Guidelines for the safe handling of hazardous drugs: Consensus recommendations

Abstract

Determining the proper precautions that employees should take to reduce their exposure to potentially hazardous drugs is very difficult due to the many risk factors that must be considered. Some of these risk factors include the inherent toxicity of the drug, the drug’s mechanism of action, the type of toxicity observed, the method and possible routes of exposure for an employee, the molecular size of the drug, how employees interact with the drug, and each employee’s medical considerations. While some data on the carcinogenicity, mutagenicity, genotoxicity, teratogenicity, reproductive toxicity, organ toxicity, and potency of these drugs are available, package labeling with respect to these effects is not comprehensive, standardized, or consistent in structure or detail. When data are available, they often are in the context of therapeutic or supratherapeutic administration of drugs using animal models. Their applicability to humans is controversial; more specifically, their applicability to humans with substantially less exposure (employees) than therapeutic administration (patients) cannot be determined. While there is some degree of risk associated with any drug, the problem arises when determining which combinations of factors provide sufficient risk to require employees to take more significant and standardized precautions to minimize exposure.