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The Life and Times of The Life and Times of Managing Hazardous Managing Hazardous Pharmaceutical Waste Pharmaceutical Waste Pamela Hale CPhT, BBA Pamela Hale CPhT, BBA Mercy Health Partners Mercy Health Partners Southwest Ohio Southwest Ohio
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The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Dec 15, 2015

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Page 1: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

The Life and Times of Managing The Life and Times of Managing Hazardous Pharmaceutical Hazardous Pharmaceutical

WasteWaste

Pamela Hale CPhT, BBAPamela Hale CPhT, BBAMercy Health Partners Mercy Health Partners

Southwest OhioSouthwest Ohio

Page 2: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

OverviewOverview

Managing pharmaceutical waste is not new – Managing pharmaceutical waste is not new – neither are the hazardous waste rules.neither are the hazardous waste rules.

Focus has typically been on management of Focus has typically been on management of chemotherapy drugschemotherapy drugs

More recent focus on other types of hazardous More recent focus on other types of hazardous pharmaceutical wastepharmaceutical waste

Regulatory agencies paying more attention to Regulatory agencies paying more attention to hospitals and management of hazardous waste, hospitals and management of hazardous waste, including pharmaceutical wasteincluding pharmaceutical waste

Page 3: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

BackgroundBackground

Why is Mercy concerned about Hazardous Why is Mercy concerned about Hazardous Waste Pharmaceuticals? Waste Pharmaceuticals?

– Hospitals inspected by Ohio EPA’s Division of Hospitals inspected by Ohio EPA’s Division of Hazardous Waste; Notices of Violation for failure to Hazardous Waste; Notices of Violation for failure to properly evaluate and manage hazardous wastes; properly evaluate and manage hazardous wastes; Enforcement Action taken by Ohio EPA – mandated Enforcement Action taken by Ohio EPA – mandated development of a regional Hazardous Waste development of a regional Hazardous Waste Management PlanManagement Plan

– Hazardous Waste Management Plan - the Plan is Hazardous Waste Management Plan - the Plan is designed to ensure proper management of all designed to ensure proper management of all hazardous waste generated at the five Mercy hazardous waste generated at the five Mercy hospitals.hospitals.

Page 4: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.
Page 5: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

ResponsibilitiesResponsibilities

Administration - ensure the Plan is fully Administration - ensure the Plan is fully implemented at all hospitals implemented at all hospitals

Site Safety Officers –oversee Site Safety Officers –oversee implementation of the Plan at their hospital implementation of the Plan at their hospital

Department Managers - implement the Department Managers - implement the Plan as it applies to their department Plan as it applies to their department

Employees – implement the Plan as Employees – implement the Plan as applicable to their specific job duties. applicable to their specific job duties.

Page 6: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

What is a “waste”?What is a “waste”?

If you are unable to use a chemical for its If you are unable to use a chemical for its intended purpose and you plan to throw it intended purpose and you plan to throw it away, it is a waste. away, it is a waste.

Page 7: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

What is a hazardous waste?What is a hazardous waste?

A waste is considered hazardous if:A waste is considered hazardous if:• It is not excluded from regulation under federal It is not excluded from regulation under federal

or state hazardous waste rules and meets one of or state hazardous waste rules and meets one of the following criteria:the following criteria:• It is listed in applicable federal or state hazardous It is listed in applicable federal or state hazardous

waste rules;waste rules;• It exhibits a characteristic of hazardous waste; orIt exhibits a characteristic of hazardous waste; or• It is a mixture of a waste and a hazardous waste.It is a mixture of a waste and a hazardous waste.

Page 8: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Pharmaceutical WastePharmaceutical Waste

Pharmaceutical Waste – How is it generated in Pharmaceutical Waste – How is it generated in hospitals?hospitals?

– IV Preparation IV Preparation – General CompoundingGeneral Compounding– Spills/BreakageSpills/Breakage– Partially Used VialsPartially Used Vials– Partially Used Syringes/IVsPartially Used Syringes/IVs– Discontinued, Unused PreparationsDiscontinued, Unused Preparations– Unused Repacks (Unit Dose)Unused Repacks (Unit Dose)– Patient Personal MedicationsPatient Personal Medications– Outdated PharmaceuticalsOutdated Pharmaceuticals

Page 9: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Characteristics of Hazardous Characteristics of Hazardous WasteWaste

Does the waste exhibit any of the four Does the waste exhibit any of the four characteristics of a hazardous waste?characteristics of a hazardous waste?

o Ignitability – easily combustible or ignitable. Ignitability – easily combustible or ignitable. e.g. – some e.g. – some nitroglycerin vials, erythromycin gel 2%, flexible collodian. nitroglycerin vials, erythromycin gel 2%, flexible collodian.

o Corrosivity – pH < 2 or > 12.5 Corrosivity – pH < 2 or > 12.5 e.g., acetic acid otic, robinul e.g., acetic acid otic, robinul

o Reactivity – unstable or causes violent chemical or physical Reactivity – unstable or causes violent chemical or physical reaction reaction e.g., silver nitrate applicators; cyanide antidote kite.g., silver nitrate applicators; cyanide antidote kit

o Toxicity – contains specific constituents above specific limitsToxicity – contains specific constituents above specific limits

e.g., barium sulfate; m-cresol (insulins); vaccines containing e.g., barium sulfate; m-cresol (insulins); vaccines containing mercury; silver- containing creams or ointmentsmercury; silver- containing creams or ointments

Page 10: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Listed Pharmaceutical WasteListed Pharmaceutical Waste

P-listed pharmaceutical waste is regulated as P-listed pharmaceutical waste is regulated as UNUSED discarded commercial chemical UNUSED discarded commercial chemical products. P-listed waste is “acute” hazardous products. P-listed waste is “acute” hazardous waste.waste.

