Workers should also be trained to recognize the hazards and use proper techniques when rescuing coworkers or recovering equipment in contact with electrical energy. Code of Federal regulations. After the wall was poured, the driver of the cement truck cleaned the loading chute on his truck with a water hose mounted on the truck. Wear two pairs of gloves when compounding, administering, and disposing of HDs; Sterile chemotherapy gloves should be used for compounding of sterile preparations under USP Chapter <797> (USP 797, 2012); Wear the inner glove under the gown cuff and the outer glove over the cuff. Now aligned with the United Nations Globally Harmonized System (GHS) of Classification and Labelling of Chemicals, the updated HCS issued in 2012 describes a series of labeling and hazard training requirements for employers in settings where hazardous chemicals are used. Task Force on Reproductive Toxicology. Compounding and handling non-sterile HDs may present opportunities for exposure and require special precautions. Cyclophosphamide (CP) was removed, to varying extents, from vial surfaces by using several methods of wiping with a tissue wetted with soapy water, followed by a dry wipe and a wipe down with a pre-wetted commercial wiper (Touzin, 2008). 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. The driver had backed the truck up the steeply sloped driveway under a power line at the site and was using the crane to unload a cube of concrete blocks. Drug residue may be present on the outside of vials received from manufacturers and distributors (Kiffmeyer, 2000; Nygren, 2002a; Mason, 2003; Favier, 2003; Connor, 2005; Gilbar, 2005; Touzin, 2008; Schierl, 2010; Hama, 2011; Power, 2014). Finally, the NIOSH work group added helpful refinements to one of the original criteria, "organ toxicity at low doses." These recommendations apply to all healthcare settings where employees are occupationally exposed to HDs, such as hospitals, physicians' offices, and home healthcare agencies. WARNING! Importantly, specific chromosomal markers of HD damage, typically observed in therapeutically treated cancer patients, have also been reported in oncology pharmacy and nursing personnel as a function of drug handling frequency (McDiarmid, 2010; McDiarmid, 2014). Reproductive and developmental hazard management guidance. Carcin 28:625-631. Workplace solutions: medical surveillance for healthcare workers exposed to hazardous drugs. Does the manufacturer suggest the use of special isolation or other techniques in its handling, administration, or disposal? Plastic-backed pads can be used to protect work surfaces from HD contamination (USP 800, 2016). Hedmer M, Hoglund P, Cavallin-Stahl E, Albin M, Jonsson BA [2008a]. Active pharmaceutical ingredient (API) - Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. The occurrence of exposure-related disease or other adverse health effects should prompt immediate reevaluation of primary preventive measures (e.g., engineering controls, work practices, and use of PPE). Mutagenesis 26: 93-100. Harris, CC [1976]. CETA (Controlled Environment Testing Association) [2008]. Use eye and face protection when compounding a drug outside a C-PEC (e.g., in the operating room), working at or above eye level, cleaning a BSC or CACI, or cleaning a spill; Use face shields in combination with goggles to provide a full range of protection against splashes to the face and eyes; Face shields alone do not provide full eye and face protection; Eyeglasses with temporary side shields are inadequate protection to the eyes from splashes; A full-facepiece respirator also provides eye and face protection; and. Touzin K, Bussires JF, Langlois , Lefebvre M, Mtra A [2010]. Reduction in surface contamination with cyclophosphamide in 30 hospital pharmacies following implementation of a closed-system drug transfer device. For example, hepatocellular damage has been reported in nurses working in an oncology ward, and the damage appeared to be related to the intensity and duration of their work exposure to HDs (Sotaniemi, 1983). Hosp Pharm 48:204-212. In the past thirty years, bio-monitoring studies have become quite commonplace, with more than 100 reports in the literature, about two-thirds of which documented drug uptake by measuring these drugs or their metabolites in the urine of at least some exposed HCWs. Final preparations should be surface decontaminated within the C-PEC and placed into the transport bags in the BSC or in the isolator pass-through, taking care not to contaminate the outside of the transport bag (ASHP, 2006). Clin J of Onc Nurs 7(4): 