Microsoft word - hazardous drugs final as of 08_5_1

 APPROVAL DATE
EFFECTIVE DATE
REVISION  
05/01/11
 
INTRODUCTION
Prior to commencing work involving carcinogens, chemotherapeutics or other hazardous drugs, the Principal Investigator must perform a hazard assessment in order to identify the
proper personal protective equipment (PPE) and engineering requirements for handling
hazardous compounds. A key element of the risk assessment is the Material Safety Data Sheet
(MSDS). All MSDS should be accessible for employees to access at any time.
The assessment should take into account not only the laboratory staff who work with these compounds, but also other personnel who may come into contact with the compounds indirectly (such as personnel handling contaminated bedding). The safety requirements developed during the hazard assessment should be applied during the disposal of these hazardous agents, as well as during the initial preparation and handling of them. The hazard assessment and safety requirements derived from the hazard assessment shall be incorporated into the standard operating procedure (SOP) for the handling of the chemical agent in question. All questions should be directed to Environmental Health & Safety Department for further clarification and assistance. DEFINITIONS

Chemotherapy waste: unused amounts and residue of pharmaceutical compounds used to
treat disease.

Group I carcinogens: carcinogens identified by the International Agency for the Research on
Cancer (IARC) as being known to cause human cancer: any pharmaceuticals that fall under the
American Society of Health-System Pharmacists (ASHP) 1990 definition of hazardous drugs
(http://www.ashp.org/s_ashp/docs/files/BP07/Prep_Gdl_HazDrugs.pdf).
These include pharmaceuticals that are P-listed or U-listed chemicals by the EPA, or those
listed in the 2010 NIOSH Alert “Preventing Occupational Exposures to Antineoplastic and Other
Hazardous Drugs in Health Care Settings”.

PROCEDURES
When indicated, the following procedures must be adhered to for the disposal of carcinogens, and/or hazardous pharmaceuticals and/or items contaminated with such compounds. All staff members who handle hazardous drugs should receive safety training that includes recognition of hazardous drugs and appropriate spill response.  
PERSONAL PROTECTIVE EQUIPMENT (PPE)

Any time an individual will be handling any hazardous agent, appropriate PPE must be worn.
This includes wearing nitrile gloves to protect the hands, lens or goggles to protect the eyes,
wearing a lab coat or scrubs when there is a danger of spillage on the individual, and wearing
a respirator when there is the chance for respiratory exposure to a hazardous agent.
Note: Use of a respirator requires fit testing and enrollment in the University of
Central Florida Respiratory Protection Program

Animal care staff guidelines:
In addition to vivarium PPE requirements, nitrile gloves shall be worn for two weeks after
animal’s last exposure to chemotherapy agent when handling the exposed animal or its
bedding. If bedding appears to be saturated during this time, it must be disposed of as
hazardous waste in the manner described.
Investigators must note with a “flag” card when the animal was last exposed to the chemotherapy agent to ensure the animal care staff is aware of the agent’s use on the animals
in the cage.
HAZARDOUS WASTE CONTAINMENT AND DISPOSAL
In 1976, the Resource Conservation and Recovery Act (RCRA) was enacted to provide a
mechanism for tracking hazardous waste from its generation to disposal. Regulations
promulgated under RCRA are enforced by the Environmental Protection Agency and apply to
pharmaceuticals and chemicals discarded by pharmacies, hospitals, clinics, and other
commercial entities. The RCRA outlines four “characteristics” of hazardous waste and contains
lists of agents that are to be considered hazardous waste when they are discarded. Any
discarded drug that is on one of the lists (a “listed” waste) or meets one of the criteria
(a “characteristic” waste) is considered hazardous waste. The listed drugs include epinephrine,
nicotine, and physostigmine, as well as nine chemotherapy drugs: arsenic trioxide,
chlorambucil, cyclophosphamide, daunomycin, diethylstilbestrol, melphalan, mitomycin C,
streptozocin, and uracil mustard. They require handling, containment, and disposal as RCRA
hazardous waste.
Drug product containers holding more than a residual amount and empty product
vials must be managed as hazardous waste and disposed in the proper container labeled
chemotherapy drugs below. Please DO NOT PLACE SHARPS in container.

 Materials that are grossly contaminated with hazardous chemicals (free liquids
or solids) with carcinogens or other hazardous drugs, such as overtly
contaminated garments and all spill cleanup materials should be placed in a
leak-proof container labeled chemotherapy hazardous waste.
 Ensure that a spill kit is available in the event of incidental spill.  Once the chemotherapy waste container is filled, then seal the container. Secure Waste disposal will pick up the sealed container on the normal scheduled day. Sample List of Drugs that Should be Handled as Hazardous*
AHFS Pharmalocologic-therapeutic classification
84:92 Miscellaneous skin and mucous membrane agents 84:36 Miscellaneous skin and mucous membrane agents 92:40 Unclassified therapeutic agents (GnRH antagonist) 92:16 Unclassified therapeutic agents (antigout agents) Not in AHFS (nonsteroidal synthetic estrogen) Unclassified therapeutic agents (5-alpha 92:40 Unclassified therapeutic agents (GnRH antagonist) Unclassified therapeutic agents (antineoplastic 28:16.04.20 Selective seretonin uptake inhibitors 84:92 Miscellaneous skin and mucousmembrane agents (mitotic inhibitor) 92:20 Unclassified therapeutic agents (biologic response modifier) 84:16 Cell stimulants and proliferants (retinoid) *Highlighted drugs are currently in use in Lake Nona Vivarium
Examples of P-Listed hazardous wastes (acutely hazardous):
Chemical/drug
Waste Code


Examples of U-Listed hazardous wastes:
Chemical/drug
Chemical/drug
REFERENCES
ASHP Guidelines on Handling Hazardous Drugs http://www.ashp.org/s_ashp/docs/files/BP07/Prep_Gdl_HazDrugs.pdf NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010 http://www.cdc.gov/niosh/docs/2010-167/pdfs/2010-167.pdf Environmental Health & Safety http://www.ehs.ucf.edu/ http://www.ehs.ucf.edu/hazwaste/wasteinstructions.html Respiratory Protection Video http://www.ehs.ucf.edu/videoonline.html FDEP’s website and click on “Pharmacies” and “Pharmaceuticals Potentially Hazardous Waste When Discarded” under “General Hazardous Waste Publications” at http://www.dep.state.fl.us/waste/quick_topics/publications/default.htm

Source: http://www.ehs.ucf.edu/procedures/Hazardous%20drugs%20final%20as%20of%2008_5_11.pdf