Fungal Infections Associated with Contaminated Methylprednisolone Injections

Abstract

Analysis of data from a large, multistate outbreak of fungal infections showed substantial morbidity and mortality. The infections were associated with injection of a contaminated glucocorticoid medication from a single compounding pharmacy. Rapid public health actions included prompt recall of the implicated product, notification of exposed persons, and early outreach to clinicians.

Polymicrobial Injection-Site Abscesses Associated with Contaminated Methylprednisolone Injections in Florida

“…This analysis identified BMI, vial age at injection, and an 11 day injection period as risk factors for the development of adverse events following injection with pf-MPA from MSFP. Given the potential health risks associated with the injection of preservative-free compounded pharmaceutical products, it is imperative to identify risk factors associated with adverse events in order to implement effective preventative measures [2,5,9,10]. Remote electronic access to the complete medical records for the 143 patients with identified exposure to pf-MPA from MSFP lots numbered 011413dan or 1201612dan greatly assisted in this investigation.…”

“…Injection practices using multiple dose vials have been linked to at least 19 outbreaks and should only be utilized when absolutely necessary [1][2][3][4][5].There is a need for clear labeling of the intended use for compounded products, especially for preservative-free formulations as there is an increased risk of infection when used inappropriately [7]. In addition, given the inherent risk for microbial contamination of preservative-free compounded products compared to the FDA-approved products (containing preservatives), clinicians need to assess the benefit to the patient prior to utilizing these preservative-free products [2,4,[8][9][10]19]. Increasing body fat, as measured by BMI in this investigation, was significantly associated with developing an abscess following injection of pf-MPA.…”

“…Identified sources include intrinsically contaminated product or a breakdown in infection control practices leading to extrinsic contamination of the product [1][2][3][4][5] In September 2012, a national outbreak investigation involving the New England Compounding Center (NECC), identified at least 61 deaths and 749 adverse events from intrinsically contaminated preservative-free Methylprednisolone acetate (pf-MPA) primarily injected through epidural or intraspinal sites [6][7][8][9]. In addition to the NECC outbreak as of 2012, 11 outbreaks are known to have occurred since January 2000 in which compounded products have resulted in an additional 207 infections and 17 deaths [10].…”

Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety

“…Epidural, spinal, or paraspinal injections accounted for 89.0% (12,068) of exposures, and 12.0% (1,648) of the exposures were attributed to peripheral-joint or other injections. 14 Three lots of compounded preservative-free methylprednisolone acetate (05212012@68, 06292012@26, or 08102012@51) were responsible for the outbreak and comprised 17,675 vials distributed to 76 facilities across 23 states. 14,15 Chart reviews of emergency room and inpatient medical records were conducted between October 1 and November 19, 2012, among the 6 states (Florida, Indiana, Michigan, New Jersey, Tennessee, and Virginia) with the most cases of fungal infections caused by methylprednisolone injections.…”

Fungal endophthalmitis associated with compounded products

“…These outbreaks of fungal infections are not the first associated with contaminated compounded products; they preceded (by only a few months) a large multistate outbreak of Exserohilum rostratum infections associated with compounded methylprednisolone acetate (29). A 2002 outbreak of meningitis and sacroiliitis attributed to compounded corticosteroid injections contaminated with Exophiala dermatitidis was also reported (30).…”