FDA: Three arrested in drug diversion scheme
MIAMI Three Florida residents were indicted last week on charges related to drug diversion, according to the Food and Drug Administration.
The FDA’s Office of Criminal Investigations and U.S. attorney for the Southern District of Florida Jeffrey Sloman announced that Jose Castillo of Fort Lauderdale, Federico Fermin of Miami Beach and Terri DeCubas of Pembroke Pines were indicted and charged with distribution of prescription drugs without a license, mail fraud, money laundering and conspiracy to commit those offenses, while DeCubas also was charged with making a false statement to an FDA agent. Between 2002 and 2005, the three allegedly grossed more than $13 million through their efforts, according to the announcement.
According to the indictment, the Castillo, Fermin and DeCubas allegedly used a method that involved health plan beneficiaries obtaining drugs they didn’t need or were willing to forgo at the plans’ expense; the three alleged diverters then bought them for less than the wholesale price and altered the labels to make them appear new; they then shipped them to a licensed wholesale distributor in Texas, which shipped them to the alleged diverters’ customers, as if they had traveled exclusively through licensed channels.
Retail Clinician special report focuses on patient-centered care
NEW YORK Drug Store News’ sister publication, Retail Clinician, has issued a special report on an exclusive study conducted by Take Care Health Systems in conjunction with Gallup Consulting that measured patient engagement levels among Take Care Clinic visitors, with an eye toward elevating the patient experience.
The report, which is anchored by the original white paper — written by Sharon Glave Frazee, Ph.D., VP corporate healthcare analytics and research team for Walgreens, along with John H. Fleming, Ph.D., principal, chief scientist customer engagement and humansigma®, Gallup, and Margaret Ozan Rafferty, R.N., M.H.A., M.B.A., healthcare global practice leader for Gallup — and also includes an interview with Take Care CEO Peter Miller discussing the significance of the findings and what it means both for Walgreens and Take Care, and the impact Take Care’s unusually high levels of patient engagement is having on clinic traffic.
A copy of the report can be downloaded here.
High doses of cholesterol drug may raise muscle injury risk, FDA warns
SILVER SPRING, Md. Patients taking a common drug for treating high cholesterol may be at increased risk of muscle injury, the Food and Drug Administration warned Friday.
The FDA warned patients and healthcare professionals of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.
Merck originally marketed simvastatin under the brand name Zocor, and it is now available as a generic from several suppliers. It’s also an active ingredient in several other cholesterol-lowering drugs, including the Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. All formulations of Simcor contain only 20 mg of simvastatin, though Vytorin is available with 80 mg, according to an FDA database.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”