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 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 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.h2e-online.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
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
U121 Melphalan (chemo) U150 Uracil mustard (chemo) U237 Please note that this list is not intended to be complete. complete. The full list of all Mercury U151 Warfarin <0.3% U248 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
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 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 (contd) 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 (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? 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 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 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 disposalafter 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_disposal.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 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 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
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 Violation Statute Frequency 1 ID of Hazardous
RCRA Hazardous 331 4 Labeling RCRA Hazardous 304 5 CFC Leak Detection Records CAA Clean Air Act
264 waste waste waste waste Adapted from Region 2 August 2006 presentation 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 Violation Type Violation Type 200 180 Number of Violations (found in 100 facilities)
160 140 120 100 80 60 40 20 0 Hazardous Waste Characterization Hazardous Waste Characterization 160 140 Number of Violations
(Found in 100 Facilities) 120 100 80 60 40 20 0 b la
ch em ica l m al et m ar ph a al
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in pa t m fil a h lco ol 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_purchasing.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 1s hospital email group for regular updates on environmental issues? Janet Bowen, EPA Region 1 617-918-1795 [email protected]
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