1. Designing, Implementing, and Managing a Pharmacy Waste “Blue Bin” Program in a Large University Hospital: the Challenges and Roadblocks

2. What is Pharmacy Waste and why is it a issue
Our Program
Pilot Program & Roll Out
Issues/Program Improvements

3. 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

4. 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.)

5. 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
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.

6. 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

7. 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
Ignitable
Toxic
Corrosive
Reactive

8. 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.
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

9. 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
Ignitable wastes
paclitaxel, etoposide, alcohols
Corrosive Wastes
Wastes containing metals
some vaccines, multivitamins
Insulins
Oxidizers – Silver nitrate
Aerosols

10. 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

11. 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

12. 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.

13. Waste Accumulation/Collection Areas
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

14. Primary and Secondary Waste Segregation Scheme
Waste Drugs
Blue Bin – targeted drugs
RCRA, Chemotherapeutics
Inhalers
RCRA Permitted TSDF
Oxidizers
Non-RCRA nor chemotherapeutics
WTE
Non-targeted drugs
Regulated Medical Waste
Primary Segregation at
the point of generation
Secondary Segregation at the
Central Accumulation Area

15. 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.

16. 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.

17. 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.

18. 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.

19. Pilot Program
Due to the resistance from hospital personnel, the pilot program ran for two years before expansion to the whole health care system.

20. 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.

21. How was the program was rolled out hospital wide?
Practices that were Cited
Discarding empty containers or packaging that held P-listed drugs (nicotine patches or warfarin packs) into RMW bags or solid waste containers. (18)
Disposing of expired or unused drugs in RMW or solid waste containers without regard to hazardous waste status. (18)
Discharging expired or unused pharmaceuticals down the drain which, without permission, could violate local sewer use ordinances. (10)

22. 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.

23. 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.

24. Organization Wide Implementation
Located and obtained space for a central accumulation area on the main hospital’s loading dock.

25. 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

26. 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).

27. 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.

28. Waste Stream Components

29. Opportunities for Improvement
Significant problem in the past with sharps being placed in the bins.

31. 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

32. Questions/Comments
Contact Information
Karen A. Trimberger, CHMM