Control of Pharmaceuticals at DHMC
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  • Introducions Handouts Policy Overview


  • 1. Control of Pharmaceuticals at DHMC Lindsey C. Waterhouse Manager, Safety and Environmental Programs 603.650.6180 [email_address]
  • 2. 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
  • 3. 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.
  • 4. Project Challenges and Considerations
  • 5. 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
  • 6. 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
  • 7. 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
  • 8. 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
  • 9. 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
  • 10. DHMC Approach
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. 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!
  • 18. Thank You