TDH Update on Outbreak of Infections Associated with Recalled Methylprednisolone Acetate-October 12, 2012

NASHVILLE – Tennessee Health Commissioner John Dreyzehner, MD, MPH, has provided an update on the investigation of infections associated with recalled methylprednisolone acetate. His statements from today’s media briefing are included below. Dreyzehner was joined today by Robert Latham, MD, chief of medicine and infectious disease specialist at Saint Thomas Hospital in Nashville; his statements are also included below.

As of 1 p.m. Central time Oct. 12, 2012, the Tennessee Department of Health is aware of 50 patients with meningitis, epidural abscess or posterior stroke associated with epidural steroid injections provided between July 1 and Sept. 28, 2012 at these three facilities:  PCA Pain Center in Oak Ridge, Saint Thomas Outpatient Neurosurgery Center in Nashville and the Specialty Surgery Center in Crossville. The number of confirmed deaths in this situation remains at six.

Individuals who have had an epidural steroid injection at one of these facilities during that time should contact their health care provider for an assessment. Tennesseans wanting to ask questions about the outbreak may contact the Tennessee Poison Control Center at 1-800-222-1222. 

Separately, the Tennessee Board of Pharmacy has called a meeting for Monday, October 15, 2012 at 11 a.m. Central time. The meeting will take place at Heritage Place, 227 French Landing in Nashville in the Poplar Room. The meeting notice may be viewed online at https://apps.tn.gov/pmn/sitemap/notice/1546.html.

Statement by Commissioner Dreyzehner October 12, 2012:

Good afternoon and thank you for your participation in today’s press briefing. We continue to appreciate the media’s important role in disseminating important public health information.

We begin by again extending our sympathy to those most affected by this tragic outbreak:  families who have lost loved ones and individuals who are now struggling to recover, or those dealing with worry about the uncertainty of this evolving situation and the imperfect scientific understanding about some important details. They are in our thoughts and prayers as the work continues.

We invited the clinician who has cared for the most patients impacted by this outbreak to attend today’s briefing. So, I’m joined by Dr. Robert Latham, who will discuss his work treating patients associated with this outbreak. He will be discussing that with you in a few moments, and then be available to answer questions. Also on the call are two key Tennessee Department of Health leaders:  Dr. David Reagan, our Chief Medical Officer, and Dr. Marion Kainer, who supervises our Healthcare Associated Infections & Antimicrobial Resistance Program.

Today, we sadly report one additional person in Tennessee has been identified as infected associated with the outbreak, since our 1 p.m. update yesterday, bringing the total number to 50 in Tennessee. The number of deaths stands at six. 

We said in our first press briefing Oct. 1, this is an evolving situation. As our investigative and outreach work goes on, what we know continues to improve, allowing us to know and share greater information than we could previously. Additional understanding about the incubation period, risk factors, attack rate and the cause or causes of the illnesses and other factors in the outbreak itself will probably change or come to light as time passes, new observations are made and the scientific understanding evolves. That is the nature of outbreak investigations, generally and particularly in the setting of uncharted territory as we have here.

Maintaining our commitment to transparency, we want to report an issue we believe will not result in new infections but warrants public information. Thanks to the very alert staff at Saint Thomas, we have learned an order of methylprednisolone acetate from a possibly contaminated lot was shipped to Tennessee in early June and was used for treatment of patients. We are working to confirm the lot number associated with this delivery from the New England Compounding Center.

Saint Thomas has identified every patient who received injections from this shipment, which we believe, but cannot yet assure, is different from the recalled lots. Out of an abundance of caution, we are now working to contact every person treated with this material. In many cases, those who were treated in this earlier time were also treated later, so many have already been contacted.

Some of you have likely been following national discussions about a second firm whose products are now a subject of inquiry by the CDC and FDA. We are having conversations with the CDC and the FDA about Ameridose products. At this time we have no information about identification or confirmation of any problems associated with Ameridose products. If we learn of any issues potentially affecting public health, we will respond rapidly and appropriately.

Some of you have asked about regulatory action regarding NECC. As you know, TDH, without waiting for regulatory action, issued two alerts via the Tennessee Health Alert Network for clinicians in Tennessee to not use any products produced or distributed by NECC. The first of these messages went out Oct. 4, two days before the expanded voluntary recall of all NECC products. While we had no knowledge of any other NECC product contamination, we did this out of an abundance of caution to offer protection to the people of Tennessee. 

We want to emphasize the cooperation we’ve received from the healthcare community and our public health partners on a most important part of this outbreak:  treatment of infected patients.  We also want to acknowledge the work of clinicians who have been most helpful and continue to work tirelessly.

Our focus has been and will continue to be on the protection of the people of Tennessee. Our early actions protected people in Tennessee from further exposure to contaminated products from NECC. Regulatory action was not necessary to accomplish this.

With us today is Dr. Robert Latham, who has himself worked tirelessly throughout this outbreak, and as one of the clinicians who initially reported early cases, allowing our team, led by Dr. Kainer, to connect the dots and alert the CDC and FDA of what we initially saw as a very unusual cluster of stroke and meningitis, as early as September 20. We’re grateful for his efforts and pleased to have him here with us.

Statement by Robert Latham, MD, October 12, 2012:

Thank you Dr. Dreyzehner. I am very pleased to be here this afternoon. As most of you know, I have been very involved with the care of the 31 patients admitted to Saint Thomas Hospital for treatment of the fungal infection resulting from receiving an epidural injection of a contaminated steroid preparation. Thus, I am uniquely positioned to speak about the status of these patients, their care at our hospital and the burden this medical accident has placed on the patients and their families. To date, we had two patients die of their infection; 28 remain in stable condition; two are critically ill in our intensive care unit; and one went home. Most of those in stable condition are showing signs of improvement, some at a faster pace than others. 

My involvement with these patients has also made me a key eyewitness to another extraordinary story:  one of selfless sacrifice and caring among nurses, associates and physicians who have come forward to help in ways that I never imagined. Most notable has been our ER nurses and physicians. We have seen 330 patients in our emergency department since Oct. 1 who have been extensively evaluated after being notified as potentially receiving the contaminated medication; 275 have required lumbar punctures, an often tedious and difficult procedure, to sample their cerebrospinal fluid to allow clear distinction between the presence or absence of any infection.

Finally, the Saint Thomas Hospital operators have been answering calls around the clock from worried members of the community, directing them where to seek assistance and, I have to add, finding me when I need to be somewhere I am not.

We appreciate the media assistance in continuing to provide the public with information. We continue to ask your assistance is assuring the public that the only center that received the tainted steroids was the ninth-floor Outpatient Neurosurgery Center, which is separate from the hospital or any other outpatient center on the Saint Thomas campus. I must emphasize that I am not affiliated with the center nor perform epidural injections; questions you have regarding either of those topics, I cannot answer. However, I am very willing to take questions about these patients, their infections and the tremendous outpouring of assistance I have witnessed among my fellow Saint Thomas workers.