Transcript Allergy-Immunology in the Army From a Triservice Perspective

Walter Reed National Vaccine
Healthcare Center (VHC) Network
Vaccine Adverse Events
Diagnosis, Evaluation, Management
& Reporting
Guidelines for Quality Care
COL Renata J. M. Engler, MC, USA
LTC(P) Bryan L. Martin, MC, USA
Chief & Assistant Chief, Allergy-Immunology Department, WRAMC
Medical Directors, Walter Reed National & Regional VHC
Immunization in the 1990’s
 Complexity: From benefit to risk assessment
– Patient assessment: one size does NOT fit all
– Immunology: new science, increasing complexity
in diversity of individual reactions identified
– Perceptions & concerns: risk communication,
required versus choice
 Competency
– Training standardization & resourcing needed
 Vaccines and Vaccine Delivery in the Military
– Defense-Wide Review of Vaccine Policy &
Practice: Report of Armed Forces Epidemiological
Board April 1999 – highlighted QI needs in DoD
Anthrax Vaccine Immunization
Program: New Challenges
 Issues for the clinician and vaccine recipients
– Complex vaccine schedule: 6 doses in 18 mos
– Increased local reactions, pain on administration
– Tracking & rigorous compliance requirements
– Occupational impact, operational program
 Infrastructure for delivery: limitations
– Education & competency
– Risk communication with low trust, high anxiety
– Knowledge gaps: VAERS, adverse drug reaction
standards of care, medical exemptions
Unintended Dilemmas: 1998


Organizational
Needs
Clinical
Challenges
Optimize readiness
Limited tools
Adhere to package
insert
Deliver vaccine with
no added resources
Clinical Issues:
Vaccine Schedule
Side Effects
Exemptions
Time pressures
Practice vs Policy
Providers
Clinical Support Network
 Clinical support needs: exponential growth
– AVIP: NOT designed as a clinical organization
– Nursing and other providers seeking guidance for
clinical issues in the context of the operational
program & perceived “safety & efficacy”
– Polarization of perceptions
 Walter Reed Allergy-Immunology Department
– Expertise in adverse drug reaction management
– Lightening rod for problem solving, clinical
consultation by phone, e-mail (>5000 e-mails in an
8 month period), complex case management req’s
– Increasing concerns for standard of care issues
Standard of Care for
Drug Use & Adverse Events Management
 Vaccines = Prescription Drugs
 Adverse drug reactions: gold standard for good
medical care is avoidance of the offending drug
UNLESS
– No alternative treatment strategy available
– Benefit-risk ratio justifies administration
– Experience with the reaction is benign, selflimited & NOT a contraindication
– Data is available for safe “desensitization”
 What is the experience with other non-live
vaccines? Could we create a helpful tool?
Clinical Response to
An Adverse Reaction: Ideal
 First, treat the patient symptomatically
 Don’t get caught up in the “program”
– Concern for administrative issues over clinical
 Document! Educate patient
– Consider risk/benefit, discuss with patient
 Refer to appropriate specialist when needed
 Monitor response to therapy, case management
 Report results, track QOL impact/disability
RJM Engler, MD
Moderate vs Large Local Reaction
>5cm<12cm
>12cm
Strategic Challenges
 Expansion of credible expert resources to support
increasing immunization requirements
– Clinical HELP: to providers & patients
– Clinical tools development, validation with
continuous updating, responsive to needs
– Advocacy: corrective action for patient & provider
needs, “safe haven” that is trusted, gender issues
– Facilitation of more uniform clinical access, bidirectional communication with providers
– Clinical research: improvements in delivery
 Epidemic (Flu) &/or bioterrorism vaccine delivery:
– Infrastructure & competency sustainment
Vaccine Healthcare Centers
Network Vision
Develop a joint DoD-wide network
of collaborative regional VHCs as
centers of excellence that support
continuous quality improvement of
immunization healthcare, education, research
and focused clinical services that support
case management and reporting of
vaccine-related events for DoD beneficiaries.
Vision
Develop a network of regional
VHC’s that support continuous
quality improvement of
immunization healthcare delivery,
education, research and case
management of complex adverse
events for DoD beneficiaries.
Mission and Goals
To provide clinical, educational, research & quality
assurance leadership for immune readiness through
outreach in support of the goals of enhanced vaccine
safety, efficacy, knowledge, trust and services to
include diagnosis & management of adverse events.
Assuring Quality
Immunization Health Care
The Right Medication for the Right Patient in
the Right Way (Dose & Route)
At the Right Time with the Right Education
& the Right Precautions
“Commitment to Continuous Performance
Improvement”
Assuring Quality
Patient Care
For Adverse Events
“Quality Improvement”
The Right Response
The Right Way
At the Right Time with
The Right Education & VAERS
The Right Access to Care
The Right Exemption
[email protected]
Immune Readiness: Vaccines, Etc.
Genetic challenges
• Influenza pandemic
• Genetic engineering
of pathogens (Man)
Biologic Threat
Live Virus or
Bacteria or Toxin
Antigenic Shift, Antigenic
Dose, Virulence Factors,
Exposure Risk
Future vaccines > 30
(next 5 years)
Immunomodulators
Vaccine, Host Factors (age, gender,
ethnic, IMR factors, etc.), Exposure
Immunologic Protection
Antibodies
• IgG (subclass?), IgA
• Affinity, specificity
Humoral
Criteria for
• Deployment?
• Fitness for Duty?
• Career progression?
T-Cell Mediated CMI
• In-vivo DTH skin testing
• In-vitro measures
Cell Mediated