Deanna Tran, PharmD, BCACP Assistant Professor Cherokee Layson-Wolf, PharmD, BCACP Associate Professor

Transcription

1 Deanna Tran, PharmD, BCACP Assistant Professor Cherokee Layson-Wolf, PharmD, BCACP Associate Professor

2 Disclosures Deanna Tran declares no conflicts of interest, real or apparent, and no financial interest in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

3 Disclosures Cherokee Layson-Wolf declares the following disclosure: Pfizer Pharmacist Advisory Panel

4 Learning Objectives At the end of the presentation, participants should be able to: Identify target populations for specific vaccines Apply specific information to the storage, preparation, and administration aspects of vaccine delivery Apply program management aspects to vaccination delivery such as documentation, billing and marketing.

5 Influenza

6 Who Wants to Be a Millionaire? Immunization Version Part 1

7 Fill in the blank. $1,000 Question 50:50 The influenza vaccine is indicated for all individuals. Team A. 1 year old and older B. 6 months old and older C. 8 months old and older D. 2 years old and older

8 Vaccine information 0.5mL dose Intramuscular Indication Influenza Vaccine Individuals 6 months Common side effects Injection site reaction

9 Fill in the blank. $5,000 Question 50:50 In the flu season, the influenza vaccine was contraindicated in individuals who have an anaphylactic reaction to. Team A. Eggs B. Latex C. Yeast D. Gentamycin

10 Egg allergy? Contraindications Severe allergic reaction from previous influenza vaccine Vaccine should be administered, regardless of allergic history, where recognition and treatment of anaphylaxis are available History of egg allergy should receive the influenza vaccine. Any vaccine is appropriate Vaccinate in an inpatient or outpatient medical setting under supervision of healthcare provider to manage possible severe allergic conditions

11 Influenza Vaccine Effectiveness CDC observational data Age 2-17 Any Virus A/H1N1 B-Yamagata B-Victoria IIV LAIV Ages 2-8 Any Virus A/H1N1 B IIV LAIV Ages 9-17 Any Virus A/H1N1 B IIV LAIV Credit: From Dr. Stephan Foster, June 2015 ACIP Immunization Update, APhA

12 Influenza Vaccine Effectiveness CDC observational data Mixed H3N H3N H1N H3N2 IIV LAIV LAIV H1N2 Credit: From Dr. Stephan Foster, June 2015 ACIP Immunization Update, APhA

13 Discussion of Vaccine Effectiveness Further discussion necessary Not randomized controlled trial Potentially limited sample size AstraZeneca ICICLE Study demonstrated similar effectiveness Could not provide explanation for differences Possible explanations Related to addition of B strain for quadrivalent Reduced immunogenicity of LAIV due to intranasal administration

14 LAIV Recommendations LAIV not recommend for influenza season

15 Effects of LAIV recommendations Decreased access? Individuals who do not like injections Children Shortages? Cannot measure effectiveness if it is not recommended

16 Timing of Influenza Vaccine Vaccine should be provided by October Vaccine should continue to be provided as long as virus is still circulating Observation period is 15 minutes after vaccination

17 New Vaccines Adjuvanted inactivated influenza vaccine (Fluad) Adjuvant to increase body s immune response to vaccine Indicated for 65yo Cell cultured (Flucelvax) Quadrivalent

18 Trivalent Influenza A/California/7/2009 (H1N1 like virus) A/Hong Kong/4801/2014 (H3N2 like virus) B/Brisbane/50/2008 (Victoria lineage) Quadrivalent Addition of B/Phuket/3073/2013 (Yamagata lineage)

19 Influenza Vaccine Options Vaccine type Inactivated (IIV) Strains Trivalent (IIV3) Quadrivalent (IIV4) Delivery method Intramuscular Intradermal (Fluzone Intradermal) High dose (Fluzone HD, IIV3) Recombinant (Flublok, RIV/RIV3) Cell cultured (Flucelvax, cciv4) Adjuvanted Inactivated (Fluad, aiiv3)

20 Influenza Vaccine Summary Indication Individuals 6 months (unless contraindicated) No longer have egg allergy as a contraindication New vaccine strains and available vaccines Provide vaccine by October if possible

