August 12, 2013
Bacterial Blood Infections In Texas Hospitals Linked To Drug Compounder
Lawrence LeBlond for redOrbit.com - Your Universe Online
Just two days after a Texas compounding facility issued a voluntary recall on all lots of sterile medications, the US Food and Drug Administration (FDA) stepped up its investigation and called for all healthcare providers and patients nationwide to return any sterile products manufactured by the firm: Cedar Park-based Specialty Compounding, LLC – a subsidiary of Peoples Pharmacy Inc.
The recall was issued due to more than a dozen reports of bacterial infection found at two Texas hospitals: Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. At least 15 patients who had been diagnosed with a bacterial bloodstream infection were also administered an IV infusion of calcium gluconate from both aforementioned hospitals prior to their infections.
While the association is preliminary, Specialty Compounding (SC) and the FDA are not taking any chances. “All sterile products produced and distributed by Specialty Compounding are being recalled and none of these products should be used by patients or administered to patients,” the FDA said in a statement.
The recall consists of any and all products that were developed by SC and had reached healthcare facilities or patient homes since May 9, 2013. Anyone with these products should discontinue use, quarantine the products and return them to SC.
According to information provided by SC, the products included in the voluntary recall had been distributed to hospitals and doctors’ office in Texas and shipped directly to patients nationwide, with the exception of North Carolina.
The FDA said it has received reports of 15 patients from the two hospitals named who had developed an infection caused by Rhodococcus equi subsequently following an IV infusion of calcium gluconate 2 grams in sodium chloride 0.9 percent. Analysis of calcium gluconate samples has shown growth of bacteria consistent with R. equi.
“Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution,” Ray Solano, RPh, pharmacist in charge at SC, said in an August 9 statement. “We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern.”
Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, said the agency believes the products developed by SC “would create an unacceptable risk for patients,” potentially resulting in a “life-threatening infection.”
The company said it is notifying all customers by phone, fax, email and/or regular mail to ensure all products are being properly quarantined and returned. It said anyone returning a product or needing assistance related to this recall should contact SC directly. Furthermore, anyone who thinks they may have developed an infection or has experienced any other anomalies while using an SC product is urged to contact their physician or visit the ER immediately.
The FDA said it was working closely with the US Centers for Disease Control and Prevention (CDC) and Texas state health officials to determine the scope of this contamination. The agency said any adverse reactions experienced from use of SC products may be reported to the FDA’s MedWatch Adverse Event Reporting program either by mail, online or fax.
This has been the most recent of a barrage of outbreaks from compounding facilities since a deadly outbreak of fungal meningitis swept the nation nearly a year ago, associated with a steroidal injectable produced by New England Compounding Center in Massachusetts. That outbreak killed 63 and sickened 749 in more than 15 states around the country.
Compounding facilities have come under increased scrutiny since that outbreak as many of these companies have gone from small-time suppliers to major manufacturers, distributing thousands of products across the country at a time.
"I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder," said Sen. Tom Harkin, D-Iowa, in a statement to USA Today. "The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs. I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans."
Harkin said this legislative act would much improve the safety of compounded drugs, in part by clarifying how much oversight authority is held by state and federal regulators. It would also protect the nation’s drug supply chain by “establishing a uniform, national prescription drug-tracing framework.”
The bill has been approved by a Senate committee in May and is now awaiting approval by the full Senate.
Apart from recalls from SC and the now-defunct NECC, several other recalls have been issued from similar compounding facilities and pharmaceuticals in recent months, reports USA Today’s Liz Szabo.
Illinois-based Nexus Pharmaceuticals earlier this month recalled two lots of the injectable drug benztropine mesylate, a drug used to treat Parkinson’s disease, after some injections were found to contain visible particles.
Beacon Hill Medical Pharmacy of Michigan recalled some of its product in July after there were concerns about sterility. And Illinois-based Fresenius Kabi USA recalled four lots of benztropine mesylate injection in June due to glass particles discovered in the product.