Transcript John Lacarrubba

WHAT HOSPITALS SHOULD KNOW
ABOUT
PHARMACEUTICAL WASTE
COMPLIANCE
Presented at:
Hospitals for a Healthy Environment in Rhode Island’s
Second Annual Conference
John LaCarrubba
April 2, 2012
PHARMACEUTICAL WASTE
MANAGEMENT
Regulations & References
The information provided in this presentation is based on the
referenced Code of Federal Regulations. This data is presented only
as a reference. For complete requirements or legal counsel on
hazardous waste regulations and interpretations, generators should
consult their legal department, the applicable Code of Federal
Regulations and applicable State regulatory agencies.
Disclosure Declaration
As a Stericycle employee, I have a vested interest in and affiliation
with a corporate organization offering financial support or grant
monies for this continuing education activity and a business interest in
pharmaceutical waste management services.
PHARMACEUTICAL WASTE
MANAGEMENT
A Growing Concern
Media Coverage
• 9/15/08 USA Today/AP report - “Hospitals dumping drugs into water”
• 5/24/10 Modern Healthcare - “Drugged”
• 3/15/12 Modern Medicine – “Hospitals at risk for hazardous
pharmaceutical waste violations”
EPA Regulatory Activity
•Notice of Violations and warnings
•Increasing regulatory scrutiny country wide
•Fines in excess of $450,000
The Joint Commission (TJC)
•Medication Management
•Environment of Care
•Emergency Management
•Leadership standards
PHARMACEUTICAL WASTE
THE ENFORCERSMANAGEMENT
EPA
DOT
TJC
Rx Waste Determination
Generator Status
EPA ID Number
Satellite Accumulation
Area
Central Accumulation Area
Documented Training
Classification, description,
and packaging (173.22)
Proper marking and
labeling (172.300)
Hospital has written plan
for managing hazardous
waste
Segregation into proper
streams (173.21)
Maintains written inventory
of hazardous materials
Training (172.202 &
172.204)
The hospital complies with
law and regulation
Publicly Owned Treatment Works (POTW)
STATE REGULATORY AGENCIES
(RIDEM)
PHARMACEUTICAL WASTE
MANAGEMENT
Common EPA Inspection Issues
• Hazardous waste determinations not done or incorrect
• Labeling of hazardous waste not done or incorrect
• Disposing HW down the drain, in red bag, in solid waste
• No or inadequate HW manifests
• Improper disposal of chemotherapy drugs
• Inadequate training for employees in HW management
• Not conducting proper weekly inspections of HW storage
• Lack of emergency contingency plan
• Improper management of expired pharmaceuticals
“Identification and Management of Regulated Hazardous Waste” – EPA Region 2
TJC Accreditation
PHARMACEUTICAL WASTE
MANAGEMENT
MM.01.01.03 - MEDICATION MANAGEMENT
• The hospital safely manages 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 hospital manages its hazardous materials wastes risks.
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.
The Joint Commission under their elements of
performance require proper management of
hazardous materials including pharmaceutical waste
(Standard EC.02.02.01, EP8)
PHARMACEUTICAL WASTE
MANAGEMENT
What are they regulating? EPA (RCRA)
Two (2) Categories of RCRA Hazardous Waste: Listed and Characteristic
Listed Wastes
• P – Listed = Acutely Hazardous
Coumadin, Nicotine, Physostigmine, Arsenic Trioxide
Epinephrine*, Nitroglycerin*
*Requires State adoption of US EPA interpretations
• U-Listed = Toxic (chemotherapy)
P-List
U-List
PHARMACEUTICAL WASTE
MANAGEMENT
What are they regulating? EPA (RCRA)
Characteristic Hazardous
Ignitable, Corrosive, Reactive, Toxic
•
•
•
•
Lantus
Humalog
Humulin N&R
Novolog
• Flovent, Albuterol,
Combivent, Cetacaine,
Dermoplast Spray, Advair
HFA
Incompatible Hazardous Waste
RCRA Incompatible drugs are those that CANNOT be placed in the
same container without danger of a chemical reaction.
(e.g. Corrosives
and
Oxidizers)
Debrox
Unused Silver Nitrate
PHARMACEUTICAL WASTE
MANAGEMENT
WASTE STREAMS THAT TYPICALLY STAY
THE SAME:
Trace Chemo
Bulk Chemo
Empty
Containers
Controlled
Substances
Plain IVs
What is different? Pharmaceutical Waste
Only when there is leftover or unused medication in a vial, syringe, ampoule
or IV bag or bottle. Pills, capsules, creams, ointments are also included.
