novartis (Fluviron, Flucelvax)# million Protein Science (Flublok) 1.5 million Sanofi Pasteur (Fluzone) 64 million TOTAL 173 million *Only Quadravalent in #flu vaccine merger with biocsl Brand Name Manufacturer Type Age Route Afluria biocsl IIV3 9 yrs + IM FluLaval ID Biomed. Corp IIV3 3 yrs + IM FluLaval Quad. ID Biomed. Corp IIV4 3 yrs + IM Fluarix Quad. GSK IIV4 3 yrs + IM FluMist Quad. MedImmune LAIV yrs Nasal Fluvirin Novartis IIV3 4 yrs + IM Fluzone Sanofi Pasteur IIV3 6mo + IM Fluzone Quad. Sanofi Pasteur IIV4 6mo + IM Fluzone ID Sanofi Pasteur IIV years ID Fluzone-HD Sanofi Pasteur IIV3 65 yrs + IM Flucelvax Novartis cciiv3 18 yrs + IM FluBlok Protein Sciences RIV3 18 yrs + IM MMWR 2015;65(30): PharmaJet with Aflura Assess immunogenicity and safety of IIV3 Needle-free jet injector vs needle & syringe 1250 employees of University of Colorado health system (18-64 years) ; during flu season 627 PharmaJet 623 needed&syringe Conclusion Geometric mean titers were non-inferior PharmaJet system is an appropriate alternative to patients not wanting to use traditional needle&syringe McAllister L, et al. Lancet. 2014;384:

10 PharmaJet with Aflura PJS NS P-value PJS NS P-value w/in 30 min of vaccination 4-6 days after of vaccination Tender. 16.7% 5.8% < % 4.1% <0.001 Itching 10.1% 2.7% < % 1.5% <0.001 Redness 18.1% 1.8% < % 1.8% <0.001 Swelling 0.8% 0.0% % 2.0% <0.001 Bruising 0% 0% NA 8.2% 1.8% <0.001 Pain 26.2% 11.1% < % 2.3% 0.02 McAllister L, et al. Lancet. 2014;384: Influenza Recommendations for Children 2014: LAIV is preferred for healthy children 2 through 8 years 2015: Preference is removed MMWR 2015;64(30): High Dose vs Standard Dose Flu Vaccine IIV3-SD versus IIV3-HD on antibody response and laboratoryconfirmed illness in patients 65 years and older 56% female; 73 years old; 94% white 31,989 patients: received IIV3-HD and received IIV3-SD 228 pts in HD had LCII vs. 301 pts in the SD 24.2% relative efficacy (95% CI: %) Antibody Titers were significantly higher in the IIV3-HD group compared to the SD group Stayed even in year 2 DiazGranados CA, et al NEJM. 2014;371:

11 Patients with Egg Allergy MMWR 2015;64(30): Which of the following patients can receive Afluria via the PharmaJet system? A. A 70 year old female B. A 13 year old male C. A 28 year old female D. A 7 year old female Your pharmacy stocks the influenza vaccines listed below. Which one(s) can be given to a: year old Type 1 Diabetic year old healthy patient 3. 4 year old healthy patient year old pregnant female year old with high cholesterol A. Fluzone ID B. Fluzone HD C. Afluria D. Flumist E. Flublok 11

12 A 68 year old male patient has an anaphylactic reaction when he consumes eggs. Which of the following vaccines is safe for him to receive during the flu season? A. Fluzone HD B. FluBlok C. Flucelvax D. None of the above are safe for him to receive One Dose of PPSV23 Pneumovax-23 Adults at least 65 years old Chronic lung disease Chronic cardiovascular diseases (minus HTN) Diabetes Mellitus Chronic renal failure Nephrotic syndrome Chronic liver disease Alcoholism Chochlear implants Cerebrospinal fluid leaks Immunocompromising condition Functional or anatomic asplenia Residents of NH and LTC facilities Smokers MMWR 2014; 63(05); Two Doses of PPSV23 Pneumovax-23 Adults years who have Chronic renal failure Functional or anatomic asplenia Immunocompromising condition Adults 65 years and older Received their first dose before turning 65 years AND has been at least 5 years from first dose MMWR 2014; 63(05);

