Pharmaceutical Waste Pharmaceutical Waste ManagementManagement

Leslie Durrant, R.Ph., BCPSLeslie Durrant, R.Ph., BCPS, and Nancy , and Nancy Dietz, R.Ph., Ph.D.Dietz, R.Ph., Ph.D.

Harry S. Truman Memorial Veterans Harry S. Truman Memorial Veterans HospitalHospital

Columbia, MissouriColumbia, Missouri

Harry S Truman Memorial VA Harry S Truman Memorial VA Hospital Columbia, Mo.Hospital Columbia, Mo.

100 Inpatient beds, 30,000 veterans100 Inpatient beds, 30,000 veterans

What is a hazardous drug?What is a hazardous drug? ASHP 2004 TAB criteria for considering a ASHP 2004 TAB criteria for considering a

drug hazardous (adopted by OSHA):drug hazardous (adopted by OSHA):1.1. Carcinogenicity Carcinogenicity 2.2. TeratogenicityTeratogenicity3.3. Fertility impairmentFertility impairment4.4. Serious organ toxicity at low dosesSerious organ toxicity at low doses5.5. GenotoxicityGenotoxicity

NIOSH criteria: 2004: ASHP’s criteria NIOSH criteria: 2004: ASHP’s criteria plusplus““Structure and toxicity profile of new Structure and toxicity profile of new drugs that mimic existing drugs drugs that mimic existing drugs determined hazardous by above criteria.”determined hazardous by above criteria.”

NIOSHNIOSH

Now updating their list of hazardous drugs. Now updating their list of hazardous drugs. 59 proposed additions.59 proposed additions.

Update is controversial: some proposed Update is controversial: some proposed drugs are toxic only after prolonged oral drugs are toxic only after prolonged oral usage such as divalproex, aripiprazole, usage such as divalproex, aripiprazole, amiodarone.amiodarone.

ASHP proposes further study on 40% of ASHP proposes further study on 40% of the proposed drugs before recommending the proposed drugs before recommending handling as “hazardous drugs”. handling as “hazardous drugs”.

Hazardous Drugs:Hazardous Drugs:

Each facility should create its own list Each facility should create its own list of “hazardous drugs” based upon of “hazardous drugs” based upon criteria. NIOSH list may be useful in criteria. NIOSH list may be useful in establishing a hospital list. MSDS, establishing a hospital list. MSDS, literature very helpful.literature very helpful.

Hazardous pharmaceutical Hazardous pharmaceutical WasteWaste

Hazardous pharmaceutical waste is NOT Hazardous pharmaceutical waste is NOT synonymous with hazardous synonymous with hazardous pharmaceuticals. pharmaceuticals.

Some drugs not considered hazardous Some drugs not considered hazardous drugs by NIOSH,OSHA and NIH are still drugs by NIOSH,OSHA and NIH are still regulated as hazardous waste by EPA-regulated as hazardous waste by EPA-RCRA.RCRA.

Some drugs not considered hazardous Some drugs not considered hazardous waste under RCRA are probable waste under RCRA are probable environmental hazards (some chemo).environmental hazards (some chemo).

Pharmaceutical Waste:Pharmaceutical Waste:

Two main types of pharmaceutical Two main types of pharmaceutical waste: hazardous and non-waste: hazardous and non-hazardous.hazardous.

Hazardous wasteHazardous waste as defined by EPA as defined by EPA RCRA is waste with properties RCRA is waste with properties making it dangerous or potentially making it dangerous or potentially harmful to human health or the harmful to human health or the environment, and includes environment, and includes chemicals and drugs. chemicals and drugs.

Hazardous Pharmaceutical Waste Hazardous Pharmaceutical Waste under RCRA:under RCRA:

Two primary ways drug waste is Two primary ways drug waste is hazardous waste under RCRA:hazardous waste under RCRA:

It contains a “P” or “U” listed waste It contains a “P” or “U” listed waste as the sole active ingredient as the sole active ingredient

OROR It exhibits at least one It exhibits at least one

“Characteristic” of a hazardous “Characteristic” of a hazardous waste.waste.

