Pharmaceutical Waste Management

1
Pharmaceutical Waste Management Minimization

• Janet Bowen, EPA
• NEHES Conference, March 21, 2008

2
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

3
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

4
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/listi
  nfo/pharmwaste

5
How Pharmaceuticals enter the Environment

• Two Routes
• Excretion of unmetabolized medications
• Waste of unused medications

6
PURPOSEFUL
INADVERTENT
7
(No Transcript)
8
Concerns with Pharmaceuticals

• May degrade quickly, but constant input to water
• Possible subtle effects, even at ppb
• Chlorine in DW or WW makes some pharm by-products
  more toxic
  
• Unknown toxicants, in unknown amounts, in varied
  conditions either singly or in combination with
  other potential toxicants
  
• Potential for cumulative and synergistic effects
  from multiple exposures
  
• More questions than answers about effects of
  pharms on aquatic species human health
  

9
Why Cant 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

10
Managing Pharmaceutical Waste10 Step Blueprint
for Health Care Facilities

• Introduction to a pharmaceutical waste management
  tool use it to implement a pharmaceutical waste
  management system!
  
• http//www.h2e-online.org/docs/h2epharmablueprint4
  1506.pdf

11
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.
  

12
Step 2 Understanding the RegulationsHazardous
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)

13
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

14
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
  

15
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

16
Step 2 Understanding the Regulations Regulatory
Interpretation Epinephrine Salts

• October 15, 2007 EPA Memohttp//www.epa.gov/regio
  n1/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

17
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
  

18
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

19
Hazardous Waste Listed

• Common U-Listed Pharmaceuticals
• 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.

20
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
  

21
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

22
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

23

• 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

24
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
  

25
Step 3 - BMPs Dartmouth Hitchcock Medical Center
Waste Characterization Summary
26
Step 3 - BMPs Summary BMPs

• 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

27

• 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

28

• Step 5 Minimizing Pharmaceutical Waste
• Consider lifecycle Impacts in Purchasing
  Process?
  
• Longer expiration date
• 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
• Products with less packaging
• 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

29

• Step 5 Minimizing Pharmaceutical Waste (contd)
• Replace Prepackaged Unit Dose Liquids
  w/Patient-Specific Oral Syringes
  
• Try to eliminate generation of controlled
  substances that are also hazardous wastes
  
• Use hard plastic buckets for delivery of
  chemotherapy drugs to hospital floors not brown
  paper bags
  
• Monitor dating on emergency syringes
• Review inventory controls to minimize
  outdates?

30
Step 5 Minimizing Pharmaceutical Waste (contd)

• 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?

31

• Step 6 Assess Current Practices
• Conduct Department Reviews
• Conduct Analyses Frequently
• Confirm your Generator Status

32

• 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

33

• 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
  
• May cost large metropolitan facilities in excess
  of 1M
  

34
Sample Guidance Poster
35

• 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

36
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

37

• 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

38

• Federal Role
• Agency Interests
• Research
• Policy Implications
• Disposal Guidelines

39
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

40
EPAs 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 EPAs 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 long-term 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
41
Federal Disposal GuidelinesFeb. 20, 2007

• Federal govt. guidelines for proper disposal of
  unwanted medications
  
• ONDCP issued February 2007
• Reaches across several Federal agencies
• Encourages trash disposalafter drugs made
  unusable
  
• Discourages flushing

42
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/facts
  ht/proper_disposal.html
  

43
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

44

• Stewardship Activities

45
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)
  

46
EPA Stewardship Activities

• EPAs 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

47
Northeast Recycling Council grantManagement 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.ht
  ml2006-a
  

48
Results EPA Region IICompliance Monitoring
Incentives Programs
48
Adapted from Region 2 August 2006
49
Healthcare Violations All R2
49
Adapted from Region 2 August 2006 presentation
50
Top 5 Violations (From 146 Voluntary Disclosures)
50
Adapted from Region 2 August 2006 presentation
51
Healthcare RCRA Violations
51
Adapted from Region 2 August 2006 presentation
52
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

53
Violation Type
54
Hazardous Waste Characterization
55
ENERGY STAR is

• A voluntary partnership
• with EPA

A strategic approach to energy management
56
Energy Star Benchmarking

• Healthcare Benchmarking
• - Evaluate your hospitals energy perf
• - Healthcare benchmarking starter kit
• www.energystar.gov/healthcare
• Portfolio Manager to benchmark energy performance
  available for
  
• - Acute care and children hospitals
• - Medical offices
• - Long Term Care, Assisted/Nursing
  Facilities (New)
  

57
New England Healthcare Facilities are Using
Energy Star

• So far, 105 New England hospitals have
  benchmarked energy performance using Portfolio
  Manager State breakdown (CT 29 MA 47, ME
  11 NH 7 RI 7 VT 4)
• Benchmarking is the first step toward improving
  energy performance
  
• Three New England hospitals have earned ENERGY
  STAR Labels
  
• St. Francis (Hartford, CT)
• VA West Haven, CT
• VA Boston Healthcare system (Jamaica Plain)

58
Energy Star ProgramE2C

• Evaluate hospitals energy performance
• July 2006 ASHE commitment to improve energy
  efficiency in hospitals by 10 Energy
  Efficiency Commitment - E2C http//www.ashe.org/a
  she/facilities/e2c/index.html
• Steps
• 1. Benchmark and share with ASHE
• 2. Leverage case studies, proven strategies, and
  networking opportunities
  
• 3. Make improvements
• 4. Apply for recognition from ASHE for 10
  improvement
  
• Resources
• E2C Quick reference Guide
• http//www.ashe.org/ashe/facilities/e2c/pdfs/e2cqu
  ickref.pdf
  

59
Energy StarPurchasing and Procurement

• Buy Energy Star Products
• Product information
• Cost saving information, saving calculators
• Procurement information, sample language
• http//www.energystar.gov/index.cfm?cbulk_purchas
  ing.bus_purchasing
  
• Take free on-line procurement training,
• http//energystar.premiereglobal.com/attendee/Conf
  erenceList.aspx

60
EnergyStar Key Resources

• Building Upgrade Manual
• http//www.energystar.gov/index.cfm?cbusiness.bus
  _upgrade_manual
  
• New Building Guidance and Target Finder
• http//www.energystar.gov/index.cfm?cnew_bldg_des
  ign.new_bldg_design
  
• Free EnergyStar Internet training
• energystar.webex.com
• New! Use Benchmarking tool to track water
  consumption http//www.energystar.gov/index.cfm?c
  business.bus_water
  

61
Contact Us
Shubhada Kambli EPA Region 1, ENERGY STAR Bos
ton, MA 617-918-1584 Kambli.Shubhada_at_epa.gov
Clark Reed National Healthcare Manager, ENERGY ST
AR Washington, D.C. reed.clark_at_epa.gov
www.energystar.gov/healthcare
62
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_Ind
  ex.cgi
  
• Practice Green Health (includes former H2E)
• http//www.h2e-online.org

63
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.htm
  l

64
Questions ?

• Want to join EPA Region 1s hospital email group
  for regular updates on environmental issues?
  
• Janet Bowen, EPA Region 1
• 617-918-1795
• Bowen.Janet_at_epa.gov
• www.epa.gov/region1/healthcare