Saving Vaccines in the Americas: A Framework for Vaccine Safety Training

Transcription

1 Saving Vaccines in the Americas: A Framework for Vaccine Safety Training Elizabeth K. Lutz, MPH Candidate Colorado School of Public Health Edwin J. Asturias, MD Director for Latin America, Center for Global Health Associate Professor, Departments of Pediatrics & Epidemiology A collaboration between the Center for Global Health & the Pan American Health Organization Global Health Symposium, November 15, 2013 UNIVERSITY OF COLORADO COLORADO STATE UNIVERSITY UNIVERSITY OF NORTHERN COLORADO

2 Importance of Vaccine Safety Use of high quality, safe, & effective vaccines prevents between 2 and 3 million deaths each year Expanded Access EPI, GAVI Alliance, Decade of Vaccines Global Vaccine Action Plan Vaccines are not 100% safe and effective Rare, adverse events following immunization (AEFI) Preventable Programmatic Errors Risk management systems are essential to maintain public confidence, especially as rumors and fears threaten immunization programs

3 The Current Situation Vaccine Safety Blueprint 2011 Guidelines to ensure minimal vaccine safety capacity in all countries Pan American Vaccine Safety Summit 2012 Hosted by Center for Global Health with 10 countries represented Enhance healthcare worker training capacity at local, subnational and national levels PAHO approached Center of Global Health to partner on training program development

4 Goal and Methods Objective: To develop a basic, intermediate, and advanced level vaccine safety training course to be delivered online to local, subnational, and national healthcare workers in the Region of the Americas Landscape Analysis What already exists? Key Informant Roundtable What experts think are the gaps? Focus Group What are perceived needs? Vaccine Safety Training Course Design

5 Landscape Analysis Systematic review of the literature and existing training courses in: Pharmacovigilance/Pharmacoepidemiology (Drugs and Vaccines) Vaccine safety and risk/benefit assessment Vaccinology and related topics 30 programs were identified and evaluated Content, Audience, Delivery, Accessibility

6 Landscape Findings/Gaps Content Limited courses targeting LMICs and Region Developed world specific not addressing infrastructure and resource challenges Pharmacovigilance of all medicines, not Vaccine Specific Delivery 2 3 day workshops Fragmented topics Limited Availability & Accessibility Facilitators; financial and staff capacity to travel Online courses: limited in modern features related to interactive learning

7 Key Informant Roundtable 3 PAHO experts from Immunization Division including the Regional Advisor of the Comprehensive Family Immunization Program Confirmed need for new way to approach VS training Clarified gaps/needs discussed in landscape analysis Authorities from Ministry of Health, Haiti, PAHO, CDC & GAVI visit a Haitian vaccination center during Vaccination Week 2013, photo credit: PAHO

8 Focus Group Objectives What are the gaps and priorities to meet training needs in vaccine safety in the Region of the Americas? Value of vaccine safety Current state of vaccine safety knowledge Gaps and priorities for training Audience (target levels and depth) Partners to work with in the Region To inform development of an online vaccine safety course for local, subnational and national levels

9 Focus Group Participants HAITI National Immunization Program, PAHO COLOMBIA Immunization Group Dep t of Public Health Risk Surveillance & Analysis National Institute of Health, Preventable Diseases NICARAGUA National Immunization Program, PAHO BRAZIL National Regulatory Program Manager ANVISA (Nat l Health Surveillance Agency) CHILE Immunization Department Health Planning Division, Ministry of Health ARGENTINA Vaccine Safety Coordinator National Immunization Program, Ministry of Health

10 Results: Value of Vaccine Safety Do you believe there is value in developing vaccine safety work in the region today? Why do you think this is valuable? Argentina Brazil Chile Colombia Haiti Nicaragua Value? Yes Yes Yes Yes Yes Yes Why Maintain confidence in National Immunization Program Introduction of new vaccines Notification of adverse events following immunization By law, job competencies To confront crisis situations Rotation of personnel It is extremely important in order to maintain confidence in healthcare professionals and to maintain vaccination coverage rates Argentina

