ASHP Guidelines on Handling Hazardous Drugs

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76. Connor TH, Anderson RW, Sessink PJ et al. Effective-ness of a closed-system device in containing surface contamination with cyclophosphamide and ifosfamidein an i.v. admixture area. Am J Health-Syst Pharm. 2002; 59:68–72.77. Vandenbroucke J, Robays H. How to protect environ-ment and employees against cytotoxic agents: the UZGent experience. J Oncol Pharm Pract. 2001; 6:146– 52.78. Spivey S, Connor TH. Determining sources of work-place contamination with antineoplastic drugs andcomparing conventional IV drug preparation with a closed system. Hosp Pharm. 2003; 38:135–9. Drug Distribution and Control: Preparation and Handling–Guidelines 47 79. Hoy RH, Stump LM. Effect of an air-venting filterdevice on aerosol production from vials. Am J Hosp Pharm. 1984; 41:324–6.80. Connor TH. Permeability testing of glove materials foruse with cancer chemotherapy drugs. Oncology. 1995; 52:256–9.81. Singleton LC, Connor TH. An evaluation of the perme-ability of chemotherapy gloves to three cancer chemo-therapy drugs. Oncol Nurs Forum.1999; 26:1491–6.82. Gross E, Groce DF. An evaluation of nitrile glovesas an alternative to natural rubber latex for handling chemotherapeutic agents. J Oncol Pharm Pract. 1998; 4:165–8.83. Connor TH. Permeability of nitrile rubber, latex, poly-urethane, and neoprene gloves to 18 antineoplastic drugs. Am J Health-Syst Pharm. 1999; 56:2450–3.84. Klein M, Lambov N, Samev N et al. Permeation ofcytotoxic formulations through swatches from se-lected medical gloves. Am J Health-Syst Pharm. 2003; 60:1006–11.85. American Society for Testing and Materials D 6978-05standard practice for assessment of resistance of medi-cal gloves to permeation by chemotherapy drugs. WestConshohocken, PA: American Society for Testing and Materials; 2005.86. Connor TH, Xiang Q. The effect of isopropyl alcoholon the permeation of gloves exposed to antineoplastic agents. 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Penetration and splash pro-tection of six disposable gown materials against fif-teen antineoplastic drugs. J Oncol Pharm Pract. 1999; 5:61–6.93. Laidlaw JL, Connor TH, Theiss JC et al. Permeabilityof four disposal protective-clothing materials to seven antineoplastic drugs. Am J Hosp Pharm. 1985; 42:2449–54.94. Valanis B, Shortridge L. Self protective practices ofnurses handling antineoplastic drugs. Oncol Nurs Forum.1987; 14:23–7.95. Labuhn K, Valanis B, Schoeny R et al. Nurses’ andpharmacists’ exposure to antineoplastic drugs: find-ings from industrial hygiene scans and urine mutagen-icity tests. Cancer Nurs. 1998; 21:79–89.96. NuAire. Containment capabilities of a Class II, type A2BSC using a chemo pad on the worksurface. Technical bulletin. www.nuaire.com/tech_papers/Containment_Capabilities_using_Chemo_Pad.PDF (accessed 2006 Mar 23).97. Farris J. Barrier isolators and the reduction of contam-ination in preparation of parenteral products. www.mic4.com/articles/parenteral-products.php (accessed 2006 Mar 23).98. Wilson JP, Solimando DA. Aseptic technique as asafety precaution in the preparation of antineoplastic agents. Hosp Pharm. 1981; 15:575–81.99. Harrison BR, Godefroid RJ, Kavanaugh EA. Quality-assurance testing of staff pharmacists handling cyto-toxic agents. Am J Health-Syst Pharm. 1996; 53:402– 7.100. Shahsavarani S, Godefroid RJ, Harrison BR. Evalua-tion of occupational exposure to tablet trituration dust. Paper presented at ASHP Midyear Clinical Meeting. Atlanta, GA; 1993 Dec 6.101. Johnson EG, Janosik JE. Manufacturers’ recommen-dations for handling spilled antineoplastic agents. AmJ Hosp Pharm. 1989; 46:318–9.102. Benvenuto JA, Connor TH, Monteith DK et al.Degradation and inactivation of antitumor drugs. JPharm Sci. 1993; 82:988–91.103. Hansel S, Castegnaro M, Sportouch MH et al. Chemicaldegradation of wastes of antineoplastic agents: cyclo-phosphamide, ifosfamide, and melphalan. Int Arch Occup Environ Health.1997; 69:109–14.104. Polovich M, Belcher C, Glynn-Tucker EM et al. Safehandling of hazardous drugs. Pittsburgh: Oncology Nursing Society; 2003.105. 40 C.F.R. 261.33.106. Resource Conservation and Recovery Act of 1976. 42 U.S.C. 82 §6901-92.107. 40 C.F.R. 261.20-24C.108. 40 C.F.R. 261.3.38D. 109. 40 C.F.R. 261.7.110. Vaccari PL, Tonat K, DeChristoforo R et al. Disposalof antineoplastic wastes at the National Institutes of Health. Am J Hosp Pharm. 1984; 41:87–93.111. 40 C.F.R. 261.7(b)(1)-(3).112. 49 C.F.R. 172.0-.123,173,178,179. 113. 29 C.F.R. 1910.120(e)(3)(i).114. 29 C.F.R. 1910.120(q)(1-6).115. 40 C.F.R. 260-8,270. 48 Drug Distribution and Control: Preparation and Handling–Guidelines Appendix A—Recommendationsfor Use of Class II BSCs 1. The use of a Class II BSC must be accompanied by astringent program of work practices, including train-ing, demonstrated competence, contamination reduc-tion, and decontamination.2. Only a Class II BSC with outside exhaust should beused for compounding hazardous drugs; type B2 totalexhaust is preferred. Total exhaust is required if thehazardous drug is known to be volatile.3. Without special design considerations, Class II BSCsare not recommended in traditional, positive-pressurecleanrooms, where contamination from hazardous drugs may result in airborne contamination that may spread from the open front to surrounding areas.4. Consider using closed-system drug-transfer deviceswhile compounding hazardous drugs in a Class II BSC;evidence documents a decrease in drug contaminantsinside a Class II BSC when such devices are used.5. Reduce the hazardous drug contamination burden inthe Class II BSC by wiping down hazardous drug vials before placing them in the BSC. Appendix B—Recommendations forUse of Class III BSCs and Isolators 1. Only a ventilated cabinet designed to protect workersand adjacent personnel from exposure and to providean aseptic environment may be used to compound ster-ile hazardous drugs.2. Only ventilated cabinets that are designed to containaerosolized drug product within the cabinet should be used to compound hazardous drugs.3. The use of a Class III BSC or isolator must be accom-panied by a stringent program of work practices, in-cluding operator training and demonstrated compe-tence, contamination reduction, and decontamination.4. Decontamination of the Class III BSC or isolator mustbe done in a way that contains any hazardous drug sur-face contamination during the cleaning process.5. Appropriate decontamination within the cabinet mustbe completed before the cabinet is accessed via pass-throughs or removable front panels.6. Gloves or gauntlets must not be replaced before com-pletion of appropriate decontamination within the cabinet.7. Surface decontamination of final preparations mustbe done before labeling and placing into the passthrough.8. Final preparations must be placed into a transport bagwhile in the pass-through for removal from the cabi-

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Drug Distribution and Control: Preparation and Handling–Guidelines 71 ASHP Guidelines on Handling Hazardous Drugs

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تاریخ انتشار 2007