Download Managing Pharmaceutical Wastes

31st Annual CWEA Conference
Managing Pharmaceutical Waste:
It’s a New World
February 24, 2004
Charlotte A. Smith, R. Ph., M.S.
President
[email protected]
262-814-2635
Copyright © 2004 by PharmEcology Associates, LLC
Environmental Exposure Risks in
the Pharmaceutical Supply Chain
 Manufacturing – Potentially High

Bulk chemical wastage; off-spec and residue wastage
 Distribution – Low

Damaged/non-saleable/expired
 Hospital – Potentially High

Routine disposal of partial/unused vials/syringes/IVs
 Retail – Low
 Reverse Distribution – Potentially High

20% to 30% non-returnable
 Consumer Waste – Potentially High


Discarded
Metabolized and excreted
Increasing USEPA
Regulatory Activity
 EPA Region 2 (NY, NJ, Puerto Rico, VI) contacted 480 hospitals in
2003; Rx waste included.
 Region 2 Website: http://www.epa.gov/region02/healthcare/

North Shore University Hospital, Manhasset, NY fined $40,000 (July
2003)
• http://www.epa.gov/Region2/news/2003/03066.htm

Nassau University Medical Center, East Meadow, NY fined $279,900
(Oct. 2003)
• http://www.epa.gov/region2/news/2003/03127.htm

Mountainside Hospital, Montclair, NJ fined $64,349 (Nov. 2003)
• http://www.epa.gov/Region2/news/2003/03139.htm

Memorial Sloan Kettering Cancer Center, New York , NY, fined $214,420
• http://www.epa.gov/region02/news/2004/04008.htm
 Intersecting regulatory agencies

EPA, DEA, OSHA, State Boards of Pharmacy
Increasing State Regulatory Activity

Florida
• Hospitals, drug wholesalers, and reverse distributors audited
and fined in the past several years
• A Guide on Hazardous Waste Management for Florida’s
Pharmacies
http://www.floridacenter.org/brochures_bulletins/pharmacies.ht
m

Washington State
• Managing Pharmaceutical Waste website:
http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/index.
html
• Offered pharmaceutical waste training program October, 2003

California
• Management of Pharmaceutical Medical Waste, October, 2002
• Memo on sewer disposal of drugs, September, 2003 Tri-TAC

Minnesota
• Offered pharmaceutical waste training program, October, 2003
• Compliance timeline presented to healthcare community
Hospitals for a Healthy Environment
 Memorandum of Understanding between EPA and AHA,
1998
 Waste reduction goals –



mercury elimination by 2005
33% reduction of all waste by 2005
50% reduction of all waste by 2010
 Hospitals can become H2E Partners; Govermental
organizations and companies can become H2E Champions
 Emphasis on pollution prevention, environmentally
preferable purchasing
 www.h2e-online.org
 Enhanced focus on hazardous waste and pharmaceutical
waste


http://www.h2e-online.org/tools/chem-hwm.htm
http://www.h2e-online.org/tools/chem-pharm.htm
Pharmaceuticals and
Personal Care Products
 PPCPs as environmental pollutants

http://www.epa.gov/nerlesd1/chemistry/pharma/index.htm
 Concept 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


USGS Water Quality Study*
 First nationwide reconnaissance of occurrence of
pharmaceuticals, hormones, other organic wastewater
contaminants (March, 2002)
 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
 Recent feature in Time Magazine, August 25, 2003 on
continuing research
*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
 www.ourstolenfuture.org


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Low sperm counts(50% reduction since 1939)
Infertility
Genital deformities
Hormonally triggered human cancers
Neurological disorders in children
 Hyperactivity
 Attention deficit
 Rage reaction
 Lowered IQ
 Developmental & reproductive problems in wildlife
Environmental Exposure
Risks from Consumers
 Metabolites passed into the sewer system/waste treatment
plants
 Unused/expired medications sewered or landfilled
 Surge of interest at the state, regulatory level
 Press attention in the past 12 months
 Two grant proposals on consumer take back programs
submitted to EPA in December, 2003
th
 Maine mail-back legislation posted January 9 , 2004
for comment
• http://janus.state.me.us/legis/LawMakerWeb/externa
lsiteframe.asp?ID=280012218&LD=1826&Type=1
 LA County Household Hazardous Waste program
includes Rx
• http://www.lacsd.org/HHW/HHWFLIER.htm
*http://www.cnn.com/2003/TECH/science/11/14/coolsc.frogs.fish/index.html
Consumer DrugWaste:
Making a 180° Turn
 Do not recommend drain disposal or flushing of unwanted
medications.
 Recommend dissolving tablets/capsules in a small amount
of water in a water-proof container.
 Render these suspensions and liquified meds unpalatable
by adding strong spices (turmeric, mustard, nutmeg) or
powdered charcoal.
 Place into a second opaque container (detergent bottle) and
wrap tightly with duct tape.
 Dispose in trash, preferably on the day of pick-up.
 http://www.ciwmb.ca.gov/WPIE/HealthCare/PPCP.htm
*R.M. Clayton water treatment plant in Atlanta not equipped
to remove pharmaceuticals from the water.
*http://www.cnn.com/2003/TECH/science/11/14/coolsc.frogs.fish/index.html
A Guide to Rx Waste in California
 Federal Hazardous Waste (RCRA)


