FDA Cites Continuing Deaths from Compounded Drugs

By Walter F. Roche Jr.

Citing multiple deaths and serious adverse events, two officials from the U.S. Food and Drug Administration say much more needs to be done to avoid a recurrence of a deadly 2012 fungal meningitis outbreak.
In an article published in the New England Journal of Medicine, Janet Woodcock and Julie Dohm noted it has been five years since the 2012 fungal meningitis which sickened 778 patients, killing 76 of them. The outbreak triggered passage of a new law in 2013.
Stating that more than 425 inspections have been conducted since the passage of the Drug Quality and Security Act, the report states that the FDA found during these inspections "problematic conditions during the vast majority of these inspections." There are currently 75 registered mass compounders.
"The FDA's experience in monitoring pharmacy compounding demonstrated the need for further improvement in compounding practices," the report states.
Cited were multiple violations turned up including dead insects found in compounding areas and visible mold on ceiling tiles and dog beds and dog hairs in close proximity to compounding areas.
According to the report the FDA has overseen the recall of 140 compounded drugs during the same six-year period.
Despite the new law the regulators noted that both before and after the outbreak small clusters of problems with compounded drugs have been reported.
Included in the report is a page-long list of events, some resulting in deaths that have been recorded since 2012. Citing "a steady stream of reports of serious adverse events, including deaths, the report notes that in July of this year 43 patients experienced diminished vision after treatment with a compounded drug.
In an August event two patients had severe sensitivity reactions to a compounded drug containing a substance not considered suitable for human consumption. One of those patients died.
In 2016 three infants were injected with a compounded morphine sulfate that had 25 times the labeled strength. And in 2013 bacterial bloodstream infections were reported for 15 patients, two of whom died.
The regulators noted that the adverse events they reported probably amounted to a small fraction of the actual number because most such events were not reported to the FDA.
Noting the outsourcing industry is in a state of rapid growth, the report states that it is critical that the efforts continue for compounders to meet Current Good Manufacturing Practice requirements.
"Five years after the tragic fungal meningitis outbreak is a good time to invigorate efforts to ensure that the compounded drugs given to patients...are made in facilities that are held to appropriate production standards," the report concludes.
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