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). Evaluation of Chemotherapy Drug Exposure in an Outpatient Infusion Center. Occupational Safety and Health Administration (OSHA). 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. Middendorf L [1978]. Director, National Institute for [https://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf]. In 2004, a NIOSH work group authored a NIOSH Alert: "Preventing Occupational Exposure to Antineoplastic and Other HDs in Healthcare Settings," (NIOSH, 2004), a now internationally-referenced guidance document that revised ASHP's definition of HDs, including adding two more characteristics, as Figure 1 depicts. 5th ed. [DHHS (NIOSH) Publication No. Extravasation of some agents can cause severe soft-tissue injury, consisting of necrosis and sloughing of exposed areas (Duvall and Baumann, 1980; Perry, 2008; Rudolph, 1979). Class II BSC types A2, B1, or B2 are acceptable for compounding HDs. 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). Non-sterile HD compounding should be performed in a C-PEC that provides for personnel and environmental protection, such as a Class I BSC or a Containment Ventilated Enclosure (CVE) (USP 800, 2016). January 7, 2007. 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. Train workers to follow ANSI guidelines for operating cranes near overhead power lines (ANSI Standard B30.5-1994, 5-3.4.5)[ANSI 1994]. [http://www.cetainternational.org/reference/CETACompoundingIsolatorTestingGuide2006.pdf]. Medical attention should also be sought for inhalation of HDs in powder form.). Touzin K, Bussires JF, Langlois , Lefebvre M, Mtra A [2010]. October 2011. That is, records created in connection with HD handling shall be kept, transferred, and made available for at least 30 years, and medical records shall be kept for the duration of employment plus 30 years. Standard test method for resistance of protective clothing materials to permeation by liquids or gases under conditions of continuous contact. "Physical hazard" means a chemical that is classified as posing one of the following hazardous effects: explosive; flammable (gases, aerosols, liquids, or solids); oxidizer (liquid, solid or gas); self-reactive; pyrophoric (liquid or solid); self-heating; organic peroxide; corrosive to metal; gas under pressure; or in contact with water emits flammable gas. Cleaning should proceed from the least to the most contaminated areas. Cleanroom - A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. 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). For a 24-hour service, the cabinet should be cleaned two or three times daily (ASHP, 2006). Appendix 1. Citations inside parentheses use the ampersand (&). 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. Do not spray gloves that are possibly contaminated with HDs to avoid transferring HD residue to other surfaces or into the environment. 29 U.S.C. Containment Supplemental Engineering Control - Adjunct controls used in concurrence with Primary and Secondary Control Strategies. Hum Ecol Risk Assess 8(4):805-822. Packing cartons have also been identified as sources of measurable HD contamination (Kiffmeyer, 2000). OSHA has long recognized that the implementation of a safety and health program is a way of _____ A. Of 18 wipes tested, 28 percent had measurable levels of the marker drugs, including those not directly involved with preparing HDs. The laborer kicked the lineman in the chest and the lineman fell unconscious to the ground. Pharm Weekly Sci 14:1622. The results suggest that the crisis may accelerate some workforce trends . 8-1.1. Determination of the vaporization of solutions of mutagenic antineoplastic agents at 23 and 37_C using a desiccator technique. Special aseptic technique has long been advocated to reduce aerosol formation and leakage of HDs during compounding (Wilson, 1981). Section 3: ancillary respirator information. A separate OSHA document on this topic is available at: https://www.osha.gov/waste-anesthetic-gases/workplace-exposures-guidelines (OSHA, 2000). C-PECs used for non-sterile compounding do not need to have ISO 5 air quality. 10th ed. All staff handling HDs must be fully trained in the receipt, storage, handling, and disposal of these drugs. December 2013. A review of the reproductive health risks associated with occupational exposure to HDs can be found in Connor (2014). Kusnetz E, Condon M [2003]. However, they were questioned because of evidence suggesting that sampling methods were not sufficiently robust to capture drug that existed not only as a particulate, but also in gaseous form emanating from high efficiency particulate arrestor (HEPA) filters (Larson, 2003; Kiffmeyer, 2002) through sublimation. Gowns and additional gloves should be worn by HD compounders using a CACI. Scand J Work Environ Health 20(1):22-6. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Is the drug known to be a human mutagen, carcinogen, teratogen or reproductive toxicant? Transport bags should never be placed in the BSC or the isolator work chamber during compounding to avoid inadvertent contamination of the outside surface of the bag (ASHP, 2006). Technical Bulletin General Information. Spill kits and procedures for spill management should be kept in the HD work area (NIOSH, 2004; ASHP, 2006). CETA application guide for the use of surface decontaminants in biosafety cabinets CAG-004-2007. 