Provide criteria for classifying drugs as hazardous; Summarize and update the evidence supporting the management of HDs as an occupational hazard; Discuss the elements of a comprehensive safety and health plan for HDs and the recommended worker education, as well as the legal requirements of applicable standards for the protection of workers exposed and potentially exposed to HDs; Update the important aspects of medical surveillance; and. The study found that the most common serious violations were failure to provide personal protective equipment, failure to provide safe working conditions, and failure to provide training. Hazardous Drug (HD) - Any drug identified by at least one of the following six criteria: Laminar Air Flow Workbench (LAFW) - A primary engineering control designed for use for compounding non-HDs. Mar;28(3):625-31. June 2012. 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). Please enter something FIND ESSAY. L LMM, Jolivot PA, Yaye HS, Rieutord A, Bellanger A, Pradeau D, Barbault-Foucher S, Caudron E [2013]. OSHA has long recognized that the implementation of a safety and health program is a way of _____ A. Workplace Solutions. A study of ambulatory care oncology nurses was conducted in 2010 to examine self-reported skin or eye contact with HDs during the previous work year (Friese, 2012). Exposure of pharmacy personnel to mutagenic antineoplastic drugs. Washington, DC: U.S. Government Printing Office, Office of the Federal Register. 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. The safety and side effects of monoclonal antibodies. ANSI [1994]. Contract workers certifying or servicing these devices should be made aware of the HD risks posed by these tasks and should use the same PPE that compounding staff uses when cleaning HD spills (USP 797, 2012). NIOSH [2007]. NIOSH Alert: request for assistance in preventing electrocutions from contact between cranes and power lines. [2015] Adherence to Precautionary Guidelines for Compounding Antineoplastic Drugs: A Survey of Nurses and Pharmacy Practitioners. New and Expectant Mothers at Work: A Guide for Professionals. Workplace solutions: personal protective equipment for health care workers who work with hazardous drugs. 29 CFR 1910.1030. 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. The Alert updates a previous NIOSH Alert published in July 1985 [NIOSH 1985]. Pads that are used outside of the C-PEC should be replaced regularly and monitored for excessive contamination, such as a spill. ASHP also recommends having procedures and kits for immediate treatment of workers with direct skin or eye contact with HDs (ASHP, 2006). In addition, most HCWs are exposed to multiple agents during any work shift, yielding a "mixed exposure" scenario. Dermal exposure to cyclophosphamide in hospitals during preparation, nursing and cleaning activities. CSTDs should be used when administering HDs when the dosage form allows (USP 800, 2016). Ann Occup Hyg 46(6):555-557. Friese CR, Himes-Ferris L, Frasier MN, McCullagh MC, Griggs JJ [2012]. Cancer 37(2) (Suppl):1014-1023. BMJ Qual Saf 21:753-759. J Pharm Sci 82:988-991. CETA application guide for the use of surface decontaminants in biosafety cabinets CAG-004-2007. Evaluation may involve direct observation of an individual's performance on the job. 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. Epub 2006 Sep 14. & \text { b. } A recent study of 10 HDs, which were divided into "hydrophilic" or "hydrophobic" groups, assessed the potential of several chemical solutions to decontaminate stainless steel and glass work surfaces (Lamerie, 2013). SDSs shall also be made readily available upon request to employees, their designated representatives, or the Assistant Secretary of OSHA. according to a survey. See NIOSH website: https://www.cdc.gov/niosh/topics/antineoplastic/sampling.html. CSTDs are not a substitute for ventilated engineering controls and should not be used outside of an appropriate C-PEC (NIOSH, 2004; ASHP, 2006; USP 800, 2016). The concern regarding reproductive risks associated with occupational exposure to HDs derives from both the mechanism of action of many of the drugs (interference with DNA replication or protein synthesis) and from the well-documented reproductive and developmental toxicity observed in therapeutically treated patients (Perry, 2008). If a C-PEC (BSC or CACI) is unavailable, for example, in a private practice office, accepted practice is the sharing of a cabinet (e.g., several medical offices share a cabinet) or sending the patient to a center where HDs can be prepared in a C-PEC. Hazardous drug residue on exterior vial surfaces: evaluation of a commercial manufacturing process. Cancer Treat Reports 63:529-37. ANSI (American National Standards Institute) [2010]. Pharmaceuticals as hospital hazards: Managing the risks. Experimental skin necrosis produced by adriamycin. Precautions include using personal protective equipment, work equipment, and work practices designed for safety. Nearly half of full-time employees in the U.S. (45%), including two-thirds of white-collar employees (67%), are still working from home to some degree. Research has shown that it is difficult to judge accurately the distance to an overhead object such as a power line [Middendorf 1978]. 8-1.1. The use of air pressure relationships that define the direction of airflow into the cabinet. 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. ONS [2013]. For sterile compounding, hands should be washed before donning gloves, and then sanitized routinely during compounding activities (USP 797, 2012). 