Air exchanged from the surrounding environment should not occur unless it is first passed through a microbially retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Twenty-nine (13%) of these incidents (which resulted in 31 fatalities) involved crane contact with overhead power lines. removing air from the IV administration sets by running HD containing fluid through the set (i.e., priming the line). 2012-0044-3199]. Department of Health and Human Services. NIOSH, ASHP, and others have reported on studies that found drug residue on the outside of HD vials when they arrive at the workplace from the manufacturer or distributor (NIOSH, 2004; ASHP, 2006; Power, 2014). Analysis of construction fatalitiesthe OSHA database 1985-1989. Philadelphia, PA: Lippincott, Williams & Wilkins. If priming is done at the administration location, spiking should be performed using an adapter that minimizes leakage, and IV sets should be primed with non-drug containing solution using a backflow method. Selevan SG, Lindbolm ML, Hornung RW, Hemminki K [1985]. NIOSH recommends that regular training reviews be conducted with all potentially exposed workers in workplaces where HDs are used. Hos Pharm Eur 23, 52-54. Department of Health and Human Services. Employees involved in the aerosol administration of ribavirin have noted symptoms of respiratory tract irritation (Lee, 1988). Luer-Lock fittings avoid separation during use for HD compounding and during administration. Lancet II:1284-5. The C-PEC for non-sterile HD compounding should be placed in a C-SEC that is externally vented, have at least 12 ACPH, and be at negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas (USP 800, 2016). Drugs that have been identified as requiring HD handling precautions should be clearly labeled at all times during their transport (USP 800, 2016). Infusion sets and pumps should be observed for leakage during use. This residue may transfer to workers when receiving HDs, storing HDs, performing inventory control, selecting HDs for compounding, and all other times when workers interact with potentially contaminated vials. Browse: Home. The onset of bronchospasm in a pentamidine-exposed worker has also been reported (Doll, 1989). The methods the employer will use to inform employees of the hazards of non-routine tasks in their work areas. [https://www.cdc.gov/niosh/topics/hazdrug/]. GTB0131. Pittsburgh, PA, Oncology Nursing Society. OSHA updated the guidelines in 1995 and subsequently posted them to OSHA's website in 1999 (OSHA, 1995; OSHA, 1999). The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Good organizational skills are essential to minimize contamination and maximize productivity during compounding (ASHP, 2006). Multiple studies show that workers have continued physical contact with HD contaminated surfaces in the many work areas where HDs are handled. Chemotherapy Safety Standards. Mason HJ, Morton J, Garfi tt SJ, Iqbal S, Jones K [2003]. The Cost of Stress Besides the toll on health, stress also cost businesses and the economy trillions in absenteeism, low productivity, and healthcare costs. Am J Health Syst Pharm 53(22):2713-23. Information should be included in a confidential data base that the organization manages to track exposures as a formal log. Exposure to antineoplastic drugs in two UK hospital pharmacy units. Micronuclei frequency, a count of chromosome remnants that mark flawed chromosomal segregation during cell division (Fenech, 2008), are also considered to be epidemiologically prognostic of a future cancer risk at the group level (Bonassi, 2007; Bonassi, 2008; Bonassi, 2011). A laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI) should not be used for the compounding of an antineoplastic HD (USP 800, 2016). Ann Occup Hyg 49:603-610. Which of the following is one of the purposes of OSHA quizlet? Sealable bags should be used for transporting HDs (ASHP, 2006; USP 800, 2016). to steal and pass off (the ideas or words of another) as one's own. NIOSH [2009]. Mutagenicity in urine of nurses handling cytostatic drugs. I am a teacher at Smart Start Georgia, where I work with students of all ages to help them develop their skills and learn how to be successful in life. J Oncol Pharm Pract. Handbook of Cancer Chemotherapy. Spills that cannot be contained by two spill kits may require outside assistance. HD handling areas should be established for sterile and non-sterile compounding: NIOSH, USP, and ASHP recommend that HD compounding be performed in a restricted and preferably centralized area. Appropriate PPE to protect the worker during cleanup, including two pairs of disposable chemotherapy gloves, non-permeable, disposable protective garments (coveralls or gown and shoe covers), and face shield. 