OSHA [1999]. "The intent of the HCS is to protect employees from hazardous exposures. 1 November 2022 . The interval between exams of individual workers depends on the opportunity for exposure, the duration and intensity of exposure, and (possibly) the age of the worker. Acta Med Scand 214:181-9. Information should be included in a confidential data base that the organization manages to track exposures as a formal log. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man: Some Aziridines, S-, and O-mustards and selenium. All disposable PPE should be removed and disposed of before leaving the patient care area. Int Arch Occup Environ Health 81:899-911. 2002). It is important to note that while tablets may be exempt from the HCS, many HDs in tablet form also are manufactured in another formulation, such as liquid or concentrated powder, and require reconstitution for intravenous therapy or for injection; as such, those formulations must conform to the HCS. Employees involved in the aerosol administration of ribavirin have noted symptoms of respiratory tract irritation (Lee, 1988). September 5, 2014. It is difficult to set safe levels of exposure to HDs on the basis of current scientific information because the degree of absorption that takes place during work, and the significance of early biological effects on each individual, are difficult to assess and may vary depending on the HD. OSHA. Numerous case reports have linked chemotherapeutic treatment to adverse reproductive outcomes (reviewed in NTP, 2013). Occupational Safety and Health Administration (OSHA). [2003]. Sodium hypochlorite solution, detergent, neutralizer and rinsing have been shown to be effective on hard surfaces (Touzin, 2010). Evaluation of Exposures to Healthcare Personnel from Cisplatin during a Mock Interperitoneal Operation. A study of occupational exposure to antineoplastic drugs and fetal loss in nurses. Numerous studies document the carcinogenic, mutagenic, and teratogenic effects of HD exposure in animals. Additionally, the website provides information on specific safety topics, such as how to safely operate machinery. If the dose is to be dispensed in the syringe, the plunger should be drawn back to clear fluid from the needle and hub. Date accessed October 2014. NIOSH recommends proper installation and maintenance of all types of ventilated cabinets (NIOSH, 2004). Type A1 cabinets recirculate approximately 70 percent of cabinet air through HEPA filters back into the cabinet; the rest is discharged through a HEPA filter into the preparation room. 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). The best studies performed to date were in Denmark, where linkage of health and employment records allowed this question to be studied. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. This training should include didactic overview of HDs, including mutagenic, teratogenic, and carcinogenic properties, and it should include ongoing training for each new HD (USP 800, 2016). Care should be taken not to damage the fixed-glove assembly in a CACI. Ann Arbor: National Sanitation Foundation. 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). Ann Occup Hyg 49:611-618. Sessink PJM, Boer KA, Scheefhals APH, Anzion RB, Bos RP [1992b]. Devices that do not lock on and may be transferred from one vial to another may increase the release of HD contamination (ASHP, 2006). The Occupational Safety and Health Administration (OSHA) first published guidelines for the management of cytotoxic (antineoplastic) drugs in the work place in 1986 (OSHA, 1986), and the guidelines were made available in the peer-reviewed literature that same year (Yodaiken, 1986). Eckstein G [2012]. Signs identifying that HDs are in use and restricting the access of unauthorized personnel should be prominently displayed. The cab of the crane was positioned 11 feet 6 inches from a 7200-volt power line. OSHA Quiz Find Tens of Thousands Exams, Test Answers and Flashcards in Any Category at Quizzes Studymoose Upgrade Your Brain (415) 230 53 00 . Ganciclovir product information. Reducing workplace cytotoxic surface contamination using a closed-system drug transfer device. The Act also requires employers to provide a safe and healthful workplace for their workers. Enter the email address you signed up with and we'll email you a reset link. A Guide to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Products are accompanied by full prescribing information, which is commonly known as the FDA approved manufacturer's labeling or product package insert. SDSs are required to be prepared and transported with the initial shipment of all hazardous chemicals, including covered drugs and pharmaceutical products. Personal Protective Equipment for Health Care Workers Who Work with HDs. On March 31, 1993, a 20-year-old male truck driver and his 70-year-old male employer (the company president) were electrocuted when the boom of a truck-mounted crane contacted a 7,200-volt conductor of an overhead power line. 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. Researching human factors and mature safety culture. Reproductie-toxische effecten bij ziekenhuispersonel. OSHA [1990]. Absorbent, plastic-backed sheets or spill pads. This section also requires employers to develop and implement a hazard communication program, which includes labeling of hazardous chemicals and provision of safety data sheets. Jan 2019 - May 20195 months. Hon CY, Chua PPS, Danyluk Q, Astrakianakis G [2014a]. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Some Antineoplastic and Immunosuppressive Agents. Managing Pharmaceutical Waste: A Ten-Step Blueprint for Healthcare Facilities in the United States. 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). Compounding personnel - Individuals who participate in the compounding process who are competent and knowledgeable, and responsible for the preparation of HDs, using information from Chapter <797> and <800>, the entity's SOPs, and instructions from the compounding supervisor. Some goggles will fit over corrective lenses. Temsirolimus is eliminated in feces, and is present in stool for up to 14 days (Wyeth, 2014). Prohibit persons from touching the crane or its load until a signal person indicates that it is safe to do so. Train workers to follow ANSI guidelines for operating cranes near overhead power lines (ANSI Standard B30.5-1994, 5-3.4.5)[ANSI 1994]. Staff who may be required to wear respirators must be fit tested and trained in accordance with OSHA's RPS (OSHA, 2011b; NIOSH, 2009). 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. J Pharm Pract Res 35:264-265. Philadelphia, PA; Washington, DC: Lippincott, Williams & Williams. The term "label" designates that part of the labeling on the immediate container [See General Notices and Requirements, 21 U.S.C. Kopp B, Schierl R, Nowak D [2013]. Plastic-backed absorbent pads are commercially available and may be used to cover work surfaces in the C-PECs or other areas to absorb HD leaks or small spills. Lyon, France. Overall, the principle of standard precautions is designed to protect workers from exposure to potentially harmful pathogens, regardless of their health status. OSHA is a critical resource for protecting the safety of workers in the United States. Washington, DC: Department of Labor, Occupational Safety and Health Administration, Office of Occupational Medicine Publication No. Cincinnati, OH: 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. Visit to employee health professional to document and assure complete decontamination. Which of the following statements best describes the principle of standard precautions OSHA? Evaluation of decontamination efficiency of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. The victim provided a path to ground and was electrocuted [NIOSH 1990b]. April 2013. After a previous roof joist had been set in place, the crane operator swung the crane boom and cable back toward the victim, who grabbed the choker in his left hand. HDs that are available in vials should be purchased whenever possible, as the contents of ampules are hard to contain. \hline \text { Item } & \text { Markup } & \begin{array}{c} NIOSH [2004]. The Cost of Stress Besides the toll on health, stress also cost businesses and the economy trillions in absenteeism, low productivity, and healthcare costs. Access to Employee and Medical Records Standard. He died on the scene. Ann Occup Hyg 52:95-98. Disinfect supplies placed in the compounding area when sterile compounding in the C-PEC (USP 797, 2012). NIOSH recommends that gloves should be worn and gowns should be in such circumstances (NIOSH, 2014a). The assessment allows plant management and operational teams to develop appropriate safety leadership behaviors that are necessary to sustain process safety, lower incident rates, create a learning culture and increase organizational safety maturity. 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. The program must also include the following: A list of the covered HDs known to be present using a product identifier that is referenced on the appropriate SDS. Pregnancy Category Labeling Labeling Requirements for Prescription Drugs and/or Insulin. EPA (Environmental Protection Agency) [1991a]. Evaluation of working practices and surface contamination with antineoplastic drugs in outpatient oncology health care settings. Nearly half of the incidents occurred in the construction industry. Polovich M., Olsen, M. & LeFebvre, K B, Eds. University Medical Center. Date accessed November 2014. Temsirolimus [Package Insert]. 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. . NIOSH's citation further notes that "in house" OELs in this range are typically established for drugs referred to in the pharmaceutical industry as "potent compounds" (NIOSH, 2004). No single accepted method of chemical deactivation for all HDs has been identified (Castegnaro, 1985; Benvenuto, 1993; Castegnaro, 1997). Post-exposure evaluations are tailored to the type of exposure (e.g., spills or needle sticks from syringes containing HDs). The crane cable was attached to a 1-inch-diameter galvanized pipe that ran to the pump inside the well. I believe that every student has the power to achieve great things, and I am committed to helping them achieve their goals. For example, it may be possible to use concrete pumping trucks instead of crane-suspended buckets for placing concrete near overhead power lines. ACPH); and have a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas (USP 800, 2016). CS 61C Caches Fall 2022 Discussion 9 1 Pre-Check This section is designed as a conceptual check for you to determine if you conceptually understand and have any misconceptions about this topic. These reports document how vial contamination, preparation, administration, disposal, and other HD handling activities may expose pharmacists, nurses, physicians, and other HCWs to potentially significant workplace levels of these chemicals. Of the maritime standards cited, all showed a total violation count of fewer than 10 violations, except for 1910.303(g)(1), which had 14 total violations for inadequate space surrounding electrical equipment. Biosafety in microbiological and biomedical laboratories (BMBL) 5th edition. 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