Chemo guidelines expose new risks, raise awareness

ASHP's revised guidelines on the handling of hazardous pharmaceuticals could not have come at a more opportune time. As chemotherapy agents become more powerful and chemotherapy administration shifts from the inpatient setting to physician offices and infusion centers, controlling occupational exposure to hazardous drugs has taken on a new urgency.

The guidelines are based on a growing body of scientific knowledge indicating that a new group of workers may be at risk. The guidelines reveal that mere exposure to cytotoxic and hazardous agents could harm workers at various points along the supply chain, including: manufacturing, transport, distribution, receipt, storage, and preparation.

A new body of evidence indicates that just being in the environment puts people at risk, said Luci Power, M.S., senior pharmacist and manager of parenteral support services at the University of California, San Francisco Medical Center and lead author on the revised ASHP guidelines on the handling of hazardous drugs. "The literature shows that it's not just the people who make the chemo that find traces of the drug in their urine but also people who are not immediately involved in its preparation or administration, such as housekeepers," she noted. According to ASHP's guidelines, exposure to these drugs in the workplace has been associated with acute and short-term reactions as well as long-term effects.

At Cardinal Health, hazardous drugs are flagged in a master item file and then consolidated into a single area within the warehouse. Cardinal's shipping protocol requires that hazardous agents be poly-bagged so if the package should break in transit, the spill would be contained. A prominent warning label is also attached to the shipping container so that chemo therapy drugs, for example, are easily identified by hospital personnel. "We do this for two reasons: to protect our employees during the pick, pack, and ship process and to protect the hospital employees should something break," said Steve Reardon, VP, quality and regulatory affairs for supply chain services at Cardinal.

"We are concerned about all the people in the chain of drug handling, including the person who receives the drug-not just the preparer and person who administers the drug," said Power.

Power pointed out that the guidelines protect the safety of the employee as well as the patient. And because chemotherapy agents are frequently linked to medication errors, the handling precautions are even more crucial.

So far the reaction to the revised guidelines by veteran pharmacists who work with chemo and other hazardous drugs has been generally positive. Sylvia Bartel, Pharm.D., director of pharmacy at Dana Farber Cancer Institute, Boston, said the guidelines had good references and the authors did a nice job of compiling what's been published in individual papers. "It's a good reference tool," she said, adding that the guidelines do a good job of addressing issues such as ventilation controls and protective equipment."

Bartel noted that in the future she would like to see the guidelines target oral chemo agents in the retail setting as well as patient education. "What happens when a patient gets home, particularly pediatric patients who require special interventions by the family?" Bartel pointed out that often family members have to draw up doses of a liquid chemo agent and that they need to know how, for instance, to properly wipe the counter down where they are preparing the chemo agent. Bartel noted that this presents a great opportunity for pharmacy intervention. "This would be a great role for pharmacists-to educate family members," Bartel said.

Industry observers acknowledge that there's a significant amount of contamination in the workplace. The revised guidelines are expected to increase that awareness. "This is an old problem that has not been solved," explained Power. "We continue to have this exposure and we need to address it."