1. 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.

2. 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.

3. 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

4. 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

5. 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

6. What’s Driving New Regulatory Initiatives?

7. 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

8. 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

9. 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

10. EPA Proposal to Add Pharmaceuticals to Universal Waste Rule
Federal Register publication Dec 2, 2008 – Comments due March 4, 2009
Information:
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

11. 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

12. Pioneer Rx Universal Waste States
Michigan and Florida already have added pharmaceuticals to their universal waste rules
Florida:
Michigan: 299:9228
Unintended consequences:
Un-registered entities started taking custody of legend drugs
Need to involve state boards of pharmacy, DEA

13. 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

14. 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

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

16. 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

17. 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

18. 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

19. 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.

20. 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

21. 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

22. 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

23. 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)

24. 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

25. 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

26. 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

27. Differentiation of Pharmaceuticals from other Universal Wastes

28. 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

29. 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

30. 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
ASHP Guidelines on Handling Hazardous Drugs

31. 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

32. 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

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

34. 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

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

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

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

44. 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

45. 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

46. Labeling the Pharmacy Shelves
Avery Standard Shipping labels #5164

47. 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

48. 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

49. 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

50. 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

51. 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

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

53. 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

54. Examples of Hazardous Pharm Waste Satellite Accumulation

55. Hazardous Pharmaceutical Waste Storage Accumulation

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

57. Examples of Non-Hazardous Pharmaceutical Waste Collection & Storage

58. 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

59. 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

60. 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

61. 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

62. 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!

63. Resources NIOSH Hazardous Drug Alert
ASHP Guidance on Handling Hazardous Drugs
OSHA Technical Manual
Practice GreenHealth (fka Hospitals for a Healthy Environment)
Pharmaceutical waste webpage:
Healthcare Education Resource Center (HERC)
Blueprint on Pharmaceutical Waste Management (Revised)
WM Healthcare Solutions, PharmEcology Services
FAQs, state and federal waste regulations, subscription search engine
PharmE™ Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous drugs, among additional criteria 63

64. QUESTIONS? Charlotte A. Smith, R. Ph., M.S.
Director, PharmEcology Services
WM Healthcare Solutions, Inc.
Copyright 2007 PharmEcology Associates, LLC