Identifying and Managing Hazardous Pharmaceutical Waste


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Identifying and Managing Hazardous Pharmaceutical Waste

  1. 1. Identifying and Managing Hazardous Pharmaceutical Waste H2E Teleconference September 12, 2003 Charlotte A. Smith, R. Ph., M.S. President csmith@ 262-814-2635 Copyright © 2003 by PharmEcology Associates, LLC
  2. 2. Pharmaceutical Waste: A Waste Stream Whose Time has Come <ul><li>Concept of “Green Pharmacy” Gaining Attention </li></ul><ul><li>&quot;Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition While Promoting Human Health.” </li></ul><ul><ul><li>Dr. Christian Daughton, Chief, Environmental Chemistry Branch, USEPA National Exposure Research Laboratory </li></ul></ul><ul><ul><li>I. Rationale for and Avenues toward a Green Pharmacy; </li></ul></ul><ul><ul><li>II. Drug Disposal, Waste Reduction, and Future Directions, </li></ul></ul><ul><ul><li> </li></ul></ul>
  3. 3. Increasing Regulatory Activity <ul><li>EPA Region 2 auditing 480 hospitals in 2003; Rx waste included; link from H2E to Region 2 website </li></ul><ul><ul><li> </li></ul></ul><ul><li>States beginning to focus on management of waste pharmaceuticals </li></ul><ul><ul><li>Florida </li></ul></ul><ul><ul><li>Washington State </li></ul></ul><ul><ul><li>California </li></ul></ul><ul><ul><li>Minnesota </li></ul></ul><ul><ul><li>Michigan </li></ul></ul><ul><li>Intersecting regulatory agencies </li></ul><ul><ul><li>EPA, DEA, OSHA, State Boards of Pharmacy </li></ul></ul>
  4. 4. H2E and Hazardous Pharmaceuticals <ul><li>Initial involvement while at Capital Returns, Inc., Rx reverse distributor, 1999-2000 </li></ul><ul><li>Worked on Chemical Minimization Committee with Catherine Zimmer, Minnesota Technical Assistance Program (MnTAP) </li></ul><ul><li> </li></ul><ul><li>Contributed to prioritization tool by reviewing all drug products in CRI database </li></ul><ul><li> </li></ul>
  5. 5. USGS Water Quality Study* <ul><li>First nationwide reconnaissance of occurrence of pharmaceuticals, hormones, other organic wastewater contaminants </li></ul><ul><li>139 streams in 30 states, analyzed for 95 different OWCs </li></ul><ul><li>82 of the 95 detected in at least one sample </li></ul><ul><li>One or more OWCs found in 80% of stream samples </li></ul><ul><li>13% of sites had more than 20 OWCs </li></ul><ul><li>* </li></ul>
  6. 6. Below the Dose/Response Curve: Endocrine Disruptors <ul><li>Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles) </li></ul><ul><li>Mimic hormone, trigger identical response, block a hormone </li></ul><ul><li>Do not follow the normal dose/response curve </li></ul><ul><li>Active at much lower doses, especially in the fetus and newborn </li></ul><ul><li>Estradiols, progesterone, testosterone </li></ul><ul><li>Lindane </li></ul>
  7. 7. <ul><li>Low sperm counts(50% reduction since 1939) </li></ul><ul><li>Infertility </li></ul><ul><li>Genital deformities </li></ul><ul><li>Hormonally triggered human cancers </li></ul><ul><li>Neurological disorders in children </li></ul><ul><ul><li>Hyperactivity </li></ul></ul><ul><ul><li>Attention deficit </li></ul></ul><ul><li>Developmental & reproductive problems in wildlife </li></ul>
  8. 8. Pharmaceuticals Entering the Waste Stream <ul><li>Wastage of Raw Materials from Manufacturing Process </li></ul><ul><li>Wastage at the Distributor/ Pharmacy/Healthcare Facility </li></ul><ul><li>Wastage at the LTCF or other residential facility </li></ul><ul><li>Expired Pharmaceuticals </li></ul><ul><li>Wastage at the Consumer Level </li></ul><ul><li>Metabolites Entering Wastewater </li></ul>
  9. 9. When is an Outdated Drug a Waste? <ul><li>At the time and place the decision is made to discard it </li></ul><ul><li>Two EPA guidance letters to the industry: </li></ul><ul><ul><li>Merck & Co., 1981 </li></ul></ul><ul><ul><li>BFI Pharmaceutical, 1991 </li></ul></ul><ul><li>Enables shipping of potentially creditable outdates to a reverse distributor as product </li></ul><ul><li>PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials </li></ul>
