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Safe (1995)HD


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Safe (1995)HD


Carol does not get better. Nearby trucks still seem to be spewing out exhausts. She moves into a kind of igloo that is completely sterile. Maybe she'll be safe there. And as she continues her desperate search, "Safe" reveals itself as a little more complicated than it first seemed.


The Occupational Safety and Health Administration (OSHA) first published guidelines for the management of cytotoxic (antineoplastic) drugs in the work place in 1986 (OSHA, 1986), and the guidelines were made available in the peer-reviewed literature that same year (Yodaiken, 1986). OSHA updated the guidelines in 1995 and subsequently posted them to OSHA's website in 1999 (OSHA, 1995; OSHA, 1999). Since OSHA last updated the guidelines, governmental and professional organizations have contributed substantial quantities of scientific investigation results, "best-practices", and policy recommendations, which broadened the evidence base underlying the current practices for safe hazardous drug (HD) handling. NIOSH and the American Society of Hospital Pharmacists (ASHP) (ASHP, 1990) redefined the term "hazardous drug" beyond directly cytotoxic drugs to include additional agents that exhibit specific characteristics in human and animal toxicity [See sec. II.A., Figure 1]. The World Health Organization (WHO) estimates that the number of cancer patients will almost double in the next two decades (WHO, 2014), and the number of healthcare workers (HCWs) needed to care for those patients will grow commensurately. The National Institute for Occupational Safety and Health (NIOSH) estimates that somewhere around 8 million HCWs are potentially exposed (NIOSH, 2009).


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.


Although work practices and safe HD handling practices have improved in the years since OSHA first published guidance on the subject in 1986 (OSHA, 1986), workplace exposure to HDs remains a problem (Valanis, 1992; Connor, 1999; Connor, 2010). Several recent publications have documented the ongoing failure of employers to adopt, or consistently use, recommended safety practices for handling HDs (Boiano, 2014; Polovich and Martin, 2011). This failure, in conjunction with many information requests from the public on how to safely handle HDs, and the growing population of HCWs with potential HD exposure in their work prompted OSHA to review and revise its recommendations for hazardous drug handling. Most agents that are considered HDs are covered under the Hazard Communication Standard (HCS)[29 CFR 1910.1200], which has undergone a significant update since OSHA's 1995 hazardous drug guidance was issued (OSHA, 2012b). Note that the requirements of the HCS are superseded by those of OSHA's Laboratory Standard, 29 CFR 1910.1450, when an employer is engaged in the "laboratory use of hazardous chemicals" (i.e., use of relatively small quantities of hazardous chemicals on a non-production basis), but this document focuses on the HCS requirements that apply to most healthcare employers.


While OSHA's 1986 guidelines focused on cancer chemotherapy drug safety (OSHA, 1986), OSHA's 1995 instruction enlarged the focus to include additional agents with toxicity profiles of concern. These additional agent categories were defined as hazardous drugs ("HDs") by the American Society of Health-System Pharmacists (ASHP), formerly American Society of Hospital Pharmacists, in a 1990 publication (ASHP, 1990) based on four specific criteria, which are listed below in Figure 1.


In addition to publishing the 2004 Alert on HD safe handling, NIOSH biennially updates their HD list to reflect newly Food and Drug Administration (FDA)-approved agents, and also to address any listings which may be modified in light of newly published scientific literature or other governmental agency determina




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