Pharmaceutical Waste Management & Minimization

1. Pharmaceutical Waste Management & Minimization Janet Bowen, EPA March 26, 2008

2. Overview of Presentation Environmental impacts of prescription drugs Review of 10-Step Blueprint including Regulatory Requirements Federal role: White House disposal guidelines, research, & policy implications Stewardship activities – state programs Region II enforcement summary Additional Programs

3. 1st National Study Revealed Extent of Pharms in Waterways USGS “Reconnaissance” study in 1999-2000 was 1st nationwide investigation of pharms, hormones, & other organic contaminants in 139 streams in 30 states: 82 of 95 antibiotics, prescription & non-prescrip drugs, steroids, & hormones were found in at least 1 sample 80% streams had 1 or more contaminant 75% streams contained 2 or more 54% had more than 5 34% had more than 10 13% tested positive for more than 20 targeted contaminants

4. National & International Studies Have Shown… Male fish, alligators, frogs, & other species with female organs & eggs Declines in human sperm counts, rise in female infertility Pharm compounds found at wastewater treatment plants Anti-cholesterol drug nearly killed test fish Cocktail of 13 drugs inhibited kidney cell growth Prozac linked to premature release of mussel larvae Associated Press Probe finds drugs in drinking water National Pharm Listserve http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste

5. How Pharmaceuticals enter the Environment Two Routes Excretion of unmetabolized medications Waste of unused medications

6. PURPOSEFUL INADVERTENT

8. Why Can’t We Take the PPCPs out of the Water? POTWs are not designed to remove PPCPs Promising technologies include: Oxidation Ozonation Ultrasound Activated carbon Reverse osmosis Longer retention times (POTWs with nutrient removal) look promising Focus on controlling disposal at source

9. Managing Pharmaceutical Waste:10 Step Blueprint for Health Care Facilities Introduction to a pharmaceutical waste management tool – use it to implement a pharmaceutical waste management system! http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf

10. Review of the 10 Steps Step 1 Getting Started Support from Senior Management Develop a Committee Plan for opportunities, challenges and financial implications to making changes, improvements in your facility.

11. Step 2: Understanding the RegulationsHazardous Waste Background • What is Hazardous Waste: • Waste that is dangerous or potentially harmful to human health or the environment • Can be liquids, solids, contained gases, or sludges • Hazardous waste is regulated under the Resource Conservation and Recovery Act (RCRA): • Appears on one of the four hazardous wastes lists (P-list, U-list, F-list, or K-list) • Or exhibits at least one of four characteristics (Ignitability, Corrosivity, Reactivity, or Toxicity)

12. Hazardous Waste Background In all states, the Environmental Department is the agency authorized to regulate hazardous waste under RCRA A discarded pharmaceutical may be identified as a hazardous waste if it appears on a regulatory list of hazardous wastes (P or U) or exhibits one of four hazardous characteristics (ignitability, corrosivity, reactivity or toxicity) Healthcare Environmental Resource Center www.hercenter.org

13. Step 2 Understanding the RegulationsP-Listed Wastes • P-Listed Wastes • Sole active ingredient • Unused – drug has not been given to a patient • Empty Containers • Empty if triple rinsed • Rinsate must be managed as hazardous waste • Rinsing generally not practical for pharmaceutical waste

14. Hazardous Waste: Listed • If the pharmaceuticals you are using appears on these lists, the waste must be handled as a hazardous waste • Common P-Listed Pharmaceuticals: • Please note that this list is not intended to be complete. The full list of all P-listed wastes appear in the Code of Federal Regulations, 40 CFR 261.33.

15. Step 2 Understanding the RegulationsRegulatory Interpretation: Epinephrine Salts October 15, 2007 EPA Memohttp://www.epa.gov/region1/healthcare/pdfs/EpiMemo_Final.pdf Epinephrine salts are not a P042 listed waste (federally) States are delegated the RCRA program and can be more stringent

16. Step 2 Understanding the RegulationsNitroglycerin Exemption Medical nitroglycerin removed as a P-listed waste Weak, non-reactive, formulation Some formulations may fail ignitability characteristic Waste injectables Aerosols State may be more stringent (or may be still adopting the rule) – check with your state on their position on Nitroglycerin

17. Step 2 Understanding the RegulationsU-Listed Wastes U-listed Wastes Sole active ingredient Unused Empty Containers All contents have been removed that can be removed through normal means and no more than 3% by weight remains Residues removed from container must be managed as hazardous waste

18. Hazardous Waste: Listed • Common U-Listed Pharmaceuticals • Please note that this list is not intended to be complete. The full list of all U-listed wastes appear in the Code of Federal Regulations, 40 CFR 261.33.

