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Managing Managing Pharm ac eu tical Pharm ac eu tical Waste Waste Connecticut Connecticut Hosp
Managing Managing Pharm ac eu tical Pharm ac eu tical Waste Waste Connecticut Connecticut Hosp

ManagingManaging PharmaceuticalPharmaceutical WasteWaste ConnecticutConnecticut HospitalHospital RoundtableRoundtable SeptemberSeptember 88 thth ,, 20052005

CharlotteCharlotte Smith,Smith, R.R. Ph.,Ph., M.S.M.S. csmithcsmith@@pharmecologypharmecology.com.com www.www.pharmecologypharmecology.com.com

262262--814814--26352635

www. www. pharmecology pharmecology .com .com 262262--814814--26352635 Copyright © 2005 by PharmEcology Associates, LLC
www. www. pharmecology pharmecology .com .com 262262--814814--26352635 Copyright © 2005 by PharmEcology Associates, LLC
www. www. pharmecology pharmecology .com .com 262262--814814--26352635 Copyright © 2005 by PharmEcology Associates, LLC
www. www. pharmecology pharmecology .com .com 262262--814814--26352635 Copyright © 2005 by PharmEcology Associates, LLC

Copyright © 2005 by PharmEcology Associates, LLC

GoalsGoals forfor Today’sToday’s ProgramProgram

ToTo developdevelop aa betterbetter understandingunderstanding ofof thethe regulatoryregulatory andand environmentalenvironmental reasonsreasons forfor managingmanaging pharmaceuticalpharmaceutical wastewaste moremore stringentlystringently ToTo understandunderstand howhow federalfederal hazardoushazardous wastewaste rulesrules impactimpact pharmaceuticalpharmaceutical wastewaste managementmanagement inin hospitalshospitals ToTo considerconsider specificspecific ConnecticutConnecticut requirementsrequirements ToTo examineexamine toolstools toto assistassist inin assessingassessing currentcurrent policiespolicies andand proceduresprocedures andand developingdeveloping aa

effective pharmaceutical

compliantcompliant andand costcost--effective pharmaceutical

wastewaste managementmanagement planplan

pharmaceutical compliantcompliant andand costcost -- effective pharmaceutical wastewaste managementmanagement planplan
pharmaceutical compliantcompliant andand costcost -- effective pharmaceutical wastewaste managementmanagement planplan
pharmaceutical compliantcompliant andand costcost -- effective pharmaceutical wastewaste managementmanagement planplan
pharmaceutical compliantcompliant andand costcost -- effective pharmaceutical wastewaste managementmanagement planplan
Incr ea sing Incr ea sing Focus Focus on on Pharm ac eutical Pharm ac

IncreasingIncreasing FocusFocus onon PharmaceuticalPharmaceutical WasteWaste

"Cradle"Cradle--toto--CradleCradle StewardshipStewardship ofof DrugsDrugs forfor MinimizingMinimizing TheirTheir EnvironmentalEnvironmental DispositionDisposition WhileWhile PromotingPromoting HumanHuman Health.”Health.” Dr.Dr. ChristianChristian DaughtonDaughton,, Chief,Chief, EnvironmentalEnvironmental ChemistryChemistry Branch,Branch, USEPAUSEPA NationalNational ExposureExposure ResearchResearch LaboratoryLaboratory http://www.h2ehttp://www.h2e--online.org/tools/chemonline.org/tools/chem--pharm.htmpharm.htm

Warning:Warning: SideSide EffectsEffects CanCan BeBe Severe,Severe, CommonCommon drugsdrugs areare seepingseeping intointo ourour lakes,lakes, fish,fish, andand waterwater supply.supply. MayMay 5,5, 20052005 MilwaukeeMilwaukee Journal/SentinelJournal/Sentinel

PharmaceuticalsPharmaceuticals inin WaterwaysWaterways RaiseRaise Concern:Concern: EffectEffect onon

Post, July

Wildlife, Humans Questioned. Washington Post, July

23,23, 20052005

Wildlife, Humans Questioned. Washington

onon Post, July Wildlife, Humans Questioned. Washington Post, July 23,23, 20052005 Wildlife, Humans Questioned. Washington
onon Post, July Wildlife, Humans Questioned. Washington Post, July 23,23, 20052005 Wildlife, Humans Questioned. Washington
onon Post, July Wildlife, Humans Questioned. Washington Post, July 23,23, 20052005 Wildlife, Humans Questioned. Washington
USGS USGS Water Water Quality Quality St udy* St udy* FirstFirst nationwidenationwide reconnaissancereconnaissance

USGSUSGS WaterWater QualityQuality Study*Study*

FirstFirst nationwidenationwide reconnaissancereconnaissance ofof occurrenceoccurrence ofof pharmaceuticals,pharmaceuticals, hormones,hormones, otherother organicorganic wastewaterwastewater contaminantscontaminants –– March,March, 20022002 139139 streamsstreams inin 3030 states,states, analyzedanalyzed forfor 9595 differentdifferent OWCsOWCs 8282 ofof thethe 9595 detecteddetected inin atat leastleast oneone samplesample OneOne oror moremore OWCsOWCs foundfound inin 80%80% ofof streamstream samplessamples 13%13% ofof sitessites hadhad moremore thanthan 2020 OWCsOWCs FeatureFeature inin TimeTime Magazine,Magazine, AugustAugust 25,25, 20032003 onon continuingcontinuing researchresearch

Minnesota Study: Found 79 out of 92; 23 were

Minnesota Study: Found 79 out of 92; 23 were

pharmaceuticalspharmaceuticals

Found 79 out of 92; 23 w ere pharmaceuticalspharmaceuticals
Found 79 out of 92; 23 w ere pharmaceuticalspharmaceuticals

*http://toxics.usgs.gov/pubs/OFR*http://toxics.usgs.gov/pubs/OFR--0202--94/index.html94/index.html

*http://toxics.usgs.gov/pubs/OFR*http://toxics.usgs.gov/pubs/OFR -- 0202 -- 94/index.html94/index.html

BelowBelow thethe Dose/ResponseDose/Response Curve:Curve:

EndocrineEndocrine DisruptorsDisruptors

EndocrineEndocrine Disruptors:Disruptors: chemicalschemicals thatthat interfereinterfere withwith thethe normalnormal
EndocrineEndocrine Disruptors:Disruptors: chemicalschemicals thatthat interfereinterfere withwith thethe
normalnormal functionfunction ofof thethe endocrineendocrine systemsystem (glands(glands
includingincluding thyroid,thyroid, adrenals,adrenals, ovaries,ovaries, testicles)testicles)
MimicMimic hormone,hormone, triggertrigger identicalidentical response,response, blockblock aa
hormonehormone
DoDo notnot followfollow thethe normalnormal dose/responsedose/response curvecurve
ActiveActive atat muchmuch lowerlower doses,doses, especiallyespecially inin thethe fetusfetus andand
newbornnewborn
EstradiolsEstradiols,, progesterone,progesterone, testosteronetestosterone
LindaneLindane
LowLow spermsperm counts(50%counts(50% reductionreduction s inc es inc e 1939)1939) InfertilityInfertility
LowLow spermsperm counts(50%counts(50% reductionreduction s inc es inc e 1939)1939) InfertilityInfertility
LowLow spermsperm counts(50%counts(50% reductionreduction s inc es inc e 1939)1939) InfertilityInfertility

LowLow spermsperm counts(50%counts(50% reductionreduction sincesince 1939)1939) InfertilityInfertility GenitalGenital deformitiesdeformities HormonallyHormonally triggeredtriggered humanhuman cancerscancers NeurologicalNeurological disordersdisorders inin childrenchildren

Hyperactivity,Hyperactivity, attentionattention deficitdeficit LoweredLowered IQ,IQ, ragerage reactionreaction

DevelopmentalDevelopmental && reproductivereproductive problemsproblems inin wildlifewildlife

reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org
reproductivereproductive problemsproblems inin wildlifewildlife www.www. ourstolenfutureourstolenfuture .org.org

www.www.ourstolenfutureourstolenfuture.org.org

EffectsEffects ofof PharmaceuticalsPharmaceuticals onon AquaticAquatic OrganismsOrganisms

DrugsDrugs testedtested

ClofibricClofibric acidacid andand naproxennaproxen sodiumsodium atat 10001000 nanogramsnanograms/l/l (1(1 ppb)ppb) andand 100100 nanogramsnanograms/l/l

TestTest waswas toto havehave beenbeen runrun forfor oneone weekweek HadHad toto terminateterminate afterafter 2424 hourshours

ClofibricClofibric acidacid inducedinduced milky,milky, mucousmucous response,response, difficultydifficulty withwith respiration,respiration, severesevere motilitymotility inhibitioninhibition

NaproxenNaproxen effectedeffected behaviorbehavior (slower),(slower), notnot asas dramaticdramatic