  10. 10. Reverse Distribution: Current Scenarios <ul><li>Decision to discard is made at the pharmacy </li></ul><ul><ul><li>By pharmacy </li></ul></ul><ul><ul><li>By a contracted company </li></ul></ul><ul><ul><li>Pharmacy (hospital) becomes the waste generator </li></ul></ul><ul><li>Decision to discard is made at the reverse distributor </li></ul><ul><ul><li>Reverse Distributor becomes the waste generator </li></ul></ul>
  11. 11. Where Have Waste Drugs Gone in the Past? <ul><li>Primarily concerned with rendering drugs unrecoverable </li></ul><ul><ul><li>Not in dumpsters, municipal trash </li></ul></ul><ul><ul><li>Made slurries, sewered </li></ul></ul><ul><ul><li>Burned in hospital incinerators </li></ul></ul><ul><li>No training in pharmacy curriculum on EPA regulations </li></ul>
  12. 12. Where are Waste Drugs Going Today? <ul><li>Sewer System </li></ul><ul><ul><li>Unused, partial IVs, including antibiotics </li></ul></ul><ul><ul><li>Compounding residues </li></ul></ul><ul><ul><li>Liquids </li></ul></ul><ul><li>Red Infectious Waste Sharps Containers, Bags </li></ul><ul><li>Yellow or White Chemotherapy Sharps Containers, Bags </li></ul>
  13. 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. 14. How is Pharmaceutical Waste Generated at the Healthcare Facility? <ul><li>IV Preparation </li></ul><ul><li>General Compounding </li></ul><ul><li>Spills/Breakage </li></ul><ul><li>Partially Used Vials/Syringes </li></ul><ul><ul><li>If Contaminated, Biohazardous </li></ul></ul><ul><li>Discontinued, Unused Preparations </li></ul><ul><li>Unused Repacks (Unit Dose) </li></ul><ul><li>Discontinued Indated Pharmaceuticals </li></ul><ul><li>Patients’ Personal Medications </li></ul><ul><li>Outdated Pharmaceuticals </li></ul>
  15. 15. Where is Pharmaceutical Waste Generated? <ul><li>Pharmacy/Satellites </li></ul><ul><li>Patient Care Units </li></ul><ul><li>ER/OR </li></ul><ul><li>ICU/CCU/NICU </li></ul><ul><li>Oncology/Hematology and other outpatient clinics </li></ul><ul><li>Long Term Care Facilities </li></ul><ul><li>Home Health Care Services </li></ul>
  16. 16. What Departments Get Involved in Generating and Managing Pharmaceutical Waste? <ul><li>Pharmacy </li></ul><ul><li>Nursing </li></ul><ul><li>Infection Control </li></ul><ul><li>Environmental Services </li></ul><ul><li>Safety </li></ul><ul><li>Facility Management </li></ul><ul><li>Risk Management </li></ul><ul><li>Purchasing </li></ul>
  17. 17. Federal Waste Generation Status <ul><li>Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste. </li></ul><ul><li>Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste. </li></ul><ul><li>Conditionally Exempt Small Quantity Generator (CESQG):Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/month </li></ul>
  18. 18. Which Discarded Drugs Become Hazardous Waste? <ul><li>P-listed chemicals </li></ul><ul><ul><li>Sole active ingredient </li></ul></ul><ul><li>U-listed chemicals </li></ul><ul><ul><li>Sole active ingredient </li></ul></ul><ul><li>Characteristic of hazardous waste </li></ul><ul><ul><li>Ignitability </li></ul></ul><ul><ul><li>Toxicity </li></ul></ul><ul><ul><li>Corrosivity </li></ul></ul><ul><ul><li>Reactivity </li></ul></ul>
  19. 19. Examples of P-Listed Pharmaceutical Waste <ul><li>Arsenic trioxide P012 </li></ul><ul><li>Epinephrine P042 </li></ul><ul><li>Nicotine P075 </li></ul><ul><li>Nitroglycerin P081 </li></ul><ul><li>Phentermine (CIV) P046 </li></ul><ul><li>Physostigmine P204 </li></ul><ul><li>Physostigmine Salicylate P188 </li></ul><ul><li>Warfarin >0.3% P001 </li></ul>
  20. 20. Examples of P-Listed Pharmaceuticals
  21. 21. Impact of P-listed Waste <ul><li>Only 1 kg or 2.2 pounds/month cause facility to become a large quantity generator </li></ul><ul><li>Weights of P-listed drug waste must be combined with any other P-listed waste generated at the facility in a given month </li></ul><ul><li>Technically, containers that have held P-listed wastes are not “RCRA empty” unless they are triple rinsed and the rinsate discarded as hazardous </li></ul>
