What is Pharmacy Waste and why is it a issue Our Program Pilot Program & Roll Out

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 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.

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 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 drugsand 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 Large blue bin standing on floor Hospital-based clinic blue bin mounted on wall

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 • 919-684-2794 • Karen.trimberger@duke.edu