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Bringing Out the Best to Address the Worst: Public Health Response to the Largest Healthcare Associated Outbreak in US

Bringing Out the Best to Address the Worst: Public Health Response to the Largest Healthcare Associated Outbreak in US History. Marion Kainer, MD, MPH, FRACP Tennessee Department of Health Council of State and Territorial Epidemiologists June 10, 2013.

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Bringing Out the Best to Address the Worst: Public Health Response to the Largest Healthcare Associated Outbreak in US

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  1. Bringing Out the Best to Address the Worst: Public Health Response to the Largest Healthcare Associated Outbreak in US History Marion Kainer, MD, MPH, FRACP Tennessee Department of Health Council of State and Territorial Epidemiologists June 10, 2013

  2. Tue Sept 18:The E-mail that started it all… Dr. Jones, We have a case of a [ ]yoimmunocompetent man with Aspergillusfumigatus meningitis.  He had been receiving lumbar epidural steroid injections at an outside facility which is the only explanation we can find to explain this.  He also has an L4-L5 1cm epidural abscess which supports this theory.  I wanted to inform you of this in case you feel that an investigation is warranted.  I am happy to discuss it further if you like. Thanks! April Pettit October September 2012

  3. Within 48 hours • Confirmed exposure of index patient (procedure) • Contacted CDC • Identified 2 potential additional cases in TN • Clinic A closed voluntarily • Sequestered supplies of medications, including methyl-prednisolone acetate (MPA) and other consumables at the clinic • Traced the MPA to New England Compounding Center (NECC) October September 2012

  4. Within 72 hours • On site evaluation of clinic processes and environment of care • CDC: no cases identified from other States • TN hospitals notified • Identified additional potential cases including patients presenting with strokes (posterior circulation territory) October September

  5. Within 7 Days • Worked with clinic to start contacting patients possibly exposed to contaminated medication • Identified: • 7 patients with meningitis • 3 had posterior circulation strokes • 1 patient with posterior circulation stroke (no spinal tap) • 1 patient with caudaequina syndrome and abnormal CSF • All exposed to preservative free MPA at Clinic A • Analytic study • Chart abstractions, several case had multiple procedures • Conference call with: • Massachusetts Department of Health, Massachusetts Board of Registration in Pharmacy, CDC, NECC October September 2012

  6. Within 8 Days • Epi-X : “Please report suspected cases of clinical meningitis/other neurologic infection with onset within 1 month of epidural injection since July 1 to Marion Kainer: (615) 741-7247” October 2012 September 2012

  7. Within 8 Days • NECC performed nationwide recall of 3 lots of MPA • The only lots of MPA ever linked to the outbreak • NECC provided distribution list of MPA • 17,675 vials • 76 facilities • 23 states • 2,520 vials to TN October September 2012

  8. Strong Sense of Urgency: Parallel Efforts • Chart abstraction (TDH & Clinic A) • Database construction (TDH) • Data entry (TDH) • Preparation of SAS code (TDH) • Outcome ascertainment (case/not a case): (Clinic A & TDH) • Labor intensive manual process (data on 306 patients, 586 procedures) in newly created database within 60 hours

  9. Data Collection Form

  10. TranslaminarvsTransforaminal Epidural space Translaminar Neural Foramen Transforaminal

  11. Why Cohort (vs. Case-Control) Study? • Outbreak rapidly evolving (ongoing outreach, patients were becoming cases), with cohort study could easily change outcome from non-case to case as new information became available • Lot number allocation could only be performed if obtained information on every exposed patient (lot numbers not recorded in patient charts) • Avoid introduction of bias through control selection • Allows for calculation of attack rates (important for risk communication, prioritization of patient outreach)

  12. Within 9 Days • First preliminary results from cohort study: • Outcomes known for 181 patients • No clinic related factors, but implicates MPA (dose response) MPA <80 mg RR=1.0 (Ref) MPA 81-160 mg RR=1.9 MPA >160 mg RR=2.7 October 2012 September 2012

  13. More Details on the Fungal Infection Outbreak Response: Breakout sessions Tuesday 2.00 pm Surveillance and Informatics Session “ How Information Management Saved Lives: Fungal Meningitis Case Study” Jennifer Ward Wednesday 10.30 am Infectious Diseases Session “There is a Fungus Among Us” Details of the early steps of outbreak investigation (TN) Andrew Wiese– CDC/CSTE fellow

  14. Within 9 Days • North Carolina reports potential case • Meningitis (next day: posterior circulation stroke) • Shared exposures with TN cases: • MPA from NECC (recalled lot number) • Lidocaine (same lot, same manufacturer) • Povidone iodine (same manufacturer) • Better understanding of spectrum of clinical presentations (subacute, ranging from few objective clinical signs (fever, meningism) to devastating stroke; caudaequina syndrome) October 2012 September 2012

