Recently, national news reports have focused attention on a meningitis outbreak that is apparently linked to contaminated steroid medications used for spinal epidural injections and joint injections. This outbreak has been linked to strokes and deaths due to fungal meningitis, and to other infections.
Patients who have received any such injections at the U-M Health System should know that we did not purchase any of the medication in question – specifically, preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center (NECC).
If you have had an injection for back pain or any other reason at a U-M clinic or hospital, it did not involve the drug linked to this outbreak.
We have pulled all other products made by NECC from our pharmacies as directed by the U.S. Food and Drug Administration (FDA) as a precaution. There is no indication at this time that any of these products are linked to the outbreak. It’s important to note that these other products are used only in certain highly specialized types of care, so very few patients receive them.
We stand ready to help treat any patients who have developed meningitis as a result of receiving an injection with the steroid medcation in question at a non-UMHS facility.
One patient whose meningitis was confirmed as meeting the CDC definition for this outbreak has died at our hospital. Another patient with a confirmed case is currently hospitalized here. This condition does not spread from person to person.
For more information on the outbreak please visit the Centers for Disease Control and Prevention page at http://www.cdc.gov/HAI/outbreaks/meningitis.html
More about our use of compounding pharmacies at UMHS:
At the U-M Health System, our first preference is to use medications and other products manufactured under FDA approved conditions by large-scale manufacturers. However, when there are critical shortages of any medications, we convene physicians and pharmacists to examine our options.
Often, suitable alternative medications that are not in short supply can be substituted. If no alternatives are available and we can procure components, we can compound drugs ourselves in a special “clean room” environment at University Hospital that complies with the USP 797 regulation issued by U.S. Pharmacopoeia Convention, a national standard-setting body for pharmacies. In this setting we can quarantine or test to ensure no microbes have contaminated the drug.
Only when a drug is in critically short supply, there are no alternatives and we cannot procure components, will we consider purchasing drugs from outside compounding pharmacies. This decision is carefully thought out and made by a chief physician and the chief of pharmacy, after consultation with multiple professionals. If the decision is made, we only purchase from pharmacies that we believe meet the same standards as our own internal compounding facility.
In the case of the steroid that is at the center of this outbreak, we never reached the point where we considered using a compounding pharmacy. We have been using steroid purchased from commercial sources.