At least 35 patients have come down with rare fungal meningitis after an injection they received for back pain was contaminated with fungus. Five have died so far. Because of the severity of the disease and the long incubation period, more cases – and more deaths – are expected in the coming months.
We can examine the issues related to the fungal meningitis in a Cause Map, or visual root cause analysis. Documenting the causes visually can make a complex medical issue easier to understand. We begin with the impacts to the goals. The deaths and severe sickness are an impact to the patient safety goal. While we begin with the known cases, these numbers can be updated if more cases are discovered. The compounding company which prepared the injections has voluntarily surrendered its license, an impact to the compliance goal and has recalled 3 lots of the drug used in the injection (methylprednisolone acetate), which can be considered an impact to both the organizational and property goal. The extremely difficult treatment ahead of these patients (estimated to take months) is an impact to the patient services and labor goal. The contamination of the injection itself can be considered an environmental goal.
Once we have captured these impacted goals, we can begin with the focus of our investigation – the patient safety goal – and ask “why” questions to develop the cause-and-effect relationships that resulted in the disease. The patient deaths and sickness are due to contraction of fungal meningitis. These patients came down with fungal meningitis because fungus was introduced to their nervous system. The injections that the patients received for back pain were injected epidurally, which allows access to the nervous system, and were infected with aspergillus, a common fungi. More testing is being done to determine whether the contamination was in the drug within the injection, or the numbing agent or antiseptic wipes being used. Due to the widespread (across several states) outbreak, it is believed that the drug within the injection is to blame, but because of the seriousness of this issue, all potential causes are being carefully tested.
Because the drug used in the injection was compounded, the contamination could have occurred within a raw ingredient used in the compounding, or it could have become contaminated during the compounding process. The source of the outbreak is not yet known, but because compounded drugs and compounding companies receive less oversight than drug manufacturers, it is suspected that the contaminant was introduced during the compounding process.
Initial symptoms of fungal meningitis are subtle, including headache, fever, dizziness, nausea and slurred speech. The symptoms can take up to a month from introduction of the fungus to appear. If patients have received a shot for back pain, they should contact their doctor to see if it was from the infected lot. Early and immediate treatment is important.
To view the Outline and Cause Map, please click “Download PDF” above. Or click here to read more.