Pharmaceutical Waste & EPA Updates: New Focus/New Solutions

13th Annual Pharmacy Purchasing Networking Conference

August 18th, 2009

Charlotte A. Smith, R. Ph., M.S.,HEMDirector, 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?

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?

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 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 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 2009Secure & 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 ReviewMandatory 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.

Universal WasteUniversal Waste

Federal RCRA Hazardous Waste (includes some pharmaceuticals)

Federal EPA: Batteries, Federal EPA: Batteries, Pesticides, Mercury-Pesticides, Mercury-containing devices,containing devices,Lamps (bulbs) Lamps (bulbs)

Florida: RCRA Florida: RCRA PharmaceuticalsPharmaceuticals

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 liablehttp://www.epa.gov/compliance/resources/policies/criminal/exercise.pdf

You’re Chance to Shine!

Mix & Match ExerciseThe “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.

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

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

Definition of “Empty”

• “P” ListContainers 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 codesContainers 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

Maintaining the Inventory PharmE® Waste WizardWeb-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

•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

Courtesy Lahey Clinic Medical Center, Burlington, MA

IV / Medication Label Alert: P, U, D, HD

Courtesy Lahey Clinic Medical Center, Burlington, MA

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 CovidienCourtesy North Memorial Health Care

SPECISPECIALDISPOSAL REQUIRED

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 HazardInsulin Containing M-Cresol

•A used syringe of this type of insulin

•An empty insulin vial

•A half empty insulin vial

•An outdated insulin vial

RETURN TO

PHARMACY

Courtesy Lahey Clinic Medical Center, Burlington, MA

YELLOW YELLOW ““Soft” HamperSoft” Hamper

Trace/Soft Chemo/BioTrace/Soft Chemo/Bio

Gowns, Gloves, Chux and soiled linens, ONLY)

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

NEW Hazardous Waste Containers

Courtesy Lahey Clinic Medical Center, Burlington, MA

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

QUESTIONS?Charlotte A. Smith, R. Ph., M.S.

Director, PharmEcology ServicesWM Healthcare Solutions, Inc.

www.pharmecology.com414-292-3959

csmith@pharmecology.com

Copyright 2007 PharmEcology Associates, LLCCopyright 2007 PharmEcology Associates, LLC