A Proactive Approach to Addressing Patient Safety Risks Associated With the 2012 Fungal Meningitis Outbreak

Medical Protective 10/18/12

The recent outbreak of fungal meningitis in the United States and subsequent recall of
a contaminated steroid medication have created concerns about patient safety and
liability among a number of Medical Protective’s insureds.
According to reports, the outbreak, which has been linked to an epidural steroid
injection produced and distributed by a specialty compounding pharmacy in
Massachusetts, has claimed 12 lives as of October 9, 2012. The pharmacy in question,
the New England Compounding Center (NECC), voluntarily recalled three lots of the
contaminated steroid (methylprednisolone acetate) on September 25, 2012. Less than
two weeks later, following a recommendation from the U.S. Food and Drug
Administration (FDA), NECC issued a voluntary recall of all of its products.
As of the date above, the Centers for Disease Control and Prevention (CDC) reports
that medical facilities in 23 states received the contaminated steroids, with nine states
reporting cases of fungal meningitis as of early October. States affected include
Indiana, Florida, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio,
Tennessee, and Virginia. Experts reportedly believe that more cases will emerge over
the coming days and weeks. For a list of states and facilities that received the recalled
lots of methylprednisolone acetate, visit

http://www.cdc.gov/hai/outbreaks/meningitisfacilities-map.html.
According to the CDC, the potentially contaminated injections were given beginning
May 21, 2012. Symptoms typically develop one to four weeks following injection and
may include fever, new or worsening headache, neck stiffness, sensitivity to light, new
weakness or numbness, increasing pain, and redness or swelling of the injection site.
In response to ongoing concerns, Medical Protective offers its insureds the following
risk strategies—in addition to relevant guidance from the CDC and the FDA—to address
issues related to the meningitis outbreak:
1. Determine if your medication inventory contains any products made or
distributed by NECC. These products have been recalled, and they should be
removed from circulation pursuant to CDC and/or FDA instruction.
2. Determine if your medication inventory includes any of the following lot
numbers that, according to current reports, have been linked to the fungal
meningitis outbreak:
a. Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68,
BUD 11/17/2012
b. Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26,
BUD 12/26/2012
c. Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51,
BUD 2/6/2013
3. Any identified inventory as described by 1 or 2 above (the “NECC Inventory”)
should be removed from circulation pursuant to CDC and/or FDA instruction.
Additionally, you should continue to review the CDC website to determine if any
other products require removal from your inventory.
4. Perform a current medication inventory audit. Be sure to include a review of
the record of medications previously received and administered, as they may no
longer be in your inventory. Then do the following:
a. Document that you performed the inventory audit, including dates and
times.
b. If your inventory includes items from the NECC Inventory, document the
steps you took to ensure the medication was pulled from your inventory,
including dates and times and how you sequestered the affected
medication. Take special care to document any lot numbers identified
by the CDC which appeared in your audit.
c. If your inventory does not contain items from the NECC Inventory,
document that you verified that your office did not receive or administer
any items from the NECC Inventory.