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transcript
Identifying and Managing Hazardous Pharmaceutical Waste
H2E TeleconferenceSeptember 12, 2003
Charlotte A. Smith, R. Ph., M.S.President
csmith@ pharmecology.com
www.pharmecology.com
262-814-2635
Copyright © 2003 by PharmEcology Associates, LLC
Pharmaceutical Waste: A Waste Stream Whose
Time has ComeConcept of “Green Pharmacy” Gaining Attention "Cradle-to-Cradle Stewardship of Drugs for
Minimizing Their Environmental Disposition While Promoting Human Health.”
Dr. Christian Daughton, Chief, Environmental Chemistry Branch, USEPA National Exposure Research Laboratory
I. Rationale for and Avenues toward a Green Pharmacy;
II. Drug Disposal, Waste Reduction, and Future Directions,
http://www.h2e-online.org/tools/chem-pharm.htm
Increasing Regulatory Activity EPA Region 2 auditing 480 hospitals in 2003; Rx waste
included; link from H2E to Region 2 website http://www.h2e-online.org/tools/chem-hwm.htm
States beginning to focus on management of waste pharmaceuticals
Florida Washington State California Minnesota Michigan
Intersecting regulatory agencies EPA, DEA, OSHA, State Boards of
Pharmacy
H2E and Hazardous Pharmaceuticals
Initial involvement while at Capital Returns, Inc., Rx reverse distributor, 1999-2000
Worked on Chemical Minimization Committee with Catherine Zimmer, Minnesota Technical Assistance Program (MnTAP)
http://www.h2e-online.org/pubs/chemmin/pharmacy.pdf Contributed to prioritization tool by reviewing all drug
products in CRI database http://www.h2e-online.org/pubs/chemmin/chappf.pdf
USGS Water Quality Study*First nationwide reconnaissance of occurrence of
pharmaceuticals, hormones, other organic wastewater contaminants
139 streams in 30 states, analyzed for 95 different OWCs
82 of the 95 detected in at least one sampleOne or more OWCs found in 80% of stream
samples13% of sites had more than 20 OWCs*http://toxics.usgs.gov/pubs/OFR-02-94/index.html
Below the Dose/Response Curve:Endocrine Disruptors
Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles)
Mimic hormone, trigger identical response, block a hormone
Do not follow the normal dose/response curve Active at much lower doses, especially in the fetus and
newborn Estradiols, progesterone, testosterone Lindane
Low sperm counts(50% reduction since 1939) InfertilityGenital deformitiesHormonally triggered human cancersNeurological disorders in children
Hyperactivity Attention deficit
Developmental & reproductive problems in wildlife
Pharmaceuticals Enteringthe Waste Stream
Wastage of Raw Materials from Manufacturing Process
Wastage at the Distributor/ Pharmacy/Healthcare Facility
Wastage at the LTCF or other residential facility
Expired PharmaceuticalsWastage at the Consumer LevelMetabolites Entering Wastewater
When is an Outdated Drug a Waste?
At the time and place the decision is made to discard it
Two EPA guidance letters to the industry: Merck & Co., 1981 BFI Pharmaceutical, 1991
Enables shipping of potentially creditable outdates to a reverse distributor as product
PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials
Reverse Distribution: Current Scenarios
Decision to discard is made at the pharmacy By pharmacy By a contracted company Pharmacy (hospital) becomes the waste
generator
Decision to discard is made at the reverse distributor Reverse Distributor becomes the waste
generator
Where Have Waste Drugs Gone in the Past?
Primarily concerned with rendering drugs unrecoverable Not in dumpsters, municipal trash Made slurries, sewered Burned in hospital incinerators
No training in pharmacy curriculum on EPA regulations
Where are Waste Drugs Going Today?
