Needle Facts: Immunization Update 2016

Transcription

1 Needle Facts: Immunization Update 2016 Miranda Wilhelm, Pharm.D. Clinical Associate Professor Southern Illinois University Edwardsville School of Pharmacy

2 Disclosure / Conflict of Interest Miranda Wilhelm reports she is a Speaker s bureau member for Merck Vaccines

3 Learning Objectives: Pharmacists At the conclusion of this program, the pharmacist will be able to: Discuss the new 2016 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations. Review influenza vaccine considerations in preparation for the season. Evaluate a patient s immunization history to determine appropriate vaccine recommendations based on the appropriate immunization schedule.

4 Learning Objectives: Pharmacy Technicians At the conclusion of this program, the pharmacy technician will be able to: Discuss the new 2016 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations. Review influenza vaccine considerations in preparation for the season. Evaluate a patient s immunization history to determine appropriate vaccine recommendations based on the appropriate immunization schedule.

5 Testing Your Knowledge What is the correct interval for separation of PCV13 and PPSV23 in a 65 year old patient receiving pneumococcal vaccines for the first time? a. No separation needed, can be administered on the same day b. 6 months c. 1 year d. 5 years

6 Testing Your Knowledge Which of the following is a meningococcal serogroup B vaccine? a. Bexsero b. Boostrix c. Recombivax d. Menveo

7 Testing Your Knowledge Which of the following is a method to overcome barriers to immunization? a. Refer the patient to a pro-vaccine website b. Focus on the benefits of the vaccine and downplay the risks c. Use the I m the healthcare provider and you should do what I say approach d. Take time to listen to the patient s vaccine related concerns

8 Testing Your Knowledge Which influenza vaccine is approved for use with a needle-free injection device? a. Fluzone b. Afluria c. FluMist d. Fluarix

9 Summary of ACIP Recommendations 2015 Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Update: Shortened Interval for Post-vaccination Serologic Testing of Infants Born to Hepatitis B-Infected Mothers Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices (ACIP), Use of Vaccinia Virus Smallpox Vaccine in Laboratory and Health Care Personnel at Risk for Occupational Exposure to Orthopoxviruses Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2015

10 Intervals Between PCV13 and PPSV23 Vaccines MMWR, September 4, 2015; 64(34): What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation Harmonized the dosing interval All patients at 65 years of age should receive 1 dose of PCV13 followed 1 year later by 1 dose of PPSV23

11 Intervals Between PCV13 and PPSV23 Vaccines MMWR, September 4, 2015; 64(34):

12 Pneumococcal Vaccination Recommendations for Children and Adults by Age and or Risk Factor Pneumococcal Vaccination Recommendations for Children and Adults by Age and/or Risk Factor. IAC Website. Accessed June 13, 2016.

13 Interval for Post-vaccination Serologic Testing of Infants Born to Hepatitis B-Infected Mothers MMWR, October 9, 2015; 64(39): What recommendations are being reviewed? Why are the recommendations being reviewed now? What is the new recommendation? Recommendation Not ACIP statement but related document from CDC For infants born to hepatitis B- infected mothers, postvaccination serologic testing should be completed at age 9-12 months (or 1-2 months after final dose of the vaccine series)

14 Interval for Post-vaccination Serologic Testing of Infants Born to Hepatitis B-Infected Mothers MMWR, October 9, 2015; 64(39):

15 Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults MMWR, October 23, 2015; 64(41): What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation All adolescents aged 11 or 12 years should receive 1-dose of meningococcal conjugate vaccine (MenACWY) with a booster dose at age 16 MenB vaccine series may be administered to adolescents and young adults years. Preferred for years

16 Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults Age at MenB series Cases prevented Deaths prevented NNV to prevent case NNV to prevent death Cost per QALY (million $) 11 yrs ,000 1,512, yrs , , yrs , , College student ,000 2,297, MMWR, October 23, 2015; 64(41):

17 Trumenba [package insert]. Available at: Accessed June 23, Accelerated Supplement Approval Letter. Department of Health and Human Services. Available at: Accessed June 23, FDFA approved October 29, 2014 (Pfizer) First serogroup B meningococcal vaccine Approved for patients 10 to 25 years of age 3-dose series, IM, 0.5 ml dose administered at 0, 2 and 6- months apart April 14, 2016 FDA Update: Two-dose schedule (administered at 0 and 6 months) Modification of 3-dose schedule (0, 1-2 and 6 months)

18 FDA approved January 23, 2015 (Novartis) Second serogroup B meningococcal vaccine Approved for patients 10 to 25 years of age 2-dose series, IM, 0.5 ml dose administered at least 1 month apart Bexsero [package insert]. Available at: Accessed June 23, 2016.

