the proper place for pharmacy waste keeping pharmaceuticals out of our waterways

The Proper Place for The Proper Place for Pharmacy WastePharmacy Waste

Keeping pharmaceuticals out Keeping pharmaceuticals out of our waterwaysof our waterways

www.sbeap.org 800-578-8898www.sbeap.org 800-578-8898 22

K-State’s Pollution Prevention K-State’s Pollution Prevention Institute (PPI)Institute (PPI)• PPI staff operate Small Business PPI staff operate Small Business

Environmental Assistance Environmental Assistance Program or SBEAP Program or SBEAP

• Program services are Program services are – Site visitsSite visits– HotlineHotline– WorkshopsWorkshops– NewslettersNewsletters– Multimedia Multimedia (cover air permits, haz waste, (cover air permits, haz waste,

and water regulations, integrating pollution and water regulations, integrating pollution prevention)prevention)

– FreeFree– ConfidentialConfidential

• H2E Champion H2E Champion


Pharmacy waste Pharmacy waste managementmanagement• Supported by Bureau of Water at KDHESupported by Bureau of Water at KDHE

• Target audience is LTC facilitiesTarget audience is LTC facilities

• Research, outreach and technical Research, outreach and technical assistanceassistance– Hotline 800-578-8898Hotline 800-578-8898– Site visitsSite visits

• Seeking professional input for solutionsSeeking professional input for solutions


Web cast objectivesWeb cast objectives

• Understand the environmental impacts Understand the environmental impacts related to pharmacy waste management.related to pharmacy waste management.

• Identify practices that contribute to the Identify practices that contribute to the problem.problem.

• Alternative pharmacy waste Alternative pharmacy waste management requirements and/or the management requirements and/or the best management practices.best management practices.

• Identify available resources related to Identify available resources related to pharmaceutical waste management pharmaceutical waste management questions.questions.


Pharmacy waste management, Pharmacy waste management, an emerging issuean emerging issue

• The water connectionThe water connection– Becky Gagnon-LewisBecky Gagnon-Lewis

• Why is this an issue?Why is this an issue?

• What pharmaceuticals are regulated What pharmaceuticals are regulated RCRARCRA

• Hierarchy of Rx waste managementHierarchy of Rx waste management

• ResourcesResources

• Questions and answersQuestions and answers


Pharmaceuticals – emerging Pharmaceuticals – emerging contaminants in the wastewater contaminants in the wastewater utilityutility

Synthetic or naturally occurring chemicals or microorganisms

Not commonly monitored in the environment

Potential to enter the environment and cause known or suspected adverse ecological and/or human health effects

May be new chemicals OR

Release may have occurred for a long time, but only recently

recognized as a potential problem OR

New use of existing chemicals


• One or more of the following chemicals were found in One or more of the following chemicals were found in over 80% of the streams sampled downstream of over 80% of the streams sampled downstream of WWTPsWWTPs

• 17alpha Ethynyl Estradiol (16%)17alpha Ethynyl Estradiol (16%)

- - Median concentration 73 ng/lMedian concentration 73 ng/l

-(-(Effects at as low as 1 ng/l may result in feminization of male fish)Effects at as low as 1 ng/l may result in feminization of male fish)

• Acetaminophen (24%)Acetaminophen (24%)

• Steroids and hormones (16%)Steroids and hormones (16%)

• Diltiazem (blood pressure medication) (13%)Diltiazem (blood pressure medication) (13%)

• Codeine (11%)Codeine (11%)

• Antibiotics and antimicrobials (10%)Antibiotics and antimicrobials (10%)

• Ibuprofen (10%)Ibuprofen (10%)

Pharmaceuticals, Hormones, and other emerging contaminants study in US Streams Study


Risks associated with pharmaceutical Risks associated with pharmaceutical disposal down the draindisposal down the drain

• Wastewater Plants are biological processes Wastewater Plants are biological processes designed to treat domestic human waste - cannot designed to treat domestic human waste - cannot treat or remove pharmaceutical chemicalstreat or remove pharmaceutical chemicals

• May kill beneficial bacteria responsible for May kill beneficial bacteria responsible for breaking down waste in sewage plants and breaking down waste in sewage plants and damage septic systems; contaminate water and damage septic systems; contaminate water and aquatic life in surrounding environment ORaquatic life in surrounding environment OR

• Pass through the treatment plant and enter the Pass through the treatment plant and enter the receiving stream aquatic environmentreceiving stream aquatic environment


Why should we care?Why should we care?

• Increasing Attention to Emerging Contaminants, Increasing Attention to Emerging Contaminants, particularly pharmaceuticalsparticularly pharmaceuticals– MediaMedia– PublicPublic– Non-Governmental OrganizationsNon-Governmental Organizations

• Potential Impacts to Organisms at low Potential Impacts to Organisms at low concentrationsconcentrations– Persistence in the Environment – BioaccumulationPersistence in the Environment – Bioaccumulation– Chronic ToxicityChronic Toxicity– Endocrine DisruptionEndocrine Disruption

• Regulatory Control?Regulatory Control?


Potential regulatory controlPotential regulatory control

• Pharmaceutical Manufacturers already Pharmaceutical Manufacturers already regulated by EPA Effluent Guidelinesregulated by EPA Effluent Guidelines

• 2008 EPA Effluent Guideline Study2008 EPA Effluent Guideline Study

• Proposed Guidelines may include Proposed Guidelines may include discharge restrictions for Health care discharge restrictions for Health care facilitiesfacilities

http://www.epa.gov/EPA-WATER/2007/October/http://www.epa.gov/EPA-WATER/2007/October/Day-30/w21310.pdfDay-30/w21310.pdf

http://www.epa.gov/EPA-WATER/2007/October/Day-30/w21310.pdf

http://www.epa.gov/EPA-WATER/2007/October/Day-30/w21310.pdf


What is the concern?What is the concern?

• Drugs are designed to be biologically Drugs are designed to be biologically activeactive

• Life-long trace level exposuresLife-long trace level exposures

• Impact on aquatic lifeImpact on aquatic life

• Exposure (minute concentration) Exposure (minute concentration) through our drinking water sourcesthrough our drinking water sources

• Action: prevention…is keyAction: prevention…is key


Never down the drainNever down the drain


What practices are harmful?What practices are harmful?

• Any drain disposal practices need to Any drain disposal practices need to be eliminatedbe eliminated

• Direct conduit to the our rivers and Direct conduit to the our rivers and water bodieswater bodies

• Eliminate land filling when possibleEliminate land filling when possible

• What about DEA restrictions on What about DEA restrictions on controlled substances?controlled substances?


NEW KDHE GuidanceNEW KDHE Guidance• New technical guidance document at New technical guidance document at

http://www.kdheks.gov/waste/guidance/sw0http://www.kdheks.gov/waste/guidance/sw07-01.pdf7-01.pdf – For residents and non-regulated For residents and non-regulated

hazardous waste generators, like nursing hazardous waste generators, like nursing homeshomes

– Hospital are generally regulated under Hospital are generally regulated under RCRARCRA

• KS Board of pharmacy has similar KS Board of pharmacy has similar guidance on their Web site at guidance on their Web site at http://www.kansas.gov/pharmacy/faq.htmlhttp://www.kansas.gov/pharmacy/faq.html

http://www.kdheks.gov/waste/guidance/sw07-01.pdf

http://www.kdheks.gov/waste/guidance/sw07-01.pdf

http://www.kansas.gov/pharmacy/faq.html


Waste management Waste management hierarchyhierarchyNew KDHE guidanceNew KDHE guidance

• Waste minimizationWaste minimization

• Reverse distributionReverse distribution

• Collection events or programsCollection events or programs

• Incineration*Incineration*

• Hazardous waste landfillHazardous waste landfill

• Render non-recoverable and landfillRender non-recoverable and landfill

• Sanitary sewer (last resort option for Sanitary sewer (last resort option for disposal)disposal)


Emerging issue for Emerging issue for healthcarehealthcare• Hospitals, larger sources, just now Hospitals, larger sources, just now

beginning to recognize this as an issuebeginning to recognize this as an issue– EPA is beginning to inspect themEPA is beginning to inspect them– Most are considered regulated under the Most are considered regulated under the

hazardous waste regulations (RCRA)hazardous waste regulations (RCRA)– Hospitals for a Healthy Environment Hospitals for a Healthy Environment

Workshop and Trade Show Workshop and Trade Show •Dec 6, 2007 in KC, Kansas Dec 6, 2007 in KC, Kansas

What types of What types of pharmaceuticals are RCRA pharmaceuticals are RCRA

hazardous or regulated hazardous or regulated wastes?wastes?

The reason we administer these The reason we administer these drugs in controlled measures, is drugs in controlled measures, is

the same reason we need to the same reason we need to managed them carefully when managed them carefully when

discardeddiscarded


What is RCRAWhat is RCRA

• Resource Conservation Recovery ActResource Conservation Recovery Act• Hazardous waste regulationHazardous waste regulation• Generator has cradle to grave Generator has cradle to grave

responsibilityresponsibility• Most LTC facilities do not fall into the Most LTC facilities do not fall into the

regulatory category of generators, so regulatory category of generators, so they have options for land filling RCRA they have options for land filling RCRA wasteswastes– Caution facilities linked to hospitals Caution facilities linked to hospitals


Categories of RCRA Categories of RCRA Hazardous WastesHazardous Wastes• Listed WastesListed Wastes

– U-listed – toxicU-listed – toxic– P-listed - acutely hazardousP-listed - acutely hazardous

• Characteristic WastesCharacteristic Wastes– Specific measurable propertiesSpecific measurable properties

• IgnitableIgnitable

•CorrosiveCorrosive

•ReactiveReactive

•ToxicToxic


P-Listed WastesP-Listed Wastes•P-Listed Wastes P-Listed Wastes – Sole active ingredient Sole active ingredient – Unused – drug has not been given to a patientUnused – drug has not been given to a patient

•Empty ContainersEmpty Containers– Must be triple rinsed to be RCRC emptyMust be triple rinsed to be RCRC empty– Rinsate managed as hazardous wasteRinsate managed as hazardous waste– Rinsing generally not practical for Rinsing generally not practical for

pharmaceutical wastepharmaceutical waste– Generally easier to manage container as Generally easier to manage container as

hazardous wastehazardous waste


Examples of P-Listed Examples of P-Listed Pharmaceutical WastePharmaceutical Waste

• Arsenic trioxideArsenic trioxide P012P012• Epinephrine Epinephrine (non-salts)(non-salts) P042P042• NicotineNicotine P075P075• Nitroglycerin*Nitroglycerin* P081P081• Phentermine (CIV)Phentermine (CIV) P046P046• Physostigmine Physostigmine P204P204• Physostigmine SalicylatePhysostigmine Salicylate P188P188• Warfarin >0.3%Warfarin >0.3% P001P001

* Excluded from the P list federally and in a number of * Excluded from the P list federally and in a number of states if in final dosage forms, including Kansasstates if in final dosage forms, including Kansas


Examples of U-listed Examples of U-listed Pharmaceutical Waste*Pharmaceutical Waste*

• Chloral Hydrate(CIV)Chloral Hydrate(CIV) U034U034

• ChlorambucilChlorambucil ** U035U035

• Cyclophosphamide*Cyclophosphamide* U058U058

• Daunomycin*Daunomycin* U059U059

• Diethylstilbestrol*Diethylstilbestrol* U089U089

• Melphalan*Melphalan* U150U150

• Mitomycin C Mitomycin C ** U010U010

• StreptozotocinStreptozotocin U206U206

• LindaneLindane U129U129

• SaccharinSaccharin U202U202

• Selenium SulfideSelenium Sulfide U205U205

• Uracil Mustard*Uracil Mustard* U237U237

• Warfarin<0.3%Warfarin<0.3% U248U248

*Chemotherapy agents


Characteristic Hazardous Characteristic Hazardous WasteWaste• Ignitable Ignitable

– Aqueous solutions with 24% or more Aqueous solutions with 24% or more alcohol and a flashpoint less than 140°Falcohol and a flashpoint less than 140°F

– Non-aqueous drug formulations with Non-aqueous drug formulations with flashpoint less than 140° F flashpoint less than 140° F

– Strong oxidizers Strong oxidizers •Potassium permanganate and silver nitrate Potassium permanganate and silver nitrate

– Compressed gases Compressed gases


Characteristic Hazardous Characteristic Hazardous WasteWaste• CorrosiveCorrosive

– pH of less than or equal to 2 (highly acidic) pH of less than or equal to 2 (highly acidic) – pH greater than or equal to 12.5 (highly basic)pH greater than or equal to 12.5 (highly basic)

• ReactiveReactive

• ToxicToxic– 10 of the 40 Toxicity Characteristic (TC) 10 of the 40 Toxicity Characteristic (TC)

chemicals and heavy metals are found in drug chemicals and heavy metals are found in drug formulationsformulations

– Silver, barium or other metals compoundsSilver, barium or other metals compounds


Regulated levelsRegulated levels

• Based on monthly waste generationBased on monthly waste generation• P-Listed waste regulated at 2.2 lbs/monthP-Listed waste regulated at 2.2 lbs/month• Others regulated at 55 lbs/monthOthers regulated at 55 lbs/month

• Categories of generators in KSCategories of generators in KS– SQGSQG– KSGKSG– EPAGEPAG


Are long-term care facilities Are long-term care facilities regulated under RCRA?regulated under RCRA?

• Most LTC facilities do not generate Most LTC facilities do not generate enough hazardous waste total to be enough hazardous waste total to be regulated hazardous waste generators. regulated hazardous waste generators.

• Most are non-regulated SQGs.Most are non-regulated SQGs.

• SQG have disposal options SQG have disposal options – Reverse distribution, collection programs, Reverse distribution, collection programs,

the landfill and only as a last resort (with the landfill and only as a last resort (with written approval), the sewer.written approval), the sewer.


SQGs in Sedgwick CountySQGs in Sedgwick County

• Can use the Household Hazardous Can use the Household Hazardous Waste program servicesWaste program services– Contact 316-6607464 in Sedgwick Contact 316-6607464 in Sedgwick

countycounty

• Can not take controlled substancesCan not take controlled substances


Pharm waste regulatorsPharm waste regulators

• KDHE under RCRAKDHE under RCRA– Just detailed regulatory levelJust detailed regulatory level

• Kansas Department on Aging Kansas Department on Aging • Board of PharmacyBoard of Pharmacy

– Concurs with KDHE and DEA guidelinesConcurs with KDHE and DEA guidelines

• Drug Enforcement AgencyDrug Enforcement Agency– Judy Williams, DEA contact for BOPJudy Williams, DEA contact for BOP– 21 CFR 1307.2121 CFR 1307.21


Code of Federal Code of Federal RegulationsRegulations

• DISPOSAL OF CONTROLLED SUBSTANCESDISPOSAL OF CONTROLLED SUBSTANCES • Section 1307.21 Procedure for disposing of Section 1307.21 Procedure for disposing of

controlled substances. controlled substances. • (a) Any person in possession of any controlled substance (a) Any person in possession of any controlled substance

and desiring or required to dispose of such substance may and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for Administration in the area in which the person is located for authority and instructions to dispose of such substance. The authority and instructions to dispose of such substance. The request should be made as follows: request should be made as follows:

• (1) If the person is a registrant, he/she shall list the (1) If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area; or …form to the Special Agent in Charge in his/her area; or …


Can a long term care facility (LTCF) Can a long term care facility (LTCF) return a resident’s unused controlled return a resident’s unused controlled substance medication to a pharmacy?substance medication to a pharmacy?

• Answer: No. There are no provisions in the Controlled Answer: No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-pharmacy) to acquire controlled substances from a non-registrant (i.e., resident of a LTCF). Most long term care registrant (i.e., resident of a LTCF). Most long term care facilities are not licensed by their respective state to facilities are not licensed by their respective state to handle controlled substances and therefore are not handle controlled substances and therefore are not registered with DEA. Long term care facilities act in a registered with DEA. Long term care facilities act in a custodial capacity, holding controlled substances that, custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal laws and belong to the resident of the LTCF. Federal laws and regulations make no provisions for controlled substances regulations make no provisions for controlled substances that have already been dispensed to patients, regardless that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy of the packaging method, to be returned to a pharmacy for further dispensing or disposal.for further dispensing or disposal.

• http://www.deadiversion.usdoj.gov/faq/general.htm#5http://www.deadiversion.usdoj.gov/faq/general.htm#5

http://www.deadiversion.usdoj.gov/faq/general.htm#Pharmacy%20waste%20management,%20an%20emerging%20issue


Can an individual return their Can an individual return their controlled substance prescription controlled substance prescription medication to a pharmacy?medication to a pharmacy?

• Answer: No. An individual patient may not return their unused Answer: No. An individual patient may not return their unused controlled substance prescription medication to the pharmacy. controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to Federal laws and regulations make no provisions for an individual to return their controlled substance prescription medication to a return their controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e. individual acquire controlled substances from a non-registrant (i.e. individual patient).patient).

• The CFR does have a provision for an individual to return their The CFR does have a provision for an individual to return their unused controlled substance medication to the pharmacy in the unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing event of the controlled substance being recalled or a dispensing error has occurred.error has occurred.

