1 Pharmaceutical Waste Program for Inpatient Pharmacy Portland Service Area Pharmacy Leadership Team
2 What is Pharmaceutical Waste? Pharmaceutical waste is waste generated through IV preparation, compounding, spills or breakage, partially used vials syringes, and IV s, and outdated products Pharmaceutical agents (solid, liquid, or gas) that can pose a substantial hazard to human health or the environment when not properly managed are deemed hazardous These agents have been characterized and identified by: Regulatory Agencies (EPA, OSHA, DOT) Professional consensus groups (NIOSH, NTP)
3 Hazardous Waste in Pharmacy Pharmacy will now sort pharmaceutical waste designated as regulated and/or hazardous from that which is non-regulated and not described as hazardous New bins will be utilized within pharmacy in order to differentiate this waste for transport and appropriate disposal once it leaves the pharmacy
4 Why Separate Pharmaceutical Waste? Employee Safety To minimize risks associated with managing hazardous medications Environmental Safety To keep pharmaceutical waste out of our groundwater and landfills and reduce potential harmful effects to our environment Regulatory Compliance EPA regulations regarding hazardous waste management are increasingly being applied to hospitals and pharmacies.
5 Which Drugs are Hazardous? Those defined by the Environmental Protection Agency Resource Conservation and Recovery Act (RCRA) creates lists of regulated waste: 1. Specifically listed waste P-list = acutely toxic chemicals U-list = toxic chemicals 2. Waste exhibiting particular hazardous characteristics: D-list = ignitable, corrosive, containing heavy metal (i.e. mercury, silver) or reactive
6 P-Listed Waste - acutely toxic Arsenic Trioxide Nicotine Physostigmine Warfarin Discarded products or mixtures containing at least 3% of these P-listed materials are regulated as hazardous waste. Also, any empty containers (vials, etc) formerly holding P- listed waste must also be managed as hazardous waste. Exception: wrappers from oral agents (nicotine, warfarin) can go in trash Waste must be incinerated at licensed facility.
7 U-Listed Waste - toxic Chloral Hydrate Chlorambucil Cyclophosphamide Melphalan Phenol -Cepastat Lozenges -Chloraseptic Spray Reserpine Selenium Sulfide Mitomycin or Daunomycin Discarded products or mixtures containing at least 10% of these U-listed materials are regulated as hazardous waste. Empty containers are not regulated (containers do not need to be rinsed, just empty by conventional means ). Waste must be incinerated at licensed facility.
8 D-Listed Waste Contain mercury preservative: Blephamide Neo/Poly/HC Neo/Poly/Gra Flurbiprofen Contain other heavy metals: Chromium Thermazene Silver Sulfadiazene Contain m-cresol: Insulin Forteo Levemir Acetone (ignitable) Waste containing these toxic characteristics have potential to leach from a landfill into the groundwater.
9 D-Listed Ignitable These materials have a flash point less than 140 o F or are mixed with more than 24% alcohol ALL AEROSOLS Alcohol Alprostadil Aluminum Chloride Soln Ammonia Androgel-Testosterone Gel Benzoin Betamethasone Calcipotriene Ciclopirox Soln Clindamycin Soln Clobetasol Propionate Collodion Dexamethasone Dimethyl Sulfoxide Fluocinonide Soln Hurricaine Gel Mastisol Podofilox Gel Podocon Prednisone Ritonavir Soln Tacrolimus
10 D-Listed Corrosive or Oxidizer Potassium Hydroxide (alkaline) Trichloracetic Acid (acid) Expired/unused silver nitrate (oxidizer) Corrosive wastes are liquids with ph less than 2 or greater than Oxidizers can react with other hazardous materials when mixed together. Because these materials are not compatible with ignitable liquids, they cannot be collected in the same bin as other hazardous waste.
11 Other Hazardous Drugs RCRA went into effect in 1976 Drugs such as chemotherapy agents were not reviewed Professional consensus groups have developed standards to identify additional hazardous drugs based on recommendations from organizations including: OSHA (Occupational Safety and Health Administration) NIOSH (National Institute for Occupational Safety and Health) National Toxicology Report on Carcinogens PharmEcology: A company that aids in meeting EPA regulations and following recommendations from consensus groups Provided Providence with additional hazardous drugs List is extensive and will be provided on-site
12 PharmEcology hazardous drugs Chemotherapy drugs Endocrine disrupters Pharmaceuticals listed as potential carcinogens Immuno-suppressives Marine pollutants Reproductive toxins not otherwise regulated Drugs listed on NIOSH Hazardous Drug Alert Drug formulations with LD50 less than 50 mg/kg Doxorubicin Cisplatin Dacarbazine Climara Estrogen Oxytocin Azathioprene Ribavirin Deferoxamine Ketamine Quelicin Clotrimazole And more
13 Pharmaceutical Waste Containers Providence will utilize 5 different containers to segregate waste All pharmaceutical waste must be appropriately sorted into one of these bins
14 Pharmaceutical Waste and Disposal Toxic & Hazardous Waste; Bulk Chemo; Empty P-list vials Aerosols and Corrosive liquids Trace Chemo Non regulated drugs, Empty vials Sharps, Empty and partially full Syringes UNUSED syringes containing toxic drugs & USED P-list syringes
15 Black Bin #1 Waste: (no sharps) P-listed drugs Including partially full or empty containers (excluding wrappers for oral dosage forms) D-listed drugs U-listed drugs Ignitable liquids Bulk chemotherapy PharmEcology hazardous drugs
16 Black Bin #2 Waste: (no sharps or syringes) Aerosols pressurized and ignitable Corrosive acid/bases Trichloroacetic acid Potassium hydroxide solution Oxidizers UNUSED Silver nitrate products only (used silver nitrate goes in blue bin) NO SHARPS
17 Blue/White Bin Waste: (no sharps or syringes) All non-regulated drugs not identified as hazardous Includes partially full and empty glass and plastic vials Exception: Vials that contain the 4 P- listed drugs. These go in Black Bin #1 NO SHARPS OR SYRINGES Note: you may recycle empty glass bottles as long as they are TRULY EMPTY
18 Yellow Bin Waste: (no sharps or syringes) Trace Chemo Only Empty vials, tubing, syringes, and iv bags, as well as gowns, gloves, wipes, and other items contaminated with less than 3% of chemotherapy drug. Bulk chemo will now go in black bin #1 Empty syringes and sharps go in red sharps containers.
19 Red Sharps Containers ALL empty syringes ALL syringes that have been used even if they contain residual drug. Exceptions: Syringes containing UNUSED HAZARDOUS drugs (expired medication) must go in black sharps container. Syringes used for P-list drugs must go in dual waste container
20 Sewer System IV s containing sterile water, sugar/salt solutions (i.e. NS, LR, D5LR, D5NS20K, KCl) All controlled substances
21 Identifying Black Bin #1 Drugs There will be a black dot placed on the shelf or container in which the drug resides within our inventory There will be a printed, alphabetized list attached to the wall near the bin for reference Other containers will have a label to help identify what is to be placed in them Add picture of label / pharmacy shelf
22 Questions? See your site-specific coordinator for more information
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