(slower), (slower), not not as as dramatic dramatic AlsoAlso examinedexamined genegene expressionexpression

AlsoAlso examinedexamined genegene expressionexpression

dramatic AlsoAlso examinedexamined genegene expressionexpression Courtesy of Rebecc a Klaper, Great Lake s WATER Institute
dramatic AlsoAlso examinedexamined genegene expressionexpression Courtesy of Rebecc a Klaper, Great Lake s WATER Institute
dramatic AlsoAlso examinedexamined genegene expressionexpression Courtesy of Rebecc a Klaper, Great Lake s WATER Institute

Courtesy of Rebecca Klaper, Great Lakes WATER Institute

ImpactImpact onon ExposureExposure toto MultipleMultiple DrugsDrugs onon DaphniaDaphnia

DaphniaDaphnia –– thethe lablab animalanimal forfor waterwater researchresearch TestTest involvedinvolved clofibricclofibric acid,acid, fluoxetinefluoxetine,, erythromycin,erythromycin, triclosantriclosan,, andand trimethoprimtrimethoprim ReproductionReproduction waswas disrupteddisrupted toto varyingvarying degreesdegrees indicatingindicating stressstress onon organismsorganisms MostMost dramaticdramatic effect:effect: significantsignificant increaseincrease

effect:effect: significantsignificant increaseincrease inin mortalitymortality inin combocombo solutionssolutions

inin mortalitymortality inin combocombo solutionssolutions

inin mortalitymortality inin combocombo solutionssolutions Colleen M. Flaherty, Stanley I Dodson. Effects of
inin mortalitymortality inin combocombo solutionssolutions Colleen M. Flaherty, Stanley I Dodson. Effects of
inin mortalitymortality inin combocombo solutionssolutions Colleen M. Flaherty, Stanley I Dodson. Effects of

Colleen M. Flaherty, Stanley I Dodson. Effects of pharmaceuticals on Daphnia

survival, growth, and reproduction. Chemosphere, In

press, 2005.

AreAre WeWe inin Trouble…

OrTrouble…

Or

Not???Not???

InIn thethe absenceabsence ofof definitivedefinitive data,data, thethe argumentargument hashas beenbeen mademade thatthat thethe presencepresence ofof EDCsEDCs,, (including(including butbut notnot limitedlimited toto drugs),drugs), andand otherother drugs,drugs, manymany ofof whichwhich areare notnot EDCsEDCs butbut includeinclude antibiotics,antibiotics, antianti--cholesterolcholesterol products,products, psychoactivespsychoactives,, etc.etc. isis notnot anan issue.issue. InIn thethe absenceabsence ofof definitivedefinitive data,data, othersothers promotepromote thethe PrecautionaryPrecautionary PrinciplePrinciple

ofof definitivedefinitive data,data, othersothers promotepromote thethe PrecautionaryPrecautionary PrinciplePrinciple
ofof definitivedefinitive data,data, othersothers promotepromote thethe PrecautionaryPrecautionary PrinciplePrinciple
"When"When anan activityactivity raisesraises threatsthreats ofof harmharm toto humanhuman healthhealth oror

"When"When anan activityactivity raisesraises threatsthreats ofof harmharm toto humanhuman healthhealth oror thethe environment,environment, precautionaryprecautionary measuresmeasures shouldshould bebe takentaken eveneven ifif somesome causecause andand effecteffect relationshipsrelationships areare notnot fullyfully establishedestablished scientifically."scientifically." WingspreadWingspread Conference,Conference, Racine,Racine, WIWI 19981998

scientifically."scientifically." WingspreadWingspread Conference,Conference, Racine,Racine, WIWI 19981998
scientifically."scientifically." WingspreadWingspread Conference,Conference, Racine,Racine, WIWI 19981998

EPAEPA ConferenceConference onon PharmaceuticalsPharmaceuticals inin thethe EnvironmentEnvironment

FirstFirst everever conferenceconference ofof thisthis nature,nature, heldheld AugustAugust

2323 rdrd 2525 thth

ExposureExposure ResearchResearch LabLab MultipleMultiple researchresearch reportsreports onon thethe ocurrenceocurrence ofof commoncommon drugsdrugs inin surface,surface, groundground andand drinkingdrinking waterwater

,, 20052005 inin LasLas Vegas,Vegas, EPAEPA NationalNational

MultipleMultiple stakeholdersstakeholders inin attendance,attendance, includingincluding EPA,EPA, DEA,DEA, PhARMAPhARMA,, VeteransVeterans AdministrationAdministration

(Pharmacy, Safety), academia, private industry

(Pharmacy, Safety), academia, private industry

explored explored methods, methods, etc. etc.
explored
explored
methods,
methods, etc.
etc.

Developed priority action items to be

Developed priority action items to be

involving regulatory changes, voluntary take--

involving regulatory changes, voluntary take

take -- involving regulatory changes, voluntary take back programs, better research back programs, better research
take -- involving regulatory changes, voluntary take back programs, better research back programs, better research

back programs, better research

back programs, better research

HospitalsHospitals forfor aa HealthyHealthy EnvironmentEnvironment

or a a Healthy Healthy E n viro nment E n vir onment EnhancedEnhanced focu s

EnhancedEnhanced focusfocus onon hazardoushazardous wastewaste andand pharmaceuticalpharmaceutical wastewaste

http://www.h2ehttp://www.h2e--online.org/tools/chemonline.org/tools/chem--hwm.htmhwm.htm http://www.h2ehttp://www.h2e--online.org/tools/chemonline.org/tools/chem--pharm.htmpharm.htm

EPAEPA grantgrant toto H2EH2E toto developdevelop aa pharmaceuticalpharmaceutical wastewaste managementmanagement blueprintblueprint EPAEPA grantgrant toto H2EH2E toto traintrain JCAHOJCAHO inspectorsinspectors

onon environmentalenvironmental issuesissues www.h2ewww.h2e--online.orgonline.org
onon environmentalenvironmental issuesissues
www.h2ewww.h2e--online.orgonline.org
O JCAH O in spectors in spectors onon environmentalenvironmental issuesissues www.h2ewww.h2e--online.orgonline.org
HealthcareHealthcare EnvironmentalEnvironmental Res o urce Res o urce CenterCenter FundedFunded byby EPAEPA

HealthcareHealthcare EnvironmentalEnvironmental ResourceResource CenterCenter FundedFunded byby EPAEPA OfficeOffice ofof EnEnforcementforcement andand ComplianceCompliance AssistanceAssistance andand H2EH2E LaunchedLaunched inin April,April, 20052005 EnvironmentalEnvironmental ComplianceCompliance andand ImprovementImprovement GuideGuide

“To“To improveimprove compliancecompliance withwith JCAHOJCAHO EnvironmentEnvironment ofof CareCare Standards”Standards” http://www.http://www.hercenterhercenter.org/.org/regsandstandardsregsandstandards//jcahointrojcahointro.html.html

HazardousHazardous wastewaste determinationdetermination

http://www.http://www.hercenterhercenter.org/hazmat/.org/hazmat/hazdetermhazdeterm.html.html

atio n http://www. http://www. hercenter hercenter .org/haz mat/ .org/haz mat/ ha zdet erm ha zdet erm
atio n http://www. http://www. hercenter hercenter .org/haz mat/ .org/haz mat/ ha zdet erm ha zdet erm
Inc re a sin g In cre a sin g U S E P A
Inc re a sin g In cre a sin g U S E P A

IncreasingIncreasing USEPAUSEPA RegulatoryRegulatory ActivityActivity

EPAEPA RegionRegion 22 (NY,(NY, NJ,NJ, PuertoPuerto Rico,Rico, VI)VI) contactedcontacted 480480 hospitalshospitals inin 2003;2003; RxRx wastewaste included.included. RegionRegion 22 Website:Website:

http://www.http://www.epaepa govgov/region02/healthcare//region02/healthcare/

NorthNorth ShoreShore UniversityUniversity Hospital,Hospital, Manhasset,Manhasset, NYNY finedfined $40,000$40,000 (July(July 2003)2003)

http://www.http://www.epaepa govgov/Region2/news/2003/03066./Region2/news/2003/03066.htmhtm

NassauNassau UniversityUniversity MedicalMedical Center,Center, EastEast Meadow,Meadow, NYNY finedfined $279,900$279,900 (Oct.(Oct. 2003)2003)

http://www.http://www.epaepa govgov/region2/news/2003/03127./region2/news/2003/03127.htmhtm

MountainsideMountainside Hospital,Hospital, MontclMontclair,air, NJNJ finedfined $64,349$64,349 (Nov.(Nov.

