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7/13/2001

Meningitis Deaths Linked to Drug Shortage

Kate Traynor

A series of events that led to the deaths of three San Francisco Bay-area patients seems to have its roots in a national problem—the shortage of injectable corticosteroids.

All three patients contracted bacterial meningitis after receiving epidural injections of betamethasone at the Sierra Surgery Center, an outpatient unit of the John Muir/Mt. Diablo Health System in Walnut Creek. A physician, unable to obtain Schering-Plough Corp.’s Celestone Soluspan, had a batch of betamethasone prepared at a nearby compounding pharmacy, where the contamination purportedly occurred. More than 12 people were treated with the contaminated material in May.

"Use of the compounded product was a result of the shortage," said Martin K. Iyoya, Pharm.D., FCHSP, pharmacy director for the health system.

In May, Schering-Plough limited its distribution of betamethasone for injection to labor and delivery settings, making the product unavailable for other uses. As usual when a drug product becomes unavailable, Iyoya’s staff provided the medical staff with a list of alternative products.

But betamethasone is not the only injectable corticosteroid for which pharmacists need to find alternatives. National shortages of dexamethasone sodium phosphate and methylprednisolone sodium succinate have been reported this year.

Patricia Harris, with the California State Board of Pharmacy, said its investigation into the patient deaths did not address the betamethasone shortage. "We weren’t even dealing with the issue as to why they were compounding it," she said.

ASHP’s Joseph H. Deffenbaugh, M.P.H., who monitors reports of drug product shortages, is not surprised that compounding is sometimes seen as a solution to the supply problem.

"Patients are in need," he said. "Physicians are frustrated. They expect pharmacists to prepare and have available products even though commercial sources are not available."

Plans are now afoot in the California state legislature to regulate the preparation of sterile products in pharmacies.

State Sens. Tom Torlakson and Liz Figueroa met with members of the board of pharmacy and the California Pharmacists Association (CPhA) in late June to discuss oversight of pharmaceutical compounding. Carlo Michelotti, M.P.H., with CPhA, said two ideas—licensure of pharmacies that compound and professional oversight of compounding—are being debated.

Harris, from the board of pharmacy, speculated that the legislation would require "separate licensure for pharmacies that do [sterile] compounding."

California Society of Health-System Pharmacists' Teresa A. Miller, Pharm.D., said before a mid-July meeting with the senators that she would urge for "giving 'deemed status' to any pharmacy" accredited by the Joint Commission on Accreditation of Healthcare Organizations.

Michelotti, however, favors professional oversight instead of licensure. Sterile compounding, he said, is done by "sophisticated pharmacists" who understand the complexities of the process.

Although John Muir/Mt. Diablo now has strict policies regulating the use of compounded products at the health system’s facilities, Iyoya believes that most compounding is done properly. "I think, for the most part, the pharmacies are doing their best to provide a safe environment.... I have faith in my profession."