1. Charlotte A. Smith, R. Ph., M.S.
Identifying and Managing Hazardous Pharmaceutical Waste H2E Teleconference September 12, 2003
Charlotte A. Smith, R. Ph., M.S.
President
pharmecology.com
Copyright © 2003 by PharmEcology Associates, LLC

2. Pharmaceutical Waste: A Waste Stream Whose Time has Come
Concept of “Green Pharmacy” Gaining Attention
"Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition While Promoting Human Health.”
Dr. Christian Daughton, Chief, Environmental Chemistry Branch, USEPA National Exposure Research Laboratory
I. Rationale for and Avenues toward a Green Pharmacy;
II. Drug Disposal, Waste Reduction, and Future Directions,

3. Increasing Regulatory Activity
EPA Region 2 auditing 480 hospitals in 2003; Rx waste included; link from H2E to Region 2 website
States beginning to focus on management of waste pharmaceuticals
Florida
Washington State
California
Minnesota
Michigan
Intersecting regulatory agencies
EPA, DEA, OSHA, State Boards of Pharmacy

4. H2E and Hazardous Pharmaceuticals
Initial involvement while at Capital Returns, Inc., Rx reverse distributor,
Worked on Chemical Minimization Committee with Catherine Zimmer, Minnesota Technical Assistance Program (MnTAP)
Contributed to prioritization tool by reviewing all drug products in CRI database

5. USGS Water Quality Study*
First nationwide reconnaissance of occurrence of pharmaceuticals, hormones, other organic wastewater contaminants
139 streams in 30 states, analyzed for 95 different OWCs
82 of the 95 detected in at least one sample
One or more OWCs found in 80% of stream samples
13% of sites had more than 20 OWCs *

6. Below the Dose/Response Curve: Endocrine Disruptors
Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles)
Mimic hormone, trigger identical response, block a hormone
Do not follow the normal dose/response curve
Active at much lower doses, especially in the fetus and newborn
Estradiols, progesterone, testosterone
Lindane

7. Playing in an Ecosystem Near You
Low sperm counts(50% reduction since 1939)
Infertility
Genital deformities
Hormonally triggered human cancers
Neurological disorders in children
Hyperactivity
Attention deficit
Developmental & reproductive problems in wildlife

8. Pharmaceuticals Entering the Waste Stream
Wastage of Raw Materials from Manufacturing Process
Wastage at the Distributor/ Pharmacy/Healthcare Facility
Wastage at the LTCF or other residential facility
Expired Pharmaceuticals
Wastage at the Consumer Level
Metabolites Entering Wastewater

9. When is an Outdated Drug a Waste?
At the time and place the decision is made to discard it
Two EPA guidance letters to the industry:
Merck & Co., 1981
BFI Pharmaceutical, 1991
Enables shipping of potentially creditable outdates to a reverse distributor as product
PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials

10. Reverse Distribution: Current Scenarios
Decision to discard is made at the pharmacy
By pharmacy
By a contracted company
Pharmacy (hospital) becomes the waste generator
Decision to discard is made at the reverse distributor
Reverse Distributor becomes the waste generator

11. Where Have Waste Drugs Gone in the Past?
Primarily concerned with rendering drugs unrecoverable
Not in dumpsters, municipal trash
Made slurries, sewered
Burned in hospital incinerators
No training in pharmacy curriculum on EPA regulations

12. Where are Waste Drugs Going Today?
Sewer System
Unused, partial IVs, including antibiotics
Compounding residues
Liquids
Red Infectious Waste Sharps Containers, Bags
Yellow or White Chemotherapy Sharps Containers, Bags

13. Contents of Current Pharmaceutical Waste Streams
CHEMO WASTE
- SHARPS
CHEMO WASTE
- SOFT
MUNICIPAL WASTE
SEWER SYSTEM
RED SHARPS
• Packaging
• Empty glass bottles
• Empty plastic bottles
• Paper
• Plastic
• Food waste, etc.
• IV’s
- D5W
- NaCl
- Other?
• Controlled
substances?
• Antibiotics?
• Vials
- Empty (trace)
- Partial (residue)
• Syringes/Needles
- Empty
- Unused, partial
• IV’s
• Spill clean up?
• Gowns
• Gloves
• Goggles
• Tubing
• Wipes
• Spill clean up?
• Vials
- Empty
- Partial
• Syringes/Needles
- Unused, partial
• IV’s
LANDFILL OR
MUNICIPAL INCINERATOR
WATER
TREATMENT PLANT
AUTOCLAVE/
MICROWAVE
MEDICAL WASTE INCINERATOR
Ash
Shredded (?)
Leachate into
ground water or
air emissions
Discharge to
surface waters
NON-HAZARDOUS LANDFILL
Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC

14. How is Pharmaceutical Waste Generated at the Healthcare Facility?
IV Preparation
General Compounding
Spills/Breakage
Partially Used Vials/Syringes
If Contaminated, Biohazardous
Discontinued, Unused Preparations
Unused Repacks (Unit Dose)
Discontinued Indated Pharmaceuticals
Patients’ Personal Medications
Outdated Pharmaceuticals

15. Where is Pharmaceutical Waste Generated?
Pharmacy/Satellites
Patient Care Units
ER/OR
ICU/CCU/NICU
Oncology/Hematology and other outpatient clinics
Long Term Care Facilities
Home Health Care Services

16. What Departments Get Involved in Generating and Managing Pharmaceutical Waste?
Pharmacy
Nursing
Infection Control
Environmental Services
Safety
Facility Management
Risk Management
Purchasing

17. Federal Waste Generation Status
Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste.
Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste.
Conditionally Exempt Small Quantity Generator (CESQG):Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/month

18. Which Discarded Drugs Become Hazardous Waste?
P-listed chemicals
Sole active ingredient
U-listed chemicals
Characteristic of hazardous waste
Ignitability
Toxicity
Corrosivity
Reactivity

19. Examples of P-Listed Pharmaceutical Waste
Arsenic trioxide P012
Epinephrine P042
Nicotine P075
Nitroglycerin P081
Phentermine (CIV) P046
Physostigmine P204
Physostigmine Salicylate P188
Warfarin >0.3% P001

20. Examples of P-Listed Pharmaceuticals

21. Impact of P-listed Waste
Only 1 kg or 2.2 pounds/month cause facility to become a large quantity generator
Weights of P-listed drug waste must be combined with any other P-listed waste generated at the facility in a given month
Technically, containers that have held P-listed wastes are not “RCRA empty” unless they are triple rinsed and the rinsate discarded as hazardous

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

23. Examples of
U-Listed
Pharmaceuticals

24. Chemotherapy Waste
Seven chemotherapy agents are U-listed; one is P-listed
Medical waste hauler protocols for “Chemo Waste”
Empty vials, syringes, IV’s
Treated as infectious medical waste preferably through regulated medical waste incineration
If not empty, should be placed into Hazardous Waste container
“Empty” for U-listed waste means all contents removed that can be removed through normal means
3 ml allowance in common practice is a misunderstanding of the definition of “RCRA empty”

25. Chemotherapy Residue: Infectious and Hazardous
If chemo IV bag has been hung, is not completely used and can be separated from patient exposed sharp without exposing the employee, remove and dispose as RCRA hazardous waste
If chemo residue cannot be removed safely, dispose in trace chemotherapy container (yellow/white) as infectious chemo waste
No consensus yet on this issue among hazardous waste regulators

26. in vials, unused IV’s, P, U. toxic D
Chemo Waste
Hazardous Waste
Residue or bulk chemo
in vials, unused IV’s, P, U. toxic D
Empty vials,
syringes, IVs,
tubing, gowns,
gloves,etc.

27. Characteristic of Ignitability
Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F.
Hazardous Waste Number: D001
Rubbing Alcohol
Topical Preparation
Injections

28. 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

29. Characteristic of Toxicity
Approximately 40 chemicals which meet specific leaching concentrations
Examples of potential toxic pharmaceuticals:
Arsenic m-Cresol
Barium Mercury (thimerosal)
Cadmium phenylmercuric acetate)
Chloroform Selenium
Chromium Silver
Lindane

30. Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity
Heavy Metals: Selenium, Chromium and Silver
Preservatives: thimerosal & m-cresol

31. Characteristic of Reactivity
Meet eight separate criteria identifying certain explosive and water reactive wastes
Nitroglycerin formulations may be considered exempt as of August 14, under FR: May 16, States must still adopt.
Hazardous Waste Number: D003

32. How Can RCRA Hazardous Waste be Identified?
Web-based database enabling search by product for waste management recommendations
Search by NDC, product or generic name, active ingredient
Recommendations citing federal regulations and recommended waste streams
State regulation alerts if more stringent than federal
Risk Management alerts based on professional knowledge (e.g. chemotherapy agents not regulated at the state or federal level)

34. Readi-Cat

38. How Should RCRA Hazardous Waste be Handled?
Need a new waste stream in Pharmacy, certain Patient Care Areas, Oncology Clinics
RCRA Hazardous Waste: Toxic
P, U, toxic Ds, all Chemotherapy Residues, Chemo Spills
RCRA Hazardous Waste: Ignitable (D001)
Hospitec has developed a dedicated hazardous waste containment system
Can also use hazardous waste buckets available from brokers and disposal firms

39. Recommended Additional Pharmaceutical Waste Streams
HAZARDOUS WASTE
- TOXIC
HAZARDOUS WASTE
- IGNITABLE
NON-HAZARDOUS
NON-INFECTIOUS RX
MUNICIPAL INCINERATOR
PERMITTED
FOR SPECIAL WASTE
Hazardous waste
broker and transporter
MEDICAL
WASTE
INCINERATOR
Ash
Ash
FEDERALLY PERMITTED
HAZARDOUS WASTE INCINERATOR
(HIGH TEMPERATURE, SCRUBBERS)
NON-HAZARDOUS LANDFILL
Ash
Leachate
LINED HAZARDOUS
WASTE LANDFILL
Copyright © 2002 by PharmEcology™ Associates, LLC

40. Recommended Revised Pharmaceutical Waste Streams
SEWER
SYSTEM
HAZARDOUS WASTE
- TOXIC
HAZARDOUS WASTE
- IGNITABLE
CHEMO
WASTE
- SHARPS
CHEMO
WASTE
- SOFT
NON-HAZARDOUS RX
RED SHARPS
MUNICIPAL
• Packaging
• Empty bottles
• Paper
• Plastic
• Food waste, etc.
• IV’s
- D5W
- NaCl
• Controlled
Substances?
• Antibiotics?
• P-listed
• U-listed
• D-listed toxic
(Heavy metals)
• Chemo agents
(residue, bulk)
• Chemo spill clean up
• Hazardous spill clean up
• Risk management:
- Antivirals
- Others
• D-listed Ignitable
- Collodion
- Oxidizers
- Ignitable
compressed
gas
• Vials
- Empty
• Syringes/Needles
• IV’s
• Gowns
• Gloves
• Goggles
• Tubing
• Wipes
All waste
pharmaceuticals
NOT hazardous
including
antibiotics, IV’s
• Non-chemo
vials
- Empty
syringes/
needles
• Recycle as much paper, glass, plastic
as possible
• Use shredder where patient privacy is an issue
• Check with
municipal water treatment plant
for limits, recommendations
MUNICIPAL INCINERATOR
PERMITTED
FOR SPECIAL WASTE
MEDICAL WASTE INCINERATOR
AUTOCLAVE/
MICROWAVE
FEDERALLY PERMITTED
HAZARDOUS WASTE
INCINERATOR (HIGH TEMPERATURE, SCRUBBERS)
Ash
Ash
Shredded (?)
Ash
NON-HAZARDOUS LANDFILL
LINED HAZARDOUS
WASTE LANDFILL
Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC

41. Where Should RCRA Hazardous Waste Be Stored?
Hazardous Waste Storage Accumulation Site:
Same locked area as mercury, xylene, formaldehyde, lab chemicals
Maximum storage time: 90 or 180 days based on generator status
Yellow Hazardous
Waste Label

42. How Should RCRA Hazardous Waste Be Disposed?
Either contract with a hazardous waste broker or develop internal expertise for:
Lab packing
Manifest preparation
Land ban preparation
Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility)

43. How Can Hazardous RX Waste Generation Be Minimized?
Inherent limitations on substitution of a less hazardous drug since the hazardous nature of the chemical often provides the therapeutic effect
Tighter inventory control to reduce outdate generation, both original manufacturers’ containers and repacks
Single dose vials vs. multiple dose vials
Patient specific oral syringes vs. 10 cc. repacks (e.g. choral hydrate for pediatric use)
Reformulation of heavy metal concentration, especially mercury and m-cresol as preservatives

44. What About Non-Hazardous Drugs?
Segregate into a non-red, non-yellow container, such as beige or white with blue top (California Pharmaceutical Waste)
Label “Non-hazardous Pharmaceutical Waste – Incinerate Only”
Dispose at a regulated medical waste or municipal incinerator that is permitted to accept non-hazardous pharmaceutical waste

45. Where to Begin?
Purchase appropriate containers for collecting toxic and ignitable hazardous waste
Pilot bulk and residue chemotherapy segregation in the pharmacy and on the oncology unit
Extend the program to all units that handle any chemotherapy agents (methotrexate and cyclophosphamide used in other units)
Begin identifying other P, U and D hazardous wastes
Train all relevant staff on the reasons for the new system

46. Jump-Starting the Process
Electronic formulary review service
Send PharmEcology Associates your drug formulary information
We compare it to our database of over 107,000 drug items
You receive back a list of which drugs are hazardous waste or risk management hazardous waste
On-site review
A one or two day visit to your facility followed by an Action Plan and Findings and Recommendations

47. Benefits of a Comprehensive Hazardous Waste Disposal Plan
JCAHO Environment of Care Performance Improvement Initiative
New 2004 Standards – see both Medication Management and Environment of Care
Reduces EPA liability and risk exposure to a minimum
Protects employees and patients
Demonstrates responsible care in dealing with hazardous substances, hazardous wastes

48. Resources www.pharmecology.com
Pharmaceutical Waste:
“Safely Managing Hazardous Materials and Hazardous Waste,” ASHP Clinical Midyear, 2001, Handouts on CD-Rom
RCRA On-Line
RCRA Hot Line
Improper Discard of Toxic Drugs Hurts Environment, Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp

49. Resources
Pharmaceutical Waste Survey, King County, Washington State, April 29, 2003,
Your Risks in Handling Outdated and Unusable Drugs: A Guide to JCAHO and Regulatory Standards. Capital Returns, Inc., Call
A Guide on Hazardous Waste Management for Florida’s Pharmacies, www. floridacenter.org.
Guidelines for Reverse Distributors: Minimum Federal Regulatory Standards,