GROUP 1 CARCINOGEN, CHEMOTHERAPY WASTE & OTHER HAZARDOUS DRUG DISPOSAL NAME APPROVAL DATE EFFECTIVE DATE REVISION RENEE MICHEL 05/01/11 0

Transcription

1 GROUP 1 CARCINOGEN, CHEMOTHERAPY WASTE & OTHER HAZARDOUS DRUG DISPOSAL NAME APPROVAL DATE EFFECTIVE DATE REVISION RENEE MICHEL 05/01/11 0

2 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 ( 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. 1

3 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. 2

4 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. 3

5 Sample List of Drugs that Should be Handled as Hazardous* Drug AHFS Pharmalocologic-therapeutic classification Aldesleukin Alefacept 84:92 Miscellaneous skin and mucous membrane agents Alemtuzumab Alitretinoin Altretamine Amsacrine Anastrozole Arsenic trioxide Asparaginase Azacitidine Azathioprine Bacillus Calmette-Guerin (BCG) Bexarotene Bicalutamide Bleomycin Bortezomib Bosentan Busulfan Capecitabine Carboplatin Carmustine Cetrorelix acetate Chlorambucil Chloramphenicol Choriogonadotropin alfa Cidofovir Cisplatin Cladribine Clofarabine 84:36 Miscellaneous skin and mucous membrane agents (retinoid) 92:44 Unclassified therapeutic agents (immunosuppressant) 80:12 Vaccines 24:12.92 Vasodilating agents 92:40 Unclassified therapeutic agents (GnRH antagonist) 8:12.08 Antibacterials 68:18 Gonadotropins 8:18.32 Antiviral nucleoside Colchicine Cyclophosphamide Cyclosporin Cytarabine Dacarbazine 92:16 Unclassified therapeutic agents (antigout agents) 92:00 Immunosuppressive agents 4

6 Dactinomycin Dasatinib Daunorubicin HCl Decitabine Denileukin Dienestrol Diethylstilbestrol 68:16.04 Estrogens Not in AHFS (nonsteroidal synthetic estrogen) Dinoprostone Docetaxel Doxorubicin Dutasteride Entecavir Epirubicin Ergonovine/methylergonovine 76:00 Oxytocics 92:08 Unclassified therapeutic agents (5-alpha reductase inhibitor) 8:18.32 Antiviral nucleoside 76:00 Oxytocics Estradiol Estramustine phosphate Estrogen-progestin combinations Estrogens, conjugated Estrone Estropipate Etoposide Exemestane Finasteride Floxuridine Fludarabine Fluorouracil Fluoxymesterone Flutamide Fulvestrant Ganciclovir Ganirelix acetate Gemcitabine Gemtuzumab ozogamicin Gonadotropin, chorionic Goserelin Hydroxyurea Ibritumomab tiuxetan Idarubicin Ifosfamide 68:16.04 Estrogens 68:12 Contraceptives 68:16.04 Estrogens 68:16.04 Estrogens 68:16.04 Estrogens 92:08 Unclassified therapeutic agents (5-alpha reductase inhibitor) 68:08 Androgens 8:18.32 Antiviral nucleoside 92:40 Unclassified therapeutic agents (GnRH antagonist) 68:18 Gonadotropins 5

7 Imatinib mesylate Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Interferon alfa-n3 Irinotecan HCl Leflunomide Lenalidomide Letrozole Leuprolide acetate Lomustine Mechlorethamine Megestrol Medroxyprogesterone acetat 92:36 Unclassified therapeutic agents (antineoplastic agent) 92:20 Unclassified therapeutic agents (biologic response modifiers) 68:32 Progestins Melphalan Menotropins Mercaptopurine Methotrexate Methyltestosterone Mifepristone Mitomycin Mitotane Mitoxantrone HCl Mycophenolate mofetil Nafarelin Nelarabine Nilutamide Oxaliplatin Oxytocin Paclitaxel Palifermin Paroxetine HCl 68:18 Gonadotropins 68:08 Androgens 76:00 Oxytocics 92:44 Unclassified therapeutic agents (immunosuppressive agents) 68:18 Gonadotropins 76:00 Oxytocics 84:16 Cell stimulants 28: Selective seretonin uptake inhibitors Pegaspargase Pemetrexed Pentamidine isethionate Pentetate calcium trisodium Pentostatin Perphosphamide Pipobroman 8:40 Miscellaneous anti-infectives Not in AHFS 6

8 Piritrexim isethionate Plicamycin Podofilox Podophyllum resin Prednimustine Procarbazine Progesterone Progestins Raltitrexed Rasagiline mesylate Ribavirin Risperidone Sirolimus Sorafenib Streptozocin Sunitinib malate Tacrolimus Tamoxifen Temozolomide Teniposide Testolactone Testosterone Thalidomide Thioguanine Thiotepa Topotecan Toremifene citrate Tositumomab Tretinoin 84:92 Miscellaneous skin and mucous membrane agents (mitotic inhibitor) 84:92 Miscellaneous skin and mucousmembrane agents (mitotic inhibitor) 68:32 Progestins 68:12 Contraceptives 28:36 Antiparkinsonian agents 8:18.32 Antiviral nucleoside 28: Atypical antipsychotics 92:00 Immunosuppressive agents 92:44 Unclassified therapeutic agents (immunosuppressant) 68:08 Androgens 92:20 Unclassified therapeutic agents (biologic response modifier) 84:16 Cell stimulants and proliferants (retinoid) Trifluridine Trimetrexate glucuronate Triptorelin Uracil mustard Valganciclovir Valrubicin Vidarabine Vinblastine sulfate Vincristine sulfate Vindesine Vinorelbine tartrate 52:04.06 Antivirals 8:30.92 Miscellaneous antiprotozoals 8:18.32 Antiviral nucleoside Not in AHFS 7

9 Vorinostat Zidovudine 8:18:08 Antiretroviral agents Zonisamide 28:12.92 Anticonvulsant *Highlighted drugs are currently in use in Lake Nona Vivarium Examples of P-Listed hazardous wastes (acutely hazardous): Chemical/drug Arsenic trioxide Nicotine Phentermine (CIV) Physostigmine Physostigmine salicylate` Warfarin >0.3% Waste Code P012 P075 P046 P204 P188 P001 Examples of U-Listed hazardous wastes: Chemical/drug Waste Chemical/drug Waste Code Code Chloral hydrate U034 Paraldehyde U182 Chlorambucil U035 Phenol U188 Cyclophosphamide U058 Reserpine U200 Daunomycin U059 Resorcinol U201 Dichlorodifluoromethane U075 Saccharin U202 Diethylstilbestrol U089 Selenium sulfide U205 Hexachlorophene U132 Streptozotocin U206 Lindane U129 Trichloromonofluromethane U121 Melphalan U150 Uracil mustard U237 Mitomycin C U010 Warfarin <0.3% U248 8

10 REFERENCES ASHP Guidelines on Handling Hazardous Drugs NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings Environmental Health & Safety Respiratory Protection Video FDEP s website and click on Pharmacies and Pharmaceuticals Potentially Hazardous Waste When Discarded under General Hazardous Waste Publications at 9