Transcript Managing Pharmaceutical Waste Stanford Hospital & Clinics

Pharmaceutical Waste
Management &
Minimization
Janet Bowen, EPA
March 26, 2008
Overview of Presentation
• Environmental impacts of prescription drugs
• Review of 10-Step Blueprint including Regulatory
Requirements
• Federal role: White House disposal guidelines,
research, & policy implications
• Stewardship activities – state programs
• Region II enforcement summary
• Additional Programs
1st National Study Revealed Extent of
Pharms in Waterways
• USGS “Reconnaissance” study in 1999-2000 was
1st nationwide investigation of pharms, hormones,
& other organic contaminants in 139 streams in 30
states:
– 82 of 95 antibiotics, prescription & non-prescrip drugs,
steroids, & hormones were found in at least 1 sample
– 80% streams had 1 or more contaminant
– 75% streams contained 2 or more
– 54% had more than 5
– 34% had more than 10
– 13% tested positive for more than 20 targeted contaminants
National & International Studies Have
Shown…
• Male fish, alligators, frogs, & other species with female organs &
eggs
• Declines in human sperm counts, rise in female infertility
• Pharm compounds found at wastewater treatment plants
• Anti-cholesterol drug nearly killed test fish
• Cocktail of 13 drugs inhibited kidney cell growth
• Prozac linked to premature release of mussel larvae
• Associated Press Probe finds drugs in drinking water
• National Pharm Listserve
http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste
How Pharmaceuticals enter the
Environment
Two Routes
• Excretion of unmetabolized medications
• Waste of unused medications
PURPOSEFUL
INADVERTENT
Why Can’t We Take the PPCPs out of the
Water?
• POTWs are not designed to remove PPCPs
• Promising technologies include:
–
–
–
–
–
Oxidation
Ozonation
Ultrasound
Activated carbon
Reverse osmosis
• Longer retention times (POTWs with nutrient removal)
look promising
• Focus on controlling disposal at source
Managing Pharmaceutical Waste:10
Step Blueprint for Health Care
Facilities
Introduction to a pharmaceutical waste
management tool – use it to implement
a pharmaceutical waste management
system!
http://www.h2eonline.org/docs/h2epharmablueprint41506.pdf
Review of the 10 Steps
Step 1 Getting Started
– Support from Senior Management
– Develop a Committee
– Plan for opportunities, challenges and
financial implications to making changes,
improvements in your facility.
Step 2: Understanding the Regulations
Hazardous Waste Background

What is Hazardous Waste:
• Waste that is dangerous or potentially harmful to
human health or the environment
• Can be liquids, solids, contained gases, or sludges

Hazardous waste is regulated under the Resource
Conservation and Recovery Act (RCRA):
• Appears on one of the four hazardous wastes lists
(P-list, U-list, F-list, or K-list)
• Or exhibits at least one of four characteristics
(Ignitability, Corrosivity, Reactivity, or Toxicity)
Hazardous Waste Background
• In all states, the Environmental Department is the agency
authorized to regulate hazardous waste under RCRA
• A discarded pharmaceutical may be identified as a
hazardous waste if it appears on a regulatory list of
hazardous wastes (P or U) or exhibits one of four
hazardous characteristics (ignitability, corrosivity,
reactivity or toxicity)
Healthcare Environmental Resource Center
www.hercenter.org
Step 2 Understanding the Regulations
P-Listed Wastes
• P-Listed Wastes
– Sole active ingredient
– Unused – drug has not been given to a patient
• Empty Containers
– Empty if triple rinsed
– Rinsate must be managed as hazardous waste
– Rinsing generally not practical for pharmaceutical
waste
Hazardous Waste:
Listed

If the pharmaceuticals you are using appears on these
lists, the waste must be handled as a hazardous waste

Common P-Listed Pharmaceuticals:
Arsenic trioxide
P012
Epinephrine
P042
Nicotine
P075
Nitroglycerin
P081
Physostigmine
P204
Physostigmine salicylate
P188
Warfarin >0.3%
P001
•
Please note that this list is not intended to be complete. The
full list of all P-listed wastes appear in the Code of Federal
Regulations, 40 CFR 261.33.
Step 2 Understanding the Regulations
Regulatory Interpretation:
Epinephrine Salts
• October 15, 2007 EPA Memo
http://www.epa.gov/region1/healthcare/pdfs/EpiMemo_Final.pdf
• Epinephrine salts are not a P042 listed
waste (federally)
• States are delegated the RCRA program
and can be more stringent
Step 2 Understanding the Regulations
Nitroglycerin Exemption
• Medical nitroglycerin removed as a P-listed waste
– Weak, non-reactive, formulation
• Some formulations may fail ignitability characteristic
– Waste injectables
– Aerosols
• State may be more stringent (or may be still adopting the
rule) – check with your state on their position on
Nitroglycerin
Step 2 Understanding the Regulations
U-Listed Wastes
• U-listed Wastes
– Sole active ingredient
– Unused
• Empty Containers
– All contents have been removed that can be
removed through normal means and no more
than 3% by weight remains
– Residues removed from container must be
managed as hazardous waste
Hazardous Waste:

