Chapter 71

Chemotherapeutic drugs are considered hazardous drugs. Hazardous drugs (HDs) are defined as drugs that can have adverse health effects and significant toxicity at low doses. Drugs are classified as hazardous if studies in animals or humans indicate that exposures to them have a potential to cause cancer, developmental or reproductive toxicity, or harm to organs (National Institute for Occupational Safety and Health [NIOSH], 2004).

In the United States, an estimated 500,000 veterinary health care workers potentially are exposed to HDs or drug waste at their workplaces (NIOSH, 2010). Routes of exposure include skin absorption, inhalation, and ingestion. Most HDs used in veterinary species are antineoplastic (chemotherapeutic) agents.

Because knowledge about the effects of HD exposure is evolving continually and the degree of HD absorption is difficult to assess, a general procedure for creating and enforcing protocols to minimize exposure to HDs and drug waste should be a priority at veterinary hospitals. These protocols should protect all staff working in a veterinary hospital, not only those who administer chemotherapeutic drugs. Specialized equipment and work practices are required to protect veterinary health care workers from the dangers of HD exposure.

Equipment

Drug Preparation Equipment

Biological safety cabinets (BSCs) are the hallmark equipment for the safe preparation of hazardous and cytotoxic drugs. A BSC is a ventilated cabinet that provides personnel, product, and environmental protection via inward airflow, downward high-efficiency particulate air (HEPA) airflow, and HEPA-filtered exhausted air, respectively. BSCs must be vented to the outside environment with no recirculation (U.S. Pharmacopeial Convention, 2011). The effectiveness of BSCs in containing drug contamination depends on user technique.

BSCs require initial certifications to assure proper airflow and function, as well as recertifications every 6 to 12 months, depending on manufacturer recommendations. HEPA filters may need to be replaced every 2 to 5 years depending on the level of contamination within the surrounding workspace.

Several styles of safety cabinets are available; however, the recommended cabinet type is class II, type B2. A class II, type B2 BSC can cost $8000 to $15,000 depending on size and installation charges. This type of cabinet offers the recommended level of protection for the preparation of all products used in veterinary practice when employed under the proper conditions; it is vital that the airflow and negative-pressure environment be maintained within the BSC at all times. The use of closed-system drug-transfer devices (CSTDs) to provide staff with two tiers of containment for HDs is recommended if BSCs are not located within a negative-pressure clean-room environment.

CSTDs are designed to mechanically prevent the transfer of environmental contaminants into the system and the escape of drug or vapor out of the system. Each multicomponent system has specific components for the preparation and administration of HDs, including components for drug vials, locking syringes, and administration sets. The choice of CSTD should be based on proven, independent, effectiveness data. There are several CSTD systems on the market; the authors currently use the PhaSeal system. Chemotherapy adjuncts and chemotherapy vial venting pins are not closed-system devices and should not be used in place of a closed system and proper environmental controls. CSTDs and chemotherapy adjuncts alone never should be used in place of proper two-tiered protection, such as a BSC in a clean room or a CSTD within a BSC (American Society of Health-System Pharmacists [ASHP], 2006).

When proper equipment is not available to prepare HDs, they may be sourced from pharmacies that are properly equipped in ready-to-use, unit-dose packaging. Other alternatives are sending patients to a facility where HDs can be prepared in a BSC and sharing a BSC among several private practices.

Drug Transport Equipment

When HDs are transported within the hospital, gloves always should be worn and care taken to prevent workspace exposure to drug residues. Stock bottles, commercial vials, dispensing containers, prepared doses, syringes, and administration devices containing HDs should be transported by hand in a secondary container, such as a rigid plastic closed-top bin (for stock bottles) or a clear zip-lock bag (for prepared doses), to reduce potential for spills. Transport containers never should be placed into a potentially contaminated area (such as the workspace in the BSC).

Drug Storage

Hospital areas that contain storage for HDs should be identified with distinct placards and signs that are easily recognizable, even to non-English speakers, to distinguish them from general product storage areas. Efforts should be made to store HDs in an area in close proximity to the area in which they will be used, and all HDs should be segregated from other drug inventory by physical means such as closed storage bins and boxes.

Personal Protective Equipment

In addition to physical barriers discussed earlier such as BSCs and CTSDs, all components of HD handling require some level of personal protective equipment.

Gloves

Gloves should be worn at all times during the receipt, transport, preparation, and administration of HDs, and in handling excreta from patients that have recently received HDs. Latex, nitrile, rubber, and polyurethane gloves all can provide protection against exposure to HDs. Glove packaging should note that the product meets the ASTM International standards for resistance to permeation of chemotherapeutic drugs. Generally, powder-free latex or nitrile gloves that are less than 8 mil (1 mil = 0.001 inch) in thickness should be used in a double-glove protocol, with one glove worn under the cuff of the gown and one glove over the cuff. Frequent exposure of gloves to isopropyl alcohol should be avoided. Gloves never should be worn for longer than 30 minutes and should be changed immediately if torn, punctured, or contaminated. Care always should be taken to avoid touching the contaminated outer surfaces when removing gloves. Hands always should be washed thoroughly with soap and water before gloves are donned and after removal.

Gowns

Gowns are required for preparation, administration, spill control, and waste management of HDs. Generally, gowns should be of a disposable, lint-free, closed-front style with long sleeves and tight-fitting elastic or knit cuffs. Washable cloth or reusable gowns or smocks never should be used when handling HDs. Polyethylene, polypropylene, or vinyl-coated gowns offer the best level of protection. Gowns never should be worn outside of the immediate drug preparation and administration area because they can be a source of contamination for other hospital areas and other staff members. Gowns should be disposed of immediately after use (ASHP, 2006).

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