New Nevada regulations driving Botox costs out of patient reach
LAS VEGAS — A hepatitis C outbreak in southern Nevada has prompted the state’s governor to enact new regulations barring practitioners from administering medications from single-dose vials to multiple patients. Although investigators didn’t specifically target Botox (botulinum toxin A; Allergan, Irvine, Calif.), local cosmetic surgeons say that the rule has driven Botox costs out of reach for many patients while spotlighting long-standing confusion over Botox’s labeling.
SYRINGE AND MEDICATION REUSE
At the center of the controversy sits the now-closed Endoscopy Center of Southern Nevada, reports Ihsan Azzam, M.D., M.P.H., Nevada State Health Division (NSHD) epidemiologist. In December 2007, the Southern Nevada Health District (SNHD) contacted him to report two cases of acute viral hepatitis C in patients who had outpatient procedures at this center within one to three months of disease onset. Shortly after these reports, an investigation conducted jointly by the SNHD, the Centers for Disease Control and Prevention (CDC) and the NSHD’s Bureau of Licensure and Certification found that clinic staff had been reusing syringes and single-use medication vials on multiple patients.
At press time, the investigation had uncovered a total of eight acute hepatitis C cases, seven of which were linked to the endoscopy clinic, Dr. Azzam reports. “On February 27,” he adds, “SNHD mailed a mass notification to patients who had undergone procedures at the facility from March 1, 2004, through January 11, 2008.” Subsequently, health officials tested approximately 50,000 at-risk individuals for blood borne pathogens including hepatitis C and B and HIV, and identified 77 additional chronic (asymptomatic) hepatitis C cases whose only risk factor is the clinic, says Dr. Azzam. All told, he adds, 500 patients tested positive for hepatitis C.
In response to these findings, Nevada Governor Jim Gibbons issued emergency regulations for ambulatory surgery centers, emphasizing the importance of following accepted infection control standards. On June 20, Nevada’s Board of Health adopted the regulations as permanent. Next, they will go before the Nevada Legislature’s Legislative Committee, although no date has been set, says Lorne Malkiewich, chief of Nevada’s Legislative Counsel Bureau. Barring unforeseen circumstances, he says, the legislature likely will approve the regulations without objection.
Additionally, the NSHD issued a bulletin saying all health care providers must not administer medications from single-dose vials to multiple patients. When it comes to injection safety, says Dr. Azzam, “I don’t know why additional regulation would be needed. If a vial is labeled single-dose, it must be used as a single dose, regardless of its contents.”RISK ASSESSMENT
“Most doctors know there is a risk from drawing up any injectable medication from multi-use vials,” says Joseph Niamtu, III, D.M.D., a Richmond, Virginia-based cosmetic facial surgeon who serves on the Cosmetic Surgery Foundation’s board of directors. Even with sterile syringes, he says, “Mistakes happen, and someone inadvertently picks up a contaminated syringe and inoculates the entire vial.”