Listed
Common U-Listed Pharmaceuticals
Chloral Hydrate (CIV)2
U034
Mitomycin C (chemo)
U010
Chlorambucil (chemo)
U035
Paraldehyde (CIV)2
U182
Chloroform
U044
Phenacetin
U187
Cyclophosphamide
(chemo)
U058
Phenol
U188
Daunomycin (chemo)
U059
Reserpine
U200
Dichlorodifluromethane
U075
Resorcinol
U201
Diethylstilbestrol
U089
Saccharin
U202
Formaldehyde
U122
Selenium sulfide
U205
Hexachlorophene
U132
Streptozotocin (chemo)
U206
Lindane
U129
Trichloromonofluromethane
U121
Melphalan (chemo)
U150
Uracil mustard (chemo)
U237
Mercury
U151
Warfarin <0.3%
U248
•
Please note that this list is not intended to be complete. The
full list of all U-listed wastes appear in the Code of Federal
Regulations, 40 CFR 261.33.
Hazardous Waste:


Characteristic
If the pharmaceuticals you are using exhibits one of
four hazardous characteristics, the waste must be
handled as a hazardous waste
Ignitability - having a flash point less than 60oC
• Ignitable Characteristic Pharmaceuticals:




Any formulations with more than 24% alcohol
Oxidizers such as Potassium Permanganate and
Silver Nitrate
Collodion
Corrosivity - having a pH less than 2 or greater than
12.5
• Corrosive Characteristic Pharmaceuticals:

Compounding Agents such as Glacial acetic acid and
Sodium Hydroxide
Hazardous Waste:

Characteristic
Reactivity - liable to explode, or react violently or
release toxic gases when in contact with water
• Reactive Characteristic Pharmaceuticals:


Nitroglycerin
Toxicity - containing a regulated substance at a
concentration above the limit
• Toxic Characteristic Pharmaceuticals:


Zinc (some shampoos)
Selenium
How does this apply to Pharmacy?

