Managing Waste Managing Waste Chemotherapeutic Agents: Chemotherapeutic Agents:

What to Know and What to Know and What to Find OutWhat to Find Out

H2E Teleconference H2E Teleconference March 11, 2005March 11, 2005

Eydie PinesEydie Pineseydie.pines@h2e-online.orgeydie.pines@h2e-online.org

Charlotte SmithCharlotte Smithcsmith@pharmecology.comcsmith@pharmecology.com

Know the LingoKnow the Lingo

Cytotoxic Cytotoxic Antineoplastic Antineoplastic ChemotherapeuticChemotherapeutic BiohazardousBiohazardous

• Refers to infectious waste, Blood Borne Refers to infectious waste, Blood Borne Pathogens ActPathogens Act

• In Pharmacy circles, often used to refer to In Pharmacy circles, often used to refer to agents which are hazardous to living systems, agents which are hazardous to living systems, such as chemotherapy drugssuch as chemotherapy drugs

• Need to correct this misconception and use the Need to correct this misconception and use the term only for infectious wasteterm only for infectious waste

Chemotherapeutic Agents: Chemotherapeutic Agents: The Regulatory PlayersThe Regulatory Players

OSHA Hazard Communication StandardOSHA Hazard Communication Standard• OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2-1 OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2-1 • Lists hazardous drugsLists hazardous drugs

NIOSH Hazardous Drug AlertNIOSH Hazardous Drug Alert • Recently released comprehensive new guidelines for total life Recently released comprehensive new guidelines for total life

cycle management of OSHA “Hazardous Drug” cycle management of OSHA “Hazardous Drug” • Identifies “hazardous waste” and need for appropriate disposal Identifies “hazardous waste” and need for appropriate disposal

EPA RCRAEPA RCRA• Only 9 chemotherapy drugs “listed” as hazardous waste in Only 9 chemotherapy drugs “listed” as hazardous waste in

19761976• None added to the list to keep up with drug developmentNone added to the list to keep up with drug development

State RMW RegulationsState RMW Regulations• May include trace chemotherapyMay include trace chemotherapy

Treated as infectious medical waste through regulated Treated as infectious medical waste through regulated medical waste incinerationmedical waste incineration

NIOSH Hazardous Drug AlertNIOSH Hazardous Drug Alert

• Preventing Occupational Exposures to Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Antineoplastic and Other Hazardous Drugs in Healthcare SettingHealthcare Setting

• Recognizes risks to employeesRecognizes risks to employees• Recommends engineering controls, Recommends engineering controls,

administrative controls, and personal administrative controls, and personal protective equipmentprotective equipment

• Provides waste disposal guidelinesProvides waste disposal guidelines• http://www.cdc.gov/niosh/docs/2004-165/http://www.cdc.gov/niosh/docs/2004-165/• Appendix A provides a starting list of Appendix A provides a starting list of

hazardous drugs under OSHA (not to be hazardous drugs under OSHA (not to be confused with hazardous waste under EPA)confused with hazardous waste under EPA)

Chemotherapeutic Drugs: Chemotherapeutic Drugs: Here, There and EverywhereHere, There and Everywhere

75% of pharmacy areas and 65% of 75% of pharmacy areas and 65% of administration areas demonstrated some level of administration areas demonstrated some level of contaminationcontamination

Contamination was generally higher in the Contamination was generally higher in the pharmacy than in the administration areaspharmacy than in the administration areas

Locations adjacent to handling areas were also Locations adjacent to handling areas were also contaminated.contaminated.

Conner TH, Anderson RW, Surface contamination Conner TH, Anderson RW, Surface contamination with antineoplastic agents in six cancer center with antineoplastic agents in six cancer center treatment centers in Canada and the United treatment centers in Canada and the United States. AMJ Health-System Pharm 1999: 56-1427-States. AMJ Health-System Pharm 1999: 56-1427-32.32.

