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NIOSH to publish safety alert related to cytotoxic drugs
NIOSH, the National Institute for Occupational Safety & Health, is putting the final touches on a dangerous-drug alert. With the working title of "Occupational Exposures to Hazardous Drugs in Health Care Settings," the alert warns that working with common pharmaceuticals can be hazardous.
"We wanted to let people know that there is a potential hazard in the workplace," said NIOSH industrial hygienist Edward Burroughs, who directs the group preparing the alert. "New data on residual contamination by antineoplastics sparked the alert, but we are going beyond chemotherapy to include a broad range of potentially hazardous drugs."
Drugs covered in the alert will likely include common cancer chemotherapeutics as well as antibiotics, immunosuppressives, antivirals, monoclonal antibodies, and other categories. A final draft is scheduled for review by outside experts from pharmacy, nursing, medicine, industry, and other interested parties in May. Burroughs said publication is likely during the next fiscal year.
"I think of working in an oncology clinic as getting secondhand chemotherapy," said Jim Enns, v.p. of marketing for SuperGen, a San Francisco-area based pharmaceutical and biotechnology company. SuperGen makes chemotherapy cleanup kits as well as therapeu- tic products, but Enns backs his secondhand chemo sound bite with research reports stretching back to the 1980s. One of the latest is a 1999 report on cyclophosphamide, ifosfamide, and fluorouracil residues in Canadian and U.S. hospitals. Contamination was found in 75% of pharmacy sites and 65% of patient treatment areas sampled.
"The studies that are most alarming are not that we find it on pharmacy counters," said Robert Dorr, professor of pharmacology at the Arizona Cancer Center and co-inventor of SuperGen's Surface Safe cleanup kit. "Most alarming is testing urine from personnel preparing and administering chemotherapy and finding intact alkylating agents. That is very worrisome," he said.
Outside groups agree. ASHP is revising current guidelines on handling hazardous pharmaceutical products. Luci Power, president, Power Enterprises, and associate professor, University of California, San Francisco, School of Pharmacy, who drafted ASHP's current guidelines a decade ago, heads the revision team.
OSHA, the Occupational Safety & Health Administration, is also updating workplace standards and safety procedures for hazardous drugs. Both projects are on hold until the NIOSH alert is finalized, Power said. "The idea behind a NIOSH alert is to raise concern, the way the agency did with its alert on needlestick injuries," she explained. "That opens the door for ASHP to update its guidelines and OSHA to revise standards."
This isn't the first time hazardous drugs have made workplace news. Roger Anderson, head of the division of pharmacy at M.D. Anderson Cancer Center in Houston, raised similar concerns in the 1980s. The result was today's workplace standards requiring biological safety cabinets (BSCs), caps, gloves, gowns, and other safeguards.
"If we didn't have those caps, gowns, gloves, and BSCs, we would have been in big trouble for 20 years," Power said. "As it is, those controls aren't enough."
Dutch toxicologist Paul Sessink shocked the European healthcare community in the mid-1990s when he found widespread antineoplastic contamination in hospital pharmacies, prep rooms, IV admix facilities, nursing stations, and patient care areas. European material- handling standards were at least as strict as U.S. standards, he told Drug Topics in 1997.
Anderson brought Sessink to present his findings at M.D. Anderson. He also supported studies at U.S. and Canadian hospitals that found antineoplastic contamination patterns similar to those Sessink had seen across Europe. In response, Anderson tightened product handling and preparation procedures. He also invested in PhaSeal, the only device on the U.S. market designed to eliminate leakage and spills during the preparation and administration of chemotherapy.
PhaSeal, from Swedish maker Carmel Pharma AB, uses double membranes and pressure equalization to block leakage and spills. The device works, Anderson said, but it isn't cheap. Every treatment requires two devices, one for drug preparation and one for administration. That adds $10 to the treatment bill, $1 million yearly. "Yes, there is resistance to spending that kind of money," he said. "But the problem of hazardous exposure is significant enough to make the investment to protect our employees."
Other institutions face the same financial challenge. UCSF is spending $100,000 yearly on PhaSeal, Power said, by limiting it to the most toxic products. It is also using Surface Safe to decontaminate preparation and administration areas. The two-step system contains a pad impregnated with a sodium hypochlorite soap solution and a second pad filled with sodium thiosulfate and benzyl alcohol.
The bleach deactivates many chemotherapeutic agents, Dorr said, the major exceptions being mitoxantrone (Novantrone, Immunex) and carmustine (BICNU, Bristol-Myers Squibb).
The sodium thiosulfate deactivates the bleach to protect stainless steel and other surfaces. It also chelates metals, including platinum and arsenic. The final salt residue is cleaned off with water.
"The original idea was to do something more than just move residues from one spot to another, which is all you're doing with alcohol wipe-downs," Dorr said. "If you can't prevent spills entirely, the only solution is to deactivate the contaminant."
Fred Gebhart. Watch out! Secondhand chemo alert due from NIOSH.