ELKHART — At Elkhart General Hospital, the fight hasn’t stopped.
Just as confirmed cases of fungal meningitis are waning, new infections related to contaminated drugs are trickling in. An epidemic of fungal meningitis that has spread to 19 states over the past two and a half months is still unfolding, according to local health officials.
Patients who were injected with tainted back pain medications are now developing severe infections near their spines, creating a new challenge for doctors who have been battling an illness that has killed 37 people nationally, including six people in Indiana.
“Essentially, clinicians across the country that are managing these patients are continuing to learn as we go,” said Dr. Dan Nafziger, Elkhart County’s health officer. “There isn’t really any precedent for the kind of local infections that patients are coming in with now.”
The first cases of fungal meningitis started springing up this past fall after 75 clinics across the country received contaminated batches of steroid injections from the New England Compounding Center, a pharmaceutical company based in Massachusetts.
In October, OSMC Outpatient Surgery Center in Elkhart contacted close to 400 of its patients shortly after learning that it was one of six clinics in Indiana to receive the tainted medications. Of the 63 cases reported in Indiana, 36 Elkhart County residents have been identified with fungal meningitis and related infections, according to Nafziger. There have been six deaths linked to the Hoosier state, including two people from Elkhart County.
NEW TERRITORY FOR EGH
In the beginning, there were more questions than answers.
“We didn’t know what we were faced with when we heard that there was some contaminated medications that were used as injections locally,” said Karra Heggen, vice president of nursing at Elkhart General Hospital.
Uncertainty loomed as EGH’s medical and pharmaceutical staff scrambled to learn more about fungal meningitis, an illness that the hospital had never encountered before. Patients complained of symptoms including headache, fever, nausea and neck stiffness.
“When the first patient appeared, we were kind of surprised and unsure as to what was really happening,” said Susan Hawes, director of pharmacy at the hospital. “By the next day in the afternoon, we were seeing many, many patients every hour.”
Realizing just how widespread the problem was becoming, the hospital dedicated an entire unit to patients with fungal meningitis. At one point, doctors and nurses were treating as many as 18 patients with round the clock care, Heggen said.
“Everybody just pulled together,” she said.
Hawes checked national reports from the U.S. Centers for Disease Control and Prevention at least three times a day to keep up with the latest recommendations for patients. EGH’s medical staff and pharmacy technicians huddled together three times a week to update each other on patients and treatments.
New challenges seemed to emerge every day, Hawes said. One that popped up early on was a drug shortage at the hospital. EGH does not typically keep large amounts of antifungal medications in stock and only had enough for up to 20 patients. With no end in sight, Hawes said it was obvious the hospital would need more drugs on hand, so emergency batches of medicine were flown in from across the country.
Drug shortages are part of an ongoing conversation Hawes has with doctors at the hospital. She recently made a presentation to physicians about the likelihood of more shortages in the future because of tighter inspections and recalls by the U.S. Food and Drug Administration.
“I think two years ago there were about 140 shortages posted on the FDA’s website, and now there’s about 275,” Hawes said.
Hawes keeps a running list of unavailable medications and other drugs that are in short supply.
“Drug shortages caused this problem and now because of this problem, drug shortages will probably become more severe,” she said. “New England Compounding was providing a lot of people with medications throughout the country, and with this, they had over 2,000 customers. Now they don’t have that option.”
Overall, Heggen feels EGH’s response to the outbreak has been successful, citing teamwork among the hospital’s staff with the county and state health departments.
“Being newer to the community and to the hospital, it made me thankful to be part of a team that works so well together and that the medical staff and pharmacy worked as a team to provide really great care,” she said.
There have been roughly a dozen lawsuits filed in Elkhart County against the New England Compounding Center on behalf of fungal meningitis patients and more are expected to be filed by the end of the year.
On a national level, Nafziger hopes to see more regulation of compounding pharmacies.
“I didn’t go to the congressional hearings, but from what I’ve heard in the national news, it sounded more like people pointing fingers at the FDA rather than congressional leaders stepping up to try to regulate this industry to protect patients,” Nafziger said. “I realize that regulation is a dirty word in some people’s vocabularies, but here we have hundreds of patients who have been severely impacted nationally and dozens of patients that have died, and it not clear to me that our government has done anything to be more sure that the next outbreak doesn’t happen.”
Hawes pointed out that compounding pharmacies serve an important role in producing medications that patients cannot get from large drug manufacturers. But in the case, she explained, the New England Compounding Center was illegally selling mass amounts of back pain steroids to clinics rather than limiting the medications to individual people with prescriptions.
“I think there needs to be more oversight, and more than likely, it needs to be the FDA looking at it because the FDA has delegated that out to the states which becomes the board of pharmacies who really don’t have the manpower to be responsible for what needs to be done,” Hawes said. “There are definitely going to be changes coming and there should be.”