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Dosage and Administration Instructions for Parenteral Medications: Stability, Compatibility, Coadministration, and Microbiology
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Drugs have a long-standing history of use in treating various disease states; however, virtually, all drugs have side effects associated with their use by patients. Thus, both patients and workers who handle them are at risk of suffering these effects. In addition, it is known that exposures to even very small concentrations of certain drugs may be hazardous for workers who handle them or work near them with reoccurring exposure. The term “hazardous drug” was first used by the ASHP and is currently used by the Occupational Safety and Health Administration. Drugs are classified as hazardous if studies in animals or humans indicate that exposures to them have a potential for causing cancer, developmental or reproductive toxicity, or harm to organs (9). Although the potential therapeutic benefits of hazardous drugs outweigh the risks of side effects for patients, exposed healthcare workers risk these same side effects with no therapeutic benefit. Occupational exposures to hazardous drugs can lead to (i) acute effects such as skin rashes; (ii) chronic effects, including adverse reproductive events; and (iii) possibly cancer (9). Guidelines have been established for handling hazardous drugs, but adherence to these guidelines has been reported to be sporadic (10–13). In addition, measurable concentrations of some hazardous drugs have been documented in the urine of healthcare workers who prepared or administered them—even after safety precautions had been employed (14–17). As an example, engineering controls, such as BSCs, do not always provide adequate protection for healthcare providers. Environmental studies of patient-care areas have documented measurable concentrations of drug contamination, even in facilities thought to be following recommended handling guidelines (14–17). The numbers and types of work environments containing antineoplastic drugs are expanding as these agents are used increasingly for nonmalignant rheumatologic and immunologic diseases.
Safe Handling of APIs and Drugs
Published in Sam A. Hout, Manufacturing of Quality Oral Drug Products, 2022
Employees must properly use PPE and good work techniques for minimizing occupational exposure to hazardous drugs. Use of a BSC without proper use of PPE, training, and good work techniques may increase the risk of exposure.
Efficacy of four cleaning solutions for the decontamination of selected cytotoxic drugs on the different surfaces of an automated compounding system
Published in Journal of Occupational and Environmental Hygiene, 2019
Matteo Federici, Jacopo Raffaelli, Demis Paolucci, Rudolf Schierl, Irene Krämer
According to the USP monograph <800>,[8] all areas where hazardous drugs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned. Additionally, sterile compounding areas and devices must be subsequently disinfected. Roberts et al.[12] defined decontamination as the use of physical and/or chemical means to render a surface or item safe for handling, use or disposal. The National Institute for Occupational Health and Safety (NIOSH) recommends that all work surfaces must be decontaminated with an appropriate deactivation agent, if available.[6] However, antineoplastic drug substances represent a wide range of various chemical structures that cannot be inactivated by a single decontamination agent. No universal cleaning solution can completely deactivate the whole range of the currently used antineoplastic drugs. As a consequence, surface decontamination is mostly attributed to the mechanical removal and transfer of the antineoplastic drug contamination from non-disposable surfaces to absorbent disposable materials (e.g., wipes, pads) by wiping with a cleaning agent.[8]
Evaluation of decontamination efficacy of four antineoplastics (ifosfamide, 5-fluorouracil, irinotecan, and methotrexate) after deliberate contamination
Published in Journal of Occupational and Environmental Hygiene, 2021
Marie Palamini, Marine Floutier, Sébastien Gagné, Nicolas Caron, Jean-François Bussières
The use of hazardous drugs leaves traces of these products in the work environment, such as the pharmacy, outpatient clinics, and inpatient care units (Valero-García and Poveda-Andrés 2018; Viegas et al. 2018; Hilliquin et al. 2019). Studies have shown that exposures to hazardous drugs can cause both acute and chronic health effects including skin rashes, adverse reproductive outcomes, and possibly leukemia and other cancers (National Institute for Occupational Safety and Health [NIOSH] 2004; Connor et al. 2014; McDiarmid et al. 2014).