COMMUNITY PRACTICE

Dilution case brings talk of more regulations

Most pharmacy observers agree that regulations couldn't have stopped a Missouri pharmacist from allegedly diluting chemotherapy drugs for profit. But a leading patient medication safety advocate has called for more oversight of the preparation of sterile IV drugs.

Pharmacy boards need specially trained surveyors to keep tabs on facilities that prepare chemotherapy and other sterile drugs, according to Michael Cohen, founder/president, Institute for Safe Medication Practices (ISMP). And there should be a national accreditation program for pharmacies and physician offices to make sure proper safety checks are in place.

"We need to properly train surveyors from the state pharmacy boards to provide oversight if we are going to be pushing more and more patients into the outpatient arena," Cohen said. "There must be certain standards, and they must be monitored—whether it's by the state board of pharmacy, the Joint Commission on Accreditation of Healthcare Organizations, or the state board of whatever."

The current practice standards of the state pharmacy boards are adequate to provide sufficient oversight of sterile IV and injectable drugs in pharmacies, countered Carmen Catizone, executive director, National Association of Boards of Pharmacy. What allegedly happened in Kansas City was fraud to take advantage of the system, and "no regulation is going to prevent something like that," he added.

More regulations may not be necessary, but having the profession take a look at standards of practice would not be a waste of time, according to Susan Winckler, group director of policy and advocacy, American Pharmaceutical Association.

The Kansas City drug dilution case may be a "red flag" that will prompt pharmacy boards to take a closer look at regulations, said Massachusetts' pharmacy board executive director Charles Young. However, he added, "I think we've all tried to be very responsible about drafting regulations to protect the public. Maybe we need to start developing regulations that require close quality control checks in the process."

Allowing nurses or other personnel to prepare chemotherapy drugs in physician offices and clinics is a growing trend that has many in pharmacy wondering whether there's a hole in the patient safety net. Such practices are beyond the regulatory reach of pharmacy boards. It's especially troubling when only one person handles the entire process, said ISMP's Cohen.

"I'd sure want to know that at least two individuals at a doctor's office are providing independent checks and documenting those checks," Cohen said. "There's no oversight of preparation of these toxic drugs outside of the hospital."

While the Washington pharmacy board works with the medical and nursing boards on occasion, the role of nurses in IV preparation has not been discussed, said executive director Donald Williams. "We are not allowed to regulate what physicians do in their offices," he added. "This is the responsibility of the state medical board. I have no confidence that these other boards are doing a good job of regulating IV preparation in facilities that have no pharmacist. Other boards respond only to specific complaints; they do not inspect their licensees."

Small rural hospitals without a full-time pharmacy that let nurses or other personnel prepare drugs are a concern to the Iowa pharmacy board, said executive director Lloyd Jessen. The board is mulling over how to gain more regulatory oversight in those facilities. But there's not much the board can do about what goes on in physician offices or oncology centers.

"They can have nurses prepare the drugs, because it's the practice of medicine," Jessen said. "We're not aware of any bad things happening, but we want to make sure things don't fall through the cracks in some areas where nobody is looking."

Carol Ukens

Carol Ukens. Dilution case brings talk of more regulations.

Drug Topics

2001;18:29.