Sewer System Unused, partial IVs, including antibiotics Compounding residues Liquids
Red Infectious Waste Sharps Containers, Bags
Yellow or White Chemotherapy Sharps Containers, Bags
MUNICIPAL WASTE SEWER SYSTEMCHEMO WASTE
- SHARPSCHEMO WASTE
- SOFT RED SHARPS
• Packaging• Empty glass bottles• Empty plastic bottles• Paper• Plastic• Food waste, etc.
• IV’s- D5W- NaCl- Other?
• Controlled substances?• Antibiotics?
• Vials - Empty (trace)
- Partial (residue)• Syringes/Needles - Empty
- Unused, partial• IV’s - Empty - Unused, partial• Spill clean up?
• Gowns• Gloves• Goggles• Tubing• Wipes• Spill clean up?
• Vials - Empty - Partial• Syringes/Needles - Empty - Unused, partial• IV’s - Empty - Unused, partial
LANDFILL ORMUNICIPAL INCINERATOR
WATER TREATMENT PLANT
Leachate into ground water or
air emissions
Discharge to surface waters
Leachate
Contents of Current Pharmaceutical Waste Streams
Copyright © 2002 by PharmEcology™ Associates, LLC
AUTOCLAVE/MICROWAVE
Shredded (?)
NON-HAZARDOUS LANDFILL
Ash
MEDICAL WASTE INCINERATOR
How is Pharmaceutical Waste Generated at the Healthcare Facility?
IV PreparationGeneral CompoundingSpills/BreakagePartially Used Vials/Syringes
If Contaminated, BiohazardousDiscontinued, Unused PreparationsUnused Repacks (Unit Dose)Discontinued Indated PharmaceuticalsPatients’ Personal MedicationsOutdated Pharmaceuticals
Where is Pharmaceutical Waste Generated?
Pharmacy/SatellitesPatient Care UnitsER/OR ICU/CCU/NICUOncology/Hematology and other outpatient clinicsLong Term Care FacilitiesHome Health Care Services
What Departments Get Involved in Generating and Managing
Pharmaceutical Waste?
PharmacyNursing Infection ControlEnvironmental ServicesSafetyFacility ManagementRisk ManagementPurchasing
Federal Waste Generation Status
Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste.
Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste.
Conditionally Exempt Small Quantity Generator (CESQG):Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/month
Which Discarded Drugs Become Hazardous Waste?
P-listed chemicals Sole active ingredient
U-listed chemicals Sole active ingredient
Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity
Examples of P-Listed Pharmaceutical Waste
Arsenic trioxide P012Epinephrine P042Nicotine P075Nitroglycerin P081Phentermine (CIV) P046Physostigmine P204Physostigmine Salicylate P188Warfarin >0.3% P001
Impact of P-listed Waste
Only 1 kg or 2.2 pounds/month cause facility to become a large quantity generator
Weights of P-listed drug waste must be combined with any other P-listed waste generated at the facility in a given month
Technically, containers that have held P-listed wastes are not “RCRA empty” unless they are triple rinsed and the rinsate discarded as hazardous
Examples of U-listed Pharmaceutical Waste
Chloral Hydrate(CIV) U034
Chlorambucil U035
Cyclophosphamide
U058
Daunomycin U059
Melphalan
U150
Mitomycin C U010
Streptozotocin U206
Lindane U129
Saccharin U202
Selenium Sulfide U205
Uracil Mustard U237
Warfarin<0.3% U248
Chemotherapy WasteSeven chemotherapy agents are U-listed; one is P-
listedMedical waste hauler protocols for “Chemo
Waste” Empty vials, syringes, IV’s Treated as infectious medical waste preferably through
regulated medical waste incineration If not empty, should be placed into Hazardous
Waste container“Empty” for U-listed waste means all contents
removed that can be removed through normal means
3 ml allowance in common practice is a misunderstanding of the definition of “RCRA empty”
Chemotherapy Residue: Infectious and Hazardous
If chemo IV bag has been hung, is not completely used and can be separated from patient exposed sharp without exposing the employee, remove and dispose as RCRA hazardous waste
If chemo residue cannot be removed safely, dispose in trace chemotherapy container (yellow/white) as infectious chemo waste
No consensus yet on this issue among hazardous waste regulators
Empty vials, syringes, IVs,
tubing, gowns, gloves,etc.
