1. 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.

2. 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.

3. 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.

4. 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”?

5. 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

6. 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)

7. Pharmaceutical Waste Management
A Growing Concern
USGS (US Geological Survey) Water Survey ( )
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

8. 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

9. Pharmaceutical Waste Management
TJC Accreditation
MM 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 Environment of Care
The hospital manages its hazardous materials wastes risks.
The hospital minimizes risk associated with disposing hazardous medications.
LD Leadership
The hospital complies with law and regulation.
EM – 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

10. 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?

11. 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

12. 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.

13. 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, 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 §   (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 (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, §   (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.

14. 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 ml Single Dose Vial - 25mg/5ml, box of 25
NDC ml 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

15. (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

16. Hospital RX Formulary Analysis
Pharmaceutical Waste Management
Hospital RX Formulary Analysis
# NDC’s % NDC’s
2, % Total Characterized
% RCRA Hazardous
2, % Non-Hazardous
P&U Listed vs Characteristic
% Total RCRA Hazardous
% Characteristic Hazardous
% Total P&U Listed Hazardous
30 (15.3%) P-Listed Hazardous
20 (10.2%) U-Listed Hazardous
Compatibility
% Hazardous Compatible
% Hazardous Non-Compatible

17. 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

18. 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

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

20. 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

21. 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

22. 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

23. Satellite Accumulation: EPA
Hazardous Waste
Satellite Accumulation: EPA
40 CFR (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 

24. 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
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 (
& )
Training must be completed within 90 days
Retraining required every three years
Record retention requirement

25. Pharmaceutical Waste Management
Service & Logistics

26. 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

27. 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

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

29. 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

30. 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

31. Rx Waste Management
Container Data

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

33. 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

34. 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

35. 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)

36. 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

37. 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

38. 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

39. What Drug Goes Where?

40. 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

41. 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

42. Rx Waste
Summary

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

44. RX Waste Compliance Program
Thank You