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APhA Immunization Update from the October 2013 ACIP Meeting
Stephan L. Foster, Pharm.D.
CAPT (Ret) U.S.P.H.S.
Professor and Vice Chair
University of Tennessee College of Pharmacy
Liaison Member
CDC Advisory Committee on Immunization Practices (ACIP)
Accreditation
The American Pharmacists Association is accredited by theAccreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. This activity, APhA Immunization Update from the October 2013 ACIP Meeting, is approved for 1.0 hours of continuing pharmacy education credit (0.10 CEUs). The ACPE Universal Activity Number assigned by the accredited provider is: 0202‐0000‐13‐106‐L04‐P.
To obtain continuing pharmacy education credit for this activity, participants will be required to actively participate in the entire webinar and complete an online evaluation and CPE recording form located at www.pharmacist.com/education by November 20, 2013.
Initial Release Date: November 6,2013
Target Audience: Pharmacists
ACPE Activity Type: Knowledge‐Based
Learning Level: 1
Free CPE credit is brought to you by your APhA membership. Non‐members will be assessed a $25 CPE activity fee for this webinar.
Learning Objectives
Identify changes to vaccine recommendations necessary for compliance with standards of practice
Apply recent changes to guidelines to their vaccination program
Evaluate information on new or future vaccines for potential use in their practice
Stephan L. Foster, PharmD, FAPhA, serves on the speaker bureau for Merck, and on an Advisory Committee for Pfizer.
APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures visit www.pharmacist.com/education
Disclaimer
• This contains data presented at the ACIP meeting
• Some of this data is unpublished
• If there is a slide without a reference, then it contains such data
• Do not quote this specific data until it is published
• ACIP meeting minutes will be on the ACIP website in the near future, along with the meeting slides– www.cdc.gov/vaccines/recs/acip/default.htm
Advisory Committee on Immunization Practices
• Members
– 15 Experts in the field of Immunization
• Voting Members
– Ex‐officio Members (9)
– Liaison Members (33)
• Mission
– Provide advice and Guidance to CDC
– Develop written recommendations
– Reduce the incidence of vaccine‐preventable disease
• GRADE Evaluation Process presented– Analysis demonstrated that this vaccine was similar to other meningococcal vaccines
– Recommended for high‐risk children
• Working Group Recommendation– Add Menveo as an option along with other meningococcal vaccines for use in high‐risk infants
– Only vaccine for ages 2‐8 months
• Vote: Passed
Child and Adolescent Schedule
• ACIP approval for publication in Jan‐Feb 2014– AAP and AAFP must also approve
• Footnote changes– Clarify RV1 (Rotarix) and RV5 (RotaTeq)– Tdap – lower age to 7 years, no repeat doses except pregnancy
– Hib – add MenHibrix, and clarify catch up– PCV – clarify it means PCV13 and who receives PPSV– DTaP, Hep B, Hep A, IPV, Flu, MMR, varicella, HPV, Meningococcal (Add Men‐CRM)
• minor wording changes
Adult Immunization Schedule
• Recommendation based upon:– Age, prior vaccinations, health status, lifestyle, occupations, travel
• Current low rates– Limited awareness of public– Lack of provider recommendation– Lack of assessment of vaccination status at healthcare visits
• NVAC – New Standards approved Sept 2013– Final publication in March 2014– www.publichealthreports.org
• All Providers– Needs assessment for every patient encounter
– Strongly recommend needed vaccines
– Stay up‐to‐date on recommendations
– Understand how to access IIS
• Non‐immunizing Providers– Routinely assess patients for needed vaccines
– Establish referral relationships
– Follow‐up to confirm patient receipt
NVAC Standards for Adult Immunization Practices
• Immunizing Providers
– Ensure professional competencies
– Assess status in every patient encounter
– Strongly recommend needed vaccines
– Document in IIS
• Public Health Departments
– See document
NVAC Standards for Adult Immunization Practices
• Professional healthcare related organizations/ associations/ healthcare systems– Provide education and training– Provide resources– Encourage members to stay up‐to‐date– Partner with other organizations– Collaborate with other stakeholders– Collect and share best practices.– Advocate policies to support standards– Work with insurers/payers/entities that cover vaccine services
to assure network is adequate so patients are not missing opportunities.
• Evidence from around world supports 3 dose schedule– Vaccine Effectiveness 70% ‐ 100% against vaccine‐type IPD
• PCV7, PCV9, and PCV13
– 4 dose vaccine effectiveness 81% ‐ 100%
– No head‐to‐head studies comparing 3 to 4 dose schedules
– Many difference types of studies• RCT vs Observational
• IPD vs pneumonia
Conclusion
• Three dose PCV studies shown effective against IPD, pneumonia, and otitis media
• Immunogenicity studies demonstrate after the primary series, the 3 dose is more effective than the 2 dose– This difference does not continue after the second year of life. – Little difference after the booster dose for the 2+1 vs 3+1 series.– Same pattern for nasopharyngeal carriage
• Differences may not be meaningful– PCV7 serotypes rarely cause disease– PVC13 serotype disease is disappearing– Herd effects are similar so may not expect changes at the
population level.
Working Group Conclusion
• More data needed
• Need to evaluate which dose if one is eliminated
• Vaccine needs to protect throughout the later years.
