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The books represent the analysis of the authors and should not be construed as an expression of an official U. This informational guidance document outlines OSHA’s current recommendations for addressing the health and safety hazards faced by healthcare workers who handle HDs, and the background evidence underlying those recommendations. These recommendations apply to all healthcare settings where employees are occupationally exposed to HDs, such as hospitals, physicians’ offices, and home healthcare agencies. Because many of the same drugs used to treat humans are also used to treat animals, this guidance is applicable to veterinary practices as well. Reference and describe the NIOSH HDs list that is currently in use. OSHA’s 1995 instruction enlarged the focus to include additional agents with toxicity profiles of concern.
ASHP’s definition of HDs, including adding two more characteristics, as Figure 1 depicts. Finally, the NIOSH work group added helpful refinements to one of the original criteria, “organ toxicity at low doses. Here, the work group added a qualitative and quantitative discussion of the continuum of toxicity that may be exhibited by a drug. To help readers interpret the “low dose” description, the NIOSH work group cited a series of publications authored by pharmaceutical industry toxicologists that describe industry “performance” practices for defining “low dose” effects. Under the NIOSH approach, characterizing a drug as “hazardous” requires a “hazard identification” process, in which the descriptive criteria of the drug are reviewed and screened against the six HD characteristics.
The presence of any one of the HD characteristics is enough to define a drug as hazardous. As such, this analysis does not comprise a complete four-step risk assessment. It is important to understand the rationale and logic that is used to identify a drug as “hazardous” so that employers can independently assess the hazardousness of new drugs that have not yet been evaluated by NIOSH. American Hospital Formulary Service Drug Information? Does the manufacturer suggest the use of special isolation or other techniques in its handling, administration, or disposal? Is the drug known to be a human mutagen, carcinogen, teratogen or reproductive toxicant?
Is the drug known to be carcinogenic or teratogenic in animals or mutagenic in multiple bacterial systems or animals? Is the drug known to be acutely toxic to an organ system? BACKGROUND: HAZARDOUS DRUGS AS OCCUPATIONAL RISKS In the thirty years since the publication of OSHA’s technical guidance on HD safe handling, the scientific literature on this topic has grown tremendously. In the years since the 2004 NIOSH Alert was issued, over 400 papers on HDs have been published in the peer-reviewed literature. It is difficult to set safe levels of exposure to HDs on the basis of current scientific information because the degree of absorption that takes place during work, and the significance of early biological effects on each individual, are difficult to assess and may vary depending on the HD.
However, several lines of evidence support the toxic potential of these drugs if handled improperly. Animal Data Numerous studies document the carcinogenic, mutagenic, and teratogenic effects of HD exposure in animals. Human Data at Therapeutic Levels Many HDs are known carcinogens for which there is no safe level of exposure. The literature also documents the effects of these HDs on other organ systems. Occupational Exposure: Environmental Measures Initial air sampling results often showed very low concentrations of measurable HDs. With the development of sensitive assays for certain marker HDs, the past several decades have seen a large effort to assess HD work environments using wipe samples of work surfaces, such as BSCs and countertops, and of the wider work environment, such as floors and door handles.