Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Identifying and Managing Hazardous Pharmaceutical Waste H2E Teleconference September 12, 2003 Charlotte A. Smith, R. Ph., M.S. President csmith@ pharmecology.com www.pharmecology.com 262-814-2635 Copyright © 2003 by PharmEcology Associates, LLC Pharmaceutical Waste: A Waste Stream Whose Time has Come Concept of “Green Pharmacy” Gaining Attention "Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition While Promoting Human Health.” Dr. Christian Daughton, Chief, Environmental Chemistry Branch, USEPA National Exposure Research Laboratory I. Rationale for and Avenues toward a Green Pharmacy; II. Drug Disposal, Waste Reduction, and Future Directions, http://www.h2e-online.org/tools/chem-pharm.htm Increasing Regulatory Activity EPA Region 2 auditing 480 hospitals in 2003; Rx waste included; link from H2E to Region 2 website http://www.h2e-online.org/tools/chem-hwm.htm States beginning to focus on management of waste pharmaceuticals Florida Washington State California Minnesota Michigan Intersecting regulatory agencies EPA, DEA, OSHA, State Boards of Pharmacy H2E and Hazardous Pharmaceuticals Initial involvement while at Capital Returns, Inc., Rx reverse distributor, 1999-2000 Worked on Chemical Minimization Committee with Catherine Zimmer, Minnesota Technical Assistance Program (MnTAP) http://www.h2e-online.org/pubs/chemmin/pharmacy.pdf Contributed to prioritization tool by reviewing all drug products in CRI database http://www.h2e-online.org/pubs/chemmin/chappf.pdf USGS Water Quality Study* First nationwide reconnaissance of occurrence of pharmaceuticals, hormones, other organic wastewater contaminants 139 streams in 30 states, analyzed for 95 different OWCs 82 of the 95 detected in at least one sample One or more OWCs found in 80% of stream samples 13% of sites had more than 20 OWCs *http://toxics.usgs.gov/pubs/OFR-02-94/index.html Below the Dose/Response Curve: Endocrine Disruptors Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles) Mimic hormone, trigger identical response, block a hormone Do not follow the normal dose/response curve Active at much lower doses, especially in the fetus and newborn Estradiols, progesterone, testosterone Lindane Low sperm counts(50% reduction since 1939) Infertility Genital deformities Hormonally triggered human cancers Neurological disorders in children Hyperactivity Attention deficit Developmental & reproductive problems in wildlife Pharmaceuticals Entering the Waste Stream Wastage of Raw Materials from Manufacturing Process Wastage at the Distributor/ Pharmacy/Healthcare Facility Wastage at the LTCF or other residential facility Expired Pharmaceuticals Wastage at the Consumer Level Metabolites Entering Wastewater When is an Outdated Drug a Waste? At the time and place the decision is made to discard it Two EPA guidance letters to the industry: Merck & Co., 1981 BFI Pharmaceutical, 1991 Enables shipping of potentially creditable outdates to a reverse distributor as product PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials Reverse Distribution: Current Scenarios Decision to discard is made at the pharmacy By pharmacy By a contracted company Pharmacy (hospital) becomes the waste generator Decision to discard is made at the reverse distributor Reverse Distributor becomes the waste generator Where Have Waste Drugs Gone in the Past? Primarily concerned with rendering drugs unrecoverable Not in dumpsters, municipal trash Made slurries, sewered Burned in hospital incinerators No training in pharmacy curriculum on EPA regulations Where are Waste Drugs Going Today? Sewer System Unused, partial IVs, including antibiotics Compounding residues Liquids Red Infectious Waste Sharps Containers, Bags Yellow or White Chemotherapy Sharps Containers, Bags Contents of Current Pharmaceutical Waste Streams MUNICIPAL WASTE • Packaging • Empty glass bottles • Empty plastic bottles • Paper • Plastic • Food waste, etc. LANDFILL OR MUNICIPAL INCINERATOR SEWER SYSTEM • IV’s - D5W - NaCl - Other? • Controlled substances? • Antibiotics? WATER TREATMENT PLANT CHEMO WASTE - SHARPS CHEMO WASTE - SOFT • Vials - Empty (trace) - Partial (residue) • Syringes/Needles - Empty - Unused, partial • IV’s - Empty - Unused, partial • Spill clean up? • Gowns • Gloves • Goggles • Tubing • Wipes • Spill clean up? MEDICAL WASTE INCINERATOR Ash Leachate into ground water or air emissions • Vials - Empty - Partial • Syringes/Needles - Empty - Unused, partial • IV’s - Empty - Unused, partial AUTOCLAVE/ MICROWAVE Shredded (?) Discharge to surface waters NON-HAZARDOUS LANDFILL Leachate Copyright © 2002 by PharmEcology™ Associates, LLC RED SHARPS How is Pharmaceutical Waste Generated at the Healthcare Facility? IV Preparation General Compounding Spills/Breakage Partially Used Vials/Syringes If Contaminated, Biohazardous Discontinued, Unused Preparations Unused Repacks (Unit Dose) Discontinued Indated Pharmaceuticals Patients’ Personal Medications Outdated Pharmaceuticals Where is Pharmaceutical Waste Generated? Pharmacy/Satellites Patient Care Units ER/OR ICU/CCU/NICU Oncology/Hematology and other outpatient clinics Long Term Care Facilities Home Health Care Services What Departments Get Involved in Generating and Managing Pharmaceutical Waste? Pharmacy Nursing Infection Control Environmental Services Safety Facility Management Risk Management Purchasing Federal Waste Generation Status Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste. Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste. Conditionally Exempt Small Quantity Generator (CESQG):Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/month Which Discarded Drugs Become Hazardous Waste? P-listed chemicals Sole active ingredient U-listed chemicals Sole active ingredient Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity Examples of P-Listed Pharmaceutical Waste Arsenic trioxide Epinephrine Nicotine Nitroglycerin Phentermine (CIV) Physostigmine Physostigmine Salicylate Warfarin >0.3% P012 P042 P075 P081 P046 P204 P188 P001 Examples of P-Listed Pharmaceuticals Impact of P-listed Waste Only 1 kg or 2.2 pounds/month cause facility to become a large quantity generator Weights of P-listed drug waste must be combined with any other P-listed waste generated at the facility in a given month Technically, containers that have held P-listed wastes are not “RCRA empty” unless they are triple rinsed and the rinsate discarded as hazardous Examples of U-listed Pharmaceutical Waste Chloral Hydrate(CIV) U034 Streptozotocin U206 Chlorambucil U035 Lindane U129 Cyclophosphamide U058 Saccharin U202 Daunomycin U059 Selenium Sulfide U205 Melphalan U150 Uracil Mustard U237 Mitomycin C U010 Warfarin<0.3% U248 Examples of U-Listed Pharmaceuticals Chemotherapy Waste Seven chemotherapy agents are U-listed; one is Plisted Medical waste hauler protocols for “Chemo Waste” Empty vials, syringes, IV’s Treated as infectious medical waste preferably through regulated medical waste incineration If not empty, should be placed into Hazardous Waste container “Empty” for U-listed waste means all contents removed that can be removed through normal means 3 ml allowance in common practice is a misunderstanding of the definition of “RCRA empty” Chemotherapy Residue: Infectious and Hazardous If chemo IV bag has been hung, is not completely used and can be separated from patient exposed sharp without exposing the employee, remove and dispose as RCRA hazardous waste If chemo residue cannot be removed safely, dispose in trace chemotherapy container (yellow/white) as infectious chemo waste No consensus yet on this issue among hazardous waste regulators Chemo Waste Hazardous Waste Residue or bulk chemo in vials, unused IV’s, P, U. toxic D Empty vials, syringes, IVs, tubing, gowns, gloves,etc. Characteristic of Ignitability Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F. Hazardous Waste Number: D001 Rubbing Alcohol Topical Preparation Injections Characteristic of Corrosivity An aqueous solution having a pH < or = 2 or > or = to 12.5 Examples: Primarily compounding chemicals Glacial Acetic Acid Sodium Hydroxide Hazardous waste number: D002 Characteristic of Toxicity Approximately 40 chemicals which meet specific leaching concentrations Examples of potential toxic pharmaceuticals: Arsenic m-Cresol Barium Mercury (thimerosal) Cadmium phenylmercuric acetate) Chloroform Selenium Chromium Silver Lindane Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity Heavy Metals: Selenium, Chromium and Silver Preservatives: thimerosal & m-cresol Characteristic of Reactivity Meet eight separate criteria identifying certain explosive and water reactive wastes Nitroglycerin formulations may be considered exempt as of August 14, 2001 under FR: May 16, 2001. States must still adopt. Hazardous Waste Number: D003 How Can RCRA Hazardous Waste be Identified? Web-based database enabling search by product for waste management recommendations Search by NDC, product or generic name, active ingredient Recommendations citing federal regulations and recommended waste streams State regulation alerts if more stringent than federal Risk Management alerts based on professional knowledge (e.g. chemotherapy agents not regulated at the state or federal level) Readi-Cat How Should RCRA Hazardous Waste be Handled? Need a new waste stream in Pharmacy, certain Patient Care Areas, Oncology Clinics RCRA Hazardous Waste: Toxic P, U, toxic Ds, all Chemotherapy Residues, Chemo Spills RCRA Hazardous Waste: Ignitable (D001) Hospitec has developed a dedicated hazardous waste containment system Can also use hazardous waste buckets available from brokers and disposal firms Recommended Additional Pharmaceutical Waste Streams HAZARDOUS WASTE - TOXIC HAZARDOUS WASTE - IGNITABLE Hazardous waste broker and transporter NON-HAZARDOUS NON-INFECTIOUS