• An individual may dispose of their own controlled substance An individual may dispose of their own controlled substance medication without approval from DEA. Medications should be medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled disposed of in such a manner that does not allow for the controlled substances to be easily retrieved.substances to be easily retrieved. In situations where an individual In situations where an individual has expired, a caregiver or hospice staff member may assist the has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance family with the proper disposal of any unused controlled substance medications.medications.


Controlled substances Controlled substances disposaldisposal

• Non-RCRA or KDHE regulatedNon-RCRA or KDHE regulated

• DEA approval of land fill optionDEA approval of land fill option

• BOP approval of land fill optionBOP approval of land fill option

• Kansas Department on AgingKansas Department on Aging


Pharmacy ServicesPharmacy Services

Caryl Gill, RN, BSNCaryl Gill, RN, BSN

Kansas Department on AgingKansas Department on Aging

December 13, 2007December 13, 2007


Pharmacy ServicesPharmacy ServicesCFR 483.60, F425CFR 483.60, F425• Pharmaceutical ServicesPharmaceutical Services• A facility must provide pharmaceutical A facility must provide pharmaceutical

services to meet the needs of each services to meet the needs of each resident.resident.

• What constitutes Pharmaceutical Services What constitutes Pharmaceutical Services • Definition of DispositionDefinition of Disposition• Services of a licensed pharmacistServices of a licensed pharmacist• Procedures addressing the disposition of Procedures addressing the disposition of

medications medications


State RegulationsState Regulations

• Accountability and dispositionAccountability and disposition• KAR 28-39-156 (f)-Nursing FacilitiesKAR 28-39-156 (f)-Nursing Facilities• KAR 28-39-156 (f)(3) Role of the KAR 28-39-156 (f)(3) Role of the

pharmacist-Nursing Facilitiespharmacist-Nursing Facilities• KAR 28-39-247(f)(5)-Assisted Living KAR 28-39-247(f)(5)-Assisted Living

and Residential Health Careand Residential Health Care• KAR 28-39-436 (f)(5)-Home PlusKAR 28-39-436 (f)(5)-Home Plus• KAR 28-39-282(f)(5)-Adult Day CareKAR 28-39-282(f)(5)-Adult Day Care


http://www.kslegislature.org/supplemental/2008/SN2578.pdfhttp://www.kslegislature.org/supplemental/2008/SN2578.pdf


http://www.kansas.gov/pharmacy/Newsletters/March2006.pdfhttp://www.kansas.gov/pharmacy/Newsletters/March2006.pdf


Waste minimization Waste minimization opportunitiesopportunities

• Use return processorsUse return processors

• Ask “what is being wasted?”Ask “what is being wasted?”

• Shelf life > 1 yearShelf life > 1 year

• Minimize samples that might expireMinimize samples that might expire

• Work with doctors and suppliers to Work with doctors and suppliers to control inventory and decrease wastecontrol inventory and decrease waste

• Eliminate drain disposal practicesEliminate drain disposal practices


Spread the word to othersSpread the word to others

• NursesNurses

• Safety committeesSafety committees

• Pharmacy – set policy and trainingPharmacy – set policy and training

• PatientsPatients

• Share guidance or postersShare guidance or posters


ResourcesResources

– HERC pharmacy waste guidance HERC pharmacy waste guidance http://www.hercenter.org/hazmat/pharma.cfmhttp://www.hercenter.org/hazmat/pharma.cfm

– Blue print Blue print http://www.h2e-online.org/docs/h2epharmablueprhttp://www.h2e-online.org/docs/h2epharmablueprint41506.pdfint41506.pdf

– Pharmaceutical waste webpage: Pharmaceutical waste webpage: •http://www.h2e-online.org/hazmat/pharma.htmhttp://www.h2e-online.org/hazmat/pharma.htm

ll

– BOP newsletters - BOP newsletters - http://www.kansas.gov/pharmacy/Newsletters/March2006.phttp://www.kansas.gov/pharmacy/Newsletters/March2006.pdfdf

– Your pharmacist Your pharmacist

http://www.hercenter.org/hazmat/pharma.cfm

http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf

http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf

http://www.h2e-online.org/hazmat/pharma.html

http://www.h2e-online.org/hazmat/pharma.html


Kansas resourceKansas resource

• Pollution Prevention InstitutePollution Prevention Institute• Technical assistanceTechnical assistance

– ConfidentialConfidential– FreeFree

• 800-578-8898 – 800-578-8898 – ask for Nancyask for Nancy

• Question and Answer period – Question and Answer period – operator assistedoperator assisted

the proper place for pharmacy waste keeping pharmaceuticals out of our waterways

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