11 ARGENTINA BRAZIL CHILE COLOMBIA HAITI NICARAGUA TOTALS GAPS Communication X X X X X X 6 Investigation X X X 3 Causality Assessment X X X 3 Notification X X X 3 Diagnosis of AEFI X X 2 Crisis Response/Mgmt X X 2 CONTENT PRIORITIES Communication X X X 3 Investigation X X X X 4 Causality Assessment X X X 3 Notification X X 2 Diagnosis of AEFI X X 2 Concept of AEFI X X 2 Vaccine Administration X X 2 Cold Chain X X 2 Analysis X X 2 Anti Vaccination Groups X X 2 Technical/Clinical Aspects X X 2 Response X X 2

12 An Innovative Proposal New Paradigm: Natural history of an Adverse Event Following Immunization (AEFI) Online availability Modern features for flexible training delivery 3 level progressive module training Certification potential

13 Syllabus Proposed to PAHO

14 Conclusion Enhanced vaccine safety training efforts in the Americas is valued and needed across countries and by PAHO Validates findings from the Landscape Analysis that there are gaps in existing training Content development based on identified gaps/priorities Important step in building workforce capacity to protect National Immunization Programs and public safety

15 Acknowledgments Edwin J. Asturias, MD Director for Latin America, Center for Global Health Associate Professor, Departments of Pediatrics & Epidemiology PAHO Family & Community Health Immunization Program Carlos Castillo Solórzano, MD (Regional Advisor) Pamela Bravo, MPH (Immunization Division Officer) Focus Group Participants

16 Thank you! Elizabeth K. Lutz, MPH Candidate

17 Potential Platforms Identified in Landscape Analysis (Identified 12)

18 New Paradigm: Natural History of an AEFI EJ Asturias AEFI Local Health Center or Hospital Health District Immunization Program System National Media Y Politics What, Where When, How? Cause, Why? Possible? Regulatory Authority Regional & Global DETECTION Risk? Change? Data? SURVEILLANCE & REPORTING SYSTEM INVESTIGATION & DATA MANAGEMENT MANAGEMENT COMMUNICATION PLAN, RISK & RECOMMENDATIONS

19 AEFI Classification Adverse event following immunization (AEFI): any untoward medical occurrence which follows immunization and which does not necessarilty have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease. AEFI Classification Definition Example Vaccine product related reaction An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product Limb swelling, Redness around injection site Vaccine quality defect related reaction An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product including its administration device as provided by the manufacturer Paralytic polio (manufacture failure to inactivate polio) Cold chain interruption Immunization error related reaction An AEFI that is caused by inappropriate vaccine handling, prescribing or administration and thus by its nature is preventable Inappropriate handling/administration Vial contamination Reconstitution errors Incorrect route of admin. Immunization anxiety related reaction Coincidental event An AEFI arising from anxiety about the immunization An AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety Fainting Fever with malaria, temporal association Autism

20 Communication Communication Module V: Communication I Unit 1: Perception of Risk (parents, public and HCWs) Unit 2: Communicating with Parents & Public Module VIII: Communication II Unit 1: Establishing a Strategic Risk Communication Plan & Crisis Communication Plan How to construct a message, rumor management, operational aspects Unit 2: Forming the Communication Response Team Unit 3: Damage Control Communicating with and informing stakeholders, media, public, parents Support systems (emotional, psychological, logistical, legal) Legal Aspects Unit 4: Understanding and Responding to the Anti Vaccination Movement Module XII: Communication III Unit 1: Implementing Crisis Communication Plan Unit 2: Coordination between all stakeholders (media, NRA, response team) Unit 2: Evaluating Crisis Communication Response Unit 3: Legal Aspects Unit 4: Global Communication

21 AEFI Investigation, Case Assessment, Causality Assessment Module IV: Intro to AEFI Investigation Unit 1: Basic elements of AEFI Investigation Module VII: Investigation & Case Assessment Unit 1: Investigation of Safety Signals Investigation process: back and forth Serious AEFIs, Clusters, Signals, Unexpected AEFIs to be Who to report to, feedback, etc. investigated Unit 2: Background Incidence and its Application to Signals Unit 3: Case Assessment Analysis/Background Information: Clinical History, Vaccine in question, Vaccination Process, Lab Testing, Pathology AEFI Classification/Causes o Evaluate Seriousness/Importance of Case o CIOMS Approach: Causes related to host (contraindication), vaccine (composition), system (cold chain, administration), other causes (coincidence) o Brighton Collaboration and other Case Definitions Module X: Causality Assessment Unit 1: Evaluating Causality Unit 2: Risk/Benefit Assessment Unit 3: Testing Causality: Randomized controlled clinical trials, cohort studies, case control studies, case series analyses Consistency, strength of association, specificity, temporal relation, biological plausibility