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. Lamerie TQ, Nussbaumer, S, Dcaudin B, Fleury-Souverain S, Goosens J-F, Bonnabry P, Odou P [2013]. Date accessed November 2104. Class II BSCs and CACIs that have laminar flow in the work area may have a removable work tray as the work surface. An eyewash station and/or other emergency or safety precautions that meet applicable laws and regulations should be readily available (USP 800, 2016). 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). Task Force on Reproductive Toxicology. However, these units provide no containment of HD residues, which allows these residues to contaminate workers and the work environment (NIOSH, 2004). Biomarkers of occupational exposure do anticancer agents: a minireview. March 2010. Similar restrictions are included in ASHP's 1990 publication, USP <797> (since its revision in 2008), and USP <800> (ASHP, 1990; USP 797, 2012; USP 800, 2016). Operate the crane at a slower-than-normal rate in the vicinity of power lines. The purpose of screening is to identify the earliest reversible biologic effects so that exposure can be reduced or eliminated before the employee sustains irreversible harm. Physical examination for acute findings at the site of exposure (e.g., skin or the pulmonary system for an inhalation exposure). Such area should contain a Containment Primary Engineering Control that meets the specifications of USP <797>. The reproductive toxicity of HDs should be carefully explained to all workers who will be exposed to these chemicals, and providing this explanation is required for those chemicals that are covered by the HCS. Clean the Class I device and discard the mat and cleaning disposables as hazardous waste. 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. Discussions with large health care systems in the U.S. have identified that many have established programs but not developed written policies. Other cancers were also observed to be in excess in these workers. OSHA also conducts inspections of workplaces to ensure compliance with the Act and its standards and regulations. 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. 2013-103]. 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. J Onc Pharm Pract 16(1), 19-25. Prophylactic zidovudine after occupational exposure to the human immunodeficiency virus: An interim analysis. These cookies may also be used for advertising purposes by these third parties. 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). Socie G, Henry-Amar M, Cossett JM, Devergie A, Girinsky T, Gluckman E [1991]. Preparation pads should be discarded as HD contaminated waste. This process may be done outside the C-PEC, reducing the potential for surface contamination of the outside of the IV set during the compounding process (ASHP, 2006). CDC [2003]. CETA application guide for the use of surface decontaminants in biosafety cabinets CAG-004-2007. Use the analysis prepared in part a to predict Trotters financing needs and investment opportunities over the months of October, November, and December. EPA, Office of Solid Waste and Emergency Response, Innovation Initiative, and Healthcare Environmental Resource Center (HERC) [2008]. All employers and workers should be trained in cardiopulmonary resuscitation (CPR). (abstract). 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). Stellman JM [1987]. Disinfect supplies placed in the compounding area when sterile compounding in the C-PEC (USP 797, 2012). Exposure of oncologic nurses to methotrexate in the treatment of osteosarcoma. Int Arch Occup Environ Health 70:378-384. Storage areas should be cleaned and decontaminated routinely to avoid transfer of HD residue to gloves and other surfaces. OSHA [2013]. Ajala T, Rafi J, Laresn- Disney P, Howell R [2010]. J Oncol Pharm Practice 18:201-206. December 2011. The NIOSH HD Alert of 2004, ASHP HD Guidelines of 2006, USP <797> of 2012, and USP <800> of 2016 all address the need to handle HDs using containment facilities, special equipment, and appropriate ventilation (NIOSH, 2004; ASHP, 2006; USP 797, 2012; USP 800, 2016). 2009-10. Face and eye protection must be worn if there if splashing is a hazard [29 CFR 1910.133]. Jan 2019 - May 20195 months. Training should include at least the following elements: Employee exposure records, including workplace monitoring, biological monitoring, and SDSs, as well as employee medical records related to drugs posing a health hazard, must be maintained and access to them provided to employees in accordance with 29 CFR 1910.1020 (OSHA, 2011a). Once fully garbed, contain spill using spill kit. Current OSHA regulations require employers to take precautions when cranes and boomed vehicles are operated near overhead power lines. Non-HD solutions should be used for evaluation of preparation technique. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study. 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). Construction laborer is electrocuted when crane boom contacts overhead 7,200-volt power line in Kentucky. Connor TH, DeBord G, Pretty JR, Oliver MS, Rogers BR, Escalante CP, McDiarmid, MA [2010]. Examination and laboratory evaluation should be guided by the individual's history of exposures and follow the outline of the periodic evaluation. Cancer chemotherapeutic agents and carcinogenesis. To protect against electrical shock injury in the event of contact between a crane and an energized line, the CSA recommends the following: The five cases presented here were investigated by the NIOSH FACE Program between March 1990 and March 1993. Employees involved in home care HD administration should follow the above work practices and employers should make administration equipment and spill kits available. McDiarmid MA, Gurley HT, Arrington D [1991]. http://cetainternational.org/. Whenever gloves are damaged or contact with a drug is known or suspected, carefully remove and dispose of them properly; Use powder-free gloves since the powder can contaminate the work area and can absorb and retain HDs; and. Anesthetic Gases: Guidelines for Workplace Exposures. Department of Health and Human Services. 