1. HAZARDOUS WASTE THE PHARMACY PURCHASING PROFESSIONAL’S ROLE Kathy Pflaum, Inventory Control Coordinator, Pharmacy

2. Speaker Disclaimer Kathy Pflaum is an employee of St. Francis Hospital in Topeka, Kansas and has nothing else to disclose

3. Today’s Objectives – Hazardous Waste- It Affects You Describe the pharmacy purchasing role regarding the identification and disposal of hazardous waste Define the Resources Conservation & Recovery Act of 1976 (RCRA) and the effects on Pharmacy Reverse distribution selection processes

4. Why Do We Care About Hazardous Waste?

5. What You Don’t Know May Cause Harm How much hazardous waste is generated by your facility? What happens to the current sharps and red bag waste? Who are the responsible parties in your hospital to ensure proper handling and disposal of hazardous pharmaceutical waste? Why do you care?* * Managing Hazardous Pharmaceutical Waste, Pilot Project of North Memorial Medical Center, Robbinsdale, MN Pilot Project Presentation

6. Pharmacy Purchasing Professional – What Can You Do?

7. Be observant and document the observations Always ask questions Probe the entire pharmacy and everywhere pharmaceuticals are used or stored Understand the equation between what is purchased and how the product is used Have a plan for an unidentified delivery Effecting the Purchase of Pharmacy Items

8. How Can You Effect The Purchasing? Develop and enforce a policy that states that no medications are accepted into the Pharmacy with less than 1 year dating –Medications are purchased with the least amount of packaging –Select medications without preservatives whenever possible* *These opportunities and further discussion can be found at www.h2e-online.org.www.h2e-online.org

9. Minimize waste wherever possible –Look for opportunities to change the size or style bought –Controlled substances are especially difficult to waste* Inventory controls can be tightened on many medications thus reducing waste How Can You Effect the Purchasing? *These opportunities and further discussion can be found at www.h2e-online.org.www.h2e-online.org

10. Selection of the Reverse Distribution Vendor

11. Pharmaceutical Reverse Distribution - Who Selects This Vendor at Your Facility? Proper permits are required of Reverse Distribution and you have the right to ask for copies of these and other permits that may be required by the state: DEA Registration State Board of Pharmacy EPA Waste ID Local Solid Waste Permit Local Medical Waste Permit

12. For all hazardous waste disposal, the reverse distributor should provide the site information to which it will be delivered. ALL HAZARDOUS WASTE IS “CRADLE TO GRAVE” The facility owns the waste even in the landfill. All applicable fines for improper waste disposal belongs to the facility. Pharmaceutical Reverse Distribution - Who Selects This Vendor at Your Facility?

13. What to Know When Choosing a Reverse Distribution Company Does the reverse distributor have all the proper permits? Where does the hazardous waste go from the reverse distributor? What are the charges for disposal of hazardous and non- hazardous waste per pound? Is there a processing fee? Who pays the freight from the facility to the reverse distributor facility? Off site/On site processing fee?

14. What is a Hazardous Waste? The EPA* defines a hazardous waste as: …a waste with properties that make it dangerous or potentially harmful to human health or the environment. The universe of hazardous wastes is large and diverse. Hazardous wastes can be liquids, solids, contained gases, or sludges. They can be the by-products of manufacturing processes or simply discarded commercial products, like cleaning fluids or pesticides. *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

15. RCRA Law is Administered by EPA Resources Conservation and Recovery Act of 1976* –Protect human health and the environment from the potential hazards of waste disposal –Conserve energy and natural resources –Ensure that wastes are managed in an environmentally sound manner *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

16. Categories of Hazardous Waste Hazardous waste is regulated under the Resource Conservation and Recovery Act (RCRA) Subtitle C Waste is categorized as hazardous if it appears on a hazardous waste list* –F-list –D-list –K-list –P-list –U-list *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

17. “D” listed Pharmaceuticals* –Barium D005 –Lindane D013 “U” listed Pharmaceuticals* –AcetoneU002 –Cyclophosphamide U058 –LindaneU129 –PhenolU188 “D” LIST and “U” List Examples *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

18. “P” Listed Waste Effects Pharmacy Listed below are a few examples of “P” listed Pharmaceuticals  : –Epinephrine*P042 –NicotineP075 –Nitroglycerin (weak)**P081 –PhysostigmineP204 –Warfarin (greater than 0.3%)P001 *Epinephrine salts have been federally excluded effective October 16, 2007. States may or may not have adopted this federal stance. ** Nitroglycerin has been excluded from the federal listing. States may or may not have adopted this federal stance.  EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

19. Other Categories of Hazardous Waste Not all hazardous waste is on a “list” Can be considered a hazardous waste if it exhibits at least one of four characteristics* –Ignitability –Corrosivity –Reactivity –Toxicity *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

