Designing, Implementing, and
Managing a Pharmacy Waste “Blue
Bin” Program in a Large University
Hospital: the Challenges and
Roadblocks
 What is Pharmacy Waste and why is it a issue
 Our Program
 Pilot Program & Roll Out
 Issues/Program Improvements
Why the Concern With
Pharmaceutical Waste
 Emerging data suggests that some pharmaceuticals
may be pervasive in treated wastewater, in surface
water, and our drinking water supplies throughout
the United States
 A number of pharmaceuticals are regulated as
hazardous waste under EPA environmental rules.
• The disposal of hazardous waste down the drain is
the second most common violation cited by the
US EPA when hospitals are audited
 Joint Commission
Relationship to
The Joint Commission Standards:
Environment of Care
 Standard EC.3.10
 The organization manages its hazardous materials and waste[1]
risks.
[1] Hazardous materials (HAZMAT) and waste:
Materials whose handling, use, and storage are guided or
regulated by local, state, or federal regulation. Examples include
OSHA’s Regulations for Bloodborne Pathogens (regarding the
blood, other infectious materials, contaminated items which would
release blood or other infectious materials, or contaminated
sharps), the Nuclear Regulatory Commission's regulations for
handling and disposal of radioactive waste, management of
hazardous vapors (such as glutaraldehyde, ethylene oxide, and
nitrous oxide), chemicals regulated by the EPA, Department of
Transportation requirements, and hazardous energy sources (for
example, ionizing or non-ionizing radiation, lasers, microwaves, and
ultrasound.)
Examples of Regulatory Enforcement
Actions
 2004 – Region 1 notified 250 hospitals of its intention to enforce hazardous
waste laws for health care facilities.
 2003 – 2004 – Region 2 identified violations at health care facilities that led
to fines ranging from $40,000 to $280,000.
 Concord, VT. Hospital fined $205,000 for improperly disposing of
hazardous-waste pharmaceuticals over a four-year period between 2005 09.
 NCDENR had announced an initiative to begin auditing hospitals in NC.
This plan lead to the development of Pharmacy Waste Best Management
Practices by NCDENR and the NC Hospital Association.
Where does Pharmaceutical Waste
Come From?
 Medicines that are no longer usable for their intended
purpose &/or have no return credit value
 Partially dispensed medications or samples
 Does not meet reverse distributor’s return criteria
 Unlabeled or is unidentifiable by healthcare provider
 Mixed inseparably with other pharmaceuticals
 In a damaged container or contaminated
 Released from provider’s control
 Was repackaged by healthcare provider
Which Discarded Drugs are Regulated as
RCRA Hazardous Waste?
 Listed Waste
 P or U-listed pharmaceuticals – acute hazardous wastes
 The unused portion of the drug that was the sole active
ingredient in a solution or mixture.
 Characteristic Waste

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Ignitable
Toxic
Corrosive
Reactive
Duke University Hospital “Blue Bin”
Program


Policy
Formulary Characterization – Waste Determination
•
What fraction of the formulary will become RCRA waste and other
wastes that you may want to divert from the wastewater or solid
waste stream.
•


Waste Coding for easy Recognition
Scope of the Program in the Hospital
•

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

10% of 5,000 items identified as RCRA waste
All, most critical, or selected areas in a pilot program
Process to Collect Waste in and from Accumulation Areas
Training
Waste Segregation?
Methods to Package, Transport, and Dispose of Waste
Formulary Waste Determination
Formulary contained approximately 500 formulations that are subject to RCRA
standards:
 Chemotherapeutics
• arsenic trioxide, cyclophosphamide, mitomycin, melphalan
 P & U Listed wastes
•
warfarin, nicotine
•
paclitaxel, etoposide, alcohols
•
some vaccines, multivitamins
 Ignitable wastes
 Corrosive Wastes
 Wastes containing metals
 Insulins
 Oxidizers – Silver nitrate
 Aerosols
Pharmaceuticals Targeted for
Collection
 Formulary lists EPA and OSHA hazardous drugs.
 List for labeling and collection was narrowed to the
following:
• Waste Drugs Subject to RCRA Management
• Unused or Partially Used Chemotherapeutics
• Partially Used or Empty Aerosol Inhalers
Labels On Drugs Dispensed from Pharmacy
Identified Pharmaceutical Hazardous Wastes to
be Placed into Blue Bins for Collection
HAZARDOUS DRUG – SPECIAL HANDLING AND
DISPOSAL REQUIRED
DISPOSE IN BLUE BIN ONLY
Any medication delivered from
Pharmacy will have these
labels indicating that special
handling and disposal is
required
Selection of Accumulation/Collection
Method
 Several models for the management of wastes were reviewed
 Choices:
 Manage all pharmaceutical waste as hazardous waste
 Collect targeted pharmaceutical wastes and segregate at a central
accumulation area
 Use a contractor turn-key service
 Use a blend of contractor-internal service
 Central Segregation Using Internal Resources was selected –
 Some segregation would be necessary to comply with DOT shipping rules
and manage disposal costs
 Segregation at the CAA by trained staff most likely to be successful.
Waste Accumulation/Collection Areas

