Information Sharing: Outbreak of Fungal Infections Associated with Contaminated Steroid Injections David H. Trump, MD, MPH, MPA State Epidemiologist and Director, Office of Epidemiology Virginia Department of Health

Session Objectives Specify the inter-related roles of local, state, and federal public health agencies in response to large- scale outbreaks of communicable diseases Explain the importance of coordination and information sharing between the clinical community and public health to characterize and respond effectively to such outbreaks Describe how regional coordination and public information play critical roles in support of an organized, comprehensive response

Outline Tennessee meningitis patients Methylprednisolone acetate traceback Current case definition Multistate outbreak summary Virginia outbreak summary Partnerships

Tennessee Meningitis Patients On 9/18, Tennessee Dept of Health was notified of 1 patient with Aspergillus meningitis who had been treated at an ambulatory surgical center By 9/25, 7 more patients with meningitis had been identified from the same ambulatory surgical center Symptoms included headache, stiff neck and fatigue; four patients presented with strokes CSF cultures were negative On 9/27, North Carolina reported 1 patient with similar clinical presentation All patients had received injections of preservative-free methylprednisolone acetate (MPA)

What is methylprednisolone acetate (MPA)? Corticosteroid hormone Used to treat pain and swelling Often administered to individuals with arthritis or other joint disorders Mutes immune response Frequently injected into spinal area In this case – preservative free Source: AP

Methylprednisolone Acetate Traceback - NECC Implicated product traced back to one compounding pharmacy in Massachusetts Facility identified as New England Compounding Center (NECC) 3 lots identified as being implicated Source: AP

What is a compounding pharmacy? Can customize medications to fit a patient’s needs (“made from scratch”) Physicians often prescribe compounded pharmaceuticals when manufactured drug won’t work (because of dose needed, drug delivery system, allergies, drug shortages, etc.) Compounding can be performed at independent drug centers/labs, hospitals, large chain drug stores and smaller independent pharmacies Regulated differently than non-compounding pharmacies – Not directly/routinely regulated by the FDA – Regulated primarily by State Boards of Pharmacy Source: Professional Compounding Centers of America

MPA Traceback On 10/3, NECC shut down operations On 10/4, CDC and FDA recommended all healthcare professionals cease use and remove any product produced by NECC On 10/4, FDA reported observing fungal contamination from a sealed vial from NECC On 10/6, NECC issued a recall of all products that were produced at the facility in Framingham, MA Source: Reuters

MPA Traceback On 10/18, CDC and FDA confirmed the presence of Exserohilum rostratum, a fungus, in unopened MPA On 10/26, FDA released an inspection report (483 report) – Observed and confirmed contaminated products at firm – Observed problems with NECC’s ability to maintain clean room Source: exserohilum2.jpg

Methylprednisolone Acetate Traceback Source: List of Healthcare Facilities that Received Lots of Methylprednisolone Acetate (PF) Recalled from New England Compounding Center on September 26, 2012

Current Case Definition - Meningitis and Other Infections Probable Case A person who received a preservative-free methylprednisolone acetate (MPA) injection, with preservative- free MPA that definitely or likely came from one of the following three lots produced by the New England Compounding Center (NECC) and subsequently developed any of the following: – Meningitis 1 of unknown etiology following epidural or paraspinal injection 2 after May 21, 2012; – Posterior circulation stroke without a cardioembolic source and without documentation of a normal cerebrospinal fluid (CSF) profile, following epidural or paraspinal injection 2 after May 21, 2012; 3 – Osteomyelitis, abscess or other infection (e.g., soft tissue infection) of unknown etiology, in the spinal or paraspinal structures at or near the site of injection following epidural or paraspinal injection2 after May 21, 2012; or – Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee, shoulder, or ankle) of unknown etiology diagnosed following joint injection after May 21, Clinically diagnosed meningitis with one or more of the following symptoms: headache, fever, stiff neck, or photophobia, in addition to a CSF profile showing pleocytosis (>5 white blood cells, adjusting for presence of red blood cells by subtracting 1 white blood cell for every 500 red blood cells present) regardless of glucose or protein levels. 2 Paraspinal injections include, but are not limited to, spinal facet joint injection, sacroiliac joint injection, or spinal or paraspinal nerve root/ganglion block. 3 Patients in this category who do not have any documented CSF results should have a lumbar puncture performed if possible, using a different site than was used for the epidural injection when possible. Confirmed Case A probable case with evidence (by culture, histopathology, or molecular assay) of a fungal pathogen associated with the clinical syndrome. Last Revised October 24, 2012

Multistate Outbreak Summary 733 case-patients from 20 states, including VA 53 deaths reported VA reported the 4 th most cases nationally *data as of 4/8/2013 Source:

Multistate Outbreak Summary *data as of 4/8/2013 Source:

Virginia Outbreak Summary Implicated lots of methylprednisolone acetate shipped to two facilities in Virginia – Insight Imaging, Roanoke VA (over 600 patients) – New River Valley Surgery Center, Christiansburg VA (less than 30 patients) 675 patients received implicated product (from June 28, 2012 to September 28, 2012) – Exposed resided in 10 VA health districts and 4 other states 53 case-patients from these facilities reported as of April 23, 2013 (VA – 50, WV – 3) 41 cases with meningitis only; 8 cases with meningitis and spinal/paraspinal infection; 4 cases with spinal/paraspinal infection only 2 deaths reported as of April 23, 2013

Virginia Outbreak – Clinical Information *data as of 4/23/2013 ** n = 52

LHDs with Exposed Residents = location of facility that received potentially contaminated product

Federal, State, Local and Clinical Partnerships Federal Clinical Local State