New York State Council of Health-system Pharmacists What Hospitals Need to Know About Pharmaceutical Waste Compliance New York State Council of Health-system Pharmacists May 9, 2010 Presented by Enrico Vona, Stericycle, Inc.

Regulations & References Pharmaceutical Waste Management Regulations & References   The information provided in this presentation is based on the referenced Code of Federal Regulations and State regulations. This data is presented only as a reference. For complete requirements or legal counsel on hazardous waste regulations and interpretations, generators should consult their legal department, the applicable Code of Federal Regulations and applicable State regulatory agencies.

Disclosure Declaration Pharmaceutical Waste Management Disclosure Declaration   As a Stericycle employee, I have a vested interest in and affiliation with a corporate organization offering financial support or grant monies for this continuing education activity and, a business interest in pharmaceutical waste management services.

Understanding the Issues Pharmaceutical Waste Management Understanding the Issues   Is your facility currently properly segregating and disposing of pharmaceutical waste? Does your facility manage such a disposal process internally or use outside resources? Do you know what is considered “pharmaceutical waste”?

Presentation Objectives Pharmaceutical Waste Management Presentation Objectives Issues & concerns behind the focus on RX waste Federal and State regulations Regulatory & industry issues Hazardous RX waste Service requirements for compliant RX waste management Implementing a pharmaceutical waste program

RX Waste Disposal – Who Is Involved? Pharmaceutical Waste Management RX Waste Disposal – Who Is Involved? Environmental Protection Agency (EPA-RCRA & CWA) Department of Transportation (DOT) Drug Enforcement Agency (DEA) Occupational Safety & Health (OSHA) New York State Department of Environmental Conservation (NYS DEC) New York State Attorney General (NYS AG) Publicly Owned Treatment Works (POTW) The Joint Commission (TJC)

Pharmaceutical Waste Management A Growing Concern USGS (US Geological Survey) Water Survey (1999-2000) Organic Wastewater Contaminants (OWCs) in 80% of streams tested 33% of OWCs detected were pharmaceuticals in Minnesota alone Media Coverage 3/9/08 USA Today - “AP Probe finds drugs in drinking water” 9/15/08 USA Today/AP report - “Hospitals dumping drugs into water” EPA & NYS DEC Regulatory Activity Notice of Violations and warnings Increasing regulatory scrutiny country wide Fines in excess of $275,000 NYS AG Enforcement Investigations of NYC Watershed hospitals spreading state-wide The Joint Commission (TJC) Medication Management, Environment of Care, and Leadership standards

Common EPA Inspection Issues Pharmaceutical Waste Management Common EPA Inspection Issues Hazardous waste determinations not done or incorrect Labeling of hazardous waste not done or incorrect Throwing HW down the drain Improper disposal of chemotherapy drugs Inadequate training for employees in HW management Not conducting proper weekly inspections of HW storage No or inadequate HW manifests Lack of emergency contingency plan Improper management of expired pharmaceuticals “Identification and Management of Regulated Hazardous Waste” – EPA Region 2 Common EPA Identified Violations. In light of EPA and DOT regulations, consider these common EPA identified issues: •HW determinations and labeling that is incorrect or not done – remember, HW labeling must meet U.S. DOT requirements •Pouring HW down the drain •Improper disposal of chemo waste •Inadequate or no HW management employee training •Not performing weekly inspections of HW accumulation areas •Lack of or inadequate HW manifests •Poor/improper management of expired/outdated pharmaceuticals •No Emergency Contingency Plan •Failure to determine/identify RCRA HW

Pharmaceutical Waste Management TJC Accreditation MM.01.01.03 - Medication Management The hospital safely manages high-alert and hazardous medications The hospital identifies, in writing, its high-alert and hazardous medications The hospital has a process in place that addresses how outside resources, if any, are used for the destruction of pharmaceuticals. EC.02.02.01 - Environment of Care The hospital manages its hazardous materials wastes risks. The hospital minimizes risk associated with disposing hazardous medications. LD.04.01.01 - Leadership The hospital complies with law and regulation. EM.02.02.05 – Emergency Management The organization prepares for how it will manage hazardous materials and waste. Common EPA Identified Violations. In light of EPA and DOT regulations, consider these common EPA identified issues: •HW determinations and labeling that is incorrect or not done – remember, HW labeling must meet U.S. DOT requirements •Pouring HW down the drain •Improper disposal of chemo waste •Inadequate or no HW management employee training •Not performing weekly inspections of HW accumulation areas •Lack of or inadequate HW manifests •Poor/improper management of expired/outdated pharmaceuticals •No Emergency Contingency Plan •Failure to determine/identify RCRA HW

Understanding the Issues Pharmaceutical Waste Management Understanding the Issues   Do you know what is considered “pharmaceutical waste”? Is pharmaceutical waste all either P- or U-listed?

Waste Characterization Pharmaceutical Waste Management Waste Characterization Identify all Listed and Characteristic RCRA Hazardous RX Characterization must be based on both active AND inactive or preservative ingredients Determine both EPA/RCRA and DOT hazardous material class at NDC level Consider industry best practices (NIOSH, ASHP & OSHA) re: identifying non-RCRA chemo & environmentally dangerous drugs NOTE: MSDS sheets do not always provide information on inactive/preservative ingredients

EPA-RCRA Hazardous Drugs Categories Pharmaceutical Waste Management EPA-RCRA Hazardous Drugs Categories Listed Waste (Commercial Chemical) P – Listed (Coumadin/warfarin, epinephrine*, nitroglycerin*, nicotine, arsenic trioxide) U – Listed (chemotherapy drugs) *Requires State adoption of EPA interpretations re: epinephrine salts and medicinal nitroglycerin. Characteristic Waste – Ignitable, Corrosive, Reactive, Toxic Compatible vs. Non-Compatible Drugs that can (Compatible) and CANNOT (Non-Compatible) be placed in the same container without danger of a chemical reaction EPA RCRA regs identify and define two categories of RCRA hazardous waste: Characteristic and Commercial Chemical (Listed) hazardous waste. The Characteristic definition is based on chemical properties with clearly defined parameters. Commercial Chemical or Listed haz waste is chemical specific. Two other hazardous waste categories that must be considered are: dual waste and incompatible hazardous waste.

