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Meningitis Cases Linked to Compounding Pharmacy

Darrell Hulisz, RPh, PharmD
Samantha Vraja, Ph

November 1, 2012

The Centers for Disease Control and Prevention (CDC) has reported that 354 cases of fungal meningitis in 19 states have resulted in 25 deaths nearing the close of October 2012.1 All cases have been directly linked to the use of preservative-free methylprednisolone acetate (MPA) for injection, which were produced by the New England Compounding Center (NECC), a compounding pharmacy in Massachusetts. The pharmacy has recalled all of its products and has been stripped of its pharmacy license.

The FDA released documentation reporting mold and bacteria at multiple sites dating from January through September 2012 in the company's "clean rooms" used for production of sterile drug products. 2 Furthermore, it was reported that no corrective actions were taken to remove microbial contamination from the facility during that time.2 Safety concerns involving NECC date back to December 2006, when they received a warning letter from the FDA regarding inappropriate manufacturing practices, misbranding, and repackaging of sterile injectable drugs, causing the FDA to become concerned about potential microbial contamination.3 More recently, NECC has been cited as practicing as a drug manufacturer by dispensing mass quantities of sterile drugs without having the individual patient prescriptions required for compounding pharmacies.

The CDC and FDA have confirmed the presence of the fungus, Exserohilum rostratum, in unopened medication vials of preservative-free MPA (80mg/ml). The CDC and state health departments estimate 14,000 patients may have received these injections. Symptoms are typically delayed after injection and have appeared 1 to 4 weeks following injection. Of note, Massachusetts officials began a criminal investigation on October 23rd. Pharmacists involved in compounding of injectable drugs must conduct strict quality control measures to assure sterility. Patients who may have received injectable products from NECC, but are asymptomatic can be triaged using the CDC webpage1 for further direction.

1. Multistate fungal meningitis outbreak investigation. Atlanta (GA); 2012 Oct 29 [accessed Oct 30, 2012]. Available from: http://www.cdc.gov/HAI/outbreaks/meningitis.html

2. New England District Office. Department of Health and Human Services: Food and Drug Administration. 2012 Oct [accessed Oct 30, 2012]; Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatory

3. Costello G. Warning letter. Food and Drug Administration. 2006 Dec [accessed Oct 30, 2012]; Available from: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm076196.htm

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