Four more meningitis cases in N.J.

That raises the number in the state to eight. The outbreak is fueling calls for more oversight.

Posted: October 14, 2012

TRENTON - New Jersey health officials have linked four more fungal meningitis cases to a nationwide outbreak caused by a potentially tainted medication.

The new cases announced Saturday bring the total in the state to eight.

Among the four new cases, two are women from Salem County. One is a 37-year-old who received a steroid injection Sept. 20, while the other is a 33-year-old who got her injection July 25.

The other new patients are a 77-year-old Atlantic County woman who received a steroid injection Aug. 22 and a 64-year-old Cumberland County man who got his injection Sept. 6.

The patients in the four other cases are all Cumberland County residents. Overall, seven of the patients remained hospitalized Saturday, while the other person was being treated as an outpatient.

Health officials say more than 600 patients in New Jersey received the steroid injection at six facilities across the state between May 21 and Sept. 26, and nearly all of them have been notified that they may be at risk for contracting the illness. However, it's possible that some of these people may have meningitis but not know it because symptoms - which include fever, headaches, neck stiffness, and sensitivity to light - will usually take anywhere from one to four weeks to develop after they receive a tainted injection.

Clinics in Western Pennsylvania reportedly received shipments of the questionable vials, but state health officials have not reported any cases in Pennsylvania.

All eight New Jersey cases got their injections at two of the only three locations in the Philadelphia region that received shipments of the tainted steroid: Premier Orthopaedic Associates in Vineland, Cumberland County, had four cases and South Jersey Healthcare Regional Medical Center in Vineland also had four. The third location, South Jersey Healthcare Elmer Hospital in Elmer, Salem County, has had none.

Nationwide, the drug sold by New England Compounding Center of Framingham, Mass., has been linked to 15 deaths and nearly 200 illnesses.

The meningitis outbreak has prompted calls for tighter federal regulation of compounding pharmacies, which have periodically been blamed for crippling and sometimes fatal injuries. But this isn't the first time Congress has pushed for more authority over the industry.

Such efforts stretch back to the 1990s, and after vigorous pushback by compounding pharmacists, they have left a patchwork of incomplete, overlapping laws, contradictory court rulings, and overall uncertainty about how much power the Food and Drug Administration has to regulate compounders.

With Congress gridlocked, experts don't expect to see new laws passed anytime soon.

Several members of Congress last week promised to introduce legislation giving the FDA greater authority to oversee the specialty pharmacies, which custom-mix drugs for patients for everything from menopause symptoms to cancer. The compounding industry in the United States has grown into a $3 billion business with 7,500 pharmacies, according to its trade group.

"It's incredibly complicated to explain what our authority is and is not, and the nuances of that," Deborah Autor, FDA's deputy regulatory commissioner, said Thursday. She suggested the FDA would support new laws to oversee the industry.

"The world has changed a lot since the days of mortar and pestle, and this is the time for pharmacists, for lawmakers, for regulators, and for doctors to sit down to grapple with this new model of pharmacy compounding," Autor said.

Compounding pharmacies are critical for patients who need solutions, creams, and other medicines customized for, say, smaller dosages or to remove ingredients that cause allergies. Unlike drugs that are manufactured for mass-market distribution, these products are not subject to premarket review by the FDA.

All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards, many of which date back to the 19th century. At that time nearly all drugs dispensed in the United States were individually compounded by pharmacists. The law that created the FDA in 1938 gave the agency strict authority over drug manufacturers, which quickly eclipsed pharmacists as the main producers of prescription medicines.

For decades, the state-federal divide persisted, with states overseeing compounding pharmacies and the FDA policing drug manufacturers.

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