Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine CME Conference March 10‐13, 2016 Immunizations Donald Middleton, MD & Richard Zimmerman, MD Disclosures: 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.
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Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine
CME Conference March 10‐13, 2016
Immunizations
Donald Middleton, MD &
Richard Zimmerman, MD
Disclosures: 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.
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Donald B Middleton MDRichard K Zimmerman, MD MPH
University of Pittsburgh School of Medicine
www.PittVax.pitt.edu
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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.
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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
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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
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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)
In advance, hard to know which will circulate: sometimes both lineages
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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 2009 13 million doses used in first three seasons Penetrance in market 20% among elderly in past Higher antibody titers Does it actually work better???
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
Oil-in-water - surfactant More local and systemic reactions Price unknown Available Fall 2016 in US Used in 30 countries
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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)
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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?
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Two types: PPSV 23 – 23 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.
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ACIP Meeting 14
ACIP Meeting15
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1. PCV13-type IPD rate among adults >65 years old in the US. CDC, ABCs, 2013
Baselineestimates assume 10% of all CAP due to PCV13 -types
Outpatient CAP 2013 45% (14%, 65%)4
1,110(760-3,500)
Total CAP - - 656(454-2,110)
• 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 PPSV23
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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: 293–299.
Bisgard KM, et al. Infant pertussis: who was the source? PediatrInfect DisJ 2004; 23(11):985-989.
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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
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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 27-36 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
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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
Provider Reminders and Office Systems Standing order programs (SOPs) Prompts in EMRs
Combination of 2 or 3 strategic approaches led to a 16% point increase in rates.
Multiple interventions within a single strategic approach increased rates only 4% points.
0%2%4%6%8%
10%12%14%16%18%
Increase in rates
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1. Convenience
2. Patient notification
3. Enhanced office vaccination systems
4. Motivation via an immunization champion
4pillarstoolkit.pitt.edu34
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
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Convenient Vaccination Services
Notification MethodsAutodialer; Email/text; Office posters/videos; Answering service “on-hold” messages; Mail
Physician recommendation is essential
MMWR 1988;37:657-61 36
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Providers should discuss serious nature of vaccine preventable diseases
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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
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• 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
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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
Age group
2010 (before 4 pillars toolkit)
2011 (after 4 pillars toolkit)
P value
18-49 years
23% 32% <.001
49-64 years
35% 46% <.01
≥65 years
52% 69% <.001
Influenza vaccination rates in one urban practice
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Staying Current
www.cdc.gov/emailupdates/index.html– Automatic notification of new information
www.cdc.gov/vaccines– Can download Adult Scheduler– Can download Shots 2016
www.immunizationed.org www.stfm.org
– Home site for Shots 2016
• www.immunize.org– Site for Immunization Action Coalition
www.cdc.gov/vaccines/recs/acip/default.htm– ACIP web site