The warning, which appeared in a medical journal, stemmed from a 2005 multi-state outbreak involving another big compounder, PharMEDium Services of Lake Forest, Ill.
In January 2005, six cardiac patients at Kaiser Permanente Los Angeles Medical Center came down with a rare bacterial infection. Doctors suspected contaminated magnesium sulfate made by PharMEDium. The intravenous solution is widely used to steady the heartbeat after surgery and to treat a life-threatening condition of pregnancy called pre-eclampsia.
But neither the hospital nor PharMEDium’s Houston plant that made the drug had any solution left to test. Compounders are not required to keep samples for testing later on in case patients get sick.
Federal officials were stymied until they learned five heart patients in New Jersey had developed the same infection, also after receiving magnesium sulfate made by PharMEDium. The New Jersey hospital had bags of solution left, and tests confirmed the rare bacterial strain in the bags matched that of all patients in Los Angeles and New Jersey.
“It was almost luck that we were able to make this match,” said Esther Tan, part of the CDC team that investigated the outbreak.
Investigators said the contamination could have come from the hands of technicians who made the bags of solution. No source was identified.
One patient, Joe Chacon, a heavy-equipment operator in Los Angeles, said he was infected Jan. 12, 2005, at the Kaiser hospital during heart surgery. He became feverish, required a ventilator to breathe and eventually needed to have his pacemaker removed because of concerns about a recurrence of infection, according to his civil suit against PharMEDium.
“I was in the hospital for quite a while,” said Chacon, now 59. He said he wasn’t able to go back to work. The company settled for $25,000, his wife, Rachelle Chacon, said.
All told, at least 18 people in five states were sickened.
From 2005 to 2011, hospitals and patients raised other concerns about PharMEDium medications. In 2006, the company recalled pain medication after human error led to mislabeled drugs at its Mississippi plant, according to FDA records and company officials. An Arizona man lost consciousness after receiving morphine sulfate rather than the less powerful fentanyl citrate. In 2009, a similar incident occurred at the same plant, according to FDA records.
After the bacterial outbreak, the FDA inspected the Houston plant and found staff had failed to fully investigate nine instances in the months before the outbreak where PharMEDium’s own monitoring showed higher-than-
allowed levels of “viable microorganisms,” according to FDA records.
The company increased environmental testing and training, officials said in an interview. The firm also developed a special bar-code-scanning technology to minimize manual errors, the company said. The company said that it’s not practical to keep samples because it makes small batches of drugs with short expiration dates.