Fungal Meningitis Outbreak in 2012

1. Fungal Meningitis Outbreakin 2012 Marion Kainer MD MPH FRACP - TN Department of Health Sandy Bledsoe - Assistant Vice Chancellor, Risk & Insurance Management, Vanderbilt University Julia Morris - Deputy General Counsel, Vanderbilt University January 24, 2013 AHLA Issues Affecting Academic Medical Centers and Other Teaching Institutions

2. The First Fungal Meningitis Outbreak Case • Late summer/early fall: middle aged man presented with meningitis • History of epidural steroid injections • No immunosuppression • Otherwise healthy • Initially improved with standard therapy Vanderbilt University Vanderbilt University Medical Center

3. Fungal Meningitis Outbreak • Condition deteriorated – antifungal therapy begun • CSF grew Aspergillus fumigatus • Tennessee DOH notified • Death on day 22 of hospitalization Vanderbilt University Vanderbilt University Medical Center

4. Timeline ofMajor Events

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10. Timeline of Major Events (cont’d) Vanderbilt University Vanderbilt University Medical Center

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18. Lessons Learned

19. Lessons Learned • Compounding and/or repackaging of medications must be performed safely. • Recent investments in public health infrastructure through cooperative agreements from the CDC have supported building public health capacity at the TDH. Vanderbilt University Vanderbilt University Medical Center

20. Lessons Learned (cont’d) • Relationships with Federal partners were critical in the response to this outbreak. • CDC provided invaluable assistance throughout the outbreak including weeknights and weekends • FDA provided valuable information on local inspection findings, as well as laboratory testing of products Vanderbilt University Vanderbilt University Medical Center

21. Lessons Learned (cont’d) • Relationships and Infrastructure Vanderbilt University Vanderbilt University Medical Center

22. Conclusion This has been a devastating outbreak for patients, their families and friends, healthcare providers and clinics. In Tennessee we still have many patients hospitalized and suffering from complications and others who are exposed and frightened that they may become infected. Vanderbilt University Vanderbilt University Medical Center

23. Conclusion Sustained commitment to funding for emergency preparedness and reduction of healthcare associated infections through cooperative agreements from the CDC has supported our productive relationships with our partners and healthcare providers across the state. Vanderbilt University Vanderbilt University Medical Center

24. Conclusion These pre-existing relationships allowed us to respond quickly because we trusted each other. We all need to work together to do our best to prevent such a tragedy from occurring again and to ensure that we have the public health capacity to detect and rapidly respond to any future outbreaks. Vanderbilt University Vanderbilt University Medical Center

25. Legal and Risk Management Considerations • Searching for product in our facility and affiliates • NECC • Ameridose • Potential medical malpractice claims • Case Study Publication • Communication with family • Manuscript review Vanderbilt University Vanderbilt University Medical Center

26. Legal and Risk Management Considerations • Patient notification • Obligations vs. proactive management • Compounding issues • Initial • Ongoing • Insurance coverage limits – how much is appropriate? Vanderbilt University Vanderbilt University Medical Center

27. Additional Legal Issues • HIPAA issues • Public Health Exception • Review prior to NEJM case study publication • Privacy Issues • Balancing Possible liability vs publication/1st Amendment considerations • Press inquiries – local and national Vanderbilt University Vanderbilt University Medical Center

28. Additional Legal Issues (cont’d) • Relationships with Third Parties • Pharmacies • Partnerships • Holding out to public • Branding, reputational risk Vanderbilt University Vanderbilt University Medical Center

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30. Additional Legal Issues (cont’d) • Regulatory Issues with Compounding Pharmacies, in-house compounding • Duty of Due Diligence for Purchasing from Compounding Pharmacies – a new standard? Vanderbilt University Vanderbilt University Medical Center

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32. Additional Legal Issues (cont’d) • FDA Oversight / State Law Vanderbilt University Vanderbilt University Medical Center

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34. Selected Pharmacy Sterile Compounding Misadventures Vanderbilt University Vanderbilt University Medical Center

35. Selected Pharmacy Sterile Compounding Misadventures Vanderbilt University Vanderbilt University Medical Center

36. Additional Legal Issues (cont’d) • Informed Consent • Duty to inform patients drugs obtained from compounding pharmacy? • Plethora of Plaintiff Attorney Advertisements / Websites Vanderbilt University Vanderbilt University Medical Center

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