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.”
 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 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
 Low sperm counts(50% reduction since 1939)
 Infertility
 Genital deformities
 Hormonally triggered human cancers
 Neurological disorders in children
 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:
 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
 Contents of Current Pharmaceutical Waste Streams
CHEMO WASTE CHEMO WASTE
MUNICIPAL WASTE SEWER SYSTEM - SHARPS RED SHARPS
- SOFT

• Packaging • IV’s • Vials • Gowns • Vials

• Empty glass bottles - D5W - Empty (trace) • Gloves - Empty
• Empty plastic bottles - NaCl - Partial (residue) • Goggles - Partial
• Paper - Other? • Syringes/Needles • Tubing • Syringes/Needles
- Empty • Wipes - Empty
• Plastic • Controlled
- Unused, partial • Spill clean up? - Unused, partial
• Food waste, etc. substances?
• IV’s • IV’s
• Antibiotics? - Empty - Empty
- Unused, partial - Unused, partial
• Spill clean up?

LANDFILL OR WATER AUTOCLAVE/

MEDICAL WASTE INCINERATOR
MUNICIPAL INCINERATOR TREATMENT PLANT MICROWAVE

Ash Shredded (?)

Leachate into Discharge to
ground water or surface waters
air emissions
NON-HAZARDOUS LANDFILL

Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC
How is Pharmaceutical Waste Generated
at the Healthcare Facility?
 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?
 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?
 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
 Sole active ingredient
 Characteristic of hazardous waste
 Ignitability
 Toxicity
 Corrosivity
 Reactivity
 Examples of P-Listed
Pharmaceutical Waste
 Arsenic trioxide P012
 Epinephrine P042
 Nicotine P075
 Nitroglycerin P081
 Phentermine (CIV) P046
 Physostigmine P204
 Physostigmine Salicylate P188
 Warfarin >0.3% 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 P-
listed
 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”
 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
 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 HAZARDOUS WASTE
- TOXIC - IGNITABLE NON-HAZARDOUS
NON-INFECTIOUS RX

MUNICIPAL
Hazardous waste MEDICAL INCINERATOR
broker and transporter WASTE PERMITTED
INCINERATOR FOR SPECIAL
WASTE

Ash Ash
FEDERALLY PERMITTED
HAZARDOUS WASTE INCINERATOR
(HIGH TEMPERATURE, SCRUBBERS)
NON-HAZARDOUS LANDFILL

Ash

LINED HAZARDOUS Leachate

WASTE LANDFILL

Copyright © 2002 by PharmEcology™ Associates, LLC

 Recommended Revised Pharmaceutical Waste Streams
HAZARDOUS HAZARDOUS CHEMO CHEMO NON- RED
MUNICIPAL SEWER
WASTE WASTE WASTE WASTE HAZARDOUS SHARPS
SYSTEM - TOXIC - IGNITABLE RX
- SHARPS - SOFT

• Packaging • IV’s • P-listed • D-listed Ignitable • Vials • Gowns All waste • Non-chemo
• Empty bottles - D5W • U-listed - Collodion - Empty • Gloves pharmaceuticals vials
• Paper - NaCl • D-listed toxic - Oxidizers • Syringes/Needles • Goggles NOT hazardous - Empty
• Plastic • Controlled (Heavy metals) - Ignitable - Empty • Tubing including • Non-chemo
• Chemo agents compressed • IV’s • Wipes antibiotics, IV’s syringes/
• Food waste, etc. Substances?
(residue, bulk) gas - Empty needles
• Antibiotics? • Chemo spill clean up - Empty
• Hazardous spill clean up
• Risk management:
• Recycle as • Check with - Antivirals
much paper, municipal water - Others
glass, plastic treatment plant MUNICIPAL
as possible for limits,
MEDICAL WASTE INCINERATOR AUTOCLAVE/
recommendations
INCINERATOR PERMITTED MICROWAVE
• Use shredder
where patient FOR SPECIAL
privacy is an FEDERALLY PERMITTED WASTE
issue HAZARDOUS WASTE
INCINERATOR (HIGH
TEMPERATURE, SCRUBBERS)
Ash Ash Shredded (?)

Ash

NON-HAZARDOUS LANDFILL
LINED HAZARDOUS
WASTE LANDFILL

Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC
 Where Should RCRA Hazardous
Waste Be Stored?
 Hazardous Waste Yellow Hazardous
Storage Waste Label
Accumulation Site:
 Same locked area as
mercury, xylene,
formaldehyde, lab
chemicals
 Maximum storage
time: 90 or 180 days
based on generator
status
 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 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 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
wastes
 Train all relevant staff on the reasons for the new
system
 Jump-Starting the Process
 Electronic 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 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.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#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