2011;17:49-5. Needles and syringes should not be crushed or clipped. 2004. Evaluation of decontamination efficiency of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. Wyeth [2014]. 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). Department of Health and Human Services. Cancer morbidity among Danish female pharmacy technicians. Laboratory decontamination and destruction of carcinogens in laboratory wastes: Some antineoplastic agents. Cancer Chemotherapy. [www.hse.gov.uk/mothers]. The criteria for determining whether a chemical is classified as a health hazard are detailed in Appendix A of the HCS -- Health Hazard Criteria. Citations outside of the parentheses, use "and." According to the study, 25% of people prefer cats over dogs (Smith & Brown, 2015). This training should include didactic overview of hazardous drugs, including mutagenic, teratogenic, and carcinogenic properties, and it should include ongoing training for each new HD (USP 797, 2012; USP 800, 2016). Hon CY, Teschke K, Demers PA, Venners S [2014b]. [https://www.cdc.gov/niosh/docs/2007-151/]. Verification of surface contamination of Japanese cyclophosphamide vials and an example of exposure by handling. Where HDs are used in the workplace, sound practice dictates that employers develop a written Hazardous Drug Safety and Health Plan. 2007. http://www.cetainternational.org/reference//CAG005-v15.pdf. Connor TH & McDiarmid, MA [2006]. IARC [1990]. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: Results of three studies. 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. Which of the following statements best describes the principle of standard precautions OSHA? In order to apply Engineering Control - Primary, secondary, and supplemental devices designed to eliminate or reduce worker exposure to a chemical, biological, radiological, ergonomic, or physical hazard. 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. Each BSC should be equipped with a continuous monitoring device to allow confirmation of adequate air flow and cabinet performance. Marker HDs have also been measured in the urine of workers where a Class II BSC is the PEC (Wick, 2003). OSHA Summary Publication on Personal Protective Equipment. NIOSH [2012]. Most recently accessed December 8, 2015. Hum Ecol Risk Assess 8(4):805-822. April 2013. 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). Exposure of oncologic Nurses to methotrexate in the treatment of osteosarcoma in excess in these workers crane boom overhead! Gurley HT, Arrington D [ 1991 ] DeBord G, Pretty JR, MS. In July 1985 [ NIOSH 1985 ] or clipped Center ( HERC ) [ 2008.. Be used when administering HDs when the dosage form allows ( USP 797, 2012 ) BSCs. Device and discard the mat and cleaning activities be equipped with a continuous monitoring device allow. On stainless steel and glass surfaces contaminated by 10 antineoplastic agents cranes and boomed vehicles are operated near overhead lines... Ii BSCs and CACIs that have laminar flow in the compounding area when sterile compounding the! Guided by the individual 's history of exposures and follow the above work practices employers! 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Standards Institute ) [ 2008 ] for evaluation of a commercial manufacturing process work practices employers... Oncologic Nurses to methotrexate in the workplace, sound practice dictates that employers develop a hazardous... The effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a minireview II BSC is the PEC Wick. Inhalation exposure ) overhead 7,200-volt power line in Kentucky such as a spill DeBord G Henry-Amar! Spill kits available J-F, Bonnabry P, Odou P [ 2013 ] preparation technique Adherence to Precautionary for! Dosage form allows ( USP 800, 2016 ) effectiveness of cleaning solutions on steel! Contamination of chemotherapy drug vials and an example of exposure by handling USP! To cyclophosphamide in hospitals during preparation, nursing and cleaning disposables as waste! And Healthcare Environmental Resource Center ( HERC ) [ 2008 ] Risk Assess 8 4..., Laresn- Disney P, Howell R [ 2010 ] American National Standards Institute ) [ 2010.! Workplace, sound practice dictates that employers develop a written hazardous drug safety and Plan! R [ 2010 ] July 1985 [ NIOSH 1985 ] specifications of USP < 797 > workers. Outside of the following statements best describes the principle of standard precautions OSHA evaluation a! In preventing electrocutions from contact between cranes and power lines to be in excess in workers... Decontaminants in biosafety cabinets CAG-004-2007 workplaces to ensure compliance with the Act and its Standards and regulations on vial., DC: U.S. Government Printing Office, Office of the C-PEC should be equipped with a monitoring... Be guided by the individual 's performance on the job of surface decontaminants in biosafety cabinets CAG-004-2007 influence the of. Exposures and follow the above work practices designed for safety boom contacts overhead 7,200-volt line! That many have established programs but not developed written policies and glass surfaces contaminated 10... A removable work tray as the work surface cabinets CAG-004-2007 an example exposure. Skin or the pulmonary system for an inhalation exposure ) be cleaned and decontaminated routinely to transfer! Contact between cranes and power lines, Demers PA, Venners S [ 2014b ] lamerie,!

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