19. Hazardous Waste: Characteristic • If the pharmaceuticals you are using exhibits one of four hazardous characteristics, the waste must be handled as a hazardous waste • Ignitability - having a flash point less than 60oC • Ignitable Characteristic Pharmaceuticals: • Any formulations with more than 24% alcohol • Oxidizers such as Potassium Permanganate and Silver Nitrate • Collodion • Corrosivity - having a pH less than 2 or greater than 12.5 • Corrosive Characteristic Pharmaceuticals: • Compounding Agents such as Glacial acetic acid and Sodium Hydroxide

20. Hazardous Waste: Characteristic • Reactivity - liable to explode, or react violently or release toxic gases when in contact with water • Reactive Characteristic Pharmaceuticals: • Nitroglycerin • Toxicity - containing a regulated substance at a concentration above the limit • Toxic Characteristic Pharmaceuticals: • Zinc (some shampoos) • Selenium

21. How does this apply to Pharmacy? • Facilities that generate hazardous waste are regulated as one of the following: • Conditionally Exempt Small Quantity Generators (CESQGs) Generate less than 100 kg of hazardous waste per calendar month* • Small Quantity Generators (SQGs) Generate between 100 kg and 1000 kg of hazardous waste per calendar month* • Large Quantity Generators (LQGs) Generate greater than 1000 kg of hazardous waste per calendar month * And no more than 1 kg (2.2 lbs) of acutely hazardous waste per calendar month counts weight of container

22. Step 3 Consider Best Management Practices (BMPs) for Non-Regulated Pharmaceutical Wastes Recommendations made for how to manage pharmaceutical waste to protect water bodies, aquatic species, human health. Incineration (endocrine disruptors, carcinogenic drugs, Formulations w/listed active ingredient that is not the sole active ingredient, etc.) Eliminate drain disposal Avoid Landfilling Use non PVC IV Sets

23. Step 3 - BMPsManaging to the Highest Standard Hazardous waste regulations have not kept pace with drug development Approximately 10% of the drugs that are not regulated are equally as hazardous. Best management practices encourage managing drugs that are equally harmful as hazardous waste when discarded

24. Step 3 - BMPsDartmouth Hitchcock Medical Center Waste Characterization Summary

25. Step 3 - BMPsSummary BMPs Drugs with more than one active ingredient All chemotherapy drugs Drugs meeting OSHA and NIOSH criteria Drugs on: OSHA Technical Manual Appendix DHHS list of carcinogens Drugs with low oral LD 50s Endocrine disruptors Vitamin and mineral preparations Contaminated PPE and spill clean up material Eliminate drain disposal

26. Step 4 Perform Review of Drug Inventory Obtain purchasing data from Drug Wholesaler and/or purchasing records Identify ingredients Determine RCRA hazardous waste code Consider Compounded Items & Reformulations Gather Drug-Specific Data – national drug code, brand name, generic name, Mfr, strength, dosage form, package size Document decision making process Keep the review current

27. Step 5 Minimizing Pharmaceutical Waste Consider lifecycle Impacts in Purchasing Process Longer expiration date Some epinephrine products have longer shelf life than others to minimize waste from crash carts and other areas where the drug is stored for emergencies Products with less packaging Packaging in contact with RCRA P-listed drugs must be managed as hazardous waste Products without hazardous preservatives Maximize Use of Opened Chemotherapy Vials Implement Samples Policy Labeling Drugs for Home Use Priming & Flushing IV lines w/Saline Solution Examine Size of Containers Relative to Use

28. Step 5 Minimizing Pharmaceutical Waste(cont’d) Replace Prepackaged Unit Dose Liquids w/Patient-Specific Oral Syringes Try to eliminate generation of controlled substances that are also hazardous wastes Use hard plastic buckets for delivery of chemotherapy drugs to hospital floors – not brown paper bags Monitor dating on emergency syringes Review inventory controls to minimize outdates

29. Step 5 Minimizing Pharmaceutical Waste(cont’d) Limitations on less hazardous drug substitution Hazardous nature of drug often provides therapeutic effect Always ask: What pharmaceuticals are being wasted? Why are they being wasted? How can wasting be minimized?