Non-RCRA
Rx Waste
(Non-Haz)
94%
Compatible
Hazardous
In-Compatible
5%
1%
PHARMACEUTICAL WASTE
MANAGEMENT
What Happens To Hospital Rx Inventory?
What is Pharmaceutical waste?
– Dispensed to patients
– Return to manufacturer for credit
– Rx Waste
 No longer used for its intended purpose
To be discarded
•Partial vials
•Partial syringes
•Full or partial pre-instilled IV’s
•Discontinued/un-administered meds
•Hospital repacks
•Patient prescriptions
•Pre-filled syringes
•Samples
PHARMACEUTICAL WASTE MANAGEMENT
EPA RCRA Trace, Empty and Bulk
Trace
• Used to describe RCRA empty containers
RCRA Empty - Both conditions must be met:
• All contents removed via commonly employed
practices (pouring, pumping, aspirating)
• Less than 3% of original weight by capacity if the
container is less than or equal to 119 gal
Bulk
• More than “trace”
PHARMACEUTICAL WASTE
MANAGEMENT
Federal EPA Waste Generator Status
CESQG Conditionally Exempt Small Quantity Generator
< or = 100 kg/mo (220 lbs)of non-acute hazardous waste
< 1 kg/month (2.2 lbs) of acute hazardous waste (P-Listed)*
Small Quantity Generator *
Between 100 kg (220 lbs) and 1000 kg/mo (2200 lbs)of non-acute
hazardous waste
< 1 kg/month (2.2 lbs) of acute hazardous waste (P-Listed)
Large Quantity Generator
> = 1000 kg/mo (2200 lbs) of non-acute hazardous waste
> = 1 kg/month (2.2 lbs) acute hazardous waste (P-Listed)
* SQG status must be verified & documented monthly
PHARMACEUTICAL WASTE MANAGEMENT
TRAINING
RCRA Training
• Employees involved with or occupationally exposed to hazardous waste
• Completed within 6 months
• Annual retraining
• Record retention requirement
Hazard Communication Training
• Employees involved with or occupationally exposed to hazardous chemicals
must be trained in accordance with 29 CFR 1910.200
• Completed at time of initial assignment to job
DOT Training
• Employees involved with or occupationally exposed to hazardous materials
must be trained in accordance with 49 CFR Subpart H 265 (172.702 &
172.704)
• Completed within 90 days
• Retraining every three years
• Record retention requirement
PHARMACEUTICAL WASTE MANAGEMENT
Staff Education
Implementation Training
EVS
Nursing/Clinicians
Pharmacy
OR & ED
Unit Specific
Training Topics
Regulatory requirements
Waste segregation
Aftercare
On-site follow-up
Monthly & quarterly schedule
Refresher Training
RX Waste containers
Transportation & Disposal
PHARMACEUTICAL WASTE MANAGEMENT
GETTING STARTED
1.Understand the need for a pharmaceutical
waste program based on regulatory involvement
and environmental concerns.
2.Evaluate current handling practices of
pharmaceutical waste in comparison to federal
and state regulations.
3.Identify a group of leaders in your facility that
have a passion for the environment, will champion
multi-departmental cooperation and
administration support.
PHARMACEUTICAL WASTE MANAGEMENT
A Team Effort
Departments with champions that advocate for
compliant and environmentally responsible
pharmaceutical waste disposal:
Pharmacy
Nursing
Nursing Education
Quality/Accreditation
Safety
Environmental Services
Risk Management
Infection Control
Facilities Management
Public Relations
PHARMACEUTICAL WASTE MANAGEMENT
PROGRAM IMPLEMENTATION
COMMUNICATE, COMMUNICATE, COMMUNICATE !!!
Internal communication – Talk it up
• Intranet
● Coming Soon Notices
• Web-site
● Management Meetings
• Newsletter
● Unit Huddles
Communicate to staff BEFORE implementation
• Program announcements – Who, What & Why
• Training dates
• Program start date
External communication UPON implementation
• Press releases - "Green Initiative”
• Assuring regulatory compliance
• Environmental stewardship – “The right thing
•
to do”
Employee & community safety
PHARMACEUTICAL WASTE MANAGEMENT
Questions