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Pharmacy Powerpoint with Audio

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Pharmaceutical Waste Management Program Nursing Train-the-Trainer

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Background and Regulatory Requirements Pharmaceutical Waste Collection Program What is Pharmaceutical Waste? Identification and Labeling Special Considerations Pharmaceutical Waste Containers Oncology Pharmaceuticals Waste Handling 2 Agenda

Background and Regulatory Requirements:

Background and Regulatory Requirements 3

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What are healthcare facilities required to do? Manage all identified Hazardous Waste generated within the facility, including Pharmaceuticals Why? Rules and Regulations Federal : Title 40 of the Code of Federal Regulations, Subchapter I Resource Conservation and Recovery Act (RCRA) of 1976 State: There may be additional regulations required of your facility Local: There may be additional regulations required of your facility Pharmaceuticals found in waterways and landfills 4 Introduction

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US EPA State Regulating Agency DOT (Department of Transportation) regulates segregation, packing, labeling and transport of hazardous materials Joint Commission – Draft language under the 2010 Management of Care POTW (local waste water treatment) determines what can and cannot be drained 5 Regulatory Agencies and Bodies

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Note : If you generate 2.2 or more pounds of P-listed “acutely hazardous waste” in any month, you are automatically classified as a Large Quantity Generator (LQG). Methodist is Large Quantity Generator 6 Generator Size Chart If you generate: Then your size is: 220 lbs or less per month hazardous waste (about ½ drum liquid or less) CEQG (Conditionally Exempt Quantity Generator) More than 220 lbs but less than 2,200 lbs per month hazardous waste (about ½ to 4 drums liquid) SQG (Small Quantity Generator) 2,200 lbs or more per month hazardous waste (about 4 drums liquid) LQG (Large Quantity Generator) Generator Status

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Personnel must be trained if handling hazardous waste Employees whose responsibilities include hazardous waste management, storage, transport, or recordkeeping require hazardous waste training. LQG: Employees must receive initial training within six months of the date of their employment or a change in job requirements. Annual training thereafter 7 Employee Training

What is Pharmaceutical Waste?:

What is Pharmaceutical Waste? 8

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Vials IV’s and tubing Oral Medications Wrappers Partial syringes Discontinued pharmaceuticals Un-administered pharmaceuticals Patient prescriptions Physician Samples 9 Examples of Pharmaceutical Waste

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Hazardous Waste - EPA Listed Wastes P-Listed Wastes (Coumadin, Nicotine) U-Listed Wastes (Chemotherapy) Characteristic Wastes Ignitable, Corrosive Toxic – Containing materials (Preservatives, Silver) Hazardous Materials - DOT Aerosols, Corrosives, Toxins, Oxidizers 10 Hazardous Pharmaceuticals

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Pharmaceuticals that are not defined as hazardous wastes (per regulations) Regulations last updated in 1976 (not including interpretations) Best Management Practice Several Rx defined as non-hazardous may still adversely affect the environment Manage all non-hazardous Rx through incineration 11 Non-Hazardous Rx Waste

Identification & Labeling:

Identification & Labeling What is considered hazardous? 12

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Plain Down the Drain Saline, Electrolytes, Sugars, Salt Continue to follow DEA witness / waste requirements Witness and waste per policy Do not dispose of: In RMW containers In Hazardous waste containers In Trash 13 Controlled Substances

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How to Evaluate Pharmaceuticals: Formulary Analysis Federal Hazardous Wastes (D, F, P, U waste codes) Additional State Hazardous Waste Requirements Identified only the Hazardous Messaging in the Pyxis (pop up), Label (McKesson Care Organizer 14 Evaluate and Identify Waste Streams Message Action No Message Place in Blue Container “Special Disposal Required” Place in Black Container “ Disposal – Pharmacy ” Place in Baggie and Return to Pharmacy

