1. 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

2. 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

3. 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

4.  Organizational Needs ClinicalChallenges Unintended Dilemmas: 1998 Providers Optimize readiness Adhere to package insert Deliver vaccine with no added resources Time pressures Limited tools Clinical Issues: Vaccine Schedule Side Effects Exemptions Practice vs Policy

5. 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

6. 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, self- limited & NOT a contraindication –Data is available for safe “desensitization”  What is the experience with other non-live vaccines? Could we create a helpful tool?

7. 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

9. RJM Engler, MD

10. >5cm 5cm<12cm Moderate vs Large Local Reaction >12cm

13. 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, bi- directional communication with providers –Clinical research: improvements in delivery  Epidemic (Flu) &/or bioterrorism vaccine delivery: –Infrastructure & competency sustainment

14. 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.

15. 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.

16. 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 Immunization Health Care

17. The Right Response The Right Way At the Right Time with The Right Education & VAERS The Right Access to Care The Right Exemption Assuring Quality Patient Care For Adverse Events “Quality Improvement”

18. AskVHC@na.amedd.army.mil

19. Immune Readiness: Vaccines, Etc. Biologic Threat Live Virus or Bacteria or Toxin Immunologic Protection Humoral Cell Mediated Vaccine, Host Factors (age, gender, ethnic, IMR factors, etc.), Exposure Antigenic Shift, Antigenic Dose, Virulence Factors, Exposure Risk Antibodies IgG (subclass?), IgA IgG (subclass?), IgA Affinity, specificity Affinity, specificity T-Cell Mediated CMI In-vivo DTH skin testing In-vivo DTH skin testing In-vitro measures In-vitro measures Criteria for Deployment? Deployment? Fitness for Duty? Fitness for Duty? Career progression? Career progression? Future vaccines > 30 (next 5 years) Immunomodulators Genetic challenges Influenza pandemic Influenza pandemic Genetic engineering of pathogens (Man) Genetic engineering of pathogens (Man)