History

2. History • 9/18/2012 - a case of aspergillus meningitis was reported to the Tennessee Department of Health • Investigation revealed that the initial patient and 7 more patients had received epidural injections of methylprednisolone acetate from a single compounding pharmacy and at the same ambulatory surgical center • 9/26/2012 – NECC recalled 3 lots of methylprednisolone acetate • 9/28/2012 – Health Departments and facilities that had administered the recalled lots began identifying and notifying patients

3. History, continued • 10/4/2012 – FDA announced that microscopic evaluation of unopened vials of one lot of methylprednisolone acetate revealed fungi • The CDC website disseminates statistics, patient guidance and clinician guidance updated on a daily basis for the initial weeks of the outbreak • 10/18/2012 – CDC and FDA announce finding Exserohilumrostratum in 2 lots of the recalled methylprednisolone acetate along with other nonpathogenic fungi

4. Local history • One facility in the county used the recalled lots of methylprednisolone acetate • 463 patients had received injections with the recalled lots including epidural, facet, paraspinous and sacroiliac joint injections • Notification of exposed patients began on 10/2/2012 with a large number of patients notified on 10/4/2012 • Patients began presenting to the hospital ED on 10/4/2012 PM with first patients with abnormal spinal fluid results admitted on 10/4/2012 evening • Two patient cases were identified as already admittedby initiating a search using the list of exposed patients

5. The Hospital • 325 bed community hospital • Several patients were diagnosed and being admitted with meningitis on 10/4/2012 late afternoon and evening. Telephone discussions began with nursing administration, ED, pharmacy and the infectious disease physician. Information about the reported initial cases and treatment recommendations from CDC and ISDH were reviewed. • Patients were admitted to the Intermediate Care Center (ICC) and, if needed, the ICU. Patients were placed in isolation for meningitis while bacterial meningitis was ruled out. Initial treatment with IV voriconazole, Ambisome, vancomycin, ceftriaxone and ampicillin was begun. PICC lines were placed.

6. The Hospital, continued • Multidisciplinary “Huddle” on 10/5/2012 PM to coordinate the response to the large number of patients in ED, need for numerous LPs and multiple admissions with meningitis • Huddles were held each Monday, Wednesday and Friday through the end of October • ISDH, County Health Department and others joined the huddle by teleconference • CDC physicians arrived in mid October to collect data on the outbreak

7. The Hospital Huddle • Chaired by Nursing Administration • Nursing Supervisor and Unit managers: bed situation on ICC and ICU and nursing concerns • ED physician and manager: logistics of overflow of patients, need for more LP capacity, order sets for CSF, lab and antibiotic orders, staffing • Pharmacy: availability of antifungals, updates on the FDA investigation, placement of dedicated pharmacist on ICC, monitoring drug interactions and levels, patient handouts on the antifungal medications, met with each patient at discharge for medication teaching • Interventional Radiology: LP procedures, staffing

8. The Hospital Huddle • IV team: PICC placement and supplies • Infection Prevention: reporting and recordkeeping, coordination with County HD, ISDH • Lab: specimen handling and sending specimens to IDSH/CDC, order sets • Supply Dept.: LP trays, PICC kits, laundry • Environmental Services • Marketing: press releases and interview requests • Clergy: visiting all patients, contacting their churches and meeting with community clergy to educate them on the outbreak

9. The Hospital Huddle • Hospitalists: (all new physicians as of Oct.1)keep them updated on the hospital response and outbreak information • Case Management: ongoing case review with insurance companies, review insurance issues with patients, discharge planning for prescription coverage and ECF placement, application for Pfizer drug assistance program, information to ECFs at discharge • Dietary: coordinate mealtimes with voriconazoledosing schedule, nutritional supplements and special diets • Hospital President: encouragement, support and coordination of response

10. The Hospital Huddle • Infectious Disease physician: Update huddle on current statistics of the outbreak and new CDC information Update patient status Initiate and update order sets for lab tests, medications, consultation orders Identify discharge planning needs Attempt to anticipate upcoming patient care needs in the face of rapidly changing outbreak information

11. Fungal Infection Census 10/2 -11/15/2012

12. The Hospital - Statistics • Outbreak associated ED visits (October) – 168 • LPs (10/4 – 11/15/2012) – 180 • Outbreak associated hospital days (October) – 322 • Cost of Ambisome and voriconazole (10/5-11/15/2012) - $277,971 • Meningitis patient insurance: Medicare 63% Medicaid 18% Private ins 15% Uninsured 4%

13. The Doctor • Infectious Disease physician in practice for 25 years • Solo private fee for service practice, on staff at this hospital for 18 years. Also on staff at three other hospitals and Infection Prevention consultant. Rounds at this hospital on Monday, Wednesday, Friday and PRN. Sees outpatients in office two mornings a week. • Only Infectious Disease physician on staff at this hospital

14. The Doctor and the Outbreak • Faced with a new fungal pathogen not seen in humans before and with little or no information available to guide diagnosis or treatment. • Rapid influx of patients needing complex treatment with toxic antifungal and antibiotic therapy • Patients and families with questions that had no answers: How do you know I have the infection? What kind of infection do I have? What is the treatment? How long will I be in the hospital? How long will I need to be treated? How will I know that I’m cured? Why should I have to pay for this?

15. The Doctor and the Outbreak, continued • Lots of time spent on rounds explaining things known and unknown repeatedly to patients and families • Treating a new disease when the patients, their families and their physician simultaneously learn all of the known information on www.CDC.gov updated on a daily basis • Changing practice to round at this hospital all day every day for the month of October • Seemingly endless phone calls and pages, meetings, teleconferences. Hours of time on paperwork and keeping up to date with the latest information and recommendations from the CDC

16. The Doctor and the Outbreak, continued • Experiencing excellent patient care, kindness and teamwork at the hospital under difficult conditions. • The challenges of arranging and managing complex post-discharge care • Lawsuitsand lawyers • Mental and physical fatigue • Dealing with the unknown

17. The Patient • Dealing with the unknown • Change of lifestyle: In the hospital for significant duration Off work/unable to work Need for nursing home or rehabilitation facility Driving restrictions Unable to live independently without help Debilitating side effects of voriconazole Complex outpatient care: meds, labs, office followup • Less effective chronic pain management since cannot have further injections or planned spine surgery • Cost of medical bills, deciding about filing lawsuits

18. Successful Strategies in an Outbreak • Work together • Utilize everyone and their expertise • Communicate continuously • Be flexible • Try to anticipate upcoming needs • Remain calm (at least on the outside)