In a previous blog, we discussed deaths related to fungal meningitis believed to have resulted from fungal contamination of a compounded drug used as an injection for back pain. Sadly, since our last post, the numbers of deaths and injuries has risen. So far, 29 patients have been killed and more than 360 have been sickened by the infected injections. Because drugs from the three affected lots were injected for pain relief to approximately 14,000 patients, investigators expect to see many more cases in the coming months. Some of these patients received injections in other joints, so they are suffering from peripheral joint infection, which is less severe and less likely to lead to death than fungal meningitis.
We can update the Cause Map, or visual root cause analysis, which was started in our previous blog. Specifically, as investigators are able to provide more detail about the case, we can update causes and validate them with evidence. We are also able to update the outline as more patient deaths and sickness are discovered.
Investigators have verified that the source of the fungal contamination was the compounding company. They noted in investigations that the clean room was contaminated due to lack of control of the humidity and temperature. It appears that the air conditioning was shut down at night, resulting in environmental issues. Additionally, sterilization at the company was found to be inadequate. Sterilization procedures were not followed, and sterilization equipment was found to be contaminated, possibly because it was not properly tested. Once the contamination made it into the drug, the drug was shipped without the company knowing of the contamination, because shipping on some lots took place before the results of sterility testing were received.
The Massachusetts Department of Health has announced increased oversight of compounding companies, including annual inspections. A bill has been introduced in Congress for FDA regulation of compounding companies that produce larger quantities of drugs for mass distribution, as appears to be the case in this instance. It also recommends requiring compounded drugs to contain a label stating they have not been FDA-approved. Although the compounding company responsible for the contamination has been closed down, it is hoped that a higher level of regulation will reduce the possibility of similar deaths in the future.
To view the updated Outline and Cause Map, please click “Download PDF” above. Or click here to read more.