Spills that cannot be contained by two spill kits may require outside assistance. Workplace solutions: medical surveillance for healthcare workers exposed to hazardous drugs. Since the EPA lists of hazardous wastes have not been updated since the 1980s, EPA's Office of Inspector General has strongly recommended that EPA conduct a review of drugs that have entered the market since that time, particularly chemotherapy agents, to determine which drugs should be managed as hazardous waste, in order to protect human health and the environment EPA OIG, 2012). CETA (Controlled Environment Testing Association) [2008]. Examples of manipulations that can cause escape of HD residue by splattering, spraying, and aerosolization include: piercing drug vial septa with needles or dispensing pins; withdrawal of needles or pins from drug vials; drug transfer using syringes and needles or dispensing pins; drug transfer from ampules using filtered needles or filter straws; expulsion of air from a drug-filled syringe; piercing injection ports of IV bags or bottles with needles to inject HDs; spiking delivery ports of HD-containing IV bags or bottles with the sharp spike of IV administration sets; and. What are the 4 components to the OSHA standard? Blood for baseline counts and archiving (spin and freeze) after major exposures. Sessink PJM, Boer KA, Scheefhals APH, Anzion RB, Bos RP [1992b]. 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. 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). I am passionate about education and helping students reach their fullest potential. Determining sources of workplace contamination with antineoplastic drugs and comparing conventional IV drug preparation with a closed system. OSHA [2012b]. Examination and laboratory evaluation should be guided by the individual's history of exposures and follow the outline of the periodic evaluation. Luer-Lock fittings avoid separation during use for HD compounding and during administration. A large U.S. cancer mortality study of HCWs in 24 states found a 30 percent excess of myeloid leukemia among nurses and a two-fold excess in pharmacists (Petralia, 1999). Carcin 28:625-631. The National Institute for Occupational Safety and Health (NIOSH) estimates that somewhere around 8 million HCWs are potentially exposed (NIOSH, 2009). 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). NIOSH prepared a Workplace Solution in 2009 on Personal Protective Equipment for Health Care Workers Who Work with HDs to provide guidance on the PPE needed to safely handle HDs (NIOSH, 2009). NIOSH [2012]. National Institute for Occupational Safety and Health. 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). October 2008. Each BSC should be equipped with a continuous monitoring device to allow confirmation of adequate air flow and cabinet performance. Staff should avoid entering isolation rooms during treatment, but if entry is necessary, they must wear gowns, gloves, eye protection, shoe covers, and a powered air purifying respirator. Type A2 cabinets have a higher inflow velocity, have recirculated air within the cabinet similar to the A1 and may exhaust HEPA filtered air back into the work area or to the environment through properly functioning exhaust canopies, and have all contaminated ducts and plenums under negative-pressure or surrounded by negative-pressure ducts and plenums. 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. 5 times Rapid Commun Mass Spectrom 12:1485-1493. Cisplatin contamination observed on the outside of drug vials. For example, a Danish study of female pharmacy technicians found a statistically significant increased risk of non-Hodgkin's lymphomas (Hansen, 1994), a cancer seen in excess in cancer patients following certain therapies (Krishnan and Morgan, 2007). Las Vegas, Nevada. 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). Mutat Res 154:135-149. December 2013. However, the crane boom remained in contact with the power line, the truck tires ignited, and the truck began to burn. To remove the poles, the lineman positioned the crane directly under the power line. EPA (Environmental Protection Agency) [1991a]. Exposures to pharmaceutical dust at a mail order pharmacy - Illinois. The standard addresses the following issues: The Construction Safety Association of Ontario, Canada (CSA) recommends safe work practices in addition to those addressed in the OSHA and ANSI standards [CSA 1982]. A new monitoring method using solid sorbent media for evaluation of airborne cyclophosphamide and other antineoplastic agents. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel are not exceeded for a specified cleanliness class (See USP 36, Chapter <1116>, "Microbiological Control and Monitoring of Aseptic Processing Environments," and also the definition of "Buffer Area"). While the workers were pulling out the third pole, the end of the boom contacted the overhead power line. Exposure may occur by accidental injection from needle sticks or other sharps contaminated by HDs. Therefore, it is essential to minimize exposure to all HDs. 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). What is OSHA What is its purpose quizlet? Precautions include using personal protective equipment, work equipment, and work practices designed for safety. The use of air pressure relationships that define the direction of airflow into the cabinet. Spivey S, Connor TH [2003]. Int Arch Occup Environ Health 81(3), 285-293. NIOSH [2013]. 