Safety, sanitary problems prompt scores of drug recalls

The infection came out of nowhere, 36 hours after Eloise Soler’s heart surgery last summer at the Corpus Christi Medical Center in South Texas. As her fever spiked to 103, other patients developed similar symptoms. Doctors raced to pinpoint the cause.

Tests showed that all of the patients had been sickened by the same bacteria, Rhodococcus equi, which typically infects horses and other grazing animals, and they all fell ill after infusions of the same drug, calcium gluconate.

The drug was made 200 miles away by Specialty Compounding, which sits in a category of pharmacies that mix unique or hard-to-find drugs not only for individual patients, but also in batches for doctors and hospitals. By the time the company recalled the medication days later, investigators believed it had sickened at least 15 people; two had died.

“You think because there are so many controls on drugs that you’re not going to be given something that will make you sick,” says Soler, 60, who spent months recovering. “I just couldn’t believe it.”

Two years after contaminated drugs linked to a compounding pharmacy in Massachusetts killed 64 and sickened more than 750 with fungal meningitis, the industry still struggles with serious safety problems affecting thousands of patients, a USA TODAY examination shows. A regulatory crackdown by the U.S. Food and Drug Administration since the outbreak in October 2012 has led to an unprecedented spate of drug recalls by compounding pharmacies — and scores of citations for bad practices.

 

http://www.usatoday.com/story/news/nation/2014/10/07/compounding-pharmacy-recalls-inspections-contamination/16472741/

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