• Uptake low ‐ ~20%
• Cost Effectiveness
– Immunization age 70 years – reduce PHN the most
– Immunization at 60 years – Reduce HZ cases the most
– Immunization at age 50 years least cost‐effective
WG Conclusion
• Burden of disease rapidly increases with age• Increases with age
– Incidence of HZ – Proportion of HZ progression to PHN– More complications– More interference of daily living– More hospitalizations
• Long‐term protection wanes over 11 years• Duration unable to be determined since no control group• Limited impact on prevention at age 50 years• Very difficult to do vaccine efficacy trials in elderly• No change to existing recommendation
Yellow Fever Vaccine
• New recommendations of WHO against booster doses of Yellow Fever Vaccine– Strategic Advisory Group of Experts
• Single dose of YF vaccine sufficient to protect for lifetime
• US recommendations– YF‐Vax licensed in U.S.– Used for travel to endemic areas– ACIP recommends a booster every 10 years
• Working Group– Will evaluate data and develop recommendations.– Anticipate if changes to be made, ACIP vote in 2014
– 17,000 fewer children die every day in 2012 vs 1990
– Still 18,000 children die daily
• Many are vaccine‐preventable
– 90 million lives saved since 1990
• 216 million children have died
Global Vaccine Action Plan
• SAGE and Decade of the Vaccine Collaboration• Goal to extend full benefits of vaccination to all people by 2020
• Six Guiding Principles– Country ownership– Shared responsibility and partnership– Equity– Integration– Sustainability– Innovation
Successes
• MenAfricaVac Program – 95% reduction in six countries• Removed age restriction on rotavirus vaccine• Single dose Yellow Fever Vaccine• Influenza recommendation worldwide• Other Programs underway
– Hepatitis E– Japanese Encephalitis– Malaria Vaccine– Pertussis Vaccine (global switch to aP on hold)– Polio – Pregnancy and lactation –expanding vaccination– Varicella‐Zoster– Vaccine hesitancy
• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources
• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources
Remaining Topics
• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources
Vaccine Administration: Preparation and Timely Disposal
• Syringes drawn up in a clean medication area
• Multi‐dose vials should not be kept or accessed in the immediate patient treatment area
• If single vaccine type is being, filling a small number (10 or less) of syringes may be considered.• Labeled with the type of vaccine, lot number, and date of filling
• Administered as soon as possible after filling, by the same person who filled the syringes
• Unused syringes that are prefilled by the manufacturer and activated (i.e. syringe cap removed or needle attached) should be discarded at the end of the clinic day.
Based on CDC guidance already on web site by CDC working group (distinct from GRWG)
OSHA Regulations
2011 General Recommendation are both strong and weak with respect to use of needle‐shielding syringes or needle‐free injectors
STRONG
• “These federal regulations require that safety‐engineered injection devices (e.g. needle‐shielding syringes or needle‐free injectors) be used for injectable vaccination in all clinic settings.
WEAK
• “Safety‐engineered needles and syringes or needle‐free injection devices are preferred and should be encouraged to reduce risk for injury.”
Will remove weak statements
Vaccine Route: Revision to Needle Length Table
TABLE 10. Needle length and injection site of IM injections for children aged ≤18 years (by age) and adults aged ≥19 years (by sex and weight)
Age group Needle length Injection site
Children (birth--18 yrs)
Neonates* 5/8 inch (16 mm)† Anterolateral thigh
Infants, 1--12 mos 1 inch (25 mm) Anterolateral thigh
Toddlers, 1--2 yrs 1--1.25 inch (25--32 mm) Anterolateral thigh§
5/8†--1 inch (16--25 mm) Deltoid muscle of arm
Children, 3--10 yrs 5/8†--1 inch (16--25 mm) Deltoid muscle of arm§
1--1.25 inches (25--32 mm) Anterolateral thigh
Children, 11-18 yrs5/8ϯ – 1inch(16—25mm) Deltoid muscle of arm§
1—1.5 inches (25—32 mm) Anterolateral thigh
Jackson LA, Yu O, Nelson JC, et. Al. The 15 fifth dose of Diphtheria, Tetanus and Acellular Pertussis Vaccine. Pediatrics 16 2011:127(3), p. e580‐e588
Middleman, 1 A, Anding R, Tung C, Pediatrics 2010: 125(3), p. e1‐e5
• Patients with bleeding disorders• Permissive language on routes of other vaccines• Hepatitis B in Bleeding Disorder – Give IM
o Only if physician familiar with patient’s bleeding risko Can it be given SubQ?
• Other Sub Q is OKo MCV4o Hep A
• If not mentioned that it should not be Sub Q does that imply it is OK?
• Working Group to Discuss
Provider Records
• Clarification of which vaccines are covered by the National Vaccine Injury Compensation Program – Reminder of documentation requirements
• Immunization Information Systems (IIS)– Maintain interoperability with other electronic health record
tools– Reduce health disparities– Engage patients and families in their health– Improve the coordination of care– Improve population health– Ensure adequate privacy and security protection for personal
health information.– www.cdc.gov/ehrmeaningfuluse/introduction.html
Advantages of IIS
• Prevent duplicate vaccinations
• Forecast when the next dose is due
• Limit missed appointments
– Allow recall for those who missed appointments,
• Determine when vaccines need to be repeated
• Reduce vaccine waste
• Reduce staff time required to produce or locate vaccination records or certificates.
• Next ACIP Meeting February 26‐27, 2014 in Atlanta
• If questions, please contact:– Stephan L. Foster, Pharm.D.E‐mail: [email protected]
• Questions/comments
How to Obtain CPE Credit
Record Attendance Code: Provided During Webinar Please visit: http://www.pharmacist.com/live‐activitiesand select the Claim Credit link for this activity
You will need a pharmacist.com username and password Select Enroll Now or Add to Cart from the left navigation and successfully complete the Assessment (select correct attendance code), Learning Evaluation and Activity Evaluation for access to your statement of credit. You will need to provide your NABP e‐profile ID number to access your statement of credit.
You must claim credit by November 20, 2013. No credit will be awarded after that date.