ce The NIOSH Hazardous Drug List
INTRODUCTION
The Occupational Safety and Health Administration (OSHA) published the first guidelines for the man- agement of cytotoxic (antineoplastic) drugs in the workplace in 1986. In 1990, the National Institute for Occupational Safety and Health (NIOSH) and the American Society of Hospital Pharmacists (ASHP) expanded the term "hazardous drug" beyond cyto- toxic drugs to include additional agents that exhibit specific characteristics in human and animal toxicity. Initially, ASHP based the criteria for a hazardous drug to include: • Genotoxicity which refers to the ability of a substance or agent to damage DNA or cellu- lar components responsible for regulating the genome, which may lead to mutations or other genetic alterations. • Carcinogenicity refers to the capacity of a sub- stance or agent, to cause or elevate the risk of developing cancer. • Teratogenicity or fertility impairment refers to the ability of a drug to produce deformations and abnormalities in the developing embryo or fetus. • Serious organ toxicity at low doses referring to the adverse effects or disease states caused by a substance, displayed in specific organs of the body due to their cell structures. In 2004, NIOSH defined a hazardous drug as a drug that is. • Approved for use in humans by the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), • Not otherwise regulated by the U.S. Nuclear Regulatory Commission, • Either • Is accompanied by prescribing information in the “package insert” that includes manufac- turer’s special handling information (MSHI) to protect workers handling the drug, or • It is known as a carcinogenic hazard,
developmental hazard, reproductive hazard, genotoxic hazard, or other health hazard by showing one or more of the following toxicity criteria in humans, animal models, or in vitro systems: • Carcinogenicity • Developmental toxicity including teratogenicity. • Reproductive toxicity • Genotoxicity • Organ toxicity at low doses • Structure and toxicity profile imitating existing drugs determined hazardous. In 2004, that NIOSH created the first list of hazard- ous drugs. This list was created to provide guidance for healthcare workers and employers to prevent occupational exposures to these drugs and to pro- vide safer workplaces for those who handle them. Cancer classification systems have been devel- oped by the National Toxicology Program (NTP), the National Institute for Occupational Safety and Health (NIOSH), the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC). Their cancer classification systems are outlined in Table 1 .
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