Pharmaceutical Waste & EPA Updates: New Focus/New Solutions 13th Annual Pharmacy Purchasing Networking Conference August 18th, 2009 Charlotte A. Smith, R. Ph., M.S.,HEM Director, PharmEcology Services Waste Management Healthcare Solutions, Inc.

Legal Disclaimer This presentation is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information.  

Agenda Regulatory update: What’s happening on Capitol Hill RCRA 101: How hazardous waste regulations apply to discarded pharmaceuticals Implementing a cost-effective system for managing pharmaceutical waste

Pop Quiz Is pharmaceutical waste ending up in red sharps containers in your patient care units? Are any unused IVs or other compounded prescriptions being disposed of down the drain? Are waste pharmaceuticals like warfarin and lindane, considered hazardous by EPA, being combined with non-hazardous pharmaceutical waste? 4

Pop Quiz What about items containing 24% alcohol? Or any items that contain mercury preservatives, such as vaccines, or eye and ear preparations? Are vials and IVs containing unused chemotherapy agents like Cytoxan being disposed of in chemo waste containers? 5

What’s Driving New Regulatory Initiatives?

Drugs in Drinking Water & Healthcare Pharmaceutical Waste March 9, 2008 5-month inquiry discovered that drugs were detected in the drinking water supplies of 24 major metropolitan areas September 14, 2008 Majority of 5,700 hospitals and 45,000 long-term care facilities flush unwanted drugs down the drain and do not document amounts according to EPA survey Extrapolation of data from 14 representative facilities in Minnesota yielded an estimated total volume of 250 million pounds of drug waste annually, including packaging April 19, 2009 U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water

Pending Legislation Drug Free Water Act of 2009 Introduced into the House on January 7, 2009: HR 276 Requires EPA to convene a Task Force regarding proper disposal of unused pharmaceuticals Safe Drug Disposal Act of 2009 Introduced into the House on February 25, 2009: HR 1191 Introduced into the Senate on June 24, 2009: S 1336 To amend the Controlled Substances Act to provide for the disposal of controlled substances by ultimate users and care takers through State take-back disposal programs To amend the Federal Food, Drug and Cosmetic Act to prohibit recommendations on drug labels for the disposal by flushing Secure & Responsible Drug Disposal Act of 2009 Introduced into the House on March 5, 2009: HR 1359 Introduced into the Senate on June 18, 2009: S. 1292 To amend the Controlled Substances A ct to enable consumer take-back programs

EPA’s Clean Water Act Review Mandatory Survey Mandatory survey for Unused Pharmaceuticals Disposal in the Health Services Industry All companies that receive questionnaire must respond within 60 days Failure to respond may result in criminal fines, civil penalties, and other sanctions, as provided by law May require documentation of some disposed drugs for a 30 day period Potentially 3500 facilities will be sampled Includes a sample of hospitals, long term care facilities, hospices, and veterinary practices May be administered September through November, 2009 http://www.epa.gov/fedrgstr/EPA-WATER/2008/August/Day-12/w18606.pdf http://www.epa.gov/guide/304m/ www.epa.gov/ost/ppcp

EPA Proposal to Add Pharmaceuticals to Universal Waste Rule Federal Register publication Dec 2, 2008 – Comments due March 4, 2009 http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.htm Information: http://www.epa.gov/epawaste/hazard/wastetypes/universal/pharm.htm Only applies to drug waste that meets the definition of RCRA hazardous waste Only intended for healthcare-type generators, not manufacturers Intent to streamline pharmaceutical waste management and encourage consumer take-back programs Estimated 18 months minimum for federal enactment; states may or may not adopt; Iowa and Alaska will be automatic

RCRA and Universal Waste “Universal Waste” is a subset of RCRA hazardous waste. Federal EPA: Batteries, Pesticides, Mercury- containing devices, Lamps (bulbs) Federal RCRA Hazardous Waste (includes some pharmaceuticals) Universal Waste Florida: RCRA Pharmaceuticals

Pioneer Rx Universal Waste States Michigan and Florida already have added pharmaceuticals to their universal waste rules Florida: https://www.flrules.org/Gateway/View_notice.asp?id=6599121a: Michigan: 299:9228 http://www.state.mi.us/orr/emi/admincode.asp?AdminCode=Single&Admin_Num=29909101&Dpt=&RngHigh=29999999 Unintended consequences: Un-registered entities started taking custody of legend drugs Need to involve state boards of pharmacy, DEA

