10/27/2010
Review rules and regulations that apply to pharmaceutical waste collection
Review the variety of wastes involved
Despina Kotis Pharm.D.
Director of Pharmacy
Northwestern Memorial Hospital
Chicago, IL
Outline the challenges of a pharmaceutical waste collection system
Describe successful training methods and techniques.
The speaker has nothing to disclose
Why the focus Why the focus on on Rx waste?
Rx waste?
Who is involved?
USGS (US Geological Survey) Water Survey (1999-2000)
Organic wastewater contaminants (OWCs) in 80% of streams tested
33% of OWCs detected were pharmaceuticals in Minnesota alone
Over 41 million Americans have Rx present in their drinking water
Media Coverage
3/9/08 USA Today - “AP Probe finds drugs in drinking water”
9/15/08 USA Today/AP report - “Hospitals dumping drugs into water”
4/10 National Geographic – A Special Issue: Water – Our Thirsty World
Increased EPA and State Regulatory Activity
Notice of Violations and Warnings
Increasing regulatory scrutiny country wide
Fines in excess of $275,000
Environmental Protection Agency (EPA-RCRA & CWA)
Department of Transportation (DOT)
Drug Enforcement Agency (DEA)
Occupational
Safety
p
y & Health ((OSHA))
The Joint Commission (TJC)
Publicly Owned Treatment Works (POTW)
State Regulatory Agencies
Joint Commission (TJC) Standards
Medication Management, Environment of Care, and Leadership standards
Can Rx collection affect Accreditation?
Hazardous waste determinations not done or incorrect
Labeling of hazardous waste not done or incorrect
Sewering Hazardous Waste
Improper disposal of chemotherapy drugs
Inadequate training for employees in HW management
Not conducting proper weekly inspections of HW storage
No or inadequate HW manifests
Lack of emergency contingency plan
Improper management of expired pharmaceuticals
MM.01.01.03 - Medication Management
The hospital safely manages high-alert and hazardous medications
The hospital identifies, in writing, its high-alert and hazardous medications
The hospital has a process in place that addresses how outside resources, if any, are
used for the destruction of pharmaceuticals.
EC.02.02.01 - Environment of Care
The h
Th
hospital
it l manages itits h
hazardous
d
materials
t i l wastes
t risks.
i k
The hospital minimizes risks associated with disposing of hazardous medications.
LD.04.01.01 - Leadership
The hospital complies with law and regulation.
EM.02.02.05 – Emergency Management
The organization prepares for how it will manage hazardous materials and waste.
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10/27/2010
What do you need to do?
Waste Evaluation
Characterization of Entire Rx Formulary
Establish Collection System
Collection containers on the floors
Movement of waste to storage area
Comprehensive Training
Comprehensive Training
Combination of Training Lead Staff and Nurses
Training of Pharmacy staff Program Implementation
Rolling out a complex program
Communication is key
Assessment and Ongoing Support
Listed Waste (Commercial Chemical)
Pharmaceutical Waste Characterization
Identify all Listed and Characteristic RCRA Hazardous
pharmaceuticals
Characterization must be based on both active AND
inactive or preservative ingredients
Determine both EPA/RCRA and DOT hazardous material
class at NDC level
Consider industry best practices (NIOSH, ASHP & OSHA)
re: identifying non-RCRA chemo & environmentally
dangerous drugs
Characteristic Waste
Ignitability - Aqueous Solution containing 24% alcohol or more by
volume & flash point<140° F., D001 waste.
P – Listed (Coumadin/warfarin,
epinephrine*, nitroglycerin*, nicotine, arsenic
trioxide)
*EPA interpretations
i t
t ti
off epinephrine
i
h i salts
lt and
d medicinal
di i l
nitroglycerin as Non-RCRA hazardous requires state
adoption of EPA interpretations.
U – Listed (Chemotherapy drugs)
Corrosivity - An aqueous solution having a pH <= 2.0 or >= to 12.5,
D002 waste.
Reactivity – Must meet eight separate criteria identifying certain
explosive and water reactive wastes. D003 waste.
NOTE: Nitroglycerin formulations are excluded federally from the P081
listing as non-reactive as of August 14, 2001 under FR:
May 16, 2001. States must have adopted the exclusion.
Toxicity - Approximately 40 chemicals which meet specific leaching
concentrations.