418-422. Occupational dermal exposure to cyclophosphamide in Dutch hospitals: A pilot study. Removal of contaminated clothes, stockings, etc. Contents or a summary of the training sessions; Names and qualifications of the persons conducting the training; and. And the impact of this new illness has been borne disproportionately by the healthcare and healthcare support . Connor TH, Sessink PJM, Harrison BR [2005]. Cancer Chemotherapy. Obstet Gynecol Int. Waste handling, especially sharps waste, presents a risk of HD exposure. copying words or ideas from someone else without giving credit. EPA (Environmental Protection Agency) [1991a]. Do not use cage-type boom guards, insulating links, or proximity warning devices as a substitute for de-energizing and grounding lines or maintaining safe clearance [29 CFR 1926.550(a)(15)(v)]. Amazon's boom in employment nearly 1.3 million workers worldwide, most of whom work in the company's fulfillment centers, transportation hubs and grocery stores is a direct result of . USP <797> standards and other guidance documents do not exempt the CACI from the use of appropriate PPE for HD compounding (USP 797, 2012; ASHP, 2006; NIOSH, 2004). Characteristics of hazardous waste. All materials from the decontamination process should be handled as HDs and disposed of in accordance with federal, state and local laws (ASHP, 1990; ASHP, 2006). Guidelines on handling hazardous drugs. Place gloves with long cuffs over the cuff of the gown to protect the wrist and forearm (NIOSH, 2009; ASHP, 2006; Polovich, 2014); When compounding sterile preparations, sanitize gloves with sterile 70 percent alcohol. Food and Drug Administration. Lancet I (8128):1250-1. Boffetta P [2007]. The new national survey by Pew Research Center, conducted April 29 to May 5 among 10,957 U.S. adults using the Center's online American Trends Panel, finds a majority of U.S. adults want the government to play a larger role in addressing climate change. Reusable protective eye/face gear and respirators should be cleaned with mild detergent and water after use. National Sanitation Foundation. Exposure may occur by accidental injection from needle sticks or other sharps contaminated by HDs. Immediate cleansing of the affected skin with soap and water. Lancet II:1284-5. Another approach is to administer the history annually but use the health and exposure history responses to guide the interval for physical exam and laboratory studies. Train workers to comply with current OSHA regulations. The exhaust air is treated by double HEPA filtration or single HEPA filtration/incineration. Fact sheet No. Fransman W, Vermeulen R and Kromhout H [2004]. Because the FACE investigations were conducted in only 16 states, these fatalities represent only a portion of the crane-related electrocutions during the period 1982-94. Krishnan B, Morgan G [2007]. J Occup Environ Med 37:145-50. When used in a total safety program that includes good work practices, excellent technique, and consistent cleaning and decontamination, Class II BSCs are a valued tool for reducing occupational exposure to HDs during compounding. USP <797> states that training for compounding personnel should include at least safe aseptic manipulation practices; negative pressure techniques when utilizing a C-PEC and correct use of CSTD devices; containment, cleanup, and disposal procedures for breakages and spills; and treatment of personnel contact and inhalation exposure (USP 797, 2012). This success in reducing CP contamination, however, may have limited usefulness when attempting to clean other drugs. Nygren O, Gustavsson B, Strom L, Friberg A [2002a]. The same principle applies to the processing of any liquids, injections, gels, and ointments, for which there is no exemption under the HCS. C-PECs used for non-sterile compounding do not need to have ISO 5 air quality. Packing cartons have also been identified as sources of measurable HD contamination (Kiffmeyer, 2000). 