Meningitis outbreak: 2nd Mass. pharmacy recalls all products

12:31 PM, Oct 31, 2012

A Massachusetts drug firm linked by common ownership to the company blamed for an ongoing nationwide meningitis outbreak has announced a massive recall of all its products.

In a statement released today, Ameridose disclosed that it had initiated a voluntary recall of all its products.

Ameridose is owned by the same two families that own New England Compounding Center, which issued thousands of doses of a spinal steroid tainted with fungus. The drugs have caused 28 deaths, including 11 in Tennessee.

In announcing the recall, Ameridose said that it came after the U.S. Food and Drug Administration raised questions about the company’s sterility testing process. Ameridose, which supplies hospitals in Tennessee, already had halted production at its Westborough, Mass., plant.

“This action is voluntary and represents an expansion of our cooperation with the FDA and the Massachusetts Board of Registration in Pharmacy,” the company stated.

“Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products,” the statement continued.

Contact Walter F. Roche Jr. at 615-259-8086 orwroche@tennessean.com.

Source found here

Mass. firm tied to closed pharmacy issues recall - San Diego, California News Station - KFMB Channel 8 - cbs8.com

Mass. firm tied to closed pharmacy issues recall - San Diego, California News Station - KFMB Channel 8 - cbs8.com

Can a Doctor Be Liable Under Federal False Claims Act for Prescribing a Drug Off-Label?

The theory of the plaintiff (in a qui tam suit the proper nomenclature is "the relator") in United States ex rel. Watson v. King-Vassel et al, 2012 U.S. Dist. LEXIS 152496 (E.D. Wisconsin Oct. 23, 2012), is that a doctor can be liable under the False Claims Act for prescribing a drug off-label.  The court ends up dismissing the case.

For a complete summary of this case read the Drug and Device Blog found here

CDC: Continuing to see meningitis cases | Watch the video -

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Meningitis outbreak: 89 Maryland hospitals bought tainted drugs

October 31, 2012 - 11:32 am

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• FDA,
• Food And Drug Administration,
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The Food and Drug Administration has released a new list that names 89 hospitals in Maryland that bought tainted drugs from a pharmacy linked to a deadly nationwide meningitis outbreak.

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More on this story

• Suspected meningitis cases rise in Va.

According to the Baltimore Sun, in total, the list names more than 3,000 facilities that received the medication, produced by New England Compounding Center, a specialty pharmacy in Massachusetts, which is being blamed for 354 cases in 19 states and at least 25 deaths.

The new list includes University of Maryland Medical Center, Mercy Medical Center, Saint Joseph Medical Center, Northwest Hospital and Katzen Eye Group, among others, the Sunreports.

Continue reading here

Despite bacteria in labs, a clean pharmacy report Drug firm found contaminants, gave assurances

By Kay Lazar

| Globe Staff October 31, 2012

Shortly before a national fungal meningitis outbreak was linked to New England Compounding Center, the Framingham company sent customers a “Quality Assurance Report Card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.

Charts sent to customers and obtained by the Globe show that in the first half of 2012, there were no instances of contamination exceeding the accepted standard on surfaces in the “clean rooms,” where the company produced sterile injectable medications such as the steroid now linked to 28 deaths.

But during that same period, the company’s own internal testing showed that 33 surface samples from the clean rooms contained bacteria or mold at levels requiring corrective action to remove contamination, according to company records. These test results were disclosed in a report released Friday by federal investigators.

Pharmacy and laboratory safety consultants said New England Compounding’s report card, sent to the Globe from a hospital that bought from the pharmacy, directly contradicts the findings of the company’s internal testing. The hospital provided the pharmacy report card on the condition it not be identified.
Continue reading the Boston Globe article here 

Missouri has available compounding reports for 2005-2009 on-line

Compounding Report

News Release
Pharmacy Compounding Report FY 2009
Pharmacy Compounding Report FY 2008
Pharmacy Compounding Report FY 2007
Pharmacy Compounding Report FY 2006
Pharmacy Compounding Report Calendar Year 2005

Mass adds more inspectors and ask board member to step down

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DeLauro Response to Closure of Second MA Compounding Pharmacy

Tuesday, October 30, 2012

Will Introduce Legislation Strengthening Federal Oversight Next Month

NEW HAVEN, CT—Congresswoman Rosa DeLauro (D-CT) released the following statement today on the news a Waltham, Massachusetts compounding pharmacy has been shut down after an unannounced inspection.

“It is becoming increasingly clear that problems with compounding pharmacies are not restricted to the New England Compounding Center. Now that another pharmacy has been found to be both acting beyond its license and producing drugs in an unsuitable environment, the need for congressional action is more pronounced than ever. Quite simply, this is about life or death and we cannot risk any more lives. I look forward to working with my colleagues on both sides of the aisle to address this issue and protect patient health.”

DeLauro is a senior member of the committee responsible for funding the Food and Drug Administration (FDA). She has announced plans to introduce legislation next month that will strengthen the FDA’s hand in licensing and overseeing compounding pharmacies. Over 300 people are ill and 28 dead in 19 states due to the current regulatory patchwork system supervising these pharmacies.

Repost 7/1/2012: The Role and Education of the Veterinary Pharmacist

A interesting article entitled, The Role and Education of the Veterinary Pharmacist, Am. J. Pharm. Educ. 2009 February 19; 73(1): 16, notes that the practice of veterinary pharmacy is an emerging field in the United States.  That entire article can be read by clicking here.