Pharmaceutical Waste

Management
Presented by:
Nathan Funk, MHA, BS
Environmental Health & Safety Officer
WakeMed Health & Hospitals
3000 New Bern Avenue
Raleigh, NC 27610
(919) 350-8375 Office
WakeMed.org
Objectives
• What is Hazardous Waste
• What is Pharmaceutical Waste
• Waste Disposal Options
• Regulatory Enforcement
• Pharmaceutical Waste Collection Models
• Hazardous Waste Generator Status
• Proposed Management Standards for Hazardous
Waste Pharmaceuticals Rule
• Other Program Decisions
• Training
• Additional Hazardous Waste Streams
Resource Conservation &
Recovery Act (RCRA)
• Enacted in 1976, enforced by the EPA
• Federal regulation of the disposal of solid
wastes
• Defines “hazardous waste”
• Encourages the minimization of waste
generation
Hazardous Waste (40 CFR
261.31, 261.32, 261.33)
• P-Listed chemicals (acutely toxic chemicals)
• U-Listed chemicals (toxic chemicals)
• D-Listed (characteristic hazardous waste)
– Ignitability
– Corrosivity
– Toxicity
– Reactivity
• F-list (wastes from common manufacturing and
industrial processes)
• K-list (wastes from specific industries)
Examples of P-Listed Waste

• Arsenic trioxide (chemo)-P012

• Epinephrine-P042*
• Nicotine-P075
• Nitroglycerin-P081
• Phentermine (DEA CIV)-P046
• Physostigmine-P204
• Physostigmine Salicylate-P188
• Warfarin >0.3%-P001

 Containers that have held P listed wastes are not RCRA empty unless
they are triple rinsed and the rinsate discarded as hazardous waste
Examples of U-Listed Waste
• Chloral Hydrate(DEA CIV)-U034
• Chlorambucil (chemo)-U035
• Cyclophosphamide (chemo)-U058 •
• Daunomycin (chemo)-U059
• Diethylstilbestrol-U089
• Melphalan (chemo)-U150
• Mitomycin C (chemo)-U010
• Streptozotocin (chemo)-U206
• Lindane-U129
• Saccharin-U202
• Selenium Sulfide-U205
• Uracil Mustard (chemo)-U237
Warfarin<0.3%-U248
 Containers of U-Listed and
D-Listed chemicals are
empty only when
• All contents removed
that can be removed
through normal means
• And no more than 3%
by weight remains
Characteristic - Ignitability

• Examples of ignitable wastes include:

– Flammable liquids (flash point less than 140oF)
– Aqueous solutions containing >24% alcohol
– Certain compressed gases
• There are also a few strong oxidizers used in
pharmaceuticals formulations. Examples include
silver nitrate and potassium permanganate
• The regulations covering the ignitability characteristic
can be found in Title 40 of the Code of Federal
Regulations, Part 261
Characteristic - Corrosivity

• This RCRA category refers to acids (pH less than 2)

and bases (pH greater than 12.5) that are capable of
corroding metal containers, such as storage tanks,
drums, and barrels
• Examples: Primarily compounding chemicals
– Glacial Acetic Acid
– Sodium Hydroxide
• The regulations covering the corrosivity characteristic
can be found in Title 40 of the Code of Federal
Regulations, Part 261, Section 22
Characteristic - Toxicity
• Toxic wastes are harmful or fatal when ingested or
absorbed
• Approximately 40 chemicals which meet specific
leaching concentrations
• The regulations covering the toxicity characteristic
can be found in Title 40 of the Code of Federal
Regulations, Part 261, Section 24
• Arsenic • m-Cresol
• Barium • Mercury (thimerosal)
• Cadmium • Phenylmercuric
• Chloroform acetate
• Chromium • Selenium
• Lindane • Silver
Characteristic - Reactivity

• Reactive wastes are unstable under "normal"

conditions
• They can cause explosions, toxic fumes, gases, or
vapors when heated, compressed, or mixed with
water
• Examples include
– lithium-sulfur batteries
– explosives
• The regulations covering the reactivity
characteristic can be found in Title 40 of the Code
of Federal Regulations, Part 261, Section 23
What Is Pharmaceutical Waste?

