Handling Hazardous Drugs Pharmacy Benefits Management Drug Accountability Conference May 13, 2010, San Antonio, TX George Knight, RPh VISN 2 Network Pharmacy.

In Collaboration with Kevin Hartman, CHMMEnvironmental Engineer, Syracuse VAMC

Hazardous Waste Training for Healthcare Workers – What’s Up?The EPA considers some chemicals,

including some drugs, to be hazardous waste when discarded.

Having Addressed the Manufacturing Industry, the EPA is Now Focusing on the Health Care System as the Next Largest Contributing Factor to Environmental Contamination.

Why the Focus on Pharmaceuticals?They are being found in the environment

and in our public water works.

Regulatory emphasis by all levels of the EPA (local, state and federal)

Standards require compliance with regulations; Joint Commission, CAP, CARF …

VA Directive 2003-030 Management of Hazardous Chemicals

CARTOON: “I’m going to prescribe a birth control pill and an antibiotic and a tranquilizer! Or you can drink two quarts of tap water and call me in the morning!”

Potential Problems

Increased Occurrence of CancerUnusual Physiological Processes

(Reproductive Impairment)Antibiotic-Resistant BacteriaAugmented Toxicity of Chemical

Mixtures

How is Pharmaceutical Waste Generated?

IV PreparationGeneral compoundingSpills/breakagePartially used vials/syringesDiscontinued/unused Unused repacks (unit dose)Patient’s personal medicationsOutdated pharmaceuticals

Health Care Facilities Must Follow the Hazardous Waste RegulationsProper IdentificationSegregation & StorageManifesting and TransportingProper Disposal, i.e. Incineration at a

Federally Permitted Incineration Site

Resource Conservation and Recovery Act (RCRA)RCRA Regulates the Disposal of Solid

Wastes Enforced by the EPA and the States

Defines Hazardous Waste and Procedures for Handling and Disposal of Wastes

Most States have a Hazardous Waste Program approved by the EPA

EPA Universal Waste Rule

Proposed Addition of Hazardous Pharmaceutical Waste to the Universal Waste Rule

Streamlined ManagementEncourage Disposal of Non-Hazardous

Pharmaceuticals as Universal WasteFacilitate Collection of Personal

Medications from the PublicMichigan and Florida have done this at

the State Level

Categories of RCRA Hazardous Wastes: P-Listed

Acutely HazardousSole Active Ingredient - UnusedEmpty – Only if Triple RinsedRinse Solution is Hazardous, or ….Manage Un-rinsed Containers as

Hazardous (vials, IV tubing)

Examples of P-Listed WastesArsenic Trioxide (Chemotherapy)Epinephrine (Excluded if in used syringe;

may be discarded as regulated medical waste) ** not EPI salts ** except MN

Nicotine (patch backing but not wrappers)Warfarin > 0.3% (all Rx dosages) Nitroglycerine (Excluded federally and

some states if in final dosage form)Phentermine (1 of 2 Controlled

Substances)

Categories of RCRA Hazardous Wastes: U-ListedToxic - not as disastrous as PSole Active Ingredient - UnusedEmpty Containers

All contents have been removed through normal means and < 3% by weight remains = not hazardous

Residues removed from containers must be managed as hazardous waste

Examples of U-Listed WastesChloral Hydrate (2nd CS)ChlorambucilLindaneWarfarin < 0.3% (all Rx dosages

exceed this percentage)Saccharin

Categories of RCRA Hazardous Wastes: Characteristic (D-Listed)

Pharmaceutical, chemical formulations not on P-List or U-List, which exhibit one or more of the following characteristics:Ignitability (nitroglycerin inj.)Toxicity (M-cresol or thimerosol as preservative; fluvax; reserpine)

CorrosivityReactivity

Examples of D-Listed or Characteristic WastesUsed or Unused, but only when present

in concentrations at or above the indicated RCRA regulatory level:Chloroform – 6.0 mg/LMercury – 0.2 mg/L; contains thimerosol and fails this threshold

Silver – 5.0 mg/L; silver nitrate applicators

Selenium – 1.0 mg/L; Selsun Blue

When is an Outdated Drug a Waste?At the time and place the decision is

made to discard itIf a Reverse Distributor is used and

the decision to discard is made there – we are still the generator of the waste.We can ship creditable outdates to a reverse distributor as product. All non-credit materials must be handled as hazardous waste on-site, once we know they are not creditable. Keep a list.

Uncreditable Items

Manufacturer Product Form

IVAX PHARMACEUTICALS, INC. ALBUTEROL AERO

AMERICAN REGENT LABS, INC. ALCOHOL DEHYDRATED SOL

APLICARE, INC. APLICARE IODOPHOR PVP PREP PAD

BOEHRINGER INGELHEIM ATROVENT AERO

THE PURDUE FREDERICK COMPANY BETADINE OINT

HUMCO COLLODION FLEXIBLE SOL

Pharmacy/Ward Procedures

P-Listed: Use Black ContainerU-Listed: Use Black ContainerD-Listed: Use Black ContainerUnlisted: Use Red Container

Regulated Medical WasteUn-creditable pharmacy returns

Labeling & Education

Black Dot Labeling; U-Listed & Characteristic (D-Listed)

Caution Label; Special Disposal Required P-Listed + containers

Med Cart ContainersListing by LocationDevelop a Comprehensive Facility and

Departmental SOP

Formulary ListCYCLOPHOSPHAMIDE

INJECTION Black Dot Toxic [U058] U-list

CYCLOPHOSPHAMIDE TABLETS Black Dot Toxic [U058] U-list

DAUNORUBICIN INJECTION Black Dot Toxic [U059] U-list

DEXAMETHASONE Black Dot Flammable [D001] Characteristic

DIETHYLSTILBESTROL TAB Black DotToxic [U089-

Diethylstilbestrol] U-list

WARFARIN SODIUM CautionToxic [P001-Warfarin]

Conc. > 0.3% P-list

Chemotherapy Waste (U-Listed)Two waste streams for this waste

are requiredTrace Waste (Yellow chemo containers in Pharmacy)EMPTY vials, syringes, IV bags.Soft waste: gowns, gloves, goggles, tubing and wipes UNLESS overtly contaminated, container holding any amount of free liquid, overtly contaminated garments and spill cleanup kits.

