9/22/2015. Immunization Update Disclosures. Learning Objectives. The speaker has no financial or non-financial disclosures to discuss.

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1 Immunization Update 2015 Sophia Galloway, Pharm.D. Disclosures The speaker has no financial or non-financial disclosures to discuss. Learning Objectives Upon completion of this program, attendees will be able to: Describe the ACIP recommendation changes and updates for Describe newly approved vaccines and their uses in practice. Use the CDC immunization schedule to make appropriate vaccine recommendations. Describe recent changes to the Vaccine Injury Compensation Program (VICP) regarding compensation for shoulder injuries related to vaccine administration. 1

2 Overview Pneumococcal Vaccine Recommendations Meningococcal Vaccine Recommendations HPV Vaccine Recommendations Preventing Shoulder Injuries as a Result of Vaccine Administration Patient Cases Assessment Pneumococcal Vaccine Recommendations Pneumococcal Vaccine History 1977: 14-valent polysaccharide vaccine 1983: 23-valent polysaccharide vaccine (PPSV23) 2000: 7-valent polysaccharide conjugate vaccine (PCV7) 2010:13-valent polysaccharide conjugate vaccine (PCV13) replaced PCV7 and expanded the number of antigens 2

3 Available Vaccines Prevnar13 (PCV13) Manufacturer: Wyeth Pneumovax23 (PPSV23) Manufacturer: Merck Pneumococcal Vaccine Indications PCV13 Indications 4-dose primary series in infants Adults 19 & older Only the sickest patients Immunocompromised (CKD, HIV, cancer) Asplenia Cochlear implants CSF leaks New September 2014: All adults 65 yrs old (if never received PCV-13 as an adult) PPSV23 Indications Adults 2-64 yrs Heart, lung, liver disease DM Alcoholism Cochlear implant/csf leak Immunocompromised HIV, asplenia, leukemia, lymphoma, malignancy, nephrotic syndrome, long-term steroids Residents of long term care facilities/nursing homes Adults Smokers Asthma All adults 65 yrs old ACIP Recommendation- September 2014 Both PCV13 and PPSV23 should be administered routinely to all adults aged 65 years and older Unvaccinated patients age 65 and older should receive a dose of PCV13 first, followed by a dose of PPSV23 one year later. May decrease interval in high risk groups. Minimum separation is 8 weeks. Patients age 65 and older previously vaccinated with PPSV23 should receive a dose of PCV13 at least one year after receipt of most recent PPSV23 dose. Minimum separation is one year. Recommendation will be re-evaluated in 2018 and revised as needed. 3

4 Meningococcal Vaccine Recommendations 4

5 Meningococcal Vaccines 1978: Meningococcal polysaccharide vaccine Menomune 2005: First meningococcal conjugate vaccine Menactra 2010: Second meningococcal conjugate vaccine Menveo 2014: First meningococcal serogroup B vaccine approved Trumenba 2015: Second meningococcal serogroup B vaccine approved Bexsero Menomune (Sanofi Pasteur) Meningococcal polysaccharide vaccine (quadravalent) MPSV Available since 1978 Approved for children 2 years and older MPSV is preferred in adults 56 years and older ONLY for short term travel or in outbreak situations MPSV dose must be reconstituted with diluent provided. Shake to dissolve and inject 0.5 ml subcutaneously Multi-dose vials must be used within 10 days of reconstitution; single dose vials must be used within 30 minutes of reconstitution Avoid in patients with severe latex allergies Menactra (Sanofi Pasteur) Meningococcal conjugate vaccine (quadrivalent) MCV4 Meningococcal polysaccharide diphtheria toxoid conjugate vaccine Approved in 2005 for ages 9 months to 55 years. Does not require reconstitution. Draw up 0.5 ml and inject IM. Avoid use in patients allergic to diphtheria toxoidcontaining products 5

6 Menveo (Novartis) Meningococcal conjugate vaccine (quadrivalent) MCV4-CRM Tetravalent meningococcal oligosaccharide diphtheria CRM 197 conjugate vaccine Approved in 2013 for ages 2 months to 55 years Dose must be reconstituted prior to administration: Avoid use inpatients allergic to diphtheria toxoidcontaining products All of these vaccines, which one do I give? Valuable resources on immunize.org *NEW* Meningococcal Serogroup B Vaccines Trumenba (Pfizer) and Bexsero (Novartis) Newly approved October 29, 2014 and January 23, 2015, respectively Contain 4 (Trumenba ) and 3 (Bexsero ) B serogroup strains of Neisseria meningitidis Dosing and Schedule: Both are 0.5 ml IM, pre-filled syringes Trumenba is a 3-dose series for patients 10 to 25 years given on a 0-, 2-, 6-month schedule Bexsero is 2-dose series for patients 10 to 25 years given at least 1 month apart 6

