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Compounding should take place in a ventilated cabinet (NIOSH, 2004; USP 800, 2016). Controlled Environment Testing Association (CETA). 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. Hon CY, Teschke K, Shen H, Demers PA, Venners S [2015]. This monograph will help employers to develop a HD Safety Plan that includes both patient and worker safety under a generalized "culture of safety." NIOSH recommends that gloves should be worn and gowns should be in such circumstances (NIOSH, 2014a). Lancet 336:1446. 2012-0044-3199]. Int Arch Occup Health 78:403-412. In the United States, the Occupational Safety and Health Administration (OSHA) sets the standard for workplace safety. Fenech M [2008]. J Nat Cancer Inst 85:1089-1091. Their efficacy was the highest for the most hydrophilic compounds and around 80 percent effective for anthracyclines. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Undifferentiated Nasopharyngeal-type Carcinoma in a Nurse Handling Cytostatic Agents. University Medical Center. For most known HDs, type A2 cabinets offer a simple and reliable integration with the ventilation and pressurization requirements of the C-SEC. NIOSH [1993a]. 29 CFR 1910.134. Finally, the NIOSH work group added helpful refinements to one of the original criteria, "organ toxicity at low doses." Section 3: ancillary respirator information. The properties of the HDs located in the work area; (OSHA, 2011b), The techniques and safe handling practices that have been implemented in the work area to protect employees from exposure to HDs, such as identification of drugs that should be handled as hazardous, appropriate work practices, safety equipment, and PPE to be used, and emergency procedures for spills or employee exposure; (OSHA, 2012b; NIOSH, 2009), The details of the hazard communication program developed by the employer, including an explanation of the labeling and HD identification system used by the employer, the SDSs, and how employees can obtain and use the appropriate hazard information; (OSHA, 2012b), Proper use of safety equipment such as biological safety cabinets, compounding aseptic containment isolators, and closed system transfer devices; (OSHA, 2012b), Proper donning and doffing of PPE; and (OSHA, 2011). The Occupational Safety and Health Administration (OSHA) is a Federal agency that protects workers from safety and health hazards in the workplace. Decontamination - Inactivation, neutralization, or removal of HDs, usually by chemical means. Pharmaceutical product - A commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. REV 2 9/05. From 1982 through 1994, NIOSH conducted 226 onsite investigations of work-related electrocutions under the Fatality Assessment and Control Evaluation (FACE) Program. Spill and leakage using a drug preparing system based on double-filter technology. a study conducted by OSHA showed that nearly _______ percent of work related electrocutions involved cranes 30 Who is covered by the OSH Act all workers and their employers under federal government authority what is an acceptable alternative to installing an audible back up alarm on vehicles flaggers USP <797> specifies that compounding garb for sterile doses should include the following (USP 797, 2012): NIOSH has recommended the following practices to provide eye and face protection to employees working with HD (NIOSH, 2009): Follow these recommended work practices when wearing gowns: Whenever respirators are used, OSHA's Respiratory Protection Standard (RPS) [29 CFR 1910.134] (OSHA, 2011b) must be followed, which includes requirements for respirator selection, medical evaluation, fit testing and training. NIOSH respirator selection logic 2004. For the first time in its 50-year history, OSHA faces a new hazard so grave that it has killed nearly 600,000 Start Printed Page 32377 people in the United States in barely over a year, and infected millions more (CDC, May 24, 2021a). Not having to comply with OSHA's most rigorous requirements C. Demonstrating good faith by an employer with respect to safety and health D. All of the above Q48. The use of alcohol for disinfecting (deactivating microbial contamination) the C-PEC will not deactivate any HDs and alcoholic solutions may result in the spread of contamination rather than any actual cleaning (Sessink, 1992b; Dorr, 1992; ASHP, 2006; Le, 2013). Postulating a dermal pathway for exposure to anti-neoplastic drugs among hospital workers. OSHA does this by setting and enforcing standards, providing training, outreach, and education, and creating and enforcing regulations. NTP [2013]. Exposure in susceptible individuals can lead to asthma