Fungal Meningitis

During the past several months officials and staff at a Michigan hospital have found themselves at the epicenter of spiraling fungal meningitis outbreak that has turned the facility into a learning laboratory and tested it emergency preparedness. They scramble to manage a virulent infection that has not been seen in humans. In a recent article “Anatomy of an outbreak” written in Modern Healthcare, St Joseph Mercy Ann Arbor hospital has found itself at the center of a national outbreak of fungal meningitis that has so far infected 469 patients in 19 states, killing 33, according to the most recent federal data. The infections have been traced to contaminated lots of injectable steroids, distributed by the Farmingham, Mass.-based New England Compounding Center. St Joseph has treated 123 patients with the disease 73 of whom are hospitalized and 5 that have died. About 620 patients received a total of 750 contaminated steroid injections these patients received injections at Michigan Pain Specialists in Brighton, Michigan. (McKinney, 2012).

To ensure treatments that were deemed effective, Trinity Health, St Joseph’s parent health system has set up order sets for the health systems electronic records that correspond with St Joseph’s clinicians and the Centers for Disease Control and Prevention (CDC). Trinity officials spoke with Rep. John Dingell (D-Michigan) who attended the congressional hearing to provide information and the impending shortage of anti-fungal medications (McKinney, 2012). Trinity is trying to make sure St. Joseph is not penalized for failing to meet certain targets for readmissions. More than 30% of the patients who have received treatment for fungal meningitis have been readmitted to the hospital because of spinal abscesses and fluid collections at their injection sites, a recently identified and serious complication. The problem is shifting from a medical disease that is treated with anti-fungals to one that requires surgery and antibiotics. Also, patients may be responsible for out-of-pocket expenses because they may need expensive drugs for a long periods of time. One thing St Joseph has done to accommodate the needs of patients after discharge is open a fungal-out-break clinic. This clinic coordinates and monitors patients for any new signs of illness. While the CDC usually works closely with state health departments because of the degree of outbreak the CDC has worked directly with the hospital. According to Tom Chiller, a medical epidemiologist and deputy chief of the CDC’s mycotic disease branch, “St. Joseph has been instrumental in helping to understand how this problem is evolving and how to manage it” (McKinney, 2012).

Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor and Pension Committee asked how 17,000 doses of a product so contaminated that black particles were visible by the naked eye after recall could have been shipped to 23 states. Harkin also noted that the FDA and the Massachusetts Board of Regisrtation in Pharmacy repeatedly found deficiencies in several areas at New England Compounding Center (NECC) and yet did nothing to protect the public (Zigmond, 2012). The issue now is who is to blame for the deadly meningitis outbreak at two recent congressional hearing the food and Drug Commissioner Dr. Margaret Hamburg found herself answering questions from lawmakers demanding information on what the agency could have done to prevent the outbreak. It seems the uncertainty is who has authority over compounding pharmacies with large-scale operations, states oversee pharmacies, while the FDA has oversight over manufacturing. At the present time recommendations have been made for the State boards of pharmacy continue to license and regulate traditional compounding while large-scale compounding of sterile products be subjected to FDA oversight. Rep. Henry Waxman (D-Calif.) urged his collegues to pass legislation in this congressional term to resolve the ambiguities surrounding the FDA’s authority over compounding pharmacies (Zigmond 2012). As the uncertainty of when the outbreak will begin to taper off is still unknown, St. Joseph continues to provide consistent care delivery and care management. St Joseph’s has cared for 85% if the total number of fungal meningitis cases seen in Michigan thus far. It has initiated its emergency preparedness plan allowing it to increase staff levels, granted out-of-state nurses licenses in just 24 hours, and approval for an additional MRI machine. The incident command center has be activated for nearly two months. Currently with the readmissions they have no idea when there will be an end in sight. As the legislative hearings continue it is certain the FDA will have a major role in regulations of the current compounding manufacturers. One important thing that is certain is the benefits of emergency preparedness, informatics and collaboration among all parties involved.

References

McKinney, M. (2012, November 19, 2012). Anatomy of an outbreak. Modern Healthcare, 42(47), pg.6-7, 16.

Zigmond, J. (2012, November 19,2012). Regulatory morass-Lawmakers work

to clarify policies for compounders. Modern Healthcare, 42(47