19 Use of Vaccinia Virus Smallpox Vaccine in Laboratory and Health Care Personnel MMWR, March 18, 2016; 65(10): What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation Routine vaccination with ACAM2000 is recommended for laboratory personnel who directly handle Cultures or Animals contaminated or infected with vaccinia virus Health care personnel who treat patients with vaccinia virus or administer ACAM2000 vaccine can be offered vaccination

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21 Overcoming Barriers to Vaccinations - Misconceptions Better hygiene and sanitation reduce disease Vaccines do not work as vaccinated individuals sometimes get the disease Hot lots of vaccines are associated with adverse effects Reduced disease means vaccines are no longer needed Too many vaccines overwhelm the immune system Adjuvants and preservatives in vaccines cause medical problems

22 Better Hygiene and Sanitation Reduce Disease Better nutrition, antibiotics, less crowded living conditions, lower birth rates sanitation Increased survival rates Reduced disease transmission Decreased the number of susceptible individuals Permanent drops in disease incidence coincide with wide spread vaccine use Pertussis example Six Common Misconceptions about Immunization. World Health Organization Website. Available at: Accessed June 23,

23 Vaccines do not Work as Vaccinated Individuals Sometimes get the Disease No vaccine is 100% effective Vaccines take time to work Influenza example People vaccinated vastly outnumber those who have not Measles example Six Common Misconceptions about Immunization. World Health Organization Website. Available at: Accessed June 23,

24 Vaccines do not Work as Vaccinated Individuals Sometimes get the Disease 1,000 children 995 children vaccinated for measles 7 children did not respond to the vaccine 5 are unvaccinated for measles All children are exposed to measles and susceptible students become infected All 5 unvaccinated become infected 100% of those unvaccinated were infected 7/12 or 58% of those vaccinated were infected Six Common Misconceptions about Immunization. World Health Organization Website. Available at: Accessed June 23,

25 Hot Lots of Vaccines are Associated with Adverse Effects Surveillance systems lack information to establish causality between the vaccine and the adverse effect Sizes for vaccine lots vary significantly Six Common Misconceptions about Immunization. World Health Organization Website. Available at: Accessed June 23,

26 Reduced Disease Means Vaccines are No Longer Needed Patlak M. Breakthroughs in Bioscience. Federation of American Societies for Experimental Biology Website. Accessed June 13,

27 Too Many Vaccines Overwhelms the Immune System 30 years ago, children were protected against 8 diseases; utilizing more than 3,000 immunological components Today, children are protected against 14 diseases; utilizing 150 immunologic components Too Many Vaccines? What you should know. Children s Hospital of Philadelphia Newsletter. Spring 2015;3. Accessed June 13, 2016.

28 Ingredients of Vaccines Fact Sheet. CDC Website. Available at: Accessed June 13, Adjuvants and Preservatives in Vaccines Cause Medical Problems Suspending fluid Preservatives and stabilizers Adjuvants or enhancers

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30 How to Address Misconceptions Take time to listen Solicit and welcome questions Acknowledge benefits and risks Respect patient/parents authority Reduce the stress of shots Talking with Parents about Vaccines for Infants: Strategies for Health Care Professionals. CDC Website. Available at: Accessed June 13, 2016.

31 Influenza Influenza season is October to May and commonly peaks in January to February Annual influenza vaccination is recommended for all persons 6 months of age and older

32 Influenza Algorithm for Children 6 Months to 8 Years Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines. MMWR Recomm Rep 2016;65(No. RR-5):1 54..