• Any Partially Used or Unused Medication Including:

- Syringes
- Vials, Bottles
- IV Bags and Tubing With Medicine Additives
- Loose Pills, Tablets, Capsules
- Aerosol Inhalers
- Creams, Ointments, Shampoos
- Patient Prep-Alcohol and Iodine
• Empty Vials/Containers That Held P-Listed Drugs
- Nicotine, Warfarin, etc.
Chemotherapy Waste
• Trace Chemo
– Empty containers, flushed tubing, or
gowns and gloves that were not
spilled on
– Must be incinerated but not as a
hazardous waste
– Yellow Containers
• Bulk Chemo
– Unused or partially used chemo,
contaminated gowns or gloves, and
spill cleanup material
– Treat as Hazardous Waste
– HW Containers
Why Manage Pharmaceutical
Waste?

• Federal Regulations
– Resource Conservation & Recovery Act
(RCRA)
– Comprehensive Environmental Response,
Compensation & Liability Act (CERCLA –
a.k.a. “Superfund”)
• State Regulations (NC)
– Mirror Federal Rules & Regulations
– Recent Increased Enforcement
Why Manage Pharmaceutical
Waste?
• U.S. Geological Survey
– Measured concentrations of 95 Organic
Wastewater Contaminants in water samples from
139 streams in 30 states
• Organic Wastewater Contaminants were found in 80% of
the streams sampled
– Pharmaceuticals and Other Chemicals Common in
Landfill Waste
• Study of 19 landfills across the United States found 129 of
202 pharmaceutical (prescription and nonprescription),
household, and industrial chemicals in untreated leachate
samples (prior to treatment and environmental release)
Waste Disposal Options

• Municipal Solid Waste Landfill

– May be permitted to accept non-hazardous drug waste
• Regulated Medical Waste (RMW) Vendor
– Infectious waste, sharps
– Can accept TRACE chemotherapy waste
– May be permitted to accept non-hazardous drug waste
• Hazardous Waste Incinerator
– Permitted to handle RCRA hazardous waste
– Most are NOT permitted to handle RMW
– Can accept bulk chemotherapy waste
Regulatory Enforcement: The
Joint Commission
• Adding healthcare engineers to survey
teams
• Beginning to ask questions about waste
disposal
• JC surveyors trained on pharmaceutical
waste issues on January 3rd, 2005
Regulatory Enforcement: The
Joint Commission
• EC.01.01.01
– EP 5 The hospital has a written plan for managing the
following: Hazardous materials and waste.
• EC.02.02.01 The hospital manages risks related to
hazardous materials and waste.
– EP 1 The organization creates and maintains an inventory
that identifies hazardous materials and waste used, stored,
or generated using criteria consistent with applicable law and
regulation (for example, the Environmental Protection
Agency [EPA] and the Occupational Safety and Health
Administration [OSHA]).
NC Department of
Environmental Quality
• NC DEQ
– Division of Waste Management, Hazardous
Waste Program
– Protect public health and the environment by
assuring that solid and hazardous wastes
and underground storage tanks are managed
properly, and that existing contamination is
cleaned up
US Environmental Protection
Agency Enforcement
• Maximum penalty can be $37K per day per
instance
– Instance is individual incorrect disposal per
container per unit per facility
• Facility’s monetary benefit for noncompliance
is factored into the penalty
US EPA Enforcement
• EPA Region 2 (NY, NJ, Puerto Rico, VI)
contacted 480 hospitals in 2003 with
invitations to self audit; pharmaceutical waste
included
– North Shore University Hospital, Manhasset, NY
fined $40,000 (July 2003)
– Nassau University Medical Center, East Meadow,
NY fined $279,900 (Oct. 2003)
– Mountainside Hospital, Montclair, NJ fined $64,349
(Nov.2003)
– Memorial Sloan Kettering Cancer Center, New
York, NY, fined $214,420 (2004)
US EPA Enforcement

• Region 1(New England) contacted 250

hospitals in April, 2004
– Veterans Administration Hospital, White River,
Vermont, August 5th, 2005 cited and fined
$372,254
• Region 4 (Alabama, Florida, Georgia,
Kentucky, Mississippi, North Carolina, South
Carolina, Tennessee and 6 Tribes)
– Started hospital site inspections and fines
– NC DEQ Memo to North Carolina Hospital
Association
NC Hospital Association Memo