Examples include:Examples include:

Arsenic trioxideArsenic trioxide P012 P012NicotineNicotine P075 P075Physostigmine SalicylatePhysostigmine Salicylate P188 P188Warfarin Warfarin >>0.3%0.3% P001 P001

Page 11: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Listed Pharmaceutical WasteListed Pharmaceutical Waste

U-listed pharmaceutical waste is regulated as UNUSED discarded commercial chemical productsU-listed pharmaceutical waste is regulated as UNUSED discarded commercial chemical products ..

Acetic Acid Acetic Acid Barium Sulfate Barium Sulfate Chloral Hydrate (CIV) U034 Chloral Hydrate (CIV) U034 Collodion Collodion Cyclophosphamide U058 Cyclophosphamide U058 Dermoplast Dermoplast Dimethyl sulfoxide Dimethyl sulfoxide Eythl alcohol Eythl alcohol Ferric Subsulfate Ferric Subsulfate Influenza Influenza Leukeran Leukeran Measles Vaccine (including MMR) Measles Vaccine (including MMR) Mitomycin CMitomycin C U010 U010 Neomycin/Polymixin/Gramicdin Opth Neomycin/Polymixin/Gramicdin Opth Ocufen Ocufen Phenol Phenol Selenium SulfideSelenium Sulfide U205 U205 Silver Sulfadiazine Silver Sulfadiazine TalcTalcWarfarin <0.3%Warfarin <0.3% U248 U248

Anesthesia Gases (Forane, Suprane, Anesthesia Gases (Forane, Suprane, Ultane)Ultane)BenzoinBenzoinChlorambucilChlorambucil U035 U035 Cortisporin Opth and OticCortisporin Opth and OticCyanideCyanideDiethylstibestrol U089Diethylstibestrol U089Epinephrine (only Epi-pens)Epinephrine (only Epi-pens)Ethyl ChlorideEthyl ChlorideGlycopyrrolateGlycopyrrolateInsulinsInsulinsLindane U129Lindane U129Melphalan U150Melphalan U150MutamycinMutamycinNicotineNicotinePaclitaxelPaclitaxelPhysostigminePhysostigmineSilver NitrateSilver NitrateTetanus Toxoid (including DPT, Adacel)Tetanus Toxoid (including DPT, Adacel)

Page 12: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

What is What is NOTNOT a hazardous waste? a hazardous waste?

Examples:Examples:

IV solutions such as normal saline, dextrose, IV solutions such as normal saline, dextrose, Lactated Ringers solution, electrolytes – these Lactated Ringers solution, electrolytes – these can be placed into sewer and the bag and tubing can be placed into sewer and the bag and tubing placed in regular trash.placed in regular trash.Caps from vialsCaps from vialsOutside baggiesOutside baggiesDrugs not labeled with “black bucket waste” Drugs not labeled with “black bucket waste” stickersstickers

Page 13: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Chemotherapy wasteChemotherapy waste

Trace amounts of chemotherapy waste are Trace amounts of chemotherapy waste are managed in yellow buckets (“TRACE” managed in yellow buckets (“TRACE” means less than the amount that can be means less than the amount that can be pulled into a syringe or the residual that pulled into a syringe or the residual that remains in a completely infused IV bag). remains in a completely infused IV bag).

Bulk amounts of chemotherapy waste Bulk amounts of chemotherapy waste (greater than trace amounts) are managed (greater than trace amounts) are managed as hazardous wasteas hazardous waste

Page 14: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

SyringesSyringes

According to EPA, a syringe is a delivery device, According to EPA, a syringe is a delivery device, not a container.not a container.

Any residue remaining in a syringe in which the Any residue remaining in a syringe in which the proper dose has been administered to a patient proper dose has been administered to a patient is considered to have been used for its intended is considered to have been used for its intended purpose and is not a hazardous waste.purpose and is not a hazardous waste.

Unused syringes (in which a listed drug or drug Unused syringes (in which a listed drug or drug exhibiting a characteristic of hazardous waste exhibiting a characteristic of hazardous waste has not been fully administered to the patient) has not been fully administered to the patient) shall be managed as hazardous waste.shall be managed as hazardous waste.

Page 15: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Empty rule:Empty rule:

Applies to containers such as IV bags and Applies to containers such as IV bags and tubing, bottles, ampules, etc. tubing, bottles, ampules, etc.