Pharmaceutical Waste Management RCRA Characteristic Hazardous Waste Ignitability - Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F., D001 waste. Corrosivity - An aqueous solution having a pH <= 2 or >= to 12.5, D002 waste. Reactivity – Must meet eight separate criteria identifying certain explosive and water reactive wastes. D003 waste. NOTE: Nitroglycerin formulations are excluded federally from the P081 listing as non-reactive as of August 14, 2001 under FR: May 16, 2001. States must have adopted the exclusion. Toxicity - Approximately 40 chemicals which meet specific leaching concentrations. Examples of toxic pharmaceuticals at indicated maximum concentrations: Arsenic (5.0 mg/L), Barium (100.0 mg/L), Mercury (0.2 mg/L), Cadmium 1.0 mg/L), Chloroform (6.0 mg/L), Selenium (1.0 mg/L), Chromium 5.0 mg/L), Silver (5.0 mg/L), m-Cresol (200.0 mg/L) Infectious waste—      (i)   General. Municipal and residual waste which is generated in the diagnosis, treatment, immunization or autopsy of human beings or animals, in research pertaining thereto, in the preparation of human or animal remains for interment or cremation, or in the production or testing of biologicals, and which falls under one or more of the following categories:        (A)   Cultures and stocks. Cultures and stocks of infectious agents and associated biologicals, including the following: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines except for residue in emptied containers; and culture dishes, assemblies and devices used to conduct diagnostic tests or to transfer, innoculate and mix cultures.        (B)   Pathological wastes. Human pathological wastes, including tissues, organs and body parts and body fluids that are removed during surgery, autopsy, other medical procedures or laboratory procedures. The term does not include hair, nails or extracted teeth.        (C)   Human blood and body fluid waste.          (I)   Liquid waste human blood.          (II)   Blood products.          (III)   Items saturated or dripping with human blood.          (IV)   Items that were saturated or dripping with human blood that are now caked with dried human blood, including serum, plasma and other blood components, which were used or intended for use in patient care, specimen testing or the development of pharmaceuticals.          (V)   Intravenous bags that have been used for blood transfusions.          (VI)   Items, including dialysate, that have been in contact with the blood of patients undergoing hemodialysis at hospitals or independent treatment centers.          (VII)   Items saturated or dripping with body fluids or caked with dried body fluids from persons during surgery, autopsy, other medical procedures or laboratory procedures.          (VIII)   Specimens of blood products or body fluids, and their containers.        (D)   Animal wastes. Contaminated animal carcasses, body parts, blood, blood products, secretions, excretions and bedding of animals that were known to have been exposed to zoonotic infectious agents or nonzoonotic human pathogens during research (including research in veterinary schools and hospitals), production of biologicals or testing of pharmaceuticals.        (E)   Isolation wastes. Biological wastes and waste contaminated with blood, excretion, exudates or secretions from:          (I)   Humans who are isolated to protect others from highly virulent diseases.          (II)   Isolated animals known or suspected to be infected with highly virulent diseases.        (F)   Used sharps. Sharps that have been in contact with infectious agents or that have been used in animal or human patient care or treatment, at medical, research or industrial laboratories.      (ii)   Mixtures.        (A)   The term also includes materials identified under subparagraph (i) that are mixed with municipal and residual waste, including disposable containers.        (B)   The term also includes mixtures of materials identified in subparagraph (i) with quantities of radioactive waste not subject to regulation.      (iii)   Exceptions. The term does not include the following:        (A)   Wastes generated as a result of home self-care.        (B)   Human corpses, remains and anatomical parts that are intended for interment or cremation, or are donated and used for scientific or medical education, research or treatment.        (C)   Etiologic agents being transported for purposes other than waste processing or disposal pursuant to the requirements of the United States Department of Transportation (49 CFR 171.1—190), the Department of Transportation (67 Pa. Code Part I) and other applicable shipping requirements.        (D)   Samples of infectious waste transported offsite by Commonwealth or United States government enforcement personnel during an enforcement proceeding.        (E)   Body fluids or biologicals which are being transported to or stored at a laboratory prior to laboratory testing.        (F)   Ash residue from the incineration of materials identified in subparagraphs (i) and (ii) if the incineration was conducted in accordance with §  283.402 (relating to infectious waste monitoring requirements). The ash residue shall be managed as special handling municipal waste.        (G)   Reusable or recyclable containers or other nondisposable materials, if they are cleaned and disinfected, or if there has been no direct contact between the surface of the container and materials identified in subparagraph (i). Laundry or medical equipment shall be cleaned and disinfected in accordance with the United States Occupational Safety and Health Administration Requirements in 29 CFR 1910.1030 (relating to bloodborne pathogens).        (H)   Soiled diapers which do not contain materials identified in subparagraph (i).        (I)   Mixtures of hazardous waste subject to Article VII (relating to hazardous waste management) and materials identified in subparagraph (i) shall be managed as hazardous waste and not infectious waste.        (J)   Mixtures of materials identified in subparagraph (i) and regulated radioactive waste shall be managed as radioactive waste in accordance with applicable Commonwealth and Federal statutes and regulations, including, but not limited to, §  236.521 (relating to minimum requirements for classes of waste).        (K)   Mixtures of materials identified in subparagraph (i) and chemotherapeutic waste shall be managed as chemotherapeutic waste in accordance with this article.