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. Information from previous medical examinations of the employee. Alternative methods should be carefully evaluated to ensure that they do not introduce new hazards into the workplace. Personnel competency should be reassessed every 12 months (USP 800, 2016). Care should be taken not to damage the fixed-glove assembly in a CACI. BSCs and CACIs should not be overcrowded to avoid unnecessary contamination with HD residue and possible interference with laminar flow for puncturing critical sites (ASHP, 2006; USP 797, 2012; USP 800, 2016). International Agency for Research on Cancer. HDs are administered through many different routes, in several types of settings, and for numerous disease states. Importantly, some HDs possess male mediated reproductive toxicity and, therefore, alternative duty should also be extended to male employees, especially those with a history of inability to conceive (HSE, 2003). 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. Obtain spill kit and respirator, if needed. 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. NSF/ANSI 49-2011. Hon CY, Teschke K, Chu W, Demers P, Venners S. [2013] Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals J Occup Environ Hyg. The needle should be replaced with a locking cap, and the syringe should be surface decontaminated and labeled (ASHP, 2006). Compounding of sterile doses of HDs should be done in a facility that meets USP <797> and USP <800> (USP 797, 2012; USP 800, 2016). 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. An initial physical examination is performed, which focuses on the targeted organ systems of commonly used drugs: the skin, mucous membranes, and lymphatic systems. The agency also conducts inspections of workplaces to ensure compliance with safety standards. ", (https://edit.osha.gov/laws-regs/standardinterpretations/2005-02-08-0.). [2015] Adherence to Precautionary Guidelines for Compounding Antineoplastic Drugs: A Survey of Nurses and Pharmacy Practitioners. These findings demonstrate that employers have failed to sufficiently protect all personnel potentially exposed to HDs. Nearly 30% of these electrocutions involved cranes. 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). Oral solid forms of HDs should not be placed in automated counting machines, as these have been shown to produce "pill dust" in the work area, some of which is active drug (Fent, 2014). Compliance with OSHA standards is mandatory for most employers in the United States. 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. 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. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. Healthcare workers may be occupationally exposed to HDs in many different types of settings. Roche Laboratories (Nutley, NJ) [1996]. 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). Int Arch Occup Environ Health 86:333-341. While filtered venting devices help equilibrate the pressure, large bore spikes create holes in the septa that may release drug. Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system. 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. Centers for Disease Control and Prevention. The area should be identified with a warning sign to limit access to the area (ASHP, 2006; USP 800, 2016). Foreman electrocuted and lineman injured after truck-mounted crane boom contacts 7,200-volt overhead power line in Virginia. Prohibit persons from touching the crane or its load until a signal person indicates that it is safe to do so. In both cases, no safe handling precautions were used. 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). Negative Pressure Room - A room that is at a lower pressure than the adjacent spaces and, therefore, the net flow of air is into the room. 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). 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. Department of Health and Human Services. NIOSH [1990c]. 40 CFR 261.20-24. Compounding should take place in a ventilated cabinet (NIOSH, 2004; USP 800, 2016). Pittsburgh, PA: Onc Nurs Soc. A description of any personal protective equipment used or to be used. Other aspects of the exam focus on target organs for drug(s) involved. All air is HEPA filtered. Hosp Pharm 42:219-225. HDs that have been identified as requiring safe handling precautions should be clearly labeled at all times during their transport and use (USP 800, 2016); A list of HDs in use in the facility is required by the HCS, and is also recommended by the TJC, as Elements of Performance for Medication Management (MM).01.01.03 (OSHA, 2012b; TJC, 2015); Safety Data Sheets (SDS) must be available for all HDs on the facility list; Areas and procedures for HD storage and preparation should be designated (USP 800, 2016); Specific control measures should be used to reduce employee exposure to HDs, including appropriate ventilation controls, personal protective equipment, work practices, and ancillary devices, such as closed system drug-transfer devices (USP 800, 2016); Ventilation controls should be used to protect personnel from HD exposure, such as biological safety cabinets and containment isolators (USP 800, 2016); Appropriate personal protective equipment must be available and used based on the type of HD handling activities [29 CFR 1910.132] (USP 800, 2016); Ventilation systems and other protective equipment should function properly, and specific measures to ensure proper and adequate performance of such equipment should be in place (USP 797, 2012); Safety programs must identify and include all workers who may be at risk of exposure; Information and training for personnel responsible for HD handling must be provided; Medical surveillance and methods of protection of personnel responsible for HD handling should be provided; and. The aim of Study 1 was to construct the scale and examine its psychometric properties through a cross-sectional design. On August 22, 1990, a 24-year-old foreman for a telecommunications company was electrocuted when he grabbed the door handle on a truck-mounted crane whose boom was in contact with a 7,200-volt overhead power line. Washington, DC: U.S. Department of Labor, Occupational Safety and Health Administration. Prior to cleanup, appropriate protective equipment should be donned. