The Use of Hazardous Drugs

Hazardous Drug Training

All personnel who are involved in ANY aspect of the handling of hazardous drugs, (such as physicians, nurses, pharmacists, housekeepers, and employees involved in receiving, transporting, or storing) must receive information and training to protect them in the work area.

The training should include methods of observation to detect the presence or release of an HCS-covered hazardous drug. For example, the monitoring conducted by the employer, continuous monitoring devices, or the visual appearance or odor.

Here are some other training components:

• physical and health hazards of the covered hazardous drugs in the work area
• measures employees can take to protect themselves from these hazards (including specific procedures the employer has implemented to protect employees from exposure)
• appropriate work practices
• emergency procedures for spills or employee exposure

Recommended Good Work Practice Procedures

There are other necessary work practice procedures to protect workers against hazardous drugs. For example, nursing stations on floors where hazardous drugs will be administered should have spill and emergency skin and eye decontamination kits available and relevant MSDSs for guidance.

Also, a list of drugs covered by hazardous drug policies and information on spill and emergency contact procedures should be posted or easily available to employees.

Biological Safety Cabinets

Approved Biological Safety Cabinets (BSC) should be used when preparing hazardous medications.

• Class II, type B, or Class III BSCs that vent to the outside are recommended.
• OSHA does not recommend Horizontal BSCs for the preparation of hazardous drugs, since they increase the likelihood of drug exposure.

The BSC should also contain:

• covered needle containers for needle disposal
• covered waste container for excess fluids disposal

Horizontal Flow Laminar Hood

Vertical Flow Laminar Hood

Decontamination

Decontamination of a BSC must consist of surface cleaning with water and detergent, followed by a thorough rinsing. Spray cleaners should be avoided because of the risk of spraying the HEPA filter. Ordinary decontamination procedures which include fumigation with a germicidal agent, are inappropriate in a BSC because such procedures don’t remove or deactivate the hazardous drugs.

Removable work trays should be lifted in the back of the BSC to be cleaned. During cleaning, the worker should wear appropriate personal protective equipment (PPE) similar to those used for spills. The exhaust fan/blower should be left on and cleaning should proceed from least to most contaminated areas. The drain spillage trough area should be cleaned at least twice since it can be heavily contaminated.

Hazardous Drugs During Preparation

Employees can be exposed to hazardous drugs during preparation because of ineffective engineering, or work practice controls, or personal protective equipment (PPE).

The outside of bags or bottles containing the prepared drug should be wiped with moist gauze. Entry ports should be wiped with moist alcohol pads and capped. Transport should occur in sealed plastic bags and in containers designed to avoid breakage. Shipped hazardous drugs that are subject to Environmental Protection Agency regulation as hazardous waste, are also subject to Department of Transportation regulations.

Non-liquid HD's: The handling of non-liquid forms of hazardous drugs requires special precautions as well. Tablets which may produce dust or potential exposure to the handler should be counted in a BSC. Capsules, such as gel-caps or coated tablets, are unlikely to produce dust unless broken in handling. These are counted in a BSC on equipment designated for hazardous drugs only, because even manual counting devices may be covered with dust from the drugs handled. Automated counting machines should not be used unless an enclosed process isolates the hazard from the employee(s).

Personal Protective Equipment

OSHA requires the use of effective PPE when working with hazardous drugs.

Here are some examples:

Gloves

• The thickness of the gloves used in handling hazardous drugs is more important than the type of material. The best results have been seen with latex gloves.
• Double gloving is recommended because all gloves are permeable to some extent, and their permeability increases with time.
• When double gloving, one glove should be placed under the gown cuff and one over. The glove-gown interface should be such that no skin on the arm or wrist is exposed.
• To limit transfer of contamination from the BSC into the work area, the outer gloves should be removed after each task or batch, and should be placed in "zipper" closure plastic bags or other sealable containers for disposal.

• Gloves should be changed hourly or immediately if they are torn, punctured, or contaminated with a spill.
• Thicker, longer, latex gloves that cover the gown cuff are recommended with minimal or no powder since the powder may absorb contamination.
• Hands should be washed before gloves are put on and after they are removed.

Personal Protective Equipment (Continued)

Gowns

• A protective disposable gown must be made of lint-free, low-permeability fabric with a closed front, long sleeves, and elastic or knit closed cuff should be worn.

Respiratory Protection

A NIOSH-approved respirator appropriate for the hazard must be worn to afford protection until a BSC is installed. The use of respirators must comply with OSHA's Respiratory Protection Standard 105. The standard outlines the aspects of a respirator program, including selection, fit testing, and worker training.

Surgical masks are not appropriate since they do not prevent aerosol inhalation. Permanent respirator use, in lieu of BSC's, is not good practice and should not be a substitute for engineering controls.