• NC DEQ indicated that it will

be conducting compliance inspections on
hospitals' hazardous waste management
practices
– Memo dated August 25, 2011
• Hospitals may request an onsite
compliance assistance visit from the
agency
NC Hospital Association Memo
Compliance Assistance Visits

• Conducted by NC DEQ inspectors

• Document any potential or actual
violation
• No formal Notice of Violations are issued
– Unless determined to be immediately
hazardous to health or the environment
Pharmaceutical Waste
Management Program
Action Plan
• Engage stakeholders to
provide project feedback
• Identify department to provide
program oversight
• Research vendors
• Meet with vendors to evaluate
pharmaceutical waste project
• Conduct facility assessments
with vendors to develop a
budgetary estimate
• Begin review of staff training
documents, presentations, and
policies for revision or
development
• Begin looking at supply
sourcing
• Set target dates for staff
training
• Establish central waste
accumulation areas
• Finalize staff training
documents, presentations, etc.
• Finalize contingency plans,
waste minimization plans,
other regulatory items
• Finalize date for hospital-wide
program rollout
• Conduct pharmaceutical waste
train-the-trainer sessions
system-wide
• Hospital-wide program rollout
Pharmaceutical Waste
Collection Models
Proposed Options:
• Collect only EPA regulated pharmaceutical waste
(Model 1)
• Collect all pharmaceutical waste, segregate regulated
and non-regulated (Model 2)
• Collect all pharmaceutical waste, no segregation
(Model 3)

 Also need to consider

 Who will manage program
 On-site labor support
 Supplies
Model 1 Overview

Collect only EPA regulated pharmaceutical waste

Pros:
- Lowest disposal cost (~10-15% of formulary is EPA
regulated)
- Potential for lower generator classification
- One additional container
Cons:
- Complex training
- Additional time burden for staff
- Increased liability due to potential for mistakes
Model 1 Impacts

• Have pharmaceutical formulary characterized to

determine what is EPA regulated
– Must be kept up-to-date
– New pharmaceuticals reviewed
– Service Cost
• Develop an identification system for regulated
pharmaceuticals
– Additional printers, custom labels, identify pharmaceuticals
within the Pharmacy system including at point of distribution
• Only HazWaste need to be collected
– Increased opportunity for disposal error that could lead to a
violation
Model 2 Overview

Collect all pharmaceutical waste, segregate

regulated and non-regulated
Pros:
- Accurate record of regulated waste volume
- Reduced waste costs
- Potential for lower generator classification
Cons:
- Complex training
- Additional time burden for staff
- Increased liability due to potential for mistakes
- Increased space requirements
Model 2 Impacts

• Have pharmaceutical formulary characterized to determine

what is EPA regulated
– Must be kept up-to-date
– New pharmaceuticals reviewed
– Service Cost
• Develop an identification system for regulated
pharmaceuticals
– Additional printers, custom labels, identify pharmaceuticals
within the Pharmacy system including at point of distribution
• Waste need to be segregated
– Increased opportunity for disposal error that could lead to a
violation
Model 3 Overview

Collect all pharmaceutical waste, no segregation

Pros:
- Decreased opportunity for non-compliance
- Simplified training
- Minimal time commitment for staff
- One additional container
Cons:
- Higher cost than Model 1 & 2
- Increased hazardous waste volume
- Potential for higher generator classification
Model 3 Impacts

• Do not need a pharmaceutical formulary

characterization
• Do not need to develop an identification
system for regulated pharmaceuticals
• Only need to train staff on disposal procedure
• May require higher waste generator status
 Hazardous Waste Generator
Status
Conditionally Small Quantity Large Quantity
Exempt Small Generator Generator
Regulatory
Quantity (SQG) (LQG)
Provision
Generator
(CESQG)
Hazardous Waste < 220 lbs. of HW > 220 lbs. but > 2200 lbs. of HW
Generation Rate < 2200 lbs. of HW
< 2.2 lbs. acute < 2.2 lbs. acute > 2.2 lbs. acute
HW HW HW
Pounds of hazardous waste generated in a calendar month
Management Standards for Hazardous
Waste Pharmaceuticals; Proposed Rule

• Removes Pharmaceutical Waste totals from counting

towards generator status
– Including acute hazardous waste (P-Listed)
– Still required to count other waste streams
towards total
• Bans sewer disposal of hazardous waste
pharmaceuticals
– In line with most current requirements
– Recommends to limit amount of non-hazardous
pharmaceuticals that are placed in the sewer
Management Standards for Hazardous
Waste Pharmaceuticals; Proposed Rule

• Unit dose packaging, dispensing bottles, and vials no

longer treated as hazardous waste if empty
• A healthcare facility will not have to comply with the
satellite accumulation area regulations, which are a
poor fit for healthcare facilities
• The facility will not need to specify hazardous waste
codes on manifests
• The facility will be able to accumulate hazardous
waste pharmaceuticals on site without a RCRA permit
for 365 days
• The facility will have basic training requirements
Container Decisions
• Location of containers
– Med Rooms
– Soiled Utility Rooms
– Procedure Rooms
– Nursing Stations
• Size/Type of Containers
• Single use or reusable
– Consider purchasing heavy duty liner
• Hazardous waste containers must be closed
unless waste is being added or removed
• The accumulation containers must be located
at or near the point of generation and under
the control of the operator
Pharmaceutical Waste Container
Examples
Other Supplies

• Department of Transportation rated

shipping container
– 55 gallon DOT rated Co-Pack
– Fibrous Tape
• Absorbent
– Vermiculite
• Trolleys
Privacy Labels

• Purchase additional privacy

labels
– Used on empty packaging to
cover PHI
– Empty packaging can be
disposed of in the regular
trash
Training Requirements

• Department of Transportation (DOT) Hazardous

Materials Training – required for all employees who prepare
hazardous materials for shipment, sign manifests, etc. (8 hours
every 3 years)
• OSHA Emergency Response Training (HAZWOPER) –
required for all employees who have the potential to respond or
initiate response to hazardous material spills, level of training
and classroom time dependent on employee responsibilities
(minimum 8 hours/year)
• EPA Hazardous Waste Generator Training (RCRA) –
required for all employees who handle hazardous waste
containers outside of satellite accumulation areas or who have
responsibilities related to managing central waste storage areas
(generally 8 hours/year)
Training

