In October 2012, the CDC activated its Emergency Operations Center as part of the response to the tragic outbreak of fungal meningitis linked to three contaminated lots of preservative-free methylprednisolone acetate (MPA) produced by the New England Compounding Center (NECC). As of October 23, 2013, there have been 751 cases of fungal meningitis and other infections associated with this outbreak; 64 of these patients have died. Since July 2013, one new case has been diagnosed.
The CDC has two papers in the New England Journal of Medicine, one describing the clinical aspects of the infections associated with this outbreak and the other summarizing the epidemiologic investigation. The clinical paper, focusing on the early stages of the outbreak, describes patients who experienced a wide variety of illnesses, including meningitis, stroke, arachnoiditis (inflammation of one of the membranes around the brain and spinal cord), and epidural or paraspinal infections which ranged in severity from very mild to life-threatening. The epidemiology paper finalizes the original preliminary report published by the New England Journal of Medicine and details the efforts undertaken by public health agencies to identify and stop the outbreak. This has been the largest outbreak of healthcare-associated infections ever reported in the United States.
This outbreak affected hundreds of people and their loved ones across the nation. Many patients continue to struggle with complications from the fungal infections, including side effects of the antifungal drugs used to fight the infections, and continuing problems related to their infections. Many other people who received MPA or other NECC products, but who may not meet the CDC case definition, have faced anxiety surrounding their risk of infection.
To learn more about the long-term impacts of this outbreak, the CDC awarded a contract to the University of Alabama at Birmingham to follow as many as 500 people with infections identified as a part of this outbreak. The study, which will run through at least August 2015, is designed to help answer questions about the longer-term health impacts on patients, which treatments were most effective and what their side effects are, how long treatment is needed, and whether and how often patients relapse after stopping therapy. Patients are being enrolled in the study by their infectious disease physicians. This information will be used to improve the care of current patients and any future patients linked to this outbreak, and potentially can inform treatment decisions in future cases of meningitis caused by similar types of fungal organisms.
Since the outbreak began, additional outbreaks have been identified and linked to contaminated products from other compounding pharmacies. These outbreaks show the urgent need to address shortfalls in the oversight and safety of compounded drugs to reduce the inherent risks associated with these products, which have not undergone review and approval by the FDA. The CDC supports efforts by the FDA and state Boards of Pharmacy to provide appropriate and effective oversight of compounding pharmacies.
See the CDC Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication