Safe Handling Made Simple
Help keep pharmacists, technicians, and nurses safer than ever before.
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 standards bodies 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.5 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.6
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.7
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.
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. Standards bodies, such as The United States Pharmacopeia's USP <800> recommend using a CSTD to minimize occupational exposures to hazardous drugs.8,9 The 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.10,11
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.12
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.
In response to the well-documented risks associated with handling hazardous drugs, ICU Medical has developed the ChemoClave CSTD, the world's first needlefree CSTD for the safe handling of hazardous drugs.
The ChemoClave CSTD is comprised of a selection of vial adapters that mechanically prohibit the transfer and escape of environmental contaminants, including the Genie® needlefree CSTD vial access device 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.
In addition to meeting recommended 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.13 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 14
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."15 To that end, a recent study comparing all commercially available CSTDs found that the ChemoClave CSTD 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.16