20. Characteristics of Ignitability or Corrosivity Ignitable* - Aqueous solution containing 24% alcohol or more by volume & flash point <140° F –Dehydrated Alcohol <98% Ethyl Alcohol –Rubbing alcohol –Paclitaxel in Aqueous solution Corrosive* - Aqueous solution having a pH ≤ 2 –Primarily compounding chemicals –Glacial Acetic Acid –Sodium Hydroxide *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

21. Characteristics of Reactivity or Toxicity Reactivity* - meets eight separate criteria identifying certain explosive and water reactive wastes –Nitroglycerin formulations are excluded federally from the P081 listing as non-reactive as of 8/14/2001 in FR:5/16/2001** Toxicity* - examples include but are not limited to: –Arsenic –Lindane –Barium –Mercury (thimerosal) Cadmium Chloroform Silver Chromium *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm**FR, volume 6 #95 (May 16, 2001)

22. Don’t Just Consider the Chemical! Hazardous waste (the initial chemical) combined with: –Personal Protective Equipment, packaging and spill materials –Regulated Medical Waste –Sharps –Controlled Substances All items MUST be part of the hazardous waste stream

23. What Areas Generate Hazardous Waste? Emergency Room Home Health ICU Lab Long term care facilities Maintenance Oncology/hematology Outpatient clinics Patient care units Pharmacy

24. Who Is Watching You?

25. Enforcement Agencies The Joint Commission (TJC) –Standards in the Environment of Care section 3.10 U. S. Environmental Protection Agency State Department of Health & Environment

26. The Joint Commission and Hazardous Waste Future ramifications with TJC if an executed plan not in process Surveys now include such questions as: –How do you separate your waste? –What is your plan to comply 100% with RCRA? –Do you waste medications down the drain? –How does hazardous waste leave the facility? –Where does the hazardous waste go after leaving the facility? –Can you product the logs of hazardous waste that have been transported out of your facility?

27. Additional Governing Regulations Clean Air Act Clean Water Act Emergency Planning and Community Right To Know Act (EPCRA) Toxic Substance Control Act Safe Drinking Water Act

28. EPA - Regions The mission of the Environmental Protection Agency is to protect human health and the environment. http://www.epa.gov/ Click on your region number for contact information

29. Health Care RCRA Violations from Region #2 Janet Bowen, EPA Region I 12/7/2006 presentation of Top Ten Compliance Pitfalls Based on Region II Audit Disclosure Data to SBEAP

30. Has Green Become A Color At Your Hospital?

31. This is Where the Rubber Hits the Road!

32. Be Part of the Solution Three ways to sort pharmaceutical waste –Provide appropriate disposal containers through out the facility –Centrally processed sorting of hazardous waste and medication –Treat all pharmaceuticals as hazardous waste

33. Medical Waste vs. Hazardous Waste Red containers are SHARPS containers – Not hazardous waste receptacles Medical waste is defined as waste materials that are generated at health care facilities (hospitals, clinics, etc…) –4 categories – infectious, hazardous, radioactive, other* *EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

34. Container Regulations That Apply Most states require clear verbiage stating Hazardous Waste There should be an accumulation start date Record log

35. Who is Disposing Of Your Hazardous Waste? Has the contracted company provided –Proper licensing to haul hazardous waste? (vs. medical waste) –“Bill of lading” documents to haul the waste? –Identification and proper documentation of disposal site

36. Establish a Hospital Wide Hazardous Waste Committee C-Suite Administrator Clinics Surgery Materials Management Infection Control Director of Safety Environmental Services Risk Management Pharmacy Nursing Lab Radiology Education/Training Director

37. Potential Impact of Compliance Financial Impact –Training and development of staff –Increased waste costs –Additional styles of containers –Additional staff to handle the waste –Outside consultants to achieve compliance

38. Potential Impact for Non- Compliance Fines up to $32,500 per day per violation Legal costs EPA scrutiny The Joint Commission - Requirement for Improvement (RFI)

39. Pharmacy Purchasing Professional’s Challenge Get involved Be proactive Become an expert in hazardous waste Be the “GO TO” person in the health care facility Show your leadership skills

40. Resources Used in this Presentation http://h2e-online.org http://www.epa.gov Top Ten Environmental Compliance Pitfalls - presented by Janet Bowen, EPA Region 1 12/7/2006 to SBEAP. NIOSH – National Institute for Occupational Safety & Health PharmEcology Associates, LLC - www.pharmecology.com www.pharmecology.com Managing Hazardous Pharmaceutical Waste, Pilot Project at North Memorial Medical Center, Robbinsdale, MN Presentation Covidien (Kendall SharpSafety Division) “Managing Pharmaceutical Waste – What Pharmacists Should Know”, Charlotte A. Smith, RPh, MS, Journal of the Pharmacy Society of Wisconsin, Nov./Dec. 2002, p. 17.

41. Questions?