Risk Management Alert – October 9, 2012 Update For: Facilities/providers using injectables obtained from the New England Compounding Center Regarding: Reported cases of Fungal Meningitis related to epidural injections of methylprednisolone
The following information is offered to assist facilities and physicians in the management of processes surrounding the Fungal Meningitis outbreak and the recall of methyl prednisolone. Facilities/providers should:
Remove from inventory any product produced by the New England Compounding Center (NECC). The lot
numbers of methylprednisolone most closely aligned with the recent outbreak of fungal meningitis are:
o Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, Beyond Use Date (BUD)
o Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012 o Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013
Stay current with all releases and recommendations made by the CDC and FDA
o October 4, 2012 FDA/CDC joint news conference:
http://www.cdc.gov/media/releases/2012/t1004_meningitis_outbreak.html http://www.cdc.gov/HAI/outbreaks/meningitis.html http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm - updated 10/8/2012
Maintain contact with local and state health departments for assistance and updates.
Review records to identify all patients who received injections of methylprednisolone from May 21, 2012 to
Appoint a physician/midlevel leader to develop a script for designated staff to notify patients and to respond to
patient calls and questions surrounding the contaminated product, signs and symptoms to be aware of and treatment options/management. Any questions not addressed in the prepared script should be directed to the physician/midlevel leader.
Prepare a FAQ for patients and refer them to a reliable and updated website:
o http://www.cdc.gov/hai/outbreaks/patients/faq-meningitis-outbreak-patients.html
Advise all other staff answering telephone calls that meningitis-related call should be directed to the
designated staff and/or physician/midlevel.
Keep a log of patients who should be notified and document when and how they were notified.
If unable to contact a patient by telephone or in person, send a certified letter, return receipt, notifying the patient
about the recall and alerting them to symptoms warranting immediate medical attention. Include physician contact information for any follow up questions.
Document all patient communication in the medical record along with copies of any written correspondence.
Medical Professional Mutual Insurance Company and ProSelect Insurance Company policyholders, please contact the Risk Management Department at 1-800-225-6168, ext. 5813 with any questions or concerns. MHA Insurance Company and Washington Casualty Company policyholders, please contact the Risk Management Department at 1-888-466-4272 with any questions or concerns.
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Risk Management Alert – October 9, 2012 Update