A Proactive Approach to Addressing Patient Safety Risks Associated With the 2012 Fungal Meningitis Outbreak
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 Princeton Insurance’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/meningitis-facilities-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, Princeton Insurance 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,
b. Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26,
c. Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51,
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
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.
9 Design and implement a communication plan to notify patients
who have received a “safe” injection, but who still may have concerns.
5. If you confirm receipt of NECC Inventory items and administration of such items
to patients, audit all of your patient records to determine who might have received the injections.
a. If any of your patients have received injections of NECC Inventory
items, document this fact in each of their charts. Be careful to focus on your concern for patient safety, rather than on possible liability for the drug manufacturer. Consider monitoring any such patients.
b. Design and implement a plan to notify patients who received an
injection from a CDC identified lot. Ensure that your office/facility staff communicates a consistent message.
9 Advise patients of the common symptoms of fungal meningitis.
9 Advise patients where to seek help should they experience any
of the symptoms. Consider advising referral to their local emergency department (ED). Also, consider including a reference to patient resources, including the ED, on your out-of-office voicemail message.
c. Contact your town’s local ED(s) to advise them of whether any of your
patients received an injection from a CDC-identified lot, and to put them on notice of a potential influx of patients.
d. Contact your local health department to alert them about affected CDC
identified lots of medication within your inventory. Your health department will be able to communicate this information to the broader physician community in a timely manner, while maintaining confidentiality.
6. Continually monitor relevant resources, including CDC and FDA resources, for
updates regarding the most current information and instruction.
a. Princeton Insurance advises its insureds to follow specific guidance from
the CDC and FDA on how to handle issues associated with the fungal meningitis outbreak.
http://www.cdc.gov/hai/outbreaks/clinicians/index.html. If you have any additional questions or concerns, please contact your risk management consultant or call 1-866–794-7475.
The information and guidance contained in this release is intended to supplement, but not replace, other available information and/or instruction from the United States Government.
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