Examples of toxic pharmaceuticals at indicated maximum concentrations:
Arsenic (5.0 mg/L), Barium (100.0 mg/L), Mercury (0.2 mg/L), Cadmium
1.0 mg/L), Chloroform (6.0 mg/L), Selenium (1.0 mg/L), Chromium 5.0
mg/L), Silver (5.0 mg/L), m-Cresol (200.0 mg/L)
Rules for Hazardous Waste Collection Satellite Accumulation: EPA 40 CFR 262.34(c)(1)
Accumulate as much as 55 gallons of hazardous waste or one quart of acutely hazardous (P‐Listed) waste
At or near the point of generation where wastes initially accumulate
Under the control of the operator of the process generating the waste
Container requirements
Marked “Hazardous Waste” or words identifying contents
Compatible with waste
Closed except when adding or removing waste
Not be handled, opened or stored in a manner that causes it to leak
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10/27/2010
Container Sizes and Locations
Rules for Hazardous Waste Training
Where to place containers in the Departments
At or near the point of generation
Under the control of the operator
RCRA Training
Employees who are involved with or occupationally exposed to hazardous waste Training must be completed within 6 months
Annual retraining & record retention requirements
Hazard Communication Training
Hazard Communication Training
How to collect / move waste from floor to storage
Need adequate capacity
Need adequate service level
Employees who are involved with or occupationally exposed to hazardous chemicals must be trained in accordance with 29 CFR 1910.200
Training must be completed at time of initial assignment to the job
DOT Training Employees who are involved with or occupationally exposed to hazardous materials must be trained in accordance with 49 CFR Subpart H 265 (172.702 & 172.704)
Training must be completed within 90 days
Retraining required every three years & record retention requirement
Staff Education on a Complex Program
Training Required if Exposed to Hazardous Waste
All Staff that handles Medications
Nursing
Anesthesia
h
Pharmacy
All Staff that handle Hazardous Waste Containers
Environmental Services
Facilities Staff
Safety Staff
Rolling Out a Complex Program
Follow the Steps
Get Project Approval
Develop the Program
i
i h ff
Communicate with Staff
Conduct Training
Place Containers
Collection
Assessment and Ongoing Support
Integrating Rx into your organizational “culture”
873‐bed Nationally Recognized Academic Medical Center
Tertiary care center providing a full range of services for adults and neonates
Nationally Ranked for Quality
What makes up your “culture”
The shared beliefs, customs, practices, and social b h i
behavior of a particular people f
i l
l
It is the “right thing to do” for the environment
Safety awareness and safe handling for the staff member Feinberg and Galter Pavilions Prentice Women’s Hospital
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10/27/2010
Integrating Rx into your organizational “culture”
Achieving organizational “buy‐in”
Making those key decisions
Tackling the tough challenges
Communicating with clinical and all front line staff
Nursing / Patient Care
Involve the Key Stakeholders
Gives them the chance to understand their involvement
Gives you the chance to hear their concerns and
Gives you the chance to hear their concerns and issues
Allows you to identify and address road blocks ahead of time
Allows you to understand their “cultural” issues that will affect the program development
The Northwestern Memorial Hospital experience
Leadership Champion/C‐suite
Directors/Managers from all Multidiscipline
Environmental Services, Nursing, Pharmacy, Physicians, y,
Safety, Anesthesia
Front line staff
Nurses, Pharmacists, Pharmacy Technicians, Safety Technicians, Physicians, Anesthesia Technicians, EVS workers
Education
Facilities
Pharmacy
Program Development
Infection Control
Safety
Quality
How are we How are we going to do this?
going to do this?
Leadership
Program Success
Environmental Services
The Northwestern Memorial Hospital experience
Multiple meetings with Environment of Care Committee
Presentations to Nursing Leadership, Anesthesia G dR
d E i
t lS i
Grand Rounds, Environmental Services Planning meetings with Pharmacy, Anesthesia, OR Leadership, Environmental Services
Special meetings with Infection Control
What is Northwestern Memorial Hospital going to do?
Pharmaceutical Waste Characterization
Formulary Review Analysis shows 11% Hazardous (RCRA and Chemo) and 89% Non‐Hazardous
What should we collect?
Northwestern’s culture strives on being a leader in the field Decision: Follow best management practices, going above and beyond regulatory requirement, and collect all Rx
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10/27/2010
What is Northwestern Memorial Hospital going to do?
The Collection Process
Where to place containers in the Departments?
