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					Pharmaceutical Waste Compliance
      Clinician In-Service
                      Pharmaceutical Waste
                     Why Do We Care About It?

•To comply with Federal, State and Local laws & regulations

•To comply with The Joint Commission standards

•To protect patients & staff

•To protect the environment
                  Regulatory Requirements

Agencies involved in Rx waste regulation:
• Environment Protection Agency (EPA)
   Resource Conservation and Recovery Act (RCRA)
   Missouri Dept of Natural Resources (MODNR)
•Department of Transportation (DOT)
• Drug Enforcement Administration (DEA)
• Publicly Owned Treatment Works (POTW)
• The Joint Commission (TJC)
             Common EPA Inspection Violations

•   Hazardous waste determinations not done or incorrect
•   Labeling of hazardous waste not done or incorrect
•   Throwing HW down the drain
•   Improper disposal of chemotherapy drugs
•   Inadequate training for employees in HW management
•   Not conducting proper weekly inspections of HW storage
•   No or inadequate HW manifests
•   Improper management of expired pharmaceuticals
•   Lack of emergency contingency plan
                                  TJC Accreditation Issues

• MM.01.01.03 - Medication Management
   • The organization safely manages high-alert and hazardous medications.

• EC.02.02.01 - Environment of Care
    • The organization manages risks related to hazardous materials and wastes.

• EM.02.02.05, EP 4 – Emergency Management
   • The organization prepares for how it will manage hazardous materials and

• LD.04.01.01 - Leadership
    • The organization complies with law & regulation.

TJC Standards Information
                Regulatory Summary

• Pharmaceutical waste is a regulatory concern
• Pharmaceuticals are included in EPA/RCRA hazardous waste
• Regulatory oversight by EPA, DOT & POTW
• EPA enforcement activities at hospital level
     As high as $360,000 – plus jail sentence.
           What Happens to Hospital Pharmaceuticals?

– Dispensed to patients

– Returned to manufacturer for credit

– Rx Waste
    No longer used for its intended purpose
   To be discarded
            Examples of Pharmaceutical Waste

Types of Pharmaceutical Waste in Patient Care Areas:
•Partial Rx Vials
•Partial Rx IV’s, or filled IV tubing with meds
•Partial Rx syringes
•Discontinued medicines
•Unadministered medicines
•Patient prescriptions
         Where is Pharmaceutical Waste Generated?

Wherever pharmaceuticals are prepared, used or dispensed
to patients.
 • Hospital Pharmacies (30%)
 • Inpatient and Out-Patient Care Areas (70%)
              Hazardous Versus Non-Hazardous
              Pharmaceutical Waste

EPA Resource Conservation & Recovery Act (RCRA), 1976

 • Characteristic Hazardous Waste
     Toxic, corrosive, reactive or ignitable

 • Commercial Chemical (Listed) Hazardous Waste
     P Listed - Acutely Hazardous (Nicotine, Warfarin)
     U Listed - Toxic (Chemo)

 • Non-Hazardous Waste
                          Types of Pharmaceutical Waste

Pharmaceutical Waste        Characteristic Hazardous   RMW –
• Partial vials             • Insulin                  Non-Hazardous
• Un-dispensed,             • Toradol                  • Abbokinase
  pre-instilled IV’s        • Nasal Spray              • Recombivax
• Hospital repacks          • Thera-Vitamins
• Pre-filled syringes       • Tincture of Benzoin      Dual Waste –
                            • Vaccines                 Hazardous
• Partial syringes
                                                       • Infectious waste
• Discontinued meds         P – Listed                   with medication.
• Un-administered meds      • Nicotine Wrappers
• Patient prescriptions     • Coumadin Wrappers
• Physician Rx samples
                            U – Listed                 • Unused Silver Nitrate
                            • Chemotherapy drugs
                            • Cytoxan
                            • Mitomycin
                      Compatible Versus Incompatible
                         Pharmaceutical Waste

Two categories of pharmaceutical waste identified by EPA

Compatible – Rx waste that CAN be placed in the
same container without danger of a chemical

Incompatible – Rx waste that CANNOT be placed
 in the same container with other Rx waste because it
 may cause a dangerous chemical reaction
   • Oxidizers: Silver Nitrate
          Mixtures of Wastes

               Hazardous Waste
              Non-hazardous Waste


• Keep wastes segregated

                             RCRA Empty

RCRA Empty - Both conditions must be met:
   • All contents removed via commonly employed practices
     (pouring, pumping, aspirating).
   • Less than 3% of original weight by capacity if the
     container is less than or equal to 110 gal for non P-listed
   • P-listed Waste: material and all items in contact with
     material must be placed into ziplock bag, then placed in
     black waste container.
Keep it Simple: If unclear whether item is empty, collect the
 waste in the appropriate container.
   • NOTE: The empty IV bags with tubing attached can be
     place in regular trash after any patient info is defaced.
       Pharmaceutical Waste Services

Stericycle Pharmaceutical Waste
      Compliance Program
                   Here Is Our Solution

1. Identification of waste

2. Education

3. Segregation of waste

4. Transportation and Destruction of waste
                    Compatible and Incompatible Hazardous
                               Waste Container