13 PCV13 Prevnar-13 Routine childhood vaccine schedule 2013 Approved for adults Recommended for adults (with certain conditions) in addition to PPSV23 August 2014 Recommended it for ALL patients 65 years and older PCV and Pneumococcal Pneumonia in Adults Randomized, double-blind, placebo-controlled trial 42,240 patients at least 65 years PCV13 42,256 patients received placebo Difference in rates of first episode of pneumococcal CAP Nonbacteremic and noninvasive pneumococcal CAP Invasive pneumococcal disease Results: PCV13 Placebo Efficacy 95% CI 1 st CAP % NB NI CAP % Invasive % NEJM2015;372: Pneumococcal Recommendations Vaccination Status/Needs PCV13 Spacing PPSV23 Spacing No previous vaccination or history is unknown Previous vaccination with PPSV23 (one or two doses) Already received one dose of PPSV23 but still needs a 2 nd dose Give first 1 year after last PPSV23 dose 1 year after last PPSV23 dose 12 months later* None needed 12 months after PCV13 dose* AND 5 years after first PPSV23 dose *12 month spacing is for 65 years+; patients < 65 years can receive PPSV23 at least 8 weeks after PCV13 MMWR 2015;64(34):

14 Spacing for 65 years & 1-dose PPSV Preferred Spacing PCV13 First Wait 12 months PPSV23 Alternative Spacing PPSV23 first Wait 12 months PCV13 MMWR 2015;64(34):944-7 Spacing for 65 years & 2-doses PPSV Preferred Spacing PCV13 First Wait 12 months 1 st dose of PPSV23 Wait 5 years 2 nd Dose of PPSV23 Alternative Spacing #1 1 st dose of PPSV23 first Wait 12 months PCV13 Wait 5 years from PPSV & 12 months from PCV13 2 nd Dose of PPSV23 Alternative Spacing #2 1 st dose of PPSV23 first Wait 5 years 2 nd dose of PPSV23 Wait 12 months PCV13 MMWR 2015;64(34):944-7 A 68 year old patient received PPSV23 5 years ago. What pneumococcal vaccines (if any) does he need? A. Second dose of PPSV23 B. PPSV23 and PCV13 today C. PCV13 now, PPSV23 in 12 months D. PCV13 only E. He does not need any more Pneumococcal vaccines 14

15 Adjuvanted Herpes Zoster Subunit Vaccine Randomized, placebo-controlled, phase 3 trial Evaluate efficacy and safety of HZ/su (subunit vaccine containing varicellazoster virus glycoprotein E and the ASO1b adjuvant system) Patients at least 50 years of age 2 IM doses 2 months apart 7698 received HZ/su 7713 received placebo Mean follow-up 3.2 years Results HZ/su 6 patients had shingles Placebo 210 patients Vaccine Efficacy 97.2% (95% CI: ) NEJM 2015;372(22): Meningococcal Vaccines MenACWY-CRM (Menveo) 2, 4, 6 and 12 months 1 st booster 3 years later and every 5 years Functional or anatomic asplenia Risk of outbreak Traveling to or residing in regions where meningitis is epidemic MenACWY-D (Menactra) 9 and 12 months 1 st booster 3 years later and every 5 years Same indications as Menveo (minus asplenia) Hib-MenCY-TT (MenHibrix) 2, 4, 6 and months Can t use for booster dose Not for travel MMWR. 2014;63(24): Meningococcal Serogroup B Vaccine Trumenba (Wyeth) Approved for 10 through 25 years of age Provides protection against 4 serogroup B strains 3 dose series 0, 2 and 6 months Bexsero (Novartis) Approved for 10 through 25 years of age Given to students in 2013 during outbreak 2 dose series at least one month apart ACIP recommendations At risk and at least 10 years of age Persistent complement component deficiencies Anatomic or functional asplenia Microbiologists exposed to Nisseria meningitides Serogroup B meningococcal disease outbreak MMWR. 2015;64(22) 15

16 Previous HPV Recommendations HPV4 or HPV2 for females years of age 13 to 26 years of age if not previously vaccinated HPV4 for males aged years years may be vaccinated MSM or immunocompromised (through age 26 years) should be vaccinated MMWR 2014;63(5) HPV Vaccination Rates & Safety dose 48.7% 53.0% 53.8% 57.3% Girls 2 doses 40.7% 43.9% 43.4% 47.7% 3 doses 32.0% 34.8% 33.4% 37.6% 1 dose 8.3% 20.8% 34.6% Boys 2 doses 3.8% 12.7% 23.5% 3 doses 1.3% 6.8% 13.9% 67 million doses of HPV4 / 719,000 doses of HPV2 25,176 reports of adverse events HPV4 was 99% of reports 92.4% classified as nonserious Injection site reactions, syncope, nausea, headache MMWR 2014;63(29):620-4 Reasons for Non-vaccination Lack of knowledge 15.5% Not needed or necessary 14.7% Safety concerns 14.2% Not recommended 13.0% Not sexually active 11.3% MMWR 2014;63(29):

17 Gardasil-9 Human Papillomavirus 9-valent vaccine approved by FDA on December 10, 2014 Covers HPV types 16, 18, 31, 33, 45, 52, 58 for cancers Cause 20% of cervical cancers not previously covered Covers HPV types 6 and 11 for genital warts Approved for females 9 through 26 years Males 9 through 15 years Cost Effectiveness Significant for HPV4 (gender neutral) HPV9 females only Addition benefit seen in cervical screenings Current HPV Recommendations All females years Three doses of HPV-9, HPV-4 (as long as supplies last) or HPV-2 Can be given as early as 9 years Can be given as late as 26 years All males years Three doses of HPV-9 or HPV-4 (as supplies last) Can be given as early as 9 years Can be given as late as 21 years May consider it up to the age of 26 years MSM and Immunocompromised patients through age 26 years If previous vaccine is not available or not know, may continue series with whichever HPV vaccine is readily available MMWR 2015;64(11) 17

18 Proper Vaccine Administration Storing Medications Properly Assessing Vaccine Requirements Screening for Contraindications and Precautions Educating Patients about Vaccine Using Proper Injection Technique Appropriate Documentation Vaccine Storage Live Vaccines Freezing Deteriorate rapidly -58 to +5 degrees F Inactivated Vaccines Damaged by exposure to temperature fluctuations Refrigerated between 35 and 36 degrees F Check temperatures twice daily and keep a log! 18

19 Pre-Vaccination Staff Training and Education Patient Screening Vaccine Safety & Risk Communication Check vaccination expiration date Current Vaccine Information Statement Establish open dialogue Positioning of Patient Patient is always seated or lying down Infection Control Hand washing, gloves, safety device, disposal Pre-Vaccination Staff Training and Education Patient Screening Vaccine Safety & Risk Communication Check vaccination expiration date Current Vaccine Information Statement Establish open dialogue Positioning of Patient Patient is always seated or lying down Infection Control Hand washing, gloves, safety device, disposal Subcutaneous Route Outer triceps of the arm for adults 5/8 inch, gauge needle Pinch up the fatty tissue Insert needle at a 45 degree angle Inject vaccine Withdraw needle slowly Press site with cotton ball for several seconds 19

20 Intramuscular Route Deltoid Muscle Aspiration is not necessary no major blood vessels 22 to 25 gauge needle Insert needle at a 90 degree angle Inject vaccine Withdraw needle slowly Press site with cotton ball for several seconds IM Needle Size Gender Weight Needle Size Male or Female < 130 lbs 5/8 to 1 inch Male or Female lbs 1 inch Female lbs 1 to 1 ½ inch Male lbs 1 to 1 ½ inch Female > 200 lbs 1 ½ inch Male > 260 lbs 1 ½ inch A. Which of the following needles is most appropriate for administering Fluzone High Dose? B. C. 20

21 A 66-year-old male patient has diabetes and hypertension and smokes a pack of cigarettes a day. He does not have any medication or vaccine allergies. His vaccination record shows that he completed all of his childhood vaccinations (DTaP, Hib, PCV, IPV, and MMR) as well as the Hep B series, he had the chickenpox when he was 5 years old and received his last Td booster 11 years ago. He received a PPSV23 vaccine 3 years ago at age 63. Which vaccines should this patient receive? 21