Adverse Event Reporting: Getting started Lynn Bahta, R.N., B.S.N Minnesota Department of Health August 2008
Mar 28, 2015
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
Request for Vaccine Safety Coordinator– Prompted further inquiry– Catalyst to set up 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
Which program should conduct adverse event activities?
Office of Emergency Preparedness
Capacity to response in large eventsInfrastructure exists for mass
communication to both hospitals and providers
Mass Prophylaxis Coordinator, originally housed in immunization, has strong clinical background
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.
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
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:
Clinical staff with immunization background
EpidemiologistIIS Manager
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?
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?
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.
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?
What is available at the Federal level?
VAERS is accessible on line to anyoneVAERS relies on reports that contain
subjective dataVAERS may be duplicativeVaccine Safety Datalink (VSD)
– Provides real-time analysis of dataCISA
– Provides case-based clinical evaluation
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.
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:
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
Determining MIIC capacityDetermining if/what type of relationship with
the MN VSD site would be helpfulDetermining whether a common dataset of
adverse events existUnderstanding where CDC is headed in
building Adverse Event reporting within the context of a public health emergency
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.
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
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
Common interests – – Real time data gathering– Building infrastructure– Providing data that is usable to both– Strengthening public/private
partnership
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?
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
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
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
Public vaccination venuesAdverse 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:
Cynthia Kenyon, MPH, Epidemiologist
Emily Peterson, MIIC Manager