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. Safety Trainer: Conducted weekly safety meetings, toolbox talks, First Aid/CPR and AED training, Smith System, remote safety calls using MS Teams, and . Joint Commission Resources. Fransman W, Vermeulen R and Kromhout H [2005]. Liver damage in nurses handling cytostatic agents. Smoking, drinking, applying cosmetics, and eating where HDs are prepared, stored, or used, also increase the chance of exposure and should be prohibited in these areas. Appendix 1. Without appropriate compounding work practices, both workers and patients are at risk. European Journal of Oncology Nursing, 13(5), 368-375. Section 3: ancillary respirator information. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. 2013-103. 2010-150]. McLendon BF, Bron AF [1978]. Personal protective equipment (PPE) - Items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures. Pedersen-Bjergaard J, Andersen MK, Christiansen DH, Nerlov C [2002]. Exercise caution when travelling over uneven ground that could cause the crane to weave or bob into power lines. Information about reproductive risks of the job and the procedures by which alternative duty can be requested can be part of Hazard Communication training for workers. Wick C, Slawson MH, Jorgenson JA, Tyler LS [2003]. "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. Additional HD gloves should be worn to remove broken glass in a C-PEC. Assess the size and scope of the spill. most educated ethnic group in america. Equipment for HD administration depends on the route of drug administration and the delivery system being used. If the blower is turned off, the BSC should be decontaminated before reuse (ASHP, 2006). 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. Sleeves, gauntlets, and glove assemblies develop pinholes and other damage and should be monitored for this. McDiarmid MA, Oliver MS, Roth TS, Rogers B, Escalante CP [2010]. 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. 58(18):4117-21. The NIOSH 2004 Alert on HDs and the ASHP 2006 HD Guidelines provide recommendations for similar safety programs that also include these elements (NIOSH, 2004; ASHP, 2006): Standard operating procedures (SOPs) or policy and procedures (P&Ps) that provide a comprehensive safety program to deal with all aspects of the safe handling of HDs should be in place. to present as new and original an idea or product derived from an existing source. New York, NY: American National Standards Institute, ANSI B30.5-1994. 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. NIOSH [2005]. Class II type B2 BSCs are typically reserved for use with volatile components (USP 800, 2016). Procedures for safe removal of all contaminated waste should be used by all workers (ONS, 2013; USP 800, 2016). The victim and a coworker were repairing a submersible pump for a water well at a private residence. Early speculation noted inhalation was the primary route of exposure. Nearly half of the incidents occurred in the construction industry. Laborer touching suspended cement bucket electrocuted when crane cable contacts 7,200-volt power line in North Carolina. 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. J Environ Monit 4:739-732. These bags should be sealed and then discarded. \hline A review of the reproductive health risks associated with occupational exposure to HDs can be found in Connor (2014). Cancer Epidemiol Biomarkers Prev 16(3):377-80. Accidental injection from the use of needles or contact with broken glass fragments is also of concern. Husky Superior Refinery conducted a significant community monitoring program and shared results of that monitoring with the public through the Douglas County Department of Emergency Management. The worst situations need attention first. Lamerie TQ, Nussbaumer, S, Dcaudin B, Fleury-Souverain S, Goosens J-F, Bonnabry P, Odou P [2013]. J Occup Environ Med 40(11):964-968. Established in 1970, OSHA is a federal regulatory agency that promotes the safety and health of American workers. Touzin K, Bussires JF, Langlois , Lefebvre M, Mtra A [2010]. CSTDs should be used for administration of antineoplastic HDs when the dosage form allows (Polovich, 2011; USP 800, 2016). Reusable PPE should be cleaned with detergent and thoroughly rinsed. 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). 