Chemotherapy Waste (U-Listed)

Bulk Waste Containers EMPTY vials, syringes, IV bags. A container holding any amount of free liquid, overtly contaminated garments and spill cleanup kits.

Only style used on the Nursing units

Bulk Chemo = Hazardous WasteUnused/partially used vials, or IV’s; Vials or IV’s with ANY amount of free liquid;

grossly contaminated items; and spill clean up materials

Trace Chemo WasteEmpty vials, syringes, IVs,tubing, gowns, gloves,etc.

Satellite AccumulationGood Idea to

Label as Satellite Accumulation

Must have the words “hazardous waste”

Must have a clear description of the waste

Date not required

Satellite AccumulationSatellite Accumulation

Acetone & methanol

Labeling Requirements(Storage Area)

The words “Hazardous Waste” must be on the container.

Clear description of the waste type must be neatly printed on the label.

Accumulation start date for 90 or 180 day areas.

Generator Status

Large Quantity Generator> 2.2 lbs. “P”> 2200 lbs./mo. non-acute

Small Quantity Generator< 2.2 lbs. “P”< 2200 lbs./mo. non-acute

Additional PointsIncompatible

wastes must be properly segregated.

Weekly inspections are required to be documented for all long term hazardous waste storage areas (90 or 180 day areas).

Additional PointsMust have spill response equipment

& containment equipment in the area

Secondary containment is required to prevent uncontrolled spills

Training requirements for long term storage areasWithin 6 monthsAnnual requirement

"Cradle-to-grave" responsibility

Consequences of Non-ComplianceCompliance

inspectionsFines/penaltiesLicense revokedCriminal citations

Civil actionsImprisonmentCorrective orders

08/18/2009 Department of Veterans Affairs Eastern Kansas Health Care System Civil Penalty $51,501

Department of Veterans Affairs Eastern Kansas Health Care System VA must also spend at least $482,069 on management project.

Recent Example

REGULAR TRASH

• Packaging

• Empty bottles

• Paper

• Plastic

Recycle whenever possible

SEWER SYSTEM

• Non-Haz IV’s (NaCl, D5W)

•User must evaluate if the liquid is or is not a hazardous waste**.

** Other items that our Sewer Use Permit allows

HAZARDOUS WASTE

• P-Listed + Their Containers• U-Listed• Characteristic waste

This waste stream must be properly segregated, labeled and stored. Includes pharmaceutical

wastes

Turn into the Environmental Engineer ext. 12345 for disposal at

a State or Federally Permitted Hazardous Waste Facility

CHEMO WASTE

This stream is divided in two1) Trace Chemo Waste2) Bulk Chemo Waste

1) Trace is sent to a Medical Incinerator

2) Bulk follows the requirements of the Hazardous Waste Stream.

Unused NonHaz Rx

Collected in pharmacy.

Returned for credit through Reverse Distribution.

SHARPS

Empty non-chemo & non-P-listed Ampoules

Empty non-chemo & non-P-listed needle-syringes

Note Federal Exemption for used Epinephrine syringes - treat as a sharp

Managing Our Waste Streams

Vials or IV’s with ANY amount of liquid; Grossly contaminated items; Spill clean up materials.

Bulk Chemo

Pharmaceuticals may not be disposed of down the sink, sewer, or toilets without special permission from the Environmental Engineer and Pharmacy. DEA Controlled Drugs: follow proper protocol for disposal of these items.

Contact Radiation

Safety Officer

Radiation

Paper, Glass,

Plastic,

Metal,

Toner Cartridges,

Batteries,

Newspaper,

Electronics,

Computers,

Furniture

Empty non-chemo & non-

P-listed Ampoules

Empty non-chemo & non-

P-listed syringes

**Note Federal Exemption for

Empty Epinephrine syringes - treat as a

sharp

Bloody Regulated Body Fluids (e.g. joint

fluid)Laboratory

Waste

ANY Unused or partially used Med.

Spill cleanup

aerosol cans

Special attention to: Epinephrine: including empty IV bags, tubing, ampoules, and vials.Nicotine: including wrappers Warfarin: including empty wrappers and containers

Empty vials, syringes, IVs,

tubing, gowns,

gloves, etc.

Contact Environmental

Engineer

Non-haz IV’s (NaCl,

D5W)

**Other items that our Sewer Use Permit

allows**

Packaging

Empty bottles*

Paper

Plastic

Know Where to Throw

Recycling SharpsBio HazardWaste

PharmaceuticalsTrace Chemo Hazardous

WasteSewerTrash

Know Where to Throw

Questions, comments, concerns?Be sure to evaluate your area

Do you have waste that has not been evaluated (cleaning rags, other chemicals, equipment that automatically dumps into the sewer system)?

Do you have ample/proper spill kits?

Do you have proper postings?Emergency contacts, spill plans, exit routes….