Safety violations at PharMEDium worsen hospital painkiller shortage

An investigation of PharMEDium, a major compounding pharmacy, revealed safety violations are worsening hospital shortages of painkillers, especially in California, where health officials are banning sales from one of the company's plants, according to Kaiser Health News.

In March, California’s Board of Pharmacy phobitied the distribution of medications, which included lidocaine and other local anesthetics, from a Texas factory belonging to PharMEDium. The decision followed a February cease-and-desist order against the plant from the state's pharmacy board, which cited "an immediate threat to the public health or safety."

Additionally, in December, The FDA issued a similarly damaging inspection report on the company’s Tennessee plant, which led the company to voluntarily cease production at the plant.

PharMEDium mass-produces ready-to-use IV bags, prefilled syringes and other sterile medical solutions for hospitals, surgery centers and other healthcare facilities. The company is owned by AmerisourceBergen and supplies medications to around 77 percent of hospitals across the country.

Before the investigations into PharMEDium, hospitals already had to address significant shortages of injectable opioid painkillers, such as Dilaudid, morphine and fentanyl, due to manufacturing delays at pharmaceutical giant Pfizer. The shutdown of PharMEDium's Tennessee plant, which creates those drugs, worsened the shortage on a national level.

In an effort to spare their patients pain, physicians began looking to second-choice pain drugs and have started using more local anesthetics, such as lidocaine, ropivacaine and bupivacaine. However, these local anesthetics are also in short supply due to manufacturing problems and back orders, according to the report.

Numerous hospitals in California abandoned PharMEDium altogether. "We’re having to be very creative," said Aimee Moulin, MD, an emergency physician at the University of California-Davis Health System and 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," Dr. Moulin said. As a result, Dr. Moulin frequently uses second-choice drug that might not be as effective, she added.

The California Board of Pharmacy chose not to renew the plant’s license in late March. The agency is not aware of any patient harm that may be related to the plant's failures, said Virginia Herold, the board's executive officer.

PharMEDium spokeswoman Lauren Esposito told Kaiser Health News the company is actively working to resolving the matter.

"We look forward to renewing our California licenses and resuming shipment of our products into the state of California as soon as the board feels that its observations have been satisfactorily addressed," Ms. Esposito said.

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