  15. Laboratory Tests • Index case: Aspergillusfumigatus; galactomannan (Aspergillus Ag) +ve • CSF: High protein, low glucose, high WCC (predominately neutrophils) • ALL other tests on ALL other cases NEGATIVE, (including all galactomannan/Aspergillus Ag) • despite attempts to optimize recovery (obtaining high volume of CSF and culturing pellet after spinning down CSF)

  16. Clinical Picture Consistent With Fungal Meningitis Posterior circulation stroke: Suggestive of angioinvasive fungus such as Aspergillus or Mucormycosis Concern that patients may not seek care & that physicians may not perform LP/ fungal tests or start empiric Rx with antifungals

  17. Case Finding and Investigation • 3 clinics in TN, 1021 patients exposed to 3 lots of MPA from NECC • Two resource-intensive outreach efforts to all exposed individuals • Initial outreach for case finding & follow-up and second effort to identify additional local infections • Joint effort between public health and clinics • Engaged local and regional public health nurses • Use of Tennessee Countermeasures and Response Network (TN CRN) Patient Tracking Module

  18. Wed 10.30 am Infectious Diseases“There is a Fungus Among Us”Virginia and New Jersey

  19. Wednesday 10.30 amSurveillance / Informatics II – “Syndromic Surveillance: Hearing Music in the Mayhem” Florida Experience

  20. Assignment of Lot Numbers • Lot numbers NOT recorded in patient charts • Dates of invoices and lot numbers associated with invoices • Number of vials used per procedure • No sharing of vials between patients • 1 vial: 40 mg, 80 mg • 2 vials: 120 mg, 160 mg • 3 vials: 200 mg • Number of vials still on hand • Assumed no wastage • Usage followed “First in, first out” • Walked back and assigned lot numbers until all vials for that lot number were accounted for, then started with next lot number (08, then 06 then 05) • Calculated lot specific attack rates

  21. Description of Clinical Cases • Clinical Epi-Aid: ID trained EIS officer and medical student • Assist in abstraction of charts to describe the clinical features of cases, including incubation periods • Incubation Period • Symptom onset subtle in some patients • Difficulty in assigning precise date of onset of symptoms • Patients had multiple procedures • Which date should count as the exposure?

  22. October 1 (Day 14) Press release and press briefing by TDH. October September 2012

  23. Risk communication literature identifies 4 factors that determine whether the public will perceive a messenger as trusted and credible Navy Environmental Health Center Risk Communication Primer: http://www-nehc.med.navy.mil/downloads/deployment_health/primer.pdf

  24. October 3 (Day 16) • CDC publishes interim treatment guidance • First confirmation that disease process was due to FUNGUS (other than index case) • Biopsy of dura (enhancement on imaging) • Appeared to be invading/ direct extension of infectious process through dura • Did not look like Aspergillus October September 2012

  25. Histopathology & Autopsies Collaboration: • Surgeons/OR staff • Pathology departments at healthcare facilities • Office of Chief Medical Examiner • County Medical Examiner • Across jurisdictions/state-lines • State Public Health Lab • CDC: Mycotics and Infectious Diseases Pathology Branch

  26. October 4 (Day 17) State Public Health Lab from Virgina isolates and identifies Exserohilumrostratumfrom the CSF in an unknown death investigation • Patient was exposed to MPA from NECC • Black mold (melanin), found in soil, on plants • Thrives in warm, humid environment • Very rare case reports in literature, • No reports of meningitis, CNS infection October

  27. October 4 (Day 17) FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of MPA collected from NECC October

  28. October 4 (Day 17) CDC activates Emergency Operations Center (EOC) Strategic Objectives: • Prevent severe illness and deaths due to fungal meningitis and/or infection in patients exposed to contaminated steroid injections. • Develop and distribute diagnostic and treatment guidance. • Provide advanced testing at CDC laboratories. • Conduct surveillance to identify risk exposures. • Coordinate with the FDA to identify contaminated medication(s). October

  29. CDC Emergency Operations Center Strategic Objectives: • Prevent severe illness and deaths due to fungal meningitis and/or infection in patients exposed to contaminated steroid injections. • Develop and distribute diagnostic and treatment guidance. • Provide advanced testing at CDC laboratories. • Conduct surveillance to identify risk exposures. • Coordinate with the FDA to identify contaminated medication(s).

