Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine CME Conference March 10 13, 2016

Transcription

1 Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine CME Conference March 10 13, 2016 Disclosures: Immunizations Donald Middleton, MD & Richard Zimmerman, MD Dr. Middleton: Advisory board on vaccines for Pfizer, Merck, and Sanofi Pasteur Dr. Zimmerman: Research grants from Pfizer & Merck (adolescent vaccine) and Sanofi Pasteur The speakers have attested that their presentation will be free of all commercial bias toward a specific company and its products. The speaker indicated that the content of the presentation will not include discussion of unapproved or investigational uses of products or devices. Speaker has no disclosures and there are no conflicts of interest.

2 Donald B Middleton MD Richard K Zimmerman, MD MPH University of Pittsburgh School of Medicine 1 Dr. Zimmerman: Research grants from Pfizer & Merck (adolescent vaccine) and Sanofi Pasteur Dr. Middleton: Advisory board on vaccines for Pfizer, Merck, and Sanofi Pasteur No conflict of interest exist. 2 Recommend pneumococcal vaccines appropriately Discuss pertussis outbreaks and Tdap Describe influenza vaccination options by age group Improve immunization rates in your clinical setting using a standardized approach like the 4 Pillars Toolkit Review questions from the office Update reference sources: Shots Immunizations by STFM 3 1

3 Is the vaccine effective? Is the vaccine safe? Is the public health impact based on amount of potentially preventable disease sufficient? Is it programmatically feasible to add more injections? Is it cost-effective? ACIP uses GRADE to make recommendations Explicit, evidence-based grading process 4 RIV (Flublok): indicated for 18 years of age (no longer any upper age limit) for those with egg allergy LAIV (FluMist): Contraindications: influenza antiviral use within the last 48 hours, immune suppression, egg allergy, and pregnancy Precautions: asthma and chronic lung diseases; cardiovascular, renal, and hepatic diseases; and diabetes and other conditions One brand (Afluria) is available by needle-free jet injector Intradermal vaccine is quadrivalent this season New adjuvanted vaccine Fluad for those > 65 Strains are A/California/7/2009 (H1N1), A/Switzerland/2013 (H3N2), and B/Phuket/2013 (Yamagata) 5 Age group years IIV IIV ID RIV for egg allergic Cellculture IIV LAIV IIV High Dose IIV adjuvanted X X X X X X X X X >65 X X X X X RIV = FluBlok Cell-culture = Flucelvax IIV adjuvanted = Fluad 6 2

4 Two type B lineages: Victoria and Yamagata In advance, hard to know which will circulate: sometimes both lineages 7 60 mcg per strain compared to 15 mcg typically Prefilled syringes No adjuvant or preservative Currently only trivalent; A strains dangerous for elderly Licensed in December million doses used in first three seasons Penetrance in market 20% among elderly in past Higher antibody titers Does it actually work better??? 8 NEJM 2014: 2 year study: 32,000 seniors 65 yrs old; (mild)/ (moderate). HD 24.2% [9.7%-36.5%] more effective in preventing LABORATORY CONFIRMED flu then regular dose Fluzone; absolute reduction low however as flu incidence low Lancet 2014: 1 mil HD vs 1.6 mil reg; 22% reduction in flu illness (rapid Dx) + hospitalization CID 2015: no diff in VA pts. unless age 85 yrs; one year study 9 3

5 Fluad MF59 adjuvant Squalene Natural 30 carbon compound; e.g., shark liver oil, wheat germ Oil-in-water - surfactant More local and systemic reactions Price unknown Available Fall 2016 in US Used in 30 countries 10 Study of 282 participants including 84 cases Mean age 83 Vaccine effectiveness Unadjusted: 35% for ATIV vs. -12% for TIV Adjusted: 58% for ATIV; TIV ineffective Adjusted VE 72% when limited to community dwelling (not long-term care) 11 An 18 year old girl has had 2 of the 3 required shots of Trumenba, but we only have Bexsero. Can I give her a Bexsero to finish the series? A 27-year-old man was cut on a chainsaw at work. The wound is dirty. He had a Tdap 6 years ago. He needs a tetanus booster but we only have Tdap. Can I give him a Tdap even though it will be his second one? A 72 year old woman just recovered from shingles after 3 months of debilitating pain. She wants to get a shingles vaccine (Zostavax). Should I give it to her now? 12 4

6 Two types: PPSV valent pneumococcal polysaccharide PCV13 13 valent pneumococcal conjugate They share 12 strains Pneumovax23 is FDA licensed for adults age 50 yrs Prevnar13 is FDA licensed for adults at age 50 yrs Serotypes 1, 3, 4, 5, 6A (not in PPSV23), 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Herd immunity from childhood vaccination coupled with adult vaccination. In adult IPD: 71% reduction in PCV7 strains; 53% reduction in all strains. 13 ACIP Meeting 14 ACIP Meeting 15 5