Expectations Improved management of hazardous pharmaceutical wastes Regulatory burden for many Rx waste generators will decrease Proposal provides a solution to many of the issues facing healthcare facilities and other Rx hazardous waste generators

RCRA: Risk Management & Liability Civil and criminal liability Civil: State/USEPA enforcement Criminal: FBI, Attorney General, Grand Jury Corporate fines: $37,500/violation/day Personal liability: Fines and/or imprisonment No statute of limitations Managers up through CEO liable http://www.epa.gov/compliance/resources/policies/criminal/exercise.pdf

You’re Chance to Shine! Mix & Match Exercise The “All-Seeing Eye” holds the clues!

Which Discarded Drugs Become RCRA Hazardous Waste? P-listed chemicals Sole active ingredient; unused, and empty containers U-listed chemicals Sole active ingredient; unused Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity Ref: 40 CFR Part 261

Examples of P-Listed Pharmaceutical Waste Arsenic trioxide P012 Epinephrine base* P042 Nicotine P075 Nitroglycerin** (weak) P081 Phentermine (CIV) P046 Physostigmine P204 Physostigmine Salicylate P188 Warfarin >0.3% P001 *Salts excluded federally as of Oct. 15th, 2007; Many states have adopted this position. ** Excluded from the P list federally and in many states. 17

Examples of U-listed Pharmaceutical Waste Chloral Hydrate(CIV) U034 Chlorambucil U035 Cyclophosphamide U058 Daunomycin U059 Diethylstilbestrol U089 Melphalan U150 Mitomycin C U010 Streptozotocin U206 Lindane U129 Saccharin U202 Selenium Sulfide U205 Uracil Mustard U237 Warfarin<0.3% U248

Characteristic of Ignitability Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F Non-aqueous solutions with flash points <140 ° F Oxidizers Flammable aerosols Hazardous Waste Number: D001 Rubbing Alcohol Topical Preparations Injections What about other drugs? Some may be ignitable. This is more important than the toxic characteristic. For DOT, ignitability takes precedence over characteristic waste. You can dilute during normal use, but you can’t dilute if you are doing it to “treat” ignitability.

Characteristic of Corrosivity An aqueous solution having a pH < or = 2 or > or = to 12.5 Examples: Primarily compounding chemicals Glacial Acetic Acid Sodium Hydroxide Hazardous waste number: D002

Characteristic of Toxicity 40 chemicals which must be below specific leaching concentrations Must pass the Toxicity Characteristic Leaching Procedure (TCLP) Must evaluate IVs, such as TPN – may come out of regulation due to dilution Examples of potential toxic ingredients of pharmaceuticals: Arsenic m-Cresol Barium Mercury (thimerosal, Cadmium phenylmercuric acetate) Chromium Selenium Lindane Silver

Characteristic of Reactivity Meet eight separate criteria identifying certain explosive and water reactive wastes Nitroglycerin formulations may be considered excluded federally from the P081 listing as non-reactive as of August 14, 2001 under FR: May 16, 2001, unless they exhibit another characteristics, such as ignitability. Most states have adopted the federal exclusion for nitroglycerin. Waste must still be evaluated for ignitability. Hazardous Waste Number for reactives: D003

Chemotherapy Agents: Many Are Not Regulated by RCRA About 100 chemotherapy agents not regulated by EPA Examples: Alkylating agents: Cisplatin, Thiotepa Antimetabolites: Fluorouracil, Methotrexate Hormonal (antiandrogen): Lupron® (leuprolide) Hormonal (antiestrogen): Tamoxifen Mitotic Inhibitor: Taxol® (paclitaxol)

Three Types of Chemotherapy Waste Trace Chemotherapy Waste (yellow) Medical waste hauler protocols for “Chemo Waste” Empty vials, syringes, IV’s, gowns, gloves, ziplock bags Treated as infectious medical waste through regulated medical waste incineration “Bulk” Chemotherapy Waste (black) If not empty, should be placed into RCRA Hazardous Waste container Spill Clean-up (black) Manage as RCRA Hazardous Waste 24

Definition of “Empty” “P” List Containers of “P” listed chemicals are considered hazardous waste, unless they have been rinsed three times and the rinsate discarded as hazardous waste. “U” List and D codes Containers of “U” listed chemicals or D codes are empty only when All contents removed that can be removed through normal means And no more than 3% by weight remains Example: “Empty” Cytoxan vial would be “trace” chemotherapy Epinephrine syringe exclusion expanded to other P and U-listed drugs federally by USEPA. Many states have accepted this exclusion. Ref: 40 CFR 261.7

