Hospitals say local patients not at risk from recalls

The head pharmacists at Kalispell Regional Healthcare and North Valley Hospital said Wednesday that a total of 38 patients received injections of products from New England Compounding Company but none have been implicated as related to a nationwide meningitis outbreak.

Neither hospital purchased and no patients received the preservative-free steroid products linked to the fungal meningitis outbreak that has affected 233 people and led to 15 deaths across the country. Both hospitals removed the company’s products from their shelves in early October.

Officials at the Montana Department of Public Health and Human Services sent an e-mail Wednesday asking Montana clinicians to notify any patients  injected with products from the compounding company referred to as NECC and to ask if they experienced complications.

“While there is no indication that contaminated products came to Montana, all products from NECC were recently recalled out of an abundance of caution,” a press release from the agency said.

Mark Donaldson, director of pharmacy services at Kalispell Regional Health Care, said the two hospitals purchased a limited number of drugs. He said his pharmacy purchased one product, sulfan blue, a dye that 33 patients received. 

“It is a physiologically inactive blue dye typically used for imaging studies and given as a subcutaneous injection,” Donaldson said. “So the potential for it to cause meningitis is basically zero.”

According to Donaldson, the hospital’s electronic record-keeping made it simple to track the drug and all patients who received it. The dye was used during breast cancer surgery to better image sentinel nodes. 

“We used to have methylene blue but then we contracted with NECC because they could produce the analogue called sulfan blue at a cheaper price point with a nice pedigree as well, so I felt very comfortable,” he said. “That relationship has been in place for a number of years.”

Harley Brotherton, director of pharmacy at North Valley Hospital, said that facility also purchased sulfan blue but hasn’t used any for over a year. The hospital also purchased metamycin, a chemotherapeutic agent installed “intravascularly” into the bladder to treat prostate cancer.

“We’ve had five patients that have received that here,” he said. “Again, it is not on the list of products that are being implicated. It’s a cytotoxic chemical agent designed to kill cells.”

Both pharmacists said one physician at each facility used those products and will contact patients as soon as possible. No patients at either facility have reported any problems related to injections of these drugs.

Reportedly, no health-care facilities in Montana purchased the preservative-free methylprednisolone acetate originating from New England Compounding Center and linked to the fungal meningitis outbreak. Brotherton and Donaldson said in earlier interviews that patients who received steroid injections for back pain or other conditions don’t need to worry.

“We don’t have any of the product here,” Brotherton said. “We never ordered that product. None of our patients have been exposed.”

Donaldson said he removed the sulfan blue from the inventory on Oct. 5, just before the recall notice when a problem linked to the company was announced. Brotherton removed the blue dye and metamycin on Oct. 6.

“We want to be as transparent as possible and let the public know that we always have their best interests at heart,” Donaldson said. “They’re reading things in the grocery lineup that they may be concerned about so we want to be sure they get the right message.”  

Donaldson was surprised by the suspected problem at the compounding company because he said it must comply with standards called Good Manufacturing Practices and continuous quality improvements to maintain its llicensure as a specialty pharmacy.

“I know even when we bought that blue dye from them, every four months, they would send us a pretty thick document that illustrated their contamination risk,” he said. “They do a lot of quality control.”

He added that it was unlikely that the blue dye was manufactured in the same area as the methylprednisolone. Because the blue dye has no physiological effect on the body, the production standards would be different. 

Donaldson described methylprednisolone as an injectable form of prednisone. Physicians use the drug for injections into the spinal cord (called intrathecal) for pain relief as well as for its anti-inflammatory effect.

“Let’s say for example that you tweaked your back, you slipped a disc or something,” he said. “To try to get that area to settle down, because it’s inflamed, you give an anti-inflammatory.

Donaldson said any drug injected directly into the spinal track must be free of binders, stabilizers or preservatives. It’s a purer form of the drug.

He said the Montana Center for Wellness and Pain Management does a small volume of these procedures. For those patients, the pharmacy orders a commercially prepared product rather than a pharmacy-compounded version.

“We order it from Pfizer,” he said.

Brotherton said that North Valley Hospital also orders its methylprednisolone product called Depo-Medrol from Pfizer as well. He added that physicians administer the shots in a sterile room with the patient properly draped to prevent contamination during the procedure.  

“We have a very controlled environment,” he said. “We’ve never had a problem.”

 Donaldson said the Centers for Disease Control in collaboration with the FDA has been investigating the source of the fungal meningitis outbreak linked to the steroid injections. Investigators isolated it to three lots of the drug manufactured on particular days. 

“It’s one of those just perfect storms where something must have happened in that time frame,” he said. 

He said hospitals and other medical facilities most often use drug compounding pharmacies to obtain custom concentrations of medications for certain patients.

“A really good example are our oncology or cancer patients if they suffer from a high degree of pain that can’t be addressed by commercially available concentrations of narcotics,” Donaldson said. “You’ll go to a specialty pharmacy to make up a higher concentration in order to control that patient’s pain. That’s probably the most common one we see.”

Reporter Candace Chase may be reached at 758-4436 or by email at cchase@dailyinterlake.com.