Presently working as a college lecturer at the department of Fire Safety Engineering & Management at International College of Engineering & Management, Muscat, Oman. Phila. Chromosomal aberration frequency in lymphocytes predicts the risk of cancer: results from a pooled cohort study of 22 358 subjects in 11 countries. Int Arch Occup Environ Health 81(3), 285-293. Pittsburgh, PA: Onc Nurs Soc. Comprehensive Accreditation Manuals. [http:// nioshdev.cdc.gov/niosh/docs/2010-167]. Occupational Safety Health Administration. 2:I -214. One disposable scoop for collecting glass fragments. Compounded Preparation - A sterile or non-sterile drug or nutrient preparation that is compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber. Fatal Injuries to workers in the United States, 1980-1989: a decade of surveillance. A spill kit should be accessible in the receiving area. Inhalation, especially of drugs that vaporize, is an additional exposure route, and at least one study of automatic dispensing machines of oral tablets indicates that these devices may generate dust of active pharmaceutical ingredients (APIs) during the counting and dispensing process (Fent, 2014). CDC twenty four seven. Per ASHP, decontamination may be defined as cleaning or deactivating (ASHP, 2006). 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). Laboratory decontamination and destruction of carcinogens in laboratory wastes: Some antineoplastic agents. Not more than 3,520 particles (0.5 mm and larger) per m3 should be counted during material transfer, with the particle counter probe located as near to the transfer door as possible without obstructing the transfer (USP 797, 2012). October 2011. When cleaning C-PECs, one must ensure that they appropriately rinsed, and that the cleaning and rinsing materials are collected and disposed of as contaminated waste. For drug administration by a route that is likely to result in leakage, the location should be prepared with plastic-backed absorbent pads, and locking connections should be used if possible. C-PECs used for non-sterile compounding do not need to have ISO 5 air quality. Micronuclei frequency in peripheral blood lymphocytes and cancer risk: evidence from human studies. Care should be taken in manipulating sharps at all times. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Controlled Environment Testing Association. USP Chapter <797> describes appropriate facilities, worker training, and work practices to ensure safe compounding of sterile preparations, including HD doses, and is focused primarily on. Friese CR, McArdle C, Zhao T, Sun D, Spasojevic I, Polovich M, McCullagh MC [2014]. \text { Selling } \\ 297. NSF (National Sanitation Foundation) [2012]. Antineoplastic drug exposure in an ambulatory setting. 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)]. Answer Selected Answer : Correct Answer : arrives at the establishment to be inspected and displays official credentials . Centers for Disease Control and Prevention. Workplace solutions: personal protective equipment for health care workers who work with hazardous drugs. The victim provided a path to ground and was electrocuted [NIOSH 1990b]. In order to apply In compliance with the HCS [29 CFR 1910.1200] (OSHA, 2012b), all personnel involved in any aspect of the handling of HDs (physicians, nurses, nursing assistants, pharmacists, pharmacy technicians, housekeepers, and other employees involved in receiving, transport, storage, compounding, administering, waste handling and other forms of handling) must receive information and training to apprise them of the hazards of HDs present in the work area. Additional guidance for the use of a C-PEC within a classified buffer area and the appropriate garbing and cleansing procedures for sterile compounding of HDs can be found in USP <797> and USP <800> (USP 797, 2012; USP 800, 2016). Absorbent sheets should be incinerable. Joint Commission Resources. Discarded commercial chemical products, off specification species, container residues, and spill residues thereof. Place all disposable PPE into disposal bags. The outside of bags or bottles containing the prepared drug should be wiped with moist gauze. Exposure may occur by inhalation when HD dust or droplets are generated during drug administration. While controversy previously existed as to the degree of hazard that handling HDs presented to pregnant HCWs or those attempting to conceive, data published recently have shown excess reproductive loss in those workers, even with the use of BSCs as mentioned above (Peelen, 1999). Evaluation of these preparation techniques, using fluorescent dye solutions, has shown contamination of bag ports, gloves, and the sleeves and chest of gowns (Stellman, 1987; Spivey and Connor, 2003). Onc Nur Forum 38(6):718-726. Occupational exposure to antineoplastic drugs: Identification of job categories potentially exposed throughout the hospital medication system. 