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