Hazardous Pharmaceutical Waste Hazardous Pharmaceutical Waste under RCRA: under RCRA:

In addition to exhibiting a “characteristic” or In addition to exhibiting a “characteristic” or Listing as a P, or U, “listed” waste, three Listing as a P, or U, “listed” waste, three more requirements:more requirements:

It has not been excluded by federal or It has not been excluded by federal or state law, andstate law, and

It has not been used for its intended It has not been used for its intended purpose, andpurpose, and

The decision has been made to discard it. The decision has been made to discard it.

EPA - RCRA ListingsEPA - RCRA Listings

RCRA, P, U, lists originally developed for RCRA, P, U, lists originally developed for discarded commercial chemical products.discarded commercial chemical products.

Listings only apply to pharmaceuticals that Listings only apply to pharmaceuticals that contain the listed drug as the “sole active contain the listed drug as the “sole active ingredient”. E.g. – pharmaceuticals ingredient”. E.g. – pharmaceuticals flavored by saccharin with other flavored by saccharin with other ingredients added would NOT be ingredients added would NOT be considered hazardous waste under RCRA.considered hazardous waste under RCRA.

P list – Acutely HazardousP list – Acutely Hazardous

NAMENAME EPA HAZ WASTE #EPA HAZ WASTE #

Arsenic trioxideArsenic trioxide P012P012

Epinephrine*Epinephrine* P042P042

NicotineNicotine P075P075

NitroglycerinNitroglycerin** P081P081

PhenterminePhentermine P046P046

PhysostigminePhysostigmine P204P204

Physostigmine Physostigmine salicylatesalicylate

P188P188

Warfarin >0.3%Warfarin >0.3%** P001P001

P Listed waste generation:P Listed waste generation:

Large qty generator: produces more Large qty generator: produces more than 1 Kg (2.2 lbs) per calendar than 1 Kg (2.2 lbs) per calendar month.month.

Small qty generator: < 1 Kg/month.Small qty generator: < 1 Kg/month. Conditionally exempt small quantity.Conditionally exempt small quantity. Most hospitals fall into small or large Most hospitals fall into small or large

quantity generator category.quantity generator category.

To reduce P waste generation:To reduce P waste generation:

Practice waste minimization: Minimize Practice waste minimization: Minimize inventory, “just in time” ordering.inventory, “just in time” ordering.

Purchase unit dose whenever possible on P Purchase unit dose whenever possible on P listed items.listed items.

Repackage minimal amounts at a time.Repackage minimal amounts at a time. Encourage patient to take home Encourage patient to take home

appropriately Rx labeled partial bulk appropriately Rx labeled partial bulk containers.containers.

Nitroglycerin:Nitroglycerin:

NitroglycerinNitroglycerin

Nitroglycerin in finished dosage Nitroglycerin in finished dosage forms is forms is exemptexempt by EPA/RCRA by EPA/RCRA (2001). (2001).

Some states have adopted this Some states have adopted this exemption, including Missouri, Iowa, exemption, including Missouri, Iowa, and Alaska.and Alaska.

Some states, such as Michigan, have Some states, such as Michigan, have chosen not to adopt. Check with your chosen not to adopt. Check with your state. state.

EpinephrineEpinephrine

Epinephrine in syringes:Epinephrine in syringes:

Missouri DNR Hazardous Waste Program: Missouri DNR Hazardous Waste Program: epinephrine in a discarded syringe is not a epinephrine in a discarded syringe is not a P listed waste.P listed waste.

Rationale: once the syringe has been used Rationale: once the syringe has been used for patient care, it has been used for its for patient care, it has been used for its intended purpose. intended purpose.

Applies to partially used epinephrine IV Applies to partially used epinephrine IV admixtures, also per Mo DNR.admixtures, also per Mo DNR.

RCRA: applies to any P or U listed drug in a RCRA: applies to any P or U listed drug in a syringe as waste, after patient use. syringe as waste, after patient use.

Epinephrine in syringes: Epinephrine in syringes:

Epinephine syringes after emergency Epinephine syringes after emergency use (e.g. Code Blue): discard in use (e.g. Code Blue): discard in sharps container.sharps container.

EXPIRED unused epinephrine STILL EXPIRED unused epinephrine STILL considered P listed waste.considered P listed waste.

Warfarin:Warfarin:

Warfarin:Warfarin:

If present in dosage forms over 0.3%, If present in dosage forms over 0.3%, the whole preparation is a “P” listed the whole preparation is a “P” listed pharmaceutical waste pharmaceutical waste when decision when decision is made to waste.is made to waste.