New Study Reveals New Study Reveals Chemotherapy on VialsChemotherapy on Vials

Documents external contamination on Documents external contamination on vials from manufacturersvials from manufacturers

Supports requiring personnel who check in Supports requiring personnel who check in or handle chemotherapy containers to or handle chemotherapy containers to wear appropriate personal protective wear appropriate personal protective equipmentequipment

Conner TH, Sessink JM et al, Surface Conner TH, Sessink JM et al, Surface contamination of chemotherapy drug vials contamination of chemotherapy drug vials and evaluation of new vial-cleaning and evaluation of new vial-cleaning techniques: Results of three studies. AMJ-techniques: Results of three studies. AMJ-Health-System Pharm 2005: 62-475-84Health-System Pharm 2005: 62-475-84

Beyond the Obvious: Where Beyond the Obvious: Where Chemo Wastes are GeneratedChemo Wastes are Generated

Operating RoomOperating Room• Mitomycin eye drops, bladder irrigant (U listed)Mitomycin eye drops, bladder irrigant (U listed)

Med-Surg FloorsMed-Surg Floors• Immunosuppressives, eg. Rheumatoid arthritisImmunosuppressives, eg. Rheumatoid arthritis

Methotrexate (Not listed)Methotrexate (Not listed) Cyclophosphamide (U listed)Cyclophosphamide (U listed)

Emergency DepartmentEmergency Department• Ectopic pregnancyEctopic pregnancy

MethotrexateMethotrexate

Examples of Chemotherapy Examples of Chemotherapy Dosage FormsDosage Forms

Tablets/Capsule Tablets/Capsule • Chlor-am'-bu-cil, U035 Leukeran® Chlor-am'-bu-cil, U035 Leukeran®

Vial – PowderVial – Powder• Cyclophosphamide U058Cyclophosphamide U058

Cy-clo-phos´-pha-mide, Cytoxan®, Neosar®Cy-clo-phos´-pha-mide, Cytoxan®, Neosar®• Melphalan U150Melphalan U150

Mel´-phal-an, Alkeran®Mel´-phal-an, Alkeran® Vial – LiquidVial – Liquid

• Fluorouracil (Not listed)Fluorouracil (Not listed) Fluor-o-ur’-a-cil, 5FU, Adrucil®Fluor-o-ur’-a-cil, 5FU, Adrucil®

Ampule – LiquidAmpule – Liquid• Arsenic Trioxide P012Arsenic Trioxide P012

Trisenox®Trisenox®

The Dispensing Instrument The Dispensing Instrument MattersMatters

SyringesSyringes• EPA Hotline guidance exempts epinephrine syringe that has EPA Hotline guidance exempts epinephrine syringe that has

been injected into a patient and is therefore infectious waste; been injected into a patient and is therefore infectious waste; exclusion was extended verbally to other P and U listed drugs exclusion was extended verbally to other P and U listed drugs in a used syringe – open to interpretationin a used syringe – open to interpretation

IV SetsIV Sets• IV bags that are not empty and can be separated from patient exposed IV bags that are not empty and can be separated from patient exposed

sharp without exposing the employee should be managed as RCRA sharp without exposing the employee should be managed as RCRA hazardous waste hazardous waste

• IV bags that are not empty and can NOT be separated from patient IV bags that are not empty and can NOT be separated from patient exposed sharp without exposing the employee should be managed as exposed sharp without exposing the employee should be managed as both RCRA hazardous waste and RMWboth RCRA hazardous waste and RMW

VialsVials• Vials that are not empty should be managed as RCRA hazardous wasteVials that are not empty should be managed as RCRA hazardous waste

TabletsTablets• Unused tablets should be managed as RCRA hazardous wasteUnused tablets should be managed as RCRA hazardous waste

Arsenic Trioxide: The Only Arsenic Trioxide: The Only P-Listed Chemo WasteP-Listed Chemo Waste

