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Control of Pharmaceuticals *at DHMC

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Information about Control of Pharmaceuticals *at DHMC

Published on November 21, 2008

Author: triumvirate

Source: slideshare.net

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Control of Pharmaceuticals at DHMC Lindsey C. Waterhouse Manager, Safety and Environmental Programs 603.650.6180 [email_address]

Total Employees = 7200 3800 Direct Patient Care Dartmouth-Hitchcock Medical Center 396 Inpatient beds Tertiary Care Center, New Hampshire 600 Students 16 Departments Physicians throughout NH & VT Dartmouth Medical School DHMC Mary Hitchcock Hospital Dartmouth Hitchcock Clinic

396 Inpatient beds

Tertiary Care Center, New Hampshire

600 Students

16 Departments

Physicians throughout NH & VT

Pioneering Pharmaceutical Waste Minimization & Management in Hospitals A pilot project funded by EPA and implemented through H2E in a hospital with a well established waste management program, this project will: Develop and pioneer pharmaceutical management techniques to assure regulatory compliance and implementation of best management practices; Identify and implement waste minimization techniques; Develop a blueprint for implementation that can be replicated in healthcare organizations nationwide; Share information and help educate state regulators; Provide training for healthcare organizations nationwide and JCAHO surveyors; Create measurable results.

A pilot project funded by EPA and implemented through H2E in a hospital with a well established waste management program, this project will:

Develop and pioneer pharmaceutical management techniques to assure regulatory compliance and implementation of best management practices;

Identify and implement waste minimization techniques;

Develop a blueprint for implementation that can be replicated in healthcare organizations nationwide;

Share information and help educate state regulators;

Provide training for healthcare organizations nationwide and JCAHO surveyors;

Create measurable results.

Project Challenges and Considerations

Project Challenges Identification of “potentially” hazardous waste medications New medications at the time of purchase Investigational drugs Existing formulary Who will assess and how frequently? What is your method of assessment? What are your assessment standards? Comparison of risks and collection prioritization

Identification of “potentially” hazardous waste medications

New medications at the time of purchase

Investigational drugs

Existing formulary

Who will assess and how frequently?

What is your method of assessment?

What are your assessment standards?

Comparison of risks and collection prioritization

Project Challenges Establishing control at point of waste generation User is not the purchaser or the issuing entity (pharmacy/pharmacist)/Need to train everyone No HAZCOM inventory Materials are inconsistent and constantly changing based upon patient needs, doctors orders, patient location Pharmaceuticals are not typically included on the unit HAZCOM inventory Frequency of use and potential volume of wastes generated quite variable Prioritization based upon a frequency analysis Constant potential for product expiration

Establishing control at point of waste generation

User is not the purchaser or the issuing entity (pharmacy/pharmacist)/Need to train everyone

No HAZCOM inventory

Materials are inconsistent and constantly changing based upon patient needs, doctors orders, patient location

Pharmaceuticals are not typically included on the unit HAZCOM inventory

Frequency of use and potential volume of wastes generated quite variable

Prioritization based upon a frequency analysis

Constant potential for product expiration

Project Challenges Industrial regulations in a health care environment Patient care process is vastly different than a parts cleaning line Materials and processes are designed around a single use and disposal application Doses are very small and focused Waste control presents complicated occupational exposure hazards Siting of collection containers and SAAs Presents infection control and patient safety concerns Potential for odor development in some products

Industrial regulations in a health care environment

Patient care process is vastly different than a parts cleaning line

Materials and processes are designed around a single use and disposal application

Doses are very small and focused

Waste control presents complicated occupational exposure hazards

Siting of collection containers and SAAs

Presents infection control and patient safety concerns

Potential for odor development in some products

Project Challenges Regulator Challenges Lack of familiarity with healthcare activities and processes Not experts in medication and pharmaceutical formulation and chemistry Epinephrine = CAS 51-43-4 = P042 Epinephrine Hydrochloride = CAS 329-63-5 ≠ P042 Unclear on how industrial interpretations transfer to healthcare activities RCRA empty rules More disposal of containers than products No considerations of control options Universal waste applications Project Excel for Universities No concentration based characteristic standards Competing Guidelines FDA/Boards of Pharmacy controlled substance wasting requirements