7 Meningococcal B Vaccine Place in Therapy Previous meningococcal vaccines cover A, C, W, Y serogroups Serogroup B meningitis responsible for recent outbreaks at U.S. universities resulting in 26 cases and 2 deaths. ACIP voted in February 2015 for high-risk groups People with complement deficiencies Patients currently on eculizumab (Soliris) Asplenia Microbiologists Exposure during outbreaks June 2015 ACIP meeting: Category B recommendation College students living in dorms Travelers Military recruits HPV Vaccine Recommendations HPV Facts 79 million people in the U.S. are currently infected with genital HPV 14 million new diagnoses each year 12,000 women are diagnosed with cervical cancer and 4,000 women die in the U.S. each year Worldwide, the annual incidence and death toll are 470,000 and 233,000 respectively 1% of sexually active men and women in the U.S. have genital warts. 7

8 Available Vaccines Gardisil (Merck) Quadravalent recombinant virus vaccine Protects against 4 HPV types: Types 16 and 18 (high risk) Types 6 and 11 (low risk) Protects against cervical cancer in women, as well as genital warts and cancers of the anus, vagina and vulva. Approved for females and males age 9 through 26 years old. Cervarix (GSK) Bivalent recombinant virus vaccine Protects against 2 HPV types: 6 and 18 (high risk) Protects against cervical cancer in women Approved for females age 10 through 25 years old *NEW* Gardisil 9 (Merck) Approved December 2014: Females age 9 through 26 Males age 9 through 15 Protects against 5 additional HPV types: 31, 33, 45, 52 and 58 which cause approximately 20% of cervical cancers and are not covered by previously FDAapproved HPV vaccines. Additional serotypes boost cervical cancer coverage from 70% to 90% Remains a 3 dose series: 0, 1-2 months, 6 months ACIP Recommendations Any HPV product may be used to complete or continue the 3-dose series No current recommendation to revaccinate someone with 9-valent HPV if the HPV4 series was completed 8

9 Preventing Shoulder Injuries Related to Vaccine Administration (SIRVA) What is SIRVA? SIRVA manifests as shoulder pain and limited range of motion after the administration of a vaccine intended for intramuscular administration in the upper arm. Thought to occur when a vaccine is incorrectly injected too high on the shoulder. Patients diagnosed with SIRVA have an onset of pain within 48 hours, limited mobility in the shoulder, and no prior history of shoulder pain. Cases of periarticular inflammatory response, subacromial bursitis, bicipital tendonitis, and adhesive capsulitis also reported Since 2011, $18 million has been awarded to 12 individuals with SIRVA, and half of them were paid in the last year. 9

10 How to Prevent SIRVA The upper one-third of the deltoid muscle should not be used for vaccine injections. Recommend that pharmacists make injections at a 90- degree angle in the thickest and most central part of the deltoid muscle to prevent injury. Patient Cases Patient Case 1 J.R. is a 65 year old male approaches your pharmacy counter and inquires about a pneumonia shot. The patient states they received some sort of pneumonia shot when he was diagnosed with diabetes in his early 40s. He heard on the news that he should receive this shot when he turned 65 and he is wondering if he needs another one even though he already received it. The only chronic medical conditions he has are diabetes and high blood pressure. 10

11 Patient Case 1 1. You confirm on ASIIS that J.R. received 1 dose of PPSV23 at age 40. Does J.R. need another pneumococcal vaccination? If so, which one(s)? 2. How long should J.R. wait between each vaccination? What is the dose and route of each vaccine? Patient Case 1 3. Will J.R. need to receive a booster shot? 4. What if J.R. had received a dose of PPSV23 at age 63 instead of his early 40s? Would this change your recommendations? 11

12 Patient Case 2 Jane Smith is a 47 year old female who was recently referred to the outpatient clinic that you work in. She was diagnosed with chronic renal failure last year secondary to a history of uncontrolled blood pressure. She has no other medical conditions. Her PCP would like you to review her immunization record and give any that you believe she needs. From her immunization records you notice she has remained up to date on all vaccinations except for pneumococcal. Patient Case 2 1. Assuming the patient has never received a pneumococcal vaccination, how would you approach this situation? 2. Will this patient require a booster shot? 12

