Pharmaceutical Waste Management

1
Pharmaceutical Waste Management
2
Agenda

• Why does my facility need an Rx Waste Program?
• Environment
• Regulations
• What is Rx Waste?
• Elements of a Full Service Rx Waste Program
• Waste characterization
• Waste collection segregation
• Waste transportation disposal

3
The Growing Concern- Environmental Regulatory
Impact

• USGS (US Geological Survey) Water Survey
• Organic Wastewater Contaminants (OWCs) found in
  80 of streams tested
• 33 of OWCs detected were pharmaceuticals in
  Minnesota alone
• EPA Regulatory Activity
• October 2007 four hospitals visited unannounced
  by EPA Region I (Boston Area)
• Warnings issued
• Re-visit 1Q08 looking for Rx Waste implementation
  plan
• The Joint Commission (TJC)
• Standards involving Medication Management,
  Environment of Care, and Leadership

4
Who is Involved

• Environmental Protection Agency (EPA)
• Department of Transportation (DOT)
• The Joint Commission (TJC)
• Drug Enforcement Agency (DEA)
• Local State Regulators

5
RX Waste Compliance Program

• EPA Regulations
• Managing hazardous materials inside a facility

6
RCRA
Resource Conservation and Recovery Act (RCRA)

• Enacted 1976 - targeted hazardous industrial
  waste
• Applies to chemicals (pharmaceuticals)
• Defines EPA RCRA hazardous waste
• Generator must
• determine if waste is RCRA hazardous waste
• determine their waste generator status

7
RCRA Hazardous Drug Categories
2 categories of RCRA Hazardous Waste

• Listed Waste
• P Listed (epinephrine and nitroglycerin)
• U Listed (chemotherapy drugs)
• Characteristic Waste - 4 characteristics
• Ignitability, Corrosively, Reactivity, Toxicity
• Hazardous Waste is Compatible or Non-Compatible
• Compatible can be placed in container without
  danger of reaction
• Non-Compatible potential for chemical
  reaction if co-mingled

8
Characteristic Waste Thresholds

• Ignitability - Aqueous Solution containing 24
  alcohol or more by volume flash point
  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. Nitroglycerin formulations
  are excluded federally from the P081 listing as
  non-reactive as of August 14, 2001 under FR May
  16, 2001. Some states have adopted the
  exclusion.
• Toxicity - Approximately 40 chemicals which
  meet specific leaching concentrations. Examples
  of potential toxic pharmaceuticals Arsenic,
  Barium, Mercury ,Cadmium, Chloroform, Selenium,
  Chromium, Silver

9
Formulary Analysis
Hospital Rx Formulary Breakdown

• NDCs NDCs
• 2,615 100.0 Total Characterized
• 196 7.5 RCRA Hazardous
• 2,419 92.5 Non-Hazardous

• PU Listed vs Characteristic
• 196 100.0 Total RCRA Hazardous
• 146 74.5 Characteristic Hazardous
• 30 15.3 P Listed Hazardous
• 20 10.2 U Listed Hazardous

• Compatibility
• 182 93.0 Hazardous Compatible
• 14 7.0 Hazardous Non-Compatible

10
P Listed Waste

• Acutely Hazardous
• Includes Epinephrine, Nicotine, Nitroglycerin,
  Phentermine, Physostigmine, Warfarin, Arsenic
  trioxide (chemo drug)
• Empty containers (except for used syringes) are
  hazardous waste not RMW
• P-listed waste containers are not RCRA empty,
  unless they are triple rinsed (resulting rinsate
  must be discarded as hazardous waste).

11
Epinephrine Exclusion

• A 1994 EPA Hotline interpretation, not an EPA
  regulation or law
• Allows disposal of used Epinephrine syringes
  with residue as regulated medical waste.
• Only applies to used syringes does not apply
  to vials, IV bags or other Epi containers
• Exclusion must be accepted at State level
• NH has accepted

12
Epinephrine Salts

• EPA has declared non-hazardous those
  pharmaceuticals in which the sole active
  ingredient is epinephrine salts
• Pharmaceuticals in which the sole active
  ingredient is epinephrine base are hazardous.
• Exclusion must be accepted at State level

13
U-Listed Hazardous Waste

• Toxic
• Chemo drugs
• Empty Ulisted drug containers can be disposed
  of as RMW if
• All contents have been removed using normal
  means
• AND
• No more than 3 by weight remains
• If BOTH conditions are not met, empty U-listed
  drug containers must be treated as hazardous
  waste.