Facilities that generate hazardous waste
are regulated as one of the following:
• Conditionally Exempt Small Quantity Generators
(CESQGs) Generate less than 100 kg of hazardous
waste per calendar month*
• Small Quantity Generators (SQGs)
Generate between 100 kg and 1000 kg of hazardous
waste per calendar month*
• Large Quantity Generators (LQGs)
Generate greater than 1000 kg of hazardous waste per
calendar month
*
And no more than 1 kg (2.2 lbs) of acutely
hazardous waste per calendar month counts
weight of container
Step 3 Consider Best Management
Practices (BMPs) for Non-Regulated
Pharmaceutical Wastes
– Recommendations made for how to manage
pharmaceutical waste to protect water bodies,
aquatic species, human health.
– Incineration (endocrine disruptors, carcinogenic
drugs, Formulations w/listed active ingredient
that is not the sole active ingredient, etc.)
– Eliminate drain disposal
– Avoid Landfilling
– Use non PVC IV Sets
Step 3 - BMPs
Managing to the Highest Standard
• Hazardous waste regulations have not
kept pace with drug development
• Approximately 10% of the drugs that are
not regulated are equally as hazardous.
• Best management practices encourage
managing drugs that are equally harmful
as hazardous waste when discarded
Step 3 - BMPs
Dartmouth Hitchcock Medical Center Waste
Characterization Summary
5%
11%
Federally
Hazardous
BMP
Hazardous
Non
Hazardous
84%
Step 3 - BMPs
Summary BMPs
•
•
•
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Drugs with more than one active ingredient
All chemotherapy drugs
Drugs meeting OSHA and NIOSH criteria
Drugs on:
– OSHA Technical Manual Appendix
– DHHS list of carcinogens
•
•
•
•
Drugs with low oral LD 50s
Endocrine disruptors
Vitamin and mineral preparations
Contaminated PPE and spill clean
up material
• Eliminate drain disposal
Step 4 Perform Review of Drug Inventory
• Obtain purchasing data from Drug Wholesaler
and/or purchasing records
– Identify ingredients
– Determine RCRA hazardous waste code
– Consider Compounded Items & Reformulations
• Gather Drug-Specific Data – national drug
code, brand name, generic name, Mfr, strength,
dosage form, package size
• Document decision making process
• Keep the review current
Step 5 Minimizing Pharmaceutical Waste
1. Consider lifecycle Impacts in Purchasing Process
–
Longer expiration date
•
–
Products with less packaging
•
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2.
3.
4.
5.
6.
Some epinephrine products have longer shelf life than others to
minimize waste from crash carts and other areas where the
drug is stored for emergencies
Packaging in contact with RCRA P-listed drugs must be
managed as hazardous waste
Products without hazardous preservatives
Maximize Use of Opened Chemotherapy Vials
Implement Samples Policy
Labeling Drugs for Home Use
Priming & Flushing IV lines w/Saline Solution
Examine Size of Containers Relative to Use
Step 5 Minimizing Pharmaceutical Waste
(cont’d)
7. Replace Prepackaged Unit Dose
Liquids w/Patient-Specific Oral Syringes
8. Try to eliminate generation of controlled
substances that are also hazardous
wastes
9. Use hard plastic buckets for delivery of
chemotherapy drugs to hospital floors –
not brown paper bags
10. Monitor dating on emergency syringes
11. Review inventory controls to
minimize outdates
Step 5 Minimizing Pharmaceutical
Waste (cont’d)
• Limitations on less hazardous drug
substitution
– Hazardous nature of drug often provides
therapeutic effect
• Always ask:
– What pharmaceuticals are being wasted?
– Why are they being wasted?
– How can wasting be minimized?
Step 6 Assess Current Practices
–Conduct Department Reviews
–Conduct Analyses Frequently
–Confirm your Generator Status
Step 7 Taking On Communication Labeling
Challenge
• Automating the Labeling Process
• Manually Labeling in the Pharmacy
• Providing Guidance on the Floor
• Selecting a Message for the Label
• Advocate that distributors
or
manufactures label drugs
further
up the food chain
Step 8 Consider Management Options
• Segregation at the Point of Generation
• Centralizing Segregation
• Managing all drug waste as hazardous
– May be simplest and most economical
approach for small facilities with < 50 beds
– May cost large metropolitan facilities in
excess of $1M
Sample Guidance Poster
Step 9 Getting Ready for Implementation
• Locating Your Satellite Accumulation
Areas
• Evaluating Your Storage Accumulation
Area
• Selecting the Right Vendors
• Conducting Pilots
• Putting it all together: Policies and
Procedures
• Preparing for Spills
Locating Satellite Accumulation
Areas
• Located at the point of generation and under control of
operator (check with state)
– Soiled utility room in nursing unit
– Sterile processing clean room and other areas of
pharmacy
• Hazardous waste label
• Signage indicating Satellite Accumulation
• Keep container covered when not in active use
• Quantity Limit
– Up to 1 quart of P listed waste and 55 gallons of combined U and
characteristic waste
• Have 3 days to move when limit is reached
Step 10 Launch the Program
• Educate & Train Staff
• Staging the Roll-out
• Paperwork Requirements: Filling
Out Required Forms
– Hazardous Waste Manifests
– Land Disposal Restrictions
• Tracking, Measuring &
Recording Progress
Federal Role:
Agency Interests
Research
Policy Implications
Disposal Guidelines
EPA Regulatory Agenda
• Considering revising Universal Waste Rule
for inclusion of some waste
pharmaceuticals
• Office of Water evaluating the healthcare
sector, including disposal of pharm waste
from institutions, to determine need for
development of WQ criteria
EPA’s Health Services Industry Detailed
Study
What is the Scope of the Study?
• We are studying the disposal of unused pharmaceutical from the
Health Services Industry (hospitals and long-term care facilities) as
part of the EPA’s CWA Effluent Guidelines Program
• We are looking to highlight good voluntary best management