2003)2003)

http://www.epa.gov/Regiohttp://www.epa.gov/Region2/news/2003/03139.htmn2/news/2003/03139.htm

. go v/Regio n2/news/2003/03139.htm n2/news/2003/03139.htm York , , NY, NY, Memorial Sloan Kettering Canc er Center,
York , , NY, NY,
York
, , NY,
NY,

Memorial Sloan Kettering Cancer Center, New

Memorial Sloan Kettering Cancer Center, New York

finedfined $214,420$214,420

Canc er Center, New York finedfined $214,420$214,420 • • http://www.epa.gov/region http://www.epa.gov/region

http://www.epa.gov/regionhttp://www.epa.gov/region02/news/2004/04008.htm02/news/2004/04008.htm

RegionRegion IIII StatementStatement

“Hospitals“Hospitals andand healthcarehealthcare facilitiesfacilities mustmust considerconsider thethe properproper handlinghandling ofof hazardoushazardous wastewaste anan integralintegral partpart ofof theirtheir mandatesmandates toto protectprotect people'speople's health,”health,” saidsaid JaneJane M.M. Kenny,Kenny, EPAEPA RegionalRegional Administrator.Administrator.

“Chemotherapy“Chemotherapy wastewaste isis anan especiallyespecially toxictoxic wastewaste producedproduced byby manymany medicalmedical facilities.facilities. HazardousHazardous wastewaste regulationsregulations areare inin placeplace toto helphelp toto ensureensure thatthat

Kettering do not release these or

facilitiesfacilities likelike SloanSloan--Kettering do not release these or

likelike SloanSloan -- Kettering do not release these or otherother toxictoxic chemicalschemicals intointo thethe

otherother toxictoxic chemicalschemicals intointo thethe environment.”environment.”

Kettering do not release these or otherother toxictoxic chemicalschemicals intointo thethe environment.”environment.”

RegionRegion II ActivityActivity

EPAEPA RegionRegion 11 NewNew EnglandEngland contaccontactedted 250250 hospitalshospitals inin April,April, 20042004 Website:Website: http://www.epa.gov/NE/phttp://www.epa.gov/NE/pr/2004/apr/040407.htmlr/2004/apr/040407.html

EnforcementEnforcement initiativeinitiative inin NewNew EnglandEngland H2EH2E grants:grants: PharmaceuticalPharmaceutical WasteWaste andand JCAHOJCAHO inspectorinspector trainingtraining

grant s: P harmaceutical P harmaceutical Waste Waste and and JCAHO JCAHO inspector inspector training training

VeteransVeterans AdministrationAdministration Hospital,Hospital, WhiteWhite River,River, Vermont,Vermont, AugustAugust 55 thth ,,

20052005

CitedCited andand finedfined $372,254$372,254 forfor hazhazardousardous wastewaste violationsviolations LargestLargest finefine issuedissued toto aa federalfederal facilityfacility byby RegionRegion II

Largest fin e fi ne is sued is sued to to a a federal federal facility

“It“It isis criticalcritical thatthat allall federalfederal facilitiesfacilities whichwhich useuse oror generatgeneratee hazardoushazardous wastes,wastes, includingincluding VAVA hospitals,hospitals, complycomply withwith lawslaws designeddesigned toto protectprotect publicpublic healthealthh andand thethe environment,”environment,” saidsaid RobRobertert W.W. Varney,Varney, regionalregional administratoradministrator ofof EPA’sEPA’s NewNew EnglandEngland regionalregional office.office. "The"The properproper storagestorage andand handlinghandling ofof hazardoushazardous wasteswastes reareallylly translatestranslates toto ensuringensuring protectiprotectionon forfor people,people, forfor thethe environmenenvironmentt andand

forfor property."property."

onon forfor people,people, forfor thethe environmenenvironmen tt andand forfor property."property."
onon forfor people,people, forfor thethe environmenenvironmen tt andand forfor property."property."
onon forfor people,people, forfor thethe environmenenvironmen tt andand forfor property."property."

IncreasingIncreasing StateState RegulatoryRegulatory ActivityActivity

FloridaFlorida Hospitals,Hospitals, drugdrug wholesalers,wholesalers, andand reversereverse distributorsdistributors auditedaudited andand finedfined inin thethe pastpast severalseveral yearsyears WashingtonWashington StateState ManagingManaging PharmaceuticalPharmaceutical WasteWaste website:website:

http://www.http://www.ecyecy wawa govgov/programs//programs/hwtrhwtr/pharmaceuticals/index.ht/pharmaceuticals/index.ht mlml OfferedOffered pharmaceuticalpharmaceutical wastewaste trainingtraining programprogram October,October, 20032003 CaliforniaCalifornia ManagementManagement ofof PharmaceuticalPharmaceutical MedicalMedical Waste,Waste, October,October, 20022002 MemoMemo onon sewersewer disposaldisposal ofof drugs,drugs, September,September, 20032003 TriTri--TACTAC MinnesotaMinnesota

20032003 TriTri -- TACTAC MinnesotaMinnesota • • • • • • EnforcementEnforcement beganbegan

• EnforcementEnforcement beganbegan JulyJuly 1,1, 20052005

Offered pharmaceutical waste training program, October, 2003

Offered pharmaceutical waste training program, October, 2003

Offered pharmaceutical waste training program, October, 2003 Inspections Inspections began began summer summer of 2004

Inspections Inspections began began summer summer

of 2004 of 2004
of 2004
of 2004
pharmaceutical waste training program, October, 2003 Inspections Inspections began began summer summer of 2004 of 2004
New New Initiatives Initiatives at at JCAHO JCAHO AddingAdding healthcarehealthcare engineersengineers toto

NewNew InitiativesInitiatives atat JCAHOJCAHO

AddingAdding healthcarehealthcare engineersengineers toto surveysurvey teamsteams BeginningBeginning toto askask questionsquestions aboutabout wastewaste disposaldisposal H2EH2E trainingtraining JCAHOJCAHO surveyorssurveyors onon

environmentalenvironmental issuesissues

disposaldisposal H2EH2E trainingtraining JCAHOJCAHO surveyorssurveyors onon environmentalenvironmental issuesissues
disposaldisposal H2EH2E trainingtraining JCAHOJCAHO surveyorssurveyors onon environmentalenvironmental issuesissues

RelationshipRelationship toto JCAHOJCAHO Standards:Standards:

MedicationMedication ManagementManagement

StandardStandard MM.4.80MM.4.80

MedicationsMedications returnedreturned toto thethe pharmacypharmacy areare appropriatelyappropriately managed.managed.

ElementsElements ofof PerformancePerformance MM.4.80MM.4.80

3.3. TheThe organizationorganization hashas aa processprocess inin placeplace

that addresses how outside sources, if any,

that addresses how outside sources, if any,

are used for destruction

are used for destruction

addresses how outside sources, if any, are used for destruction are used for destruction of medications.
addresses how outside sources, if any, are used for destruction are used for destruction of medications.
addresses how outside sources, if any, are used for destruction are used for destruction of medications.

of medications.

of medications.

RelationshipRelationship toto JCAHOJCAHO Standards:Standards:

EnvironmentEnvironment ofof CareCare

StandardStandard EC.3.10EC.3.10

TheThe organizationorganization managesmanages itsits hahazardouszardous materialsmaterials andand wastewaste[1][1] risks.risks.

[1][1] HazardousHazardous materialsmaterials (HAZMAT)(HAZMAT) andand wastes.wastes. MaterialsMaterials whosewhose handling,handling, use,use, andand storagestorage areare guidedguided oror regulatedregulated byby local,local, stastate,te, oror federalfederal regulation.regulation. ExamplesExamples includeinclude OSHA’sOSHA’s RegulationsRegulations forfor BloodborneBloodborne PathogensPathogens (regarding(regarding thethe blood,blood, otherother infectiousinfectious materials,materials, contaminatedcontaminated itemsitems whicwhichh wouldwould releaserelease bloodblood oror otherother infectiousinfectious materials,materials, oror contcontaminatedaminated sharps),sharps), thethe NuclearNuclear RegulatoryRegulatory Commission'sCommission's regulatiregulationsons forfor handlinghandling andand disposaldisposal ofof

radioactive waste, management of hazardous vapors (such as

radioactive waste, management of hazardous vapors (such as

glutaraldehydeglutaraldehyde,, ethyleneethylene oxide,oxide, andand nitrousnitrous oxide),oxide),

regulated by the EPA, Department of Transportation

regulated by the EPA, Department of Transportation

chemicalschemicals example, example,
chemicalschemicals
example,
example,
of Transportation chemicalschemicals example, example, requirementsrequirements , , and hazardous energy and

requirementsrequirements, , and hazardous energy

and hazardous energy

, , and hazardous energy and hazardous energy sources (for sources (for ionizingionizing oror nonnon --

sources (for

sources (for

energy and hazardous energy sources (for sources (for ionizingionizing oror nonnon -- ionizing radiation, lasers,

ionizingionizing oror nonnon--ionizing radiation, lasers, microwaves, and

ultrasound.)ultrasound.)

ionizing radiation, lasers, microwaves, and

RelationshipRelationship toto JCAHOJCAHO Standards:Standards:

EnvironmentEnvironment ofof CareCare

RationaleRationale forfor EC.3.10EC.3.10 OrganizationsOrganizations mustmust identifyidentify materialsmaterials theythey useuse thatthat needneed specialspecial handlinghandling andand implementimplement processesprocesses toto minimizeminimize thethe risksrisks ofof theirtheir unsafeunsafe useuse andand improperimproper disposal.disposal.

toto minimizeminimize thethe risksrisks ofof theirtheir unsafeunsafe useuse andand improperimproper disposal.disposal.
toto minimizeminimize thethe risksrisks ofof theirtheir unsafeunsafe useuse andand improperimproper disposal.disposal.

RelationshipRelationship toto JCAHOJCAHO Standards:Standards:

EnvironmentEnvironment ofof CareCare

ElementsElements ofof PerformancePerformance forfor EC.3.10EC.3.10 1.1. TheThe organizationorganization developsdevelops andand maintainsmaintains aa writtenwritten managementmanagement planplan describingdescribing thethe processesprocesses itit implementsimplements toto effectivelyeffectively managemanage hazardoushazardous materialsmaterials andand wastes.wastes.

2.2. TheThe organizationorganization createscreates andand maintainsmaintains anan inventoryinventory thatthat identifiesidentifies hazardoushazardous materialsmaterials andand wastewaste used,used, stored,stored, oror generatedgenerated usingusing criteriacriteria

consistent with applicable law and regulation (for

consistent with applicable law and regulation (for

Health Health
Health
Health

example, the Environmental Protection Agency

example, the Environmental Protection Agency

[EPA] and the Occupational Safety and

[EPA] and the Occupational Safety and

[EPA] and the Occupational Safety and [EPA] and the Occupational Safety and AdministrationAdministration [OSHA]).[OSHA]).
[EPA] and the Occupational Safety and [EPA] and the Occupational Safety and AdministrationAdministration [OSHA]).[OSHA]).

AdministrationAdministration [OSHA]).[OSHA]).

RelationshipRelationship toto JCAHOJCAHO Standards:Standards:

EnvironmentEnvironment ofof CareCare

ElementsElements ofof PerformancePerformance forfor EC.3.10EC.3.10

3.3. TheThe organizationorganization establishesestablishes andand implementsimplements processesprocesses forfor selecting,selecting, handling,handling, storing,storing, transporting,transporting, using,using, andand disposingdisposing ofof hazardoushazardous materialsmaterials andand wastewaste fromfrom receiptreceipt oror generationgeneration throughthrough useuse and/orand/or finalfinal disposal,disposal, includingincluding managingmanaging thethe following:following:

ChemicalsChemicals ChemotherapeuticChemotherapeutic materialsmaterials RadioactiveRadioactive materialsmaterials

sharpssharps SeeSee alsoalso 4.4. throughthrough 1010

sharpssharps SeeSee alsoalso 4.4. throughthrough 1010 including including Infectious and regulated medical
sharpssharps SeeSee alsoalso 4.4. throughthrough 1010 including including Infectious and regulated medical
sharpssharps SeeSee alsoalso 4.4. throughthrough 1010 including including Infectious and regulated medical
including including
including
including

Infectious and regulated medical wastes,

Infectious and regulated medical wastes,

NIOSH NIOSH Hazardous Hazardous Dru g Dru g A lert Alert NationalNational InstitutesInstitutes ofof

NIOSHNIOSH HazardousHazardous DrugDrug AlertAlert

NationalNational InstitutesInstitutes ofof OccupationalOccupational SafetySafety && HealthHealth NonNon--enforcementenforcement armarm ofof OSHA,OSHA, administeredadministered underunder CentersCenters forfor DiseaseDisease ControlControl (CDC)(CDC) HazardousHazardous DrugDrug WorkWork GroupGroup metmet forfor 44 yearsyears

RecentlyRecently releasedreleased comprehensivecomprehensive newnew guidelinesguidelines forfor totaltotal lifelife cyclecycle managementmanagement ofof OSHAOSHA “Hazardous“Hazardous Drug”Drug”

Identifies “hazardous waste” and need for Identifies “hazardous waste” and need for appropriateappropriate
Identifies “hazardous waste” and need for
Identifies “hazardous waste” and need for
appropriateappropriate disposaldisposal
hazdrughazdrug//

http://www.http://www.cdccdc govgov//nioshniosh/topics//topics/

FluoresceinFluorescein StudyStudy

ConductedConducted atat MDMD AndersonAnderson CancerCancer CenterCenter PerformedPerformed withwith fluorescentfluorescent dyedye InspectedInspected withwith UVUV lightlight EvaluatedEvaluated contaminationcontamination duringduring

DrugDrug reconstitutionreconstitution DrugDrug transfertransfer DrugDrug administrationadministration

duringduring DrugDrug reconstitutionreconstitution DrugDrug transfertransfer DrugDrug administrationadministration
duringduring DrugDrug reconstitutionreconstitution DrugDrug transfertransfer DrugDrug administrationadministration

DrugDrug ReconstitutionReconstitution withwith NeedleNeedle andand SyringeSyringe

Drug Drug Reconstitution Reconstitution with with Needle Needle and and Syringe Syringe
Drug Drug Reconstitution Reconstitution with with Needle Needle and and Syringe Syringe
Drug Drug Reconstitution Reconstitution with with Needle Needle and and Syringe Syringe

DrugDrug PreparationPreparation withwith ClosedClosed SystemSystem

Drug Drug Preparation Preparation with with Closed Closed System System
Drug Drug Preparation Preparation with with Closed Closed System System
Drug Drug Preparation Preparation with with Closed Closed System System

UsingUsing thethe PhaSealPhaSeal ClosedClosed TransferTransfer SystemSystem

the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp
the the PhaSeal PhaSeal Cl os ed Cl os ed Transfer Transfer System System http://www.phaseal.com/siteUS/default.asp

http://www.phaseal.com/siteUS/default.asp

Chemo Chemo Deco ntam ination Deco nta mination CleanClean workwork surfacessurfaces withwith anan a ppropriate

ChemoChemo DecontaminationDecontamination

CleanClean workwork surfacessurfaces withwith anan appropriateappropriate

deactivationdeactivation (if(if available)available) andand cleaningcleaning agentagent beforebefore andand afterafter eacheach activity,activity, atat thethe endend ofof thethe workdayworkday DecontaminationDecontamination shouldshould bebe donedone withwith sodiumsodium hypochloritehypochlorite followedfollowed byby sodiumsodium thiosulfatethiosulfate toto deactivatedeactivate thethe chemochemo agent.agent. SurfaceSafeSurfaceSafe offersoffers aa convenientconvenient towelettetowelette systemsystem ((http://www.supergen.com/subpages/products/prhttp://www.supergen.com/subpages/products/pr oducts.aspoducts.asp))

Dispose of trace contaminated items

Dispose of trace contaminated items

yellow/whiteyellow/white chemochemo containercontainer

contami nated items Dispose of trace contami nated items yellow/whiteyellow/white chemochemo containercontainer in in
contami nated items Dispose of trace contami nated items yellow/whiteyellow/white chemochemo containercontainer in in
contami nated items Dispose of trace contami nated items yellow/whiteyellow/white chemochemo containercontainer in in

in in

contami nated items Dispose of trace contami nated items yellow/whiteyellow/white chemochemo containercontainer in in

HowHow isis PharmaceuticalPharmaceutical WasteWaste GeneratedGenerated atat thethe HealthcareHealthcare Facility?Facility?

IVIV PreparationPreparation GeneralGeneral CompoundingCompounding Spills/BreakageSpills/Breakage PartiallyPartially UsedUsed VialsVials PartiallyPartially UsedUsed Syringes/IVsSyringes/IVs IfIf Contaminated,Contaminated, BiohazardousBiohazardous Discontinued,Discontinued, UnusedUnused PreparationsPreparations

UnusedUnused RepacksRepacks (Unit(Unit Dose)Dose) Patients’Patients’ PersonalPersonal MedicationsMedications

Patients’Patients’ PersonalPersonal MedicationsMedications OutdatedOutdated PharmaceuticalsPharmaceuticals
Patients’Patients’ PersonalPersonal MedicationsMedications OutdatedOutdated PharmaceuticalsPharmaceuticals
Patients’Patients’ PersonalPersonal MedicationsMedications OutdatedOutdated PharmaceuticalsPharmaceuticals
Patients’Patients’ PersonalPersonal MedicationsMedications OutdatedOutdated PharmaceuticalsPharmaceuticals

OutdatedOutdated PharmaceuticalsPharmaceuticals

Patients’Patients’ PersonalPersonal MedicationsMedications OutdatedOutdated PharmaceuticalsPharmaceuticals

WhenWhen isis anan OutdatedOutdated DrugDrug aa Waste?Waste?