14
Chemo Waste

• Bulk chemo is RCRA hazardous waste
• U-Listed
• P-Listed (Arsenic Trioxide)
• Non-RCRA Hazardous (best practice treat as haz)
• Trace chemo is RMW
• RCRA Empty
• Containers (not for p-listed)
• PPE

15
Common Chemo Wastes

• Common Chemotherapeutic/Antineoplastic Wastes
• Chlorambucil Leukeran U035
• Cyclophosphamide Cytoxan, CTX, Neosar U058
• Daunomycin Daunorubicin, Cerubidine) U059
• Melphalan Alkeran, L-PAM U150
• Mitomycin C Mitomycin, Mutamycin U010
• Streptozotocin, Chlornaphazine Zanosar U206
• Uracil Mustard U237
• Ethyl Carbamate U238
• Azaserine U015
• 3-Methylcholanthrene U157
• Arsenic Trioxide (Trisenox) P012
• Bevacizumab (Avastin) Non-RCRA Hazardous
• Carmustine (Bicnu) Non-RCRA Hazardous
• Irinotecan Hydrochloride (Campostar) Non-RCRA
  Hazardous
• Doxorubicin Hydrochloride (Doxil) Non-RCRA
  Hazardous
• Oxaliplatin (Eloxatin) Non-RCRA Hazardous

16
Chemo Waste Disposal
Improper Chemo Waste disposal practice that
violates EPA DOT regulations.
Trace Chemo (syringes, IV, tubing, PPE)
Bulk Chemo (Including P U)
Chemo Sharps Container
RMW Disposal
17
Chemo Waste Disposal
Regulatory compliant Chemo Waste disposal practice
Trace Chemo (syringe, IV, tubing,
PPE) (U-Listed Non-hazardous)
Bulk Chemo (P U Listed and
Non-hazardous)
Chemo Bulk Waste Container
Chemo Sharps Container
Hazardous Waste Disposal
RMW Disposal
18
Industry Best Practices

• Both the NIOSH Drug Alert ASHP Guidelines
• acknowledge
• EPA DOT compliance required for hazardous
  waste disposal
• Non-RCRA hazardous chemo drugs mimic hazardous
  drugs should be handled and disposed of as
  hazardous

19
Rx Waste Categories
Rx Waste
Hazardous Compatible
Hazardous Non-compatible
Non-Hazardous
Oxidizers
Trace Chemo
Organic Peroxides
Bulk Chemo
Corrosives
20
Common EPA Inspection Violations

• 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
• Improper management of expired pharmaceuticals
• Lack of emergency contingency plan
• Identification and Management of Regulated
  Hazardous Waste EPA Region 2

21
Waste Generator Status

• Amount of P-listed waste generated monthly,
  hospital wide, can determine
• EPA hazardous waste status.
• Small Quantity Generator
• More than 100kg (220.4lbs) but less than 1000kg
  (2204lbs) of hazardous waste or less than 1 kg
  (2.2 lbs) of acute hazardous (P-listed) waste
  per calendar month.
• Large Quantity Generator
• More than 1000kg (2204 lbs) of hazardous waste
  or more than 1kg/month (2.2 lbs) of acute
  hazardous (P-listed) waste per calendar month.
• NOTE 1 liter of water weighs 2.204 lbs.

22
RX Waste Compliance Program

• DOT Regulations
• Safely transporting hazardous materials

23
U.S. DOT Regulations

• DOT regulations involve 4 basic requirements (49
  CFR)
• Classification, description, and packaging
  (173.22)
• Proper marking and labeling (172.300)
• Segregation into proper streams (173.21)
• Training (172.202 172.204)
• Hazmat Implementation Act
• Fine section rewritten to raise fines.
• Currently fines average 30,000 per violation and
  range up to 100,000.

24
Compatibility DOT Waste Streams

• Waste medicine liquid flammable toxic Compatible
• Waste flammable liquids Compatible
• Waste medicine liquid toxic Compatible
• Waste flammable solid inorganic Compatible
• Waste corrosive liquids acidic organic Non-Compati
  ble
• Waste organic peroxides Non-Compatible
• Waste oxidizing liquid Non-Compatible

25
RX Waste Compliance Program

• The Joint Commission
• Accreditation not Regulation

26
TJC Accreditation Issue

• MM.4.80 - Medication Management
• The hospital has a process in place that
  addresses how outside resources, if any, are used
  for the destruction of pharmaceuticals.
• MM.8.10 Medication Management
• The hospital acts to implement improvements (on
  its medication management systems)
• EC.3.10 - Environment of Care
• The hospital manages its hazardous material waste
  risks.
• LD.1.30 - Leadership
• The hospital complies with all applicable law
  regulation.
• JCAHO Standards Information
• http//www.jcaho.org/

27
State of New Hampshire

• Non-RCRA pharmaceutical waste is solid waste
• Best industry practices for Non-RCRA
  pharmaceutical waste management
• segregate from red bag waste
• package in pharmaceutical containers
• label incinerate only or for incineration
• dispose of through incineration.