Compatible Hazardous Pharmaceuticals
• ~ 5% of the Pharmaceutical Waste
  • Dispose in Black Container =
     Black Container
  • Place in Ziplock Baggie, Dispose in Black Container =
     Packaging placed in non biohazard ziplock bag,
     then placed in Black Container (Nicotine, Coumadin)

Incompatible Pharmaceutical
Return to Pharmacy/RT = Black Non-Compatible
                  Hazardous Container
• NOTE: Incompatibles sent back to Pharmacy/RT in non biohazard
           ziplock bag – place bag in Pharmacy/RT return bin
          Facility-Wide Identification of Rx

• Options for identification through existing
  distribution systems:
  – Disposal Codes in Med Dispensers.
     • (PYXIS)
  – Disposal Codes on EMAR.
     • (Similar codes as in PYXIS)
  – Black Dots
     • (Black Dot on Med or Bin indicates Black Container

                  Service Model

• Satellite accumulation area waste containers must be “at or
  near” the point of generation and in secured areas (EPA

• Transfer of Rx waste containers to Central accumulation
  area when full – performed by Stericycle Service Tech.

• Pharmaceutical waste: Stericycle Service Tech will
  package non-hazardous waste for transport. Hazardous
  Pharmaceutical Waste will be packaged by Stericycle
  following applicable regulations, then removed.
              Satellite Accumulation

Locations containers are placed to capture waste:
• Pharmacy
• Oncology – Chemo
• Procedure Rooms
• All Other Patient Care Areas
   Medication Dispense Station
   Med Carts
   Med Rooms
   Soiled Utility Room
                           Rx Waste Flow

                                 Rx WASTE

 Compatible Hazardous       Incompatibles/Inhalers        Non-Hazardous
        <5%                                                 90-95%

                             Return to Pharmacy
    Compatible                                               Non-
    Hazardous                                              Hazardous
 Black Container           Aerosols & Inhalers           Blue Container

CAA – DOT Packed       CAA – DOT Packed                     CAA – DOT Packed
                * Incompatible containers placed in high use areas.
                               Rx Waste

• What Goes In the Reusable Rx Container
     Partial or Unused Rx IV’s with tubing
     Tubing (if applicable)
     Unused pills and capsules
     Partial vials
     Sponges soaked in liquid meds
     Topical ointments

• What Does Not Go In the Container
    No Sharps
     No Controlled Substances

• Approximately 5% of All Rx Waste Will Go Into This Container
             Satellite Accumulation Containers

Color-Coded Containers
• Compatible Pharmaceutical (Black Container)
   • Dispose in Black Container = Black Container
   • Place Wrapper in Ziplock, dispose in Black
     Container = Packaging placed in non biohazard
     ziplock, then placed in Black Container.

• Incompatible Pharmaceutical
   • Return to Pharmacy = Send to Pharmacy
      • Place in non biohazard ziplock bag
         • Return to Pharmacy!
• Non-Hazardous Pharmaceutical (Blue Container)
  • No identifier
                    BULK Chemotherapy

• Hazardous Chemo “Bulk” Container (BLACK)
  – Containers holding >3% liquid (vial, syringe, IV bag, tubing
    that is not empty)
     • Empty IV’s and tubing
  – Overtly contaminated garments and spill clean up material
     • Gowns, Goggles, Gloves
     • Spill cleanup
         – Rags
         – Wipes
         – Towels

                   TRACE Chemotherapy

• Non-Hazardous Chemo “Trace” Container
  – Fully Plunged Syringes
  – Non-contaminated PPE
     • Gowns, Goggles, Gloves
     • Wipes
  – Trace Chemo can be managed through RMW Provider

             Healthcare Waste Streams

            These waste streams stay the same
                                                                    Trace Chemo

                                                                    Bulk Chemo

                    Controlled Substances   Maintenance Solutions

 What is different? Pharmaceutical Waste

  Non-                   Compatible
Hazardous                 Rx Waste
Rx Waste

90 - 95%                    <5%                                     1%
                   Hazardous Storage Area (CAA)

• Stericycle Service Tech will exchange full containers for empty containers.

• Stericycle Service Tech will package non-hazardous pharmaceuticals for
  shipping. Hazardous pharmaceuticals will be packaged by trained
  Stericycle staff.
• EVS (Housekeeping) will serve as backup if Stericycle Tech is not available

• All Rx waste is packaged, labeled, manifested, and shipped in compliance
  with DOT regulations.
                      Container Replacement &
                      Emergency Spill Response

Container Replacement
• Contact EVS for pick-up & replacement of full Rx waste

Emergency Spill Response
• In the event of a spill, contact hospital Spill Response Team
  as directed by hospital policy
Rx Waste Compliance Program

What Goes In the Dual Waste Container
   Syringes with or without needle and
   bulk pharmaceuticals that have come into
   contact with a patient. (Infectious waste)
   Live Vaccine with RCRA Hazardous
         Tetanus Toxoid Fluid
         Decavac – Injectable Form

        Less Than 1% of Formulary

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