2007. For sterile compounding, hands should be washed before donning gloves, and then sanitized routinely during compounding activities (USP 797, 2012). Occupational exposure to anticancer drugs-potential and real hazards. Int Arch Occup Environ Health 64:105112. Transport bags should never be placed in the C-PEC work chamber during compounding to avoid inadvertent contamination of the outside surface of the bag (ASHP, 2006). Dermal exposure to cyclophosphamide in hospitals during preparation, nursing and cleaning activities. Other HDs, such as zidovudine (formerly AZT), are known to have significant side effects (i.e., hematologic abnormalities) and some monoclonal antibodies (biologics) may cause malignancy and reproductive effects in treated patients (Anderson, 1982; Henderson and Gerberding, 1989; Hansel, 2010). Blair A, Zheng T, Linos A, Stewart PA, Zhang YW, Cantor KP [2001]. The Act covers most private-sector employers and their workers. OSHA Hazard Communication Standard. Harrison BR, Peters BG and Bing MR [2006]. Some IV equipment, such as a CSTD, is designed to minimize drug leaks when HDs are administered (NIOSH, 2004). EPA (Environmental Protection Agency) [1986]. Vertical airflow C-PECs (Class II or III BSC or CACI) differ from horizontal airflow devices in several ways that require special precautions. Aerosolized medication safety recommendations are available from the Society of Infectious Disease Pharmacists (Le, 2010). They should be placed in a puncture-resistant container, then into an HD disposal bag with all other HD-contaminated materials. 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). Per ASHP, many devices labeled as "chemo adjuncts" are currently available (ASHP, 2006). Such failure to use appropriate precautions results in occupational exposure, with 4-17 percent of employees reporting known skin or mucous membrane contact with HDs in the previous year (Friese, 2012; Boiano, 2014; Boiano, 2015). These studies raise the question of whether the skin contact pathway may be not only a common but also biologically important exposure route of absorption for under-protected workers for at least some agents (Kromhout, 2000). This paragraph is for informational purposes only and is not a substitute for the requirements of the Hazard Communication Standard (HCS) [29 CFR 1910.1200] (OSHA, 2012b). Occupational Exposure to Bloodborne Pathogens Standard. Respirators should be available near the spill kits. By promoting safe and healthy working conditions, the agency helps to protect workers safety and health, and ultimately helps to improve the competitiveness of American businesses. After use, gloves and gowns should be disposed of in designated HD waste containers (NIOSH, 2004). Studies have detected the presence of HDs in the urine of HCWs who have handled these drugs, and in others who did not work directly with the drugs but who were only in the work area (Sessink, 1997; Wick, 2003; Fransman, 2004; Suspiro, 2011; Hon, 2015). USP <800> has identified C-PECs as the appropriate ISO Class 5 cabinets for sterile compounding (USP 800, 2016). HSE (Health and Safety Executive) [2003]. USP <800> states that compounding personnel of reproductive capability should confirm in writing that they understand the risks of handling HDs. OSHA [2013]. The entire cabinet is under negative pressure, and operations are performed through attached gloves. Pharmacother 30(6):562-584. Per ASHP, a C-PEC that runs continuously should be cleaned before the day's operations begin, at regular intervals, or when the day's work is completed (ASHP, 2006). NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Newer agents, such as high level disinfectants containing hydrogen peroxide and peracetic acid, may provide alternatives to bleach when used in HD equipment cleaning programs. NIOSH [2014b]. There are a number of devices marketed as CSTDs but there is currently no performance standard by which all CSTDs are evaluated for containment. Under USP <800>, storage areas for antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API should be separated from non-HDs in a manner that prevents contamination and personnel exposure. External contamination of cytotoxic drug packing: Safe handling and cleaning procedures. Polovich, M [2011]. Reusing gowns increases the likelihood of exposure to HDs (NIOSH, 2009); Wear gowns during compounding, administration, when handling waste from patients recently treated with HDs, when cleaning up spills of HDs, and whenever there is a possibility of splash or spill (ASHP, 2006; NIOSH, 2009); Do not wear gowns outside the compounding or administration area to avoid spreading drug contamination to other areas and possibly exposing non-protected workers (NIOSH, 2009); If no permeation information is available for the gowns in use, change them every 2 to 3 hours or immediately after a spill or splash (ASHP, 2006); Remove gowns with care to avoid spreading contamination. For sterile compounding, only supplies and drugs essential to compounding the dose or batch should be placed in the work area of the C-PEC (USP 800, 2016). Surgeon General has summarized the findings of study after study, none of which . Examples of C-PEC for non-sterile compounding include a Class I BSC, a containment ventilated enclosure (CVE), and an isolator intended for containment applications (USP 800, 2016). Thus, a discussion of alternative duty availability and the administrative mechanisms to request it should be part of the hazard communication discussion. 