28
RX Waste Compliance Program

• What is Pharmaceutical Waste

29
Examples of Pharmaceutical Waste

• Non - Compatible
• Silver Nitrate
• L-Cysteine
• Non-Hazardous
• Abbokinase
• Recombivax

• Pharmaceutical Waste
• Partial vials (safety caps removed)
• Un-dispensed,
• pre-instilled IVs
• Pre-filled syringes
• Partial syringes
• Discontinued meds
• Un-administered meds
• Patient prescriptions

• Characteristic Hazardous
• Lantus
• Humalog
• Humulin N
• Humulin R
• Centrum Silver
• Flovent
• Taxol
• Witch Hazel
• Benzamycin
• P Listed
• Epinephrine
• Nitroglycerin
• Coumadin/Warfarin
• U Listed
• Chemotherapy drugs
• Cytoxan
• Mutamycin

30
Pharmaceutical Waste Compliance Program
31
RX Waste Disposal Assessment

• Blood Saturated
• Materials

Sharps
Rx Waste
?
Sharps Containers
Red Bags

• Regulated Medical Waste
• Red Bag
• Sharps Containers
• Solid Waste
• Sewer
• Returns shipments through Reverse Distributor

32
How Rx Waste Will be Managed
33
All Hospital Waste Streams

• Blood Saturated
• Materials

Materials w/Trace Chemo
Sharps w/ Trace Rx
Full Partial IV Bags
Bulk Chemo (Hazardous)
Trace Chemo (RMW)
Sharps Containers
Red Bags
Rx Waste
Non-Hazardous Rx Waste
Hazardous Compatible Rx Waste
Hazardous Non compat Rx Waste
34
Major Program Steps

• Waste Characterization of hospital formulary
• Identify hazardous pharmaceuticals
• Waste collection segregation
• Place waste in appropriate container
• Transportation Disposal
• Comply with DOT regulations for transportation
• Comply with EPA regulations for disposal

35
RX Formulary Characterization

• Databases
• Identify listed and characteristically hazardous
  waste
• Kept current
• Lists
• Can be found on the internet
• May not be current (especially new chemo drugs)
• Will not have characteristically hazardous waste
• Self Characterization
• Do the research on your own to identify
  hazardous waste
• Will require people to keep it current

36
Waste Collection

• EPA requirements for hazardous waste collection
• At or near point of generation
• Under generators control
• Locations
• Pharmacy
• Patient-care areas
• Pyxis Stations
• Med Carts
• Med rooms
• Soiled utility rooms

37
Waste Segregation

• At point of generation hospital staff places
  waste into appropriate containers
• Non-RCRA into one container
• RCRA hazardous in multiple containers
• In HW Accumulation Area trained technicians
  segregate waste that was collected in one or two
  containers
• Non-RCRA into one container
• RCRA hazardous into multiple containers
• Over classify all waste as hazardous waste
• Segregate into multiple hazardous waste
  containers
• At point of generation or in HW accumulation area

38
Segregation

• Sort Code
• Append a code to the name field in labeling
  system
• Apply sort code to Pyxis second screen
• Add sort code to MAR sheet
• Drug List
• Manage RCRA by exception
• Apply list next to RCRA hazardous containers
• Approximately 7.5 of all pharmaceuticals

39
Pharmacy

• Separate Rx Waste into 3 major streams
• Non-RCRA
• Hazardous Compatible
• Flammables and Toxics
• Inhalers
• Hazardous Non-Compatible
• oxidizers (silver nitrate),

40
Patient Care Areas

• Separate Rx Waste into 2 major streams
• Non-RCRA
• Hazardous compatible
• Some Floors will have 3 waste streams
• 3. Hazardous non-compatible not on all floors.
  In some cases return to pharmacy

41

• If over classify as hazardous waste
• Hazardous compatible
• Includes non-RCRA (90)
• More expensive to dispose
• 2. Hazardous non-compatible

42
Transportation Disposal

• Non-RCRA waste is transported to an RMW facility
• RCRA hazardous is transported by a licensed
  hazardous waste hauler to a hazardous waste
  facility
• All waste is incinerated
• Non-RCRA at an RMW incinerator
• RCRA at Hazardous waste incinerator

43
Implementation

• Training for staff
• Pharmacy
• Clinicians
• EVS
• Train all shifts
• Topics
• Program implementation consulting
• Regulations
• Program Details
• Containers
• Segregation
• Transportation Disposal

44
On-going Support

• Continuous support to ensure on-going compliance
• Rx waste characterization of new drugs added to
  formulary
• Annual Audit to ensure compliance
• Manifests
• Accumulation Area weekly inspections
• Proper segregation
• Annual training

45
Program Goals

• Reduces Risk associated with hazardous waste
  compliance
• Helps meet TJC standards
• Helps stay in compliance with EPA, DOT and state
  regulations

46
RX Waste Compliance Program

• Questions?
• Tmartinez_at_stericycle.com
• [phone]