33 Recommendation for Influenza Vaccination with Egg Allergy MMWR, August 15, 2014; 63(327):

34 Influenza Vaccination of Persons with Egg Allergy Recommendations for : Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive an age-appropriate influenza vaccine Persons who report having reactions to egg involving symptoms other than hives, may receive any age-appropriate influenza vaccine. Vaccine should be administered by a health care provider able to manage severe allergic conditions Previous sever allergic reaction to influenza vaccine is a contraindication to future doses. Removal of 30 minute post-vaccination observation period (15 minutes recommended for all persons, particularly adolescents, in case syncope occurs) Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines. MMWR Recomm Rep 2016;65(No. RR-5):1 54. Proposed Recommendations Influenza Season. CDC Website. Available at: Accessed: April 8, 2016.

35 Nomenclature for Influenza Vaccine Inactivated Influenza Vaccine (IIV) Quadrivalent inactivated influenza vaccine (IIV4) Trivalent inactivated influenza vaccine (IIV3) Cell cultured inactivated influenza vaccine (cciiv3) Adjuvanted inactivated influenza vaccine (aiiv3) Recombinant hemagglutinin Influenza Vaccine (RIV) Live-attenuated Influenza Vaccine (LAIV) Quadrivalent live-attenuated influenza vaccine (LAIV4)

36 Recommended Influenza Vaccine Composition A/California/7/2009 (H1N1)pdm09-like virus A/Hong Kong/4801/2014 (H3N2)-like virus B/Brisbane/60/2008-like virus Additional strain for quadrivalent vaccines B/Phuket/3073/2013-like virus Recommended composition of influenza virus vaccines for use in the northern hemisphere influenza season. World Health Organization Website. Available at:. Accessed April 8, 2016.

37 Vaccine Inactivated Influenza Vaccine (IIV4) Fluarix Quadrivalent FluLaval Quadrivalent Fluzone Quadrivalent Fluzone Intradermal Quadrivalent Inactivated Influenza Vaccine (IIV3) Afluria Fluvirin Fluzone High-Dose Adjuvanted Inactivated Influenza Vaccine (aiiv3) Fluad Inactivated Influenza Vaccine Cell-Culture (cciiv4) Flucelvax Recombinant Influenza Vaccine (RIV3) Flublok Live Attenuated Influenza Vaccine (LAIV4) FluMist Quadrivalent Seasonal Influenza Vaccines Approved Age Indication 3 years 3 years 6 months 18 to 64 years 9 years needle/syringe 18 to 64 years jet injector 4 years 65 years 65 years 4 years 18 years 2 to 49 years (healthy, non-pregnant)

38 New Influenza Vaccine Fluad, influenza vaccine adjuvanted Approved November 24, 2015 First influenza vaccine approved containing an adjuvant (MF59C.1) Squalene based oil-in-water emulsion Trivalent inactivated influenza vaccine (IIV3) Indicated/approved for 65 years of age and older Efficacy study Fluad induced antibody levels that were comparable to non-adjuvanted vaccine Safety ADEs include injection site pain and tenderness, muscle aches, headache, fatigue FDA approves first seasonal influenza vaccine containing an adjuvant. FDA Website. Available at: Accessed June 29, 2016.

39 Needle-free Injector Technology FDA Approves PharmaJet Stratis for use with Afluria August 15, 2014 Indicated for 18 to 64 years old Afluria Vaccines, Blood and Biologics. FDA Website. Available at: Accessed June 23, 2016.

40 Needle-free Injector Technology Immunogenicity and safety trial published in Lancet 2014 Aug 23;384(9944): Immune response to influenza given by jet injector was non-inferior to needle and syringe Higher frequency of injection site reactions

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45 Case 1 NS is an 17 year old male who is completing college visits and entrance applications for next fall. At a recent college visit the health services representative mentioned several vaccines he may need to receive before starting college. He had not considered this. NS has approached the pharmacist about what vaccines he may need. What is the first question that you should ask NS about immunizations?