• Meet with leadership from key

departments
– Nursing
– Pharmacy
– Imaging
– Surgical Services
– Medical Staff
Training
Training
 Continuous Readiness Guide
Pharmaceutical Waste Program Frequently Asked Questions and Answers
# Question
1 Can sharps go into the
pharmaceutical waste
container?
Training 2 What do I do with syringes
with needles/sharps?
3 What do I do with syringes
without needles/sharps?
4 How are IV fluids disposed?
5 What if I have an IV bag with
no tubing?
6 What do I do with an empty
medication container?
7 What do I do with an aerosol,
such as an inhaler?
8 What do I do with controlled
substances?
9 What do I do with
chemotherapy waste?
Answer
If you have a sharp with an unused or partially used dose, squirt the
remaining dose into the black pharmaceutical waste container and
dispose of the sharp into the red sharps container.
If the syringe contains an unused or partially used pharmaceutical
and the needle had contact with a patient, blood, or body fluids,
engage the safety device, squirt the remaining dose into the black
pharmaceutical waste container, and dispose of the sharp into the
red sharps container.
If the needle has not had contact with a patient, blood, or body
fluids, engage the safety device, remove the sharp, place the
needle into the red sharps container, and place the syringe into the
black pharmaceutical waste container.
When in doubt or the status is not known, always consider the
sharp to be a biohazard. Dispose of the sharp into the red sharps
container.
If the syringe and needle is empty, dispose of it into the red sharps
container.
If the syringe contains an unused or partially used pharmaceutical,
place it in the black pharmaceutical waste container.
If it is empty, dispose of it as per normal practice.
IV fluids containing only the following may be disposed of down the
drain: dextrose, sodium bicarbonate, saline, vitamins, and
electrolytes. If an IV has an additional pharmaceutical added, the
unused IV fluids must be disposed of in the black pharmaceutical
waste container.
If the IV bag contains medication, place it into the black
pharmaceutical waste container in an upright position to limit the
amount of free liquid in the liner. If the IV bag does not contain
medication, the contents can be disposed of down the drain and the
empty bag placed into the trash can.
If the container does not have Protected Health Information (PHI),
place in the regular trash for disposal. If the container does have
PHI, use the Privacy Label to cover PHI and then place in the
regular trash for disposal.
All aerosols, including pressurized inhalers, will be disposed of into
the black pharmaceutical waste container.
DEA substances require a witnessed waste of partial doses. These
doses will be disposed of either down the sink drain or flushed
down the toilet. Patches need to be cut into pieces less than ¼ inch
in size before flushing.
Unused or partially used chemotherapy needs to be placed into the
black pharmaceutical waste containers.
Empty chemotherapy containers / supplies used to mix and/or to
 Continuous Readiness Guide
Pharmaceutical Waste Program Frequently Asked Questions and Answers
# Question
10 How do I remove
pharmaceutical waste from
an Isolation Precautions
Training
room?
11 What if I am unsure where to
dispose of a pharmaceutical
container?
12 Why do the containers need
to be closed?
13 Where can containers be
placed in the department?
14 How do we get more black
pharmaceutical waste
containers?
15 How do I contact the onsite
vendor program manager?
16 Can Environmental Services
pick up full black
pharmaceutical waste
containers?
17 If the department has too
many or too few black
pharmaceutical waste
containers, how do I adjust
the number and/or adjust the
locations?
18 If I have concerns about the
program, who do I call?
Answer
Refer to the CRG Removing Pharmaceutical Waste from Isolation
Precaution Rooms for step-by-step instructions.
When in doubt, place all pharmaceutical waste (with the
EXCEPTION of sharps, controlled substances,
radiopharmaceuticals, and IV fluids without medications) into the
black pharmaceutical waste container for disposal.
Regulations state that waste containers must be kept closed at all
times except when in use (actively discarding an item into them).
Regulations require the containers to be secured. Therefore,
containers will be placed into medication rooms and at continuously
occupied areas within a department.
The vendor’s staff will be rounding to remove and replace the liners
Monday thru Friday. If you have a container that is full, please
contact the vendor at the e-mail listed below. Provide your name,
the site, department, your contact number and the location of the
container that needs to be replaced.
 Nights/Weekends/Holidays:
Leave the full containers in place as only trained personnel can
move them. Obtain an additional container as per instructions
below:
o Cary Hospital and Raleigh Campus: Call Environmental
Services for your site.
o Healthplexes: Extra pharmaceutical waste containers will be
located in the MPD area on your site. Contact Campus Police
for access to this area if needed.
The vendor program manager can be contacted through the
following email address hazwaste@wakemed.org
Environmental Services is not permitted by regulations to transport
full black pharmaceutical waste containers within the facilities.
Contact Environmental Health & Safety at 919-350-8080.
Environmental Health & Safety is coordinating the budget and
operations of the program. Should you have suggestions,
questions, or concerns, contact Environmental Health & Safety at
Page 1 of 1
Training
Program Support

• How can staff contact responsible

department for questions or concerns?
– Consider a generic email address
– hazwaste@wakemed.org
• What happens on nights, weekends, or
holidays
Additional Waste Streams
• Universal Waste
– Batteries
• Need to collect for disposal/recycling all batteries except
alkaline
– Bulbs
• Fluorescent, Compact Fluorescent, Metal Halide,
Halogen, etc.
– Mercury Containing Equipment
• Thermometers, Blood Pressure Cuffs, Switches
• E-Waste
– Computers, TVs, DVD, VHS, etc.
Additional Waste Streams

• Aerosol Cans
– Maintenance Operations, Food & Nutrition,
Environmental Services, etc.
• Pathology
– Alcohols, Non-Path Vials, Analyzer Waste,
Specimens in Formalin
• Used Oil
Additional Resources

EPA BMP Guidance Practice Greenhealth

Proposed Pharmaceutical
Waste Rule Proposed Rule FAQs
Questions?
Nathan Funk
nfunk@wakemed.org