WHAT HOSPITALS SHOULD KNOW ABOUT PHARMACEUTICAL WASTE COMPLIANCE Presented at: Hospitals for a...
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Transcript of WHAT HOSPITALS SHOULD KNOW ABOUT PHARMACEUTICAL WASTE COMPLIANCE Presented at: Hospitals for a...
WHAT HOSPITALS SHOULD KNOW ABOUTPHARMACEUTICAL WASTE
COMPLIANCE
Presented at:
Hospitals for a Healthy Environment in Rhode Island’s
Second Annual ConferenceJohn LaCarrubbaApril 2, 2012
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 PHARMACEUTICAL WASTE MANAGEMENT
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
Publicly Owned Treatment Works (POTW)
THE ENFORCERS
STATE REGULATORY AGENCIES
(RIDEM)
PHARMACEUTICAL WASTE MANAGEMENT
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
PHARMACEUTICAL WASTE MANAGEMENT
TJC Accreditation 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)
What are they regulating? EPA (RCRA)
PHARMACEUTICAL WASTE MANAGEMENT
Two (2) Categories of RCRA Hazardous Waste: Listed and Characteristic
Listed Wastes• P – Listed = Acutely HazardousCoumadin, Nicotine, Physostigmine, Arsenic Trioxide
Epinephrine*, Nitroglycerin**Requires State adoption of US EPA interpretations
• U-Listed = Toxic (chemotherapy)
P-List
U-List
Characteristic HazardousIgnitable, Corrosive, Reactive, Toxic
PHARMACEUTICAL WASTE MANAGEMENT
What are they regulating? EPA (RCRA)
•Lantus •Humalog•Humulin N&R•Novolog
•Flovent, Albuterol, Combivent, Cetacaine, Dermoplast Spray, Advair HFA
Debrox
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)
Unused Silver Nitrate
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.
Bulk Chemo
Trace Chemo
ControlledSubstances
WASTE STREAMS THAT TYPICALLY STAY THE SAME:
94%
Non-RCRARx Waste(Non-Haz)
5%
CompatibleHazardous
1%
In-Compatible
Plain IVsEmpty Containers
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 purposeTo be discarded
PHARMACEUTICAL WASTE MANAGEMENT
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”
EPA RCRA Trace, Empty and Bulk
PHARMACEUTICAL WASTE MANAGEMENT
PHARMACEUTICAL WASTE MANAGEMENT
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
Federal EPA Waste Generator Status
TRAININGRCRA Training
• Employees involved with or occupationally exposed to hazardous waste • Completed within 6 months• Annual retraining • Record retention requirement
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
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
PHARMACEUTICAL WASTE MANAGEMENT
Staff Education Implementation Training
EVS Nursing/CliniciansPharmacy OR & EDUnit Specific
Training Topics Regulatory requirements RX Waste containers
Waste segregation Transportation & Disposal
AftercareOn-site follow-upMonthly & quarterly scheduleRefresher Training
PHARMACEUTICAL WASTE MANAGEMENT
PHARMACEUTICAL WASTE MANAGEMENT
GETTING STARTED1.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.
•Identify a group of leaders in your facility that have a passion for the environment, will champion multi-departmental cooperation and administration support.
A Team Effort
Departments with champions that advocate for compliant and environmentally responsible pharmaceutical waste disposal:
Pharmacy Environmental Services
Nursing Risk ManagementNursing Education Infection
Control Quality/Accreditation Facilities Management
Safety Public Relations
PHARMACEUTICAL WASTE MANAGEMENT
PROGRAM IMPLEMENTATIONCOMMUNICATE, 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 dateExternal communication UPON
implementation• Press releases - "Green Initiative”• Assuring regulatory compliance• Environmental stewardship – “The
right thing to do”• Employee & community safety
PHARMACEUTICAL WASTE MANAGEMENT
Questions
PHARMACEUTICAL WASTE MANAGEMENT