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Pharmacy Compounding Prone to Error, FDA Finds: Presented at ACCP
By Roberta Friedman, PhD
Special to DG News
SAN FRANCISCO, CA -- September 23, 2002 -- Pharmacists that compound their own versions of approved drugs do not always create the correct dosage, according to a study by the United States Food and Drug Administration (FDA) reported September 21st at the 31st Annual Meeting of the American College of Clinical Pharmacology (ACCP).
Vaiyapuri Subramaniam, Pharm.D., of the FDA's Center for Drug Evaluation and Research in Rockville, Maryland, presented a sampling of 12 pharmacies that advertise and make compounded products available for sale over the internet.
The FDA study selected 29 samples based on commonly used agents, and on the potential for health consequences if mistakes are made. Ten of the 29 samples failed, with nine testing sub-potent. One sample was contaminated. More than half had less than 70 percent of the potency stated on labelling.
Three other samples failed an initial test, but, because inadequate amounts were left for re-testing, they were not scored as failures.
Tests were carried out at an FDA laboratory with assays specific for dosage form and testing requirements of USP/NF or NDA/ANDA. By comparison, one to two percent of drugs from manufacturers fail to meet standard.
Pharmacy compounding is an art, said Dr. Subramaniam. Sometimes a patient needs a customised drug, due to allergy to a dye or preservative. There may be good intentions on the part of compounding pharmacists, he said, "but the (drugs) have to be made properly."
In the samples studied, several agents were dispensed that apparently are intended as substitutes for Viagra, Dr. Subramaniam said. These included alprostadil, a prostaglandin vasodilator, which contained endotoxin, and papavarine. Some compounded progesterone samples also failed, both as capsules and as injectables. Inhaled tobramycin, an anti-infective that might be used by someone with cystic fibrosis, also failed in an assay. Other samples that failed assays included dexamethasone and timolol, both prepared as eye drops.
Examples of severe health consequences after improper compounding were also presented in the poster, including a child who died after ingesting imipramine as an oral liquid compounded at five times the prescribed strength. Meanwhile, eight cases of meningitis resulted recently in California, when a pharmacy was compounding betamethasone injections that turned out to be contaminated.
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