HAZARDOUS DRUG EXPOSURES IN HEALTHCARE
Environmental Sampling, Decontamination, Protective Equipment, Closed System Transfer Devices, and Work Practice
Environmental Sampling
Environmental sampling is a relatively new approach used to determine the level of workplace contamination by antineoplastic agents. The procedure has been used extensively in other situations, especially for monitoring contamination by radioactive materials. Typically, work surfaces are sampled with a moistened wipe and the material is extracted and analyzed for specific antineoplastic agents. Currently, it is possible to identify and quantitate six to eight agents with this technique.
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Decontamination and Deactivation of Antineoplastic Agents
Several reports have dealt with methods for the decontamination and/or deactivation of antineoplastic agents. Although bleach (hypochlorite) is often recommended for the decontamination purposes, it is not effective with all classes of agents. Therefore, it cannot be assumed that cleaning with bleach solutions will destroy all types of antineoplastic agents. Some antineoplastic drugs are listed by the US Environmental Protection Agency as Hazardous waste and must be disposed of accordingly (see 40 CFR 261.33).
- AIHA Healthcare Working Group Hazardous Drugs Project Team. Chemotherapy hood decommissioning for disposal or recycling. Fact sheet. Approved by AIHA Board: October 17, 2016. Falls Church, VA: American Industrial Hygiene Association (AIHA).
- Anastasi M, Rudaz S, Lamerie TQ, Odou P, Bonnabry P and Fleury-Souverain S. Efficacy of two cleaning solutions for the decontamination of 10 antineoplastic agents in the biosafety cabinets of a hospital pharmacy. Ann Occup Hyg. 2015; 59:895-908.
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- Gohma H, Inoue Y, Asano M and Sugiura SI. Testing the degradation effects of three reagents on various antineoplastic compounds. J Oncol Pharm Practice. 2014; (Epub ahead of print) DOI: 10.1177/1078155214530175.
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- Hon CY, Chua PPS, Danyluk Q and Astrakianakis G. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study. J Oncol Pharm Pract. Published online 8 August 2013.
- Hon CY, Chua PPS, Danyluk Q and Astrakianakis G. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study. J Oncol Pharm Practice. 2014; 20:210-216.
- Lamerie TQ, Nussbaumer, S, Décaudin B, Fleury-Souverain S, Goosens J-F, Bonnabry P and Odou P. Evaluation of decontamination efficiency of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. Ann Occup Hyg. 2013; 57:456-469.
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- Touzin K, Bussières JF, Langlois É, Lefebvre M and Gallant C. Cyclophosphamide contamination observed on the surface of drug vials and the efficacy of cleaning on vial contamination. Ann Occup Hyg. 2008; 1-7.
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Evaluation of Protective Equipment for Handling Antineoplastic Agents
The most often used type of protective equipment for handling antineoplastic agents is gloves. Typically latex and other materials have been employed for this use. However, with the concern over latex allergies, newer materials are being marketed and evaluated for use with these agents. Protective gowns are another piece of equipment that is commonly used in the handling of antineoplastic agents. This section also deals with biological safety cabinets and closed system devices used in the preparation of antineoplastic drugs.
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- Connor TH. Using PPE to prevent occupational exposure to antineoplastic and other hazardous drugs. Pharm Purchasing & Products. 2006; 2:4-6.
- Connor TH. Personal protective equipment for use in handling hazardous drugs. Pharm Purchasing & Products. 2006; 3:2-6.
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- Laidlaw JL, Connor TH, Theiss JC, Anderson RW and Matney TS. Permeability of four disposable protective-clothing materials to seven antineoplastic drugs. Am J Hosp Pharm. 1985; 42:2449-2454.
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- Ledford A and Wetzel B. Constructing an oncology pharmacy. Pharm Purch Prod. May 2017; 14 (5):10-15.
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- Mellström GA, Wrangsjö K, Wahlberg JE and Fryklund B. The value and limitations of protective gloves in medical health service:Part III. Dermatol Nurs. 1996; 8:345-355.
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- Stoikes ME, Carlson JD, Farris FF and Walker PR. Permeability of latex and polyvinyl chloride gloves to fluorouracil and methotrexate. Am J Hosp Pharm. 1987; 44:1341-1346.
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- Tomas ME, Kundrapu S, Thota P, Sunkesula VCK, Cadnum JL, Mana TSC, Jencson A, O’Donnell M, Zabarsky TF, Hecker MT, Ray AJ, Wilson BM and Donskey CJ. Contamination of health care personnel during removal of personal protective equipment. JAMA Intern Med. 2015 (Epub ahead of print). DOI: 10.1001/jamainternmed.2015.4535.
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Robotics
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- Krämer I, Federici M, Kaiser V and Thiesen J. Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes. J Oncol Pharm Practice. 2014 (Epub ahead of print). DOI: 10.1177/1078155214565123.
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- Palma E and Bufarini C. Robotized compounding of oncology drugs in a hospital pharmacy. Int J Pharm Compd. 2014; 18:358-364.