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. NIOSH [1991]. Taskinen HK, Olsen J, Bach B [1995]. ASHP also recommends having procedures and kits for immediate treatment of workers with direct skin or eye contact with HDs (ASHP, 2006). Judging clearance distances near overhead power lines. November 2012. \end{array} & \begin{array}{c} 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. Ann Occup Hyg 52(8):765-771. The victim and a coworker were repairing a submersible pump for a water well at a private residence. One study found a commercial sodium hypochlorite/sodium thiosulfate product to be more successful at removing cyclophosphamide (CP) when compared to other cleaning solutions (Touzin, 2010). Sessink PJM, Connor TH, Jorgenson JA, Tyler TG [2011]. The purpose of this study was to investigate lens crystallin aggregate formation in hyperbaric oxygen (HBO)-treated guinea pigs by using in vivo and in vitro methods. Am J Hosp Pharm 47:1061-6. 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. Friese CR, Himes-Ferris L, Frasier MN, McCullagh MC, Griggs JJ [2012]. Question 10 Obviously, not all seven million workplaces covered by the Act can be inspected immediately. Is the drug known to be a human mutagen, carcinogen, teratogen or reproductive toxicant? Open front Class II BSCs should preferably be placed in ISO 7 buffer areas with minimal air turbulence (USP 797, 2012). Where HDs are used in the workplace, sound practice dictates that employers develop a written Hazardous Drug Safety and Health Plan. Workers should also be trained to recognize the hazards and use proper techniques when rescuing coworkers or recovering equipment in contact with electrical energy. A "closed system drug-transfer device" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system (NIOSH, 2004). Linda Rosenstock, M.D., M.P.H. Procedures should be evaluated step-by-step for the likelihood of drugs being released into the environment so that exposure can be minimized. Evaluation may involve direct observation of an individual's performance on the job. HDs and contaminated materials should be disposed of in accordance with federal, state, and local laws. Ribavirin: The need for exposure precautions. OSHA does this by setting and enforcing standards, providing training, outreach, and education, and creating and enforcing regulations. Mutat Res 154:135-149. in an occupation). 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)] Jun;29(6):1178-83. doi: 10.1093/carcin/bgn075. Employees should work below eye level to reduce the chance for eye exposure. Vol 10. Kromhout H, Hoek F, Uitterhoeve R, Huijbers R, Overmars RF, Anzion R, Vermeulen R. [2000]. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans; Genetic and related effects: An updating of selected IARC Monographs from Volumes 1-42. International Agency for Research on Cancer. All health care settings where HDs are administered should have spill kits and emergency skin and eye decontamination equipment, as well as relevant Safety Data Sheets for guidance in the case of spills or employee exposure (USP 800, 2016). Am Rev Resp Dis 139:1060. Socie G, Henry-Amar M, Cossett JM, Devergie A, Girinsky T, Gluckman E [1991]. ASTM tested "chemotherapy" gloves should be worn when counting and pouring HDs, and C-PEC designed for non-injectable HDs should be used (USP 800, 2016). The persistent presence of HD contamination in compounding and administration areas, despite adherence to HD safe handling guidelines, has generated an interest in supplemental containment controls, especially for administration areas where primary engineering controls are not available. Data from the NIOSH National Traumatic Occupational Fatalities (NTOF) Surveillance System indicate that electrocutions accounted for approximately 450 (7%) of the 6,400 work-related deaths from injury that occurred annually in the United States during the period 1980-89 [NIOSH 1993a]. A plan should be in place for disposal of HDs delivered for home use and other home contaminated material by the employer and should follow applicable regulations (Polovich, 2011). Once attached, the IV set should never be removed from an HD dose, thereby preventing the residual fluid in the bag, bottle, or tubing from leaking and contaminating personnel and the environment (ASHP, 2006). Brit J Cancer 101(7):1091-1099. Disposal of the waste bag should follow HD disposal requirements. Buffer Area - Part of the compounding area where the primary containment engineering control (CPEC) is physically located. This is an example of _____. The training should include at least the list of HDs; review of HD handling policies; proper use of PPE, equipment and devices; response to known or suspected HD exposure; spill management; proper disposal of HDs and trace contaminated equipment (USP 800, 2016). This section includes requirements for process safety information, process hazard analyses, and operating procedures. Notably of the 184 drugs that NIOSH identifies as HDs in its 2014 list (NIOSH, 2014), about 80 percent are classified by the FDA as Pregnancy Category D or X, which indicates a potential for fetal harm when used during pregnancy (FDA, 1997). Nearly 30% (113) of these electrocutions involved cranes. Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs. While filtered venting devices help equilibrate the pressure, large bore spikes create holes in the septa that may release drug. The CSA recommendations also address the limitations of proximity warning devices, hook insulators, insulating boom guards, swing limit stops, nonconductive taglines, ground rods, and similar devices for protection against electrical hazards. Class II BSCs and CACIs that have laminar flow in the work area may have a removable work tray as the work surface. NIOSH [2014b]. CA, Cancer J Clin 56:354-365. Containment Secondary Engineering Controls - The design and operation of the room in which the C-PEC is placed. The principal contributor to this Alert is Paul H. Moore, Division of Safety Research. While the concentrations of drug measured were often not high, the frequency of positive (measurable) results, the frequency of positive (measurable) results suggested extensive contamination, and thus exposure opportunities for workers. Wipe the neck with sterile alcohol and allow it to dry. Presently working as a college lecturer at the department of Fire Safety Engineering & Management at International College of Engineering & Management, Muscat, Oman. USP Chapter <800> Proposed Chapter: General Chapter <800>- Hazardous DrugsHandling in Healthcare Settings. Cleanroom - A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Per USP <800>, all areas where HDs are handled and all reusable equipment and devices should be deactivated, decontaminated, and cleaned (USP 800, 2016). 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. Shipped HDs that are subject to EPA regulation as hazardous waste are also subject to Department of Transportation regulations as specified in 49 CFR 172.101. HDs should be dispensed in the final dose and form whenever possible (ASHP, 2006). Occupational dermal exposure to cyclophosphamide in Dutch hospitals: A pilot study. NIOSH encourages employers to consider de-energization (where possible) as the primary means of preventing injury from contact between cranes and power lines. The US Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. Per USP, training should occur prior to preparing or handling HDs, and its effectiveness should be verified by testing specific HD preparation techniques. Other aspects of the exam focus on target organs for drug(s) involved. In: Drug distribution and control: preparation and handlingguidelines. Castegnaro M, De Meo M, Laget M, Michelon J, Garren L, Sportouch MH, Hansel S [1997].Chemical degradation of wastes of antineoplastic agents 2: Six anthracyclines: idarubicin, doxorubicin, epirubicin, pirarubicin, aclarubicin, and daunorubicin. NSF (National Sanitation Foundation) [2012]. Initial decontamination (cleaning) should consist of surface cleaning with water and detergent followed by thorough rinsing. Don PPE including double gloves and respirator. A new monitoring method using solid sorbent media for evaluation of airborne cyclophosphamide and other antineoplastic agents. J Occup Environ Hyg. Gowns or gloves that are knowingly contaminated should be changed immediately. Risk of handling injectable antineoplastic agents. For HD administration, use of protective gowns ranged from 50-65 percent, use of chemotherapy gloves ranged from 78-85 percent, and double-gloving was particularly low, at only 11-20 percent (Polovich, 2011, 2012; Boiano, 2014). Schierl R, Herwig A, Pfaller A, Groebmair S, Fischer E [2010]. Sargent EV, Kirk GD [1988]. Department of Health and Human Services. The general principles of aseptic technique, therefore, will not be detailed here. OSHA Hazard Communication Standard. Access to Employee and Medical Records Standard. When designating a drug as hazardous, professionals trained in pharmacology and toxicology have historically considered several factors (McDiarmid, 1991) that are similar to the considerations used in NIOSH's approach, including: 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 determinations. Additionally, the website provides