46 NS s Profile and Immunization Record Profile Multiple vitamin 1 PO Daily Amoxicillin 500 mg 1 PO BID x 10 days (August 2016) Immunization Record Up-to-date at 5 year old well child visit

47 Screening Questionnaire Screening Question Response 1. Are you sick today? No 2. Does the child have allergies to medications, food, a vaccine component, or latex? No 3. Has the child had a serious reaction after receiving a vaccine in the past? No 4. As the child had a health problem with lung, heart kidney or metabolic disease (e.g. diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy? 5. If the child to be vaccinated is 2 through 4 years of age, has a healthcare provider told you that the child had wheezing or asthma in the past 12 months? 6. If your child is a baby, have you ever been told he or she has had intussusception? N/A 7. Has the child, a sibling, or a parent had a seizure; has the child had brain or other nervous system problems? No No N/A 8. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? No 9. In the past 3 months, has the child taken medications that affect the immune system, such as prednisone, other steroids, or anticancer drugs; drugs for the treatment of rheumatoid arthritis, Crohn s disease, or psoriasis; or had radiation treatments? No 10. In the past year, has the child received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? No 11. Is the child/teen pregnant or is there a chance she could become pregnant during the next month? N/A 12. Has the child received vaccinations in the past 4 weeks? No What vaccinations are recommended for NS?

48 Schedule for Persons Aged 0 Through 18 Years

49 Case 1 Summary Inactivated influenza vaccine (IIV3/IIV4) Meningococcal conjugate vaccine (MCV4) Human papillomavirus vaccine (HPV9) Meningococcal serogroup B vaccine

50 Case 2 AW, a 70 year old female, presents to the community pharmacy for an annual influenza vaccine. What is the first question that you should ask AW about immunizations?

51 AW s Profile and Immunization Record Profile Metformin 1,000 mg 1 PO BID Lisinopril 20 mg 1 PO Daily Atorvastatin 40 mg 1 PO QHS Levothyroxine 100 mcg 1 PO Daily Alendronate 70 mg 1 PO Weekly Calcium citrate 200 mg + Vitamin D 250 IU 2 PO BID Aspirin 81 mg 1 PO Daily Multiple Vitamin 1 PO Daily Immunization Record Influenza yearly X 20 years Pneumonia shot at 65 years Unsure of childhood immunizations

52 Screening Questionnaire Screening Question Response 1. Are you sick today? No 2. Do you have allergies to medications, food, a vaccine component, or latex? YES 3. Have you ever had a serious reaction after receiving a vaccination? No 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g. diabetes), anemia, or other blood disorder? 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? No 6. In the past 3 months, have you taken medications that affect your immune system, such as prednisone, other steroids, or anticancer drugs; drugs for the treatment of rheumatoid arthritis, Crohn s disease, or psoriasis; or have you had radiation treatments? 7. Have you had a seizure or a brain or other nervous system problem? No 8. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? 9. For women: Are you pregnant or is there a chance you could become pregnant during the next month? No 10. Have you received any vaccinations in the past 4 weeks? No YES No No What vaccinations are recommended for AW?

53 Schedule for Adults by Age and Medical / Other Indications

54 Neomycin Allergy What do we do? Fluzone Package Insert / Pink Book Table Boostrix Package Insert / Pink Book Table Zostavax Package Insert / Pink Book Table Prevnar 13 Package Insert / Pink Book Table Recombivax Package Insert / Pink Book Table

55 Zostavax Package Insert Neomycin Allergy What do we do?

56 Case 2 Summary Inactivated influenza vaccine (IIV3/IIV4) Tetanus-diphtheria-acellular pertussis vaccine (Tdap) Zoster vaccine Pneumococcal 13-valent conjugate vaccine (PCV13) Hepatitis B vaccine?

57 Testing Your Knowledge What is the correct interval for separation of PCV13 and PPSV23 in a 65 year old patient receiving pneumococcal vaccines for the first time? a. No separation needed, can be administered on the same day b. 6 months c. 1 year d. 5 years

58 Testing Your Knowledge Which of the following is a meningococcal serogroup B vaccine? a. Bexsero b. Boostrix c. Recombivax d. Menveo

59 Testing Your Knowledge Which of the following is a method to overcome barriers to immunization? a. Refer the patient to a pro-vaccine website b. Focus on the benefits of the vaccine and downplay the risks c. Use the I m the healthcare provider and you should do what I say approach d. Take time to listen to the patient s vaccine related concerns

60 Testing Your Knowledge Which influenza vaccine is approved for use with a needle-free injection device? a. Fluzone b. Afluria c. FluMist d. Fluarix

61 Needle Facts: Immunization Update 2016 Miranda Wilhelm, Pharm.D. Clinical Associate Professor Southern Illinois University Edwardsville School of Pharmacy