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)]. Date accessed December 2014. These findings demonstrate that employers have failed to sufficiently protect all personnel potentially exposed to HDs. Several studies examining cleaning techniques in HD compounding and administration areas have found residual HD contamination after cleaning in most instances (Acampora, 2005; Hedmer, 2008b; Touzin, 2010; Turci, 2011; Chu, 2011). 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)]. | Learn more about Saravana Raja Kumar's work experience, education, connections & more by visiting . Evaluation of safety climate, health concerns, and pharmaceutical dust exposures at a mail order pharmacy. One of the primary objectives of the OSHA program is to prevent workplace injuries and illnesses. He died on the scene. Cash budget: Scenario analysis Trotter Enterprises, Inc., has gathered the following data to plan for its cash requirements and short-term investment opportunities for October, November, and December. 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). Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. Equipment should either be disposable as HD contaminated waste, or, if reusable, should be able to be decontaminated with a suitable chemical without adding exposure risk to the worker and contamination risk to the environment (USP 800, 2016). The laborer (who was working in the back of the truck) noticed that the lineman was being shocked and was unable to let go of the hand control. Works by two authors. 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. Bystander uptake of drug in non-drug handling health workers, including support staff, has also been reported (Sessink, 1992b; Hon, 2015). Kiffmeyer TK, Kube C, Opiolka S, Schmidt KG, Schoppe G, Sessink PJM [2002]. Wipe the neck with sterile alcohol and allow it to dry. The criteria for determining whether a chemical is classified as a health hazard are detailed in Appendix A of the HCS -- Health Hazard Criteria. Hosp Pharm 38:135-139. J Occup Environ Hyg 11:728-740. Spill Kit - A container of supplies, warning signage, and related materials used to contain the spill of a HD. 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. Mason HJ, Blair S, Sams C, Jones K, Garfitt SJ, Cuschieri MJ, Baxter PJ [2005]. Ann Occup Hyg 48(3):237-244. [DHHS (NIOSH) Publication No. 2008. Sotaniemi EA, Sutinen S, Arranto AJ, [1983]. Occupational health and safety of personnel handling chemotherapeutic agents in Greek hospitals. Date most recently accessed December 11, 2015. NIOSH [2004]. 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. Lee, SB [1988]. Sterile gauze should be placed around syringe connection sites (ASHP, 2006, Polovich, 2011). Precautions include using personal protective equipment, work equipment, and work practices designed for safety. If the damaged package should be opened, USP recommends the following additional action (USP 800, 2016): Seal the container in plastic or an impervious container and transport it to a Class I containment device for non-sterile HD compounding; Place a plastic-backed preparation mat on the work surface of the Class I device; Open the package and remove usable items; Wipe the outside of the usable items with a disposable wipe; Enclose the damaged item(s) in an impervious container, label the outside container as "Hazardous", and contact the supplier for instructions. The truck driver was airlifted to a nearby burn center where he later died as a result of electrical burns [NIOSH 1993b]. Finally, the NIOSH work group added helpful refinements to one of the original criteria, "organ toxicity at low doses." Morgantown, WV: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupa- tional Safety and Health, Fatal Accident Circumstances and Epidemiology (FACE) Report No. 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. NABP (National Association of Boards of Pharmacy) [2014]. Connor TH, DeBord G, Pretty JR, Oliver MS, Rogers BR, Escalante CP, McDiarmid, MA [2010]. . 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. J Occup Environ Med 52:1028-1034. Its primary mission is to ensure safe and healthy working conditions for American workers by setting and enforcing standards. The OSHA 30 hour training course for general industry is designed to help foremen, supervisors, managers, safety committee members, safety staff, and others with responsibility for . Date accessed October 2014. C-PECs used for sterile compounding should be disinfected routinely, per USP <797> (USP 797, 2012). These findings demonstrate that employers have failed to sufficiently protect all personnel potentially exposed HDs! 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