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Fungal Infections Associated with Contaminated Methylprednisolone Acetate in Michigan, 2012-2013 Joseph R. Coyle, MPH Michigan Department of Community Health Exserohilum rostratum 2 Acknowledgements • Michigan Outbreak Response Team: ▫ ▫ ▫ ▫ Brenda Brennan Jim Collins Joe Coyle Jay Fiedler ▫ ▫ ▫ ▫ ▫ Jennie Finks Shannon Johnson Jevon McFadden Mawuli Nyaku Many others… • Michigan Pain Clinics and Staff • Michigan Hospitals- Administrators, Clinicians, IPs • State Health Departments • Centers for Disease Control and Prevention 3 Outline • Outbreak Timeline • Role of the MDCH • Michigan Pain Clinics ▫ Patient Notification • Identifying and Counting Cases ▫ Surveillance definitions • Characterization and Epidemiology of Fungal Infections in Michigan • Summarizing the MDCH Contribution 4 Outline Case Count October 8th, 2012 Case Count June 3rd, 2013 5 Outbreak Timeline 6 Outbreak Timeline • September 18th, 2012 – Tennessee Department of Health (TDH) receives report of 56-year old patient with Aspergillus meningitis • September 25th, 2012 – TDH identified an additional 7 patients with meningitis ▫ All TN patients received an epidural steroid injection from a common Ambulatory Surgery Center ▫ All injections were from three lots of methylprednisolone acetate (MPA) from the New England Compounding Center (NECC) 7 Outbreak Timeline • September 26th, 2012 – NECC voluntarily recalls three lots of MPA (05212012, 06292012, and 08102012) • September 27th, 2012 – North Carolina Department of Health and Human Services identifies a patient with meningitis also exposed to one of the three recalled lots of MPA TN and NC patients had similar presentations (subacute meningitis with pleocytosis) with a common exposure (NECC MPA) 8 Outbreak Timeline • September 28th, 2012 – Growing evidence of connection between meningitis cases and NECC MPA shared on multi-state call with CDC • October 1st, 2012 –NECC customer invoice list shared with the Michigan Department of Community Health (MDCH) Bureau of Epidemiology • October 2nd, 2012 – MDCH begins contacting Michigan clinics who were recipients of recalled lots of NECC MPA 9 Role of the Michigan Department Community Health 10 MDCH Role • Maintaining daily contact with CDC (Epi, Lab, and Clinical) • Retrospectively and prospectively identifying cases and maintaining case count / line list • Coordinating with Michigan hospitals and clinicians • Sharing information via the Michigan Health Alert Network (MIHAN) • Updating media via press releases and our PIO • Collection of specimens to be forwarded to CDC lab for testing 11 MDCH Role • Chart abstraction and data collection • Patient Notification and Coordinating with Michigan Clinics: ▫ Re-enforcing recall and instructing clinics to pull any recalled product from circulation ▫ Identifying a point-of-contact at each pain clinic ▫ Working with clinics to determine a list of patients potentially exposed to a recalled lot of NECC MPA ▫ Assisting clinics with direct patient notification: Direct contact via phone (voicemail not sufficient) Registered letter 12 Michigan Pain Clinics 13 Michigan Pain Clinics Location Recalled Product Received Lot Number Clinic A Clinic B Clinic C Clinic D Amount Product Patients Injections 638 759 1,032 1,668 102 114 32 40 1,804 2,581 06292012 400 vials MPA 80mg/mL – 5mL PF 05212012 1,000 vials MPA 80mg/mL – 1mL PF 06292012 500 vials MPA 80mg/mL – 1mL PF 05212012 100 vials MPA 80mg/mL – 1mL PF 06292012 100 vials MPA 80mg/mL – 1mL PF 08102012 100 vials MPA 80mg/mL – 1mL PF 05212012 25 vials MPA 80mg/mL – 1mL PF MI TOTAL *Estimates 2,225 vials Exposures* 14 Michigan Pain Clinics Location Recalled Product Received Lot Number Clinic A Clinic B Clinic C Clinic D Amount Product Patients Injections 638 759 1,032 1,668 102 114 32 40 1,804 2,581 06292012 400 vials MPA 80mg/mL – 5mL PF 