Cancer is the world's leading cause of death, claiming the lives of an estimated 7.9 million people in 2007 alone, and experts expect these numbers to double before 2030.1 The unsafe handling of hazardous drugs used to treat many forms of cancer has been recognized since the 1970s as a significant health hazard to workers. The toxicity of hazardous drugs and the dangers of prolonged exposure have been proven to cause hair loss, skin rashes, infertility, miscarriage, birth defects, and even leukemia or other forms of cancer in healthcare workers.2,3,4,5 Studies have shown that workers can be at risk of exposure to these drugs throughout their lifecycle - from manufacturing, to distribution, to use in the clinical or home care environment, to waste disposal. Healthcare workers who handle these drugs may be exposed by inhaling aerosols or dust generated during pharmacy preparation and nursing administration, or by direct contact with the skin during accidental needlesticks, spills, or spill cleanup.
The basic occupational health approach to minimize exposure to any workplace hazard is a hierarchy of control methods, including elimination or substitution of hazard, engineering controls, administrative controls, and personal protective equipment (PPE). The current guidelines for the safe handling of hazardous drugs set forth by NIOSH, ASHP, and ONS are based on these occupational health principles.
Procedures for drug preparation can vary from one institution to the next. In some locations, Class II or Class III biological safety cabinets (BSCs) are used for hazardous drug preparation, while others use isolators to achieve asepsis and containment.6 Drug preparation should take place in a clutter-free and properly cleaned controlled environment with access limited to authorized personnel following all PPE recommendations.
Detailed guidelines for the administration of hazardous drugs have been developed by the Oncology Nursing Society (ONS) that stress the criticality of PPE for the task being performed, the use of needlefree systems whenever possible, and the use of intravenous tubing primed by the pharmacy or primed at the point of care with a solution other than the drug.7
Inside an institution, hazardous drugs should be packaged and transported in such a way as to prevent damage and subsequent contamination of the environment, the drug itself, and all personnel involved in the routine handling and transportation of these drugs. Protective containers should be made of molded foam or a sponge-like material so that the drugs are securely positioned. The containers should also be labeled to identify the contents as hazardous and to specify appropriate light and temperature conditions under which the drugs should be maintained.8
Reliance on BSCs and PPE to provide total protection from exposure to hazardous drugs may provide a false sense of security. Other factors that may contribute to contamination include unreported or inadequately cleaned spills as well as transport and placement of contaminated objects.
Closed System Transfer Devices
The use of a closed system transfer device (CSTD) in conjunction with other safety precautions such as gloves, gowns, masks, and vented preparation hoods presents a proven way to increase safety levels when preparing, transporting, administering, and disposing of hazardous drugs. CSTD is a generic term used to describe a device that does not allow any substance-including vapors, liquids, or powders-to escape outside the vial or bag during the entire safe handling process. NIOSH and The United States Pharmacopeia's (USP) General Chapter 797 recommend using a CSTD to minimize occupational exposures to hazardous drugs.9,10 The NIOSH definition of a closed system is one that mechanically prevents the transfer of environmental contaminants into the system and the escape of drug or vapor out of the system.
Several studies have demonstrated the effectiveness of CSTDs in reducing surface contamination, airborne emission, and exposure to healthcare workers.11,12
One study compared surface contamination across 22 US hospital pharmacies following preparation with standard drug preparation techniques versus a CSTD. The study concluded that a significant reduction in levels of contamination was observed for all drugs sampled - cyclophosphamide, ifosfamide, and 5-fluorouracil - by 95%, 90%, and 65% respectively.13
When evaluating CSTDs, clinicians and healthcare facilities need to take into consideration several factors to determine which system is right for them. As mentioned above, studies have clearly shown that using a CSTD can significantly increase the safety of those tasked with handling hazardous drugs. And while these systems provide an enhanced level of protection for all those involved in the safe handling continuum - from preparation, to transportation, to administration, to disposal - the technology is still evolving, and no commercially available CSTD can, at this point in time, claim a 100% elimination of any and all exposure to hazardous drugs, despite their ability to substantially mitigate risk.
ChemoClave™ Closed System Transfer Device
In response to the well-documented risks associated with handling hazardous drugs, ICU Medical has developed the ChemoClave closed system transfer device, the world's only needlefree CSTD for the safe handling of hazardous drugs.
ChemoClave CSTDs are comprised of the Genie® needlefree CSTD vial access device, designed with an internal balloon that automatically equalizes drug vial pressure when extracting hazardous medications from vials; a selection of needlefree bag spikes; and primary add-on and administration sets featuring the Spiros ® CSTD male luer. Spiros can be attached to a syringe or the end of an IV set, and automatically self-seals whenever disconnected in order to protect the integrity of the IV fluid container. The Spiros can also access the Genie's bonded Clave® needlefree connector.
