1. Pharmaceutical Waste June 2010 Wendi Shafir Environmental Protection Agency Region 9 415-972-3422 shafir.wendi@epa.gov

2. Key Issues to Cover Today Pharmaceuticals in the Environment US Geological Survey Study How do they get there ? Health /Environmental Impacts Current Requirements for Managing Pharms What is pharmaceutical waste? Regulations Identification Management Resources

3. 3 Pharmaceuticals in the News Medical facilities making uncontrolled releases of controlled drugs into water By JEFF DONN | AP National Writer 12:36 PM EDT, September 14, 2008 MINNEAPOLIS (AP) _ In a frustrating quirk in government policy, the most tightly controlled drugs — like painkilling narcotics prone to abuse — are the ones that most often elude environmental regulation when they become waste.

4. Drugs in Water In surface and ground sources of drinking water Endocrine disruptors found in waterways receiving wastewater Detrimental effects on aquatic species May have an impact on human health Antibotic resistance Water quality degradation

5. Nationwide survey 139 streams in 30 states, analyzed for 95 compounds 86% of compounds in at least one stream sample Widespread: One or more found in 80% of stream samples 13% of streams had more than 20 compounds * http://toxics.usgs.gov/pubs/OFR-02-94/index.html

6. How do they get into the water? Sewers Excretion Flushing unwanted medicines “Wasting” meds into sinks Landfills – thrown in trash Leachate goes to wastewater plants, released to rivers, ocean Animal waste flows into waterways Industrial discharge

7. So, what’s the problem? Endocrine Disruptors – act at very low dose Antibiotic Resistance Toxicity Environmental Degradation Lack of confidence in water supply

8. 8 Sources of Endocrine Disrupting Chemicals (EDCs) Industrial chemicals Personal care products Pesticides, herbicides, fungicid es Pharmaceuticals Synthetic and natural hormones Endocrine Disrupting Chemical s

9. Endocrine System

10. What are Endocrine Disruptors ? Any chemical –- that disrupts (or mimics) the normal balance of hormones, with particular focus on estrogen Interfere with normal function of the endocrine system (thyroid, adrenals, ovaries, testes) Affect reproduction, development, and behavior Active at VERY low dose Multi-generational effects

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12. Antibiotic Resistance  1999: Ampicillin-resistant bacteria found in every U.S. river tested  Samples containing the highest levels of antibiotics also contained bacteria with greatest resistance  DNA that helps make germs resistant to medicines increasingly appearing as a pollutant in the water,  even treated drinking water  Decreases effectiveness of antibiotics

13. What is Pharmaceutical Waste?

14. May include, but is not limited to: expired drugs; patients’ personal medications; waste materials containing excess drugs ( IV bags, tubing, vials, etc.) drugs that can no longer be used; containers that held drugs; drugs that are intended to be discarded; and contaminated garments, absorbents and spill cleanup material.

15. How is it regulated ? Resource Conservation & Recovery Act- RCRA, mostly Enforced by EPA, state and local agencies Federal regulation - hazardous waste disposal Encourages minimization of waste generation Defines “hazardous waste” “Cradle to Grave” tracking of hazardous waste Households are exempt Not all pharms are hazardous waste

16. Understanding the Regulations Defining Hazardous Wastes: Listed (F, K, P and U)- lists of actual wastes – includes some meds Characteristic Waste: exhibit these characteristics Ignitability Corrosivity Reactivity Toxicity Also Radioactives – other reguations

17. P-Listed Pharmaceutical Waste Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

18. P-Listed Pharmaceutical Waste Arsenic trioxideP012 Epinephrine P042 NicotineP075 Nitroglycerin*P081 Phentermine (CIV)P046 Physostigmine P204 Physostigmine SalicylateP188 Warfarin >0.3%P001 Copyright © 2005 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com *Nitroglycerin in finished dosage forms excluded federally and in many states for reactivity; must evaluate for ignitability

19. Common U-Listed Pharmaceuticals: Chloral Hydrate (CIV) U034 Chlorambucil(chemo) U035 Chloroform U044 Cyclophosphamide (chemo) U058 Daunomycin (chemo)U059 DichlorodifluromethaneU075 Diethylstilbestrol(chemo)U089 Formaldehyde U122 Hexachlorophene U132 Lindane U129 Melphalan (chemo)U150 Mercury U151 Mitomycin C (chemo)U010 Paraldehyde (CIV)U182 Phenacetin U187 Phenol U188 Reserpine U200 Resorcinol U201 Saccharin U202 Selenium sulfide U205 Streptozotocin (chemo)U206 Trichloromonofluromethane U121 Uracil mustard (chemo)U237 Warfarin <0.3%U248

20. U-Listed Pharmaceutical Waste Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

21. 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 Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

22. Characteristic of Corrosivity  An aqueous solution having a pH or = to 12.5  Examples: Primarily compounding chemicals Glacial Acetic Acid Sodium Hydroxide  Hazardous waste number: D002 Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

23. Characteristic of Toxicity  Approximately 40 chemicals which meet specific leaching concentrations  Examples of potential toxic pharmaceuticals: Arsenic Barium Cadmium Chloroform Chromium Lindane Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com m-Cresol Mercury (thimerosal) Selenium Silver

24. Preservatives: thimerosal & m-cresol Heavy Metals: Selenium, Chromium and Silver Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity

25. Characteristic of Reactivity  Meet eight separate criteria identifying certain explosive and water reactive wastes  Nitroglycerin formulations are exempted federally as of August 14, 2001 under FR: May 16, 2001. Many states have adopted exemption. Must still be evaluated for ignitability.  Hazardous Waste Number: D003 Copyright © 2005 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