  30. Specimens Received in CDC Lab • 799 specimens from 469 case-patients* • 547 CSF from 350 patients • 147 tissues from 91 patients • 120 fresh frozen; 27 FFPE • 67 fungal isolates from 64 patients • 38 “other” samples • abscess fluid, joint fluid • States: MI, TN, IN, VA (74% of specimens) *Between Oct 2, 2012 and Feb 14, 2013

  31. CDC Emergency Operations Center Strategic Objectives: • Prevent severe illness and deaths due to fungal meningitis and/or infection in patients exposed to contaminated steroid injections. • Develop and distribute diagnostic and treatment guidance. • Provide advanced testing at CDC laboratories. • Conduct surveillance to identify risk exposures. • Coordinate with the FDA to identify contaminated medication(s).

  32. Clinical Challenges • Patient notification resulted in thousands of patients seeking care • Many physicians had never seen or treated fungal meningitis • Often difficult for patients to distinguish new symptoms from baseline symptoms • Diagnostic tests not without risk

  33. Clinical Guidance • Engaged clinicians with experience in fungal infections • Established best practices for diagnosis, treatment and management • Resulted in real-time development, dissemination of guidelines for patient care • Evolved with the constantly changing outbreak

  34. Who Covers Costs of Diagnostic Work up & Treatment?Centers for Medicare & Medicaid Services (CMS) • Worked to remove prior approvals and any other barriers to expedite treatment for patients • Reached out to Americas Health Insurance Plans (AHIP) early, communicated the serious nature of the outbreak and noted what CMS was doing to ensure access to treatment • October 16: Coverage for Medicare Part D prescriptions • October 25: Items and services to diagnose and treat patients . . . qualify for the Medicare Part A or Part B benefit. . . Due to the severity of this situation, CMS advises providers that Medicare contractors are expected to expedite all coverage determination requests for these items and services to include antifungal medication.

  35. TDH Epidemiology Snapshot: Oct. 7 • 31 cases from Clinic A in Tennessee as of 10/7/2012 4:30pm • 51 procedures performed on cases from Clinic A since 7/1/2012 • 798 patients underwent procedures at Clinic A since 7/1/2012 • 1,313 procedures performed at Clinic A since 7/1/2012 LOT B (06) • 25 cases/449 patients receiving lot B (06) • 56 cases per 1,000 patients receiving lot B (06) • 25 cases/619 procedures using lot B (06) • 40 cases per 1,000 procedures using lot B (06) • 40 procedures/619 total procedures using lot B (06) • 65 case-procedures per 1,000 procedures using lot B (06) • 25 cases per 1,000 vials of lot B (06)

  36. TDH Lot Analysis on Oct 7, 2012

  37. Kainer MA et al, Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee, NEJM, 2012; 367:2194-2203

  38. Kainer MA et al, Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee, NEJM, 2012; 367:2194-2203

  39. Univariate Analysis, Clinic A Kainer MA et al, Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee, NEJM, 2012; 367:2194-2203

  40. Cumulative Risk of Fungal Infection Logistic Regression Model, Excluding Lot Overlap For: Female >60, Translaminar approach

  41. Poster Monday 3.30 pm

  42. Stroke and Death as of Oct. 19th • 8 deaths • 7 had posterior circulation stroke • 13 patients had strokes • 5 patients developed stroke during hospitalization • 8 patients presented with posterior circulation stroke • 4 had onset of symptoms < 48 hours before admission • No opportunity for intervention to prevent devastating outcome if wait until develop symptoms • Reassess if additional interventions warranted, especially with some patients who are at high risk of becoming a case

  43. Poster Monday 3.30 pm

  44. CDC Communication Strategies • Electronic communication dissemination • Epi-X posting • Emerging Infections Network • ClinMicroNet • Blast emails to professional societies and listservs • Dedicated CDC website • Health Alert Network (10 HANs) • Clinical Outreach Communication Activity (COCA) calls (4 plus 2 webinars) >5,500 clinicians • Media press releases • Direct patient communication

  45. Patient Notification • September 28: CDC requests all 23 states with clinics that received the three MPA lots from NECC begin contacting patients. • October 6: CDC sets up a call center to assist states in contacting patients. • October 10: Approximately 90% of ~14,000 of patients exposed had been contacted at least once by telephone, voicemail, home visit, or registered mail. • CDC completes call-assistance requested by four states: New Jersey, Maryland, West Virginia, and Ohio.

  46. TDH Communication • Patient contacts, working along with clinics • Phone, certified mail, home visits, neighbors, etc. • More contacts as outbreak progressed • Medical community • Clinics involved, hospitals caring for patients • Other states, especially Kentucky • Federal partners (CDC, FDA, Senate hearing) • The medical community at large • Media - Prompt and insightful reporting • TDH web site updated daily • Legislative partners, state and federal

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