AtAt thethe timetime andand placeplace thethe decisiondecision isis mademade toto discarddiscard itit TwoTwo EPAEPA guidanceguidance lettersletters toto thethe industry:industry:

MerckMerck && Co.,Co., 19811981 BFIBFI Pharmaceutical,Pharmaceutical, 19911991 Note:Note: TheseThese lettersletters areare beingbeing revisitedrevisited byby EPAEPA andand states.states.

EnablesEnables shippingshipping ofof potentiallypotentially creditablecreditable outdatesoutdates toto aa reversereverse distributordistributor asas productproduct PROHIBITSPROHIBITS thethe shippingshipping ofof wastewaste--likelike items,items, suchsuch asas

unused IVs, partial vials, expired repacks, samples

unused IVs, partial vials, expired repacks, samples

samples unused IVs, partial vials, expired repacks, samples Hospital is responsible for doi ng due diligence

Hospital is responsible for doing due diligence

Hospital is responsible for doing due diligence

diligence Hospital is responsible for doi ng due diligence in the selection of a reverse distributor

in the selection of a reverse distributor

in the selection of a reverse distributor

responsible for doi ng due diligence in the selection of a reverse distributor in the selection
responsible for doi ng due diligence in the selection of a reverse distributor in the selection

WhereWhere isis PharmaceuticalPharmaceutical WasteWaste Generated?Generated?

Pharmacy/SatellitesPharmacy/Satellites PatientPatient CareCare UnitsUnits ER/ORER/OR ICU/CCU/NICUICU/CCU/NICU Oncology/HematologyOncology/Hematology andand otherother outpatientoutpatient clinicsclinics LongLong TermTerm CareCare FacilitiesFacilities HomeHome HealthHealth CareCare ServicesServices

clinicsclinics LongLong TermTerm CareCare FacilitiesFacilities HomeHome HealthHealth CareCare ServicesServices
clinicsclinics LongLong TermTerm CareCare FacilitiesFacilities HomeHome HealthHealth CareCare ServicesServices

WhatWhat DepartmentsDepartments GetGet InvolvedInvolved inin GeneratingGenerating andand ManagingManaging PharmaceuticalPharmaceutical Waste?Waste?

PharmacyPharmacy NursingNursing InfectionInfection ControlControl EnvironmentalEnvironmental ServicesServices SafetySafety FacilityFacility ManagementManagement RiskRisk ManagementManagement

PurchasingPurchasing

SafetySafety FacilityFacility ManagementManagement RiskRisk ManagementManagement PurchasingPurchasing
SafetySafety FacilityFacility ManagementManagement RiskRisk ManagementManagement PurchasingPurchasing
SafetySafety FacilityFacility ManagementManagement RiskRisk ManagementManagement PurchasingPurchasing

EverythingEverything YouYou NEVERNEVER WantedWanted toto

KnowKnow AboutAbout Incinerators… Incinerators…

MunicipalMunicipal IncineratorIncinerator

PermittedPermitted toto burnburn municipalmunicipal “garbage”“garbage” UsuallyUsually notnot permittedpermitted
PermittedPermitted toto burnburn municipalmunicipal “garbage”“garbage”
UsuallyUsually notnot permittedpermitted toto handlehandle infectiousinfectious
wastewaste
MayMay bebe permittedpermitted toto handlehandle nonnon--hazardoushazardous
pharmaceuticals,pharmaceuticals, withwith certaincertain volumevolume
restrictionsrestrictions

RegulatedRegulated MedicalMedical (Infectious)(Infectious) WasteWaste IncineratorsIncinerators

PermittedPermitted byby USEPAUSEPA andand thethe statestate toto acceptaccept pathologypathology waste,waste, redred bagbag andand redred sharpssharps waste,waste, tracetrace chemochemo wastewaste MayMay bebe permittedpermitted toto acceptaccept nonnon--hazardoushazardous pharmaceuticalpharmaceutical wastewaste RegulatedRegulated underunder thethe CleanClean AirAir ActAct LowerLower temperature,temperature, lessless controlscontrols thanthan TSDFTSDF AshAsh disposeddisposed ofof inin aa municipalmunicipal (non(non--hazardous)hazardous)

inin aa municipalmunicipal (non(non --hazardous)hazardous) landfill;landfill; maymay oror maymay notnot bebe linedlined

landfill;landfill; maymay oror maymay notnot bebe linedlined

inin aa municipalmunicipal (non(non --hazardous)hazardous) landfill;landfill; maymay oror maymay notnot bebe linedlined
inin aa municipalmunicipal (non(non --hazardous)hazardous) landfill;landfill; maymay oror maymay notnot bebe linedlined
inin aa municipalmunicipal (non(non --hazardous)hazardous) landfill;landfill; maymay oror maymay notnot bebe linedlined

HazardousHazardous WasteWaste IncineratorsIncinerators

PermittedPermitted byby USEPA,USEPA, knownknown asas aa Treatment,Treatment,

StorageStorage andand DisposalDisposal FacilityFacility (TSDF)(TSDF) HighHigh temperature,temperature, molecularmolecular bondsbonds brokenbroken

PollutantsPollutants scrubbed,scrubbed, emitsemits onlyonly waterwater vapor,vapor, ashash storedstored inin aa lined,lined, hazardoushazardous wastewaste landfilllandfill

AuthorizedAuthorized toto acceptaccept thethe “worst“worst ofof thethe worst”worst” hazardoushazardous chemicals,chemicals, shippedshipped onon aa 55--partpart manifestmanifest Examples:Examples:

CleanClean HarborsHarbors HeritageHeritage OnyxOnyx TerisTeris

partpart manifestmanifest Examples:Examples: CleanClean HarborsHarbors HeritageHeritage OnyxOnyx TerisTeris
partpart manifestmanifest Examples:Examples: CleanClean HarborsHarbors HeritageHeritage OnyxOnyx TerisTeris

RCRA:RCRA:

TheThe DefiningDefining RegulationRegulation

ResourceResource ConservationConservation && RecoveryRecovery ActAct EnactedEnacted inin 1976,1976, enforcedenforced byby thethe EPAEPA FederalFederal regulationregulation ofof thethe disposaldisposal ofof solidsolid wasteswastes EncouragesEncourages thethe minimizationminimization ofof wastewaste generationgeneration DefinesDefines “hazardous“hazardous waste”waste” “Cradle“Cradle toto Grave”Grave” trackingtracking ofof hazardoushazardous wastewaste

HouseholdsHouseholds areare exemptexempt

toto Grave”Grave” trackingtracking ofof hazardoushazardous wastewaste HouseholdsHouseholds areare exemptexempt
toto Grave”Grave” trackingtracking ofof hazardoushazardous wastewaste HouseholdsHouseholds areare exemptexempt
toto Grave”Grave” trackingtracking ofof hazardoushazardous wastewaste HouseholdsHouseholds areare exemptexempt
toto Grave”Grave” trackingtracking ofof hazardoushazardous wastewaste HouseholdsHouseholds areare exemptexempt

RCRARCRA RiskRisk ManagementManagement && LiabilityLiability

CivilCivil andand criminalcriminal liabilityliability

Civil:Civil: State/USEPAState/USEPA enforcementenforcement Criminal:Criminal: FBI,FBI, ChiefChief State’sState’s Atty.,Atty., GrandGrand JuryJury

CorporateCorporate fines:fines: upup toto $100,000$100,000 perper violationviolation perper dayday PersonalPersonal liability:liability: finesfines and/orand/or imprisonmentimprisonment

NoNo statutestatute ofof limitationslimitations (civil)(civil)

NoNo statutestatute ofof limitationslimitations (civil)(civil) ManagersManagers upup throughthrough CEOCEO
NoNo statutestatute ofof limitationslimitations (civil)(civil) ManagersManagers upup throughthrough CEOCEO
NoNo statutestatute ofof limitationslimitations (civil)(civil) ManagersManagers upup throughthrough CEOCEO

ManagersManagers upup throughthrough CEOCEO

NoNo statutestatute ofof limitationslimitations (civil)(civil) ManagersManagers upup throughthrough CEOCEO

WhichWhich DiscardedDiscarded DrugsDrugs BecomeBecome HazardousHazardous Waste?Waste?

PP--listedlisted chemicalschemicals SoleSole activeactive ingredientingredient UU--listedlisted chemicalschemicals
PP--listedlisted chemicalschemicals
SoleSole activeactive ingredientingredient
UU--listedlisted chemicalschemicals
SoleSole activeactive ingredientingredient
CharacteristicCharacteristic ofof hazardoushazardous wastewaste
IgnitabilityIgnitability
ToxicityToxicity
CorrosivityCorrosivity
ReactivityReactivity

HazardousHazardous WasteWaste SegregationSegregation CanCan bebe FUN!FUN!