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BLUE CONTAINER (Non-Hazardous) Pharmaceutical Waste (not labeled) BLACK CONTAINERS (Hazardous) Compatible Pharmaceutical Wastes P-listed Waste (Acutely Hazardous) Coumadin, Nicotine RETURN TO PHARMACY (Hazardous) Incompatible Pharmaceutical Waste Aerosols Toxics (Botox) Oxidizers 15 Presort Collection Process

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Options for identification through existing distribution systems: Computerized Distribution System Alert ( Pyxis ) Label on McKesson Care Organizer 16 Facility-Wide Identification of Rx

Special Considerations:

Special Considerations 17

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Both conditions must be met (except P-listed): All contents removed via commonly employed practices (pouring, pumping, aspirating) Less than 3% of original volume P-listed Waste: material and all items in contact with material must be placed into black compatible hazardous waste container Keep it Simple: Put all pharmaceutical peripherals in proper containers (full or Partial) 18 Empty Containers Defined

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Keep wastes segregated When in doubt, treat as hazardous waste 19 Hazardous Waste + Non-hazardous Waste ALL HAZARDOUS WASTE Mixtures of Wastes

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Regulated Medical Waste Sharps containers (needles, etc.) Red bag wastes Controlled Substances Handling Witness and waste to drain IV Draining Can still cut and drain non-pharmaceuticals to the drain Maintenance IVs and Fluids (saline, potassium, sodium chloride, etc.) If Pharmaceutical is added, then manage as it is identified 20 Processes Not Changing

Pharmaceutical Waste Containers:

Pharmaceutical Waste Containers 21

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Any Rx without a Pyxis Message, Label If Non-hazardous Rx remains in a syringe, discharge the remaining Rx into some gauze. Place the syringe into the SHARPS container and the gauze into the Blue Container. Not hazardous under EPA, but still will collect Managed by placing waste into BLUE Container Majority of Rx will be Non-hazardous - therefore no label No sharps or “free” liquids. (In container or absorbent material) 22 NO LABEL Non-Hazardous Pharmaceutical Waste

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Identified with the Pyxis Message, Label If Compatible Hazardous Rx remains in a syringe, discharge the remaining Rx into some gauze. The gauze is then placed into the BLACK container and then place the syringe into the SHARPS container The Rx and all containers having contact with Rx (vials, IVs & Tubing, unit dose packaging, etc.) placed into container (full or partials) No sharps or “free” liquids. (In container or absorbent material) Place in BLACK Container 23 “Special Disposal Required” Compatible Hazardous Pharmaceutical Waste on

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Characteristic Hazardous Lantus Humalog Humulin N Humulin R Flovent Taxol Benzamycin P-Listed Coumadin / Warfarin Nicotine Arsenic Trioxide U-Listed Chemotherapy drugs Cytoxan Mitomycin 24 Identified Rx Examples

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Identified with the Pyxis Message, Label Waste that cannot be collected in the same container due to EPA and DOT regulations Examples: Aerosols (mouthpiece removed), Corrosives, Oxidizers (unused silver nitrate sticks), Toxins ( botox ) Place in Zip-lock Bag and Return to Pharmacy No sharps or “free” liquids. (In container or absorbent material) 25 Bag and to Pharmacy Incompatible Waste “Disposal - Pharmacy”

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RARE Infectious and hazardous waste Pharmaceuticals that are both Regulated Medical Waste (RMW) and contain RCRA hazardous ingredients cannot be disposed of in “red bags” due to hazardous constituent Example: Infectious vaccine with preservative Labeling : Biohazard sticker needed in addition to Hazardous waste sticker CURRENTLY THERE ARE NO PHARMACEUTICALS THAT FALL INTO THIS CATEGORY 26 Dual Waste “Disposal - Pharmacy”

Oncology Pharmaceuticals:

Oncology Pharmaceuticals Management BULK Chemotherapy TRACE Chemotherapy

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Many Chemotherapy Pharmaceuticals were developed after the establishment of the RCRA Rules in 1976 Additionally, several Chemotherapy Pharmaceuticals are Listed hazardous wastes 28 Antineoplastic Waste Waste Code Chlorambucil U035 Mitomycin U010 Chemotherapy Pharmaceuticals