or allergic contact dermatitis (Kusnetz and Condon, 2003). The Act covers most private-sector employers and their workers. The comprehensive plan should address all aspects of safe handling of HDs throughout the facility, be developed using a collaborative effort including all affected departments, and specify measures that the employer is taking to ensure employee protection. September 2011. Biohazard - A biological agent, such as a virus or a condition that constitutes a threat to humans. National Toxicology Program. Occupational Safety Health Administration. Chemotherapy glove - A medical glove that meets the American Society for Testing and Materials (ASTM) Standard Practice (D6978-05(2013)) for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. 29 CFR 1910.1200. The OSHA regulations are summarized as follows: De-energize and visibly ground electrical distribution and transmission lines [29 CFR 1910.333(c)(3); 29 CFR 1926.550(a)(15)] Information should be included in a confidential data base that the organization manages to track exposures as a formal log. Work equipment for HDs should be suitable for the task and reduce the risk of exposure to the HD. Plante R, Malenfant R [1998]. All employers and workers should be trained in cardiopulmonary resuscitation (CPR). IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Pharmaceutical Drugs. GTB0131. Studies on the decontamination of surfaces exposed to cytotoxic drugs in chemotherapy workstations. Safety and Health Management Systems and Joint Commission Standards - A Comparison. Methods in Molecular Bio 410:185-216. NIOSH Alert: request for assistance in preventing electrocutions from contact between cranes and power lines. 1095 Willowdale Road Construction laborer is electrocuted when crane boom contacts overhead 7,200-volt power line in Kentucky. Patient gowns and linens should be considered contaminated and changed after treatment (Latchford, 2003; Mooney, 2014). Contamination with marker HDs has been found on the work surface, front lip and grill of the BSC, on areas around the BSC, and on the floor in front of the Class II BSC. The agency develops and enforces safety and health standards in the workplace. Oral Oncol 29:153. Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. External contamination of cytotoxic drug vials. Per ASHP's 2006 guidelines, workers should understand that the Class II BSC does not prevent the generation of contamination within the cabinet and that the effectiveness of such cabinets in containing HD contamination depends on operators' use of proper technique (ASHP, 2006). As such a pad may absorb small spills, it may become a source of HD contamination, and that contamination may be transferred to other surfaces (ASHP, 2006). 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). J. Epidem. EPA (Environmental Protection Agency) [1991a]. The sash on the Class II BSC should remain down during cleaning and the front of the CACI should remain closed. Int Arch Occup Environ Health 81(3), 285-293. 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). Prophylactic zidovudine after occupational exposure to the human immunodeficiency virus: An interim analysis. One of the purposes of OSHA quizlet is to ensure that employees are aware of their rights and responsibilities in the workplace. 8-1.1. Some CSTDs have been shown to limit the potential for generating aerosols during compounding and to avoid leakage and disconnects during administration, which results in less measurable HD surface contamination in HD work areas. NTP Monogr. While most commonly used HDs are members of several chemically unrelated classes of agents, most of those used for anti-cancer chemotherapy exert their action by binding to cellular macromolecules, including deoxyribonucleic acid (DNA), or through disruption of DNA and protein synthesis (Skeel, 1987; Chabner and Longo, 2010). 93-14. Christensen CJ, Lemasters GK, Wakeman MA [1990]. Levin L, Holly E, Seward J [1993]. The following are general suggestions for acute exposure management (Polovich, 2011): The exit examination completes the information on the employee's medical, reproductive, and exposure histories. External contamination of antineoplastic drug vials. In: Proceedings of the Human Factors Society, 22nd annual meeting. "Health hazard" means a chemical which is classified as posing one of the following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (single or repeated exposure); or aspiration hazard. Training required under the HCS must include all employees potentially exposed to these agents, which includes not only healthcare professional staff, but also physical plant, maintenance, or others who potentially come into contact with the HDs. National Institute for Occupational Safety and Health: DHHS (NIOSH) Publication No. 2014-138 (September). The healthcare worker's private physician may also play a role in providing "validation" of the worker's request for alternative duty assignment. Experiences in developing legislation protecting reproductive health. Together, these three violations accounted for more than 60% of all violations cited. 