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, Californias Board of Pharmacy barred the distribution of medications including lidocaine and other local anesthetics 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 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 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 nations 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 PharMEDiums 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 , and 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 PharMEDiums 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.
Were having 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 were 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 Universitys Lucile Packard Childrens 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 cant provide patients with adequate pain relief, then its 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.
Its unbelievably frustrating, Agarwal said. The solutions are [being] snatched away from us.
Californias concern about PharMEDium dates to at least 2016, when the state warned the company about drugs lacking in quality or strength 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 Pharmacys temporary , issued Feb. 27, faulted PharMEDiums Sugar Land, Texas, plant for 14 violations, including flawed expiration dating and improper labeling. Virginia Herold, the boards executive officer, called the action an extraordinary authority that it doesnt use frequently.
In late March, the board decided not to renew the plants license. The agency is not aware of any patient harm that may be related to the plants failures, Herold said.
PharMEDium spokeswoman Lauren Esposito said the company is committed 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, she said.
Californias 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.
This can get pretty hairy for PharMEDium pretty fast, he said.
At the federal level, the FDAs December report on PharMEDiums Memphis, Tenn., plant listed .
The report said the plant, which supplies injectable opioids to hospitals around the country, wasnt 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 industrys 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 compounders supervising pharmacist, and that created new requirements for the pharmacies.
PharMEDium doesnt know when the Memphis plant will start production again, Esposito said.
We are actively working to address the items noted by FDA during the inspection and will resume activities when we have determined our own readiness, she said.
Because the Memphis plant is still offline, shortages of injectable opioids have worsened, according to a large California medical system.
Its been a struggle 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.
Thats the case with Mayers Memorial Hospital District in Shasta County, whose chief clinical officer Keith Earnest said it hasnt used PharMEDiums products in five years.
I am glad they are finally no longer allowed to ship to California, he said. It has been a long time coming.
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