Adverse Event Reporting: Getting started

1. Adverse Event Reporting: Getting started Lynn Bahta, R.N., B.S.N Minnesota Department of Health August 2008

2. 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

3. 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

4. Which program should conduct adverse event activities?

5. 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

6. 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

7. 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

8. 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

9. Current workgroup: • Clinical staff with immunization background • Epidemiologist • IIS Manager

10. 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

11. 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

12. 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

13. 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

14. Does such a system exist?

15. 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

16. 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

17. 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

18. 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?

19. 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

20. 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

21. 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.

22. 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

23. Meeting with Health Partners • Common interests – • Real time data gathering • Building infrastructure • Providing data that is usable to both • Strengthening public/private partnership

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. Acknowledgements: • Cynthia Kenyon, MPH, Epidemiologist • Emily Peterson, MIIC Manager