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. Technicians servicing these cabinets or changing the HEPA filters should be aware of HD risks through hazard communication training from their employers and should use the same PPE as recommended for large spills. The agency has a comprehensive set of standards and regulations, which are updated regularly. [http://www.cetainternational.org/reference/CETACompoundingIsolatorTestingGuide2006.pdf]. OSHA, The Joint Commission, and NIOSH joint letter to hospitals, dated 4 April 2011, on hazardous drugs. Waste Anesthetic Gases-Occupational Hazards in Hospitals. Nygren O, Gustavsson B, Strom L, Friberg A [2002a]. Blood 99:1909-1912. J. Infect Disease 160:321-7. Occupational exposure to antineoplastic drugs: Identification of job categories potentially exposed throughout the hospital medication system. 2004. We take your privacy seriously. In addition, the HCS does not require training documentation, but sound practice dictates that training records should be created, and include the following information: It is wise to maintain training records for some period of time from the date on which the training occurred but the HCS no longer requires such retention. All personnel responsible for administering HDs must wear appropriate personal protective equipment as described in the PPE section. 29 CFR 1910.1020. Therefore, NIOSH recommends that no other duties or responsibilities be assigned when workers are designated to observe clearance during crane movement or operation. When CACI are used for sterile compounding, the recovery time to achieve ISO Class 5 air quality should be documented and internal procedures developed to ensure that adequate recovery time is allowed after material transfer before and during compounding operations. Personal Protective Equipment for Health Care Workers Who Work with HDs. J Occup Med 34:149-55. Occupational Safety and Health Administration (OSHA). Contact dermatitis associated with adriamycin (NSC-123127) and daunorubicin (NSC-82151). Antineoplastic drug exposure in an ambulatory setting. Even if care is taken, opportunity for absorption through inhalation or direct eye or skin contact can occur (Kromhout, 2000; Fransman, 2004; Fransman, 2005; Fransman, 2007; Friese, 2012; Suspiro, 2011). USP <800> notes that water sources and drains should not interfere with ISO classifications where required and should be located at least one meter away from the C-PEC (USP 800, 2016). Date most recently accessed December 11, 2015. Carcinogenesis. Rogers B [1987]. With the potential increase in aerosol administration of HDs, exposure controls should be applied to minimize widespread environmental contamination and protect HCWs. [DHHS (NIOSH) Publication No. CSTDs are not a substitute for ventilated engineering controls and should not be used outside of an appropriate C-PEC (NIOSH, 2004; ASHP, 2006; USP 800, 2016). It should focus on the known target organs of commonly used HDs (skin, kidney, bladder, hematopoetic) (Polovich, 2011). The examining physician should consider the reproductive status of employees and inform them regarding relevant reproductive issues. Summary tables of much of the data presented below can be found in the scientific literature (Sorsa, 1985; Rogers, 1987; Connor and McDiarmid, 2006). AM J Ind Med 44:107-109. Guidelines for cytotoxic (antineoplastic) drugs. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Benvenuto JA, Connor TH, Monteith DK, Laidlaw JA, Adams SC, Matney TS and Theiss JC [1993]. Phila. Romito P, Saurel-Cubizolles M [1992]. Anesthetic agents are not considered in this review, even though exposure to some of these agents is a well-recognized health hazard (NIOSH, 2007). Br J Ind Med 49:855-861. ASTM D6978-05 [2013]. Occupational exposure to antineoplastic agents at several departments in a hospital. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Or nutrient that has been evaluated for safety and Health hazards in the United States the! In aerosol Administration of HDs, type A2 cabinets offer a simple and integration! Quizlet is to ensure that employees are aware of their rights and responsibilities in the section. 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