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March 16, 2010
Antineoplastic drugs comprise the largest group of drugs considered hazardous by NIOSH (http://www.cdc.gov/niosh/), OSHA (http://www.osha.gov/ and ASHP (http://www.ashp.org/). They affect cell growth and proliferation, either by binding directly to the genetic material in the cell nucleus or by affecting cellular protein synthesis. These drugs cannot distinguish between normal and cancerous cells. As a consequence, secondary malignancies were reported in patients who received antineoplastic drugs for other, usually solid, primary malignancies. New generation drugs, such monoclonal antibodies may target sites other than genetic material and accordingly be more selective in their mechanism of action and be as a result safer.
The problem is not just for cancer patients, but also for workers who manipulate these drugs. A hazardous drug is defined as an agent that presents a danger to health care personnel due to its inherent toxicity. These drugs are identified from the following characteristics: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity and genotoxicity. Hazardous drugs include anticancer and cytotoxic drugs, hormonal agents, immunosuppressants , antiviral medications and monoclonal antibodies. The use of Chemotherapy gloves (http://www.isotechdesign.com/docs/consumables/en/P.BrochureConsumable.pdf) can help protect compounding personnel from exposure to hazardous drugs.
To determine exposure, environmental air and surface sampling techniques to assess workplace contamination and analysis of the urine to determine the presence of parent drugs and or metabolites of hazardous drugs handled by health care workers. Dermal and inhalation routes are the likely routes of exposure to anticancer drugs in health care facilities. Surface wipes sampling for airborne drugs have been employed to determine workplace contamination with anticancer drugs. It is important to use a gloves brand that has been approved by the FDA for use with antineoplastic drugs. These gloves are labelled Chemotherapy gloves and are made of latex, nitrile and neoprene. When handling chemotherapy drugs, NIOSH (http://www.cdc.gov/niosh/)recommends double gloving to reduce the amount of contamination that leaves the biological safety cabinet ( BSC) or compounding aseptic compounding isolator( CACI)( http://www.isotechdesign.com/en/products-pharmacies-rx/chemo-compounding.php) since studies have shown that gloves are usually contaminated during drug preparation. The outer glove should be removed carefully before the preparer exits the BSC or the CACI when the preparation is completed and the outer glove should be disposed of inside the BSC or the CACI.
The proper use if recommended PPE, such as protective gloves ad gowns can help reduce worker exposure to hazardous drugs, especially chemotherapy drugs. However, PPE is only effective if all aspects of a safe handling program are in place, including engineering controls, training and administrative controls.
This article was written by Thomas H. Connor, PhD and published in the Pharmacy Purchasing & Products, Vol.2No.7 (http://www.pppmag.com).