21 Meningococcal

22 $10,000 Question Meningococcal vaccine could cause which of the following diseases? 50:50 Team A. Meningitis B. Bacteremia C. Septicemia D. All of the above (A, B, C)

23 Meningococcal Disease Neisseria meningitidis Serogroups B, C, and Y are major culprits Cause of meningitis, bacteremia, septicemia

24 Fill in the blank. $50,000 Question 50:50 Meningococcal vaccine is a vaccine. Team A. Live B. Inactivated

25 Meningococcal Vaccines Vaccine information Routine administration 11-18yo (11-12yo, 16yo) Inactivated, 0.5mL doses Vaccine Type Serogroups Indicated Age Administration Menactra Conjugate ACWY 9mo 55yo IM Menomune Polysaccharide ACWY 2yo+ SubQ Menveo Conjugate ACWY 2mo 55yo IM MenHibrix Conjugate CY (Hib) 6 weeks- 18mo IM

26 Meningococcal Vaccines Common side effects Injection site reaction Contraindications Severe allergic reaction to previous meningococcal vaccine

27 Meningococcal ACYW Vaccine High risk patients 2-23 months Schedule Initiating 2-6 months: 4 dose series Initiating 7-23 months: 2 dose series Indication Complement component deficiencies (C3, C5-C9, properdin, factor D, factor H) Functional or anatomic asplenia Sickle cell disease Infants in an area with active meningococcal disease outbreak Traveling to an area where meningococcal disease is hyperendemic or experiencing epidemic Individuals with HIV 2 months old

28 Serogroup B Meningococcal Vaccines Vaccine Type Serogroups Indicated Age Administration Bexsero Recombinant B 10-25yo IM Trumenba Recombinant B 10-25yo IM Trumenba: 2 and 3 dose series 0, 1-2 months, 6 months 0, 6 months Bexsero: 2 dose series 0, 1-6 months

29 New Serogroup B Meningococcal Vaccines Recommendations 10 yo at increased risk for meningococcal disease Persistent complement component deficiencies Anatomic or functional asplenia Microbiologists routinely exposed to Neisseria meningitidis At increased risk due to serogroup B meningococcal disease outbreak 16-23yo short-term protection (optional)

30 Meningococcal Summary All individuals should be vaccinated with the quadrivalent vaccine Indicated for high risk infants including those with HIV Serogroup B vaccine for patients with increased risk, and optional short term protection for 16-23yo

31 Human Papillomavirus Infection (HPV)

32 Fill in the blank. $100,000 Question 50:50 HPV is the MOST common STD. One in every individuals in the United States are infected. Team A. Two B. Four C. Six D. Eight

33 Human Papillomavirus Infection Most common STD More than 100 serotypes High risk: 16, 18, 31, 33, 39, 45, 51, 52, 58 Found in 99% of cervical cancers Low risk types: 6, 11, 40, 42, 43, 44, 54

34 HPV Vaccines Vaccine information Inactivated 0.5mL dose Intramuscular Indications All children years old Given as early as 9 years old Catch up series through age 26 Females: Prevention of anal, cervical, vulvar, vaginal cancers, precancerous or dysplastic lesions, genital warts Males: Prevention of anal cancer, precancerous or dysplastic lesions, genital warts

35 HPV Vaccines 3 dose series: Age dose series: Age 9-14 Not recommended in pregnancy Common side effects Injection site reaction Headache Possible fainting

36 HPV Recommendations Vaccine Serotypes Indications Dosing Status Cervarix (2vHPV) Gardasil (4vHPV) Gardasil 9 (9vHPV) 16, 18 Females 9-26 yo 0, 1, 6 months 6, 11, 16, 18 Males & Females 9-26 yo 6, 11, 16, 18, 31, 33, 45, 52, 58 Males & Females 9-26 yo 0, 2, 6 months 0, 2, 6 months Withdraw 11/2016 Withdraw end of 2016

37 HPV Vaccine Counseling Does not prevent against sexually transmitted diseases Continue regular screenings Cervical cancer screenings (females, starting age 21yo) Anal cancer screenings (including men who have sex with men)