- Schierl R, Masini C, Groeneveld S, Fischer E, Bohlandt A, Rosini V and Paolucci D. Environmental contamination by cyclophosphamide preparation: comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo. J Oncol Pharm Practice. 2016; 22:37-45.
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- Yaniv AW and Knoer SJ. Implementation of an i.v.-compounding robot in a hospital-based cancer center pharmacy. Am J Health-Syst Pharm. 2013; 70:2030-2037.
Closed System Drug-Transfer Devices (CSTDs) and Similar Devices
NIOSH defines a closed system drug transfer device as: “A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.” There are several CDTDs currently available from different manufacturers. CSTDs have been shown to reduce the levels of surface contamination present where antineoplastic drugs are handled and to reduce the percentage of wipe samples that have detectable amounts of antineoplastic drugs.
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- Connor TH, Anderson RW, Sessink PJ and Spivey SM. Effectiveness of a closed-system device in containing surface contamination with cyclophosphamide and ifosfamide in an i.v. admixture area. Am J Health-Syst Pharm. 2002; 59:68-72.
- Clark BA and Sessink PJM. Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. J Oncol Pharm Prac. 2013; 19:99-104.
- De Ausen L, DeFreitas EF, Littleton L and Lustik M. Leakage from closed-system transfer devices as detected by a radioactive tracer. Am J Health-Syst Pharm. 2013; 70:619-623.
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- Edwards MS, Solimando DA, Grollman FR, Pang JL, Chasick AH, Hightman CM, Johnson AD, Mickens MG and Preston LM. Cost savings realized by use of the PhaSeal® closed-system transfer device for preparation of antineoplastic agents. J Oncol Pharm Pract. 2013; 19:338-347.
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- Garrigue P, Montana M, Ventre C, Gauthier-Villano L, Pisano P and Pourroy B. Safe cytotoxic drug preparation using closed-system transfer device: technical and practical evaluation of a new device (Vialshield/Texium) comparatively to a reference one (Phaseal). Int J Pharm Compounding. 2016; 20:148-154.
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- Haifler M, Lang E, Sabler I, Gutman Y, Lindner A and Zisman A. Increasing medical staff safety by using a closed system for intravesical instillation of mitomycin C. Urology. 2010; 76:649-651.
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- Harrison BR, Peters BG and Bing MR. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health-Syst Pharm. 2006; 63:1736-1744
- Ho KV, Edwards MS, Solimando DA Jr, Johnson AD. Determination of extended sterility for single-use vials using the Phaseal closed-system transfer device. J Hematol Oncol Pharm. 2016; 6:46-50.
- Jorgenson JA, Spivey SM, Au C, Canann D, Ritter H and Smith B. Contamination comparison of transfer devices intended for handling hazardous drugs. Hosp Pharm. 2008; 43:723-727.
- Jorgenson JA and Stevenson JG. Special Report: Closed-system drug-transfer devices: ONB classification and the draft NIOSH protocol. Pharm Pract News. June 2017; Supp:1-4.
- Kelley L. Response to the study: ‘syringe plunger contamination by hazardous drugs: a comparative study’ by Stephen T Smith and Mark C Szlaczky. J Oncol Pharm Practice. 2014; 20:397-398.
- Kicenuik K, Northrup N, Dawson A, Locke J, Villamil JA, Chretin J, Sfiligoi G, Clifford C, Rosenberg M, Hamilton T, Regan R, Parsons-Doherty M, Mallett C, Philibert J, Imperllizeri J and Hofmeister E. Treatment time, ease of ue and cost associated with use of Equashield™, PhaSeal®, or no closed system transfer device for administration of cancer chemotherapy to a dog model. Vet Comp Oncol. 2015 (Epub ahead of print). DOI: 10.1111/vco.12148.
- Kopp B, Schierl R and Nowak D. Evaluation of working practices and surface contamination with antineoplastic drugs in outpatient oncology health care settings. Int Arch Occup Environ Health. 2013; 86:47-55.
- Koraleski M, Massoomi F and Zock M. Evaluation of FDA-approved ONB closed-system transfer devices utilizing Cyclophosphamide as a marker. ICU Medical Inc. 2013; M1-1455 Rev.01.
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- Le Garlantezec P, Rizzo-Padoin N, Aupee O, Lamand V, Broto H and Almeras D. Evaluation of the performance of transfer devices in a closed system using a radioactive solution of [(99m) Tc]. Ann Pharm Fr. 2011; 69:192-191 (French, English abstract).
- Massoomi F. The evolution of the CSTD. Pharm Purchasing and Products. 2015; 12 (2): S1-S12.
- Massoomi F and Eisenberg S. Pharmacy and nursing collaborate on CSTD training. Pharm Purchasing Prod. 2015; May:12-16.
