Hazardous drug exposure should be closely monitored and properly managed from beginning to end (or dock-to-dock) in a health care facility as the potential for exposure to health care personnel begins with the receipt of hazardous drugs from a manufacturer or wholesaler. Often, drug vials are damaged during shipping and the packaging is insufficient for proper containment. As a result, many wholesalers have been using plastic and bubble wrap for more protection, as well as specially labeled totes to alert workers on the loading dock to beware and at least be gloved. While there are a number of best work practices available for these workers, they may not be in place.
Loading dock workers, or those receiving drug shipments, must be made fully aware of the potential hazards that they could encounter. The Hazard Communication Standard (HCS)* requires that all workers be informed of hazards in the workplace, be trained to protect themselves, and have appropriate personal protective equipment (PPE) provided to them. At minimum, these workers should be trained to assess packaging for any signs of damage. A broken carton of a hazardous drug represents an inhalation hazard, so respiratory protection (both particle and vapor) should be added to standard double (thick) gloves and gown or coverall. Sturdy plastic bags for containment must be available as well. Any potentially damaged packaging should be bagged and moved to an isolated area for opening; use of a fume hood would be ideal for this situation, but such equipment is rarely available in this setting. All workers who may be required to use a respirator must be trained to use that equipment, and fit testing is required by OSHA to ensure effectiveness.
Hazardous Drugs in the Pharmacy
Inventory control is another area where special precaution should be taken as contamination is commonly found on the outside of individual drug vials shipped from most manufacturers regardless of vial breakage. This circumstance has been known since at least 1992, but most manufacturers have done little to reduce this contamination, which also has been found inside the packaging and on the individual carton surrounding the vials. While some generic chemotherapy products are available in specially designed vials that have PVC bottoms and shrink-wrapped plastic covers to reduce breakage, in general, most vials are contaminated. All hazardous drug handling guidelines advocate the use of gloves for all inventory functions, but this is not well adhered to.
Contaminated vials become sources of drug exposure in all areas where they are stored. To address this, USP <797> has developed inventory control standards for hazardous drugs and clear air changes per hour (ACPH) requirements for storage, as hazardous drug residue has the potential to vaporize from vial surfaces and other contaminated surfaces into the air.
Acquiring and moving drug vials and supplies into a primary engineering control (PEC) should be done using proper PPE, such as chemotherapy tested gloves1, due to the possibility of contamination transfer. Contaminated gloves also pose a potential risk for transfer to other inanimate surfaces and skin surfaces. Double gloving and practicing proper removal techniques all help mitigate further exposure. As a general rule, removal of contaminated gloves should always be skin-to-skin and glove-to-glove—the unprotected skin of fingers must not touch the contaminated side of the glove. The first glove is pinched with the gloved fingers of the opposite hand; carefully remove the glove then turn that glove inside out to contain the residue. The ungloved fingers are placed inside the wrist of the second glove (on the skin of the other hand) to remove the glove by sliding it off and turning it inside out.
Role of Closed System Transfer Devices
Most guidelines governing hazardous drugs address the actual compounding and administration of those drugs as this is where the greatest risk of exposure is seen due to the high concentrations and volumes handled in this setting. Many practitioners may argue that since closed system transfer devices (CSTDs) do not address all areas of potential exposure, such as receiving and wasting, they are not worth the expense to acquire and implement. Despite this sentiment, CSTDs have been shown to reduce the contamination generated in the compounding and administration of hazardous drugs, an activity set that represents a significant risk for hazardous drug exposure. Contamination generated during these activities is almost always transferred down stream to other workers and the environment. It should be noted that in the absence of CSTDs, nurses have no tools to help in administering hazardous drugs. Studies of work practices show that open spiking of hazardous drug doses, priming of lines, and removing hazardous drug-contaminated lines from Y-sites can result in significant contamination of patient areas where other staff members, non-chemo patients, and visitors also may be exposed.
Hazardous Drug Wasting
Once the compounding and infusion of a hazardous drug is completed, handling the waste produced by these activities creates a new source of exposure. Contaminated drug containers, supplies, and solutions may be dumped into open hazardous waste containers. This can result in hazardous products dripping outside the containers and the drug residue on the outside of vials and other containers can easily vaporize. Processes of waste handling and cleaning of areas where hazardous drugs have been compounded or administered are significant sources of drug contamination and exposure. Studies of health care workers have shown traces of hazardous drugs in the urine of housekeepers and other support staff. Waste accumulation and handling areas represent other areas of risk. Thus, dock-to-dock containment is vital. Hazardous drug waste, including supplies used in cleaning, should be contained in thick, zipper-lock bags and discarded in appropriate waste containers. This provides a second level of waste containment and reduces open waste in any of the larger containers.
Ultimately, handling precautions should be in place in all areas where hazardous drugs are received, stored, compounded, administered, and wasted to reduce contamination in the workplace and the resulting exposure to health care workers and others.
* For more information on the Hazard Communication Standard, visit www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099
Luci A. Power, MS, RPh, is an independent lecturer and consultant on pharmacy IV and hazardous drug systems. She was with the department of pharmaceutical services at the University of California Medical Center in San Francisco for over 25 years serving in various capacities, including senior pharmacist and manager of the parenteral support services, and manager of IV additive services where she was responsible for inpatient chemotherapy and other hazardous drug compounding.