Regulator Challenges

Lack of familiarity with healthcare activities and processes

Not experts in medication and pharmaceutical formulation and chemistry

Epinephrine = CAS 51-43-4 = P042

Epinephrine Hydrochloride = CAS 329-63-5 ≠ P042

Unclear on how industrial interpretations transfer to healthcare activities

RCRA empty rules

More disposal of containers than products

No considerations of control options

Universal waste applications

Project Excel for Universities

No concentration based characteristic standards

Competing Guidelines

FDA/Boards of Pharmacy controlled substance wasting requirements

Project Challenges Examples for consideration Keeping waste collection container lids closed Placement of containers at point of use Under constant control of the generator No regulatory standard for many toxic drugs Paclitaxel versus cychlophosphamide Storage volumes of containers P wastes =1 quart maximum allowed at an SAA Based upon container volume not material quantity Complicates collection of multiple wastes in one container Availability of containers Processes force education of all staff in waste assessment process Adequate staff to support/manage the program

Examples for consideration

Keeping waste collection container lids closed

Placement of containers at point of use

Under constant control of the generator

No regulatory standard for many toxic drugs

Paclitaxel versus cychlophosphamide

Storage volumes of containers

P wastes =1 quart maximum allowed at an SAA

Based upon container volume not material quantity

Complicates collection of multiple wastes in one container

Availability of containers

Processes force education of all staff in waste assessment process

Adequate staff to support/manage the program

DHMC Approach

Anticipation No collection of waste pharmaceuticals with exception of: Trace chemo wastes Reverse distribution (EXP) Partnership with H2E, EPA, NH DES, PharmEcology Awareness of EPA Region I Hospital Compliance Focus Conducted a multimedia environmental audit Initiated an executive oversight group Estimated increased costs Sensitivities associated with increased staff awareness How to store increased waste volumes Reviewed contractor services and capabilities

No collection of waste pharmaceuticals with exception of:

Trace chemo wastes

Reverse distribution (EXP)

Partnership with H2E, EPA, NH DES, PharmEcology

Awareness of EPA Region I Hospital Compliance Focus

Conducted a multimedia environmental audit

Initiated an executive oversight group

Estimated increased costs

Sensitivities associated with increased staff awareness

How to store increased waste volumes

Reviewed contractor services and capabilities

Identification No existing models identified to emulate Through the Pharmacy project, defined the program scope and general approach Established a project plan of action Very aggressive, and exceeded our ability to complete all aspects of the project Focused on the Institution’s Formulary and Pharmacy staff knowledge Regulatory knowledge obtained from DHMC and contractor staff Consultation with NH DES

No existing models identified to emulate

Through the Pharmacy project, defined the program scope and general approach

Established a project plan of action

Very aggressive, and exceeded our ability to complete all aspects of the project

Focused on the Institution’s Formulary and Pharmacy staff knowledge

Regulatory knowledge obtained from DHMC and contractor staff

Consultation with NH DES

Evaluation Used PharmEcology Wizard to assess potentially hazardous waste pharmaceuticals contained in DHMC formulary Very difficult to define locations of use and use volumes Conducted a frequency analysis using pharmacy purchasing records over a 3 month/1 year period (Cerner System) Helped define high use locations and medications Conducted assessments of units use and wasting practices Considered but did not employ the use of logs to determine disposal activities Incorporated unit (Nursing) champions Briefed project plan/approach to the DHMC Nursing Council Assessed pharmacy production and distribution process Options for labeling and communication to the user

