Page 72

70

back pain (22). Fewer patients who received steroid injections in their joints became infected, but those who did experienced increasing pain for several months after injection (22). Initially, the CDC and the FDA recommended aggressive treatment with the antifungal agents voriconazole and liposomal amphotericin B for 3-6 months, based on the Aspergillus fumigatus infection diagnosed in Thomas Rybinski. Unfortunately, the high doses of amphotericin B required to clear the spinal infection caused a host of adverse reactions and drug-drug interactions (22). In view of this, and the discovery that Exserohilum rostratum was the primary culprit, the treatment regimen was modified in favor of monotherapy with voriconazole (22). Although voriconazole is usually well tolerated, it caused adverse reactions at the doses needed to treat fungal meningitis. So, the sickest patients and those who had substantial side effects from voriconazole were given liposomal amphotericin B alone or in combination with lower voriconazole doses (22).

Poor Prognosis Eventually, the CDC compiled 753 cases of infection and reports of 64 deaths spread across 20 states, all traced back to NECC’s contaminated methylprednisolone acetate (21). Although the first reports came from Tennessee, Michigan was hit hardest, with 264 cases and 19 deaths (2, 17, 21). About half of the victims developed fungal meningitis, and more than 30 suffered a stroke. The other half acquired joint or spinal infections (13, 20). Interestingly, no infections or deaths were reported in Massachusetts, where NECC was located.

The CDC compiled 753 cases of infection and reports of 64 deaths spread across 20 states, all traced back to NECC’s contaminated methylprednisolone acetate For many of those who survived meningitis, recovery was long and painful due to residual effects of the initial fungal infection, adverse drug reactions, or both (22). Some suffered blinding headaches and burning pain (19, 24). Two years after receiving the

Reprinted from The Pharmacologist • June 2017

contaminated steroid for back pain, one woman told reporters, “My head is always in a vice. Even if I get the pain under control with medication, I still feel the grip” (24). In Howell, Michigan, 64-year-old John Nedroscik struggled to recover and experienced nightmares (24). In Nashville, 71-year-old Joan Peay recovered after contracting fungal meningitis in the fall of 2012 (2). But a year later, she was again in the hospital with meningitis. “The whole month of October my family thought I was going to die. And I was so sick I wish I would’ve” (2). As a result of the recurring infection, Peay suffered hearing loss and still deals with the back pain that brought her to the clinic in the first place. She looks and feels 10 years older than her age, but she says she has learned to cope with the lingering consequences of her infection and treatment (2).

Cracking Down The widespread injuries and deaths from NECC’s contaminated drugs focused public attention on compounding pharmacy practices. State pharmacy boards and national pharmacy organizations strengthened their oversight of drug compounding and increased their pharmacy inspections. The National Association of Boards of Pharmacy and state pharmacy boards began coordinating efforts to ensure regulatory compliance of compounded drugs shipped across state lines (9). Public pressure also prompted Congressional hearings. In testimony before the US House of Representatives, FDA Commissioner Margaret Hamburg and FDA Center for Drug Evaluation and Research Director Janet Woodcock both cited the confusing and conflicting statutory constraints that complicated FDA’s ability to regulate large compounding pharmacies such as NECC (10). “We believe there are hundreds of other firms operating as compounding pharmacies, producing what should be sterile products and shipping across State lines in advance of or without a prescription,” Woodcock said (10). The FDA’s lack of tools for oversight and/or enforcement had resulted in a string of unnecessary patient injuries and deaths of which the NECC incident was only the most recent example. On November 27, 2013, the Compounding Quality Act (which was part of the Drug Quality and Security

Profile for ASPET

2018 Special Compilation Issue of The Pharmacologist  

ASPET is pleased to present the second in a series of special editions of our quarterly news magazine, The Pharmacologist. This special com...

2018 Special Compilation Issue of The Pharmacologist  

ASPET is pleased to present the second in a series of special editions of our quarterly news magazine, The Pharmacologist. This special com...