Consider all containers that have held arsenic Consider all containers that have held arsenic trioxide to be hazardous wastetrioxide to be hazardous waste• RCRA empty for P-listed drugs requires triple rinsing of RCRA empty for P-listed drugs requires triple rinsing of

the container – not practicalthe container – not practical Over 1 kg (2.2 lbs) of P waste in a calendar month Over 1 kg (2.2 lbs) of P waste in a calendar month

results in large quantity generator statusresults in large quantity generator status Weights of P-listed drug waste must be combined Weights of P-listed drug waste must be combined

with any other P-listed waste generated at the with any other P-listed waste generated at the facility in a given month facility in a given month

If an IV set containing P-listed wastes is also If an IV set containing P-listed wastes is also considered infectious waste, it may have to be considered infectious waste, it may have to be managed by a facility permitted to handle both managed by a facility permitted to handle both hazardous waste and RMWhazardous waste and RMW

Chemotherapy Agents: Many Are Chemotherapy Agents: Many Are Not Regulated by RCRA Not Regulated by RCRA

Over 100 chemotherapy agents not Over 100 chemotherapy agents not regulated by EPAregulated by EPA

Examples:Examples:• Alkylating agents: Cisplatin, ThiotepaAlkylating agents: Cisplatin, Thiotepa• Antimetabolites: Fluorouracil, MethotrexateAntimetabolites: Fluorouracil, Methotrexate• Hormonal (antiandrogen): LupronHormonal (antiandrogen): Lupron® (leuprolide)® (leuprolide)• Hormonal (antiestrogen): TamoxifenHormonal (antiestrogen): Tamoxifen• Mitotic Inhibitor: Taxol® (paclitaxol) Mitotic Inhibitor: Taxol® (paclitaxol)

Some Chemotherapy Drugs May Some Chemotherapy Drugs May Also Be IgnitableAlso Be Ignitable

Aqueous Solution containing 24% Aqueous Solution containing 24% alcohol or more by volume & flash alcohol or more by volume & flash point<140° F.point<140° F.

Hazardous Waste Number: D001Hazardous Waste Number: D001 Example: Paclitaxel Inj contains Example: Paclitaxel Inj contains

49.7% ethanol49.7% ethanol Dispose in ignitable containerDispose in ignitable container

Trace Chemotherapeutic WasteTrace Chemotherapeutic Waste A term used to define items which are RCRA A term used to define items which are RCRA

empty but which have held any chemotherapy or empty but which have held any chemotherapy or been potentially exposed to chemotherapybeen potentially exposed to chemotherapy

To avoid autoclaving or microwaving of items To avoid autoclaving or microwaving of items which may be contaminated at the molecular which may be contaminated at the molecular level with undetected chemotherapylevel with undetected chemotherapy

Requires incineration at an RMW incinerator; may Requires incineration at an RMW incinerator; may be infectious such as used needlesbe infectious such as used needles

IV tubes primed with saline by the pharmacy and IV tubes primed with saline by the pharmacy and flushed with saline before being removed from flushed with saline before being removed from patient can be managed as trace patient can be managed as trace chemotherapeutic waste, reducing the volume of chemotherapeutic waste, reducing the volume of hazardous waste generated, reducing hazardous waste generated, reducing contamination of PPE, and lessening employee contamination of PPE, and lessening employee exposureexposure

Discarding Contaminated Personal Discarding Contaminated Personal Protective Equipment and Spill Clean Protective Equipment and Spill Clean

Up MaterialUp Material

Personal Protective Equipment (PPE) Personal Protective Equipment (PPE) and spill clean up material and spill clean up material contaminated with P- or U-listed contaminated with P- or U-listed waste must be managed as waste must be managed as hazardous wastehazardous waste

Empty vials, syringes, IVs,

tubing, gowns, gloves,etc.