MixMix andand MatchMatch opportunityopportunity toto applyapply hazardoushazardous wastewaste informationinformation toto realreal lifelife simulationssimulations KeepKeep anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS

anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS
anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS
anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS
anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS
anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS
anan eyeeye outout forfor thethe “All“All SeeingSeeing Eye”Eye” WatchWatch forfor BOLDEDBOLDED ITEMSITEMS
Examples Examples of of P P - - Listed Listed Pharmaceutical Pharmaceutical Waste Waste Arsenic
Examples Examples of of P P - - Listed Listed Pharmaceutical Pharmaceutical Waste Waste Arsenic
Examples Examples of of P P - - Listed Listed Pharmaceutical Pharmaceutical Waste Waste Arsenic

ExamplesExamples ofof PP--ListedListed PharmaceuticalPharmaceutical WasteWaste

ArsenicArsenic trioxidetrioxide

P012P012

EpinephrineEpinephrine

P042P042

NicotineNicotine

P075P075

Nitroglycerin*Nitroglycerin*

P081P081

PhenterminePhentermine (CIV)(CIV)

P046P046

PhysostigminePhysostigmine

P204P204

PhysostigminePhysostigmine SalicylateSalicylate

P188P188

WarfarinWarfarin >0.3%>0.3%

P001P001

CT, planned CT, planned
CT, planned
CT, planned

*Excluded *Excluded from from the the P P list list federally; federally; not not yet yet in in forfor 20062006

planned *Excluded *Excluded from from the the P P list list federally; federally; not not yet
Examples Examples of of P P - - Listed Listed Pharmaceuticals Pharmaceuticals

ExamplesExamples ofof PP--ListedListed PharmaceuticalsPharmaceuticals

Examples Examples of of P P - - Listed Listed Pharmaceuticals Pharmaceuticals
Examples Examples of of P P - - Listed Listed Pharmaceuticals Pharmaceuticals
Examples Examples of of U U - - listed listed Pharmaceutical Pharmaceutical Waste Waste ChloralChloral
Examples Examples of of U U - - listed listed Pharmaceutical Pharmaceutical Waste Waste ChloralChloral
Examples Examples of of U U - - listed listed Pharmaceutical Pharmaceutical Waste Waste ChloralChloral

ExamplesExamples ofof UU--listedlisted PharmaceuticalPharmaceutical WasteWaste

ChloralChloral Hydrate(CIV)Hydrate(CIV) ChlorambucilChlorambucil CyclophosphamideCyclophosphamide DaunomycinDaunomycin DiethylstilbestrolDiethylstilbestrol MelphalanMelphalan MitomycinMitomycin CC

U034U034

U035U035

U058U058

U059U059

U089U089

U150U150

U010U010

StreptozotocinStreptozotocin

U206U206

LindaneLindane

U129U129

SaccharinSaccharin

U202U202

SeleniumSelenium SulfideSulfide U205U205

UracilUracil MustardMustard

U237U237

Warfarin<0.3%Warfarin<0.3%

U248U248

U205U205 Uracil Uracil Mustard Mustard U237 U237 Warfarin<0.3% Warfarin<0.3% U248 U248
U205U205 Uracil Uracil Mustard Mustard U237 U237 Warfarin<0.3% Warfarin<0.3% U248 U248

Examples of U-Listed Pharmaceuticals

Examples of U-Listed Pharmaceuticals
Examples of U-Listed Pharmaceuticals
Examples of U-Listed Pharmaceuticals
Examples of U-Listed Pharmaceuticals

ChemotherapyChemotherapy WasteWaste SummarySummary

EightEight chemotherapychemotherapy agentsagents areare UU--listed;listed; oneone isis PP--listedlisted MedicalMedical wastewaste haulerhauler protocolsprotocols forfor “Chemo“Chemo Waste”Waste” EmptyEmpty vials,vials, syringes,syringes, IV’sIV’s TreatedTreated asas infectiousinfectious medicalmedical wastewaste preferablypreferably throughthrough regulatedregulated medicalmedical wastewaste incinerationincineration

If not empty, should be placed into

If not empty, should be placed into

HazardousHazardous WasteWaste containercontainer

If not empty, should be placed into If not empty, should be placed into HazardousHazardous WasteWaste
If not empty, should be placed into If not empty, should be placed into HazardousHazardous WasteWaste
If not empty, should be placed into If not empty, should be placed into HazardousHazardous WasteWaste

DefinitionDefinition ofof “Empty”“Empty”

• Definition Definition of of “Empty” “Empty” “P”“P” ListList ContainersContainers ofof
• Definition Definition of of “Empty” “Empty” “P”“P” ListList ContainersContainers ofof

“P”“P” ListList ContainersContainers ofof “P”“P” listedlisted chemicalschemicals areare consideredconsidered hazardoushazardous waste,waste, unlessunless theythey havehave beenbeen rinsedrinsed threethree timestimes andand thethe rinsaterinsate discardeddiscarded asas hazardoushazardous waste.waste. “U”“U” ListList ContainersContainers ofof “U”“U” listedlisted chemicalschemicals areare emptyempty onlyonly whenwhen AllAll contentscontents removedremoved thatthat cancan bebe removedremoved throughthrough normalnormal meansmeans

bebe removedremoved throughthrough normalnormal meansmeans And no more than 3% by weight remains And no more

And no more than 3% by weight remains

And no more than 3% by weight remains

throughthrough normalnormal meansmeans And no more than 3% by weight remains And no more than 3%
throughthrough normalnormal meansmeans And no more than 3% by weight remains And no more than 3%
throughthrough normalnormal meansmeans And no more than 3% by weight remains And no more than 3%
Characteristic Characteristic of of Ignitability Ignitability AqueousAqueous SolutionSolution containingcontaining

CharacteristicCharacteristic ofof IgnitabilityIgnitability

AqueousAqueous SolutionSolution containingcontaining 24%24% alcoholalcohol oror moremore byby volumevolume && flashflash point<140°point<140° F.F. HazardousHazardous WasteWaste Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections

Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections
Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections
Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections
Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections
Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections
Number:Number: D001D001 RubbingRubbing AlcoholAlcohol TopicalTopical PreparationPreparation InjectionsInjections
Characteristic Characteristic of of Corrosivity Corrosivity AnAn aqueousaqueous solutionsolution havinghaving aa pHpH
Characteristic Characteristic of of Corrosivity Corrosivity AnAn aqueousaqueous solutionsolution havinghaving aa pHpH

CharacteristicCharacteristic ofof CorrosivityCorrosivity

AnAn aqueousaqueous solutionsolution havinghaving aa pHpH << oror == 22 oror >> oror == toto 12.512.5 Examples:Examples: PrimarilyPrimarily compoundingcompounding chemicalschemicals

GlacialGlacial AceticAcetic AcidAcid SodiumSodium HydroxideHydroxide

HazardousHazardous wastewaste number:number: D002D002

AceticAcetic AcidAcid SodiumSodium HydroxideHydroxide HazardousHazardous wastewaste number:number: D002D002
AceticAcetic AcidAcid SodiumSodium HydroxideHydroxide HazardousHazardous wastewaste number:number: D002D002
Characteristic Characteristic of of Toxicity Toxicity ApproximatelyApproximately 4040 chemicalschemicals whichwhich

CharacteristicCharacteristic ofof ToxicityToxicity

ApproximatelyApproximately 4040 chemicalschemicals whichwhich meetmeet specificspecific leachingleaching concentrationsconcentrations ExamplesExamples ofof potentialpotential toxictoxic pharmaceuticals:pharmaceuticals:

ArsenicArsenic BariumBarium CadmiumCadmium ChloroformChloroform

ChromiumChromium SilverSilver LindaneLindane

mm--CresolCresol MercuryMercury (thimerosal)(thimerosal) ((phenylmercuricphenylmercuric acetate)acetate) SeleniumSelenium

CresolCresol MercuryMercury (thimerosal)(thimerosal) ((phenylmercuricphenylmercuric acetate)acetate) SeleniumSelenium
CresolCresol MercuryMercury (thimerosal)(thimerosal) ((phenylmercuricphenylmercuric acetate)acetate) SeleniumSelenium

Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity

Preservatives: thimerosal & m-cresol
Preservatives: thimerosal
&
m-cresol
the Characteristic of Toxicity Preservatives: thimerosal & m-cresol Heavy Metals: Selenium, Chromium and Silver

Heavy Metals: Selenium, Chromium and Silver

Characteristic Characteristic of of Reactivity Reactivity MeetMeet eighteight separateseparate criteriacriteria

CharacteristicCharacteristic ofof ReactivityReactivity

MeetMeet eighteight separateseparate criteriacriteria identifyingidentifying certaincertain explosiveexplosive andand wwaterater reactivereactive wasteswastes

NitroglycerinNitroglycerin formulationsformulations maymay bebe consideredconsidered excludedexcluded federallyfederally fromfrom thethe P081P081 listinglisting asas nonnon--reactivereactive asas ofof AugustAugust 14,14, 20012001 underunder FR:FR: MayMay 16,16, 2001,2001, unlessunless theythey exexhibithibit anotheranother characteristics,characteristics, ssuchuch asas ignitability.ignitability.