RX MEDICAL WASTE INCINERATOR MUNICIPAL INCINERATOR PERMITTED FOR SPECIAL WASTE Ash Ash FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS) NON-HAZARDOUS LANDFILL Ash LINED HAZARDOUS WASTE LANDFILL Copyright © 2002 by PharmEcology™ Associates, LLC Leachate Recommended Revised Pharmaceutical Waste Streams MUNICIPAL SEWER SYSTEM • IV’s • Packaging - D5W • Empty bottles - NaCl • Paper • Controlled • Plastic Substances? • Food waste, etc. • Antibiotics? • Recycle as much paper, glass, plastic as possible • Use shredder where patient privacy is an issue • Check with municipal water treatment plant for limits, recommendations HAZARDOUS WASTE - TOXIC HAZARDOUS WASTE - IGNITABLE • P-listed • D-listed Ignitable • U-listed - Collodion • D-listed toxic - Oxidizers (Heavy metals) - Ignitable • Chemo agents compressed (residue, bulk) gas • Chemo spill clean up • Hazardous spill clean up • Risk management: - Antivirals - Others CHEMO WASTE - SHARPS CHEMO WASTE - SOFT • Vials - Empty • Syringes/Needles - Empty • IV’s - Empty • Gowns • Gloves • Goggles • Tubing • Wipes NONHAZARDOUS RX All waste pharmaceuticals NOT hazardous including antibiotics, IV’s MEDICAL WASTE INCINERATOR AUTOCLAVE/ MICROWAVE Ash Ash Shredded (?) Ash Copyright © 2002 by PharmEcology™ Associates, LLC • Non-chemo vials - Empty • Non-chemo syringes/ needles - Empty MUNICIPAL INCINERATOR PERMITTED FOR SPECIAL WASTE FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS) LINED HAZARDOUS WASTE LANDFILL RED SHARPS NON-HAZARDOUS LANDFILL Leachate Where Should RCRA Hazardous Waste Be Stored? Hazardous Waste Storage Accumulation Site: Same locked area as mercury, xylene, formaldehyde, lab chemicals Maximum storage time: 90 or 180 days based on generator status Yellow Hazardous Waste Label How Should RCRA Hazardous Waste Be Disposed? Either contract with a hazardous waste broker or develop internal expertise for: Lab packing Manifest preparation Land ban preparation Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility) How Can Hazardous RX Waste Generation Be Minimized? Inherent limitations on substitution of a less hazardous drug since the hazardous nature of the chemical often provides the therapeutic effect Tighter inventory control to reduce outdate generation, both original manufacturers’ containers and repacks Single dose vials vs. multiple dose vials Patient specific oral syringes vs. 10 cc. repacks (e.g. choral hydrate for pediatric use) Reformulation of heavy metal concentration, especially mercury and m-cresol as preservatives What About Non-Hazardous Drugs? Segregate into a non-red, non-yellow container, such as beige or white with blue top (California Pharmaceutical Waste) Label “Non-hazardous Pharmaceutical Waste – Incinerate Only” Dispose at a regulated medical waste or municipal incinerator that is permitted to accept nonhazardous pharmaceutical waste Where to Begin? Purchase appropriate containers for collecting toxic and ignitable hazardous waste Pilot bulk and residue chemotherapy segregation in the pharmacy and on the oncology unit Extend the program to all units that handle any chemotherapy agents (methotrexate and cyclophosphamide used in other units) Begin identifying other P, U and D hazardous wastes Train all relevant staff on the reasons for the new system Jump-Starting the Process Electronic formulary review service Send PharmEcology Associates your drug formulary information We compare it to our database of over 107,000 drug items You receive back a list of which drugs are hazardous waste or risk management hazardous waste On-site review A one or two day visit to your facility followed by an Action Plan and Findings and Recommendations Benefits of a Comprehensive Hazardous Waste Disposal Plan JCAHO Environment of Care Performance Improvement Initiative New 2004 Standards – see both Medication Management and Environment of Care Reduces EPA liability and risk exposure to a minimum Protects employees and patients Demonstrates responsible care in dealing with hazardous substances, hazardous wastes Resources www.pharmecology.com Pharmaceutical Waste: http://www.h2eonline.org/tools/chem-pharm.htm “Safely Managing Hazardous Materials and Hazardous Waste,” ASHP Clinical Midyear, 2001, Handouts on CDRom RCRA On-Line www.epa.gov/rcraonline RCRA Hot Line 1-800-424-9346 Improper Discard of Toxic Drugs Hurts Environment, Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp 1576-1578. Resources Pharmaceutical Waste Survey, King County, Washington State, April 29, 2003, http://www.metrokc.gov/hazwaste/pubs/studies.html#phar mwastesurvey Your Risks in Handling Outdated and Unusable Drugs: A Guide to JCAHO and Regulatory Standards. Capital Returns, Inc., 1998 Call 1-800-950-5479 A Guide on Hazardous Waste Management for Florida’s Pharmacies, www. floridacenter.org. Guidelines for Reverse Distributors: Minimum Federal Regulatory Standards, www.returnsindustry.com