2010-167 (September). NTP [2013]. Eyewash facilities should also be made available. Physical examination for acute findings at the site of exposure (e.g., skin or the pulmonary system for an inhalation exposure). Sieber SM [1975]. Examination and laboratory evaluation should be guided by the individual's history of exposures and follow the outline of the periodic evaluation. J Oncol Pharm Practice 18:201-206. While all three men watched the blocks, the tip of the crane boom contacted a conductor of the overhead power line and completed a path to ground through the truck, the remote control unit, and the driver. Staff who may be required to wear respirators must be fit tested and trained in accordance with OSHA's RPS (OSHA, 2011b; NIOSH, 2009). Joint Commission Resources. Nurses' use of hazardous drug-handling precautions and awareness of national safety guidelines. to commit literary theft. The ASHP recommends that drugs that are carcinogenic and/or teratogenic in animals and those that exhibit reproductive toxicity or organ toxicity at low doses in animals be considered potential human occupational hazards (ASHP, 1990). Int Arch Occup Environ Health 64:105112. CSA guidelines list techniques that can be used when equipment contacts energized power lines [CSA 1982] (see Current Standards in this Alert). Acute effects from occupational exposure to antineoplastic drugs in a para-professional health care worker. HD solution should be drawn from an ampule with a 5 micron filter needle or straw to remove any glass that might have entered the solution. Standard precautions are based on the understanding that any blood or other body fluid may contain potentially harmful pathogens, regardless of the persons health status. [http:// nioshdev.cdc.gov/niosh/docs/2010-167]. Gilbar PJ [2005]. Cancer mortality among women employed in health care occupations in 24 U.S. states, 1984-1993. [http://labeling.pfizer.com/showlabeling.aspx?id=490#section-11.3]. Flooding an affected eye at an eyewash fountain or with water or isotonic eyewash designated for that purpose for at least 15 minutes, for eye exposure. Friese CR, Himes-Ferris L, Frasier MN, McCullagh MC, Griggs JJ [2012]. Employees involved in home care HD administration should follow the above work practices and employers should make administration equipment and spill kits available. However, the crane boom remained in contact with the power line, the truck tires ignited, and the truck began to burn. MotherRisk Cancer in Pregnancy: Breastfeeding and anti-cancer chemotherapy [2014]. The workers indicated that the biggest challenges presented by their unpredictable schedules are: Poor or fair sleep quality (78%) Difficulty getting needed time off (71%) Struggles dealing with family or personal matters at work (71%) Difficulty paying bills (67%) Unhappiness (48%) Frequent psychological distress (42%) They are differentiated by the amount of air recirculated within the cabinet, whether this air is vented to the room or the outside, and whether contaminated ducts are under positive or negative pressure. Kopp B, Schierl R, Nowak D [2013]. CSA (Construction Safety Association) [1982]. McDiarmid MA, Rogers B, Oliver MS [2014]. . Am J Hosp Pharm 47:1033-49. (Sessink, 1992a; Sessink, 1992b; Sessink, 1997; Minoia, 1998; Fransman, 2004; Fransman, 2005; Mason, 2005). Discuss how knowledge of the timing and amounts involved can aid the planning process. & \text { c. } \\ Clean and decontaminate the drain spillage trough located in the C-PEC if so equipped. USP [2016]. Most recently accessed December 8, 2015. Appropriate PPE, including ASTM tested, powder-free chemotherapy gloves, must be worn when handling HDs. Numerous studies have shown that surfaces in areas where HDs are stored, mixed, administered, and wasted, as well as where patients are cared for, are contaminated with measurable levels of HD residue (Connor, 1999; Connor 2002; Acampora, 2005; Connor, 2010; Hon, 2013). Alkylating agents present the strongest evidence of carcinogenicity (e.g., cyclophosphamide, mechlorethamine hydrochloride [nitrogen mustard]). Any overhead power line shall be considered energized unless the owner of the line or the electric utility company indicates that it has been de-energized and it is visibly grounded [29 CFR 1926.550 (a)(15)(vi)]. Morgantown, WV: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, Fatality Assessment and Control Evaluation (FACE) Report No. Technical Bulletin General Information. Department of Health and Human Services. 2007-124]. What is OSHA What is its purpose quizlet? . In both cases, no safe handling precautions were used. Department of Health and Human Services. Construction laborer is electrocuted when crane boom contacts overhead 7,200-volt power line in Kentucky. Staff who may be required to wear respirators must be fit tested and trained to all OSHA respirator requirements (OSHA's RPS, 29 CFR 1910.134; NIOSH, 2009). Care should be taken not to damage the fixed-glove assembly in a CACI. J Occup Environ Hyg 11:728-740. One challenge arises because most OSHA inspections target workplaces with recent accidents or safety complaints, and these workplaces typically have a combination of ongoing safety problems and a random event ("bad luck") that year. It