38 HPV Summary Recommend Gardasil 9 (9vHPV) All children years old 3 dose series (0, 2, 6 months) Contraindication: hypersensitivity to yeast

39 Measles, Mumps, Rubella

40 $250,000 Question Mumps cause which of the following complications? 50:50 Team A. Swelling of the testicles or ovaries B. Deafness C. Inflammation of the brain and spinal cord D. Death

41 Mumps Mumps virus Cold like symptoms Fever, headache, muscle ache, tiredness, loss of appetite Parotitis Spread through close contact Incubation period days Complications Swelling of testicles or ovaries Deafness Inflammation of the brain Encephalitis/meningitis

42 Arkansas Mumps Outbreak 39 cases in Springdale, AR (9/8/16) Those who did not receive the vaccine are required to remain home New York 36 cases in Long Island, NY

43 Measles Very contagious infection caused by paramyxovirus group Symptoms: fever, cough, runny nose, conjunctivitis, Koplik spots, followed by maculopapular rash 14 days after exposure Complications: diarrhea, otitis media, pneumonia, encephalitis, and death

44 Fill in the blank. $500,000 Question 50:50 Measles is a highly transmissible disease. It requires of people to be vaccinated (immune) in order to protect the entire population (achieve herd immunity). Team A. 80% B. 85% C. 90% D. 95%

45 Measles Outbreak 189 people from 24 states and DC Largest number of cases since measles elimination was documented in the U.S. in 2000.

46 Cold like symptoms Complications Rubella Rubella: pregnant women - Miscarriage or serious birth defects for the baby

47 $1 MILLION Question Which of the following is true about the MMR vaccine? 50:50 Team A. It is an inactivated vaccine B. It requires a 3 dose series C. Individuals born before 1957 do not need the vaccine D. It is given intramuscularly

48 MMR Vaccine Measles, mumps, and rubella Vaccine information Live vaccine Subcutaneous 0.5mL

49 MMR Recommendation Children 1st dose: months of age 2nd dose: 4-6 years old Adults Born 1957 or later should be given at least 1 dose of MMR Healthcare personnel (HCP) born in 1957 or later should get 2 doses of MMR (separated by 28 days) HCP before 1957 (acceptable evidence of measles), 2 doses should be considered for unvaccinated HCPs who don t have laboratory evidence. Consider at least 1 dose

50 MMR Contraindications Immunocompromised individuals Pregnant women Severe allergic reaction from vaccine component

51 MMR Summary Disease may not be prominent but it only takes one individual to cause an outbreak Get your MMR vaccine if you haven t already!

52 Just Keep Advocating. Discuss the consequences for the vaccinepreventable disease Bring awareness to vaccines Tell your story!! Dispel myths

53 Upcoming Vaccination Updates

54 Changes Coming Up! New recommendations for hepatitis Respiratory Syncytial Virus (RSV) vaccine needs Phase 1-3 trials for infants/children (liveattenuated vaccines), pregnant women (subunit vaccine), older adults (subunit inactivated vaccine) Tdap in pregnant women Potentially also recommending in 2 nd trimester

55 Zika Changes Coming Up! 18 agencies developing vaccine Phase one trials began 8/2

56 Who Wants to Be a Millionaire? Immunization Version Part 2

57 $1000 Question Refrigerated vaccinations should be kept at F degrees 50:50 Team A B C D

58 Storage of Vaccines Refrigerator Temperature o F Goal: 40 o F Freezer Temperature -58 to +5 o F

59 General Vaccination Storage Principles oolkit/storage-handling-toolkit.pdf

60 $5000 Question A needle is used to administer MPSV. 50:50 Team A. 5/8 B. 1

61 Administration of Meningococcal Meningococcal Conjugate (MCV4/MenACWY) Meningococcal serogroup B Meningococcal polysaccharide (MPSV) Vaccine Dose Route 0.5 ml IM 0.5 ml IM 0.5 ml SQ

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63 $ Question OSHA does NOT require the following when administering vaccinations 50:50 Team A. Gloves B. ECP C. SHARPS container D. Safer devices

64 OSHA Requirements Initial training and re-training annually Maryland occupational safety and health AV catalog: alog.pdf

