Area, too, had deadly link to ‘compounding’ pharmacy

BY JIM HALL

The first person to become sick was a man in his 50s, who arrived at a hospital in Tennessee last September, complaining of headache and neck pain.

The man was discharged from the hospital after several days, then died after being re-admitted.

The man had a rare fungal infection, caused by a spinal injection he had received weeks earlier. Instead of offering relief for his back pain, the medicine had poisoned him.

Soon hundreds more people in several states became sick, and dozens died. And now there is legislation proposed at the state and federal levels to prevent it from happening again.

The cause of the problem was a contaminated drug, methylprednisolone acetate, made by a compounding, or speciality, pharmacy in Massachusetts.

The New England Journal of Medicine described the fungal meningitis outbreak as “unprecedented.” However, residents of the Fredericksburg area could be forgiven for thinking they’d seen it all before.

Fredericksburg and Mary Washington Hospital were the focus of a similar tragedy in 2005. As in Massachusetts, the incident involved a compounding pharmacy, contaminated medicine and patient injuries and death. And again, there were questions and accusations.

“If you do it right, it should not be contaminated. I just don’t understand how stuff like that happens,” said John Fick, a former pharmacist and now chairman of the board of trustees at Mary Washington Healthcare.

In September 2005, Mary Washington announced that it was voluntarily stopping all elective heart surgeries after two patients became ill and one died.

At first, hospital officials couldn’t figure out what was wrong. Then they realized that one of the medicines used during heart bypass surgery, called cardioplegia, was contaminated with bacteria.

Mary Washington had purchased the medicine from a compounding pharmacy, which mixed it to Mary Washington’s specifications. The company was Central Admixture Pharmacy Services, or CAPS.

The U.S. Food and Drug Administration issued an “urgent drug recall” for several of CAPS’ medicines, and the company closed the Maryland plant where it made Mary Washington’s medicine.

When FDA inspectors visited the plant, they found bacteria throughout. Bacteria were in a water container used for cleaning, in test tube holders, and in spray bottles that were supposed to contain sterile water.

Later, the FDA told the company that inspectors found untrained workers, sloppy production methods and ineffective supervision at its plants in Alabama, Missouri, Pennsylvania and Maryland.

In local courts, former patients at Mary Washington and their survivors filed suit. The suits claimed that six patients died and four were injured by the contaminated medicine.

In 2007, CAPS reached out-of-court settlements with the plaintiffs. Many of the details were sealed, though the company was forced to reveal that it paid at least $5.5 million to plaintiffs.

In Massachusetts last fall, the New England Compounding Center in Framingham shipped three lots of what were discovered to be contaminated injectable steroids.

The company eventually closed the plant and recalled the medicine. In October, it expanded the list of recalled medicines, after the FDA and the Centers for Disease Control and Prevention found contamination in its plant and in unopened vials of its cardioplegia and other medicines.

To date, 48 people have been killed by the company’s medicine. More than 700 people have been injured in 20 states.

In Virginia, cases have clustered around an imaging center in Roanoke and a surgery center in Christiansburg. In all, 52 people in Virginia were injured by the contaminated steroid. Two people died.

“We certainly are on the lookout, but we’re not aware of any illnesses attributed to the other products that were recalled,” said Dr. David Trump, state epidemiologist at the Virginia Department of Health.

The Virginia General Assembly last week passed legislation imposing new regulations on compounding pharmacies. The rules require out-of-state pharmacies to submit current inspection reports from their home jurisdictions. The bill awaits Gov. Bob McDonnell’s signature.

The federal government is also considering tighter regulations for compounding pharmacies. A proposed bill is now in a House of Representatives subcommittee.

Ironically, Mary Washington was a customer of the New England Compounding Center. NECC was a backup supplier for a drug used by anesthesia personnel during surgery and for an alum solution used by urologists.

“There have been no issues with these two medications,” a Mary Washington spokeswoman said.

As for cardioplegia, Mary Washington has been making its own since the CAPS incident in 2005.

Jim Hall: 540/374-5433

jhall@freelancestar.com

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