Hazardous Drug, Radioactive Materials, and Infectious Agent Guidelines for Researchers & the CLAC/CCM Biohazard Material Information Questionnaire
INTRODUCTION
The purpose of this guidance document is to provide researchers with sufficient background information regarding how hazardous drugs should be handled in the laboratory in order to minimize personal exposures. This information will also be used by the researchers when completing the Center Laboratory Animal Care (CLAC)/Center for Comparative Medicine (CCM) animal care and use program’s “Biohazard Material Information Questionnaire”.
Whenever researchers administer hazardous drugs (including antineoplastic/cytotoxic drugs) to animals, specific procedures must be followed to insure that employees will not be exposed to hazardous drugs or waste products. Antineoplastic drugs are increasingly being used in the treatment of non-malignant rheumatologic and immunologic diseases as well as in veterinary medicine for anti-cancer chemotherapy. Studies have associated personal exposures to hazardous drugs with negative health effects such as skin rashes and adverse reproductive events (including infertility, spontaneous abortions, or congenital malformations) and possibly leukemia and other cancers. The National Institute for Occupational Safety & Health (NIOSH) has a document available which addresses the proper handling of these drugs; “Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Health Care Settings” and it is found at: . Researchers are encouraged to read this NIOSH document in order to become familiar with the proper procedures for handling hazardous drugs.
IDENTIFYING HAZARDOUS DRUGS
The following is a list of common hazardous drugs, however the list is not all-inclusive: .
Whenever a chemical substance is not found on the above list of “hazardous drugs” the material safety data sheet (MSDS) and other informational sources must be reviewed by the researcher in order to determine whether the substance has any of the following hazardous properties: carcinogen, mutagen, teratogen, reproductive or developmental toxicity or has organ toxicity at low doses (1mg/kg/day). If the chemical substance has any of the above hazardous properties the material and its waste products must be handled as though it were a hazardous drug.
The first step in determining whether a chemical substance is a “hazardous drug” is to check the following resources for information about the substance:
- Material Safety Data Sheet (MSDS).
- U.S. Food and Drug Administration approved product labeling (package inserts).
- Special health warnings form drug manufacturers, the FDA and other professional groups and organizations.
- Reports and case studies published in medical and other healthcare profession journals.
- Evidence-based recommendations form other facilities that meet the criteria defining hazardous drugs.
Experimental or investigational drugs must be handled properly whenever these substances are likely to have a hazardous mechanism of action (antineoplastic agent) or are related to a class of hazardous drugs. In many cases the experimental drug may have minimal information available regarding its toxicity and other hazards.
Chemical substances which are classified as moderately toxic chemicals and have no unusual hazardous properties (vitamins, aspirin, etc.) may be administered to animals without any special containment procedures for collecting the spent animal bedding or decontaminating the dirty cages.
HANDLING HAZARDOUS DRUGS SAFELY
Whenever researchers are handling hazardous drugs they should wear personal protective equipment (gloves, pants, shoes that cover feet, lab coat or gown, face shield) in order to minimize personal exposures to toxic substances.
Researchers should prepare/handle hazardous drugs inside a properly functioning Class II biological safety cabinet (BSC) or inside a chemical fume hood in order to minimize exposures. Non-volatile hazardous drugs may be prepared inside a Class II BSC as long as the BSC has a proper HEPA filter installed, the cabinet is exhausted to the outside of the building and the cabinet has been recently certified to insure that it is functioning properly.
In addition, hazardous drugs should be prepared inside closed-system drug-transfer devices, gloves bags and needle-less systems whenever feasible. Provide syringes and intravenous (IV) sets with Luer-LocTM fittings for preparing and administering hazardous drugs.
The following procedures below should be incorporated into the UCHSC Animal Care & Use Program’s Biohazard Material Information Questionnaire whenever research animals are exposed to hazardous drugs:
- How should dirty animal bedding containing hazardous drugs/metabolites be handled and disposed?
When animals are exposed to the hazardous drugs some of the drug and toxic drug metabolites will be excreted by the animals into the animal bedding. Most hazardous drugs and metabolites should be excreted into the animal bedding 72 hours post administration. For some hazardous drugs there may be extended retention times within the animal.
The contaminated animal bedding should be removed from the cage inside a chemical fume hood or Class II BSC in order to minimize personal exposures. Employees should wear proper PPE (gloves, lab coat, eye protection, etc.) while changing the dirty bedding. The contaminated animal bedding should be collected inside a lined yellow biohazard tub labeled with a yellow bar code label for offsite incineration.
2. How should contaminated dry wastes from animal cages where hazardous drugs were administered be disposed?
Any dry waste (paper, cardboard, etc.) which is trace contaminated with hazardous drugs from inside an animal cage should be collected inside a lined yellow biohazard tub labeled with a yellow bar code label for offsite incineration. Dry debris which has been in contact with the contaminated animal bedding should be considered hazardous since un-reacted drugs or toxic metabolites will be present.
