handling hazardous drugs pharmacy benefits management drug accountability conference may 13, 2010,...
TRANSCRIPT
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….