Breaking News
February 17, 2019 - Exercise gives a better brain boost to older men than women
February 17, 2019 - New research disproves previous assumptions of how looks influence personality
February 17, 2019 - Cannabis use as a teenager linked to depression later in life
February 17, 2019 - Sinks by Toilets in ICU Patient Rooms Harbor Harmful Bacteria
February 17, 2019 - Cancer cells’ plasticity makes them harder to stop
February 17, 2019 - Young cannabis users have increased risk of depression and suicidal behavior
February 17, 2019 - Tasmanian Devils Likely to Survive Cancer Scourge
February 17, 2019 - Neoadjuvant PD-1 blockade seems effective in glioblastoma
February 17, 2019 - Personal, social factors play role in enabling sustainable return to work after ill health
February 17, 2019 - Mouse studies show ‘inhibition’ theory of autism wrong
February 17, 2019 - Study shows how neuroactive steroids inhibit activity of pro-inflammatory proteins
February 17, 2019 - Use of liver grafts from older donors decreased despite better outcomes in recipients
February 17, 2019 - MUSC researchers discover new mechanism for a class of anti-cancer drugs
February 17, 2019 - HPV misconceptions are causing women to miss smear tests
February 17, 2019 - Sanofi and Regeneron Offer Praluent (alirocumab) at a New Reduced U.S. List Price
February 17, 2019 - Researchers say auditory testing can identify children for autism screening
February 17, 2019 - New method analyzes how single biological cells react to stressful situations
February 17, 2019 - WVU gynecologic oncologist investigates novel treatment for cervical and vaginal cancers
February 17, 2019 - ADHD diagnoses poorly documented
February 17, 2019 - Majority of gender minority youth do not identify with traditional sexual identity labels
February 17, 2019 - AbbVie, Teneobio enter into strategic transaction to develop potential treatment for multiple myeloma
February 17, 2019 - Lower Birth Weight May Up Risk for Psychiatric Disorders
February 17, 2019 - Scientists identify reversible molecular defect underlying rheumatoid arthritis
February 17, 2019 - Moffitt researchers shed light on how CAR T cells function mechanistically
February 16, 2019 - Female Anatomy May Play Big Role in Sperm’s Success
February 16, 2019 - BMI may mediate inverse link between fiber intake, knee OA
February 16, 2019 - Movement impairments in autism can be reversed through behavioral training
February 16, 2019 - Studies address racial disparities in postpartum period and cardiovascular health
February 16, 2019 - Scientists implicate hidden genes in the severity of autism symptoms
February 16, 2019 - Decreased deep sleep linked to early signs of Alzheimer’s disease
February 16, 2019 - Neuroscientists show how the brain responds to texture
February 16, 2019 - Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
February 16, 2019 - What Can I Do About Sweating? (for Teens)
February 16, 2019 - Companies navigate dementia conversations with older workers
February 16, 2019 - Newly developed stem cell technologies show promise for treating PD patients
February 16, 2019 - Collaborative material research could advance self-assembling nanomaterials
February 16, 2019 - Researchers take major step in creating technology that mimics the human brain
February 16, 2019 - Erasing memories associated with cocaine use reduces drug seeking behavior
February 16, 2019 - Artificial intelligence can accurately predict prognosis of ovarian cancer patients
February 16, 2019 - Racial disparities in cancer deaths on the decline for America
February 16, 2019 - FDA authorizes new interoperable insulin pump for children, adults with diabetes
February 16, 2019 - Coexisting Medical Conditions, Smoking Explain PTSD-CVD Link
February 16, 2019 - Skin Cancer Screening: MedlinePlus Lab Test Information
February 16, 2019 - ‘Happiness’ exercises can boost mood in those recovering from substance use disorder
February 16, 2019 - Cell manipulation could soon halt or reverse aging
February 16, 2019 - Pumped Breast Milk Falls Short of Breastfed Version
February 16, 2019 - Men’s porn habits could fuel partners’ eating disorders, study suggests
February 16, 2019 - Rapid progression of age-related diseases may result from formation of vicious cycles
February 16, 2019 - Immune checkpoint molecule protects against future development of cancer
February 16, 2019 - New method produces hydrogels that have properties similar to cells’ environment
February 16, 2019 - $4.1 million funding for heart research on Valentine’s Day
February 16, 2019 - General anesthesia in early infancy unlikely to have lasting effects on developing brains
February 16, 2019 - New breakthroughs for muscular dystrophy research
February 16, 2019 - First Opinion: Embryo editing for higher IQ is a fantasy. Embryo profiling for it is almost here
February 16, 2019 - Vapers develop cancer-related gene deregulation as cigarette smokers
February 16, 2019 - Bringing Antimicrobial Susceptibility Testing (AST) to the Community
February 16, 2019 - Decolonization protocol after hospital discharge can prevent dangerous infections
February 16, 2019 - Children with ASD more likely to face maltreatment, study finds
February 16, 2019 - Study finds genetic vulnerability to use of menthol cigarettes
February 16, 2019 - Promising drug developed to rejuvenate muscle cells
February 16, 2019 - H-RT should be the standard of care for men with low risk prostate cancer, study shows
February 16, 2019 - New technique using patients’ own modified cells could help treat Crohn’s disease
February 16, 2019 - Therapeutic endoscopy has an expanding role in the treatment of IBD
February 16, 2019 - Blood clot discovery could lead to development of better treatments for blood diseases
February 16, 2019 - Intervention can increase exclusive breastfeeding rates
February 16, 2019 - New project explores how gaming technologies can help cancer patients communicate better
February 16, 2019 - Catalyst Biosciences Presents Updated Data from Its Phase 2/3 Trial of Subcutaneous Marzeptacog Alfa (Activated) in Individuals with Hemophilia A or B with Inhibitors at the 12th Annual EAHAD Congress
February 16, 2019 - Rerouting nerves during amputation reduces phantom limb pain before it starts
February 16, 2019 - A Hormone Produced When We Exercise Might Help Fight Alzheimer’s
February 16, 2019 - Millions of British people breathe toxic air travelling to GPs
February 16, 2019 - Conformance of genetic characteristics found to be crucial for longer preservation of kidney graft
February 16, 2019 - Researchers use optogenetic tool to control, visualize receptor signals in neural cells
February 16, 2019 - New reversible antiplatelet therapy could reduce risk of blood clots, prevent cancer metastasis
February 16, 2019 - Testosterone is not the only hormone needed for penis development
February 16, 2019 - FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
February 15, 2019 - Heart surgery technology developed at Baptist Health debuts after years of secrecy
February 15, 2019 - Prescription Opioids Double Risk of Triggering Fatal Car Crash
February 15, 2019 - New study helps doctors better understand high blood pressure in pregnant women
February 15, 2019 - Beta wave control in Parkinson’s diseased brain could be a potential therapy
February 15, 2019 - Media representations of love may justify gender-based violence in young people
Safety violations compound pain of painkiller shortages

Safety violations compound pain of painkiller shortages

image_pdfDownload PDFimage_print

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 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’s largest compounding pharmacy companies, is owned by AmerisourceBergen and supplies medications to about 77 percent of hospitals nationwide.

Before the crackdown on PharMEDium, hospitals already were facing critical shortages of the injectable opioid painkillers Dilaudid, morphine and fentanyl, which started with manufacturing delays at pharmaceutical giant Pfizer. The shutdown at PharMEDium’s 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 — lidocaine, ropivacaine and bupivacaine — 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’s 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.

“We’re 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 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.”

California’s 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 Pharmacy’s temporary cease-and-desist order, issued Feb. 27, 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.

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

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.

“This can get pretty hairy for PharMEDium pretty fast,” he said.

At the federal level, the FDA’s December report on PharMEDium’s Memphis, Tenn., plant listed a litany 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.

In the industry’s 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 killed 64 people and sickened 793 patients. The incident led to an eight-year prison sentence for the compounder’s supervising pharmacist, and a 2013 federal law that created new requirements for the pharmacies.

PharMEDium doesn’t 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.

“It’s 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.

That’s the case with Mayers Memorial Hospital District in Shasta County, whose chief clinical officer Keith Earnest said it hasn’t used PharMEDium’s 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.”

This story also ran on Los Angeles Times. This story can be republished for free (details).

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Pauline Bartolone: [email protected], @pbartolone


Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Tagged with:

About author

Related Articles