Specific Reasons to Add Pharmaceuticals to UWR Generation of pharmaceutical waste at a large number of points in relatively small quantities across the facility Generation of hundreds of different types of pharmaceutical waste Industry concerns regarding waste determination, generator status of acutely hazardous waste, hazardous waste listings, and accumulation time limits

Differentiation of Pharmaceuticals from other Universal Wastes

Why Pharmaceuticals are NOT Analogous to Current UWR Items: Security Issues Legend Pharmaceuticals (Rx only) are deliberately restricted in their availability to the consumer AND within the supply chain due to their inherently “ dangerous” status regarding human use The street value of non-controlled substances continues to climb due to increased drug costs and shrinking personal resources Waste pharmaceuticals continue to have value, including empty vials of IV admixtures that can be used for introducing counterfeit drugs back into the supply chain

Why Pharmaceuticals are NOT Analogous to Current UWR Items: Security Issues Pharmaceutical manufacture, transport, warehousing, distribution, sale, and disposal are regulated by multiple state and federal agencies FDA DEA State Boards of Pharmacy State Controlled Substance Boards

Why Pharmaceuticals are NOT Analogous to Current UWR Items: OSHA Issues Handling and sorting of hazardous materials such as chemotherapy agents can cause a significant risk to employees NIOSH Hazardous Drug Alert http://www.cdc.gov/niosh/docs/2004-165/ ASHP Guidelines on Handling Hazardous Drugs http://www.ashp.org/DocLibrary/BestPractices/ASHPGuidelinesHandlingHazardousDrugs.aspx

Unintended Consequences: Loss of Manifest How is receipt and destruction assured? What if a shipment, or partial shipment, is diverted? How will UW handlers and transporters manage state differences? Can a shipment get “marooned” in transit? Common carrier until it reaches a non-UWR state; wrong carrier, no manifest

Economic Impact Current waste disposal practices: (est. 80% of hospitals) Sewering – no documented costs Autoclave/landfill – minimal costs absorbed in normal operating costs Suggested practice of managing all Rx waste as universal waste Fee differential as large as 5x to 10x between municipal or regulated medical incineration and RCRA hazardous waste incinerator Municipal: $.19/lb - $.50/lb RCRA: $.95/lb - $4.95/lb

Percentage of RCRA & PharmE Haz ® in 149 Hospitals, 2008

PharmE Hazardous® Drug Criteria Examples NIOSH Hazardous Drug Alert Appendix A OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2 -1 The US Department of Health and Human Services National Toxicology Program's Report on Carcinogens (11th Edition) Other chemotherapy agents not already listed as RCRA hazardous Additional drugs meeting OSHA or NIOSH criteria Drugs with LD50s at or below 50mg/kg Endocrine disruptors

Weekly Volumes of 55 gal drums: 16 Non-haz; 4-5 Haz Photos courtesy of Abbott Northwestern Hospital

Healthcare Homerun! Removing P-listed waste from generator calculations is primary benefit Reduction in storage, employee training, and notification requirements are excellent Only need to evaluate inventory initially and upon receipt of new RCRA drugs

Tailoring the UWR for Pharmaceuticals Apply UWR for in-house management of waste pharmaceuticals at relatively small quantity waste generators such as distributors, pharmacies, hospitals, clinics, long term care facilities, veterinary clinics, other primary care facilities

Tailoring the UWR for Pharmaceuticals Require full identification and manifesting of pharmaceutical waste at the point of shipment to the final disposal site IF sorting/re-packaging occurs at a transfer station, full RCRA and HAZWOPER training and employee protection requirements should apply

Benefits of Tailored System Primary concern of healthcare facilities is alleviated: need to document P-listed waste to justify generator status and fear of increasing generator status Cradle-to-grave tracking system is maintained for both environmental and diversion reasons Employee safety is enhanced by reducing additional sorting in-transit

Burning Question: Should I Wait for the UWR to Develop My System? NO! It will take a MINIMUM of 18 months for a new rule to adopted; probably 2011 It will take YEARS for each state to adopt either the federal version or their own version of the UWR Hazardous waste will still need to be identified and manifested when traveling through states that have not adopted the UWR Your organization will still need to segregate hazardous waste to avoid premier disposal charges