practices
What are We Studying?
• Identifying current management of unused pharmaceuticals at longterm care facilities and hospitals
• Summarizing federal, local, and regional requirements, guidance,
and voluntary initiatives
• We are soliciting volunteers to fill out a data request
What is our Schedule?
• August 2008 Preliminary Report of Health Services
Health Services Industry Study Outreach
January 2008
Federal Disposal Guidelines
Feb. 20, 2007
• Federal govt. guidelines for proper disposal of unwanted
medications
– ONDCP issued February 2007
– Reaches across several Federal agencies
– Encourages trash disposal—after drugs made
unusable
– Discourages flushing
Federal Disposal Guidelines
• Take unwanted meds out of original containers & put
in trash
• Mix prescription drugs with undesirable substance,
(e.g., used coffee grounds or kitty litter) & put in
impermeable, non-descript containers
• Flush only if label says to do so
– FDA lists 13 pharms that should be flushed
• Use community return programs where available
http://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_dispo
sal.html
SMARxT Disposal
The SMARXT DISPOSAL campaign is designed to raise
awareness about the potential environmental impact from
improperly disposed of medications and to provide proactive
guidance through proper disposal alternatives.
SMARXT DISPOSAL is a unique public-private partnership
between the U.S. Fish and Wildlife Service, the American
Pharmacists Association, and the Pharmaceutical Research
and Manufacturers of America. This support and involvement
is what separates SMARXT DISPOSAL from other initiatives
and it will ultimately make this campaign successful.
Website just released!
SMARxTDisposal.net
Stewardship Activities
Types of Stewardship Activities
•
•
•
•
•
•
•
1-time consumer return collections
Household haz waste collections
Permanent collection boxes
Use of police stations
Pilot use of reverse distributors
Pilot mail-back programs
Many of these programs require
involvement of a pharmacist (DEA)
EPA Stewardship Activities
• EPA’s new PPCP web site
http://www.epa.gov/ppcp/
• 2 recently funded programs in Maine &
Missouri thru Aging Initiative
– Mail-back & take-back return programs
– Inventories of types & quantities of drugs
returned
Northeast Recycling Council grant
Management of Unwanted Pharmaceuticals
• Researching and addressing legal issues with
take-back programs,
• Developing drug collection pilots, including one
nearby in South Portland, Maine,
• Developing a “Guidebook for Holding Unwanted
Medication Collections,”
• Developing Best Management Practices for the
end-of-life management of plastic medication
containers.
Website – where you can download all materials
http://www.nerc.org/projects/completed_projects.html#2006-a
Results EPA Region II:
Compliance Monitoring & Incentives Programs
Hospitals
Universe
480
Inspections
49
Enforcement Actions
36
Formal Enforcement Actions
11 ($1,523,613)
Settlements
9 ($642,612)
Audit Agreements
41
Voluntary Disclosures
156 covering 581 facilities ($29,947,688
for 143 resolved)
Violations Corrected
3223
Adapted from Region 2 August 2006
47
Healthcare Violations – All R2
Breakout of Violations from Hospital Disclosures
-Clean Air Act
CAA Violations
18%
Emergency
& Planning
Community Right
to Know - EPCRA
Violations 7%
- Clean Water Act
CWA Violations
4%
Toxic Substance
Control Act -TSCA
Violations 1%
-Hazardous Waste
RCRA Violations
70%
Adapted from Region 2 August 2006
presentation
Safe Drinking
Water Act - SDWA
Violations 0%
48
Top 5 Violations
(From 146 Voluntary Disclosures)
Rank
1
Violation
Statute
ID of Hazardous Waste RCRA – Hazardous
Frequency
592
waste
2
Universal Waste
RCRA– Hazardous
446
waste
3
4
Container
Management
Labeling
RCRA– Hazardous
331
waste
RCRA– Hazardous
304
waste
5
CFC Leak Detection
Records
CAA – Clean Air Act
Adapted from Region 2 August 2006
presentation
264
49
Healthcare RCRA Violations
Breakout of RCRA Violations from Hospital Disclosures
UST 3%
Generator
Requirements 5%
Container
Management 30%
ID of HW 26%
General Facility
Standards 10%
Accumulation Time
1%
Manifest 5%
Adapted from Region 2 August 2006
presentation
Universal Waste
20%
50
Region II Data – New Data
• Region II summer intern recently reviewed
disclosures for "failure to identify" and
"mischaracterization of HW" related
violations.
• Data based on 100 hospitals
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Number of Violations
(found in 100 facilities)
Violation Type
Violation Type
200
180
160
140
120
100
80
60
40
20
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Hazardous Waste
Characterization
Hazardous Waste Characterization
160
140
120
100
80
60
40
20
0
ENERGY STAR is…
A voluntary partnership
with EPA
A strategic approach to
energy management
54
Energy Star
Purchasing and Procurement
• Buy Energy Star Products
Product information
Cost saving information, saving calculators
Procurement information, sample language
http://www.energystar.gov/index.cfm?c=bulk_purch
asing.bus_purchasing
• Take free on-line procurement training,
http://energystar.premiereglobal.com/attendee/ConferenceList.aspx
General Resources
Healthcare Environment Resource Center
www.hercenter.org
Healthcare Without Harm
http://www.noharm.org/
Sustainable Hospital Project
http://www.sustainablehospitals.org/cgi-bin/DB_Index.cgi
Practice Green Health (includes former H2E)
http://www.h2e-online.org
56
General Resources (Cont.)
• Building Healthy Hospitals: Top 5 Green Building
Strategies for Healthcare (2007)
•
•
•
•
•
#1 Energy Efficiency
#2 Process Water Efficiency
#3 Sustainable Flooring Material Selection
#4 Indoor Air Quality: Material Selection
#5 Lighting Efficiency
http://www.epa.gov/region09/waste/p2/greenbldg.html
Questions ?
Want to join EPA Region 1’s hospital email
group for regular updates on
environmental issues?
Janet Bowen, EPA Region 1
617-918-1795
[email protected]