““EMPTY” means all the contents have been EMPTY” means all the contents have been removed by normal means (fully administering removed by normal means (fully administering the contents of an IV bag, pulling back all the contents of an IV bag, pulling back all contents of a vial into a syringe). This is same contents of a vial into a syringe). This is same as “trace” – less than the amount that can be as “trace” – less than the amount that can be pulled into a syringe or the residual that remains pulled into a syringe or the residual that remains in a completely infused IV bag and tubing.in a completely infused IV bag and tubing.

Page 16: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Regular TrashRegular Trash

EMPTY IV bags and tubing, bottles or EMPTY IV bags and tubing, bottles or other container. “EMPTY” means all the other container. “EMPTY” means all the content have been removed by normal content have been removed by normal means (fully administering the contents of means (fully administering the contents of an IV bag, pulling back all contents of a an IV bag, pulling back all contents of a vial into a syringe). vial into a syringe).

Page 17: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Disposing of Pharmaceutical wasteDisposing of Pharmaceutical waste

Yellow BucketYellow Bucket

Trace chemotherapy waste (includes IV Trace chemotherapy waste (includes IV bags, tubing, syringes, gloves, supplies bags, tubing, syringes, gloves, supplies used to administer chemotherapy drugs). used to administer chemotherapy drugs). “TRACE” means less than the amount that “TRACE” means less than the amount that can be pulled into a syringe or the residual can be pulled into a syringe or the residual that remains in a completely infused IV that remains in a completely infused IV bagbag

Page 18: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Disposing of Pharmaceutical wasteDisposing of Pharmaceutical waste

Sharps ContainerSharps Container

Empty syringes of medications. “EMPTY” Empty syringes of medications. “EMPTY” means the dose has been fully means the dose has been fully administered to the patient. administered to the patient.

Page 19: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Disposing of Pharmaceutical wasteDisposing of Pharmaceutical waste

Black Bucket (Hazardous Waste) Black Bucket (Hazardous Waste) PHYSOSTAGMINE SALICYLATE AND COUMADIN IV PHYSOSTAGMINE SALICYLATE AND COUMADIN IV VIALS - EMPTY OR FULL.VIALS - EMPTY OR FULL.All partially filled vials, IV bags, bottles or other All partially filled vials, IV bags, bottles or other containers. containers. Partially filled syringesPartially filled syringesBulk chemotherapy – includes incomplete chemotherapy Bulk chemotherapy – includes incomplete chemotherapy infusions, syringes containing unused chemotherapy infusions, syringes containing unused chemotherapy drug, and all items used in cleanup of chemotherapy drug, and all items used in cleanup of chemotherapy drug spills.drug spills.PPE and other items contaminated from cleanup of spills PPE and other items contaminated from cleanup of spills involving hazardous waste drugs. involving hazardous waste drugs.

Page 20: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Disposing of Pharmaceutical wasteDisposing of Pharmaceutical waste

White Bucket (Hazardous Waste) White Bucket (Hazardous Waste) All Black Bucket waste that is also All Black Bucket waste that is also considered infectious waste this includes considered infectious waste this includes partially filled vials, IV bags, bottles or partially filled vials, IV bags, bottles or other containersother containers

Page 21: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Disposing of Pharmaceutical wasteDisposing of Pharmaceutical waste

Specific Wastes not mentioned:Specific Wastes not mentioned:

– Nicotine – USED nicotine gum and patches Nicotine – USED nicotine gum and patches are NOT hazardous waste. Place used are NOT hazardous waste. Place used nicotine patches, gum and wrappers in nicotine patches, gum and wrappers in regular trash. regular trash.

Page 22: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Specific Wastes not mentionedSpecific Wastes not mentioned

Pharmacy will provide Nursing personnel Pharmacy will provide Nursing personnel with information (label) to assist with with information (label) to assist with proper designation for drugs that are proper designation for drugs that are dispensed to the nursing units.dispensed to the nursing units.Black buckets will be available in med Black buckets will be available in med rooms on patient care unitsrooms on patient care unitsEnvironmental Services will pick up Environmental Services will pick up buckets when full for transportation to buckets when full for transportation to hazardous waste holding area.hazardous waste holding area.

Page 23: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

Pharmaceutical Waste For questions regarding what to discard where contact Pharmacy

For replacement of buckets please contact Housekeeping

e

All HazardousPharmaceutical Waste

Will have the following label:

Black Bucket Waste includes:•Bulk amounts of chemo

•All drugs with the “Black Bucket Waste” label

•Any bag, bottle or container that is labeled as “BLACK BUCKET WASTE”

•Contaminated items from cleanup of spills involving hazardous

waste drugs

Partially used syringes go inWhite Bucket

BLACK BUCKET WASTE

Yellow Bucket: •Trace Chemo

Sharps Container:•All used empty syringes

Sewer System:•Narcotics (Controlled Substances)

Dispose via the sewer systemwith authorized witness.

• IV solutions such as NS, LR,Electrolytes

Regular Trash:•Non labeled IV tubing and bags

(after removing pt. label)•USED nicotine patches & gum

White bucketUnused/Partially used Syringes with Black

Bucket label

Page 24: The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio.

QuestionsQuestions