Managing Waste Chemotherapeutic Agents: What to Know and What to Find Out

1. Managing Waste Chemotherapeutic Agents: What to Know and What to Find Out H2E Teleconference March 11, 2005 Eydie Pines eydie.pines@h2e-online.org Charlotte Smith csmith@pharmecology.com

2. Know the Lingo • Cytotoxic • Antineoplastic • Chemotherapeutic • Biohazardous • Refers to infectious waste, Blood Borne Pathogens Act • In Pharmacy circles, often used to refer to agents which are hazardous to living systems, such as chemotherapy drugs • Need to correct this misconception and use the term only for infectious waste

3. Chemotherapeutic Agents: The Regulatory Players • OSHA Hazard Communication Standard • OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2-1 • Lists hazardous drugs • NIOSH Hazardous Drug Alert • Recently released comprehensive new guidelines for total life cycle management of OSHA “Hazardous Drug” • Identifies “hazardous waste” and need for appropriate disposal • EPA RCRA • Only 9 chemotherapy drugs “listed” as hazardous waste in 1976 • None added to the list to keep up with drug development • State RMW Regulations • May include trace chemotherapy • Treated as infectious medical waste through regulated medical waste incineration

4. NIOSH Hazardous Drug Alert • Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Setting • Recognizes risks to employees • Recommends engineering controls, administrative controls, and personal protective equipment • Provides waste disposal guidelines • http://www.cdc.gov/niosh/docs/2004-165/ • Appendix A provides a starting list of hazardous drugs under OSHA (not to be confused with hazardous waste under EPA)

5. Chemotherapeutic Drugs: Here, There and Everywhere • 75% of pharmacy areas and 65% of administration areas demonstrated some level of contamination • Contamination was generally higher in the pharmacy than in the administration areas • Locations adjacent to handling areas were also contaminated. • Conner TH, Anderson RW, Surface contamination with antineoplastic agents in six cancer center treatment centers in Canada and the United States. AMJ Health-System Pharm 1999: 56-1427-32.

6. New Study Reveals Chemotherapy on Vials • Documents external contamination on vials from manufacturers • Supports requiring personnel who check in or handle chemotherapy containers to wear appropriate personal protective equipment • Conner TH, Sessink JM et al, Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: Results of three studies. AMJ-Health-System Pharm 2005: 62-475-84

7. Beyond the Obvious: Where Chemo Wastes are Generated • Operating Room • Mitomycin eye drops, bladder irrigant (U listed) • Med-Surg Floors • Immunosuppressives, eg. Rheumatoid arthritis • Methotrexate (Not listed) • Cyclophosphamide (U listed) • Emergency Department • Ectopic pregnancy • Methotrexate

8. Examples of Chemotherapy Dosage Forms • Tablets/Capsule • Chlor-am'-bu-cil, U035 Leukeran® • Vial – Powder • Cyclophosphamide U058 • Cy-clo-phos´-pha-mide, Cytoxan®, Neosar® • Melphalan U150 • Mel´-phal-an, Alkeran® • Vial – Liquid • Fluorouracil (Not listed) • Fluor-o-ur’-a-cil, 5FU, Adrucil® • Ampule – Liquid • Arsenic Trioxide P012 • Trisenox®

9. The Dispensing Instrument Matters • Syringes • EPA Hotline guidance exempts epinephrine syringe that has been injected into a patient and is therefore infectious waste; exclusion was extended verbally to other P and U listed drugs in a used syringe – open to interpretation • IV Sets • IV bags that are not empty and can be separated from patient exposed sharp without exposing the employee should be managed as RCRA hazardous waste • IV bags that are not empty and can NOT be separated from patient exposed sharp without exposing the employee should be managed as both RCRA hazardous waste and RMW • Vials • Vials that are not empty should be managed as RCRA hazardous waste • Tablets • Unused tablets should be managed as RCRA hazardous waste

10. Arsenic Trioxide: The Only P-Listed Chemo Waste • Consider all containers that have held arsenic trioxide to be hazardous waste • RCRA empty for P-listed drugs requires triple rinsing of the container – not practical • Over 1 kg (2.2 lbs) of P waste in a calendar month results in large quantity generator status • Weights of P-listed drug waste must be combined with any other P-listed waste generated at the facility in a given month • If an IV set containing P-listed wastes is also considered infectious waste, it may have to be managed by a facility permitted to handle both hazardous waste and RMW

11. Chemotherapy Agents: Many Are Not Regulated by RCRA • 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)

12. Some Chemotherapy Drugs May Also Be Ignitable • Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F. • Hazardous Waste Number: D001 • Example: Paclitaxel Inj contains 49.7% ethanol • Dispose in ignitable container

13. Trace Chemotherapeutic Waste • A term used to define items which are RCRA empty but which have held any chemotherapy or been potentially exposed to chemotherapy • To avoid autoclaving or microwaving of items which may be contaminated at the molecular level with undetected chemotherapy • Requires incineration at an RMW incinerator; may be infectious such as used needles • IV tubes primed with saline by the pharmacy 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

14. Discarding Contaminated Personal Protective Equipment and Spill Clean Up Material • Personal Protective Equipment (PPE) and spill clean up material contaminated with P- or U-listed waste must be managed as hazardous waste

15. New Hazardous Waste Containers Traditional Trace Chemo Waste Containers Bulk chemo in vials, unused IV’s, P, U, toxic D and associated spill clean up materials DOT approved Hospitec Empty vials, syringes, IVs, tubing, gowns, gloves,etc. Kendall