information on specific safety topics, such as how to safely operate machinery. The National Institute for Occupational Safety and Health (NIOSH) requests assistance in preventing electrocutions of crane operators and crew members working near overhead power lines. Am J Ind Med 40(1):3-14. if his coworker on the ground hears his cry, how much time do they have to take measures to break his fall, based on OSHA definitions of workers and their roles, every person working at a construction site should be, lead most commonly enters the body through, it is mandatory for employers to provide a stairway or ladder at points of access where the elevation between 2 steps is ___ or more, which hard hat class protects against falling objects and high voltage electric shock and burns, a study conducted by OSHA showed that nearly _______ percent of work related electrocutions involved cranes, all workers and their employers under federal government authority, what is an acceptable alternative to installing an audible back up alarm on vehicles, running ropes must be taken out of service of the have ________ broken wires in one strand in one lay, ladders having a pitch in excess of ________ from horizontal are not permitted, when not in use, hand held electric power tools should be, Occupational Safety and Health Administration, under certain circumstances, which one of these engineering controls can create a caught between hazord, which one of the following circuit interrupts is most effective at preventing major shocks, When can you use the cross bracing given on the rear of a step ladder for climbing, only when the ladder is designed for that purpose, when going up or down a ladder, workers should do all of the following except, as part of a written. National Institute for Occupational Safety and Health. Occupational exposure to antineoplastic drugs in seven Italian hospitals: the effect of quality assurance ad adherence to guidelines. Toxic effects on reproduction in hospital personnel (in Dutch). December 2013. Individuals responsible for HD preparation reported failure to wear protective gowns 20-36 percent of the time and failure to wear chemotherapy gloves 8-10 percent of the time (Polovich, 2012; Boiano, 2015). After use, gloves and gowns should be disposed of in designated HD waste containers (NIOSH, 2004). Lyon, France. Post-exposure evaluations are tailored to the type of exposure (e.g., spills or needle sticks from syringes containing HDs). Early speculation noted inhalation was the primary route of exposure. Int Arch Occup Environ Health 81(3), 285-293. In 2015, there were 124,587,000 (Source: United States Census) households in the United States. Unused drugs should be returned to the pharmacy. 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. OSHA [2015]. . Occupational exposures among nurses and risk of spontaneous abortion. Mutagenesis 26: 93-100. Sodium hypochlorite 0.5 percent, a degradation type solution, showed the highest overall effectiveness, with removed 98 percent contamination all 10 drugs from both surfaces. 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 [29 CFR 1910.333(c)(3); 29 CFR 1926.550(a)(15)]: De-energize and visibly ground electrical distribution and transmission lines at the point of work, Use insulated barriers that are not a part of the crane to prevent contact with the lines. Risk for physicians handling antineoplastic drugs [letter to the editor]. Toxicol Lett 207:42-52. The victim grasped the handle of the bucket door and pushed down to open it, bringing the crane cable into contact with the power line. 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). USP <800>, TJC, NIOSH, and ASHP include periodic evaluations of the HD list, facilities, and worker training. This approach is the only prudent public health approach, since safe concentrations for occupational exposure to HDs have not been conclusively determined (NIOSH, 2004). Evaluation of decontamination efficiency of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. OSHA has a number of standards that cover specific hazards in the workplace. 40 CFR 261.20-24. Maintain minimum clearance between energized power lines and the crane and its load [29 CFR 1910.333(c)(3)(iii); 29 CFR 1926.550(a)(15)(i), (ii), (iii)]. J Oncol Pharm Pract 20:210-216. Preventing Worker Deaths and Injuries When Handling Micotil 300. Drug preparation, administration, disposal and spill management procedures that minimize worker and environmental exposure (USP 800, 2016). Date accessed November 2014. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. >, TJC, niosh, 2004 ) ( CDC ) can not detailed! 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