Tablet weighings demonstrated that Tablet weighings demonstrated that all of the common tablet strengths all of the common tablet strengths are >0.3% warfarin, and therefore P are >0.3% warfarin, and therefore P waste when discarded.waste when discarded.

5mg/210mg (tablet weight) = 2.4%5mg/210mg (tablet weight) = 2.4%

Nicotine:Nicotine:

Nicotine:Nicotine:

Patch dosage forms: after patient Patch dosage forms: after patient use, consider “used”? Or “unused”?use, consider “used”? Or “unused”?

Expired unused may be returned to Expired unused may be returned to reverse distributor for credit.reverse distributor for credit.

Patient home disposal not regulated Patient home disposal not regulated by RCRA. by RCRA.

U List – Toxic WastesU List – Toxic Wastes

NAMENAME ## NAMENAME ##

ChlorambucilChlorambucil U035U035 HexachlorophenHexachlorophenee

U132U132

CyclophosphamideCyclophosphamide U058U058 PhenacetinPhenacetin U187U187

DaunomycinDaunomycin U059U059 ReserpineReserpine U200U200

MelphalanMelphalan U150U150 ResorcinolResorcinol U201U201

Mitomycin CMitomycin C U010U010 SaccharinSaccharin U202U202

StreptozocinStreptozocin U206U206 Selenium sulfideSelenium sulfide U205U205

Uracil MustardUracil Mustard U237U237 Warfarin <0.3%Warfarin <0.3% U248U248

DiethylstilbestrolDiethylstilbestrol U089U089

D list: Characteristic wasteD list: Characteristic waste

Waste exhibits one of 4 Waste exhibits one of 4 characteristics of hazardous wastes:characteristics of hazardous wastes:

1. ignitability – 1. ignitability –

2. corrosivity – 2. corrosivity –

3. reactivity -3. reactivity -

4. toxicity – if concentration of 4. toxicity – if concentration of chemical above regulatory level in chemical above regulatory level in mg/L.mg/L.

Characteristic Waste:Characteristic Waste:

The generator (the hospital) is The generator (the hospital) is responsible for deciding if a drug responsible for deciding if a drug product that is being discarded product that is being discarded exhibits a characteristic.exhibits a characteristic.

Decision is based upon testing or Decision is based upon testing or knowledge of the drug product knowledge of the drug product properties. properties.

MSDS, pharmacy references and MSDS, pharmacy references and literature can help determine this.literature can help determine this.

Characteristic waste: ToxicityCharacteristic waste: Toxicity

NAMENAME EPA #EPA # REG.LEVELREG.LEVEL

ArsenicArsenic D004D004 5 mg/L5 mg/L

BariumBarium D005D005 100 mg/L100 mg/L

CadmiumCadmium D006D006 1 mg/L1 mg/L

ChloroformChloroform D022D022 6 mg/L6 mg/L

M-CresolM-Cresol D024D024 200 mg/L200 mg/L

LindaneLindane D013D013 0.4 mg/L0.4 mg/L

MercuryMercury D009D009 0.2 mg/L0.2 mg/L

SilverSilver D011D011 5 mg/L5 mg/L

Toxicity characteristicToxicity characteristic

Mercury: most vaccines reformulated Mercury: most vaccines reformulated and now preservative free.and now preservative free.

Silver: present in silver sulfadiazine Silver: present in silver sulfadiazine cream, silver nitrate sticks.cream, silver nitrate sticks.

Barium: in contrast media. Radiology Barium: in contrast media. Radiology is a satellite accumulation point.is a satellite accumulation point.

ChemotherapyChemotherapy

Only seven chemotherapy drugs on Only seven chemotherapy drugs on the U list. However, RCRA was the U list. However, RCRA was enacted in 1976 and the list has not enacted in 1976 and the list has not been updated since then.been updated since then.

Most hospital consider all cytotoxic Most hospital consider all cytotoxic chemotherapy to be hazardous chemotherapy to be hazardous waste, including our VA hospital. waste, including our VA hospital.