05212012 1,000 vials MPA 80mg/mL – 1mL PF 06292012 500 vials MPA 80mg/mL – 1mL PF 05212012 100 vials MPA 80mg/mL – 1mL PF 06292012 100 vials MPA 80mg/mL – 1mL PF 08102012 100 vials MPA 80mg/mL – 1mL PF 05212012 25 vials MPA 80mg/mL – 1mL PF MI TOTAL *Estimates 2,225 vials Exposures* 15 Michigan Shipments of NECC MPA Lot Number Michigan (mLs) Nationwide (mLs)1 MI % of Nation 05212012 1,125 11,622 9.7% 06292012 2,600 10,665 24.4% 08102012 100 4,303 2.3% TOTAL 3,825 26,591 14.4% 16 Michigan Shipments of NECC MPA Lot Number Michigan (mLs) Nationwide (mLs)1 MI % of Nation 05212012 1,125 11,622 9.7% 06292012 2,600 10,665 24.4% 08102012 100 4,303 2.3% TOTAL 3,825 26,591 14.4% • Preliminary data analysis indicated lot 06292012 had the highest attack rate of the three recalled lots1,2 1Smith et al. “Fungal Infections Associated with Contaminated Methylprednisolone Injections – Preliminary Report”. New England Journal of Medicine. 2012. 2Kainer et al. “Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee”. New England Journal of Medicine 367(23):2194-203 17 Patient Notification • Objectives: ▫ Explain patient’s exposure and evaluate individual for current signs and symptoms of meningitis or localized infection ▫ If the patient is symptomatic: Refer patient to receive immediate medical evaluation ▫ If the patient is asymptomatic: Discuss signs and symptoms of disease Inform patients to receive immediate medical evaluation if they experience symptoms in the future ▫ Answer any other questions or concerns patients might have 18 Patient Notification 100.0% 1750 1500 80.0% 1250 60.0% 1000 750 40.0% 500 20.0% 250 0 0.0% 10/2 10/9 10/16 10/23 10/30 11/6 • MDCH staff helped a Clinic A place phone calls on 10/6 • MDCH and Local Health Department staff dispatched to Clinic B from 10/8 to 10/10 to aid in contacting patients • Patients hard to reach by phone sent registered letter Percentage of Patients Notified Number of Patients Notified Michigan NECC Patient Notification Estimates 19 Identifying and Counting Cases 20 Case Definitions (http://www.cdc.gov/hai/outbreaks/clinicians/casedef_multistate_outbreak.html ) An individual potentially exposed to one of the three recalled lots of NECC MPA who meets one of the following criteria: • Meningitis - Meningitis of unknown etiology • Stroke - Posterior circulation stroke without a cardioembolic source and without documentation of a normal cerebrospinal fluid (CSF) profile • Paraspinal Infection - Osteomyelitis, abscess or other infection (e.g., soft tissue infection), in the spinal or paraspinal structures at or near the site of injection • Joint Infection - Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee, shoulder, or ankle) 21 Case Identification (http://www.cdc.gov/hai/outbreaks/clinicians/casedef_multistate_outbreak.html ) • Case definitions are not mutually exclusive ▫ e.g. a patient could have both meningitis and a paraspinal infection • Cases were counted in the state where they received their injection ▫ e.g. Michigan residents who received NECC injections in Indiana are counted as Indiana cases • Deaths reported are from all causes among persons who meet at least one of the case definitions ▫ Deaths are not necessarily directly attributed to a fungal infection or treatment complications 22 Case Identification (http://www.cdc.gov/hai/outbreaks/clinicians/casedef_multistate_outbreak.html ) • Determination of infection was made by clinical teams, including neuroradiologists and infectious disease specialists, who interpreted findings in the context of patient signs and symptoms • For example: ▫ Clinical judgment – determining what is an infectious versus non-specific enhancement on MRI ▫ Patient judgment – determining new or worsening pain beyond baseline • MDCH counted cases, but did not ‘call’ cases 23 Epidemiology of Fungal Infections in Michigan 24 Case Count (as of June 3rd, 2013 - http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html) 25 Case Count (as of June 3rd, 2013 - http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html) State Meningitis + Stroke w/out Peripheral Total Case Meningitis Paraspinal/Spinal Paraspinal/Spinal Lumbar Puncture Joint Infection Count Only Infection only Infection Only Only Paraspinal/Spinal Infection + Peripheral Joint Infection Deaths Florida (FL) Georgia (GA) Idaho (ID) Illinois (IL) Indiana (IN) Maryland (MD) Michigan (MI) Minnesota (MN) North Carolina (NC) New Hampshire (NH) New Jersey (NJ) New York (NY) Ohio (OH) Pennsylvania (PA) Rhode Island (RI) South Carolina (SC) Tennessee (TN) Texas (TX) Virginia (VA) West Virginia (WV) 25 1 1 2 88 26 264 12 18 14 51 1 20 1 3 3 152 2 54 7 22 1 1 2 30 23 23 10 1 9 30 0 12 1 1 2 21 2 41 0 1 0 0 0 17 1 44 0 3 0 11 0 3 0 1 0 58 0 8 2 1 0 0 0 1 0 2 0 0 0 0 0 0 0 0 0 3 0 0 0 1 0 0 0 40 2 168 2 14 0 9 1 5 0 1 1 68 0 4 5 0 0 0 0 0 0 25 0 0 5 1 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 5 0 0 0 11 3 16 1 1 0 0 0 1 0 0 0 15 0 5 0 TOTAL 745 232 150 7 321 33 2 58* 26 Case Count (as of June 3rd, 2013 - http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html) State Meningitis + Stroke w/out Peripheral Total Case Meningitis Paraspinal/Spinal Paraspinal/Spinal Lumbar Puncture Joint Infection Count Only Infection only Infection Only Only Paraspinal/Spinal Infection + Peripheral Joint Infection Deaths Florida (FL) Georgia (GA) Idaho (ID) Illinois (IL) Indiana (IN) Maryland (MD) Michigan (MI) Minnesota (MN) North Carolina (NC) New Hampshire (NH) New Jersey (NJ) New York (NY) Ohio (OH) Pennsylvania (PA) Rhode Island (RI) South Carolina (SC) Tennessee (TN) Texas (TX) Virginia (VA) West Virginia (WV) 25 1 1 2 88 26 264 12 18 14 51 1 20 1 3 3 152 2 54 7 22 1 1 2 30 23 23 10 1 9 30 0 12 1 1 2 21 2 41 0 1 0 0 0 17 1 44 0 3 0 11 0 3 0 1 0 58 0 8 2 1 0 0 0 1 0 2 0 0 0 0 0 0 0 0 0 3 0 0 0 1 0 0 0 40 2 168 2 14 0 9 1 5 0 1 1 68 0 4 5 0 0 0 0 0 0 25 0 0 5 1 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 5 0 0 0 11 3 16 1 1 0 0 0 1 0 0 0 15 0 5 0 TOTAL 745 232 150 7 321 33 2 58* 27 Case Breakdown Michigan Fungal Infections be Case Definition (n=264a,b) 25 9% 2 1% 23 9% Meningitis Only 44 17% Meningitis + Paraspinal/Spinal Infection Stroke w/out Lumbar Puncture Only 2 1% Paraspinal/Spinal Infection only Peripheral Joint Infection Only Paraspinal/Spinal Infection + 168 Peripheral Joint Infection 63% a 16 deaths among persons meeting one of the case definitions b 83 (31.8%) cases laboratory confirmed by culture, histopathology or molecular assay 28 Case Count (as of June 3rd, 2013 - http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html) Meningitis (with or without other infection) Michigan Nationwide Paraspinal/Spinal Infection only Peripheral Joint Infection Only Total Case Count 0 100 200 300 400 500 600 700 800 60 70 Deaths 0 10 20 30 40 50 29 Case Breakdown 25 9% 2 1% 23 9% Michigan N=264 44 17% 4 0 8% 0% 0 0% Virginia N=54 8 15% 2 1% 168 63% Meningitis Only Meningitis + Paraspinal/Spinal Infection Stroke w/out Lumbar Puncture Only Paraspinal/Spinal Infection only Peripheral Joint Infection Only Paraspinal/Spinal Infection + Peripheral Joint Infection 41 77% 30 Case Count (as of June 3rd, 2013 - http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html) Patients Exposed1 Patients Infected 13.3% 35.4% 64.6% 86.7% Michigan 1Smith Nationwide et al. “Fungal Infections Associated with Contaminated Methylprednisolone Injections – Preliminary Report”. New England Journal of Medicine. 2012. 