  22. 22. Examples of U-listed Pharmaceutical Waste <ul><li>Chloral Hydrate(CIV) U034 </li></ul><ul><li>Chlorambucil U035 </li></ul><ul><li>Cyclophosphamide U058 </li></ul><ul><li>Daunomycin U059 </li></ul><ul><li>Melphalan U150 </li></ul><ul><li>Mitomycin C U010 </li></ul><ul><li>Streptozotocin U206 </li></ul><ul><li>Lindane U129 </li></ul><ul><li>Saccharin U202 </li></ul><ul><li>Selenium Sulfide U205 </li></ul><ul><li>Uracil Mustard U237 </li></ul><ul><li>Warfarin<0.3% U248 </li></ul>
  23. 23. Examples of U-Listed Pharmaceuticals
  24. 24. Chemotherapy Waste <ul><li>Seven chemotherapy agents are U-listed; one is P-listed </li></ul><ul><li>Medical waste hauler protocols for “Chemo Waste” </li></ul><ul><ul><li>Empty vials, syringes, IV’s </li></ul></ul><ul><ul><li>Treated as infectious medical waste preferably through regulated medical waste incineration </li></ul></ul><ul><li>If not empty, should be placed into Hazardous Waste container </li></ul><ul><li>“ Empty” for U-listed waste means all contents removed that can be removed through normal means </li></ul><ul><ul><li>3 ml allowance in common practice is a misunderstanding of the definition of “RCRA empty” </li></ul></ul>
  25. 25. Chemotherapy Residue: Infectious and Hazardous <ul><li>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 </li></ul><ul><li>If chemo residue cannot be removed safely, dispose in trace chemotherapy container (yellow/white) as infectious chemo waste </li></ul><ul><li>No consensus yet on this issue among hazardous waste regulators </li></ul>
  26. 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. 27. Characteristic of Ignitability <ul><li>Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F. </li></ul><ul><li>Hazardous Waste Number: D001 </li></ul><ul><li>Rubbing Alcohol </li></ul><ul><li>Topical Preparation </li></ul><ul><li>Injections </li></ul>
  28. 28. Characteristic of Corrosivity <ul><li>An aqueous solution having a pH < or = 2 or > or = to 12.5 </li></ul><ul><li>Examples: Primarily compounding chemicals </li></ul><ul><ul><li>Glacial Acetic Acid </li></ul></ul><ul><ul><li>Sodium Hydroxide </li></ul></ul><ul><li>Hazardous waste number: D002 </li></ul>
  29. 29. Characteristic of Toxicity <ul><li>Approximately 40 chemicals which meet specific leaching concentrations </li></ul><ul><li>Examples of potential toxic pharmaceuticals: </li></ul><ul><li>Arsenic m-Cresol </li></ul><ul><li>Barium Mercury (thimerosal) </li></ul><ul><li>Cadmium phenylmercuric acetate) </li></ul><ul><li>Chloroform Selenium </li></ul><ul><li>Chromium Silver </li></ul><ul><li>Lindane </li></ul>
  30. 30. Preservatives: thimerosal & m-cresol Heavy Metals: Selenium, Chromium and Silver Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity
  31. 31. Characteristic of Reactivity <ul><li>Meet eight separate criteria identifying certain explosive and water reactive wastes </li></ul><ul><li>Nitroglycerin formulations may be considered exempt as of August 14, 2001 under FR: May 16, 2001. States must still adopt. </li></ul><ul><li>Hazardous Waste Number: D003 </li></ul>
  32. 32. How Can RCRA Hazardous Waste be Identified? <ul><li>Web-based database enabling search by product for waste management recommendations </li></ul><ul><li>Search by NDC, product or generic name, active ingredient </li></ul><ul><ul><li>Recommendations citing federal regulations and recommended waste streams </li></ul></ul><ul><ul><li>State regulation alerts if more stringent than federal </li></ul></ul><ul><ul><li>Risk Management alerts based on professional knowledge (e.g. chemotherapy agents not regulated at the state or federal level) </li></ul></ul>
  33. 34. Readi-Cat
  34. 38. How Should RCRA Hazardous Waste be Handled? <ul><li>Need a new waste stream in Pharmacy, certain Patient Care Areas, Oncology Clinics </li></ul><ul><li>RCRA Hazardous Waste: Toxic </li></ul><ul><ul><li>P, U, toxic Ds, all Chemotherapy Residues, Chemo Spills </li></ul></ul><ul><li>RCRA Hazardous Waste: Ignitable (D001) </li></ul><ul><li>Hospitec has developed a dedicated hazardous waste containment system </li></ul><ul><li>Can also use hazardous waste buckets available from brokers and disposal firms </li></ul>
  36. 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
