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The NIOSH Hazardous Drug List
Table 1-Cancer Classification Designation by Organization
Finally, the United States Pharmacopoeia (USP) establishes standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel to include pharmacists and pharmacy technicians, patients, and the environment. IDENTIFYING, SCREENING, EVALUATING DRUGS FOR PLACEMENT ON THE NIOSH LIST OF HAZARDOUS DRUGS NIOSH assesses and interprets scientific informa- tion to decide whether an FDA CDER-approved drug meets the NIOSH definition of a hazardous drug. NIOSH’s approach to evaluating the hazard potential of a drug includes: • Reviewing FDA databases (Drugs@FDA and Drug Safety-related Labeling Changes) to identify drugs that have the potential to meet the NIOSH criteria of a hazardous drug. • Screening identified drugs to determine whether the drug package insert specifies Manufacturer’s Special Handling Information (MSHI) or information in • the drug package insert suggests that a drug may exhibit at least one of the types of toxicity criteria found in the NIOSH definition of hazardous drug. • Evaluating information from humans and ani- mals using the toxicity criteria to determine whether the drug exhibits one of the toxicities established in the NIOSH definition of hazard- ous drug. In addition, the NIOSH assesses whether the molecular drug properties may reduce the potential for adverse health effects in healthcare workers exposed to the hazardous drug. • Conducting peer review examining NIOSH’s approach to identifying, screening, evaluating, and placing a drug on, moving a drug within, or removing a drug from the List of Hazardous drugs. • Publishing in the Federal Register a notice seeking public comment on the screened and evaluated drugs, and for drugs proposed for
Organization Carcinogen Classification NTP
Known to be carcinogenic to humans Reasonably anticipated to be carcino- genic to humans
EPA (2005 cri- teria)
Carcinogenic to humans
Likely to be carcinogenic to humans Suggestive evidence of carcinogenic potential Inadequate information to assess car- cinogenic potential Not likely to be carcinogenic to humans Group 1 (carcinogenic to humans) Group 2A (probably carcinogenic to humans) Group 2B (possibly carcinogenic to humans Group 3 (Not classifiable as to its car- cinogenicity to humans Occupational chemical carcinogens
IARC
NIOSH
OSHA identified worker exposure to hazardous drugs as a problem of increasing health concern. Preparation, administration, manufacturing, and disposal of hazardous medications may expose thousands of workers in healthcare facilities and the pharmaceutical industry, to significant workplace levels of these substances which include antineo- plastic cytotoxic medications, anesthetic agents, anti-viral agents, and others, as hazardous. These hazardous medications can produce serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. OSHA has established standards requiring the reporting of employee exposure to hazardous med- ications and permits access to these records by employees. In addition, OSHA enacted Hazard Communication Standard which requires a health- care facility to ensure workers are aware of chemical hazards in the workplace. Under this stan- dard, employers are required to provide safety data sheets (SDSs), train employees on chemical haz- ards, and label containers of hazardous chemicals.
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