Monday, April 1, 2013
Regulators scrutinize compounding pharmacies in Tennessee, nation (with video) by Kate Harrison
Compounding pharmacies see renewed attention after meningitis outbreak
Chattanooga-area compounding pharmacies have seen renewed attention from both customers and the Tennessee Legislature after a deadly meningitis outbreak that stemmed from a Massachusetts pharmacy. Access Family Pharmacy, which fills about 60 compounding prescriptions per day, has specialized in compounding prescriptions since 1962.
Compounding pharmacies long have been able to fill the gap between mass-produced drugs and highly personal medical needs.
These pharmacies can customize a drug product into a liquid or a gas for patients who can't swallow pills. They can make a medication without specific allergens. They can flavor a medicine with mint or tropical fruit to be more palatable. And they can compound drugs that are on back order -- such as Tamiflu for children.
"Maybe [the patient] can't take something that's commercially made because it's one-size-fits all. Or it's something that's not commercially made and they've got to have it," explains pharmacist Phil Smith at Access Pharmacy, which has been compounding drugs in the Hixson store for more than 50 years.
But over the last few months, state and federal officials have said the gap that compounding pharmacies have filled has been far too unregulated, leading to abuse by certain pharmacies.
"It has been a crazy few months for compounding," said Smith. "We have been letting our customers know that our chemicals are tested, our manufacturers are FDA tested and approved. Things like that let people know what our quality standards are."
A deadly meningitis outbreak prompted heightened scrutiny from both state and federal regulators. Just last month, there were two more recalls of sterile compounded and repackaged drug products, first from a New Jersey compounding pharmacy after fungal contamination was found at a hospital. Days later, a compounding pharmacy in Martinez, Ga., recalled syringes of the drug Avastin after it received reports of eye infections among patients.
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Dr. David F. Chang Reminds Ophthalmologists of Importance of Compounding Pharmacies David F. Chang interviews Charles Leiter regarding the state of compounding and how pharmacies, such as Leiter’s, maintain high standards of quality when compounding medications.
San Jose, CA (PRWEB) April 01, 2013
In the March 2013 issue of EyeWorld magazine, Dr. David F. Chang interviewed CEO of Leiter’sCompounding Pharmacy, Charles Leiter. As compounding pharmacies continue to reel from the devastating Meningitis outbreak caused by the negligence of New England Compounding Center, Dr. David F. Chang reminds the industry of the importance of quality compounding in “Compounding pharmacies: Let’s not throw the baby out with the bathwater.”
In the op-ed and interview, Dr. Chang discusses what happened in Massachusetts, the state of the industry, the results of the Meningitis outbreak, and the utmost need for quality medication from reliable compounding pharmacies such as Leiter’s.
Dr Chang said, “The disastrous fungal infections caused by contaminated medications from the New England Compounding Center(NECC) have rocked the pharmaceutical compounding industry. As a result of this horrible outbreak, the confidence of many physicians and their patients in compounded medications has been shaken.” Leiter expands, “What happened at NECC was a disaster. They were operating under horrific, unsafe conditions, and they never should have been in business. They’ve unfairly tarnished our entire industry. No responsible doctor should have ever ordered from NECC. The FDA and pharmacy boards should have shut them down years ago, and the owners should never have allowed product to ship.”
Dr. Chang follows by explaining the continued need for high quality medication from compounding pharmacies. He said, “Of course, drug compounding has always filled important and otherwise unmet pharmaceutical needs.” Leiter reiterates this point, saying “The role of compounding drugs is paramount in the U.S. because compounding meets very tangible and very serious medical needs that cannot be met anywhere else.”
As scrutiny intensifies on compounding pharmacies, Chang reminds industry professionals of the compounding pharmacies that are producing quality medications and the distinction of a PCAB accredited pharmacy. “As you will see, there is only a small minority of compounding pharmacies that are accredited, and this is a very important distinction.” Leiter expands on the accreditation and the importance of not distinguishing based on cost. “NECC was not PCAB accredited. The number one rule for doctors when ordering a compounded medication is to verify that the pharmacy is PCAB accredited. Doctors or buyers at their clinics or ASCs should know and trust who they are doing business with and should not procure on the basis of selecting the lowest cost provider.”
Dr. Chang summarizes, “With the increased scrutiny and regulation that are sure to follow in the wake of the fungal meningitis outbreak, we must heed the idiom in this column’s title and preserve patient access to appropriate and properly compounded medications.”
About Dr. David F. Chang:
David F. Chang, MD is clinical professor at the University of California, San Francisco, and the current president of the American Society of Cataract and Refractive Surgery. He is also Chairman of the American Academy of Ophthalmology’s Cataract Preferred Practice Pattern Committee, and is considered a leading expert in cataract surgery. Dr. Chang is the chief medical editor of EyeWorld and was previously co-chief medical editor for Cataract and Refractive Surgery Today.
State Weighs New Regulations for Compounding Pharmacies April 1st, 2013
BOSTON (AP) — Lawmakers are considering changes in how sterile compounding pharmacies are regulated after a deadly nationwide fungal meningitis outbreak that was linked to a steroid distributed by a Massachusetts firm.
The Legislature’s public health committee has scheduled a hearing for Tuesday on several proposals that call for strengthening oversight and licensing of the pharmacies.
Among them is a bill filed by Gov. Deval Patrick that would require compounding pharmacies to obtain a special state license. The bill would also create whistleblower protections for pharmacy workers and enforce new fines and penalties for compounding pharmacies that break the rules.
More than 50 deaths and hundreds of illnesses have been tied to the meningitis outbreak. New England Compounding Center of Framingham shut down operations last fall.
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