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Safety violations at a major compounding pharmacy are exacerbating hospital shortages of key painkillers, particularly in California where health officials have taken the 鈥渆xtraordinary鈥� step of prohibiting sales from one of its plants.

In late March, California鈥檚 Board of Pharmacy barred the distribution of medications 鈥� including lidocaine and other local anesthetics 鈥� from a Texas factory belonging to the company, . The decision came after the pharmacy board had issued a cease-and-desist order against the plant in February, citing 鈥渁n immediate threat to the public health or safety.鈥�

In December, the Food and Drug Administration issued a damning inspection report on PharMEDium鈥檚 Tennessee plant that led the company to voluntarily cease production there.

There are 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 health care facilities.

PharMEDium, one of the nation鈥檚 largest compounding pharmacy companies, is owned by and supplies medications to about 77 percent of hospitals nationwide.

Before the crackdown on PharMEDium, hospitals already were facing of the injectable opioid painkillers Dilaudid, morphine and fentanyl, which started with manufacturing delays at pharmaceutical giant Pfizer. The shutdown at PharMEDium鈥檚 Tennessee plant, which makes those drugs, has intensified the shortage nationally.

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 鈥� , and 鈥� are in short supply due to manufacturing problems and back orders, according to doctors and federal regulators.

Shortages of both types of painkillers have hit California health care providers especially hard. They must contend with the state crackdown on PharMEDium鈥檚 Texas plant, which produces local anesthetics, and federal scrutiny of the Tennessee plant, which produces the injectable opioids. Some California hospitals have abandoned the company altogether.

鈥淲e鈥檙e having to be very creative,鈥� 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.

鈥淭here are times when we鈥檙e not able to achieve that amount of anesthesia that we would like,鈥� 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鈥檚 Lucile Packard Children鈥檚 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.

鈥淚f we can鈥檛 provide patients with adequate pain relief, then it鈥檚 sort of barbaric to do the surgery,鈥� 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.

鈥淚t鈥檚 unbelievably frustrating,鈥� Agarwal said. 鈥淭he solutions are [being] snatched away from us.鈥�

California鈥檚 concern about PharMEDium dates to at least 2016, when the state warned the company about drugs 鈥渓acking in quality or strength鈥� and fined it for failing to notify state officials about a product recall, according to public records obtained by California Healthline.

Then, the California Board of Pharmacy鈥檚 temporary , issued Feb. 27, faulted PharMEDium鈥檚 Sugar Land, Texas, plant for 14 violations, including flawed expiration dating and improper labeling. Virginia Herold, the board鈥檚 executive officer, called the action an 鈥渆xtraordinary authority鈥� that it doesn鈥檛 use frequently.

In late March, the board decided not to renew the plant鈥檚 license. The agency is not aware of any patient harm that may be related to the plant鈥檚 failures, Herold said.

PharMEDium spokeswoman Lauren Esposito said the company is committed to resolving the matter.

鈥淲e 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,鈥� she said.

California鈥檚 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.

鈥淭his can get pretty hairy for PharMEDium pretty fast,鈥� he said.

At the federal level, the FDA鈥檚 December report on PharMEDium鈥檚 Memphis, Tenn., plant listed .

The report said the plant, which supplies injectable opioids to hospitals around the country, wasn鈥檛 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.

In the industry鈥檚 defense, said Thomas, the consultant, FDA inspectors can be inconsistent and deficiencies cited at compounding plants can depend on the person writing the report.

Government officials have stepped up scrutiny of compounding pharmacies since 2012, when contaminated drugs from the New England Compounding Center led to a national meningitis outbreak that and sickened 793 patients. The incident led to an eight-year prison sentence for the compounder鈥檚 supervising pharmacist, and that created new requirements for the pharmacies.

PharMEDium doesn鈥檛 know when the Memphis plant will start production again, Esposito said.

鈥淲e are actively working to address the items noted by FDA during the inspection and will resume 鈥� activities when we have determined our own readiness,鈥� she said.

Because the Memphis plant is still offline, shortages of injectable opioids have worsened, according to a large California medical system.

鈥淚t鈥檚 been a struggle鈥� to maintain an adequate stock of the medications since the plant stopped producing, said Donald Kaplan, a pharmacy director at Kaiser Permanente in Southern California. (California Healthline is produced by Kaiser Health News, which is not affiliated with Kaiser Permanente.)

Opioid supplies have dwindled so dramatically that Kaiser is shipping medications from one hospital to others that are in short supply, sometimes multiple times per week, he said.

In recent years, some hospitals have sought alternatives to PharMEDium because of quality problems, according to the California Hospital Association.

That鈥檚 the case with Mayers Memorial Hospital District in Shasta County, whose chief clinical officer Keith Earnest said it hasn鈥檛 used PharMEDium鈥檚 products in five years.

鈥淚 am glad they are finally no longer allowed to ship to California,鈥� he said. 鈥淚t has been a long time coming.鈥�

This story was produced by聽, which publishes聽, an editorially independent service of the聽.