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. Cancer Nurs. Under the final OSHA cadmium rule (29 CFR part 1910), monitoring of biological specimens and several periodic medical examinations are required for eligible employees.These medical examinations are to be conducted regularly, and medical monitoring is to include the periodic analysis of cadmium in blood (CDB), cadmium in urine (CDU) and beta-2-microglobulin in urine (B2MU). Additionally, the website provides information on specific safety topics, such as how to safely operate machinery. Risk for physicians handling antineoplastic drugs [letter to the editor]. Four main types of Class II BSCs are available. A study conducted by the Occupational Safety and Health Administration (OSHA) showed that 377 (65%) of 580 work-related electrocutions occurred in the construction industry during the period 1985-89 [OSHA 1990]. Thus, a discussion of alternative duty availability and the administrative mechanisms to request it should be part of the hazard communication discussion. A 1997 three year study conducted by one large corporation found that 60% of employee absences could be traced to psychological problems that were due to job stress. Cancer Nurs 3:305-6. Department of Health and Human Services. According to a study conducted by three dermatologists at Stanford University School of Medicine, nearly all "natural" skin care products sold in the top three U.S. retail stores contain allergens.<br> <br>Nearly 90 percent of the 1,651 skin care products studied, including lotions, soaps and moisturizers, contained at least one of the 100 most common allergens known to cause contact . In 2015, there were 124,587,000 (Source: United States Census) households in the United States. Per USP, training should occur prior to preparing or handling HDs, and its effectiveness should be verified by testing specific HD preparation techniques. Use of the bacterial fluctation test to detect mutagenicity in urine of nurses handling cytostatic drugs. To achieve this goal, the agency develops and enforces safety and health standards, provides training and education resources, and conducts inspections and investigations. This section includes requirements for hazard identification and assessment, hazard control, and safety and health training. NIOSH and ASHP have provided the following guidance on the selection respirators to protect against exposure to HD: All gowns, gloves, and disposable materials used in HD preparation should be disposed of according to the facility's HD waste procedures and as described under this review's section on Waste Disposal (Section IV. 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. Hemminki K, Kyyronen P, and Lindbohm ML [1985]. 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). 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). Also, because many of these drugs are known to enter breast milk, and possess hazard warnings from FDA (FDA, 1997), breast-feeding workers should also have alternative work assignment options. Such verification should be documented for each person at least annually. Hon CY, Teschke K, Shen H, Demers PA, Venners S [2015]. 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)]. Harrison BR, Peters BG and Bing MR [2006]. This Alert describes five cases (six electrocutions) that resulted from such hazards and makes recommendations for preventing similar incidents. OSHA has also prepared a comparison of the OSHA Safety and Health Management Systems and Joint Commission Standards to further assist employers to develop comprehensive safety programs (OSHA, 2013). Cleanroom - A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Cancer Res 42: 4792-4796. Morgantown, WV: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, Fatal Accident Circumstances and Epidemiology (FACE) Report No. Sorsa M, Hemminki K, Vainio H [1985]. Perry, MC [2008]. Spill kits and procedures for spill management should be kept in the HD work area (NIOSH, 2004; ASHP, 2006). Employees must be trained in proper methods to remove contaminated gloves and gowns [29 CFR 1910.132(f)]. NIOSH recommends that gloves should be worn and gowns should be in such circumstances (NIOSH, 2014a). Activities that occur in this area are limited to the preparation and staging of components and supplies used when compounding HDs. according to research carried out. At the time of job termination or transfer (exit examination). Cancer Investig 5:75-81. Morgantown, WV: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, Fatal Accident Circumstances and Epidemiology (FACE) Report No. Food and Drug Administration. Anderson RW, Puckett WH, Dana WJ [1982]. These studies frequently found widespread contamination (Minoia, 1998; Connor, 1999; Hedmer, 2004; Nygren and Aspman, 2004). A recent study used pre-moistened tissue to wipe the hands of workers who were preparing or checking HDs, as well as workers who were in the preparation area but were not involved in preparing the HDs (Hon, 2011). If splashing is possible during the administration of oral HDs, appropriate PPE must be used [29 CFR 1910.132]. Initial decontamination (cleaning) should consist of surface cleaning with water and detergent followed by thorough rinsing. December 8, 2008. The survey found that the overall rate of exposure to the skin or eyes was 16.9 percent. Use an appropriate, full-face piece, chemical cartridge-type respirator for events such as large spills when an IV bag breaks or a line disconnects and leaks, or where there is known or suspected airborne exposure to vapors or gases (NIOSH, 2005; NIOSH, 2009); A respirator of correct size and appropriate to the aerosol size, physical state (i.e., particulate or vapor), and concentration of the airborne drug should be available at all times (ASHP, 2006); and. We take your privacy seriously. An increased risk of leukemia was found for physicians with at least six months of exposure, but this excess did not reach statistical significance and participant numbers were small (Skov, 1990).