Approaches to Pharmaceutical Waste Management Model I: Automatic Sorting Device Model 2: Data Applied to Dispensing Software Model 3: Stickers Applied Manually Model 4: Centralizing Segregation Model 5: Managing All Drug Waste As Hazardous

Performing a Drug Inventory Review Perform initial inventory review Obtain drug specific data from purchasing records Identify ingredients Determine RCRA hazardous waste code Make Best Management Practice determinations Document decision making process Keep the review current Commercial services available Resource decision Team approach Hospitals stock between 2000 – 4000 drugs in inventory Request 12 month purchasing records from wholesaler Drug specific data – NDC, brand name, generic name, manufacturer, strength, dosage form, package size NDC more accurate from wholesaler – catch formulation changes Ingredients from Facts and Comparisons and Efacts – need to make sure to identify ingredients in preservatives as well and may need molecular weights H2E is developing an Inventory Review Spreadsheet to help with this effort

Maintaining the Inventory PharmE® Waste Wizard Web-based annual subscription service. Waste classifications, including container recommendations & MSDSs

Assessing Current Practices Performing department reviews Quantitative volumes/weights of discarded drugs difficult to obtain Informal but well documented interview process in pharmacy and nursing units can determine current medication disposal practices Schedule units in advance Emphasize “no wrong answer” approach Utilize data from automated dispensing machines Conduct a frequency analysis, especially for drugs which become hazardous waste

Considering the Optimal Management Options Need to label items that need segregation in a manner that makes it easy for pharmacy and nursing personnel Shelf stickers in pharmacy Data Applied to Dispensing Software and/or Message inserted into Pyxis, etc. and MAR (Medication Administration Record) and/or Stickers Applied Manually

Labeling the Pharmacy Shelves Avery Standard Shipping labels #5164

Label Alert: PYXIS Courtesy Lahey Clinic Medical Center, Burlington, MA Medications dispensed by the PYXIS medication station P, U, D, or HD a pop-up alert to properly dispose of the medication For example: Pyxis alert: THIS DRUG IS A FEDERAL HAZARDOUS WASTE TYPE (specifies P, U, D) DISPOSE >TRACE IN “BLACK” CONTAINER OR RETURN TO PHARMACY All medications dispensed by the pyxis that are a P, U, D, or HD hazardous medications will have a “Pop-Up”, alerting the nurse to dispose of the medication properly. The Pyxis pop-up alert language: requires the nurse to click on, (acknowledge) the message before the medication will be dispensed to the nurse. For example: If you are retrieving a tablet of warfarin, the pop-up alert reads: THIS DRUG IS A FEDERAL HAZARDOUS WASTE (specifies: P, U, D) TYPE DISPOSE >TRACE IN “BLACK” CONTAINER OR RETURN TO PHARMACY. 47

IV / Medication Label Alert: P, U, D, HD Courtesy Lahey Clinic Medical Center, Burlington, MA The new P, U, D, and “HD” labeling system will also appear on all pharmacy prepared medications. Many common medications will have a hazardous drug label alerting you to handle and dispose of the drug safely. Examples: Cortisporin Otic suspension, is a D listed agent Nitroglycerin ointment is a P listed agent Lindane shampoo is a U listed agent And Chloramphenical eye drops is an HD listed agent *Please look at the label carefully, highlighting is not available at this time. 48

Labeling & Containers Items identified by PharmE Inventory Analysis Marked with black labels “Special Disposal Required” Coded in Pyxis dispensing machine also Black hazardous waste containers purchased from Covidien SPECISPECIAL DISPOSAL REQUIRED Courtesy North Memorial Health Care

Selecting the Right Waste Vendor(s) For RCRA hazardous waste, vendor must be permitted by EPA as a treatment, storage and disposal facility (TSDF) Request a copy of their notification Insure your current vendor can handle all new waste codes Provide them with all P, U and D codes Ask for a waste profile to be generated to enable manifesting without documenting each item in each container Ask if vendor can pre-certify the items and combine ignitables with toxics to simplify waste segregation Determine if you will have special needs, such as hazardous controlled substances or mixed hazardous/regulated medical waste streams

