Transcript Identifying and Managing Hazardous Pharmaceutical Waste

Identifying and Managing Hazardous
Pharmaceutical Waste
H2E Teleconference
September 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 Come
 Concept of “Green Pharmacy” Gaining Attention
 "Cradle-to-Cradle Stewardship of Drugs for
Minimizing Their Environmental Disposition
While Promoting Human Health.”
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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
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Florida
Washington State
California
Minnesota
Michigan
 Intersecting regulatory agencies
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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 sample
 One or more OWCs found in 80% of stream
samples
 13% 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
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Low sperm counts(50% reduction since 1939)
Infertility
Genital deformities
Hormonally triggered human cancers
Neurological disorders in children
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Hyperactivity
Attention deficit
 Developmental & reproductive
problems in wildlife
Pharmaceuticals Entering
the 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 Pharmaceuticals
 Wastage at the Consumer Level
 Metabolites 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:
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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
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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
Contents of Current Pharmaceutical Waste Streams
MUNICIPAL WASTE
• Packaging
• Empty glass bottles
• Empty plastic bottles
• Paper
• Plastic
• Food waste, etc.
LANDFILL OR
MUNICIPAL INCINERATOR
SEWER SYSTEM
• IV’s
- D5W
- NaCl
- Other?
• Controlled
substances?
• Antibiotics?
WATER
TREATMENT PLANT
CHEMO WASTE
- SHARPS
CHEMO WASTE
- SOFT
• 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?
MEDICAL WASTE INCINERATOR
Ash
Leachate into
ground water or
air emissions
• Vials
- Empty
- Partial
• Syringes/Needles
- Empty
- Unused, partial
• IV’s
- Empty
- Unused, partial
AUTOCLAVE/
MICROWAVE
Shredded (?)
Discharge to
surface waters
NON-HAZARDOUS LANDFILL
Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC
RED SHARPS
How is Pharmaceutical Waste Generated
at the Healthcare Facility?
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IV Preparation
General Compounding
Spills/Breakage
Partially Used Vials/Syringes
 If Contaminated, Biohazardous
Discontinued, Unused Preparations
Unused Repacks (Unit Dose)
Discontinued Indated Pharmaceuticals
Patients’ Personal Medications
Outdated Pharmaceuticals
Where is Pharmaceutical Waste
Generated?
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Pharmacy/Satellites
Patient Care Units
ER/OR
ICU/CCU/NICU
Oncology/Hematology and other outpatient clinics
Long Term Care Facilities
Home Health Care Services
What Departments Get Involved in
Generating and Managing
Pharmaceutical Waste?
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Pharmacy
Nursing
Infection Control
Environmental Services
Safety
Facility Management
Risk Management
Purchasing
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
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Sole active ingredient
 Characteristic of hazardous waste
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Ignitability
Toxicity
Corrosivity
Reactivity
Examples of P-Listed
Pharmaceutical Waste
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Arsenic trioxide
Epinephrine
Nicotine
Nitroglycerin
Phentermine (CIV)
Physostigmine
Physostigmine Salicylate
Warfarin >0.3%
P012
P042
P075
P081
P046
P204
P188
P001
Examples of
P-Listed
Pharmaceuticals
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
 Streptozotocin
U206
 Chlorambucil
U035
 Lindane
U129
 Cyclophosphamide
U058
 Saccharin
U202
 Daunomycin
U059
 Selenium Sulfide U205
 Melphalan
U150
 Uracil Mustard
U237
 Mitomycin C
U010
 Warfarin<0.3%
U248
Examples of
U-Listed
Pharmaceuticals
Chemotherapy Waste
 Seven chemotherapy agents are U-listed; one is Plisted
 Medical waste hauler protocols for “Chemo
Waste”
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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
Chemo Waste
Hazardous
Waste
Residue or bulk chemo
in vials, unused IV’s, P, U. toxic D
Empty vials,
syringes, IVs,
tubing, gowns,
gloves,etc.
Characteristic of Ignitability
 Aqueous Solution
containing 24% alcohol
or more by volume &
flash point<140° F.