10:374-83. Assess the size and scope of the spill. Falck K, Grohn P, Sorsa M, Vainio H, Heinonen E, Holsti LR [1979]. Any operation/procedure in their work area where drugs that present a hazard are present; The location and availability of the written hazard communication program; The location and availability of the list(s) identifying HDs present in the work area; and. Some CSTDs have been shown in peer-reviewed studies to reduce HD contamination in the workplace (Connor, 2002; Clark, 2013; Harrison, 2006; Nygren, 2002 b; Nygren, 2008; Nyman, 2007; Sessink, 2011; Sessink, 2013; Tans, 2004; Wick, 2003; Zock, 2011). Linda Rosenstock, M.D., M.P.H. Date accessed November 2014. The agencys comprehensive standards and resources help employers and workers stay safe on the job. USP <800> advises that sterile and non-sterile HDs should be compounded within a Containment Primary Engineering Control (C-PEC) located in a Containment Secondary Engineering Control (C-SEC) (USP 800, 2016). 1515 W. 22nd St, Ste 1300W, Oak Brook, IL 60523. The agency sets and enforces safety standards in the workplace, and provides education and training resources to help employers and workers stay safe. OSHA issued a letter of interpretation regarding this topic in 2004, a quote from which follows below: Employers shall develop, implement, and maintain at the workplace a written hazard communication program for employees handling or otherwise exposed to chemicals, including drugs that represent a health hazard to employees. Hazardous drug exposures in health care. Hand hygiene in healthcare settings. \end{array} & \begin{array}{c} Twenty-nine (13%) of these incidents (which resulted in 31 fatalities) involved crane contact with overhead power lines. Since sharps and potentially infectious materials may also be included in the trace contaminated materials, such containers should be managed as biohazardous waste under the Bloodborne Pathogens Standard [29 CFR 1910.1030(d)(4)(iii)] (OSHA, 2012a). Boffetta P [2007]. Fransman W, Vermeulen R and Kromhout H [2004]. ASHP's Recommended General Spill Procedures (ASHP, 2006), ASHP's Recommended Procedures for Spills in a C-PEC (ASHP, 2006). 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). Henderson DK, Gerberding JL [1989]. Date accessed November 2014. Seal bags and place them in the appropriate final container for disposal as hazardous waste. Cancer morbidity among Danish female pharmacy technicians. These recommendations apply to all healthcare settings where employees are occupationally exposed to HDs, such as hospitals, physicians' offices, and home healthcare agencies. In the first condition, the participants read an article indicating that obesity is a disease. The periodic examination may also be incorporated into an existing, broader, periodic health assessment for an organization's healthcare workers rather than function as a "stand-alone" program. Investment shifts aggregate demand when more expenditures are made on ____. A case study: Surface contamination of cyclophosphamide due to working practices and cleaning procedures in two Italian hospitals. OSHA. Controlled Environment Testing Association. 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). Accordingly, hazard training and safety practices must include hazardous drugs in tablet form. Date accessed November 2014. Wash hands thoroughly with soap and water. The victim was a member of a crew that was constructing the back concrete wall of an underground water-holding tank at a sewage treatment plant. These SOPs and P&Ps should address receiving, storage, transport, preparation, administration, spill cleanup, handling HD waste, handling patient waste, and disposal of HDs in order to protect the safety and health of all health care workers who are responsible for handling HDs. EPA (Environmental Protection Agency) [1991b]. Carcinogenesis. J Oncol Pharm Pract 20:210-216. Int J Cancer 135: 1764-1773. The authors did not report using detergent or neutralizer with this bleach solution. 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. A laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI) should not be used for the compounding of an antineoplastic HD (USP 800, 2016). Specialized settings (e.g., operating room or interventional radiology departments) may infrequently be involved in HD handling. The poles stood 20 feet high and were buried 5 feet in the ground. 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. Date accessed December 15 2014. Evaluation may involve direct observation of an individual's performance on the job. Department of Health and Human Services. Occup Med: State Art Reviews 2:513-24. [DHHS (NIOSH) Publication No. Occupational exposure to antineoplastic drugs: Identification of job categories potentially exposed throughout the hospital medication system. Exhaust air from the isolator should be appropriately removed by properly designed building ventilation. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. USP chapter 797 ("Pharmaceutical CompoundingSterile Preparations"), notes that when compounding sterile preparations of HDs, they should be handled with caution at all times during receiving distribution, stocking, inventorying, preparation, and disposal (USP 797, 2012). J Pharm Pract Res 35:264-265. Available from CETA website: http://www.cetainternational.org/reference/CETACompoundingIsolatorTestingGuide2006.pdf. Occupational exposures among nurses and risk of spontaneous abortion. Chemotherapy-handling practices of outpatient and office-based oncology nurses. Am J Health Syst Pharm 62:475-484. The exhaust fan or blower of the Class II or Class III BSC should be on at all times, except when the cabinet is being mechanically repaired or moved. Favier B, Gilles L, Ardiet C, Latour JF [2003]. The use of a pad that is large enough to block the front and/or rear grills of a Class II BSC or a CACI should be avoided. Am J Hosp Pharm 47:1033-49. A compounding dilemma: I've kept the drug sterile but have I contaminated myself? Course: "Geotechnical Engineering Laboratory", Prepared lessons according to the course outline to convey all required . J Onc Pharm Pract 6:13. For most known HDs, type A2 cabinets offer a simple and reliable integration with the ventilation and pressurization requirements of the C-SEC. OSHA also works with employers and workers to identify and correct workplace hazards. 