22 BASIC INTERMEDIATE ADVANCED Introduction to Vaccine Safety Module I: Introduction to Vaccine Safety Unit 1: Evolution of Vaccine Safety Unit 2: How is Vaccine Safety Evaluated Unit 3: Vaccine Types and System What is a Vaccine How Vaccines Work Types and Examples of Vaccines Overview of Immunization System Unit 4: Natural History of an AEFI AEFI Surveillance/Monitoring Module II: Unit 1: Types of Adverse Events Unit 2: Diagnosis of an AEFI Serious and Non serious AEFI Frequency of Types of AEFI Unit 3: AEFI Notification/Reporting Standard Data Collection (Core Variables) Reporting Forms Supportive Data (laboratory, pathology, verbal autopsy) Unit 4: Surveillance Systems Management of an AEFI Module III: AEFI Management Unit 1: Diagnosis/Basic Treatment (Technical/Clinical Aspects) Basic measures Module VI Unit 1: Pre registration Vaccine Safety Unit 2: Post Registration Vaccine Safety and Surveillance/Monitoring Passive, Passive Stimulated, Active and Sentinel Surveillance for Signal Detection Electronic and Paper Systems (new e SAVI system) Incorporated into other modules Module IX: Vaccine Safety Systems Management Unit 1: Developing a National System for Dealing with AEFIs Ensuring Functioning System Capacity for HCWs to Carry out Vaccine Safety Process Technology/Equipment Human Resources, Training Economic Resource Allocation Unit 2: Introduction of New Vaccines Unit 3: Vaccines in Special Populations Unit 4: Evaluating Success of Surveillance System/Monitoring Unit 5: International Surveillance/Monitoring System and Processes Module XI: AEFI Decision Making, Response and Policy Unit 1: Coordination with NRA, NITAG, AEFI Review Committees andother stakeholders

23 Competencies for Online VS Course Detection, Identification, Management of an AEFI Basic Intermediate Advanced 1A1. Identifies an event as an AEFI when an illness presents itself after vaccination and has a suspected association with the vaccine 1B1. Identifies and responds to AEFIs that may impact the immunization program at the local or subnational level 1C1. Responds and manages AEFIs and signals of national and international importance for the NIP 1A2. Defines the different types of adverse events following immunization 1A3. Applies basic measures and specific therapies to manage AEFI upon diagnosis 1A4. Participates in reporting and standard data collection of core data 1B2. Reviews and integrates standard case definitions and classification of AEFIs 1B3. Treats and manages more serious AEFIs, and coordinates investigation 1B4. Analyzes core data from AEFI reports to manage AEFI 1C2. Coordinates the integration of AEFI data and evidence, and uses the proper channels for AEFI notification and response 1C3. Ensures immunization program capacity to treat/manage AEFI 1C4. Oversees systems for processing AEFI information and feedback AEFI Investigation Basic Intermediate Advanced 2A1. Describes basic elements of an AEFI investigation and AEFI investigation process 2B1. Conducts comprehensive AEFI investigation 2C1. Conducts, coordinates, and assesses AEFI investigations 2A2. Identifies what to report and who to report to regarding an AEFI 2A3. Understands risks and benefits of specific vaccines 2B2. Detects serious AEFIs, clusters, signals and other AEFIs to be investigated 2B3. Assesses Risk/Benefit relationship between vaccine and adverse event 2B4. Understands, assesses, and uses background incidence of an investigation AEFI 2C2. Assesses/Tests causality of AEFI 2C3. Assesses Risk/Benefit relationship between vaccine and adverse events 2C4. Ability to develop local and national background incidence data for immunization program

24 Limitations Selected Sample of countries Participant Bias (work within immunization departments) Does not fully reflect healthcare worker experiences Limited representation from Caribbean countries Cannot account for vaccine safety system differences across countries (more advanced vs. less)

25 New Introductions: Pneumococcal Conjugate Vaccine (PCV) Hepatitis B (HepB) Haemophilus influenza type B (Hib) Rotavirus (RV) HPV Meningococcal Yellow Fever Typhoid Pipeline Malaria Cholera Dengue

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