Residue or bulk chemoin vials, unused IV’s, P, U. toxic D
Chemo Waste Hazardous Waste
Characteristic of IgnitabilityAqueous Solution
containing 24% alcohol or more by volume & flash point<140° F.
Hazardous Waste Number: D001
Rubbing AlcoholTopical Preparation Injections
Characteristic of Corrosivity
An aqueous solution having a pH < or = 2 or > or = to 12.5
Examples: Primarily compounding chemicals Glacial Acetic Acid Sodium Hydroxide
Hazardous waste number: D002
Characteristic of Toxicity
Approximately 40 chemicals which meet specific leaching concentrations
Examples of potential toxic pharmaceuticals:Arsenic m-CresolBarium Mercury (thimerosal)Cadmium phenylmercuric acetate)Chloroform Selenium Chromium SilverLindane
Preservatives: thimerosal & m-cresol
Heavy Metals: Selenium, Chromium and Silver
Examples of Pharmaceuticals Exhibiting the Characteristic of
Toxicity
Characteristic of Reactivity
Meet eight separate criteria identifying certain explosive and water reactive wastes
Nitroglycerin formulations may be considered exempt as of August 14, 2001 under FR: May 16, 2001. States must still adopt.
Hazardous Waste Number: D003
How Can RCRA Hazardous Waste be Identified?
Web-based database enabling search by product for waste management recommendations
Search by NDC, product or generic name, active ingredient Recommendations citing federal regulations and
recommended waste streams State regulation alerts if more stringent than federal Risk Management alerts based on professional
knowledge (e.g. chemotherapy agents not regulated at the state or federal level)
How Should RCRA Hazardous Waste be Handled?
Need a new waste stream in Pharmacy, certain Patient Care Areas, Oncology Clinics
RCRA Hazardous Waste: Toxic P, U, toxic Ds, all Chemotherapy Residues,
Chemo Spills RCRA Hazardous Waste: Ignitable (D001) Hospitec has developed a dedicated hazardous waste
containment system Can also use hazardous waste buckets available from
brokers and disposal firms
Recommended Additional Pharmaceutical Waste Streams
HAZARDOUS WASTE - IGNITABLE
HAZARDOUS WASTE - TOXIC NON-HAZARDOUS
NON-INFECTIOUS RX
FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS)
LINED HAZARDOUS WASTE LANDFILL
Hazardous waste broker and transporter
Ash
NON-HAZARDOUS LANDFILL
MEDICAL WASTE
INCINERATOR
Ash
Copyright © 2002 by PharmEcology™ Associates, LLC
Leachate
MUNICIPAL INCINERATORPERMITTED
FOR SPECIAL WASTE
Ash
MUNICIPAL
• Packaging• Empty bottles• Paper• Plastic• Food waste, etc.
• Gowns• Gloves• Goggles• Tubing• Wipes
• Vials - Empty• Syringes/Needles - Empty• IV’s - Empty
Recommended Revised Pharmaceutical Waste Streams
Copyright © 2002 by PharmEcology™ Associates, LLC
SEWER SYSTEM
• Recycle as much paper, glass, plastic as possible
• Use shredder where patient privacy is an
issue
HAZARDOUS WASTE - TOXIC
HAZARDOUS WASTE
- IGNITABLE
CHEMO WASTE- SOFT
CHEMO WASTE
- SHARPS
NON-HAZARDOUS
RX
RED SHARPS
• IV’s - D5W
- NaCl• Controlled Substances?• Antibiotics?
