University of the Sciences
Environmental Health & Radiation Safety Department
Standard Operating Procedure
Cytotoxic Agents
What are Cytotoxic Drugs?
Cytotoxic drugs (CDs) are primarily used as anti-cancer drugs because they are toxic to cells.
These drugs have been associated with human cancers at high (therapeutic) levels of
exposure and are carcinogens and teratogens in many animal species. Under current work
practices, CDs have demonstrated the ability to cause elevations in sister chromatid
exchanges and chromosome breakage in circulating lymphocytes and mutagenic activity in
urine. In addition, many of these drugs have been shown to cause a variety of acute effects in
humans, such as localized skin necrosis (death of tissue) after surface contact with abraded
skin or damage to normal skin.
What are the Routes of Exposure?
 Inhalation – drug dusts or droplets
 Absorption – via skin or mucous membranes (eyes, nose, mouth)
 Ingestion – mouth pipetting or handling food, drink, cigarettes, cosmetics while in the
laboratory
How can you protect yourself when working with Cytotoxic Drugs?
1. Engineering Controls
 Biological Safety Cabinet (Class II vertical flow, Type A2, ducted)
 Chemical Fume Hood
2. Personal Protective Equipment
 Gloves appropriate for the chemical being handled and double-glove. (Powderfree nitrile or latex are recommended. Remember that latex gloves should never
be used for protection against hazardous chemicals that are simultaneously
used.)
 Protective Disposable gown
 Lint free, low permeability
 Closed front, long sleeves, elastic/knit closed cuffs
 Cuffs tucked under gloves
 Wear only in prep area
1
University of the Sciences
Environmental Health & Radiation Safety Department
 Safety Glasses
 Respiratory Protection
 N95 HEPA Mask when local exhaust ventilation is not available.
3. Work Practices
Standard Procedures
 Work in a biological safety cabinet (Class II vertical flow, Type A2,
ducted), or chemical fume hood, especially during all drug preparations.
 No Eating or Drinking.
 Label contaminated containers with a biohazard label and write
“CHEMO” on the label.
 Store all waste in closed biohazard/chemo waste receptacles (keep
closed at all times unless adding waste to prevent aerosolization and
conform to regulations).
 Minimize aerosols by taking care when:




Withdrawing needles from drug-filled vials
Transferring drugs via needles/syringes or filter straws
Breaking open ampoules
Expelling or expulsion of air from a drug-filled syringe
 To help, it is recommended to use a gauze pad wrapped
around the needle and vial top when withdrawing solution.
(Care should be taken to avoid needle sticks during this
procedure)
 If aerosols will be created, working in a hood will also minimize
exposure
 Work areas where cytotoxic agents will be used must be covered with
plastic-backed paper liner and labeled with “designated area” tape.
(Tape is available in the Griffith Hall Central Stockroom) The top liner must
be changed after work was performed, or after any contamination.
 Work surfaces and the hood should be decontaminated on a regular basis
(when a procedure is complete) and whenever there is a spill.
2
University of the Sciences
Environmental Health & Radiation Safety Department
Decontamination should consist of surface cleaning with water and detergent
(or another appropriate agent) followed by thorough rinsing.
 A suitable eyewash facility should be available nearby (and flushed weekly to
remove contaminants) and everyone should wear safety goggles whenever
splashes, sprays or aerosols may be generated.
 Safety glasses should always be worn in a laboratory.
How to Dispose of Cytotoxic Waste?
 Discarded contaminated items containing trace amounts of chemo/cytotoxic drugs and
hazardous pharmaceuticals may be disposed of into the appropriate red (for hazardous
pharmaceuticals) or yellow (for chemo/cytotoxic) biohazard waste container.
 Original cytotoxic/hazardous drug bottles or diluted stocks containing drugs must be
disposed as hazardous chemical waste, tagged and brought to the Central
Stockroom(s).
However, bottles, tubing, vials, syringes and other discarded
contaminated items containing residual or trace amounts of these drugs may be placed
into the appropriate red (for hazardous pharmaceuticals) or yellow (for chemo/cytotoxic)
biohazard container.
 Sharps containing chemo-cytotoxic drugs must be placed in yellow chemo/cytotoxic
biohazard sharps containers only.
 Waste containers must always be kept closed (unless adding) to prevent aerosolization
and to conform to State and Federal Regulations.
What To Do in an Emergency?
1. Cleanup of Small Spills
 Spills of less than 5 ml or 5 gm outside a hood should be cleaned immediately by
personnel wearing gowns and double surgical nitrile or latex gloves and eye
protection.
 Liquids should be wiped with absorbent pads or towels; solids should be wiped
with wet absorbent pads or towels. The spill area then should be cleaned (three
times) using a detergent solution followed by thorough rinsing of clean water.
 Any contaminated broken glass fragments should be placed in an appropriate
sharps container.
3
University of the Sciences
Environmental Health & Radiation Safety Department
2. Cleanup of Large Spills
 Contact EHRS for assistance at X8925, X8843, or X3141, or after hours, call
Public Safety at X7000.
 For spills of amounts larger than 5 ml or 5 gm, spread should be limited by gently
covering with absorbent sheets or spill-control pads or pillows or, if a powder is
involved, with damp cloths or towels. Be sure not to generate aerosols.
 Access to the spill area should be restricted.
 Protective apparel should be used with the addition of a respirator when there is
any danger of airborne powder or an aerosol being generated. The dispersal of
CD particles into surrounding air and the possibility of inhalation is a serious
matter and should be treated as such.
3. Personnel Contamination
 Overt contamination of gloves or gowns, or direct skin or eye contact should be
treated as follows:
 Immediate removal of the gloves or gown. (Someone should temporarily
place in a sealed bag. After the emergency, place in an appropriate
biohazard waste container).
 Immediately wash the affected skin area with soap (not germicidal
cleaner) and water.
 For eye exposure, immediately flood the affected eye with water or
isotonic eyewash designated for that purpose for at least 15 minutes.
 Obtain medical attention immediately by calling 911 or Public Safety at
X7000.
Resources
 Procedures for the Safe Disposal of Biohazardous Waste:
http://www.usciences.edu/safety/bimanual/probiowaste.htm
 OSHA Technical Manual: Controlling Occupational Exposure to Hazardous Drugs
4
University of the Sciences
Environmental Health & Radiation Safety Department
http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
 NIOSH – Preventing Occupational Exposures to Antineoplastic and Other
Hazardous Drugs in Health Care Settings
www.cdc.gov/niosh/docs/2004-165
5
University of the Sciences
Environmental Health & Radiation Safety Department
Standard Operating Procedure: The Safe Use of Cytotoxic Agents
Signature Page
Principal Investigators/Laboratory Supervisors:
Use the following table to list all personnel/student workers under your responsibility who may
be potentially exposed to cytotoxic agents. The laboratory staff member’s initials indicates that
he/she has read this SOP and understands the hazards and safe work practices contained
therein, and he/she accepts the procedures as a working document that he/she will support
and follow in their daily work.
As the Principal Investigator (PI) signing this Standard Operating Procedure, I am also
documenting that training on the specific hazards and equipment used in the laboratory
was conducted and I will ensure compliance with all applicable requirements and safety
procedures in this document and in the Laboratory Safety Manual. Also, that
workers/students are/will be provided appropriate supervision and oversight.
Name
Job Title
Initials
Principal Investigator/Laboratory Supervisor (Print): __________________________________
Principal Investigator/Laboratory Supervisor (Signature): ______________________________
Date: __________________________________
Please complete this form and return to the
Department of Environmental Health & Radiation Safety, Box #85 or STC #223.
6