Thursday, May 30, 2013

KUDOS--This Article MAKES AN EXCELLENT POINT THAT HAS BEEN MADE SEVERAL TIMES ON THIS BLOG: Make pharmacy regulations meaningful May 28, 2013 10:12 PM


How much clearer does it have to be? The laws that are meant to ensure compounded medications are safe are not getting the job done.
Last year’s outbreak of fungal meningitis caused by contaminated medicine killed 55 patients, including 15 people in Tennessee. Hundreds more were sickened.
And yet, another compounding pharmacy, this one in West Tennessee, has been identified as the likely source of a new spate of infections in North Carolina and Illinois.
Facilities in 13 states overall received supplies of the medicine.
Main Street Family Pharmacy LLC in Newbern has now recalled all its sterile products. Tennessee health officials on Tuesday released the names of seven Tennessee facilities that received the drug.
Main Street shipped the medications about two weeks after state inspectors found violations at the pharmacy in November. Inspectors concluded that “the processes they were following at the time did not indicate there was any problem,” says Terry Grinder, interim director of the Tennessee Pharmacy Board.
How can that be, since the inspection helped lead to Main Street’s top pharmacist being fined and placed on two years’ probation; 109 medications on the pharmacy’s shelves were found to be outdated, and 11 prescriptions were not written on tamper-resistant paper as required under state law?
Main Street also was cited in 2011 for having expired medications used for drug compounding; sterilization equipment out of compliance; and shipping compounded drugs directly to physicians’ offices without patient-specific prescriptions, a direct violation of state law.
The state did not shut down the pharmacy then, either.
So maybe these dangerous problems continue because compounding pharmacies know that the consequences for breaking the rules are minor, if they are imposed at all.
And let’s not pretend that health officials and pharmacies do not understand the risk to patients’ safety if their medications are not compounded under strictly controlled conditions and made for specific patients. The deadly outbreak caused by the New England Compounding Center unfolded before Main Street was inspected in November.
Then, early in 2013, the Tennessee General Assembly acted irresponsibly by approving a loophole in the specific-patient prescription requirement. It was suggested that the risk of shortages outweighs the risk of contamination.
That is an important discussion to have, but why are the only options ample supply or lax safeguards? Shouldn’t compounding pharmacies ensure that they are adequately staffed and supplied without resorting to shortcuts?
Pharmacists are not physicians, but they are their partners in care. Shouldn’t they also adhere to the key tenet, “First, do no harm”?
quoted from here

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