Safety violations at a major compounding pharmacy are exacerbating hospital shortages of key painkillers, particularly in California where health officials have taken the "extraordinary" step of prohibiting sales from one of its plants.
In late March, California's Board of Pharmacy barred the distribution of medications including lidocaine and other local anesthetics from a Texas factory belonging to the company, PharMEDium.
The decision came after the pharmacy board had issued a cease-and-desist order against the plant in February, citing "an immediate threat to the public health or safety." In December, the Food and Drug Administration issued a damning inspection report on PharMEDium’s Tennessee plant that led the company to voluntarily cease production there.
There were two kinds of compounding pharmacies: ones that mix custom prescriptions for individual patients, from chemotherapy cocktails to thyroid drugs, and those like PharMEDium, which mass-produce ready-to-use IV bags, prefilled syringes and other sterile medical solutions for hospitals, surgery centers, and other healthcare facilities.
PharMEDium, one of the nation's largest compounding pharmacy companies, has been owned by AmerisourceBergen and supplies medications to about 77% of hospitals nationwide. Doctors, determined to spare their patients pain, consequently have turned to second-choice pain drugs and increased their use of local anesthetics such as lidocaine.
But now, even those local anesthetics lidocaine, ropivacaine, and bupivacaine are in short supply due to manufacturing problems and back orders, according to doctors and federal regulators.
"We have to be very creative," said Dr. Aimee Moulin, an emergency doctor at the University of California-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."
"California's crackdown could make waves economically and symbolically, because of the size of its market and the message it sends to other states," said Dave Thomas, a principal with LDT Health Solutions, a consulting firm for compounding pharmacies.
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.