EPA Interpretations & Guidance Statements Pharmaceutical Waste Management EPA Interpretations & Guidance Statements Epinephrine Salts Epinephrine salts/hydrochloride considered non-hazardous Medicinal Nitroglycerin Nitroglycerin formulations are excluded federally from the P081 listing as non-reactive. NOTE: Does not address RCRA Characteristic of Ignitability of inert or preservative ingredient in some injectable forms of nitroglycerin NDC 0517-4805-25 5ml Single Dose Vial - 25mg/5ml, box of 25 NDC 0517-4810-25 10ml Single Dose Vial – 50 mg/10ml, box of 25 Each ml contains: Nitroglycerin 5 mg, Alcohol 30%, Propylene Glycol 30% and water for injection. Flashpoint of 31°C/83ºF. Syringe Exclusion Allows disposal of used epinephrine syringes with residue as well as used syringes used to administer other P- and U-listed pharmaceuticals in red sharps containers as regulated medical waste

(U-Listed & Non-hazardous) Chemo Waste Disposal “Trace” Chemo (syringe, IV, tubing, PPE) (U-Listed & Non-hazardous) “Bulk” Chemo (syringe, IV, tubing, PPE (P & U Listed) Bulk Chemo Waste Container This is how it should be done. Note the proper segregation. Chemo Sharps Container Hazardous Waste Disposal RMW Disposal

Hospital RX Formulary Analysis Pharmaceutical Waste Management Hospital RX Formulary Analysis # NDC’s % NDC’s 2,615 100.0% Total Characterized 196 7.5% RCRA Hazardous 2,419 92.5% Non-Hazardous P&U Listed vs Characteristic 196 100.0% Total RCRA Hazardous 146 74.5% Characteristic Hazardous 50 25.5% Total P&U Listed Hazardous 30 (15.3%) P-Listed Hazardous 20 (10.2%) U-Listed Hazardous Compatibility 182 93.0% Hazardous Compatible 14 7.0% Hazardous Non-Compatible

The Basics of Pharmaceutical Waste Pharmaceutical Waste consists of any Pharmaceutical Product that is: No longer used for their intended purpose Designated for discard Not returnable for credit Pharmaceutical Waste Partial vials (safety caps removed) Un-dispensed, pre-instilled IV’s Hospital repacks Pre-filled syringes Partial syringes Discontinued meds Un-administered meds Patient prescriptions Physician RX samples

Examples of Listed RX Waste U – Listed Chemotherapy drugs Cytoxan Chloroform Mercury Mitomycin Phenol Saccharin Selenium Sulfide P – Listed Arsenic trioxide Epinephrine (Base) Nicotine Physostigmine Warfarin

Characteristically Hazardous Waste Characteristic Hazardous Lantus Humalog Humulin N Humulin R Centrum Silver Flovent Taxol Atrovent

Pharmaceutical Waste Management Status Pharmaceutical Waste Management EPA Waste Generator Status Large Quantity Generator > = 1000 kg/mo of non-acute hazardous waste = 1 kg/mo acute hazardous waste (P-Listed) Small Quantity Generator Between 100 kg and 1000 kg/mo of non-acute hazardous waste < 1 kg/mo of acute hazardous waste (P-Listed) CESQG Conditionally Exempt Small Quantity Generator < or = 100 kg/mo of non-acute hazardous waste

Pharmaceutical Waste Management U.S. DOT Regulations DOT regulations (49 CFR): Classification, description, and packaging Proper marking and labeling Segregation into proper streams Training Security Hazmat Implementation Act: Fine section recently rewritten to raise fines Currently fines average $30,000 per violation and range up to $100,000 U.S. DOT HM229 If a generator ships hazmat without proper documentation the carrier must report it or the carrier can be prosecuted with the shipper. DOT regulations involve 4 basic requirements: 1.Classification, description, and packaging 2.Proper marking and labeling 3.Segregation into proper streams 4.Training   Hazmat Implementation Act Recently, the fine section was rewritten to raise fines. Currently fines average $30,000 per violation but can range up to $100,000. US DOT HM229 If a generator i.e. hospital ships Hazmat without proper documentation the carrier must report it or the carrier can be prosecuted with the shipper 2

