10/27/2010

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Despina Kotis Pharm.D.Director of PharmacyNorthwestern Memorial HospitalChicago, IL

The speaker has nothing to disclose

Review rules and regulations that apply to pharmaceutical waste collection

Review the variety of wastes involved

Outline the challenges of a pharmaceutical waste collection system

Describe successful training methods and techniques.

Why Why the focus the focus on on Rx waste?Rx waste?USGS (US Geological Survey) Water Survey (1999-2000)

Organic wastewater contaminants (OWCs) in 80% of streams tested33% of OWCs detected were pharmaceuticals in Minnesota aloneOver 41 million Americans have Rx present in their drinking water

Media Coverage3/9/08 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 ActivityNotice of Violations and Warnings Increasing regulatory scrutiny country wideFines in excess of $275,000

Joint Commission (TJC) StandardsMedication Management, Environment of Care, and Leadership standards

Who is involved?Who is involved?

Environmental Protection Agency (EPA-RCRA & CWA) Department of Transportation (DOT)Drug Enforcement Agency (DEA)Occupational Safety & Health (OSHA)p y ( )The Joint Commission (TJC)Publicly Owned Treatment Works (POTW)State Regulatory Agencies

Hazardous waste determinations not done or incorrect Labeling of hazardous waste not done or incorrectSewering Hazardous WasteImproper disposal of chemotherapy drugsInadequate training for employees in HW managementNot conducting proper weekly inspections of HW storageNo or inadequate HW manifestsLack of emergency contingency planImproper management of expired pharmaceuticals

Can Rx collection affect Accreditation?Can Rx collection affect Accreditation?

MM.01.01.03 - Medication ManagementThe hospital safely manages high-alert and hazardous medicationsThe hospital identifies, in writing, its high-alert and hazardous medicationsThe 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 CareTh h it l it h d t i l t i kThe hospital manages its hazardous materials wastes risks.The hospital minimizes risks associated with disposing of hazardous medications.

LD.04.01.01 - LeadershipThe hospital complies with law and regulation.

EM.02.02.05 – Emergency ManagementThe organization prepares for how it will manage hazardous materials and waste.

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What do you need to do?What do you need to do?Waste Evaluation

Characterization of Entire Rx FormularyEstablish Collection System

Collection containers on the floorsMovement of waste to storage area

Comprehensive TrainingComprehensive TrainingCombination of Training Lead Staff  and NursesTraining  of Pharmacy staff 

Program ImplementationRolling out a complex programCommunication is key

Assessment and Ongoing Support

Pharmaceutical Waste CharacterizationPharmaceutical Waste CharacterizationIdentify all Listed and Characteristic RCRA Hazardous pharmaceuticals

Characterization must be based on both active ANDinactive 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

Listed Waste (Commercial Chemical)

P – Listed (Coumadin/warfarin, epinephrine*, nitroglycerin*, nicotine, arsenic trioxide)*EPA i t t ti f i h i lt d di i l*EPA interpretations of epinephrine salts and medicinal

nitroglycerin as Non-RCRA hazardous requires stateadoption of EPA interpretations.

U – Listed (Chemotherapy drugs)

Characteristic WasteIgnitability - Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F., D001 waste.

Corrosivity - An aqueous solution having a pH <= 2.0 or >= to 12.5, D002 waste.

Reactivity Must meet eight separate criteria identifying certainReactivity – 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 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 requirementsMarked “Hazardous Waste” or words identifying contentsCompatible with wasteClosed except when adding or removing wasteNot be handled, opened or stored in a manner that causes it to leak

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Container Sizes and LocationsContainer Sizes and Locations

Where to place containers in the DepartmentsAt or near the point of generationUnder the control of the operator

How to collect / move waste from floor to storage

Need adequate capacityNeed adequate service level

Rules for Hazardous Waste TrainingRules for Hazardous Waste TrainingRCRA Training

Employees who are involved with or occupationally exposed to hazardous waste Training must be completed within 6 monthsAnnual retraining & record retention requirements

Hazard Communication TrainingHazard Communication TrainingEmployees who are involved with or occupationally exposed to hazardous chemicals must be trained in accordance with 29 CFR 1910.200Training 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 daysRetraining required every three years & record retention requirement

Staff Education on a Complex ProgramStaff Education on a Complex Program

Training Required if Exposed to Hazardous WasteAll Staff that handles Medications

NursingAnesthesiahPharmacy

All Staff that handle Hazardous Waste ContainersEnvironmental ServicesFacilities StaffSafety Staff

Rolling Out a Complex ProgramRolling Out a Complex Program

Follow the StepsGet Project ApprovalDevelop the Program

i i h ffCommunicate with StaffConduct TrainingPlace ContainersCollectionAssessment and Ongoing Support

873‐bed Nationally Recognized Academic Medical Center

Tertiary care center providing a full range of services for adults and 

Feinberg and Galter Pavilions Prentice Women’s Hospital

neonates

Nationally Ranked for Quality

Integrating Rx into your organizational “culture”Integrating Rx into your organizational “culture”

What makes up your “culture”

The shared beliefs, customs, practices, and social b h i f i l lbehavior of a particular people 

It is the “right thing to do” for the environment

Safety awareness and safe handling for the staff member 

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Integrating Rx into your organizational “culture”Integrating Rx into your organizational “culture”

Achieving organizational “buy‐in”Making those key decisionsTackling the tough challengesCommunicating with clinical and all front line staff

FacilitiesFacilities

Program Program 

Nursing / Nursing / Patient CarePatient Care LeadershipLeadership

PharmacyPharmacy

EducationEducation

Program Program SuccessSuccess

DevelopmentDevelopment

Environmental Environmental ServicesServices

SafetySafetyInfection Infection ControlControl

QualityQuality

How How are we are we going to do this?going to do this?

