Beyond Compounding Pharmacies: Nurses and the Meningitis Outbreak
By Darrell Hulisz, RPh, PharmD, Associate Professor, CWRU School of Medicine, and Samantha Vraja, PharmD Candidate, Ohio Northern University
At the end of October 2012, the Centers for Disease Control and Prevention (CDC) reported that 354 cases of fungal meningitis in 19 states had resulted in 25 deaths (CDC, 2012). All cases were directly linked to the use of preservative-free methylprednisolone acetate for injection, which were produced by the New England Compounding Center (NECC), a compounding pharmacy in Massachusetts. While the focus of the outbreak has been on such pharmacies, healthcare professionals from many disciplines have been called on to respond and are now being asked to help implement solutions to avoid future calamities.
The FDA recently released documentation reporting mold and bacteria at multiple sites dating from January through September 2012 in the NECC’s “clean rooms” used for production of sterile drug products (FDA, 2012). Furthermore, it was reported that no corrective actions were taken to remove microbial contamination from the facility during that time.
Safety concerns involving NECC date back to December 2006, when the company received a warning letter from the U.S. Food and Drug Administration (FDA) regarding inappropriate manufacturing practices, misbranding, and repackaging of sterile injectable drugs, which had raised concerns about potential microbial contamination (FDA, 2006). More recently, NECC was cited as practicing as a drug manufacturer by dispensing mass quantities of sterile drugs without having the required individual patient prescriptions.
In the midst of the deadly outbreak, there has also been a recent surge in potentially-dangerous injection site infections, both in patients who already have been diagnosed with meningitis and in those who have not (The Tennessean, 2012).
Nurses play an important role in containing this outbreak. Patient education is vital to ensure that those exposed to the contaminated injections seek medical assistance. Symptoms typically appear one to four weeks following injection and patients do not always relate the symptoms to the injection. The CDC has warned that while some patients will experience new or worsening back pain, symptoms of infection can be mild and clinically difficult to distinguish from chronic back pain. It is recommended that MRIs with contrast of the affected area be ordered in patients with new and worsening symptoms.
Hospitals are educating affected communities about this public health issue through newsletters, websites, community forums, and call centers. Nurses can help patients stay informed as the FDA investigation continues, and should also comply with required reporting to the regulatory agencies monitoring this outbreak, including state departments of health, the CDC, and FDA. Check your facility’s policy regarding mandatory reporting for more information.
Centers for Disease Control and Prevention [CDC] (2012). Multistate fungal meningitis outbreak investigation. Retrieved from: http://www.cdc.gov/HAI/outbreaks/meningitis.html
Food and Drug Administration [FDA] (2012). New England District Office, Department of Health and Human Services: Food and Drug Administration. Retrieved from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf
Food and Drug Administration [FDA] (2006). Warning letter. Retrieved from: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm076196.htm
Nurse-Anasthesia.org (2012). Meningitis Outbreak: Important Update and Resources for Nurse Anesthetists. Retrieved from: http://www.nurse-anesthesia.org/content.php/556-Meningitis-Outbreak-Important-Update-and-Resources-for-Nurse-Anesthetists
The Tennessean (2012). Meningitis outbreak: Officials warn of new fungal infections. Retrieved from: http://www.tennessean.com/article/20121121/NEWS07/311210114/Meningitis-outbreak-Officials-warn-new-fungal-infections
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Dr. Hulisz, RPh, PharmD, currently practices as a clinical pharmacist with University Hospitals of Cleveland, Family Medicine Residency Program, where he works in consultation with family physicians, both on inpatient and outpatient services.