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Hazardous Chemo “Bulk” Container (BLACK) Non-empty containers holding free liquid (vial, IV bag, tubing) Overtly contaminated garments and spill clean up material Gowns, Goggles, Gloves Spill cleanup Rags Wipes Towels 29 BULK Chemotherapy

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Non-Hazardous Chemo “Trace” Container (YELLOW) Empty IV’s and tubing Syringes Non-contaminated PPE Gowns, Goggles, Gloves Wipes Trace Chemo can be managed through RMW Provider 30 TRACE Chemotherapy

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Items that can be cut and poured down the drain Plain IV Solutions Solutions containing additives, such as: Potassium chloride Potassium phosphate Saline Dextrose Calcium Sodium bicarbonate Controlled Substances Place into a BAGGIE and RETURN TO PHARMACY Place into BLACK CONTAINER Place into BLACK CONTAINER Place into YELLOW CONTAINER Place into BLUE CONTAINER Incompatible Rx Wastes Require Segregation to Meet DOT, Safety & Disposal Requirements Place in zip lock bag Aerosols Inhalers with canister Oxidizers (Example) Unused Silver Nitrate Items identified with a message or black dot Examples Insulin Some Vaccines Trace elements Coumadin and Packaging Nicotine and Packaging Miscellaneous Rx Spill Cleanup Debris Rx in Syringe – Discharge into gauze, gauze in container, syringe to SHARPS Chemotherapy Rx and containers that are NOT empty Chemo Agents IVs with Residual Chemo Agents Chemo Spill Cleanup Debris Vials with Residual Chemo Agents Tablets, caps etc. Chemotherapy Rx and containers that ARE empty Empty Syringes Gowns with chemo small amount of contamination Gloves Goggles Wipes Empty IVs / Tubing Vials Not Labeled or Identified as Hazardous Rx by Pharmacy Examples Lidocaine Marcaine Heparin Antibiotics Miscellaneous Full/partially filled syringe – expel into gauze, gauze in container, empty syringe in SHARPS Pharmaceutical Waste Stream Management Labeled or Identified as Hazardous / Incompatible Rx Hazardous Rx Waste “Special Disposal Required” Non-Hazardous Rx Waste No Messaging Bulk & Trace Chemotherapy Rx Waste Sewer System Discharge to Drain SHARPS Needles Empty syringes (See Above) Empty controlled substance containers REGULAR TRASH Empty Packaging, Empty Wrappers, Empty IV’s. Regular Trash Shipping packaging Incompatible Rx Waste “Disposal–Pharmacy”

Waste Handling:

Waste Handling Movement of Containers Spill Response

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Hazardous wastes must be stored in a closed and labeled container. Close the containers when not using them The label must have at least the words “Hazardous Waste”, a description of the contents, and the date that the container was filled. 33 PHARMACEUTICAL HAZARDOUS WASTE START DATE _____________________________ CONTAINER FULL DATE ___________________ Container Requirements INCOMPATIBLE PHARMACEUTICAL HAZARDOUS WASTE START DATE _____________________________ CONTAINER FULL DATE ___________________

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The containers will be transported to the Hazardous Waste Storage Area when full. A new empty container will replace the removed container. Collect full containers during the day shifts If containers are full and must be replaced 34 Movement of Containers

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Containers will be taken to the designated Hazardous Waste Storage Area. Containers will be placed in the storage area so that labels are easily readable and there is adequate aisle spacing between them for access. 35 Movement of Containers

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Refer to facility Spill Response Policy, which may include the following: Secure Area Identify Material Contain and Clean-up if Safe to do so Spill Kits, Absorbents Dispose of Hazardous Clean-up Materials Properly Hazardous Waste Container 36 Spill Response

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37 Questions???

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