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Thank you to Kenneth Woliner, MD, ABFM, www.holisticfamilymed.com, for providing the link to the press release.
Wednesday, May 29, 2013
News Release: FLORIDA DEPARTMENT OF HEALTH PROVIDES UPDATE ON MULTISTATE EPIDEMIOLOGICAL INVESTIGATION ASSOCIATED WITH STEROID INJECTIONS
Thank you to Kenneth Woliner, MD, ABFM, www.holisticfamilymed.com, for providing the link to the press release.
13 new illnesses linked to TN drug compounder May 29, 2013 5:45 PM
The number of adverse events suspected of coming from steroid medications from a Tennessee drug compounder has nearly tripled with 13 new cases reported by the Florida Health Department.
In a statement released Wednesday, Florida officials said adverse reactions were limited to skin abscesses and did not involve any life-threatening conditions. The disclosure boosts the total number of cases in the growing cluster to 20, including five in Illinois and two in North Carolina.
According to Florida health officials, the victims were all given intramuscular injections of methylprednisolone acetate shipped from the Main Street Family Pharmacy in Newbern, Tenn. Four Florida facilities received the suspect drugs.
No adverse reactions have been reported in Tennessee, where seven clinics got the drugs. Among them was Axis Medical Clinic in Robertson County.
Dr. Paul Yim, who has been operating the clinic in White House for 15 years, said in a telephone interview Wednesday that he is contacting an estimated 200 patients who were injected with the steroids.
“We’ve not had any complaints or reports of infection,” Yim said. “None at all.”
The drug is the same one blamed for a nationwide fungal meningitis outbreak that has taken the lives of 15 Tennessee patients and 55 nationwide. Those tainted spinal steroids were shipped around the country by the now-bankrupt New England Compounding Center in Massachusetts.
Yim said Axis Medical is contacting any patients who got shots with methylprednisolone acetate over the past six months. He said he has been working with the state health department to collect information on the patients, including their age, the date of the shots and the date of the last visit.
He said Main Street Family Pharmacy was suggested to him by a medical supply firm and he has been buying drugs from the firm for about two years without any problems. He described Main Street sales staff as “pleasant and professional.”
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According to Florida health officials, the victims were all given intramuscular injections of methylprednisolone acetate shipped from the Main Street Family Pharmacy in Newbern, Tenn. Four Florida facilities received the suspect drugs.
No adverse reactions have been reported in Tennessee, where seven clinics got the drugs. Among them was Axis Medical Clinic in Robertson County.
Dr. Paul Yim, who has been operating the clinic in White House for 15 years, said in a telephone interview Wednesday that he is contacting an estimated 200 patients who were injected with the steroids.
“We’ve not had any complaints or reports of infection,” Yim said. “None at all.”
The drug is the same one blamed for a nationwide fungal meningitis outbreak that has taken the lives of 15 Tennessee patients and 55 nationwide. Those tainted spinal steroids were shipped around the country by the now-bankrupt New England Compounding Center in Massachusetts.
Yim said Axis Medical is contacting any patients who got shots with methylprednisolone acetate over the past six months. He said he has been working with the state health department to collect information on the patients, including their age, the date of the shots and the date of the last visit.
He said Main Street Family Pharmacy was suggested to him by a medical supply firm and he has been buying drugs from the firm for about two years without any problems. He described Main Street sales staff as “pleasant and professional.”
continue reading here
American Academy of Ophthalmology Issues Statement on Provisions to Pharmaceutical Compounding Quality and Accountability Act
WASHINGTON, May 29, 2013 /PRNewswire-USNewswire/ -- As legislation to toughen oversight of compounding pharmaceuticals goes to the Senate floor for further debate, ophthalmologists are warning Congress of the unintended consequences of proposed provisions to the bill that require a named prescription for many uses of compounded drugs. While it is largely supportive of the higher safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) would impose on compounding pharmacies and manufacturers, the American Academy of Ophthalmology is seeking exemptions from Sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation. The Academy points out that there is no evidence to suggest that labeling a drug with a patient's name increases the safety of the repackaging process.
"Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients," said David W. Parke II , M.D., CEO of the American Academy of Ophthalmology. "The American Academy of Ophthalmology shares the concerns of Congress regarding the need to ensure that these products are compounded in the most sterile and safest manner possible in order to protect public health. As part of that process, however, the Academy urges the continued availability of these sight-saving medications without requiring patient-specific prescriptions, as time is often a critical element in preventing irreversible blindness. The Academy believes that compounding can be done in a safe and efficacious manner and support Congress in ensuring the safe availability of these medications for eye physicians and surgeons and the patients they serve."
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New Compounding Pharmacy Scandal in TN May 29th, 2013 // 1:01 pm @ jmpickett
Last month, Tennessee passed a law that eased the restrictions on the state’s compounding pharmacies. Now FDA is looking into seven cases of patients suffering adverse events after they were injected with possibly contaminated drugs that were compounded by a TN pharmacy.
That is why Main Street Family Pharmacy is doing a recall of all of its sterile drug products. Most of them are injectable drugs. It appears that the drugs that are related to the adverse events have methylprednisolone acetate, which is the drug that led to the killer outbreak of fungal meningitis last year.
That outbreak has 740 cases and led to 55 deaths so far. It is the most grave public health crisis in the US in 40 years, and was traced to the New England Compounding Center. That scandal has led FDA to scrutinize drug compounders more closely.
For example, in 2013, FDA started an aggressive effort to do inspections of dozens of drug compounders in many states. There have been some product recalls, too. FDA wants Congress to give them more oversight authority, as well.
Records show that Main Street Family Pharmacy shipped product to AL, AR, CA, FL, KY, IL, LA, MS, NM, NC, SC, TN, and TX. So far, patients in NC and IL have infections.
It is not clear how many patients got injected with the tainted drugs, but the TN Department of Health says that the firm had a license as a manufacturer, wholesaler and distributor in 2010.
quoted here
That is why Main Street Family Pharmacy is doing a recall of all of its sterile drug products. Most of them are injectable drugs. It appears that the drugs that are related to the adverse events have methylprednisolone acetate, which is the drug that led to the killer outbreak of fungal meningitis last year.
That outbreak has 740 cases and led to 55 deaths so far. It is the most grave public health crisis in the US in 40 years, and was traced to the New England Compounding Center. That scandal has led FDA to scrutinize drug compounders more closely.
For example, in 2013, FDA started an aggressive effort to do inspections of dozens of drug compounders in many states. There have been some product recalls, too. FDA wants Congress to give them more oversight authority, as well.
- May 30 – Audit Your Lab Like an FDAer
- June 12 – Avoid Warning Letter Disasters with a Strong cGMP Quality Agreement
Records show that Main Street Family Pharmacy shipped product to AL, AR, CA, FL, KY, IL, LA, MS, NM, NC, SC, TN, and TX. So far, patients in NC and IL have infections.
It is not clear how many patients got injected with the tainted drugs, but the TN Department of Health says that the firm had a license as a manufacturer, wholesaler and distributor in 2010.
quoted here
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