Putting it all together:Putting it all together: Receipt into pharmacyReceipt into pharmacy: As the : As the

medication order received is sorted, medication order received is sorted, medications that could become medications that could become hazardous wastes are placed into hazardous wastes are placed into specially labeled bins:specially labeled bins:

Repackaging:Repackaging: As drugs that could become As drugs that could become

hazardous waste are repackaged, a hazardous waste are repackaged, a code is included on the label for code is included on the label for Nursing notification: ”HW-P list”Nursing notification: ”HW-P list”

Re-packaged drug:Re-packaged drug:

““HW-P List”: text chosen to alert HW-P List”: text chosen to alert Nurse, but not alarm Veteran:Nurse, but not alarm Veteran:

Dispensing:Dispensing:Before dispensing, a drug that couldBefore dispensing, a drug that could

become hazardous waste become hazardous waste

Has the code included on Has the code included on

the barcode label:the barcode label:

Patient discharge:Patient discharge:

Partial bulk medication that could Partial bulk medication that could become hazardous waste, if become hazardous waste, if prescribed at discharge, is re-labeled prescribed at discharge, is re-labeled and given to the patient during and given to the patient during discharge counseling by the discharge counseling by the Pharmacist.Pharmacist.

Reverse DistributorsReverse Distributors

Receive outdated drugs (“products”) Receive outdated drugs (“products”) from pharmacies and ship to from pharmacies and ship to manufacturer for credit. manufacturer for credit.

Outdates not meeting Outdates not meeting manufacturer’s policy become manufacturer’s policy become “waste” once the RD makes the “waste” once the RD makes the decision to discard.decision to discard.

EPA supports this practice as long as EPA supports this practice as long as it is not the sole waste management it is not the sole waste management practice. practice.

Disposal: P,U, or D listed itemsDisposal: P,U, or D listed items

Drug with “P,U”Or “D” Listed

ingredient

Bulk: at dischargeIf ordered,Give to pt.

Expired unused: Reverse

Distributor forcredit

Not suitable For R.D.:“P” ,”U”,

Or “D” bucket

““P” Bucket: Satellite accumulationP” Bucket: Satellite accumulation

P,U, and D buckets:P,U, and D buckets:Satellite accumulation PointSatellite accumulation Point

Pharmacy satellite accumulation Pharmacy satellite accumulation point:point:

Satellite accumulation: List of all Satellite accumulation: List of all contents with dates required:contents with dates required:

Satellite Accumulation:Satellite Accumulation:

Satellite storage up to 1 year before Satellite storage up to 1 year before sending to facility hazardous waste sending to facility hazardous waste storage area, unless > 1 quart of P storage area, unless > 1 quart of P listed or 55 gallons of hazardous listed or 55 gallons of hazardous waste.waste.

Industrial Hygienist utilizes licensed Industrial Hygienist utilizes licensed hazardous waste contractor to pick hazardous waste contractor to pick up from facility hazardous waste up from facility hazardous waste area. area.

Disposal: ChemotherapyDisposal: Chemotherapy

Chemo “U” listed

OR cytotoxicchemo:

Bulk: (>3%),“hazardous

Waste”BULK yellow

Chemo bucket

Trace:(<3%):Empty vials,

Syringes,gowns,

Yellow chemobucket

Chemo sharps:Needles:

Yellow chemobucket

Trace Chemo:Trace Chemo:

Bulk Chemo:Bulk Chemo:

Contains: expired and partially used Contains: expired and partially used vials, IV bags.vials, IV bags.

Grossly contaminated itemsGrossly contaminated items Spill clean up materialSpill clean up material Must label bucket as Must label bucket as

“Chemotherapy” AND “Hazardous “Chemotherapy” AND “Hazardous waste”. Must include names of EACH waste”. Must include names of EACH drug within, and date 1drug within, and date 1stst waste waste placed. Keep closed!placed. Keep closed!

Disposal: non hazardousDisposal: non hazardouspharmaceuticals:pharmaceuticals:

Non-chemoNon-cytotoxic

non-RCRA:

Expired: Reverse

distributor

“plain” IVS:(NS,D5W,LR)Sink disposal

ControlledSubstances:RD licensed

For controlledsubstances

Take home points:Take home points:

Know P, U, and D toxicity lists. Know P, U, and D toxicity lists. Know State law.Know State law. Label all P, U, and D drugs as “HW” Label all P, U, and D drugs as “HW”

all through chain from receipt to final all through chain from receipt to final dispensing or segregation for pickup. dispensing or segregation for pickup.

Implement safe handling practices Implement safe handling practices and policies for hazardous drugs.and policies for hazardous drugs.

Questions?Questions?