ChemoClave CSTD maintains a mechanically and microbiologically closed needlefree system during the preparation of hazardous drugs to help keep you safe and comply with recommended guidelines.
By maintaining a closed system, ChemoClave CSTD helps you prevent leaks and spills during the transport of hazardous drugs from pharmacy to nursing.
ChemoClave CSTD makes it safer for you and your patients by preventing accidental disconnects to minimize drug exposure without having to change any standard nursing protocols.
ChemoClave CSTD remains mechanically and microbiologically closed all the way through disposal to eliminate potenial drug exposure to you or the environment.
Clinical and Operational Advantages
In addition to meeting NIOSH and ASHP guidelines, ChemoClave CSTD is an intuitive, easy-to-use, needlefree system that is preferred by nurses, helping ensure compliance from beginning to end. A study comparing the PhaSeal and ChemoClave systems found that work practices and procedures regarding product operation appeared to be an important factor in hazardous drug containment and needle safety when using PhaSeal, but not when using ChemoClave, which requires fewer user steps and is needlefree.14 In a previous report comparing the same two CSTDs in a head-to-head fashion, the authors concluded that there was no difference between the two systems in their efficacy at controlling surface contamination.15
In a March 2011 editorial in Journal of Oncology Pharmacy Practice, the authors concluded that "if, in fact, the different closed systems currently available are equally effective, then the choice comes down to cost and ease of use." In addition, the editorial urged hospitals to make sure that the CSTD they choose "is capable of containing the hazardous drug throughout all handling steps from reconstitution to administration."16 To that end, a recent study comparing all commercially available CSTDs found that ChemoClave provided significant cost savings to hospitals while scoring highest in terms of ease of use, practicality, and perceived safety by a cross-functional evaluation team of pharmacists, nurses, and value analysis professionals.17
- World Health organization (WHO). http://www.who.int/features/qa/15/en/index.html (accessed august 2009).
- Connor TH, McDiarmid MA. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J Clin 2006; 56: 354-365.
- National Institute for Occupational Safety and Health. NIOSH Alert: preventing occupational exposures to antineoplastic and other hazardous drugs in the health care setting. Centers for Disease Control and Prevention, National Institute for Occupation Safety and Health, DHHS (NIOSH) Publication No. 2004-165. Washington, DC: U.S. Department of Health and Human Services.
- Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. Journal of Occupational and Environmental Medicine: 41(8) August 1999;632-638.
- Skov T, Maarrup B, Olsen J et al. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. British J of Industrial Medicine 1992; 49:855-861.
- National Institute for Occupational Safety and Health. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in the health care setting. Centers for Disease Control and Prevention, national institute for occupation Safety and Health, DHHS (NIOSH) Publication no. 2004-165. Washington, DC: U.S. Department of Health and Human Services.
- Polovoch M, White JM, Kelleher LO, eds. Chemotherapy and biotherapy guidelines and recommendations for practice. Pittsburgh, Pa. oncology nurses Society; 2005.
- International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Section 2 - Transport of cytotoxics. J oncol Pharm Pract. 2007; 13 Suppl:1-81.
- American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. am J Hosp Pharm 1990; 47:1033-1049.
- The United States Pharmacopial Convention. USP<797> Guidebook to pharmaceutical compounding - sterile preparations. in: The United States Pharmacopial Convention, Rockville, MD, 2008.
- Harrison BR, Peters BG, 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 Phar 2006; 63: 1736-1744.
- Sessink PJM, Rolf ME, Ryden NS. Evaluation of the PhaSeal Hazardous Drug Containment System. Hosp Pharm 1999; 34:1311-1317.
- Sessink PJ, Connor TH, Jorgenson JA, 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 Mar; 17(1):39-48.Epub 2010 feb 15.
- Zock M, Soefje S, Rickabaugh K. Evaluation of surface contamination with cyclophosphamide following simulated hazardous drug preparation activities using two closed-system products. J oncol Pharm Practice, August 12, 2010.
- Ledford a, Maliakal P, Rogers Tl, Mackey M. Evaluation of two closed system transfer devices in an outpatient community cancer centre. Poster 144. in: American College of Clinical Pharmacy annual meeting, Orlando, FL, October 2009.
- Davis J, Mclauchlan R, Connor TH. Exposure to hazardous drugs in Healthcare: an issue that will not go away. J Oncol Pharm Pract 2011 17: 9.
- Saria M et al. The Cost of Safety: Closed System Transfer Devices, abstract accepted at the International Forum on Quality & Safety in Healthcare, april 2011, Amsterdam NL.