Study Finds Continued Compounding Errors

By Walter F. Roche Jr.

Errors in drug compounding have continued despite a new federal law and regulatory efforts by some state pharmacy boards, according to an updated report from the Pew Charitable Trust.
The report issued Tuesday cites some 335 new adverse reports from compounded drugs since the original report was issued two years ago.
Even in states with strong adverse event reporting requirements, illnesses and deaths are not always recorded, the report states.
A major chunk of the new incidents came from a Texas company, BioTE, which acted as the distributor for hormone pellets produced by two other companies.
Citing testimony by a top official of the U.S. Food and Drug administration, the report states that despite evidence of 4,202 adverse events stemming from BioTE products, the company never reported them to the FDA. The agency was subsequently able to confirm 61 of the adverse incidents.
Concerns with drug compounding surfaced following the 2012 fungal meningitis outbreak. Federal officials say some 800 patients were sickened and over 100 subsequently died after being injected with contaminated steroids produced by the now defunct New England Compounding Center.
The Pew study concludes that contaminated sterile drugs, like NECC's methylprednislone acetate, accounted for most of the adverse events.
Cited were 23 adverse events, two resulting in deaths, from cesium chloride, and 46 adverse events from re-packaged Avastin, a cancer fighting drug also used to treat certain eye conditions.
Several other adverse events cited in the report resulted in blindness or eye injury. Other examples include super-potent morphine produced in Indiana and resulting in adverse events in Indiana and Illinois.
Citing data from the update and the original study, the report cites 1,562 adverse events including 116 deaths from 2001 to 2019.
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