Pharmacy compounding, which involves mixing several medicines together
is a lax area that is not subject to extensive regulations. Consequently,
several instances have arisen where patients became sick or even died
as a result of medicines used in the compounding process that became contaminated.
The New York Times reported that a compounding pharmacy called Specialty Compounding of Cedar
Park recalled its compounded sterile product line after 15 patients suffered
illness from tainted sterile infusions through a substance used to treat
low calcium levels. This occurred in two Texas hospitals. Fortunately,
no patients died.
Last year a meningitis outbreak made the New EnglandCompoundingCenter the
focus of a failure to detect and handle contamination. A fungal meningitis
outbreak traced to contaminated steroids at this compounding center in
Framingham, Massachusetts killed dozens of people nationwide.
Boston.com published an article describing how the FDA had apparently received years
of bad reports on the facility before it acted and consequently, the FDA’s
failure also came under scrutiny.
Of these two incidents the New EnglandCompoundingCenter is the most notable,
resulting in 63 deaths and more than 700 cases of fungal meningitis.
The American Society of Health-System Pharmacists (ASHP) has called for
bi-partisan legislation that creates accountability in the oversight of
compounding outsourcers so patients are not the adverse effect of bacterial
infections due to contamination. The legislation adds a new category for
regulation to existing law that requires FDA registration and monitoring
of sterile compounding done by compounding manufacturers. Currently, there
is a hole in federal law that leaves out such manufacturers.
By working with
experienced lawyers, patients who are victims of unsafe compounding or their families can
take legal recourse in Maine to seek compensation for damages.