Creating a Hazardous Waste Profile Work with hazardous vendors to create a certified hazardous waste profile of all toxic & ignitable drug waste, including ignitable aerosols Ship commingled as UN3248, Waste Medicine, Liquid, Flammable,Toxic, n.o.s., 3 (6.1), PG II Ship any corrosive acids/bases or oxidizers separately

Percentage of Hazard Categories in 149 Hospitals (2008) 97% Toxic or Ignitable

Conducting a Pilot Program Pilot the program in the pharmacy first Requires shelf stickers on drugs that become hazardous waste Introduces concept to pharmacy staff Consider inpatient and/or outpatient oncology and cardiac ICU next Find nursing “champions” within the system

Examples of Hazardous Pharm Waste Satellite Accumulation

Hazardous Pharmaceutical Waste Storage Accumulation

Non-Hazardous Pharmaceutical Waste Managed through non-hazardous incineration as a Best Management Practice Courtesy North Memorial Health Care

Examples of Non-Hazardous Pharmaceutical Waste Collection & Storage

Develop Policies and Procedures Complete pilots to determine best methods to use Develop policies and procedures applicable to the entire facility Be sure to involve all stakeholders Consider developing a pharmaceutical waste flow chart and/or pictorial diagrams for each area Be sure to update spill management plans to include non-chemo hazardous waste

Launching the Program Educating and training staff Notify the entire facility of the timetable for training and roll out Train all shifts immediately before their units/department is to begin waste segregation Stick with the timetable! Take advantage of Safety Fairs, Nursing Education Expos, or other hospital-wide events for a general introduction Involve nursing educators initially, with new hires, and for annual training

Example: “D” Type Hazard Insulin Containing M-Cresol A used syringe of this type of insulin An empty insulin vial A half empty insulin vial An outdated insulin vial Many insulin products are “D” listed because they contain a preservative known as M-Cresol which is a “D” listed agent If a syringe of this type of insulin has been administered: it is disposed of in the “RED” needle box. If a insulin vial is completely empty it can be disposed of in the trash. If a vial or syringe is not empty it must be discarded in the BLACK hazardous waste container. If a vial of insulin is outdated, Please return the product to pharmacy for reverse distribution RETURN TO PHARMACY Courtesy Lahey Clinic Medical Center, Burlington, MA 60

NEW Hazardous Waste Containers YELLOW HARD CONTAINER Trace / Sharps Syringes or Sharps Trace amounts of Chemo / Biotherapy; ONLY Empty syringes, IV bags, tubing P, U, D, HD, BLACK CONTAINE BULK (Larger than TRACE) amounts of Chemo / Bio Chemo-Spill products YELLOW “Soft” Hamper Trace/Soft Chemo/Bio Gowns, Gloves, Chux and soiled linens, ONLY) Additional waste streams are required for hazardous pharmaceuticals. The YELLOW Chemotherapy hazardous “hamper” is for trace/soft waste (for chemo gloves, gowns, soiled linens, etc.) The YELLOW Chemotherapy hard container is for Trace chemotherapy waste such as empty syringes and IV bags with their tubing The BLACK container is for larger than trace amounts of chemotherapy and for P, U, D hazardous drugs. For example, you would dispose of a partially filled vial or iv bag containing cyclosporin would be placed into the BLACK container. Courtesy Lahey Clinic Medical Center, Burlington, MA 61

Summary Expect increased attention to be focused on pharmaceutical waste management Don’t wait for rule changes – the risk is now! Protect your organization and your community Avoid crisis mode!

Resources NIOSH Hazardous Drug Alert http://www.cdc.gov/niosh/docs/2004-165/#sum ASHP Guidance on Handling Hazardous Drugs http://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF OSHA Technical Manual http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html Practice GreenHealth (fka Hospitals for a Healthy Environment) http://www.practicegreenhealth.org/ Pharmaceutical waste webpage: http://www.h2e-online.org/hazmat/pharma.html Healthcare Education Resource Center (HERC) Blueprint on Pharmaceutical Waste Management (Revised) http://www.hercenter.org/hazmat/tenstepblueprint.pdf WM Healthcare Solutions, PharmEcology Services www.pharmecology.com FAQs, state and federal waste regulations, subscription search engine PharmE™ Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous drugs, among additional criteria 63

QUESTIONS? Charlotte A. Smith, R. Ph., M.S. Director, PharmEcology Services WM Healthcare Solutions, Inc. www.pharmecology.com 414-292-3959 csmith@pharmecology.com Copyright 2007 PharmEcology Associates, LLC