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  • 1. 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
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
  • 7.
    • 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
  • 8. 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
  • 9. 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
  • 10. 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
  • 11. 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
  • 12. 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
  • 13. MUNICIPAL WASTE SEWER SYSTEM CHEMO WASTE - SHARPS CHEMO WASTE - SOFT RED SHARPS • Packaging • Empty glass bottles • Empty plastic bottles • Paper •  Plastic • Food waste, etc. •  IV’s - D5W - NaCl - Other? • Controlled substances? •  Antibiotics? • 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? • Vials - Empty - Partial • Syringes/Needles - Empty - Unused, partial • IV’s - Empty - Unused, partial LANDFILL OR MUNICIPAL INCINERATOR WATER TREATMENT PLANT Leachate into ground water or air emissions Discharge to surface waters Leachate Contents of Current Pharmaceutical Waste Streams Copyright © 2002 by PharmEcology™ Associates, LLC AUTOCLAVE/ MICROWAVE Shredded (?) NON-HAZARDOUS LANDFILL Ash MEDICAL WASTE INCINERATOR
  • 14. 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
  • 15. 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
  • 16. What Departments Get Involved in Generating and Managing Pharmaceutical Waste?
    • Pharmacy
    • Nursing
    • Infection Control
    • Environmental Services
    • Safety
    • Facility Management
    • Risk Management
    • Purchasing
  • 17. 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
  • 18. 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
  • 19. Examples of P-Listed Pharmaceutical Waste
    • Arsenic trioxide P012
    • Epinephrine P042
    • Nicotine P075
    • Nitroglycerin P081
    • Phentermine (CIV) P046
    • Physostigmine P204
    • Physostigmine Salicylate P188
    • Warfarin >0.3% P001
  • 20. Examples of P-Listed Pharmaceuticals
  • 21. 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
  • 22. Examples of U-listed Pharmaceutical Waste
    • Chloral Hydrate(CIV) U034
    • Chlorambucil U035
    • Cyclophosphamide U058
    • Daunomycin U059
    • Melphalan U150
    • Mitomycin C U010
    • Streptozotocin U206
    • Lindane U129
    • Saccharin U202
    • Selenium Sulfide U205
    • Uracil Mustard U237
    • Warfarin<0.3% U248
  • 23. Examples of U-Listed Pharmaceuticals
  • 24. Chemotherapy Waste
    • Seven chemotherapy agents are U-listed; one is P-listed
    • 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”
  • 25. 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
  • 26. Empty vials, syringes, IVs, tubing, gowns, gloves,etc. Residue or bulk chemo in vials, unused IV’s, P, U. toxic D Chemo Waste Hazardous Waste
  • 27. 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
  • 28. 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
  • 29. 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
  • 30. Preservatives: thimerosal & m-cresol Heavy Metals: Selenium, Chromium and Silver Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity
  • 31. 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
  • 32. 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)
  • 33.  
  • 34. Readi-Cat
  • 35.  
  • 36.  
  • 37.  
  • 38. 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
  • 39. Recommended Additional Pharmaceutical Waste Streams HAZARDOUS WASTE - IGNITABLE HAZARDOUS WASTE - TOXIC NON-HAZARDOUS NON-INFECTIOUS RX FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS) LINED HAZARDOUS WASTE LANDFILL Hazardous waste broker and transporter Ash NON-HAZARDOUS LANDFILL MEDICAL WASTE INCINERATOR Ash Copyright © 2002 by PharmEcology™ Associates, LLC Leachate MUNICIPAL INCINERATOR PERMITTED FOR SPECIAL WASTE Ash
  • 40. MUNICIPAL • Packaging • Empty bottles • Paper •  Plastic • Food waste, etc. • Gowns • Gloves • Goggles • Tubing • Wipes • Vials - Empty • Syringes/Needles - Empty • IV’s - Empty Recommended Revised Pharmaceutical Waste Streams Copyright © 2002 by PharmEcology™ Associates, LLC SEWER SYSTEM • Recycle as much paper, glass, plastic as possible • Use shredder where patient privacy is an issue HAZARDOUS WASTE - TOXIC HAZARDOUS WASTE - IGNITABLE CHEMO WASTE - SOFT CHEMO WASTE - SHARPS NON-HAZARDOUS RX RED SHARPS • IV’s - D5W - NaCl • Controlled Substances? • Antibiotics? • P-listed • U-listed • D-listed toxic (Heavy metals) • Chemo agents (residue, bulk) • Chemo spill clean up • Hazardous spill clean up • Risk management: - Antivirals - Others • D-listed Ignitable - Collodion - Oxidizers - Ignitable compressed gas All waste pharmaceuticals NOT hazardous including antibiotics, IV’s • Non-chemo vials - Empty • Non-chemo syringes/ needles - Empty • Check with municipal water treatment plant for limits, recommendations NON-HAZARDOUS LANDFILL Leachate MUNICIPAL INCINERATOR PERMITTED FOR SPECIAL WASTE AUTOCLAVE/ MICROWAVE Shredded (?) MEDICAL WASTE INCINERATOR Ash Ash FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS) LINED HAZARDOUS WASTE LANDFILL Ash
  • 41. 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
  • 42. 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)
  • 43. 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
  • 44. 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 non-hazardous pharmaceutical waste
  • 45. 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
  • 46. 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
  • 47. 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
  • 48. Resources
    • www.pharmecology.com
    • Pharmaceutical Waste: http://www.h2e-online.org/tools/chem-pharm.htm
    • “ Safely Managing Hazardous Materials and Hazardous Waste,” ASHP Clinical Midyear, 2001, Handouts on CD-Rom
    • 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.
  • 49. Resources
    • Pharmaceutical Waste Survey, King County, Washington State, April 29, 2003, http://www.metrokc.gov/hazwaste/pubs/studies.html#pharmwastesurvey
    • 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
  • 50.