designing, implementing, and managing a pharmacy waste “blue bin” program in a large university...
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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
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
Why the Concern With Pharmaceutical Waste
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.)
Relationship to The Joint Commission Standards:
Environment of Care
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.
Examples of Regulatory Enforcement Actions
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
Where does Pharmaceutical Waste Come From?
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
Ignitable Toxic Corrosive Reactive
Which Discarded Drugs are Regulated as RCRA Hazardous Waste?
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.• 10% of 5,000 items identified as RCRA waste
Waste Coding for easy Recognition Scope of the Program in the Hospital
• 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
Duke University Hospital “Blue Bin” Program
Formulary contained approximately 500 formulations that are subject to RCRA standards:
Chemotherapeutics• arsenic trioxide, cyclophosphamide, mitomycin, melphalan
P & U Listed wastes• warfarin, nicotine
Ignitable wastes• paclitaxel, etoposide, alcohols
Corrosive Wastes Wastes containing metals
• some vaccines, multivitamins
Insulins Oxidizers – Silver nitrate Aerosols
Formulary Waste Determination
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
Pharmaceuticals Targeted for Collection
Labels On Drugs Dispensed from Pharmacy Identified Pharmaceutical Hazardous Wastes to be Placed into Blue Bins for Collection
Any medication delivered from Pharmacy will have these labels indicating that special handling and disposal is required
HAZARDOUS DRUG – SPECIAL HANDLING AND
DISPOSAL REQUIRED DISPOSE IN BLUE BIN ONLY
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.
Selection of Accumulation/Collection Method
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
Waste Accumulation/Collection Areas
Primary and Secondary Waste Segregation Scheme
Waste Drugs
Blue Bin – targeted drugs
RCRA, Chemotherapeutics
Inhalers
RCRA Permitted
TSDF
Oxidizers
Non-RCRA nor chemotherap
eutics
WTE
Non-targeted drugs
Regulated Medical Waste
Primary Segregation atthe point of generation
Secondary Segregation at the Central Accumulation Area
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
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 Results
Due to the resistance from hospital personnel, the pilot program ran for two years before expansion to the whole health care system.
Pilot Program
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
P-listed 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.
How was the program was rolled out hospital wide?
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
Organization Wide Implementation
Blue bin containers were placed in ICU rooms, at nurses stations, and in soiled linen rooms
Large blue bin standing on floorHospital-based clinic blue bin mounted on wall
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).
Program Summary
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.
Opportunities for Improvement
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