3. How should the dirty cages to be cleaned if hazardous drugs were used?
The first cage changing should be done 72 hours post administration by animal care personnel inside a chemical fume hood or Class II BSC. Employees should wear proper PPE (gloves, lab coat, eye protection, etc.) while cleaning the dirty cages. The dirty bedding will be wiped off the bottom of the cage using disposable paper towels. After all the debris has been removed from the cage it should be sprayed with a detergent cleaning solution and wiped down with paper towels. The contaminated rags or paper towels should be placed into the yellow biohazard tub for offsite incineration. After the cages have been properly wiped down they may be washed inside the automatic cage washer in the animal facility along with other cages.
4. How should the animal carcasses exposed to hazardous drugs be disposed?
Animal carcasses normally contain minimal amounts of hazardous drugs 72 hours post administration. There may be some drugs that have longer retention times inside the animal. Normally the animal carcass may be disposed without regard to the chemical it was exposed. The animal carcasses should be wrapped in a clear plastic bag and placed in the designated container inside the animal facility carcass cooler (or other animal facility designated area).
- How will uneaten animal food or water containing the hazardous drugs be disposed?
The water containing the hazardous drugs should be collected inside a properly labeled chemical waste container. Food pellets containing the hazardous drug should also be collected inside a properly labeled chemical waste container. The chemical waste containers should be disposed of through UCHSC Health & Safety by submitting a UCHSC Chemical Waste Disposal Form through the campus mail to have them removed from the laboratory.
- How will unused hazardous drugs or unused formulations be disposed?
The unused formulations of the hazardous drugs should be collected inside a properly labeled chemical waste container. The hazardous drugs waste should be handled inside a Class II BSC or inside a chemical fume hood in order to minimize personal exposures. Employees should wear proper PPE (gloves, lab coat, eye protection, etc.) while handling the hazardous drugs. Unused hazardous drugs should be disposed of through UCHSC Health & Safety by submitting a UCHSC Chemical Waste Disposal Form through the campus mail to have them removed from the laboratory.
- How will spent HEPA filters removed from Class II BSC where hazardous drugs were prepared be disposed?
When the outside contractor removes the spent HEPA filter form the BSC, the person should wrap the filter inside a secure plastic bag. The HEPA filter should be labeled with a UCHSC Chemical Waste label with the names of the hazardous drugs that were prepared inside the cabinet. The contaminated HEPA filter should be disposed of through UCHSC Health Safety by submitting a UCHSC Chemical Waste Disposal Form through the campus mail to have it removed from the laboratory.
- How will spills of hazardous drugs be handled?
Minor spills of hazardous drugs should be wiped up with paper towels while wearing proper PPE (gloves, lab coat, eye protection, etc.). The contaminated surface should be washed with soap and water. The contaminated paper towels should be collected inside a properly labeled chemical waste container. The chemical waste containers should be disposed of through UCHSC Health & Safety by submitting a UCHSC Chemical Waste Disposal Form through the campus mail to have them removed from the laboratory.
For larger spills of hazardous drugs, the area should be evacuated and the UCHSC Health & Safety Division contacted for assistance with cleaning up the spill.
9. How will used gowns and gloves used in handling or administering hazardous drugs be disposed?
The used gowns and gloves used in handling hazardous drugs should be collected inside a lined yellow biohazard tub labeled with a yellow bar code label for offsite incineration.
10. How will spent needles and sharps used to administer hazardous drugs be disposed?
The spent needles/sharps used to administer the hazardous drugs should be collected inside a red plastic sharps container. When the sharps container is full, the sealed container should be placed inside a lined yellow biohazard tub labeled with a yellow bar code label for offsite incineration.
11. How will employees handling hazardous drugs respond to personal exposures?
Whenever skin has contact with a hazardous drug, immediately flush skin with copious amounts of running water. For large spills of hazardous drugs to the body (arms, legs, body, etc.) use a safety shower. For exposures to the eye, hold the eye open and flush in an eyewash for 20 minutes before seeking medical attention.
For serious injuries seek immediate medical care at a University of Colorado Hospital’s emergency room. For minor exposures or injuries seek medical care at a Concentra Medical Center. The employee must notify their supervisors, in writing, within 4 business days.
Anyone whose work involves regular and frequent handling of toxicologically significant quantities of hazardous drugs should consider consulting with a qualified physician to determine on an individual basis whether a regular schedule of medical surveillance is desirable.