RX Waste - Sewer Disposal Pharmaceutical Waste Management RX Waste - Sewer Disposal Clean Water Act (40 CFR Parts 122 and 403) A sewer connected to a publicly owned treatment works (POTW) is regulated by Federal, State, and POTW issued permits Pollutants include, sewage, chemical wastes (i.e. pharmaceuticals) and biological materials EPA notification requirement for sewer discharge of RCRA hazardous waste

Satellite Accumulation: EPA Hazardous Waste Satellite Accumulation: EPA 40 CFR 262.34(c)(1) Accumulate as much as 55 gallons of hazardous waste or one quart of acutely hazardous (P-Listed) waste At or near the point of generation where wastes initially accumulate Under the control of the operator of the process generating the waste Container requirements Marked “Hazardous Waste” or words identifying contents Compatible with waste Closed except when adding or removing waste Not be handled, opened or stored in a manner that causes it to leak 

Training RCRA Training Hazard Communication Training DOT Training Employees who are involved with or occupationally exposed to hazardous waste must be trained. Training must be completed within 6 months Annual retraining Record retention requirement Hazard Communication Training Employees who are involved with or occupationally exposed to hazardous chemicals must be trained in accordance with 29 CFR 1910.200 Training must be completed at time of initial assignment to the job DOT Training Employees who are involved with or occupationally exposed to hazardous materials must be trained in accordance with 49 CFR Subpart H 265 (172.702 & 172.704) Training must be completed within 90 days Retraining required every three years Record retention requirement

Pharmaceutical Waste Management Service & Logistics

Satellite Accumulation Identify satellite accumulation areas EPA requirements for satellite accumulation: At or near point of generation Under generator’s control Locations Pharmacy Patient-care areas Med rooms Soiled utility rooms Nurses stations

Transportation & Disposal Industry “best practice” is to incinerate all Rx Waste (ASHP, Practice Greenhealth, EPA Office of Water) Non-RCRA can be over-classified and incinerated at a regulated medical waste incineration facility RCRA hazardous waste must be transported by a licensed hazardous waste hauler RCRA hazardous waste must be incinerated at an EPA permitted hazardous waste facility Check permit limitations of hazardous waste incinerators

Staff Education Train EVS Pharmacy Nursing/Clinicians Training Topics Regulatory requirements Containers Waste segregation Transportation & Disposal

Characterization of new additions to formulary On-going Support Characterization of new additions to formulary Ongoing support - program audit and training Annual audit to ensure compliance Manifests Training Records Accumulation Area weekly inspections Proper segregation Annual EPA-RCRA training

Current Service Models RX Waste Management Current Service Models Single Container – Hazardous & Non-hazardous Not EPA or DOT compliant re: incompatible waste Requires clinician identification of 150 to 200 hazardous Rx’s Disposable container costs Over-classification of waste results in high disposal costs Computer/Bar Code Sort Floor space requirements Compatibility Based Satellite Accumulation EPA and DOT compliant re: incompatible waste Only requires clinician identification based on waste codes Reusable satellite accumulation containers Minimal floor space required

Rx Waste Management Container Data

Pharmaceutical Waste Management Rx Waste Developing a Plan for Pharmaceutical Waste Management

Pharmaceutical Waste Management Getting Started Understanding the need for a pharmaceutical waste program based on regulatory involvement and environmental concerns Evaluate how pharmaceutical waste is currently being handled in comparison to federal and state regulations Identify a group of leaders in your facility that have a passion for the environment who will champion multi-departmental cooperation and administration support  

Pharmaceutical Waste Management Getting Started Departments with champions that help advocate for compliant and environmentally responsible pharmaceutical waste disposal: Pharmacy Environmental Services Nursing Risk Management Nursing Education Infection Control Quality/Accreditation Facilities Safety