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). Int Arch Occup Environ Health 86:47-55. Brit J Cancer 101(7):1091-1099. 90-38. Bonassi S, Norppa H, Ceppi M, Strmberg U, Vermeulen R, Znaor A, Cebulska-Wasilewska A, Fabianova E, Fucic A, Gundy S, Hansteen IL, Knudsen LE, Lazutka J, Rossner P, Sram RJ, Boffetta P [2008]. Hosp Pharm 49:355-362. Carcin 29(6):1178-83. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Toxicol Lett 207:42-52. The safety and health management systems section requires employers to develop, implement, and maintain a written safety and health program. World Health Organization. J Oncol Pharm Pract 17:39-48. A study conducted last year indicated that adults spent an average of 14 hours on household chores during the weekend. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Pharmaceutical Drugs. Selevan SG, Lindbolm ML, Hornung RW, Hemminki K [1985]. 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. 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. Department of Health and Human Services. 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. 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). The area should be identified with a warning sign to limit access to the area (ASHP, 2006; USP 800, 2016). \text { Net-Profit } \\ Numerous case reports have linked chemotherapeutic treatment to adverse reproductive outcomes (reviewed in NTP, 2013). The victim provided a path to ground and was electrocuted [NIOSH 1990b]. Eating, drinking, applying makeup, and the presence of foodstuffs should be avoided in HD work areas (ASHP, 2006). Several of these studies, including the Harvard Nurses' Study, report on a period after the initial safe handling guidance was promulgated in the mid-1980s and imply that some safe handling practices were being implemented. Using a handheld remote-control pendant, the victim fully extended the end of the boom 36 feet above the ground. 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. Harrison BR, Godefroid RJ, Kavanaugh EA [1996]. The victim and a coworker were repairing a submersible pump for a water well at a private residence. OSHA [1995]. Chromosomal aberrations can result from chemotherapy treatment as well (Chabner and Longo, 2010). Clean and decontaminate the drain spillage trough located in the C-PEC if so equipped. McDiarmid MA, Oliver MS, Roth TS, Rogers B, Escalante CP [2010]. These regulations require workers and employers to consider all overhead power lines to be energized until (1) the owner of the lines or the electric utility indicates that they are not energized, and (2) they have been visibly grounded [29 CFR 1910.333 (c)(3); 29 CFR 1926.550(a)(15)]. Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs. 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. [2014]. Reproductive health risks associated with occupational exposures to antineoplastic drugs in health care settings: A review of the evidence. A non-shedding gown that closes in the back, has sleeves that fit snugly around the wrists and is enclosed at the neck; Head and facial hair covers (e.g., beard covers in addition to face masks [see also 3.c. The location and availability of safety data sheets for all HDs in the work area. Use of a dedicated C-PEC, where only HDs are prepared, is prudent practice. Toronto, Ontario, Canada: Construction Safety Association of Ontario. Many HDs are known carcinogens for which there is no safe level of exposure. 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. Date accessed October 2014. Washington, DC: Occupational Safety and Health Administration. Per USP <800>, the entity should enforce policies that include a tiered approach, including (USP 800, 2016): USP <800> differentiates between transporting from receiving to the storage and compounding area, transporting from compounding to patient areas within the healthcare entity, and transporting from compounding to outside the healthcare entity (USP 800, 2016). The literature also documents the effects of these HDs on other organ systems. 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). Fatal Injuries to workers in the United States, 1980-1989: a decade of surveillance. Other aspects of the exam focus on target organs for drug(s) involved. The study found that the most common serious violations were failure to provide personal protective equipment, failure to Gunnarsdottir HK, Aspelund T, Karlsson T, Rafnsson VV [1997]. Postulating a dermal pathway for exposure to anti-neoplastic drugs among hospital workers. Containment Segregated Compounding Area (CSCA) - A segregated room that is restricted to preparing low-risk HD CSPs with a 12-hour or less BUD or a segregated room that is restricted to preparing non-sterile HDs. In 2004, NIOSH formulated a generic definition to describe a device used in the compounding and administration of sterile HD doses that was designed to reduce the aerosol and drug residue that may escape during a traditional needle and syringe and open IV set technique (NIOSH, 2004). 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. 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). J. Ophthalmol 62:97-9. OSHA [1986]. Safe work practices when handling HDs should include the following: The administration of aerosolized HDs requires special engineering controls to prevent exposure of health care workers and others in the vicinity.
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