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

Waste Stream Components

57

9

18

17

Percent

RCRAOxidizersInhalersNon RCRANon toxic

Significant problem in the past with sharps being placed in the bins.

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

Contact Information Karen A. Trimberger, CHMM 919-684-2794 Karen.trimberger@duke.edu

Questions/Comments