HANDLING RADIOACTIVE MATERIALS SAFELY
Whenever researchers intend to perform research with radioactive materials they must submit a detailed protocol to UCHSC Health & Safety’s Radiation Safety Officer. The Radiation Safety Manual has specific procedures for managing radioactive waste and decontaminating surfaces that have been in contact with radioactive isotopes.
IDENTIFYING INFECTIOUS AGENTS
Infectious agents include those viruses, bacteria, fungi, rickettsia, and parasitic species capable of causing infectious disease in humans or other animals. Transmission between infected animals and other animals or humans is either by direct contact with the infected animal or indirect contact by exposure to contaminated bedding, equipment or supplies. The primary reference for identification of the biosafety “level” practices (including containment) required for a specific infectious agent is:
CDC-NIH (Centers for Disease Control and Prevention-National Institutes of Health) (4th May, 1999). “Biosafety in Microbiological and Biomedical Laboratories”. 4th ed. U.S. Department of Health and Human Services. Washington, D, C.
Other sources of information are:
Human infectious agents:
Animal infectious agents:
All work with infectious agents must be registered with and approved by the UCHSC Biosafety Committee as well s the UCHSC Animal Care and Use Committee (ACUC). For more information contact the Biosafety Office, health and Safety Division (phone 303-724-0235) or check their web site (
HANDLING INFECTIOUS AGENTS SAFELY
Whenever researchers are handling infectious agents they should wear appropriate personal
protective equipment (gloves, pants, shoes that cover feet, lab coat or gown, face shield) in order to
minimize personal exposures to toxic substances.
Researchers should prepare/handle infectious agents inside a properly functioning Class II biological
safety cabinet (BSC) minimize exposures.
In addition, researchers are encouraged to use needle-less systems whenever feasible. Syringes and
intravenous (IV) sets with Luer-LocTM fittings should be used for preparing and administering
infectious agents to animal subjects.
The following procedures below should be incorporated into the UCHSC Animal Care & Use
Program’s Biohazard Material Information Questionnaire whenever research animals are exposed to
infectious agents:
- How are infectious or potentially infectious biomedical wastes disposed of at UCHSC?
Biomedical waste containers and disposal services are provided by a third party vendor (Stericycle)
through the UCHSC Health and Safety Division. Tubs and boxes are used for disposal of
biomedical wastes. Red tubs are used for those materials which can be effective treated with
steam sterilization (autoclaving). Yellow tubs are reserved for those materials which must be
incinerated in a biomedical waste incinerator for disposal. This includes infectious carcasses
and infectious tissues. Empty tubs and boxes can be obtained at the central biomedical waste
location (9th Avenue campus: SOM horseshoe loading area; Fitzsimmons campus: north loading
dock of RC-1). All Stericycle tubs and boxes must be lined with a red bag and filled to capacity
(35 pounds). Bags must be tied or taped shut and the container closed (lids for tubes and proper
folding for boxes). A barcode label must be placed on one side of the tub or box. Barcode labels
are available from the Biosafety Office.
2. How should dirty animal bedding containing an infectious agent be handled and disposed?
When animals are exposed to the infectious agent, some of the agent may be excreted by the animals into the animal bedding/cage environment.
During cage changing procedures, the contaminated animal cage should be opened inside a Class II BSC in order to minimize personal exposures. Employees should wear proper PPE (gloves, lab coat, eye protection, etc.) while changing the dirty bedding. The entire dirty cage should be placed inside an autoclave bag, the bag should be closed, and the exterior of the bag sprayed with a disinfectant prior to removal from the animal housing room. The bag and contents will be autoclaved
prior to regular cage washing.
3. How should contaminated dry wastes from animal cages where an infectious agent was administered be disposed?
Any dry waste (paper, cardboard, etc), which is contaminated with an infectious agent and is inside an animal cage, should be left in the cage for placement in autoclave bags.
4. How should the dirty cages to be cleaned if an infectious agent was used?
The first cage changing should be done by animal care personnel inside a Class II BSC. Employees should wear proper PPE (gloves, lab coat, eye protection, etc.) while handling the dirty cages. The entire dirty cage should be placed inside an autoclave bag, the bag should be closed, and the exterior of the bag sprayed with a disinfectant. After the dirty cages have been properly autoclaved they may be washed inside the automatic cage washer in the animal facility along with other cages.
5. How should the animal carcasses exposed to an infectious agent be disposed?
The animal carcasses should be placed in biohazard carcass bags and placed in the designated container inside the animal facility carcass cooler (or other animal facility designated area). Biohazard carcass bags are clear bags with the biohazard symbol imprinted on them.
6. How will uneaten animal food or water in cages containing an infectious agent be disposed?
The water (such as in a water bottle) and uneaten animal food should be left in the cage and placed with the same entire cage in the autoclave bags.
- How will any unused infectious agent be disposed?
If the infectious agent is in a disposable syringe, place the entire syringe and needle assembly