ConnecticutConnecticut hashas notnot yetyet adoptedadopted ththee federalfederal exemption,exemption, butbut willwill bebe doingdoing soso inin 2006.2006. NitroglycerinNitroglycerin mustmust continuecontinue toto bebe managedmanaged asas PP listedlisted hazardoushazardous waste.waste. SomeSome preparationspreparations areare alsoalso ignitable,ignitable, whichwhich takestakes precedenceprecedence forfor packingpacking purposes.purposes.

HazardousHazardous WasteWaste NumberNumber forfor reactivesreactives:: D003D003

packing packing purposes. purposes. HazardousHazardous WasteWaste NumberNumber forfor reactivesreactives :: D003D003
packing packing purposes. purposes. HazardousHazardous WasteWaste NumberNumber forfor reactivesreactives :: D003D003
packing packing purposes. purposes. HazardousHazardous WasteWaste NumberNumber forfor reactivesreactives :: D003D003
Hazardous Hazardous Waste Waste Generation Generation Status Status in in CT CT LargeLarge QuantityQuantity
Hazardous Hazardous Waste Waste Generation Generation Status Status in in CT CT LargeLarge QuantityQuantity
Hazardous Hazardous Waste Waste Generation Generation Status Status in in CT CT LargeLarge QuantityQuantity

HazardousHazardous WasteWaste GenerationGeneration StatusStatus inin CTCT

LargeLarge QuantityQuantity GeneratorGenerator (LQG):(LQG): (1)(1) generatesgenerates moremore thanthan 10001000 kg/monthkg/month ofof hazardoushazardous wastewaste oror >1>1 kg/monthkg/month “P”“P” listedlisted waste,waste, OROR (2)(2) accumulatesaccumulates moremore thanthan 10001000 kgkg ofof hazardoushazardous wastewaste atat anyany oneone time.time. SmallSmall QuantityQuantity GeneratorGenerator (SQG):Generates(SQG):Generates <1000<1000 kg/monthkg/month butbut >100>100 kg/monthkg/month ofof hazardoushazardous wastewaste && << oror == 11 kg/monthkg/month “P”“P” listedlisted waste.waste. ConditionallyConditionally ExemptExempt SmallSmall QuantityQuantity GeneratorGenerator (CESQG):(CESQG): GeneratesGenerates << oror == 100100 kgkg hazhaz

waste/month,waste/month, << oror == 1kg1kg “P”“P” listedlisted waste/monthwaste/month

100100 kgkg hazhaz waste/month,waste/month, << oror == 1kg1kg “P”“P” listedlisted waste/monthwaste/month
100100 kgkg hazhaz waste/month,waste/month, << oror == 1kg1kg “P”“P” listedlisted waste/monthwaste/month

ImpactImpact ofof PP--listedlisted WasteWaste onon GeneratorGenerator StatusStatus

OnlyOnly 11 kgkg oror 2.22.2 pounds/monthpounds/month causecause facilityfacility toto becomebecome aa largelarge quantityquantity generatorgenerator

WeightsWeights ofof PP--listedlisted drugdrug wastewaste mustmust bebe combinedcombined withwith anyany otherother PP--listedlisted wastewaste generatedgenerated atat thethe facilityfacility inin aa givengiven monthmonth

Technically,Technically, containerscontainers thatthat havehave heldheld PP--listedlisted wasteswastes areare notnot “RCRA“RCRA empty”empty” unlessunless theythey areare tripletriple rinsedrinsed andand thethe rinsaterinsate discardeddiscarded asas hazardoushazardous

Exception: EPA Hotline guidance exempts used epinephrine

Exception: EPA Hotline guidance exempts used epinephrine

waste waste
waste
waste
EPA Hotline guidance exempts used epinephrine waste waste syringes which can be discarded as infectious syringes

syringes which can be discarded as infectious

syringes which can be discarded as infectious

used epinephrine waste waste syringes which can be discarded as infectious syringes which can be discarded

DocumentingDocumenting GeneratorGenerator StatusStatus

LargeLarge quantityquantity generator:generator: nono needneed toto recordrecord PP wastewaste separately.separately. SmallSmall oror conditionallyconditionally exemptexempt smallsmall quantityquantity generator:generator: needneed toto segregatesegregate allall PP--listedlisted includingincluding emptyempty containerscontainers andand documentdocument weightsweights perper calendarcalendar monthmonth CannotCannot exceedexceed 11 kgkg oror 2.22.2 lbs/monthlbs/month forfor anyany givengiven monthmonth

monthmonth CannotCannot exceedexceed 11 kgkg oror 2.22.2 lbs/monthlbs/month forfor anyany givengiven monthmonth
monthmonth CannotCannot exceedexceed 11 kgkg oror 2.22.2 lbs/monthlbs/month forfor anyany givengiven monthmonth

WhereWhere areare WasteWaste DrugsDrugs GoingGoing Today?Today?

SewerSewer SystemSystem Unused,Unused, partialpartial IVs,IVs, includingincluding antibioticsantibiotics CompoundingCompounding residuesresidues LiquidsLiquids RedRed InfectiousInfectious WasteWaste SharpsSharps Containers,Containers, BagsBags

Yellow or White Chemotherapy Sharps

Yellow or White Chemotherapy Sharps

Containers,Containers, BagsBags

or White Chemotherapy Sharps Containers,Containers, BagsBags ???? ???? Hazardous Waste Containers Hazardous Waste
or White Chemotherapy Sharps Containers,Containers, BagsBags ???? ???? Hazardous Waste Containers Hazardous Waste
???? ????
????
????

Hazardous Waste Containers

Hazardous Waste Containers

White Chemotherapy Sharps Containers,Containers, BagsBags ???? ???? Hazardous Waste Containers Hazardous Waste Containers
Hospital Hospital Waste Waste Management: Management: A A World World Unto Unto Itself Itself RedRed

HospitalHospital WasteWaste Management:Management:

AA WorldWorld UntoUnto ItselfItself

RedRed--bag,bag, redred sharps:sharps: infectious,infectious, bloodblood borneborne YellowYellow oror WhiteWhite sharps:sharps: tracetrace chemotherapychemotherapy vialsvials YellowYellow oror WhiteWhite bags:bags: tracetrace chemotherapychemotherapy gowns,gowns, gloves,gloves, goggles,goggles, tubing,tubing, etc.etc. BlackBlack oror DarkDark Blue:Blue: RCRARCRA HazardousHazardous waste:waste: chemicalschemicals (pharmaceuticals)(pharmaceuticals) defineddefined asas hazardoushazardous byby USEPA;USEPA;

WhiteWhite withwith BlueBlue Top:Top: NonNon--hazardoushazardous pharmaceuticalpharmaceutical wastewaste (Best(Best ManagementManagement Practice)Practice)

(Best(Best ManagementManagement Practice)Practice) Drain:Drain: InIn CT,CT, concentratedconcentrated

Drain:Drain: InIn CT,CT, concentratedconcentrated wasteswastes notnot allowedallowed

concentratedconcentrated wasteswastes notnot allowedallowed cause cause DEP permit required to discharge pollutants in
concentratedconcentrated wasteswastes notnot allowedallowed cause cause DEP permit required to discharge pollutants in
concentratedconcentrated wasteswastes notnot allowedallowed cause cause DEP permit required to discharge pollutants in
cause cause
cause
cause

DEP permit required to discharge pollutants in quantities

DEP permit required to discharge pollutants in quantities

that will not adversely affect POTW/

that will not adversely affect POTW/

pollution.pollution.