65 $ Question requires that we document the date the VIS is given as well as the date on the VIS 50:50 Team A. CDC B. ACIP C. FDA D. VICP

66 Documentation requirements Patient Name Date administered Manufacturer/Lot Number Name, title, and address of vaccinator Date printed on VIS/Date VIS given

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68 $ 100,000 Question The length of time that vaccination records are maintained in Maryland for patients aged 18 and up 50:50 Team A. 1 year B. 5 years C. 7 years D. Indefinitely

69 Maryland Documentation Requirements Signed consent is required in Maryland Documentation must be maintained for 5 years for those age 18 and up Documentation for those under 18: maintained until age of majority OR 5 years, whichever is longer Required fields needed to be covered under VICP All vaccinations must be documented in Immunet (Maryland Immunization Information System) Patients must be requested to stay in area for 15 minutes for observation post vaccination

70 $ 250,000 Question A patient you immunized 5 minutes ago returns to the pharmacy complaining of itching and now has shortness of breath and wheezing. What is your first course of action? 50:50 Team A. Observe B. Administer diphenhydramine C. Call 911 D. Administer epinephrine

71 Responding to emergencies Emergency Kit Have an emergency plan and practice it Call 911 when you suspect anaphylaxis

72 $ 500,000 Question What is an effective means to communicate with a patient who is resistant to receiving a flu shot? 50:50 Team A. Immunize them while they re not looking B. Obtain an order of Tamiflu C. Motivational techniques D. Call their physician for an order

73 Communication techniques Ask for permission to discuss concerns Empathize/show concern Provide information on addressing myths or misconceptions Ask the patient for their thoughts The patient has the final decision!

74 $1 MILLION Question Are you up to date? 50:50 Team A. Yes B. No

75 Questions?

76 Travel Vaccinations

77 Cholera

78 Vibrio cholera Cholera Acute intestinal infection from ingestion of contaminated food/water Causes watery diarrhea Supportive treatment

79 Cholera Vaccine Vaxchora Approved 6/2016 Live vaccine Oral dose, Take at least 10 days before possible exposure Indicated for 18-64yo Covers 99% of the strains of cholera ADE: tiredness, headache, abdominal pain, N/V, diarrhea Duration: last 3-6 months No data on pregnancy, breastfeeding, immunocompromised individuals

80 Cholera Vaccine Recommendations Continue nonpharmacologic recommendations for safe food and water Recommended for those traveling to active cholera outbreak (not endemic) or have risk factors Blood type O Pregnancy Immunodeficiency CV or renal disease Low gastric acidity

81 Cholera outbreaks

82 Yellow Fever

83 Yellow Fever Yellow Fever (YF) Virus occurs in sub- Saharan Africa and South America Infectious Agent: Flavivirus, a singlestranded RNA virus Infection Initial infection: Sudden onset of fever, headache, chills, myalgia, nausea, vomiting Remission Progression: Jaundice, hemorrhagic symptoms, shock, multi-system organ failure, death Flaviviruses Mosquitoborne virus Flaviviridae Japanese Encephalitis Dengue virus Zika Virus Yellow Fever Pestivirus Tick borne virus 1. Gershman M, Staples JE. Yellow Fever. Yellow Book. Centers for Disease Control and Prevention. 2. Gardner CL, Ryman KD. Yellow Fever: A Reemerging Threat. Clin Lab Med 2010;30: Mirzaian E, Durham MJ, Hess K, et al. Mosquito-Borne Illnesses in Travelers: A Review of Risk and Prevention. Pharmacotherapy 2010;30(10):

84 Yellow Fever Outbreak Angola 2, 149 suspected cases (277 deaths) since December 2015 Cases from infected travelers from Angola in Democratic Republic of Congo, Kenya Pan American Health Organization declared epidemiological alert in April 2016 Country-wide vaccination programs have emerged

85 Yellow Fever Vaccine Live attenuated vaccine Given subcutaneously Indication: 9 months old and older Confers protection within 10 days

86 Yellow Fever Vaccine Update No booster needed Single primary dose is sufficient to sustain lifelong protection Supported by Systematic review of published data on duration of immunity Extremely rare vaccine failures Additional studies may be needed to determine potential need for high risk populations

87 Questions?