30. Step 6 Assess Current Practices Conduct Department Reviews Conduct Analyses Frequently Confirm your Generator Status

31. Step 7 Taking On Communication Labeling Challenge Automating the Labeling Process Manually Labeling in the Pharmacy Providing Guidance on the Floor Selecting a Message for the Label Advocate that distributors or manufactures label drugs further up the food chain

32. Step 8 Consider Management Options Segregation at the Point of Generation Centralizing Segregation Managing all drug waste as hazardous May be simplest and most economical approach for small facilities with < 50 beds May cost large metropolitan facilities in excess of $1M

33. Sample Guidance Poster

34. Step 9 Getting Ready for Implementation Locating Your Satellite Accumulation Areas Evaluating Your Storage Accumulation Area Selecting the Right Vendors Conducting Pilots Putting it all together: Policies and Procedures Preparing for Spills

35. Locating Satellite Accumulation Areas Located at the point of generation and under control of operator (check with state) Soiled utility room in nursing unit Sterile processing clean room and other areas of pharmacy Hazardous waste label Signage indicating Satellite Accumulation Keep container covered when not in active use Quantity Limit Up to 1 quart of P listed waste and 55 gallons of combined U and characteristic waste Have 3 days to move when limit is reached

36. Step 10 Launch the Program Educate & Train Staff Staging the Roll-out Paperwork Requirements: Filling Out Required Forms Hazardous Waste Manifests Land Disposal Restrictions Tracking, Measuring & Recording Progress

37. Federal Role: Agency Interests Research Policy Implications Disposal Guidelines

38. EPA Regulatory Agenda Considering revising Universal Waste Rule for inclusion of some waste pharmaceuticals Office of Water evaluating the healthcare sector, including disposal of pharm waste from institutions, to determine need for development of WQ criteria

39. What is the Scope of the Study? We are studying the disposal of unused pharmaceutical from the Health Services Industry (hospitals and long-term care facilities) as part of the EPA’s CWA Effluent Guidelines Program We are looking to highlight good voluntary best management practices What are We Studying? Identifying current management of unused pharmaceuticals at long-term care facilities and hospitals Summarizing federal, local, and regional requirements, guidance, and voluntary initiatives We are soliciting volunteers to fill out a data request What is our Schedule? August 2008 Preliminary Report of Health Services EPA’s Health Services Industry Detailed Study Health Services Industry Study Outreach January 2008

40. Federal Disposal GuidelinesFeb. 20, 2007 Federal govt. guidelines for proper disposal of unwanted medications ONDCP issued February 2007 Reaches across several Federal agencies Encourages trash disposal—after drugs made unusable Discourages flushing

41. Federal Disposal Guidelines Take unwanted meds out of original containers & put in trash Mix prescription drugs with undesirable substance, (e.g., used coffee grounds or kitty litter) & put in impermeable, non-descript containers Flush only if label says to do so FDA lists 13 pharms that should be flushed Use community return programs where available http://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_disposal.html

42. SMARxT Disposal • The SMARXT DISPOSAL campaign is designed to raise awareness about the potential environmental impact from improperly disposed of medications and to provide proactive guidance through proper disposal alternatives. • SMARXT DISPOSAL is a unique public-private partnership between the U.S. Fish and Wildlife Service, the American Pharmacists Association, and the Pharmaceutical Research and Manufacturers of America. This support and involvement is what separates SMARXT DISPOSAL from other initiatives and it will ultimately make this campaign successful. • Website just released! • SMARxTDisposal.net

43. Stewardship Activities

44. Types of Stewardship Activities 1-time consumer return collections Household haz waste collections Permanent collection boxes Use of police stations Pilot use of reverse distributors Pilot mail-back programs Many of these programs require involvement of a pharmacist (DEA)

45. EPA Stewardship Activities EPA’s new PPCP web site http://www.epa.gov/ppcp/ 2 recently funded programs in Maine & Missouri thru Aging Initiative Mail-back & take-back return programs Inventories of types & quantities of drugs returned

46. Northeast Recycling Council grantManagement of Unwanted Pharmaceuticals • Researching and addressing legal issues with take-back programs, • Developing drug collection pilots, including one nearby in South Portland, Maine, • Developing a “Guidebook for Holding Unwanted Medication Collections,” • Developing Best Management Practices for the end-of-life management of plastic medication containers. Website – where you can download all materials http://www.nerc.org/projects/completed_projects.html#2006-a

47. Results EPA Region II:Compliance Monitoring & Incentives Programs Adapted from Region 2 August 2006

48. Healthcare Violations – All R2 Adapted from Region 2 August 2006 presentation

49. Top 5 Violations (From 146 Voluntary Disclosures) Adapted from Region 2 August 2006 presentation

50. Healthcare RCRA Violations Adapted from Region 2 August 2006 presentation