Pharma Plant Safety Violations Causing Critical Medication Shortages


Safety violations and other manufacturing challenges have caused shutdowns at major pharmaceutical production facilities, worsening an already-serious medication shortage at hospitals and hospices.

A Texas factory belonging to PharMEDium has been barred from distributing medications — including lidocaine and other local anesthetics — by the California Board of Pharmacy. PharMEDium is one of the nation’s largest compounding pharmacy companies and is owned by AmerisourceBergen. It supplies medications to about 77% of hospitals nationwide.

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The California Board of Pharmacy’s cease-and-desist order faulted PharMEDium’s Sugar Land, Texas, plant for 14 violations, including flawed expiration dating and improper labeling. Virginia Herold, the board’s executive officer, called the action an “extraordinary authority” that it doesn’t use frequently.

This comes after a December crackdown on another of PharMEDium’s plants in Tennessee by the Food and Drug Administration. The FDA‘s inspection report on the plant listed a series of deficiencies. The report said the plant, which supplies injectable opioids to hospitals around the country, wasn’t doing enough to ensure medications were sterile before shipping them. The FDA also reprimanded the company for poor employee training and failure to report and thoroughly investigate a case in which a patient became unconscious after receiving an injection of morphine produced by PharMEDium.

Alarms are now ringing at all kinds of medical providers, from sprawling academic hospitals to small hospice programs as staple medications used to treat a wide array of patients are becoming in shorter supply.

“We’re having to be very creative,” said Dr. Aimee Moulin, an emergency doctor at the UC Davis Health system who is president of the California chapter of the American College of Emergency Physicians.

“There are times when we’re not able to achieve that amount of anesthesia that we would like,” Moulin said. When that happens, she often turns to a second-choice drug that might not be as effective.

Dr. Rita Agarwal, who practices at Stanford University’s Lucile Packard Children’s Hospital, said the facility has a sufficient supply of local anesthetics to cope with the injectable opioid shortages. But if that changes, doctors may have to cancel elective surgeries, she said.

“If we can’t provide patients with adequate pain relief, then it’s sort of barbaric to do the surgery,” said Agarwal, who is also a professor of anesthesiology at Stanford. In the meantime, her team is using more drugs like Demerol or remifentanil, which are not ideal in many cases because they have side effects or are short-acting.

“It’s unbelievably frustrating,” Agarwal said. “The solutions are [being] snatched away from us.”

Others in the industry point to a need for backup manufacturing capabilities to ensure crucial medications get to the patients that need them.

“After this last round of shortages, I think it’s become pretty apparent there is still some work that needs to be done,” said Jillanne Schulte, director of regulatory affairs for the American Society of Health-System Pharmacists. The organization has pushed for changes to make reporting of shortages more timely and transparent, and ensure backup manufacturing capabilities are available for certain crucial medicines. “If you don’t have enough manufacturing capacity going, and something goes offline, you may be in a very uncomfortable position very quickly,” Schulte said.


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