29 Apr. 2014

Pharmacy Compounding Comes Under Scrutiny Again

Posted By Shaheen & Gordon, P.A.

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.

Recently, 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.

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