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Pharmacies – Central Pharmacy + Satellites
Patient Care – Inpatient, ICUs
Oncology
Clinics
Surgery Suites
Emergency Department
Radiology, Endoscopy and others that prepare or administer
drugs to patients
Primary and Secondary Waste
Segregation Scheme
Waste Drugs
Primary Segregation at
the point of generation
RCRA,
Chemotherapeutics
Blue Bin – targeted
drugs
Inhalers
RCRA Permitted
TSDF
Oxidizers
Non-targeted drugs
Non-RCRA nor
chemotherapeutics
WTE
Regulated Medical
Waste
Secondary Segregation at the
Central Accumulation Area
Pilot Program
 OESO EP began development of our “Blue Bin” program in
2006.
• Requested and received approval for an FTE specifically for
the program.
• Determined that the program should be rolled out slowly
over time by unit.
• Decided to conduct a pilot program to determine best
methods for compliance throughout the hospital.
• The pilot program would be conducted in two units. One unit
would use 9 gallon floor bins and the other would use 3
gallon wall mounted bins in each patient room.
Pilot Program
• Additional floor bins were placed at every med station
and dirty utility rooms on each unit.
• Floor bins at med stations and in room were secured by
a cable to the wall.
• Floor bins would be managed by OESO EP. The wall bins
would be handled by EVS. All waste would be stored in
an caged and locked area on the loading dock.
• Pilot Program roll-out was tentatively schedule for
November 2008 (actually project begins March 2009).
• Pilot would run for three months and then the data
collected would be used to improve the program prior
to full hospital implementation.
Pilot Program
 Meetings were held with Hospital Administration,
Nursing, Pharmacy, and EVS personnel.
 After some resistance, Pharmacy agreed to modify
labels on the EPA regulated drugs.
 EVS reluctantly agreed to the pilot program.
 Nursing was not receptive to the idea at all. Did not
agree to the program until Hospital Administration
stated they would participate.
Pilot Program Results
 Wall mounted bins were not used (resembled sharps
containers too much)Nurses preferred the floor
mounted bins.
 Large amount of non-target waste being placed in the
bins.
 Segregation of waste is large part of job (takes a lot
of time)
 Additional training is needed.
Pilot Program
 Due to the resistance from hospital personnel, the
pilot program ran for two years before expansion to
the whole health care system.
How was the program was rolled out
hospital wide?
Sentinel Event - Pharmaceutical Waste Management Audit
 In March of 2010, an audit of the Duke University Health
System Hospitals, Clinical Laboratories, Pharmacies, and
Hospital-Based Clinics was initiated to evaluate compliance
to a number of environmental laws and regulations under
the US EPA Voluntary Disclosure Policy.
 Based on the outcome of the audit, a number of current
drug disposal practices inconsistent with RCRA standards
were noted.
How was the program was rolled out
hospital wide?
Practices that were Cited
1. Discarding empty containers or packaging that held Plisted drugs (nicotine patches or warfarin packs) into
RMW bags or solid waste containers. (18)
2. Disposing of expired or unused drugs in RMW or solid
waste containers without regard to hazardous waste
status. (18)
3. Discharging expired or unused pharmaceuticals down the
drain which, without permission, could violate local
sewer use ordinances. (10)
How was the program was rolled out
hospital wide?
After the results of the audit and with the voluntary
audit requirements, the hospital administration decided
to implement the “Blue Bin” program organization
wide.
Organization Wide Implementation
 More meetings with affected parties (pharmacy,
nursing, etc)
 Coordinated online training update for all nursing
staff and others who handle or administer targeted
drugs and developed a program information poster
with Hospital Ed.
 Coordinated bin installation with the maintenance
department since all floor bins not located in dirty
utility rooms had to be secured to the wall.
Organization Wide Implementation
 Located and obtained space for a central
accumulation area on the main hospital’s loading
dock.
Organization Wide Implementation
Blue bin containers were placed in ICU rooms, at nurses
stations, and in soiled linen rooms
Hospital-based clinic blue
bin mounted on wall
Large blue bin standing on floor
Program Summary
 All patient care, ICUs, pharmacies, oncology units,
surgical suites, and hospital-based clinics participate
in the program.
 Since November 2010, more than 18,000 lbs of waste
have been collected for disposal.
 Program costs have been manageable ($60,000 in
FY2013).
Opportunities for Improvement
 Even though “target drugs” are identified on labels,
in MARs and Omnicells, a significant amount of waste
(~35%) is non-targeted waste.
 Segregation of collected waste needs to be improved
at the unit.
 Number of personnel taking the online training needs
to be improved. Currently, the training is voluntary.
 Management of P-listed wastes.
Waste Stream Components
Percent
17
18
RCRA
57
9 0
Oxidizers
Inhalers
Non RCRA
Non toxic
Opportunities for Improvement
 Significant problem in the past with sharps being
placed in the bins.
Opportunities for Improvement
 Creating a “Blue Bin” Brand add a recognizable icon to
drug labels
 Retrain, train, and train.
 Note: DMP adding 150 beds as
of June 1, 2013
Questions/Comments
 Contact Information
 Karen A. Trimberger, CHMM
 919-684-2794
 Karen.trimberger@duke.edu