The outbreak of fungal meningitis due to contaminated epidural steroid injections that began last month in Tennessee continues apace, with 169 cases and 14 deaths reported in 11 states as of this afternoon. This represents an increase of more than 100 cases from last week.
As reported on pharmacist.com last week, the outbreak was linked to three lots of methylprednisolone acetate compounded by the New England Compounding Center (NECC) in Massachusetts. These lots were initially recalled on September 26; on October 6, the recall was expanded to include all products compounded at NECC.
CDC has reported that 76 facilities in 23 states received products from the initially recalled lots. In a news conference this afternoon, J. Todd Weber, MD, Incident Manager of the Multistate Meningitis Outbreak and Chief of the Prevention and Response Branch in the CDC Division of Healthcare Quality Promotion, noted that the agency has estimated that some 14,000 patients have received medication from the recalled lots. More than 12,000 of those patients have already been contacted, he added.
“We know are not out of the woods yet,” Weber continued, noting that fungal infections can be slow to develop, and in some cases could take several months, although 1 week to 4 weeks is more common. He urged health professionals to continue reaching out to patients who may have received a tainted products, noting that “we can save lives by identifying patients early.”
Signs and symptoms of meningitis include headache, fever, stiff neck, or photophobia accompanied by a positive cerebrospinal fluid test. CDC has recommended a combination antifungal regimen consisting of I.V. voriconazole 6 mg/kg every 12 hours and I.V. liposomal amphotericin B 7.5 mg/kg daily. The duration of therapy is unknown at this point, but will likely take months and should be tailored to clinical response to treatment.
CDC does not recommend antifungal prophylaxis or lumbar puncture in asymptomatic patients, nor does it recommend empiric antifungal therapy in symptomatic patients with normal cerebrospinal fluid profiles. The agency also noted that intrathecal amphotericin B should be avoided due to limited data on associated toxicity and that there is “no clear evidence” for the use of adjuvant steroid therapy.
Weber also offered an update on the joint CDC/FDA investigation into the fungi causing the disease. An Aspergillus fungus was initially thought to be the culprit, as it was found in the first patient diagnosed with fungal meningitis linked to the NECC products. All other cases confirmed by the CDC laboratories, however, were caused by Exserohilum fungus. Weber noted that fungal meningitis is a rare condition and has never been linked to Exserohilum before, describing it as “new territory” for CDC.
In a statement issued today, APhA expressed its support for “compounding that is done according to defined standards and within the triad relationship of the physician, pharmacist and patient working together to individualize care for maximum patient benefit.”
The Association added, “Importantly, compounding is performed in response to a prescription from a licensed prescriber for an individual patient and allows pharmacists to use their extensive medication knowledge and expertise to produce individualized medication formulations that meet patient’s needs and improve health outcomes.” APhA also noted that compounding is regulated by state boards of pharmacy, FDA is responsible for the ingredients used, and the compounding pharmacists are “expected to follow appropriate procedures for the types of products that are compounded.”
APhA also emphasized its dedication to working with FDA, CDC, the Pharmacy Compounding Accreditation Board, the United States Pharmacopeia, state boards of pharmacy, and other industry stake holders to ensure the enforcement of good compounding practices and standards.
In this afternoon’s news conference, Deborah Autor, JD, FDA Deputy Commissioner for Global Regulatory Operations and Policy, said, “We want to work with Congress, compounders, states, and all other stakeholders … to prevent tragedies like this in the future.” She added that “compounding pharmacies have a responsibility to have processes in place to ensure that their products are safe.” The agency’s drug shortage office has also confirmed that the NECC recall will not affect the nation’s supply of methylprednisolone acetate.
Madeleine Biondolillo, MD, Director of the Massachusetts Department of Public Health Bureau of Health Care Safety and Quality, alleged in the news conference that NECC “appears” to have violated state regulations requiring that compounds be linked to patient-specific prescriptions only. The Massachusetts Board of Pharmacy has issued an alert to all pharmacies in the state reinforcing the rules and requirements of compounding, she added. “We urge Congress to act quickly,” Biondolillo said, calling for “clear authority” on compounding rules.