Monday, July 14, 2014

Hello Again and Again! History will continue to repeat itself until something is done.

 In North Carolina, one patient died and three became ill from fungal
meningitis traced to methylprednisolone compounded by Urgent Care
Pharmacy of Spartansburg, S.C. In September 2002, the pharmacy recalled
the contaminated product. State and federal inspections found several
instances of nonadherence to sterile technique. However, when Urgent Care
refused to recall all its compounded products, the Food & Drug
Administration issued a national alert advising against use of any products
compounded by the pharmacy.
• On Sept. 20, the FDA put Med-Mart Pulmonary Services of Novato, Calif.,
on notice that it was operating as a drug manufacturer, not a retail
pharmacy. Citing concerns about "large-scale production of massive
quantities of inhalation solutions," the FDA threatened actions such as
seizure and/or injunction if the firm did not provide a plan to correct
numerous operational deficiencies.
• Although Robert Courtney's dilution of chemotherapy drugs was not
strictly compounding, the finer points of the Kansas City pharmacist's
operation were lost on the media and the public following discovery of his
criminal actions in August 2001. He was recently sentenced to 30 years in
prison.
• Last July, two pharmacists and six healthcare professionals were
convicted in Miami of defrauding Medicare of millions of dollars with bogus
billing for compounded aerosol medications through South Beach
Pharmacy, LaModerna Pharmacy, and/or CDC of South Florida Inc. The
compounded drugs contained little or no active ingredients.
• On Sept. 18, 2002, the U.S. Department of Justice sent a letter to
Pharmaceutical Compounding Centers of America (PCCA) informing the
Houston firm that the huge volume of chemicals it had supplied to Miami
pharmacies should have been a "red flag" that there was Medicare fraud
going on. The firm was also informed that its actions "have assisted in the
systematic defrauding of the Medicare Trust Fund."
• PCCA was also the target of an FDA warning letter in July 2001 taking the
firm to task for violations of good manufacturing practices, including failure
to ensure against cross contamination between cephalosporins and
penicillin repackaged on common equipment. The FDA also alleged that
PCCA had been repacking and distributing bulk drugs that had been
removed from the market, such as phenacetin, dipyrone, and adenosine
phosphate.
• On April 10, 2002, the FDA warned three pharmacies that the nicotine
http://www.drugtopics.com/be_core/MVC?mag=d&action=viewArticle&y=2003&m=01&... 2/24/2004 Cover Story: COMPOUNDING UNDER SIEGE Page 8 of9
lollipops and lip balm they were selling were illegal because they were
compounded without an Rx and were made from nicotine salicylate, which
is not approved for compounding.
• Last June, Portage Pharmacy, Portage, Mich., issued a class I recall of 791
vials of compounded drugs, including methylprednisolone, due to
contamination and a class II recall of 175 vials of other compounded
medications due to lack of assurance of sterility.
• Two patients in Michigan who had received compounded medication for
spinal injection became ill with Chryseomonas meningitis last year,
according to CDC.
• In March 2001, four Atlanta patients had severe adverse reactions to a
compounded thyroid drug prescribed for Wilson's syndrome, a quack
diagnosis created by a Florida doctor who lost his license. One R.Ph. was
put on probation for five years and the owner-R.Ph. surrendered his license.
He had been sanctioned in 1986 for felony convictions for mail fraud and
misbranding and adulteration of drugs.
• Thirteen people were hospitalized and three others died from meningitis
traced to contaminated betamethasone compounded by Doc's Pharmacy in
Walnut Creek, Calif., in May 2001. The pharmacist-owner's license was
revoked for one year, but a young pharmacist who co-owned the pharmacy
later committed suicide following a 90-day license suspension.

Quoted from here

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