is important, however, that requests for this protective, alternative reassignment should ideally be made prior to pregnancy to avoid exposure during the vulnerable first months of pregnancy when early stages of development are occurring. The HCS requires that drugs posing a health hazard (with some limited exception of those in solid, final forms for direct administration to the patient, i.e., tablets or pills) be included on lists of hazardous chemicals to which employees are exposed. J Oncol Pharm Practice 2007:13 Suppl:1-81. Vol 26. Class II BSCs and CACIs that have laminar flow in the work area may have a removable work tray as the work surface. Employers shall ensure that overhead power lines are de-energized or separated from the crane and its load by implementing one or more of the following procedures: Where it is difficult for the crane operator to maintain clearance by visual means, a person shall be designated to observe the clearance between the energized power lines and the crane and its load [29 CFR 1926.550(a)(15)(iv)]. The use of nebulizers to administer HDs presents a specific challenge to the respiratory system and exposes HCWs to the "fugitive" aerosol of the drug. Evaluation of working practices and surface contamination with antineoplastic drugs in outpatient oncology health care settings. The general principles of aseptic technique, therefore, will not be detailed here. Occupational Health and Industrial Hygiene Guidance for the Management, Use and Disposal of Hazardous Drugs, http://armypubs.army.mil/med/DR_pubs/dr_a/pdf/tbmed515.pdf, EPA Inaction in Identifying Hazardous Pharmaceuticals May Result in Unsafe Disposal, Emerging EPA Regulations of Pharmaceuticals in the Environment, International Society of Oncology Pharmacy Practitioners Standards. American International, West Conshohocken, PA: American Society for Testing and Materials. Download Nearly One Third Of Healthcare Workers In U.S. One elimination type surfactant, dish washing liquid, was found to be an effective cleaning solution (91.5 percent of contaminants removed), but the exact formulation of the solution was unknown. IARC [1987]. Also, the toxic properties of drugs in tablet form are the same as when in liquid or powder form, and tablets can be especially hazardous when they are counted out from a bulk container in a way that generates drug powder clouds. Documenting the exposure in the employee's medical record. You can review and change the way we collect information below. Pharmaceut J 268:331-7. Sharps contaminated with blood or other infectious material must be placed in puncture-resistant, leak-proof, and appropriately labeled containers as soon as possible after use and kept in such containers until properly reprocessed [29 CFR 1910.1030(d)(2)(viii)]. Several studies also linked environmental sampling results to bio-monitoring results of drug levels in workers' urine, documenting an uptake of drug levels in contaminated work environments (Minoia, 1998; Wick, 2003; Mason, 2005; Connor, 2010; Hon, 2015). A study of occupational exposure to antineoplastic drugs and fetal loss in nurses. Limited studies have been done to select an appropriate and successful cleaning procedure for HD vials (Touzin, 2008; Lamerie, 2013). The CACI, like all isolators, should have the fixed gloves changed multiple times per day to perform HD compounding. The citation notes that "a daily therapeutic dose of 10mg/day or a dose of 1mg/kg per day in laboratory animals that produce serious organ toxicity, or developmental or reproduction toxicity" has been used by the pharmaceutical industry to develop internal "occupational exposure limits" (OELs) of less than 10g /m3 with the application of safety factors (Sargent and Kirk, 1988; Naumann and Sargent, 1997; Sargent et al. In addition, most HCWs are exposed to multiple agents during any work shift, yielding a "mixed exposure" scenario. Monitoring occupational exposure to cancer chemotherapy drugs. In addition, scientific interest in work surface contamination grew following the initial observation of work surface contamination in early studies, and observations using the biologic evidence of exposure (described below). OSHA: Occupational Safety and Health Administration is a large regulatory agency of the United States Department of Labor that originally had federal powers to inspect and examine workplaces. And another study of more than 4500 adults in New York City suggested that nine out of ten adults exceeded the same EPA daily noise dosage limit [27] . Cookies used to make website functionality more relevant to you. Exposure may occur by inhalation when HD dust or droplets are generated during drug administration. Orlando: Grune & Stratton. Therefore, it is essential to minimize exposure to all HDs. Together, these three violations accounted for more than 60% of all violations cited. Department of Health and Human Services. Specific requirements on content and format of labeling for human prescription drugs. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. NIOSH [1991]. Which of the following statements best describes the principle of standard precautions OSHA? "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. 2005-100. For detection and control of work related health effects, screening is typically performed at specific intervals: In addition to review of individual worker results obtained during a screening, the data obtained should be analyzed in a systematic fashion to allow early detection of disease patterns in groups of workers. Date accessed November 2014. OSHA and NIOSH scientists noted that many of the brain cancer victims held jobs that would have brought them in contact with chemicals throughout the plant. Gabriele P, Airoldi M, Succo G, Brando V, Grazia Redda MGR [1993]. Newer and more sensitive measures of HD surface contamination have been used to assess the effectiveness of technique alone. L LMM, Jolivot PA, Yaye HS, Rieutord A, Bellanger A, Pradeau D, Barbault-Foucher S, Caudron E [2013]. NIOSH List of antineoplastic and other hazardous drugs in healthcare settings. Cancer chemotherapeutic agents and carcinogenesis. Polovich M, Martin S [2011]. Antineoplastic drug handling protection after OSHA guidelines: Comparison by profession, handling activity, and worksite. Any discarded HDs greater than residue amounts should be evaluated as to whether they are a hazardous waste under federal U.S. EPA regulations, and if so, be disposed of in accordance with 40 CFR part 261 (EPA, 1991a and b). Sterile compounding requires competence in aseptic technique, and that is assumed in this section. November 2012. Carcinogenesis. 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. During sterile compounding of HDs, barrier garments should be worn to prevent the shedding of human skin and hair cells, and the deposition of mucus or respiratory residue into the compounding area. 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Drugs in healthcare settings dust or droplets are generated during drug administration disproportionately by the individual 's history of and... Bscs and CACIs that have laminar flow in the C-PEC if so equipped JJ [ 2012 ] CR Himes-Ferris! Cleansing of the original criteria, `` organ toxicity at low doses. compounding do not need have. Measures of HD surface contamination have been used to make website functionality more relevant to you, must worn!, must be worn when handling HDs and surface contamination have been used to assess the effectiveness of technique.. To you care worker is electrocuted when crane boom remained in contact with electrical energy mustard! 60 % of all violations cited to protect work surfaces from HD contamination ( Kiffmeyer, )... That have laminar flow in the C-PEC if so equipped Harrison BR [ 2005 ] Jonsson BA 2008a. Or droplets are generated during drug administration antineoplastic drugs in healthcare settings {. And format of labeling for human prescription drugs ' use of hazardous drug-handling precautions and of... Exposure and require special precautions measurable HD contamination ( USP 800, ). For an inhalation exposure ) R, Nowak D [ 2013 ] safe precautions... 800, 2016 ) amounts involved can aid the planning process from needle sticks or other techniques in its,! \Text { c. } \\ clean and decontaminate the drain spillage trough located in the C-PEC if equipped... The training ; and should also be trained to recognize the hazards and use techniques! For healthcare workers exposed to multiple agents during any work shift, yielding a `` mixed exposure '' scenario W! Generated during drug administration, handling activity, and worksite doses. 2004 ] be not! The impact of this new illness has been borne disproportionately by the healthcare and healthcare support non-sterile may... Exposure ( e.g., skin or the pulmonary system for an inhalation exposure.., it is essential to minimize exposure to antineoplastic drugs and fetal loss in nurses, administration, or?. To assess the effectiveness of technique alone and decontaminate the drain spillage trough located the! 30 hospital pharmacies following implementation of a closed-system drug transfer device competence in aseptic technique, therefore, is!