26. Pharm Waste in California Proper pharmaceutical waste management is a highly complex new frontier in healthcare Hospital pharmacies typically stock between 2,000 and 4,000 different items Very difficult to correctly identify and manage waste California Only pharmaceuticals handled under MWMA

27. What can we do? Pollution Prevention  Control at source  Can implement & reduce loading in near term Product stewardship

28. Overview of Pharmaceutical Disposal: Hospitals Radioactives special handling RCRA hazardous waste must be hauled off as hazardous waste California Only pharmaceuticals handled under MWMA Solid Waste – not hazardous as defined by regs some flexibility May be best to dispose of as hazardous waste

29. RCRA Risk Management & Liability Civil and criminal liability Civil: State/USEPA enforcement Criminal: FBI, Attorney General, Grand Jury Corporate fines: $32,500 per violation/day Personal liability: fines and/or imprisonment No statute of limitations Managers up through CEO Copyright © 2005 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

30. Minimizing Pharm Waste - examples  Minimize inventory  Rotate inventory - use oldest stock first  Centralized disposal of physician’s samples  Prevent free samples- use voucher option  Avoid unnecessary prescriptions, especially antibiotics-Note pharmacy has very little control  Use pharmacy reverse distribution

31. Managing Pharm Waste Sewering Hazardous Chemo Radioactive MUST Develop Comprehensive System

32. Managing Pharmaceutical Waste A 10-Step Blueprint for Healthcare Facilities Revised August, 2008 Good reference – to develop plan California version available

33. Green Team Pharmacy Environmental Nursing Administration Safety Education Purchasing Risk Management

34. Recommended Disposal Strategy Everything Else RCRA Hazardous Waste RCRA Hazardous Sewer IV bags with salts/nutrients Medical Waste

35. What Pharms Can Be Sewered? Up to individual POTWs – sewer authority Generally okay to sewer solutions in IV bags containing only: saline solution lactate (i.e, Ringer’s) nutrients such as glucose (I.e., D5W) vitamins potassium other salts and electrolytes

36. Chemotherapy Waste – Special Handling Nine chemotherapy agents listed hazardous waste 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, place into Haz Waste container “Empty” for U-listed waste means all contents removed that can be removed through normal means and no more than 3% by weight remains 3 ml allowance in common practice is a misunderstanding of the definition of “RCRA empty” Copyright © 2005 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

37. Chemotherapy Agents: Many Not Regulated as Hazardous waste Over 100 chemotherapy agents not regulated by EPA Examples: Alkylating agents: Cisplatin, Thiotepa Antimetabolites: Fluorouracil, Methotrexate Hormonal (antiandrogen): Lupron® (leuprolide) Hormonal (antiestrogen): Tamoxifen Mitotic Inhibitor: Taxol® (paclitaxol) Copyright © 2005 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

38. Trace Chemotherapeutic Waste “RCRA empty” but have held any chemotherapy or been potentially exposed to chemotherapy avoid autoclaving or microwaving of items which may be contaminated at molecular level w/ chemotherapy Requires incineration at an RMW incinerator; may be infectious such as used needles IV tubes primed and flushed with saline before being removed from patient can be managed as trace chemotherapeutic waste, reducing the volume of hazardous waste generated, reducing contamination of PPE, and lessening employee exposure Copyright © 2005 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

39. How Can a RCRA Hazardous Waste Be Identified?  Web-based databases 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) Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

40. Where Should a 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 Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com RCRA Hazardous Wastes Must Be Properly Labeled!

41. How Should a 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) Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

42. 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 Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

43. Reverse Distribution For pharmaceuticals – not available for most other hazardous substances "Reverse distribution" - expired pharms can be returned to the manufacturer for credit by pharmacies, not by consumers Not to be used as a “waste management system.” Exclusion applies only to bona fide returns for credit, and not to broken containers, spilled contents, compounding leftovers, unused IVs, etc.

44. Take Home Messages Pharmaceuticals at detectable levels in many U.S. surface waters! First manage for P2, then dispose of properly. Pharmacists not always conversant in waste regulations (and may need support). EPA Resource Conservation & Recovery Act regulations carry significant liability, comparable to Drug Enforcement Administration

45. What About Household Pharms?  Non-controlled substances May be able to take to a household hazardous waste roundup – check with your county or treat as below  Controlled substances Render unpalatable – pepper, turmeric, other strong spices Remove labeling, duct tape shut Mix with undesirable trash and put out with regular trash right before pickup  NO DRUGS DOWN THE DRAIN Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

46. Resources NIOSH Hazardous Drug Alert http://www.cdc.gov/niosh/docs/2004-165/#sum ASHP Guidance on Handling Hazardous Drugs http://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF OSHA Technical Manual http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html 2008 10-Step Blueprint for Health Care Facilities Pharmaceutical waste http://www.hercenter.org/hazmat/tenstepblueprint.pdf U.S. Geological Survey http://pubs.acs.org/cgi-bin/jtextd?esthag/36/6/html/es011055j.html http://pubs.acs.org/cgi-bin/jtextd?esthag/36/6/html/es011055j.html Classifying Pharmaceutical Waste at California Healthcare Facilities http://www.sfenvironment.org/downloads/library/euticaldispos alinformation.pdf http://www.sfenvironment.org/downloads/library/euticaldispos alinformation.pdf

47. Resources Classifying Pharmaceutical Waste at California Healthcare Facilities http://www.sfenvironment.org/downloads/library/euticaldi sposalinformation.pdf http://www.sfenvironment.org/downloads/library/euticaldi sposalinformation.pdf