Personal Protective Equipment (Continued)

Eye and Face Protection

Whenever splashes, sprays, or aerosols of HD's may be generated that can result in eye, nose, or mouth contamination, chemical-barrier face and eye protection must be provided and used in accordance with 29 CFR 1910.133. Eyeglasses with temporary side shields are inadequate protection.

When a respirator is used to provide temporary protection as described above, and splashes, sprays, or aerosols are possible, employee protection should be:

• respirator with a full face piece
• plastic face shield or splash goggles complying with ANSI standards2 when using a respirator of less than full-face piece design

Eyewash facilities should also be made available.

Restricted Preparation Areas

OSHA and the American Society of Hospital Pharmacists recommend hazardous drug preparation should be performed in a restricted area. This area should have visible signs to restrict the access of unauthorized personnel.

• Bins or shelves where hazardous drugs are stored should be designed to prevent breakage and to limit contamination in the event of leakage, with bins with barrier fronts, or other design features that reduce the chance of drug containers falling to the floor.
• Warning labels should be applied to all hazardous drug containers, shelves, and bins, where these containers are stored.

The American Society of Hospital Pharmacists (ASHP) recommends hazardous drugs requiring refrigeration be stored separately from non-hazardous drugs in individual bins designed to prevent breakage and contain leakage.

Restricted Activities

Smoking, drinking, applying cosmetics, or eating where hazardous drugs are prepared, stored, or use, increases the chance of exposure, and should be prohibited.

Handling Practices

Workers can be exposed to hazardous drugs through improper handling practices, needle or sharps handling and disposal, and priming IV lines or labeling.

When handling these hazardous drugs, good work practice should be in place. The hazardous drugs should be prepared by pharmacists, not nurses or physicians without proper PPE and engineering controls.

The risk of exposure to hazardous drugs through inhalation or direct skin contact, is present in procedures such as:

• transferring hazardous drugs from one container to another, reconstituting or manipulating them
• withdrawal of needles from drug vials
• expulsion of air from a drug-filled syringe

Sharps Handling

OSHA and the American Society of Hospital Pharmacists (ASHP) recommend all syringes and needles used in the course of preparation be placed in "sharps" containers for disposal without being crushed, clipped or capped.

Priming of Tubing for Hazardous Drugs

OSHA recommends drug administration sets be attached and primed within the BSC prior to addition of the drug. This eliminates the need to prime the set in a less well-controlled environment. The priming should be done with non-drug containing solution or a back-flow closed system should be used.

Labeling Practices

In addition to standard pharmacy labeling practices, all syringes and IV bags containing hazardous drugs should be labeled with a warning label such as, “Special Handling/Disposal Precautions.”

Hazardous Drugs During Administration

Workers can be exposed to hazardous drugs during administration; therefore, personnel should wear gowns, latex gloves, and chemical splash goggles or equivalent safety glasses.

When administering aerosolized drugs, additional precautions may be necessary to protect employees from exposure such as:

• wearing NIOSH-approved respirators
• using treatment booths with local exhaust ventilation systems, or isolation rooms with separate HEPA filtered ventilation systems

The American Society of Hospital Pharmacists (ASHP) recommends these guidelines when administering hazardous drugs:

• Only those trained to administer hazardous drugs should be allowed to perform this function.
• Disposable gloves and gowns should be worn. The glove and gown cuffs should be worn in a manner that produces a tight fit (e.g., loose glove tucked under gown cuff; tight glove fitted over gown cuff).
• Intravenous containers designed with venting tubes should not be used.
• The use of plastic backed absorbent liners under IV tubing during administration of hazardous drugs to absorb any leakage and prevent the solution from spilling onto patient skin.
• Work at waist level, if possible; avoid working above the head or reaching up for connections or ports.
• Until the reproductive risks associated with handling hazardous drugs have been substantiated, staff who are pregnant or breast-feeding should avoid contact with these drugs.

Disposal of Hazardous Drugs

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OSHA requires bags containing materials contaminated with hazardous drugs be covered under the Hazard Communication Standard and must be properly labeled.

Thick, leak-proof plastic bags, colored differently from other hospital trash bags, should be used for routine collection of discarded gloves, gowns and other disposable material, and labeled as “Hazardous Drug-related wastes.” The waste bag should be kept inside a covered waste container clearly labeled “Hazardous Drug WASTE ONLY.” At least one such receptacle should be located in every area where the drugs are prepared or administered. Waste should not be moved from one area to another. The bag should be sealed when filled and the covered waste container taped.

Hazardous drug-related wastes should be disposed of according to EPA, state and local regulations for hazardous waste. This disposal can occur at either an incinerator or a licensed sanitary landfill for toxic wastes, as appropriate. Commercial waste disposal is performed by a licensed company. While awaiting removal, the waste should be held in a secure area in covered, labeled drums with plastic liners.

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