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 events Infrastructure 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 Epidemiologist IIS 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 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) 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 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 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 AEs 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 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: Cynthia Kenyon, MPH, Epidemiologist Emily Peterson, MIIC Manager