Northwestern’s culture is to be as accommodating as possible to the needs of the staff
Pharmacy locations‐‐‐9‐‐‐2 clean rooms
Decision: Central collection of Rx in most areas (Nurses Stations, Soiled Utility), but additional containers in heavy use areas (ICU)
Decision: Special accommodations for Anesthesia to facilitate ease of use / better compliance
What is Northwestern Memorial Hospital going to do?
The Collection Process
How to provide adequate capacity to the Departments and maintain service levels by Environmental Services?
How to move waste long distances from Departments to waste storage areas
Northwestern’s culture is facing the reality of balancing h
’
l
i f i
h
li
fb l i
service needs with the substantial reduction of Environmental Services staff
Decision: Use 55‐gallon drums to collect waste in Soiled Utility Rooms of heavy use areas (ICU / OR)
Decision: Use 55‐gallon drums for waste consolidation in Trash Chute Rooms, instead of moving Satellite Collection Containers to storage areas.
What is Northwestern Memorial Hospital going to do?
Multidisciplinary Team Approach
EVS, Safety, Pharmacy, Nursing, Anesthesia, Physician
Communication Communication Communication
Communication, Communication, Communication
Use messaging in Electronic Medical Record, Automated Dispensing Machines
Use of laminated cards posted in Pharmacies and OR suites
Training
Staff Education on a Complex Program
Effective Training Must Be:
Concise Comprehensive
Compliant
Customized
Implementation
Pharmacy Department
Professional Services (Radiology, GI Lab, Cath Lab)
i
Operating Rooms, Recovery Rooms
Patient Care Areas
Training
Effective Training Must Be:
Concise One page flyers for all trainings
Waste Flow Diagram Posters
5 minute In‐Service Trainings Comprehensive
Multiple trainings at different times for each Department
Different learning environments (digital, in‐service, break‐
room visits, presentations)
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10/27/2010
Training
Effective Training Must Be:
Compliant
Training
Effective Training Must Be:
Customized
Reviewing requirements for proper segregation of Hazardous vs Non‐Hazardous
Hazardous vs. Non
Hazardous Customized Waste Flow Diagrams for Anesthesia and OR Nursing framed and hung on wall of each OR suite
Nursing framed and hung on wall of each OR suite.
Defining “RCRA Empty” to ensure collection of all hazardous items
Annual training is key for sustainability
Specific Training Modules created for OR, Anesthesia, EVS, Pharmacy, PACU, General Nursing
Online streaming video module Online Video Training Module
Northwestern’s culture involves the use of leading edge technology in all applications
Video Department with state‐of‐the‐art equipment involved with incorporating video learning into a i t f
li ti
variety of applications
Video Department already involved with incorporating video learning into a variety of applications
Looking for opportunities to expand the use of this technology in other areas throughout the hospital
Assessment and Ongoing Support
Keeping the Program Successful
Feedback from Nursing Staff
Follow‐Up Meetings with Leadership
Waste and Container Audits
d
i
di
Training Built in for New Employees
Refresher Trainings
“Tracers” to Identify Problem Areas
Which of the following are the most effective principals to keep in mind regarding pharmaceutical waste training?
1. Creative, Complex, Costly
l
l
2. Concise, Comprehensive, Compliant, Customized
3. Colorful, Concise, Comprehensive
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10/27/2010
Which of the following factors affects decision making regarding the handling of medications?
1.
2.
3.
4.
Inherent toxicity of drug
Area under the curve data on absorption
The package size of the product
Medication class it belongs too
Which regulatory agency is involved in pharmaceutical waste management?
1.
2.
3.
4.
The Joint Commission (TJC)
The Department of Transportation (DOT)
The Federal Drug Administration (FDA)
1 and 2
Which of the following items need to be part of personnel training procedures?
1. Medication package insert locations
2. Number of your human resources representative 3. Use of personal protective equipment
4. Brightly colored labels
What do you need to do when preparing your pharmacy department for a pharmaceutical waste program?
1. Evaluate your drug formulary
l
d
f
l
2. Take a 2 week vacation to a Greek Island before you begin
3. Call in the FDA to visit your facility What are 3 categories of pharmaceutical waste? 1. Solid, liquid, gas
2. Hazardous, chemical, cytotoxic
3. Chemotherapy, hazardous, non‐hazardous
Despina Kotis, Pharm.D.
Director, Pharmacy
Northwestern Memorial Hospital
251 East Huron Street
251 East Huron Street
Feinberg Pavilion LC‐700H
Chicago, IL 60611
(312) 926‐6961
[email protected]
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