Used PharmEcology Wizard to assess potentially hazardous waste pharmaceuticals contained in DHMC formulary

Very difficult to define locations of use and use volumes

Conducted a frequency analysis using pharmacy purchasing records over a 3 month/1 year period (Cerner System)

Helped define high use locations and medications

Conducted assessments of units use and wasting practices

Considered but did not employ the use of logs to determine disposal activities

Incorporated unit (Nursing) champions

Briefed project plan/approach to the DHMC Nursing Council

Assessed pharmacy production and distribution process

Options for labeling and communication to the user

Control Validated our regulatory assumptions Internal team and regulators Validated formulation, use and wasting procedures Worked with nursing staff/pharmacy to understand procedures for medication formulation, medicating patients and wasting Considered deployment options Focused on specific medication types Antineoplastic agents Epinephrine Warfarin Other Considerations Staff knowledge and interest (Heme Onc Nurses) Waste quantity and toxicity Existing labeling procedures

Validated our regulatory assumptions

Internal team and regulators

Validated formulation, use and wasting procedures

Worked with nursing staff/pharmacy to understand procedures for medication formulation, medicating patients and wasting

Considered deployment options

Focused on specific medication types

Antineoplastic agents

Epinephrine

Warfarin

Other Considerations

Staff knowledge and interest (Heme Onc Nurses)

Waste quantity and toxicity

Existing labeling procedures

Control Developed and initiated staff education programs Expanded or adapted by some units for internal use Included health and safety expectations along with environmental concerns Identified waste accumulation points (SAAs) Identified SAA managers Unit staff helped identify storage and collection areas Identified and tested waste collection containers Kendal and Hospitec Continued use of reverse distribution Systems Established information/communication tools

Developed and initiated staff education programs

Expanded or adapted by some units for internal use

Included health and safety expectations along with environmental concerns

Identified waste accumulation points (SAAs)

Identified SAA managers

Unit staff helped identify storage and collection areas

Identified and tested waste collection containers

Kendal and Hospitec

Continued use of reverse distribution Systems

Established information/communication tools

Control Public Health and Community Awareness Collaboration with the City of Lebanon, NH Solid Waste and Waste-water departments U.S. Fish and Wildlife Service SMARxT Disposal Out Patent Disposal Guidelines provided with each prescription Institutional focus on non-hazardous waste pharmaceuticals “ One Stop Drop” Focus on destruction through incineration

Public Health and Community Awareness

Collaboration with the City of Lebanon, NH

Solid Waste and Waste-water departments

U.S. Fish and Wildlife Service SMARxT Disposal

Out Patent Disposal Guidelines provided with each prescription

Institutional focus on non-hazardous waste pharmaceuticals

“ One Stop Drop”

Focus on destruction through incineration

Parting Thoughts and Considerations Reference the H2E 10-Step Blueprint Thoroughly assess each material considered for collection Integrate your Pharmaceutical waste program with your “Industrial” Waste program Control at the front end of our system is the critical challenge Identification Labeling Working with the affected staff and depts. is the key to success Need for better regulation and integrated guidance Capitalize on professional organization guidance ONS Awareness of waste concerns prompts occupational exposure concerns Need for better support from and regulation of suppliers Pre-assessment and quantification by EPA ID Code National labeling strategy Need for state/municipal funded public collection programs KISS was never more important!

Reference the H2E 10-Step Blueprint

Thoroughly assess each material considered for collection

Integrate your Pharmaceutical waste program with your “Industrial” Waste program

Control at the front end of our system is the critical challenge

Identification

Labeling

Working with the affected staff and depts. is the key to success

Need for better regulation and integrated guidance

Capitalize on professional organization guidance

ONS

Awareness of waste concerns prompts occupational exposure concerns

Need for better support from and regulation of suppliers

Pre-assessment and quantification by EPA ID Code

National labeling strategy

Need for state/municipal funded public collection programs

KISS was never more important!

Thank You

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