16. Treatment Technologies: Regulated Medical (Infectious) Waste Incinerators • Permitted by the state to accept pathology waste, infectious waste and sharps, trace chemo waste • Regulated under the Clean Air Act • Lower temperature, less controls than RCRA permitted hazardous waste incinerators • Ash disposed of in a municipal (non-hazardous) landfill

17. Characteristic and Listed Hazardous Waste: Toxic Regulation: Resource Conservation & Recovery Act Acronym: RCRA • P,U,D hazardous RX (non-chemo) • Bulk chemo vials, IV bags • Chemo and haz spill materials • Investigational drugs Contents: Toxic Hazardous Waste Treatment: Incineration at a RCRA hazardous waste incinerator Purpose: Destroy chemical compound entirely Final Disposition: Lined hazardous waste landfill

18. Characteristic Hazardous Waste: Ignitable Regulation: Resource Conservation & Recovery Act Acronym: RCRA • D001 Ignitable hazardous RX Contents: Ignitable Hazardous Waste Incineration at a RCRA hazardous waste incinerator Treatment: Purpose: Destroy chemical compound entirely Final Disposition: Lined hazardous waste landfill

19. Treatment Technologies: Hazardous Waste Incinerators • Permitted by USEPA, known as a Treatment, Storage and Disposal Facility (TSDF) • High temperature, molecular bonds broken • Pollutants scrubbed, emits only water vapor, ash stored in a lined, hazardous waste landfill • Authorized to accept the “worst of the worst” hazardous chemicals, shipped on a 5-part manifest • Examples: • Clean Harbors/Safety Kleen • Heritage • Onyx • Teris

20. Combination Wastes: Infectious and Hazardous • If IV bag chemo drug has been hung, is not completely used and can be separated from patient exposed sharp or catheter without exposing the employee, remove and incinerate IV set as RCRA hazardous waste • If chemo residue cannot be removed safely, states differ on regulatory requirements • Florida – may dispose as biohazardous, infectious waste • Minnesota – must dispose as hazardous waste; may be considered infectious • Engineering controls are making this scenario less frequent • Clean Harbors is permitted to incinerate combination wastes at their RCRA/RMW facility in Deer Park, Texas and Aragonite, Utah • P-listed Arsenic Trioxide is likely to be both a hazardous and infectious waste

21. Satellite Accumulation • At the point of generation • Need only a Hazardous Waste (Toxic) or (Ignitable) label • May need signage indicating it is Satellite Accumulation based on state requirements • Need to keep covered when not in use • Can accumulate up to 1 quart of P listed waste; 55 gallons of U and mixed waste • Have 3 days to move when limit is reached • No other time limit involved

22. Storage Accumulation • 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 • Additional regulatory requirements Hazardous Waste Label

23. Storage Capacity and Location • Does your existing hazardous waste storage facility have sufficient capacity for the chemotherapeutic waste stream and other hazardous drug waste? • Is the storage accumulation area well removed from patient traffic areas? • Consider how waste will be transported from point of generation to storage accumulation area

24. Manifesting Toxic Chemotherapeutic Wastes • Approach # 1 • Document all listed P and U drugs that may be used in the organization • Have this list pre-certified by the waste vendor as a bulk shipment, rather than a lab pack • List all waste codes on the manifest regardless of contents • Approach #2 • Document exactly which P and U listed drugs are deposited in a particular container • List only those waste codes on the manifest • Very time consuming, but required in Minnesota in particular

25. Manifesting IgnitableChemotherapeutic Wastes • Segregated into RCRA Ignitable waste container • May combine with other ignitable drug wastes • Manifest using the D001 code for ignitability • If a P or U listed drug is involved, list the waste code in the shipping name along with the proper DOT ignitable shipping name

26. Federal Waste Generator 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

27. OSHA HAZWOPER* Training Requirements • If not Large Quantity Generator, general awareness training and specific work training sufficient • For Large Quantity Generator, need appropriate levels of HAZWOPER training for employees handling and transporting hazardous waste • http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9765 *Hazardous Waste Operations and Emergency Response 1920.120

28. Discovering Waste Minimization Opportunities • Is the pharmacy disposing of opened chemo drugs before the expiration date? • Is the pharmacy priming the IV tube with saline? • Does the nursing staff flush the IV tube with saline before it is removed from the patient?

29. Questions for Nursing, Pharmacy and Housekeeping Staff • How often are IV bags partially used? • Do the IV bags have sharps or catheters attached? • Are the IV tubes primed with saline by the pharmacy? • Are the IV tubes flushed with saline before being removed from the patient? • How often are gowns changed? • How many trace chemotherapy containers are currently being generated? • Are opened vials of chemotherapeutic agents disposed of prior to their expiration date? • How often are opened expired chemotherapeutic drugs discarded?

30. Managing to the Highest Standard • Treat all bulk chemotherapy waste (greater than trace amounts) as RCRA hazardous waste • Easier to implement – no lists or sorting required • The right thing to do for human health and the environment • Complies with the RCRA statutory definition of hazardous waste

31. References • www.pharmecology.com • Pharmaceutical Waste: http://www.h2e-online.org/tools/chem-pharm.htm • RCRA On-Line http://www.epa.gov/rcraonline/ • NIOSH Hazardous Drug Alert: http://www.cdc.gov/niosh/docs/2004-165/ • Pharmaceuticals and Personal Care Products as Environmental Pollutants: http://www.epa.gov/nerlesd1/chemistry/pharma/index.htm • Containers • Hospitec: Christopher Hahn, (561) 833-2296, chris@hospitecinc.com • Kendall: Mike Liscio, (508) 261-8493, mike.liscio@tycohealthcare.com