20 Policy
Pharmacy Practice News • May 2022
Compounding
Hazardous Drug Containment: How Much Is Enough? By Marcus A. Banks
Nashville, Tenn.—It is impossible to eliminate all hazardous drug (HD) residue contamination in sterile compounding suites. In fact, exposure to very small amounts of HDs may not always present a health risk. That’s why adhering to the principle of “as low as reasonably achievable” (ALARA) with respect to hazardous residue removal, rather than complete elimination, is a
more attainable standard, a safe handling expert noted during a workshop at the National Home Infusion Association 2022 Annual Conference. The outside of chemotherapy vials sometimes contains trace residues of HDs, with the residue adhering to technicians’ gloves as they transport the drugs within a facility. When this happens, the residues can wind up on surfaces without anyone knowing they are
there. Whereas obvious dangers such as spills have clear mitigation plans, the more subtle risks of trace contamination are harder to manage. “People may think, ‘I didn’t drop a vial today. I didn’t squirt a syringe into the hood.’ So, things seem fine,” said workshop presenter Mark Wiencek, MS, PhD, the lead microbiologist for Contec Healthcare, in Spartanburg, S.C. Wipe sampling—a method that Dr. Wiencek
noted is recommended but not required in USP General Chapter <800>—can detect trace amounts of an HD. If a wipe sample detects the presence of an HD, the question immediately becomes, “How do I get rid of these residues?” Dr. Wiencek said. It turns out that the answer is complex.
The Difference Between Decontamination And Deactivation
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The most reliable response to HD residue is decontamination, Dr. Wiencek explained. This involves removing the drug onto a wipe, pad or towel, and disposing of it in an HD/ hazardous waste/chemotherapy bag. While this solves the immediate problem, decontamination doesn’t guarantee that every particle of the dangerous drug is removed. That’s where deactivation comes in— to chemically neutralize a harmful compound or product. But Dr. Wiencek noted that with more than 200 drugs on the HD list maintained by the National Institute for Occupational Safety and Health (NIOSH), each with its own complex chemical structures, developing a chemical that can deactivate every one of these drugs is a tall order. “Can’t we have a chemical that breaks down or degrades these hazardous drugs? Well, it turns out that this is more complicated than killing a germ. You’re basically doing a chemistry experiment,” Dr. Wiencek said, and often with unsatisfying results because the complex chemistries of HDs repel full neutralization, at least within a reasonable time frame. “Whatever’s going to happen has to happen quickly,” Dr. Wiencek said. Even if a chemical could perfectly neutralize a hazardous compound, he added, one still has to remove the neutralized residues. Given the number of drugs on the NIOSH list, many different chemicals would need to be on hand to neutralize many different drugs—an unfeasible situation, in Dr. Wiencek’s view. “That’s why USP <800> doesn’t depend on deactivation as the sole containment strategy,” Dr. Wiencek said. Rather, the thrust of USP <800> is to keep the drugs contained (or “from escaping”) in the first place. This requires proper use of engineering and administrative controls, extensive training and the appropriate use of personal protective equipment. Wipe sample tests are so sensitive that they can detect extremely trace