7 Outcome (PCV13-type) Baseline incidence (per 100,000 population) Vaccine efficacy (95% CI) Number needed to vaccinate 5 IPD % (41%, 91%) 4 20,400 (16,950-37,000) 1,620 1,110 Inpatient CAP % (14%, 65%) 4 (1,110-5,130) Outpatient CAP % (14%, 65%) 4 (760-3,500) Total CAP (454-2,110) Caveat: VE vs. placebo Baseline estimates assume 10% of all CAP due to PCV13 -types 1. PCV13-type IPD rate among adults >65 years old in the US. CDC, ABCs, Simonsen et al Lancet Resp. Med Nelson et al. Vaccine CAPITA 5. Number-needed-to vaccinate (NNV) =1 / (Rate baseline Rate vaccinated) PCV13 should be given first when possible Interval between pneumococcal doses: 1 year Immunocompromised persons 19 yrs old, Both vaccines PCV13 first and then PPSV23, at least 8 weeks later If PPSV23 given first, then wait 1 year for PCV13 One PPSV23 revaccination 5 years after first PPSV

8 19 20 Household members responsible for 75% 83%: Parents (55%) Siblings (16%-20%) Aunts/uncles (10%) Friends/cousins/others (10%-24%) Grandparents (6%) WendelboeAM, et al. Transmission of Bordetellapertussis to Young Infants. PediatrInfect DisJ 2007;26: Bisgard KM, et al. Infant pertussis: who was the source? PediatrInfect DisJ 2004; 23(11):

9 22 23 VAERS does not show any signals of concern for mother or fetus Review of manufacturer s pregnancy registry did not reveal signals of concerns Td and TT used extensively in pregnant women Data and expert opinion support that Tdap is acceptably safe to both a pregnant woman and unborn fetus 24 8

10 Adults > 19 years who have not previously received Tdap should receive a single Tdap. ONCE Tdap can be administered regardless of interval since the last tetanus- or diphtheria-toxoid containing vaccine. Tdap should be administered during each pregnancy, at weeks (preferred but any better than none) Many unanswered questions about repeat Tdap Tdap duration in adolescents <4 years; unknown in adults Less if primed with DTaP than DTP Imbalance in Th1/Th2 immune response with Tdap whereas balanced with disease Manufacturers are conducting repeat Tdap booster trials and when thru FDA will lead to a review by CDC

11 28 Uptick in hepatitis B: Kentucky, West Virginia, Tennessee MMWR 2016;65(3); injection drug use one cause; nonurban cases increasing; 25% of adults age 19 years are vaccinated. 12.5% of children and adolescents (9 million!) remain susceptible to measles Meningococcus is rare but when it occurs it is devastating

12 31 Tdap: 20% HCP 42% HPV: 1 dose in years: Women 40%; Men 8% Zoster: 60 years 28% Hepatitis B: 25%; Diabetics years 24% 32 Increase Patient Demand Patient reminders 18% Enhance Access 16% Office hours express vaccination 14% After hours express vaccine-only clinics 12% Provider Reminders and Office 10% Systems 8% Standing order programs (SOPs) 6% Prompts in EMRs 4% 2% Combination of 2 or 3 strategic approaches 0% led to a 16% point increase in rates. Multiple interventions within a single strategic approach increased rates only 4% points. Increase in rates 33 11

13 1. Convenience 2. Patient notification 3. Enhanced office vaccination systems 4. Motivation via an immunization champion 4pillarstoolkit.pitt.edu 34 Extended vaccination season Starts when influenza vaccine arrives Continues into the influenza disease season for unvaccinated Season unpredictable & some benefit possible 2 waves of influenza may occur Express vaccination services Vaccination only services: Dedicated evening or weekend vaccine-only services Walk-in vaccination station Nursing vaccination visits 35 Convenient Vaccination Services Notification Methods Autodialer; /text; Office posters/videos; Answering service on-hold messages; Mail Physician recommendation is essential MMWR 1988;37:

14 Providers should discuss serious nature of vaccine preventable diseases 37 Assessment of vaccination as a routine part of the office visit by nursing staff at check-in/rooming: Prompts in EMR Health maintenance or immunization section review Routinely address Is vaccination status up to date? as part of vital signs Empowering staff to vaccinate by standing orders Combination of assessment and SOPs should reduce missed opportunities 38 Ongoing motivation is a key to success Set goals for improving rates Identify an Immunization Champion Champion monitors weekly progress towards goals Shares progress with team Celebrate achievements Consider rewards 39 13

15 Effective office manager and lead physician (Immunization Champions) Leaders inspired staff to take responsibility for assessing vaccination status and vaccinating patients, using SOPs Staff appreciated regular feedback on performance and comparison with other sites Staff believed that their performance made the difference vaccination rates Influenza vaccination rates in one urban practice Age group years years 65 years 2010 (before 4 pillars toolkit) 2011 (after 4 pillars toolkit) P value 23% 32% < % 46% <.01 52% 69% < Staying Current Automatic notification of new information Can download Adult Scheduler Can download Shots Home site for Shots Site for Immunization Action Coalition ACIP web site 41 14