NH monitoring new recalls of compounded drugs
The federal Food and Drug Administration last week announced voluntary recalls by Clinical Specialties Compounding Pharmacy and Med Prep Consulting of all products compounded at those facilities, "due to lack of sterility assurance."
The actions echo the nationwide recall last year of all drugs made by New England Compounding Center of Framingham, Mass., after a deadly multi-state outbreak of fungal infections was linked to contaminated drugs made there.
Fourteen cases of illness in New Hampshire were linked to that outbreak, and health officials are still monitoring more than 750 patients who got NECC medications for any symptoms.
Dr. Sharon Alroy-Preis, state epidemiologist, said the public health division has been investigating whether any products in the new recalls could have come to New Hampshire.
She stressed there are no reports of illness here and, so far, no evidence the recalled medications were sent here.
In some cases, she said, "We know that the products did not come to New Hampshire."
"But there are still pending ones in which it could have, and we are trying to get more information, whether from the FDA or from the Board of Pharmacy in those states where the compounding pharmacies are located."
Clinical Specialties Compounding Pharmacy in Georgia initially recalled a number of lots of Avastin last Monday after five patients who had gotten injections of the medicine were diagnosed with serious eye infections, according to an FDA statement. On Friday, the company recalled all lots of all sterile products "repackaged and distributed" by the pharmacy.
Austin Gore is the owner and pharmacist at Clinical Specialties, which he described as "a small, private specialty pharmacy." In a telephone interview, he told the New Hampshire Sunday News his pharmacy does not ship products to New England.
Gore, who does the sterile compounding himself, said the FDA has inspected his facility and found "no signs of contamination." And he said he was "just being cautious" by recalling all products made at his facility and distributed between Oct. 19 and March 19.
But he said the incident has destroyed his practice and in some cases deprived patients of needed medication. "This just breaks your heart," he said.
No illnesses have been reported in connection with the Med Prep Consulting recall on March 18, which came after a Connecticut hospital observed "visible particulate contaminants" in bags of intravenous magnesium sulfate solution, according to the FDA.
The contamination was later confirmed to be mold, and the New Jersey company recalled all lots of all products compounded at its facility.
The recall notice stated that Med Prep shipped directly to hospital pharmacies in Connecticut, Delaware, New Jersey and Pennsylvania.
And a company news release said the contaminated bags of medicine were "unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital."
But the issue is complicated by the fact that compounded medication is sometimes redistributed by clinics or pharmacies to other providers, Alroy-Preis said. That's what happened in the NECC case.
"We knew of two clinics who got the medication originally, and then we heard that, internally within the pain care clinic network, they redistributed and a third clinic got the same recalled lot."
That's why with the latest recalls, she said, "We really want to be very, very careful before we say there is nothing."
Alroy-Preis said she doesn't want the public to be "scared unnecessarily" by the latest recalls of compounded drugs.
Her message: "Rest assured, we are doing that job of trying to make sure no one was at risk. And if we find anything, we will let people know."
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