13 Patient Case 3 You work in a community pharmacy that provides many vaccinations, including travel vaccines. BT is a 65 year old woman who has been experiencing recurrent cold sores. Today she is picking up her acyclovir prescription at your pharmacy. While at pick-up, BT asks about receiving her flu and pneumonia vaccine as well. During this encounter she also tells you that 3 weeks from now she is traveling to a region with a rising number of cases of meningitis. BT states that she went to this region about 7 years ago, and prior to leaving she was immunized with Menactra (MCV4-D). She will be there for close to a year. You know this patient well and know that she has no serious medical conditions or immunocompromising conditions. Patient Case 3 1. Assuming the patient has never received a pneumococcal vaccination, how would you approach this situation? Patient Case 3 2. You have both Prevnar (PCV13) and Pneumovax (PPSV23). Which one should the patient receive today? When should she return? 13

14 Patient Case 3 3. Currently, you do not have any meningococcal vaccinations in stock. You go to place an order for this vaccination. Which product is the best choice for BT: Menveo, Menactra, or Menomune? What are the doses and routes of administration for each vaccine? Patient Case 3 3. Currently, you do not have any meningococcal vaccinations in stock. You go to place an order for this vaccination. Which product is the best choice for BT: Menveo, Menactra, or Menomune? What are the doses and routes of administration for each vaccine? Answer: Prevnar and Menveo may be administered simultaneously, but ACIP recommends to have at least a 4 week separation between administration of Prevnar and Menactra. BT is leaving in 3 weeks, making Menactra not the best choice. Therefore, Menveo is the best choice. Both Menveo and Menactra are 0.5mL given IM. Patient Case 3 4. About a year later this patient returns to your pharmacy for their PPSV23 vaccination. You notice this time that have not received a shingles vaccination. Upon research, you notice the package insert of Zostavax states it should not be given simultaneously with PPSV23. Should BT receive both today? If not, how long should separation be? What are the doses and routes of administration for these vaccinations? 14

15 Patient Case 3 5. Will BT s acyclovir prescription reduce the effectiveness of any of these vaccines? Patient Case 4 Jane Doe is a 12 year old female at your pharmacy with her mother. Her mother is here to have her daughter s immunization record reviewed. She would like Jane to receive any vaccinations that are recommended. Her mother states that Jane s last visit to a physician was about a year ago, and at that time the doctor said everything was up to date. Review Jane s immunization record and screening questionnaire below and make your recommendations. 15

16 Patient Case 4 1. What vaccinations would you recommend for Jane today? Can they be given on the same day? In what order should you give these vaccinations? Patient Case 4 2. You review the screening questionnaire and confirm that Jane received a flu shot 4 weeks ago, and her medical conditions include asthma. Does Jane have any contraindications to any vaccines that she will be receiving today? What is the dose and route for each vaccine? Patient Case 4 3. Will the meningococcal vaccine protect against all serogroups? 4. Will Jane need to return for additional doses/boosters for any of these vaccinations? If so, when? 16

17 Patient Case 4 5. Jane s HPV series was delayed, should it be restarted? Is there an accelerated schedule for this series? Assessment Pneumococcal 1. If PPSV23 is given first, how long should the patient wait before receiving PCV13? Why should they wait? A. They should wait 6-12 months because PCV13 is thought to decrease the effectiveness of PPSV23. B. They should wait at least 1 year because PPSV23 is thought to decrease the effectiveness of PCV13. C. The patient no longer needs to receive PCV13 if PPSV23 is given first. D. They should wait at least 5 years since PCV13 will act as a booster dose. 2. Which of these patients is not routinely recommended to receive PPSV23? A. 21 year old male recently diagnosed with HIV. B. 35 year old pregnant female. C. 47 year old male with DM type 2 and a history of CHF. D. 27 year old female who smokes at least 1 pack of cigarettes per day 17

18 Meningococcal 1. Which of the following patients should be vaccinated against meningococcal disease? A. Adolescents age B. Military recruits C. People who travel to countries where meningococcal disease is an epidemic D. All of the above 2. The meningococcal polysaccharide vaccine is known as: A. Menactra B. Menomune C. MenHibrix D. Menveo Meningococcal 3. Which of the following is a contraindication to receiving Menactra? A. Allergy to latex-containing products B. Episode of fainting from previous flu vaccine C. Allergy to diphtheria toxoid-containing products D. Immunocompromising condition 4. Which meningococcal vaccine is given subcutaneously? A. Menactra B. Menomune C. MenHibrix D. Menveo HPV 1. Which of the following statements is true regarding the HPV Vaccines Gardasil and Gardasil 9? A. They are exactly the same, except the Gardasil 9 should not be used in males B. A patient that already completed the quadrivalent Gardasil 3 dose series would need to restart Gardasil 9 series C. A patient that recieved 1 dose of quadrivalent Gardasil could complete the series with Gardasil 9 D. Males over the age of 15 do not need HPV vaccinations 2. True or False: If a dose of HPV vaccine is delayed by more than 1 year, the series must be restarted. A. True B. False 18

19 Questions? 19

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