Enforced by California EPA, Dept. of Toxic Substances Control
www.calregs.com Title 22 Division 4.5 Chapter 11
 California Hazardous Waste




Pharmaceuticals moved from DTSC to DHS January 1, 1997
Enforced by Dept. of Health Services
Medical Waste Management Act
www.dhs.ca.gov/medicalwaste/
 Non-hazardous waste

Trace chemo
 Bulk chemo falls between the cracks if not federal
California Hazardous Waste:
Catch 22
 Primary applicable criteria is an LD50 of 2500 mg/kg or
less
 Changed from original criteria of LD50 of 5000 mg/kg or
less
 New criteria is half as stringent
 Acute aquatic 96-hour LC50 < 500mg/liter
 Carcinogenicity, acute toxicity, chronic toxicity,
bioaccumulative, persistence in the environment
 No complete list


Kaiser Permanente has done some work
Lists epinephrine as non-hazardous – depends on situation
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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
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IV Preparation
General Compounding
Spills/Breakage
Partially Used Vials/IVs/Syringes
 If Contaminated, Biohazardous
Discontinued, Unused Preparations
Unused Repacks (Unit Dose)
Discontinued Indated Pharmaceuticals
Patients’ Personal Medications
Outdated Pharmaceuticals
RCRA:
The Defining Regulation
 Resource Conservation & Recovery Act
 Enacted in 1976, enforced by the EPA
 Federal regulation of the disposal of solid
wastes
 Encourages the minimization of waste
generation
 Defines “hazardous waste”
 “Cradle to Grave” tracking of
hazardous waste
 Households are exempt
RCRA Risk Management
& Liability
 Civil and criminal liability


Civil: State/USEPA enforcement
Criminal: FBI, Attorney General, Grand Jury
 Corporate fines: $27,500 per violation/day
 Personal liability: fines and/or
imprisonment
 No statute of limitations
 Managers up through CEO
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, in MN VSQG):

Generates < or = 100 kg haz waste/month, and < 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

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
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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”


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”
Trace or Residual
Chemo Waste
Hazardous
Waste
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


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?
 The PharmEcology Wizard enables a search by product for
waste management recommendations
 Over 114.000 items, updated with an average of 175 new
items weekly; over 500 new hazardous items added in the
past six months
 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, Bulk Chemotherapy Drugs,
Chemo Spills
 RCRA Hazardous Waste: Ignitable (D001)
 Empty Chemo Containers, Sharps, Gowns,
Gloves, Goggles are not Hazardous Waste

Dispose into Yellow Chemotherapy Containers for
Incineration
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 California Pharmaceutical Waste Streams
FEDERAL
HAZARDOUS
WASTE
- TOXIC
FEDERAL
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
TRACE
CHEMO
WASTE
- SHARPS
TRACE
CHEMO
WASTE
- SOFT
• Vials
- Empty
• Syringes/Needles
- Empty
• IV’s
- Empty
CALIFORNIA
HAZARDOUS RX
WASTE
• Gowns
• Gloves
• Goggles
• Tubing
• Wipes
NONHAZARDOUS
RX WASTE
• LD50 <- 2500 mg/kg
• LC50 < 500mg/l
(aquatic)
SUBJECT
TO
LOCAL
POTW
APPROVAL
REGULATED
MEDICAL WASTE INCINERATOR
FEDERALLY PERMITTED
HAZARDOUS WASTE
INCINERATOR (HIGH
TEMPERATURE, SCRUBBERS)
AUTOCLAVE/
MICROWAVE
Shredded (?)
Ash
Copyright © 2003 by PharmEcology™ Associates, LLC
• Non-chemo
vials
- Empty
• Non-chemo
syringes/
needles
- Empty
SEWER
SYSTEM
Ash
LINED HAZARDOUS
WASTE LANDFILL
RED
SHARPS
NON-HAZARDOUS LANDFILL
Leachate
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
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 should CAL HAZ and nonhazardous drugs be stored and disposed?
 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 that is
permitted to accept non-hazardous pharmaceutical
waste
Helping Healthcare See Water
Treatment from a New Perspective
 Dialog

How would you prioritize your drug waste concerns?
• Antibiotics?
• Hormones?
• Controlled substances?
 Education of healthcare facilities, consumers


How do water treatment systems work?
What are their vulnerabilities?
 Pollution Prevention


Networking with DHS, Cal EPA
Recommendations for consumers
Resources
 www.pharmecology.com
 w ww.h2e-online.org/pubs/news/envsvcs.pdf Bad
Medicine: Managing Drug Waste Liabilities
 “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
 Improper Discard of Toxic Drugs Hurts Environment,
Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp
1576-1578.
 Pharmaceutical Waste Survey, King County, Washington
State, April 29, 2003,
http://apps01.metrokc.gov/govlink/hazwaste/publications/i
ndex.cfm Go to IRAQ for several references on Rx
 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