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 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.Īlthough 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). The National Institute for Occupational Safety and Health (NIOSH) estimates that somewhere around 8 million HCWs are potentially exposed (NIOSH, 2009). 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. 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.
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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. OSHA updated the guidelines in 1995 and subsequently posted them to OSHA's website in 1999 (OSHA, 1995 OSHA, 1999). 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).
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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 I.
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Containment Supplemental Engineering ControlsĪcronyms 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.Decontamination, Deactivation, and Cleaning.Compounding Aseptic Containment Isolators (CACI).Primary Engineering Controls (PEC) and Ventilated Cabinets.Disposal of Drugs and Contaminated Materials.Pharmacy or Other Compounding or Dispensing Areas.Occupational Exposure: Biological Evidence of Absorption.Occupational Exposure: Environmental Measures.
BACKGROUND: HAZARDOUS DRUGS AS OCCUPATIONAL RISKS.Hazard Definition Based on Pharmacology/Toxicology.
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