- Mayer J, Menetre S, Serrurier C, Delfour A and May I. Comparison of closed-system devices for the preparation of cytotoxic drugs. Le Pharmacien Hospitalier et Clinicien. 2011; 46:116-122. (French, English abstract)
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- Nyman H, Jorgenson J and Slawson MH. Workplace contamination with antineoplastic agents in a new cancer hospital using a closed-system drug transfer device. Hosp Pharm. 2007; 42:219-225.
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- Rosenthal M. CSTD buyers need advocacy help. Pharm Prac News. 2016; April 4.
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- Rosenthal M. Establishing procedures for testing CSTDs (Part 2). Pharm Pract News. March 2017; 44 (3):32-33.
- Sanchez-Rubio Ferrrandez J, Lozano MC, Iglesias I, Sanchez-Rubio Ferrandez L, Rodriguez Vargas B and Moreno Diaz R. Use of a closed-system drug transfer device (PhaSeal®) and impact on preparation time. Int J Pharm Compd. 2012; 5:431-433.
- Sessink PJM, Rolf M-AE and Ryden NS. Evaluation of the PhaSeal hazardous drug containment system. Hosp Pharm. 1999; 34:1311-17.
- Sessink PJM, Connor TH, Jorgenson JA and Tyler TG. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. J Oncol Pharm Practice. 2011; 17:39-48.
- Sessink PJM, Trahan J and Coyne JW. Reduction in surface contamination with cyclophosphamide in 30 hospital pharmacies following implementation of a closed-system drug transfer device. Hosp Pharm. 2013; 48:204-212.
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- Sidikou O, Simon N, Sergent G, Vasseur M, Pinturaud M, Richeval C, Allorge D, Decaudin B and Odou P. In vitro assessment of a new extension set intended to reduce occupational exposure to antineoplastic drugs during hepatic chemoembolisation. Cardiovasc Intervent Radiol. 2015 (Epub ahead of print).
- Simons A and Toland S. Closed systems for drug delivery: a necessity, not an option. Brit J Nurs. 2015; 24:S20,S22.
- Smith ST and Szlaczky MC. Syringe plunger contamination by hazardous drugs: a comparative study. J Oncol Pharm Practice. 2014; 20:381-385.
- Smith ST and Szlaczky MC. Response to the editor. J Oncol Pharm Practice. 2014; 20:399-400.
- Spivey S and Connor TH. Determining sources of workplace contamination with antineoplastic drugs and comparing conventional IV drug preparation with a closed system. Hosp Pharm. 2003; 38:135-139.
- Tans B and Willems L. Comparative contamination study with cyclophosphamide, fluorouracil and ifosfamide: standard versus a proprietary closed-handling system. J Oncol Pharm Practice. 2004; 10:217-223.
- Vandenbroucke J and Robays H. How to protect environment and employees against cytotoxic agents, the UZ Ghent experience. J Oncol Pharm Practice. 2001; 6:146-152.
- Vyas N, Turner A, Clark JM and Sewell GJ. Evaluation of a closed-system cytotoxic transfer device in a pharmaceutical isolator. J Oncol Pharm Practice. 2014; (Epub ahead of print) DOI: 10.1177/1078155214544993.
- Vyas N, Yiannakis D, Turner A and Sewell GJ. Occupational exposure to anti-cancer drugs: A review of effects of new technology. J Oncol Pharm Pract. 2014; 20:278-287.
- Wakui N, Ookubo T, Iwasaki Y, Ito R, Saito K and Nakazawa H. Development of a closed drug preparation method for oral anticancer drugs. J Oncol Pharm Practice. 2013; 19:315-320.
- Wick C, Slawson MH, Jorgenson JA and Tyler LS. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health-Syst Pharm. 2003; 60:2314-2320.
- Yoshida J, Tei G, Mochizuki C, Masu Y, Koda S and Kumagai S. Use of a closed system device to reduce occupational contamination and exposure to antineoplastic drugs in the hospital work environment. Ann Occup Hyg. 2009; 53:153-160.
- Zock MD, Soefje S and Rickabaugh K. Evaluation of surface contamination with cyclophosphamide following simulated hazardous drug preparation activities using two closed-system products. J Oncol Pharm Practice. 2011; 17:49-54.
Work Practice Evaluation
Several approaches have been developed for evaluating work practice techniques for drug preparation and drug administration. These approaches typically rely on a non-toxic substitute for the drug that can be easily visualized by ultra violet light or other means. Some test kits are available for various manufacturers.
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- Harrison BR, Godefroid RJ and Kavanaugh EA. Quality-assurance testing of staff pharmacists handling cytotoxic agents. Am J Health-Syst Pharm. 1996; 53:402-407.
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- Spivey S and Connor TH. Determining sources of workplace contamination with antineoplastic drugs and comparing conventional IV drug preparation with a closed system. Hosp Pharm. 2003; 38:135-139.
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- Page last reviewed: September 13, 2017
- Page last updated: September 13, 2017
- Content source:
- National Institute for Occupational Safety and Health Division of Applied Research and Technology