• P-listed• U-listed• D-listed toxic (Heavy metals)• Chemo agents (residue, bulk)• Chemo spill clean up• Hazardous spill clean up• Risk management: - Antivirals - Others
• D-listed Ignitable- Collodion- Oxidizers- Ignitable
compressed gas
All waste pharmaceuticals NOT hazardousincludingantibiotics, IV’s
• Non-chemo vials - Empty• Non-chemo syringes/ needles - Empty
• Check withmunicipal water treatment plant
for limits, recommendations
NON-HAZARDOUS LANDFILL
Leachate
MUNICIPAL INCINERATORPERMITTED
FOR SPECIAL WASTE
AUTOCLAVE/MICROWAVE
Shredded (?)
MEDICAL WASTE INCINERATOR
AshAsh
FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH
TEMPERATURE, SCRUBBERS)
LINED HAZARDOUS WASTE LANDFILL
Ash
Where Should RCRA Hazardous Waste Be Stored?
Hazardous Waste Storage Accumulation Site:
Same locked area as mercury, xylene, formaldehyde, lab chemicals
Maximum storage time: 90 or 180 days based on generator status
Yellow Hazardous
Waste Label
How Should RCRA Hazardous Waste Be Disposed?
Either contract with a hazardous waste broker or develop internal expertise for: Lab packing Manifest preparation Land ban preparation
Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility)
How Can Hazardous RX Waste Generation Be Minimized?
Inherent limitations on substitution of a less hazardous drug since the hazardous nature of the chemical often provides the therapeutic effect
Tighter inventory control to reduce outdate generation, both original manufacturers’ containers and repacks
Single dose vials vs. multiple dose vialsPatient specific oral syringes vs. 10 cc. repacks
(e.g. choral hydrate for pediatric use)Reformulation of heavy metal concentration,
especially mercury and m-cresol as preservatives
What About Non-Hazardous Drugs?
Segregate into a non-red, non-yellow container, such as beige or white with blue top (California Pharmaceutical Waste)
Label “Non-hazardous Pharmaceutical Waste – Incinerate Only”
Dispose at a regulated medical waste or municipal incinerator that is permitted to accept non-hazardous pharmaceutical waste
Where to Begin?
Purchase appropriate containers for collecting toxic and ignitable hazardous waste
Pilot bulk and residue chemotherapy segregation in the pharmacy and on the oncology unit
Extend the program to all units that handle any chemotherapy agents (methotrexate and cyclophosphamide used in other units)
Begin identifying other P, U and D hazardous wastesTrain all relevant staff on the reasons for the new
system
Jump-Starting the ProcessElectronic formulary review service
Send PharmEcology Associates your drug formulary information
We compare it to our database of over 107,000 drug items
You receive back a list of which drugs are hazardous waste or risk management hazardous waste
On-site review A one or two day visit to your facility followed by an
Action Plan and Findings and Recommendations
Benefits of a Comprehensive Hazardous Waste Disposal Plan
JCAHO Environment of Care Performance Improvement Initiative New 2004 Standards – see both Medication
Management and Environment of CareReduces EPA liability and risk exposure to a
minimumProtects employees and patientsDemonstrates responsible care in dealing with
hazardous substances, hazardous wastes
Resources www.pharmecology.com Pharmaceutical Waste:
http://www.h2e-online.org/tools/chem-pharm.htm “Safely Managing Hazardous Materials and Hazardous
Waste,” ASHP Clinical Midyear, 2001, Handouts on CD-Rom
RCRA On-Line www.epa.gov/rcraonline RCRA Hot Line 1-800-424-9346 Improper Discard of Toxic Drugs Hurts Environment,
Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp 1576-1578.
Resources Pharmaceutical Waste Survey, King County, Washington
State, April 29, 2003, http://www.metrokc.gov/hazwaste/pubs/studies.html#pharmwastesurvey
Your Risks in Handling Outdated and Unusable Drugs: A Guide to JCAHO and Regulatory Standards. Capital Returns, Inc., 1998 Call 1-800-950-5479
A Guide on Hazardous Waste Management for Florida’s Pharmacies, www. floridacenter.org.
Guidelines for Reverse Distributors: Minimum Federal Regulatory Standards, www.returnsindustry.com