Involve the Key StakeholdersGives them the chance to understand their involvementGives you the chance to hear their concerns andGives you the chance to hear their concerns and issuesAllows you to identify and address road blocks ahead of timeAllows you to understand their “cultural” issues that will affect the program development

The Northwestern Memorial Hospital experienceThe Northwestern Memorial Hospital experience

Multiple meetings with Environment of Care CommitteePresentations to Nursing Leadership, Anesthesia G d R d E i t l S iGrand Rounds, Environmental Services Planning meetings with Pharmacy, Anesthesia, OR Leadership, Environmental ServicesSpecial meetings with Infection Control

The Northwestern Memorial Hospital experienceThe Northwestern Memorial Hospital experience

Leadership Champion/C‐suiteDirectors/Managers from all Multidiscipline

Environmental Services, Nursing, Pharmacy, Physicians, Safety, Anesthesiay,

Front line staffNurses, Pharmacists, Pharmacy Technicians, Safety Technicians, Physicians, Anesthesia Technicians, EVS workers

What is Northwestern Memorial Hospital going to do?What is Northwestern Memorial Hospital going to do?

Pharmaceutical Waste CharacterizationFormulary Review Analysis shows 11% Hazardous (RCRA and Chemo) and 89% Non‐HazardousWhat 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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What is Northwestern Memorial Hospital going to do?What is Northwestern Memorial Hospital going to do?

The Collection ProcessWhere to place containers in the Departments?Northwestern’s culture is to be as accommodating as possible to the needs of the staffPharmacy locations‐‐‐9‐‐‐2 clean roomsDecision: 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?What is Northwestern Memorial Hospital going to do?

The Collection ProcessHow 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

h ’ l i f i h li f b l iNorthwestern’s culture is facing the reality of balancing service needs with the substantial reduction of Environmental Services staffDecision: 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?What is Northwestern Memorial Hospital going to do?

Multidisciplinary Team ApproachEVS, Safety, Pharmacy, Nursing, Anesthesia, PhysicianCommunication Communication CommunicationCommunication, Communication, CommunicationUse messaging in Electronic Medical Record, Automated Dispensing MachinesUse of laminated cards posted in Pharmacies and OR suites

ImplementationPharmacy DepartmentProfessional Services (Radiology, GI Lab, Cath Lab)

iOperating Rooms, Recovery RoomsPatient Care Areas

TrainingTraining

Staff Education on a Complex ProgramEffective Training Must Be:

Concise ComprehensiveCompliantCustomized

TrainingTraining

Effective Training Must Be:Concise 

One page flyers for all trainingsWaste Flow Diagram Posters5 minute In‐Service Trainings 

ComprehensiveMultiple trainings at different times for each DepartmentDifferent learning environments (digital, in‐service, break‐room visits, presentations)

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TrainingTraining

Effective Training Must Be:Compliant

Reviewing requirements for proper segregation of Hazardous vs Non‐HazardousHazardous vs. Non Hazardous 

Defining “RCRA Empty” to ensure collection of all hazardous itemsAnnual training is key for sustainability

TrainingTraining

Effective Training Must Be:Customized

Customized Waste Flow Diagrams for Anesthesia and OR Nursing framed and hung on wall of each OR suiteNursing framed and hung on wall of each OR suite.

Specific Training Modules created for OR, Anesthesia, EVS, Pharmacy, PACU, General Nursing

Online streaming video module 

Online Video Training ModuleOnline 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 tivariety of applicationsVideo Department already involved with incorporating video learning into a variety of applicationsLooking for opportunities to expand the use of this technology in other areas throughout the hospital

Assessment and Ongoing SupportAssessment and Ongoing Support

Keeping the Program SuccessfulFeedback from Nursing StaffFollow‐Up Meetings with Leadership

d i diWaste and Container AuditsTraining Built in for New EmployeesRefresher Trainings“Tracers” to Identify Problem Areas

Which of the following are the most effective principals to keep in mind regarding pharmaceutical waste training?

l l1. Creative, Complex, Costly2. Concise, Comprehensive, Compliant, 

Customized3. Colorful, Concise, Comprehensive

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Which of the following factors affects decision making regarding the handling of medications?

1. Inherent toxicity of drug2. Area under the curve data on absorption3. The package size of the product4. Medication class it belongs too

Which of the following items need to be part of personnel training procedures?

1. Medication package insert locations2. Number of your human resources 

representative 3. Use of personal protective equipment4. Brightly colored labels

Which regulatory agency is involved in pharmaceutical waste management?

1. The Joint Commission (TJC)2. The Department of Transportation (DOT)3. The Federal Drug Administration (FDA)4. 1 and 2

What do you need to do when preparing your pharmacy department for a pharmaceutical waste program?

l d f l1. Evaluate your drug formulary2. Take a 2 week vacation to a Greek Island before 

you begin3. Call in the FDA to visit your facility 

What are 3 categories of pharmaceutical waste?  

1. Solid, liquid, gas2. Hazardous, chemical, cytotoxic3. Chemotherapy, hazardous, non‐hazardous

Despina Kotis, Pharm.D.Director, PharmacyNorthwestern Memorial Hospital251 East Huron Street251 East Huron StreetFeinberg Pavilion LC‐700HChicago, IL 60611(312) 926‐6961dkotis@nmh.org