Tennessee Department of Health issues update on Outbreak of Infections Associated with Epidural Steroid Injections, October 8th 2012

Nashville, TN – Tennessee Health Commissioner John Dreyzehner, MD, MPH, has provided an update on the investigation of infections associated with epidural steroid injections. His statements from today’s media briefing are included below.

Dreyzehner has activated the State Health Operations Center in response to the multi-state outbreak of infections first identified September 18th, 2012. TDH will staff the SHOC daily, and an on-call physician will answer calls after hours.

The outbreak has been linked to patients receiving spinal steroid injections, a common treatment for back pain, between June 27th and September 28th, 2012 in Nashville and between July 1st and September 28th, 2012 in Crossville and Oak Ridge.

The incubation period for onset of illness is estimated at two to 28 days. The steroid drugs believed to be responsible were compounded by the New England Compounding Center in Framingham, MA. NECC has now voluntarily recalled all products compounded and distributed from its Massachusetts facility.

At A Glance

• Status: Ongoing Investigation
• Infection: Fungal Meningitis
• Facility Type: Outpatient Setting
• Case Count: 105
• States: 9
• Deaths: 8

Statement by Commissioner Dreyzehner October 8th 2012

Good afternoon. I want to thank you for being with us. We appreciate the public health value of your continuing coverage.

Before I go into details about activities and facts, I want to again offer our sympathy to the people whose lives have been significantly impacted by this very tragic situation. To those whose families or circle of friends have been affected, please know we keep you in our thoughts and prayers.

Today we confirm three new cases and one additional death. The total number of cases in Tennessee is now 35 and the number of deaths is four. Friday we opened the State Health Operations Center here in the Cordell Hull Building and four regional health operations centers.

These are our emergency operations centers, allowing a network of professionals to rapidly exchange information and data. At the conclusion of this news briefing, those of you who want to see the center here will have that opportunity.

Local health department teams in many areas of the state worked tirelessly over the weekend, making personal contact with approximately 66 at-risk patients who we previously had not been able to verify were contacted with the latest information. In many cases, that meant knocking on doors and asking and answering questions.

This Saturday, the New England Compounding Center announced a voluntary recall of all products compounded and distributed from its Massachusetts facility.

We issued a Tennessee Health Alert Network message to state clinicians two days before, on Thursday afternoon, directing them to not use any NECC products. To reinforce that message, we sent another alert via THAN his morning.

It is important to be clear our colleagues at the CDC and FDA have not found any problems with any of the multiple other products they have identified as coming from NECC. But we believe they should not be used in Tennessee as long as we, the CDC and the FDA lack assurance that no other product is contaminated.

We understand NECC has committed to fax notices of the recall to every practice location where their products have been sent. We are carefully double-checking to identify which practice locations might have used these NECC products. That work will continue until we know where every product went and if it was used, and we will work to assure that staff at every practice location that received recalled products from NECC are aware of the message to not use those products. We are also sharing information through our network of health departments, our website, and through all of you in the media.

Based on their analysis of cases nationally, the CDC has expanded the case definition for patients included in this outbreak, and we are following the expanded definitions in Tennessee. The new date is June 27th in Tennessee. This is in contrast to the national date of May 21st and our June 27th date reflects when materials were actually received in Tennessee.

Our goal is to continue to identify at-risk patients as soon as possible, knowing early recognition can benefit treatment results. Because of the aggressive follow-up of involved clinics and other efforts, patients are now being identified earlier in the course of their illness, when treatment is expected to be more effective.

One of the challenges for clinicians in Tennessee known to have possibly used contaminated methylprednisolone acetate has been the demanding process of assuring that all patients potentially at risk have up-to-date information.

As you know our team here at TDH identified the outbreak and also that methylprednisolone acetate was the primary suspect, and we have modified our messages as our scientific investigation has led to new findings. As the situation has evolved, our outreach efforts have also evolved in concert with our scientific investigation. Our regional county leaders, county health directors and public health nurses have been instrumental in this effort.

At present our plans include partnering with the clinics to assure regular person-to-person contact with each of the at-risk patients, for as long as deemed necessary. We will continue to cooperate with the staff of the affected clinics and to provide ongoing information and evaluation to those who were possibly exposed to contaminated medication.

We are cautiously optimistic that many of the efforts to reach patients and clinicians with information about this outbreak are succeeding in allowing earlier recognition of infection and earlier institution of treatment. We appreciate your reporting and helping to inform the public about the evolving developments and uncertainties in this outbreak.