Bulk chemo in vials, unused IV’s, P, U, toxic D and

associated spill clean up materials

Traditional Trace Chemo Waste Containers

New Hazardous Waste

Containers

Hospitec

Kendall

DOT approved

Treatment Technologies: Regulated Treatment Technologies: Regulated Medical (Infectious) Waste IncineratorsMedical (Infectious) Waste Incinerators

Permitted by the state to accept Permitted by the state to accept pathology waste, infectious waste pathology waste, infectious waste and sharps, trace chemo wasteand sharps, trace chemo waste

Regulated under the Clean Air ActRegulated under the Clean Air Act Lower temperature, less controls Lower temperature, less controls

than RCRA permitted hazardous than RCRA permitted hazardous waste incineratorswaste incinerators

Ash disposed of in a municipal (non-Ash disposed of in a municipal (non-hazardous) landfillhazardous) landfill

Characteristic and Listed Characteristic and Listed Hazardous Waste: ToxicHazardous Waste: Toxic

• P,U,D hazardous RX (non-chemo)• Bulk chemo vials, IV bags• Chemo and haz spill materials• Investigational drugs

Regulation:

Acronym:

Contents:

Treatment:

Purpose:

Resource Conservation & Recovery Act

RCRA

Toxic Hazardous Waste

Incineration at a RCRA hazardous waste incinerator

Destroy chemical compound entirely

Final Disposition: Lined hazardous waste landfill

Characteristic Hazardous Characteristic Hazardous Waste: IgnitableWaste: Ignitable

• D001 Ignitable hazardous RX

Regulation:

Acronym:

Contents:

Treatment:

Purpose:

Resource Conservation & Recovery Act

RCRA

Ignitable Hazardous Waste

Incineration at a RCRA hazardous waste

incineratorDestroy chemical

compound entirelyFinal

Disposition: Lined hazardous waste landfill

Treatment Technologies: Treatment Technologies: Hazardous Waste IncineratorsHazardous Waste Incinerators

Permitted by USEPA, known as a Treatment, Permitted by USEPA, known as a Treatment, Storage and Disposal Facility (TSDF)Storage and Disposal Facility (TSDF)

High temperature, molecular bonds brokenHigh temperature, molecular bonds broken Pollutants scrubbed, emits only water vapor, ash Pollutants scrubbed, emits only water vapor, ash

stored in a lined, hazardous waste landfillstored in a lined, hazardous waste landfill Authorized to accept the “worst of the worst” Authorized to accept the “worst of the worst”

hazardous chemicals, shipped on a 5-part hazardous chemicals, shipped on a 5-part manifestmanifest

Examples: Examples: • Clean Harbors/Safety KleenClean Harbors/Safety Kleen• HeritageHeritage• Onyx Onyx • TerisTeris

Combination Wastes: Combination Wastes: Infectious and HazardousInfectious and Hazardous

If IV bag chemo drug has been hung, is not completely used If IV bag chemo drug has been hung, is not completely used and can be separated from patient exposed sharp or and can be separated from patient exposed sharp or catheter without exposing the employee, remove and catheter without exposing the employee, remove and incinerate IV set as RCRA hazardous waste incinerate IV set as RCRA hazardous waste

If chemo residue cannot be removed safely, states differ on If chemo residue cannot be removed safely, states differ on regulatory requirementsregulatory requirements• Florida – may dispose as biohazardous, infectious wasteFlorida – may dispose as biohazardous, infectious waste• Minnesota – must dispose as hazardous waste; may be Minnesota – must dispose as hazardous waste; may be

considered infectiousconsidered infectious Engineering controls are making this scenario less frequentEngineering controls are making this scenario less frequent Clean Harbors is permitted to incinerate combination Clean Harbors is permitted to incinerate combination

wastes at their RCRA/RMW facility in Deer Park, Texas and wastes at their RCRA/RMW facility in Deer Park, Texas and Aragonite, UtahAragonite, Utah

