ALARA As Low As Reasonably Achievable API Active Pharmaceutical Ingredient ASCO American Society of Clinical Oncology ASHP American Society of Health-System Pharmacists (formerly American Society of Hospital Pharmacists) ASTM American Society for Testing and Materials BSC Biological Safety Cabinet BUD Beyond-Use Date CACI Compounding Aseptic Containment Isolator CAI Compounding Aseptic Isolator CDC Centers for Disease Control and Prevention (Department of Health and Human Services) CFR Code of Federal Regulations CSTD Closed System Drug-Transfer Device CP Cyclophosphamide C-PEC Containment Primary Engineering Control C-SCA Containment Segregated Compounding Area C-SEC Containment Secondary Engineering Control CSP Compounded Sterile Preparations DNA Deoxyribonucleic Acid DOL U.S.
Environmental Protection Agency FDA U. click to book plumber in .S. Food and Drug Administration GHS Globally Harmonized System HCS Hazard Communication Standard HCWs Healthcare Workers HD Hazardous Drug HEPA High-Efficiency Particulate Air "or Arrestor" IARC International Agency for Research on Cancer IM Intramuscular IND Investigational New Drugs ISO International Organization for Standardization IT Intrathecal IV Intravenous ONS Oncology Nursing Society NIOSH National Institute for Occupational Safety and Health OEL Occupational Exposure Limit OSHA Occupational Safety and Health Administration (Department of Labor) PEC Primary Engineering Control P&P Policy and Procedure PPE Personal Protective Equipment SCE Sister Chromatid Exchange SDS Safety Data Sheet (formerly Material Safety Data Sheet) SOP Standard Operating Procedure SQ Subcutaneous TJC The Joint Commission USP US Pharmacopeial Convention WHO World Health Organization 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).
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.
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).
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).
Most agents that are considered HDs are covered under the Hazard Communication Standard (HCS), 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.
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. These recommendations apply to all healthcare settings where employees are occupationally exposed to HDs, such as hospitals, physicians' offices, and home healthcare agencies.
Sections dealing with work areas and prevention of employee exposure to HDs at a workplace refer to workplaces where pharmaceuticals are used in concentrations appropriate for patient therapy. In settings where employees work with drugs in a more potentially hazardous form (e. g., a more concentrated form encountered in certain components of pharmaceutical manufacturing), measures that afford employees a greater degree of protection from exposure are commonly employed and should be used.
This review will: Provide criteria for classifying drugs as hazardous; Summarize and update the evidence supporting the management of HDs as an occupational hazard; Discuss the elements of a comprehensive safety and health plan for HDs and the recommended worker education, as well as the legal requirements of applicable standards for the protection of workers exposed and potentially exposed to HDs; Update the important aspects of medical surveillance; and Reference and describe the NIOSH HDs list that is currently in use.
A separate OSHA document on this topic is available at: https://www. osha.gov/dts/osta/anestheticgases/index. html (OSHA, 2000). 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.