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Adverse Event Reporting: Getting started. Lynn Bahta, R.N., B.S.N Minnesota Department of Health August 2008. Early promptings. Growing interest in vaccine safety issues in Minnesota Very active and articulate anti-vaccine groups Safety questions raised about new vaccines

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adverse event reporting getting started

Adverse Event Reporting: Getting started

Lynn Bahta, R.N., B.S.N

Minnesota Department of Health

August 2008

early promptings
Early promptings
  • Growing interest in vaccine safety issues in Minnesota
    • Very active and articulate anti-vaccine groups
    • Safety questions raised about new vaccines
  • Request for Vaccine Safety Coordinator
    • Prompted further inquiry
    • Catalyst to set up workgroup
birth of the adverse event workgroup
Birth of the Adverse Event Workgroup
  • Determine which program should house activities
    • Immunization program or
    • Office of Emergency Preparedness
  • Assess current resource strengths and weaknesses
  • Identify who the key staff would be
office of emergency preparedness
Office of Emergency Preparedness
  • Capacity to response in large events
  • Infrastructure exists for mass communication to both hospitals and providers
  • Mass Prophylaxis Coordinator, originally housed in immunization, has strong clinical background
immunization program
Immunization Program
  • Basic infrastructure and knowledge already exists
  • Relationships with vaccine safety advocates well established
  • Houses both clinicians and epidemiologists
  • Houses immunization information system – familiar to most providers
immunization program cont
Immunization Program cont.
  • Provided oversight for adverse events during smallpox vaccination
  • Staff already involved in monitoring VAERS reports and responding to significant adverse events
  • Immunization Information System is located within the Immunization Program
joint decision
Joint Decision
  • The Immunization Program will continue to be responsible for adverse event reporting and monitoring and building infrastructure for public health emergencies
  • Immunization program clinical consultant will collaborate with the Mass Prophylaxis Coordinator regarding vaccine safety and adverse events needs in a public health emergency
current workgroup
Current workgroup:
  • Clinical staff with immunization background
  • Epidemiologist
  • IIS Manager
needs assessment
Needs Assessment
  • How do providers currently report adverse events?
  • What is the best venue for reporting adverse events when immunization activities are ramped up during a public health emergency?
  • What systems exist and what are their capacities?
    • Federal
    • State
how do providers currently report adverse events
How do providers currently report adverse events?
  • VFC site visit information shows that providers report knowing about and using VAERS for reporting adverse events.
  • Most VAERS reports in MN are filed electronically
  • The clinical consultant occasionally receives reports that are discussed with CDC staff
what is the best venue for reporting adverse events during a public health emergency
What is the best venue for reporting adverse events during a public health emergency?
  • It should be familiar to providers
    • Clinics
    • Urgent Centers
    • Hospitals
  • It should be easy to use
what is the best venue for reporting adverse events during a public health emergency cont
What is the best venue for reporting adverse events during a public health emergency? cont.
  • It should be consistent with national systems
  • There needs to be a clinical feedback mechanism to the provider reporting the event
what is available at the federal level
What is available at the Federal level?
  • VAERS is accessible on line to anyone
  • VAERS relies on reports that contain subjective data
  • VAERS may be duplicative
  • Vaccine Safety Datalink (VSD)
    • Provides real-time analysis of data
  • CISA
    • Provides case-based clinical evaluation
state minnesota immunization information connection miic
State: Minnesota Immunization Information Connection (MIIC)
  • Providers that vaccinate are familiar with MIIC
  • It is set up in both public and private clinics
  • Technical support exists, both regionally and at the state
miic cont
MIIC cont.
  • It has the capacity to add a data entry port for reporting
  • It will be the main source for reporting doses given in mass prophylaxis
  • There is no electronic connection between VAERS and MIIC
  • Minnesota does not have a state system for reporting adverse events
  • If we develop a reporting system, we should use systems that already exists
  • Avoid re-inventing the wheel - how can we expand on what already exists?
step two
Step Two
  • Determining MIIC capacity
  • Determining if/what type of relationship with the MN VSD site would be helpful
  • Determining whether a common dataset of adverse events exist
  • Understanding where CDC is headed in building Adverse Event reporting within the context of a public health emergency
miic capacity
MIIC Capacity
  • Inventory data can be preloaded and includes vaccine, manufacturer, lot number and expiration date
  • 87% of Minnesota VFC providers* are enrolled in MIIC – but not all are actively entering data
  • MIIC is enrolling adult immunization clinics and provider sites, including flu vendors, LTC, Urgent Care centers, pharmacists

*Minnesota VFC providers include both public and private clinics that vaccinate MA enrolled patients – both children and adults

miic capacity cont
MIIC capacity cont.
  • Minnesota is currently a sentinel site for IIS
    • Southwest region in the past
    • Metro region currently
  • Hospital sentinel sites are entering seasonal influenza disease data into MIIC
  • In the past 2 years MIIC and immunization program staff have promoted the importance of entering influenza clinic data into MIIC.
health partners vaccine safety datalink project
Health Partners Vaccine Safety Datalink Project
  • MDH has a collaborative relationship with Health Partners through several of its programs
  • Jim Nordin, MD is the project lead for Health Partners’ VDS project, and is a member of the MN Immunization Practices Advisory Committee
meeting with health partners
Meeting with Health Partners
  • Common interests –
    • Real time data gathering
    • Building infrastructure
    • Providing data that is usable to both
    • Strengthening public/private partnership
meeting with health partners cont
Meeting with Health Partners cont.
  • Different goals
    • HP would like to include broader data to do more comprehensive analysis of their current projects
    • MDH needs to determine how to develop basic reporting infrastructure that can be ramped up for public health emergencies
what is next
What is next?
  • Discuss issues/questions with CDC Immunization Safety Office (ISO)
  • Using influenza vaccination adverse events data to develop a pre-populated dataset
  • Using the IIS sentinel site to pilot adverse event reporting
  • Determining whether to focus on influenza-only AE’s or any vaccine AE
discussions with cdc iso
VAERS would still need to be used

Working on an IIS/VAERS interface

Piloting surveillance using HL7 and ICD-9 medical coding signals

Developing a Pass/active surveillance system model

VAERS remains free text

Discussions with CDC ISO
outstanding issues
Outstanding issues:
  • How to keep AE symptom dataset streamlined and consistent with other datasets – need more national guidance
  • Developing an internal clinical team to respond to AE reported during a pandemic or other public health emergency
  • Learn from August training
going forward
Going forward
  • Decision to proceed to develop a reporting system within MIIC. It will require:
    • Expanding inventory capacity into MIIC
      • Working to get providers to use inventory feature
    • Improving flu vaccination data entry
    • Developing an influenza AE dataset
  • Pilot sentinel site providers to enter AE reports
  • Include Mass Prophylaxis Coordinator in team meetings
system for responding to aes in a public health emergency
System for responding to AEs in a Public Health Emergency
  • Public vaccination venues
  • Adverse events will come from private sector – medical home providers, hospital emergency room
  • Education will need to be directed at vaccinees and private medical sector so that reporting occurs
  • Cynthia Kenyon, MPH, Epidemiologist
  • Emily Peterson, MIIC Manager