Fungal Outbreak May Still Threaten NJ Patients, Nine Months Later

Andrew Kitchenman | June 24, 2013 | Health Care
Uncertainty reveals shortcomings, frustrations associated with state healthcare system

Dr. Barbara Montana, medical director of the state Department of Health communicable disease service.
Nine months after more than four dozen New Jerseyans got sick from the largest healthcare-associated fungal outbreak in U.S. history, state officials still aren’t sure if there will be more cases.

That is one of several open issues that continue to be monitored concerning the incident, which led to a range of illnesses including fungal meningitis and strokes.

“Patients are still at risk, even though it’s many months after the incident,” said Dr. Barbara Montana, the medical director for the state Department of Health communicable disease service.

The outbreak, which began last September due to contaminated steroid products from Massachusetts compounding pharmacy New England Compounding Center (NECC), led to 51 New Jersey residents becoming ill, including some who have suffered long-term damage.

Montana discussed the response to the outbreak at an event focused on reducing healthcare-associated infections hosted by the Healthcare Quality Professionals of New Jersey at the New Jersey Hospital Association office in West Windsor.

The steroid products were used in injections in six New Jersey facilities. The infections were concentrated at two Cumberland County centers.

The longest time thus far recorded between a New Jersey patient receiving an infected shot and becoming sick is 228 days, according to state officials. This extended period has made it a challenge to keep track of all of the patients who received the shots.

“Patients are dispersing and people are becoming less aware of this problem as time goes on,” said Montana, who was deeply involved in the state response to the outbreak.

“This was incredibly complex to deal with — the disease was complex, the situation was complex, there were a large number of individuals who were impacted and it really required rapid patient notification and identification,” Montana said.

Montana noted several troubling issues that have surfaced in the wake of the outbreak, such as the lower level of regulatory oversight that compounding pharmacies receive.

These companies are supposed to develop medications that are customized to meet the specific needs of patients, such as those with allergies. But they increasingly make a wide variety of products, while continuing to be regulated by state boards of pharmacy rather than the U.S. Food and Drug Administration.

“Anything that’s manufactured by a [pharmaceutical] company has to follow the FDA regulations for good manufacturing practices. These don’t follow those guidelines,” Montana noted.

New Jersey compounding pharmacy Med Prep Consulting of Tinton Falls shut down its operations in March and has remained closed after Connecticut found that some of its products appeared to be contaminated. No illnesses were linked to that case.

Recalling the NECC products and notifying patients also were challenges for the state, Montana said. “Tracking this stuff down really become quite complicated and some places didn’t do a good job in taking it off the shelves and people were exposed after the recall,” she said.

She noted that while federal law requires that all vaccines be labeled with their lot numbers to make them easier to track, this isn’t true for other injectable medications.

The outbreak proved to be a challenge to several aspects of the health system, including the ability to inform patients and doctors quickly about the seriousness of the problem. Doctors who weren’t familiar with fungal meningitis questioned the state recommendation to put patients on powerful antifungal drugs that have may have severe side effects.

“We were telling docs to do things with really no evidence that [what] we were telling them was the right thing to do, and we got pushback from the docs who were treating these patients,” Montana said. “We kept saying, ‘Yeah, but you know, we think that these people could get a stroke tomorrow.’ ”

Some of the cases took many weeks to treat.

Montana described the case of a 72-year-old woman who became ill 15 days after receiving an injection in her back . While she improved and was released after 11 days of treatment in a hospital, she had to be hospitalized again 36 days later. She was finally discharged 71 days after the original injection.

The New Jersey Board of Pharmacy also has proposed a series of revisions to its compounding pharmacy regulations, and Sen. Jeff Van Drew (D-Atlantic, Cape May and Cumberland) proposed a bill, S-3265, requiring the pharmacies to follow national standards.

In addition, the outbreak has put a spotlight on the widespread use of steroid injections as a way to relieve inflammation and pain, even when the effectiveness of the shots hasn’t been proven. More than 2 million Medicare beneficiaries receive steroid injections each year.

Another continuing mystery from the outbreak is the widely varying “attack rates,” the percentage of patients who received the shots who became ill. They ranged from 17 percent in North Carolina to less than 1 percent in Pennsylvania.

At roughly 7 percent, New Jersey had the fifth-highest percentage of patients who suffered illnesses. Nationally, 745 people became ill and 55 people died from the injections. No New Jerseyans have died.

“People struggle with this, why are states seeing different attack rates?” Montana said. Potential causes of these different rates include the age of the vials and the levels of contamination of the vials.