Tuesday, September 3, 2013
Monday, September 2, 2013
FDA Compounding Enforcement Extends To Contract Laboratory, Spurs Recalls FDA's alert last week raising concerns with a Colorado-based laboratory's verification of compounded drugs from several states sent compounders searching for other means to check the sterility of their products and prompted several recalls.
from Health Policy Newsstand
Meningitis deaths may be undercounted in Tenn. From Compounding Pharmacy Mistakes At NECC
Walter F. Roche Jr., The Tennessean 7:26 p.m. EDT September 2, 2013
ASHVILLE -- Records in a newly filed federal lawsuit indicate the official death toll among Tennessee patients from the nationwide fungal meningitis outbreak may be understated.
According to the complaint filed in U.S. District Court in Boston last week, Gokulbhai Patel of Goodlettsville, Tenn., died Jan. 13 from fungal meningitis caused by two spinal steroid injections he received at the Saint Thomas Outpatient Neurosurgical Center in Nashville.
However, the official death count maintained by state and federal officials shows no deaths among Tennessee patients in that month from the outbreak blamed on Massachusetts-based New England Compounding Center, the source of the tainted methylprednisolone acetate steroid injections.
STORY: Many meningitis victims owe tens of thousands in bills
STORY: Fallout from fungal meningitis crisis continues
STORY: Fallout from fungal meningitis crisis continues
The official Tennessee death toll, which climbed to 14 in mid-December, did not increase to 15 until a Kentucky woman, who had undergone injections in Nashville and contracted fungal meningitis, died April 16. The official count remains at 15, according to the latest data from the U.S. Centers for Disease Control and Prevention.
State health officials confirmed Thursday that no fungal meningitis deaths among Tennessee patients were reported in the month Patel died.
"We have not been made aware of any deaths that occurred in January linked to the meningitis outbreak associated with products from NECC," Shelley Walker, Tennessee Health Department spokeswoman, wrote in an email response to questions.
CDC officials said they rely upon state health officials to gather the data from health-care providers on deaths from outbreaks.
Undercount doesn't surprise attorneys
While the Patel case gives the first indication of a possible undercount in a public record, it comes as no surprise to attorneys representing victims of the outbreak.
"Clearly we don't have the exact count," said J. Gerard Stranch, who represents several area victims or their families. He said he was personally aware of about a half dozen cases not included in the official count.
Stranch said there could be a variety of reasons, including the fact that some other illness was listed as the final cause of death when, in fact, a cascade of illness was initially triggered by fungal meningitis.
Sept 2013 GAO Study Calls for Clearer FDA Authority Over Compounders The Government Accountability Office (GAO) says in a new report that the FDA needs clearer authority over large compounding pharmacies, giving reform proponents a boost.
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Question of the Day September 2, 2013 How many employees, pharmacists and certified technicians does a compounding pharmacy need to have before it is considered to be doing more than traditional compounding? This one has 170 employees, 24 pharmacists and 40 techs according to its website.
Roadrunner Pharmacy began in 1999 with one pharmacist and one salesman in Phoenix, Arizona. Today, Roadrunner Pharmacy employs over 170 employees including 24 Pharmacists and over 40 Certified Technicians. Our Sales reps in the field continually update the vet hospitals on the latest medications & delivery techniques.
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