 Hazardous Waste
Number: D001
 Rubbing Alcohol
 Topical Preparation
 Injections
Characteristic of Corrosivity
 An aqueous solution having a pH < or = 2
or > or = to 12.5
 Examples: Primarily compounding
chemicals
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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-Cresol
 Barium
Mercury (thimerosal)
 Cadmium
phenylmercuric acetate)
 Chloroform
Selenium
 Chromium
Silver
 Lindane
Examples of Pharmaceuticals
Exhibiting the Characteristic of
Toxicity
Heavy Metals: Selenium,
Chromium and Silver
Preservatives: thimerosal & m-cresol
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)
Readi-Cat
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
- TOXIC
HAZARDOUS WASTE
- IGNITABLE
Hazardous waste
broker and transporter
NON-HAZARDOUS
NON-INFECTIOUS RX
MEDICAL
WASTE
INCINERATOR
MUNICIPAL
INCINERATOR
PERMITTED
FOR SPECIAL
WASTE
Ash
Ash
FEDERALLY PERMITTED
HAZARDOUS WASTE INCINERATOR
(HIGH TEMPERATURE, SCRUBBERS)
NON-HAZARDOUS LANDFILL
Ash
LINED HAZARDOUS
WASTE LANDFILL
Copyright © 2002 by PharmEcology™ Associates, LLC
Leachate
Recommended Revised Pharmaceutical Waste Streams
MUNICIPAL
SEWER
SYSTEM
• IV’s
• Packaging
- D5W
• Empty bottles
- NaCl
• Paper
• Controlled
• Plastic
Substances?
• Food waste, etc.
• Antibiotics?
• Recycle as
much paper,
glass, plastic
as possible
• Use shredder
where patient
privacy is an
issue
• Check with
municipal water
treatment plant
for limits,
recommendations
HAZARDOUS
WASTE
- TOXIC
HAZARDOUS
WASTE
- IGNITABLE
• P-listed
• D-listed Ignitable
• U-listed
- Collodion
• D-listed toxic
- Oxidizers
(Heavy metals)
- Ignitable
• Chemo agents
compressed
(residue, bulk)
gas
• Chemo spill clean up
• Hazardous spill clean up
• Risk management:
- Antivirals
- Others
CHEMO
WASTE
- SHARPS
CHEMO
WASTE
- SOFT
• Vials
- Empty
• Syringes/Needles
- Empty
• IV’s
- Empty
• Gowns
• Gloves
• Goggles
• Tubing
• Wipes
NONHAZARDOUS
RX
All waste
pharmaceuticals
NOT hazardous
including
antibiotics, IV’s
MEDICAL WASTE
INCINERATOR
AUTOCLAVE/
MICROWAVE
Ash
Ash
Shredded (?)
Ash
Copyright © 2002 by PharmEcology™ Associates, LLC
• Non-chemo
vials
- Empty
• Non-chemo
syringes/
needles
- Empty
MUNICIPAL
INCINERATOR
PERMITTED
FOR SPECIAL
WASTE
FEDERALLY PERMITTED
HAZARDOUS WASTE
INCINERATOR (HIGH
TEMPERATURE, SCRUBBERS)
LINED HAZARDOUS
WASTE LANDFILL
RED
SHARPS
NON-HAZARDOUS LANDFILL
Leachate
Where Should RCRA Hazardous
Waste Be Stored?
 Hazardous Waste
Storage
Accumulation Site:
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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:
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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 vials
 Patient 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 nonhazardous 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
wastes
 Train all relevant staff on the reasons for the new
system
Jump-Starting the Process
 Electronic formulary review service
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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 Care
 Reduces EPA liability and risk exposure to a
minimum
 Protects employees and patients
 Demonstrates responsible care in dealing with
hazardous substances, hazardous wastes
Resources
 www.pharmecology.com
 Pharmaceutical Waste: http://www.h2eonline.org/tools/chem-pharm.htm
 “Safely Managing Hazardous Materials and Hazardous
Waste,” ASHP Clinical Midyear, 2001, Handouts on CDRom
 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#phar
mwastesurvey
 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