P-listed Arsenic Trioxide is likely to be both a hazardous and P-listed Arsenic Trioxide is likely to be both a hazardous and infectious waste infectious waste

Satellite AccumulationSatellite Accumulation At the point of generationAt the point of generation Need only a Hazardous Waste (Toxic) or Need only a Hazardous Waste (Toxic) or

(Ignitable) label(Ignitable) label May need signage indicating it is Satellite May need signage indicating it is Satellite

Accumulation based on state requirementsAccumulation based on state requirements Need to keep covered when not in useNeed to keep covered when not in use Can accumulate up to 1 quart of P listed Can accumulate up to 1 quart of P listed

waste; 55 gallons of U and mixed wastewaste; 55 gallons of U and mixed waste Have 3 days to move when limit is reachedHave 3 days to move when limit is reached No other time limit involvedNo other time limit involved

Storage AccumulationStorage Accumulation

Hazardous Waste Hazardous Waste Storage Accumulation Storage Accumulation SiteSite• Same locked area as Same locked area as

mercury, xylene, mercury, xylene, formaldehyde, lab formaldehyde, lab chemicalschemicals

• Maximum storage time: Maximum storage time: 90 or 180 days based 90 or 180 days based on generator statuson generator status

• Additional regulatory Additional regulatory requirementsrequirements

Hazardous

Waste Label

Storage Capacity and LocationStorage Capacity and Location

Does your existing hazardous waste Does your existing hazardous waste storage facility have sufficient capacity for storage facility have sufficient capacity for the chemotherapeutic waste stream and the chemotherapeutic waste stream and other hazardous drug waste?other hazardous drug waste?

Is the storage accumulation area well Is the storage accumulation area well removed from patient traffic areas? removed from patient traffic areas?

Consider how waste will be transported Consider how waste will be transported from point of generation to storage from point of generation to storage accumulation areaaccumulation area

Manifesting Toxic Manifesting Toxic Chemotherapeutic WastesChemotherapeutic Wastes

Approach # 1Approach # 1• Document all listed P and U drugs that may be Document all listed P and U drugs that may be

used in the organizationused in the organization• Have this list pre-certified by the waste vendor Have this list pre-certified by the waste vendor

as a bulk shipment, rather than a lab packas a bulk shipment, rather than a lab pack• List all waste codes on the manifest regardless List all waste codes on the manifest regardless

of contentsof contents Approach #2Approach #2

• Document exactly which P and U listed drugs Document exactly which P and U listed drugs are deposited in a particular containerare deposited in a particular container

• List only those waste codes on the manifestList only those waste codes on the manifest• Very time consuming, but required in Very time consuming, but required in

Minnesota in particularMinnesota in particular

Manifesting IgnitableManifesting IgnitableChemotherapeutic WastesChemotherapeutic Wastes

Segregated into RCRA Ignitable waste Segregated into RCRA Ignitable waste containercontainer

May combine with other ignitable drug May combine with other ignitable drug wasteswastes

Manifest using the D001 code for Manifest using the D001 code for ignitabilityignitability

If a P or U listed drug is involved, list the If a P or U listed drug is involved, list the waste code in the shipping name along waste code in the shipping name along with the proper DOT ignitable shipping with the proper DOT ignitable shipping namename

Federal Waste Federal Waste Generator StatusGenerator Status

Large Quantity Generator (LQG): generates Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste.waste or >1 kg/month “P” listed waste.

Small Quantity Generator (SQG):Generates Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” hazardous waste & < or = 1 kg/month “P” listed waste.listed waste.