Selection and Assessment Pharmaceutical Waste Management Selection and Assessment Understanding the scope of the issue by learning which pharmaceuticals are hazardous Identifying program options In-house program or outside vendor? Compare potential cost and risk associated with each program option In-house program (cost, availability of hospital personnel) Computer system (cost, compliance concerns with commingling of compatible and non-compatible waste) Hazardous waste broker-single container (cost, compliance concerns regarding commingling, lack of knowledge and dependability) Multi-waste stream company (comprehensive, turnkey program)

Selection and Assessment Pharmaceutical Waste Management Selection and Assessment What should a Pharmaceutical Waste Program include? Characterization of entire formulary according to EPA and DOT regulations Education for staff (pharmacy, nursing, environmental services) Container system for waste collection that allows segregation according to hazard class (preferably with reusable containers to minimize waste volumes and reduce costs) Waste packing to minimize staff exposure Incineration of all pharmaceutical waste in the correct facility to assure compliance and control costs Ongoing characterization of new products Ongoing support (operations, regulatory updates, continuing staff education) Single point of contact

Program Implementation Pharmaceutical Waste Management Program Implementation Identification and Information Systems Formulary characterization Employing waste codes on pharmacy labels and in dispensing cabinets (Pyxis, Omnicell, etc.) to simplify waste segregation & disposal Select locations for pharmaceutical waste containers in pharmacies and patient care areas Staff education Pharmacy Nursing Environmental Services

What Drug Goes Where? PHARMACEUTICAL WASTE PROGRAM QUICK REFERENCE LIST 92% OF THE PHARMACEUTICAL WASTE GO IN THE BLUE BIN   EXAMPLES: IF THE BOX IS EMPTY, IT GOES IN THE BLUE BIN 6% OF THE PHARMACEUTICAL WASTE GOES IN THE BLACK BIN B WARFARIN, NICOTINE, NITRO-SUBLIGNUAL, EPINEPHRINE 1:1000 INSULINS, MOST INHALERS, NASAL SPRAYS & PATCHES 1% OF PHARMACEUTICAL WASTE GOES IN THE RED BAG R IVIG, ALBUMIN, HEMOPHILIC FACTORS 1% OF PHARMACEUTICAL WASTE IS RETURNED TO PHARMACY S GLYCOPYRROLATE, SILVER NITRATE STICKS ITRACONAZOLE SUSPENSION, CYANIDE ANTIDOTE KIT (ED) REMINDER: CHEMOTHERAPY FOLLOWS EXISTING POLICY Y GANCICLOVIR, GEMCITABINE, RITUXIMAB, CYTARABINE

What Drug Goes Where?

Waste Collection Process Pharmaceutical Waste Management Waste Collection Process Installation of pharmaceutical waste collection containers done immediately after staff training Reinforcing proper and compliant pharmaceutical waste disposal practices with posters and “cheat sheets” Identify how to handle: Controlled Substances IV solutions that can still go down the drain Partial IV’s with instilled medications P-listed (acutely hazardous) medications and their packaging Chemotherapy 4. Container collection/exchange process

Pharmaceutical Waste Work Group Top 10 List 1. GOAL: Help protect the environment and comply with regulations & industry best practices 2. Team Building: Solicit Champions from specific disciplines. 3. Understanding the Laws and Regulations: As applicable to pharmaceutical waste 4. Assessment of the Facility: Liability, Hazardous Collection Area, Space Constraints 5. Waste Characterization: Formulary, Waste Codes & Bin Colors 6. Reverse Distributors: Expired Medications, Credits, Repackaged Medication 7. Information Systems: Labels, Reminders, Electronic Dispensing Cabinets 8. Education: Training, Surveys, Follow-up, Yearly Competencies 9. Collection Process: Timely, Back-up Plan, Sort Data, Re-tooling 10. Continuous Follow-up: Regular Program Evaluations, Continuous Improvements

Rx Waste Summary

Pharmaceutical Waste Management Regulatory and TJC compliance Environmental Stewardship Understanding what pharmaceutical waste is and how to handle it Implementing a sustainable program Questions?

RX Waste Compliance Program Thank You