31 Epi Curve • Change in case presentation from meningitis to primarily paraspinal infections around late October prompted one hospital to recommend screening MRIs for all asymptomatic patients potentially exposed at Clinic A 32 Screening MRIs • Approach initiated by a single Michigan hospital • 414 asymptomatic patients targeted as part of outreach ▫ Preliminary data on 292 patients who received MRI screens Preliminary Results on Screening MRIs (n=292) 16% Normal Equivocal 18% Abnormal 66% Represents approximately 50 patients who may not have been otherwise identified 33 Infection Timeline N=5 N=41 34 Infection Timeline N=73 N=214 35 Infection Timeline N=255 36 Case Demographics Age (n=264) Median 66 Range 28-89 Sex (n=264) Female 154 58.3 % Male 110 41.7 % American Indian / Alaskan Native 1 0.4 % Asian 1 0.4 % Black / African American 4 1.5 % Caucasian 247 93.6 % Unknown 11 4.2 % Race (n=264) 37 Clinic Attack Rates Location Clinic A Clinic B Clinic C Clinic D Recalled Product Received Lot Number Amount (vials) 06292012 400 MPA 80mg/mL – 5mL 05212012 1,000 MPA 80mg/mL – 1mL 06292012 500 MPA 80mg/mL – 1mL 05212012 100 MPA 80mg/mL – 1mL 06292012 100 MPA 80mg/mL – 1mL 08102012 100 MPA 80mg/mL – 1mL 05212012 25 MPA 80mg/mL – 1mL Product Exposures* Infections Patients Cases Attack Rate 638 212 33.2 % 1,032 52 5.0 % 102 0 0.0 % 32 0 0.0 % MI Total 2,225 1,804 264 14.6 % Nationwide 26,5911 13,5342 7453 5.5 % 1Smith et al. “Fungal Infections Associated with Contaminated Methylprednisolone Injections – Preliminary Report”. New England Journal of Medicine. 2012. 2http://www.cdc.gov/hai/outbreaks/infographic.html *Estimates 3http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html 38 Clinic Attack Rates Location Clinic A Clinic B Clinic C Clinic D Recalled Product Received Lot Number Amount (vials) 06292012 400 MPA 80mg/mL – 5mL 05212012 1,000 MPA 80mg/mL – 1mL 06292012 500 MPA 80mg/mL – 1mL 05212012 100 MPA 80mg/mL – 1mL 06292012 100 MPA 80mg/mL – 1mL 08102012 100 MPA 80mg/mL – 1mL 05212012 25 MPA 80mg/mL – 1mL Product Exposures* Infections Patients Cases Attack Rate 638 212 33.2 % 1,032 52 5.0 % 102 0 0.0 % 32 0 0.0 % MI Total 2,225 1,804 264 14.6 % Nationwide 26,5911 13,5342 7453 5.5 % 1Smith et al. “Fungal Infections Associated with Contaminated Methylprednisolone Injections – Preliminary Report”. New England Journal of Medicine. 2012. 2http://www.cdc.gov/hai/outbreaks/infographic.html *Estimates 3http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html 39 Factors contributing to burden of cases in Michigan • Michigan had the highest number of potentially exposed patients1 • Michigan received a disproportionate amount of the 06292012 ‘Hot Lot’ • Potentially higher contamination in 5mL vials of MPA? • Enhanced surveillance and MRI screenings may have identified cases that might have otherwise been missed 1Smith et al. “Fungal Infections Associated with Contaminated Methylprednisolone Injections – Preliminary Report”. New England Journal of Medicine. 2012. 40 Summary 41 Contributions from MDCH • MDCH dedicated ~4,000 hours during the first three months of the outbreak (equivalent of two FTEs) • Case report form completion – over 10,000 pages of hospitalization information from fungal cases abstracted from medical records sent to CDC: ▫ 264 case report forms, each a minimum of 27 pages in length – totaling ~7,128 pages ▫ 277 additional admission case report forms, each a minimum of 12 pages in length – totaling ~3,324 pages • Sharing information to help inform national guidelines and recommendations 42 Contributions from MDCH • Providing hospital assistance and support clinical decision making: ▫ MDCH Certificates of Need through Licensing and Regulatory Affairs Allowed hospital to obtain an additional mobile MRI Allowed hospital to open an additional operating suite ▫ Redirected patients to hospitals with lower burden of infected patients ▫ Assisted with staffing augmentation at overburdened facilities FEP Volunteer Management expedited out-of-state nurse licensure 43 Contributions from MDCH • Facilitated patient notification which led to early diagnosis and treatment http://www.cdc.gov/hai/outbreaks/infographic.html 44 Thanks! 45 Questions?