  37. 41. Where Should RCRA Hazardous Waste Be Stored? <ul><li>Hazardous Waste Storage Accumulation Site: </li></ul><ul><ul><li>Same locked area as mercury, xylene, formaldehyde, lab chemicals </li></ul></ul><ul><ul><li>Maximum storage time: 90 or 180 days based on generator status </li></ul></ul>Yellow Hazardous Waste Label
  38. 42. How Should RCRA Hazardous Waste Be Disposed? <ul><li>Either contract with a hazardous waste broker or develop internal expertise for: </li></ul><ul><ul><li>Lab packing </li></ul></ul><ul><ul><li>Manifest preparation </li></ul></ul><ul><ul><li>Land ban preparation </li></ul></ul><ul><li>Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility) </li></ul>
  39. 43. How Can Hazardous RX Waste Generation Be Minimized? <ul><li>Inherent limitations on substitution of a less hazardous drug since the hazardous nature of the chemical often provides the therapeutic effect </li></ul><ul><li>Tighter inventory control to reduce outdate generation, both original manufacturers’ containers and repacks </li></ul><ul><li>Single dose vials vs. multiple dose vials </li></ul><ul><li>Patient specific oral syringes vs. 10 cc. repacks (e.g. choral hydrate for pediatric use) </li></ul><ul><li>Reformulation of heavy metal concentration, especially mercury and m-cresol as preservatives </li></ul>
  40. 44. What About Non-Hazardous Drugs? <ul><li>Segregate into a non-red, non-yellow container, such as beige or white with blue top (California Pharmaceutical Waste) </li></ul><ul><li>Label “Non-hazardous Pharmaceutical Waste – Incinerate Only” </li></ul><ul><li>Dispose at a regulated medical waste or municipal incinerator that is permitted to accept non-hazardous pharmaceutical waste </li></ul>
  41. 45. Where to Begin? <ul><li>Purchase appropriate containers for collecting toxic and ignitable hazardous waste </li></ul><ul><li>Pilot bulk and residue chemotherapy segregation in the pharmacy and on the oncology unit </li></ul><ul><li>Extend the program to all units that handle any chemotherapy agents (methotrexate and cyclophosphamide used in other units) </li></ul><ul><li>Begin identifying other P, U and D hazardous wastes </li></ul><ul><li>Train all relevant staff on the reasons for the new system </li></ul>
  42. 46. Jump-Starting the Process <ul><li>Electronic formulary review service </li></ul><ul><ul><li>Send PharmEcology Associates your drug formulary information </li></ul></ul><ul><ul><li>We compare it to our database of over 107,000 drug items </li></ul></ul><ul><ul><li>You receive back a list of which drugs are hazardous waste or risk management hazardous waste </li></ul></ul><ul><li>On-site review </li></ul><ul><ul><li>A one or two day visit to your facility followed by an Action Plan and Findings and Recommendations </li></ul></ul>
  43. 47. Benefits of a Comprehensive Hazardous Waste Disposal Plan <ul><li>JCAHO Environment of Care Performance Improvement Initiative </li></ul><ul><ul><li>New 2004 Standards – see both Medication Management and Environment of Care </li></ul></ul><ul><li>Reduces EPA liability and risk exposure to a minimum </li></ul><ul><li>Protects employees and patients </li></ul><ul><li>Demonstrates responsible care in dealing with hazardous substances, hazardous wastes </li></ul>
  44. 48. Resources <ul><li> </li></ul><ul><li>Pharmaceutical Waste: </li></ul><ul><li>“ Safely Managing Hazardous Materials and Hazardous Waste,” ASHP Clinical Midyear, 2001, Handouts on CD-Rom </li></ul><ul><li>RCRA On-Line </li></ul><ul><li>RCRA Hot Line 1-800-424-9346 </li></ul><ul><li>Improper Discard of Toxic Drugs Hurts Environment, Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp 1576-1578. </li></ul>
  45. 49. Resources <ul><li>Pharmaceutical Waste Survey, King County, Washington State, April 29, 2003, </li></ul><ul><li>Your Risks in Handling Outdated and Unusable Drugs: A Guide to JCAHO and Regulatory Standards. Capital Returns, Inc., 1998 Call 1-800-950-5479 </li></ul><ul><li>A Guide on Hazardous Waste Management for Florida’s Pharmacies, www. </li></ul><ul><li>Guidelines for Reverse Distributors: Minimum Federal Regulatory Standards, </li></ul>