Conditionally Exempt Small Quantity Conditionally Exempt Small Quantity Generator (CESQG):Generates < or = 100 Generator (CESQG):Generates < or = 100 kg haz waste/month, < or = 1kg P listed kg haz waste/month, < or = 1kg P listed waste/monthwaste/month

OSHA HAZWOPER* Training OSHA HAZWOPER* Training RequirementsRequirements

If not Large Quantity Generator, general If not Large Quantity Generator, general awareness training and specific work awareness training and specific work training sufficienttraining sufficient

For Large Quantity Generator, need For Large Quantity Generator, need appropriate levels of HAZWOPER training appropriate levels of HAZWOPER training for employees handling and transporting for employees handling and transporting hazardous wastehazardous waste

http://www.osha.gov/pls/oshaweb/http://www.osha.gov/pls/oshaweb/owadisp.show_document?owadisp.show_document?p_table=STANDARDS&p_id=9765p_table=STANDARDS&p_id=9765

*Hazardous Waste Operations and Emergency Response 1920.120

Discovering Waste Minimization Discovering Waste Minimization OpportunitiesOpportunities

Is the pharmacy disposing of opened Is the pharmacy disposing of opened chemo drugs before the expiration chemo drugs before the expiration date?date?

Is the pharmacy priming the IV tube Is the pharmacy priming the IV tube with saline?with saline?

Does the nursing staff flush the IV Does the nursing staff flush the IV tube with saline before it is removed tube with saline before it is removed from the patient?from the patient?

Questions for Nursing, Pharmacy Questions for Nursing, Pharmacy and Housekeeping Staffand Housekeeping Staff

• How often are IV bags partially used?How often are IV bags partially used?• Do the IV bags have sharps or catheters attached?Do the IV bags have sharps or catheters attached?• Are the IV tubes primed with saline by the Are the IV tubes primed with saline by the

pharmacy?pharmacy?• Are the IV tubes flushed with saline before being Are the IV tubes flushed with saline before being

removed from the patient?removed from the patient?• How often are gowns changed?How often are gowns changed?• How many trace chemotherapy containers are How many trace chemotherapy containers are

currently being generated?currently being generated?• Are opened vials of chemotherapeutic agents Are opened vials of chemotherapeutic agents

disposed of prior to their expiration date?disposed of prior to their expiration date?• How often are opened expired chemotherapeutic How often are opened expired chemotherapeutic

drugs discarded?drugs discarded?

Managing to the Highest StandardManaging to the Highest Standard Treat all bulk chemotherapy waste Treat all bulk chemotherapy waste

(greater than trace amounts) as (greater than trace amounts) as RCRA hazardous wasteRCRA hazardous waste• Easier to implement – no lists or sorting Easier to implement – no lists or sorting

requiredrequired• The right thing to do for human health The right thing to do for human health

and the environmentand the environment• Complies with the RCRA statutory Complies with the RCRA statutory

definition of hazardous wastedefinition of hazardous waste

ReferencesReferences www.pharmecology.comwww.pharmecology.com Pharmaceutical Waste: Pharmaceutical Waste:

http://www.h2e-online.org/tools/chem-pharm.htmhttp://www.h2e-online.org/tools/chem-pharm.htm RCRA On-Line RCRA On-Line http://www.epa.gov/rcraonline/http://www.epa.gov/rcraonline/ NIOSH Hazardous Drug Alert: NIOSH Hazardous Drug Alert:

http://www.cdc.gov/niosh/docs/2004-165/http://www.cdc.gov/niosh/docs/2004-165/ Pharmaceuticals and Personal Care Products as Pharmaceuticals and Personal Care Products as

Environmental Pollutants: Environmental Pollutants: http://www.epa.gov/nerlesd1/chemistry/pharma/index.hthttp://www.epa.gov/nerlesd1/chemistry/pharma/index.htmm

ContainersContainers• Hospitec: Christopher Hahn, (561) 833-2296, Hospitec: Christopher Hahn, (561) 833-2296,

chris@hospitecinc.comchris@hospitecinc.com• Kendall: Mike Liscio, (508) 261-8493, Kendall: Mike Liscio, (508) 261-8493,

mike.liscio@tycohealthcare.commike.liscio@tycohealthcare.com