RedRed BagBag WasteWaste

Empty IV bags & sets OR canisters Gloves, tubing, related contaminated paraphernalia
Empty IV bags & sets
OR canisters
Gloves, tubing, related
contaminated
paraphernalia

Regulation:

Acronym:

Contents:

Treatment:

Purpose:

CT BMW Regs., RCSA 22a-209-15 Blood Borne Pathogens, OSHA

RMW: Regulated Medical Waste

Pourable, squeezable, flakable, drippable, blood, body fluids (state specific)

Primarily autoclave, microwave

Render materials non-infectious,

non-recognizable (most states)

landfill
landfill

Non-hazardous

Final Disposition:

microwave Render materials non-infectious, non-recognizable (most states) landfill Non-hazardous Final Disposition:
microwave Render materials non-infectious, non-recognizable (most states) landfill Non-hazardous Final Disposition:
microwave Render materials non-infectious, non-recognizable (most states) landfill Non-hazardous Final Disposition:
Red Red Sharps Sharps Waste Waste Regulation: CT BMW Regs., RCSA 22a-209-15 Blood Borne Pathogens,
Red Red Sharps Sharps Waste Waste Regulation: CT BMW Regs., RCSA 22a-209-15 Blood Borne Pathogens,
Red Red Sharps Sharps Waste Waste Regulation: CT BMW Regs., RCSA 22a-209-15 Blood Borne Pathogens,

RedRed SharpsSharps WasteWaste

Regulation:

CT BMW Regs., RCSA 22a-209-15 Blood Borne Pathogens, OSHA

• Syringes/needles • Empty vials • Empty ampules
• Syringes/needles
• Empty vials
• Empty ampules

Acronym:

Contents:

Treatment:

Purpose:

BMW: Biomedical Waste

Pourable, squeezable, flakable blood; Sharps – used/unused (state specific)

Primarily autoclave, microwave

Render materials non-infectious,

non-recognizable (most states)

landfill
landfill

Non-hazardous

Final Disposition:

microwave Render materials non-infectious, non-recognizable (most states) landfill Non-hazardous Final Disposition:
microwave Render materials non-infectious, non-recognizable (most states) landfill Non-hazardous Final Disposition:
microwave Render materials non-infectious, non-recognizable (most states) landfill Non-hazardous Final Disposition:

TraceTrace ChemotherapyChemotherapy WasteWaste

Regulation:

CT BMW Regs., RCSA 22a-209-15

• Empty chemo vials, syringes, IV bags & sets •Blue chemo gowns Chemo gloves, tubing,
• Empty chemo vials,
syringes, IV bags
& sets
•Blue chemo gowns
Chemo gloves,
tubing,
paraphernalia

Acronym:

Contents:

Treatment:

Trace Chemo/BMW

Trace contaminated chemo paraphernalia/RMW

Incineration at an RMW facility

Purpose:

Final Disposition:

Deactivation of chemo; disinfection

Incineration at an RMW facility Purpose: Final Disposition: Deactivation of chemo; disinfection Non-hazardous landfill

Non-hazardous landfill

Incineration at an RMW facility Purpose: Final Disposition: Deactivation of chemo; disinfection Non-hazardous landfill
Incineration at an RMW facility Purpose: Final Disposition: Deactivation of chemo; disinfection Non-hazardous landfill
Incineration at an RMW facility Purpose: Final Disposition: Deactivation of chemo; disinfection Non-hazardous landfill

HazardousHazardous WasteWaste -- ToxicToxic

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

Regulation:

Acronym:

Contents:

Treatment:

Resource Conservation & Recovery Act

RCRA

Toxic Hazardous Waste

Incineration at a RCRA hazardous waste incinerator

Waste Incineration at a RCRA hazardous waste incinerator Purpose: Destroy chemical waste landfill compound entirely

Purpose:

Destroy chemical

waste landfill
waste landfill

compound entirely

hazardous waste incinerator Purpose: Destroy chemical waste landfill compound entirely Final Disposition: Lined hazardous
hazardous waste incinerator Purpose: Destroy chemical waste landfill compound entirely Final Disposition: Lined hazardous

Final Disposition:

hazardous waste incinerator Purpose: Destroy chemical waste landfill compound entirely Final Disposition: Lined hazardous

Lined hazardous

Hazardous Hazardous Waste Waste - - Ignitable Ignitable • D001 Ignitable hazardous RX Regulation: Acronym:

HazardousHazardous WasteWaste -- IgnitableIgnitable

• D001 Ignitable hazardous RX
• D001 Ignitable
hazardous RX

Regulation:

Acronym:

Contents:

Treatment:

Resource Conservation & Recovery Act

RCRA

Ignitable Hazardous Waste

Incineration at a RCRA hazardous waste incinerator

Purpose:

Destroy chemical

hazardous waste landfill
hazardous waste
landfill

compound entirely

hazardous waste incinerator Purpose: Destroy chemical hazardous waste landfill compound entirely Final Disposition: Lined

Final Disposition:

hazardous waste incinerator Purpose: Destroy chemical hazardous waste landfill compound entirely Final Disposition: Lined
hazardous waste incinerator Purpose: Destroy chemical hazardous waste landfill compound entirely Final Disposition: Lined

Lined

New Hazardous Waste Containers

Traditional Chemo Waste Containers

Waste Containers Traditional Chemo Waste Containers Bulk chemo in vials, unused IV’s, P, U. toxic D
Waste Containers Traditional Chemo Waste Containers Bulk chemo in vials, unused IV’s, P, U. toxic D

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

Hospitec

Empty vials, syringes, IVs, tubing, gowns, gloves,etc.

Kendall
Kendall
chemo in vials, unused IV’s, P, U. toxic D Hospitec Empty vials, syringes, IVs, tubing, gowns,
chemo in vials, unused IV’s, P, U. toxic D Hospitec Empty vials, syringes, IVs, tubing, gowns,
chemo in vials, unused IV’s, P, U. toxic D Hospitec Empty vials, syringes, IVs, tubing, gowns,

SewerSewer SystemSystem

Contents of unused, partial IV’s/syringes - Controlled substances - - Salts, dextrose & electrolytes
Contents of unused,
partial IV’s/syringes
- Controlled substances
- - Salts, dextrose
& electrolytes

Regulation:

Acronym:

Contents:

Treatment:

Purpose:

Clean Water Act & RCSA 22a-430

CWA

Wastewaters only (no concentrated wastes)

Pretreatment, then discharge to sewer

Remove solids/pH adjustment, etc.

disposal
disposal

Final Disposition:

Surface water, land

then discharge to sewer Remove solids/pH adjustment, etc. disposal Final Disposition: Surface water, land (sludge)

(sludge)

then discharge to sewer Remove solids/pH adjustment, etc. disposal Final Disposition: Surface water, land (sludge)
then discharge to sewer Remove solids/pH adjustment, etc. disposal Final Disposition: Surface water, land (sludge)

SeweringSewering HazardousHazardous WasteWaste

PermitPermit requiredrequired fromfrom CTCT DEPDEP WaterWater BureauBureau

WillWill requirerequire prepre--treatmenttreatment priorprior toto dischargedischarge toto sewersewer WastewatersWastewaters onlyonly (no(no concentratedconcentrated wastes)wastes)

NotificationNotification ofof locallocal POTWPOTW

4040 CFRCFR 403.12403.12 (p)(p) andand RCSARCSA 22a22a--430430--3(11)(A)3(11)(A) http://www.http://www.gpoaccessgpoaccess govgov//ecfrecfr//

StronglyStrongly discourageddiscouraged atat EPAEPA ConferenceConference

gpoaccess g ov g ov / / ecfr ecfr / / StronglyStrongly discourageddiscouraged atat EPAEPA ConferenceConference
gpoaccess g ov g ov / / ecfr ecfr / / StronglyStrongly discourageddiscouraged atat EPAEPA ConferenceConference
gpoaccess g ov g ov / / ecfr ecfr / / StronglyStrongly discourageddiscouraged atat EPAEPA ConferenceConference

NonNon--HazardousHazardous RxRx WasteWaste

Non Non - - Hazardous Hazardous Rx Rx Waste Waste Regulation: CGS 22a-454 (CT-regulated waste RCSA
Non Non - - Hazardous Hazardous Rx Rx Waste Waste Regulation: CGS 22a-454 (CT-regulated waste RCSA
Non Non - - Hazardous Hazardous Rx Rx Waste Waste Regulation: CGS 22a-454 (CT-regulated waste RCSA

Regulation:

CGS 22a-454 (CT-regulated waste RCSA 22a-209-8 (Special Waste) Non-hazardous Rx

All Rx not RCRA

Non-hazardous Rx
Non-hazardous Rx

Acronym:

Contents:

Treatment:

Disposal at a CT-regulated waste facility or comparable out-of state facility; Disposal or incineration at an approved landfill or

incinerator

and landfilling landfill
and
landfilling
landfill

Purpose:

landfill or incinerator and landfilling landfill Purpose: Prevent drain disposal untreated Final Disposition:

Prevent drain disposal

or incinerator and landfilling landfill Purpose: Prevent drain disposal untreated Final Disposition: Non-hazardous

untreated

Final Disposition:
Final Disposition:
Final Disposition:
Final Disposition:
Final Disposition:
Final Disposition:

Final Disposition:

Final Disposition:
Final Disposition:
Final Disposition:
Final Disposition:
Final Disposition:
Final Disposition: