Compounding Pharmacy Violated License

More troubles for the compounding pharmacy that produced thousands of contaminated vials of a steroid injection blamed for the fungal meningitis outbreak that has spread to 12 states, sickened 205 patients and killed 15 more. Public health officials now say that the New England Compounding Center was operating in violation of its Massachusetts board of pharmacy license, producing thousands of vials of steroids at a time instead of in response to individual prescriptions.

"Our statutory and regulatory requirements stipulate that compounding can only be conducted upon receipt of a patient-specific prescription," says Madeleine Biondolillo, MD, director of the state division of health care quality. "NECC under Massachusetts board of pharmacy licensing regulations was licensed to deliver compounded products in response to individual patient-specific prescriptions. And it looks through the investigation as though they have violated that aspect of the state licensing regulation despite their assertion that they were operating under the regulations."

This isn't the first time New England Compounding has been implicated in below-standard compounding procedures. In 2006, the compounding pharmacy received a warning letter from the FDA regarding concerns about the scale of production and potential health risks, particularly with injectable sterile drugs.

NECC has ceased operations and recalled all of its products, including the steroid methylprednisolone acetate, which is believed to be the source of the fungal meningitis outbreak. NECC declined to comment on specific accusations, saying in a statement that its "intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations."

  • More deaths, more affected patients. There are now 205 meningitis cases and 15 deaths in 12 states — Illinois, Idaho and Texas (1 case each); North Carolina (2); Ohio (3); Minnesota and New Hampshire (4); New Jersey (8); Florida (10 cases/2 deaths); Maryland (15/1); Indiana (28/2), Virginia (34/1), Michigan (41/3) and Tennessee (53/6). "Several of these patients also suffered strokes that are believed to have resulted from their infection[s]," says the CDC, and of the 205 cases, 2 are fungal joint infection identified over the past week. Twenty-three states have received lots of methylprednisolone acetate.

  • Recall expanded. The CDC and FDA are coordinating to conduct a multi-state investigation of cases of fungal meningitis among patients who received an epidural steroid injection with a potentially contaminated product. The investigation has now been expanded to include fungal infections from other steroid injections. In addition, "out of an abundance of caution, CDC recommends that patients cease use of any product produced by [NECC] until further information is available."
  • Ameridose potentially implicated. "Based on the business relationship between NECC and Ameridose, FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on October 10," says the state health department. "As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility." At this time, there's no known contamination of products produced by Ameridose.
  • First lawsuit filed in Minnesota. A Minnesota woman who underwent steroid injections to relieve pain in her neck has filed suit against NECC, saying she was injected multiple times with the contaminated compound. The claim was filed in federal court Thursday on behalf of Barbe Puro of Savage, Minn., by the law firm of Sieben, Grose, Van Holtum, and Carey, according to a news report. Ms. Puro is seeking damages and the creation of a class of affected state residents to proceed with a class-action suit.
  • Outbreak not over. Approximately 14,000 patients are thought to have been exposed to the potentially contaminated preservative-free methylprednisolone acetate. The CDC says more than 12,000 of them have been successfully contacted. According to Benjamin Park, MD, medical officer for the CDC, the time from injection to onset of symptoms tends to be about 2 weeks. However, "the longest we have is about 42 days," he says. "We want to emphasize that we don't know what the longest will be, so we don't quite know at this point how long people need to be vigilant for." Essentially, says J. Todd Weber, MD, incident manager of the CDC's investigation, "We are not out of the woods yet."

    Stephanie Wasek

  • How Durable is Hip Resurfacing?

    Women who have hip resurfacing surgery are 5 times more likely to see the implants fail than those who undergo traditional total hip arthroplasty, according to a British study. Additionally, implants with smaller femoral heads tend to fail more than larger ones do.

    For the study, recently published in the Lancet journal, researchers at the University of Bristol reviewed data from 434,560 hip operations between April 2003 and September 2011 in the National Joint Registry for England and Wales, 7.3% of which represented hip resurfacings.

    While male patients whose resurfacing implants sported larger femoral heads saw 7-year post-op success rates roughly equivalent to patients of other hip replacement options, researchers ascertained that resurfacing's metal-on-metal implants failed female patients (regardless of femoral head size) earlier and more often than other options, as it did with smaller-headed implants.

    The study's authors suggest that the risks and benefits of hip resurfacing versus other joint replacement options be carefully assessed for each patient. In light of the "unacceptably high" female failure rate, however, orthopedic surgery professor Ashley Blom, MBChB, MD, PhD, FRCS, FRCS, notes that "we recommend that resurfacing procedures are not undertaken in women."

    David Bernard

    Nurses Know Quality Care

    Hospital leaders don't need to look any further than their nurses for an accurate barometer of the quality of care their facilities provide, according to a study in the journal Research in Nursing and Health.

    Researchers at the University of Pennsylvania School of Nursing in Philadelphia examined quality measures, including life-threatening surgical complications, reported by more than 16,000 nurses from nearly 400 hospitals in 4 states. Then they compared them to the hospitals' actual outcome measures and feedback from patients about the care they received.

    The nurses' assessments closely matched measured data, according to the study, leading the researchers to conclude that nurse-reported quality of care is a useful indicator of hospital performance.

    The study's lead author, Matthew McHugh, PhD, JD, MPH, RN, CRNP, says nurses have unique perspectives on patient-provider interactions, use of technology and how well patients and their families are educated about the care they received and required follow-up care once they're home — insights that don't show up in medical records, but often mean the difference between positive and negative care outcomes.

    "For a complete picture of hospital performance, data from nurses is essential," says Dr. McHugh, an assistant professor of nursing and public health policy expert at Penn. He says nurses' assessments of quality are built on more than an isolated encounter or single process. "They are developed over time through a series of interactions and direct observations of care."

    Daniel Cook

    InstaPoll: What Do You Wish You Knew More About?

    You have to wear many hats in and oversee many facets of your facility. From clinical outcomes to safety to infection prevention to purchasing, the buck stops with you. Tell us in Outpatient Surgery Magazine's InstaPoll what area of surgical facility management you wish you knew more about.

    Last week we asked: How has the meningitis outbreak changed your opinion of custom compounding pharmacies? The results, based on 316 responses:

    • It was an isolated incident, and I'll continue to use my compounding pharmacy. 32%
    • I'll only use a compounding pharmacy to obtain drugs that are in short supply. 27%
    • Now I'll never use a compounding pharmacy. 12%
    • This news is making some of our pain management patients cancel. 15%
    • Doesn't affect me one way or the other. 14%

    Dan O'Connor

    News & Notes
    • Hospira recalls Lactated Ringer's The FDA and Hospira have announced a voluntary, user-level recall of 1 lot of Lactated Ringer's and 5% dextrose injection. In one case, a leak has been identified and confirmed in the primary container between the cobra cap and fill-tube seal; a spore-like structured particulate, consistent with mold, was noted in the solution. The overwrap on the primary container isn't sterile, so if the primary container has a leak, leaked fluid could become contaminated, then reintroduced to the primary container. The affected product is Lactated Ringer's and 5% Dextrose Injection, USP, 1000mL, flexible container, NDC 0409-7929-09, batch 12-160-JT (the lot number may be followed by 01 or 90). The affected lot was distributed in every state except Alaska between January and June, and it expires December 1, 2013. For more information or to report an incident, see the FDA's safety alert.
    • Risks of work-life imbalance Administrators, take note: Healthcare employees who described high levels of conflict between their work hours and family demands are doubly likely to suffer musculoskeletal injuries, according to a study published online in the American Journal of Industrial Medicine.
    • Cooperation controls MRSA Neighboring hospitals that test all patients for methicillin-resistant Staphylococcus aureus upon admission and implement contact isolation practices on patients who test positive decreases the spread of infections across neighboring facilities, even those that did not employ isolation tactics, according to a study in the October issue of the journal Health Affairs. "Hospitals are rarely isolated islands and instead share patients extensively with other hospitals in their area, which can facilitate the spread of MRSA infections," says the study's lead author, Bruce Lee, MD, MBA, director of public health computational and operations research at the University of Pittsburgh. "The more that hospitals work together and coordinate infection-control efforts, the more they all benefit."