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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


Does such a system exist
Does such a system exist? public health emergency? cont.


What is available at the federal level
What is available at the public health emergency? cont.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) public health emergency? cont.

  • 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. public health emergency? 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


Conclusions
Conclusions: public health emergency? cont.

  • 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 public health emergency? cont.

  • 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 public health emergency? cont.

  • 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. public health emergency? 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 public health emergency? cont.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 public health emergency? cont.

  • 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. public health emergency? 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? public health emergency? cont.

  • 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 public health emergency? cont.

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: public health emergency? cont.

  • 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 public health emergency? cont.

  • 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 health emergency? cont.

  • 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


Acknowledgements
Acknowledgements: public health emergency? cont.

  • Cynthia Kenyon, MPH, Epidemiologist

  • Emily Peterson, MIIC Manager


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