Control of Pharmaceuticals at DHMC


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  • Introducions Handouts Policy Overview
  • Control of Pharmaceuticals at DHMC

    1. 1. Control of Pharmaceuticals at DHMC Lindsey C. Waterhouse Manager, Safety and Environmental Programs 603.650.6180 [email_address]
    2. 2. Total Employees = 7200 3800 Direct Patient Care Dartmouth-Hitchcock Medical Center <ul><ul><li>396 Inpatient beds </li></ul></ul><ul><ul><li>Tertiary Care Center, New Hampshire </li></ul></ul><ul><ul><li>600 Students </li></ul></ul><ul><ul><li>16 Departments </li></ul></ul><ul><ul><li>Physicians throughout NH & VT </li></ul></ul>Dartmouth Medical School DHMC Mary Hitchcock Hospital Dartmouth Hitchcock Clinic
    3. 3. Pioneering Pharmaceutical Waste Minimization & Management in Hospitals <ul><li>A pilot project funded by EPA and implemented through H2E in a hospital with a well established waste management program, this project will: </li></ul><ul><ul><li>Develop and pioneer pharmaceutical management techniques to assure regulatory compliance and implementation of best management practices; </li></ul></ul><ul><ul><li>Identify and implement waste minimization techniques; </li></ul></ul><ul><ul><li>Develop a blueprint for implementation that can be replicated in healthcare organizations nationwide; </li></ul></ul><ul><ul><li>Share information and help educate state regulators; </li></ul></ul><ul><ul><li>Provide training for healthcare organizations nationwide and JCAHO surveyors; </li></ul></ul><ul><ul><li>Create measurable results. </li></ul></ul>
    4. 4. Project Challenges and Considerations
    5. 5. Project Challenges <ul><li>Identification of “potentially” hazardous waste medications </li></ul><ul><ul><li>New medications at the time of purchase </li></ul></ul><ul><ul><ul><li>Investigational drugs </li></ul></ul></ul><ul><ul><li>Existing formulary </li></ul></ul><ul><ul><li>Who will assess and how frequently? </li></ul></ul><ul><ul><li>What is your method of assessment? </li></ul></ul><ul><ul><ul><li>What are your assessment standards? </li></ul></ul></ul><ul><ul><li>Comparison of risks and collection prioritization </li></ul></ul>
    6. 6. Project Challenges <ul><li>Establishing control at point of waste generation </li></ul><ul><ul><li>User is not the purchaser or the issuing entity (pharmacy/pharmacist)/Need to train everyone </li></ul></ul><ul><ul><li>No HAZCOM inventory </li></ul></ul><ul><ul><ul><li>Materials are inconsistent and constantly changing based upon patient needs, doctors orders, patient location </li></ul></ul></ul><ul><ul><ul><li>Pharmaceuticals are not typically included on the unit HAZCOM inventory </li></ul></ul></ul><ul><ul><ul><li>Frequency of use and potential volume of wastes generated quite variable </li></ul></ul></ul><ul><ul><li>Prioritization based upon a frequency analysis </li></ul></ul><ul><ul><li>Constant potential for product expiration </li></ul></ul>
    7. 7. Project Challenges <ul><li>Industrial regulations in a health care environment </li></ul><ul><ul><li>Patient care process is vastly different than a parts cleaning line </li></ul></ul><ul><ul><ul><li>Materials and processes are designed around a single use and disposal application </li></ul></ul></ul><ul><ul><ul><li>Doses are very small and focused </li></ul></ul></ul><ul><ul><ul><li>Waste control presents complicated occupational exposure hazards </li></ul></ul></ul><ul><ul><ul><li>Siting of collection containers and SAAs </li></ul></ul></ul><ul><ul><ul><li>Presents infection control and patient safety concerns </li></ul></ul></ul><ul><ul><ul><li>Potential for odor development in some products </li></ul></ul></ul>
    8. 8. Project Challenges <ul><li>Regulator Challenges </li></ul><ul><ul><li>Lack of familiarity with healthcare activities and processes </li></ul></ul><ul><ul><ul><li>Not experts in medication and pharmaceutical formulation and chemistry </li></ul></ul></ul><ul><ul><ul><ul><li>Epinephrine = CAS 51-43-4 = P042 </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Epinephrine Hydrochloride = CAS 329-63-5 ≠ P042 </li></ul></ul></ul></ul><ul><ul><li>Unclear on how industrial interpretations transfer to healthcare activities </li></ul></ul><ul><ul><ul><li>RCRA empty rules </li></ul></ul></ul><ul><ul><li>More disposal of containers than products </li></ul></ul><ul><ul><ul><li>No considerations of control options </li></ul></ul></ul><ul><ul><ul><ul><li>Universal waste applications </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Project Excel for Universities </li></ul></ul></ul></ul><ul><ul><ul><ul><li>No concentration based characteristic standards </li></ul></ul></ul></ul><ul><ul><li>Competing Guidelines </li></ul></ul><ul><ul><ul><li>FDA/Boards of Pharmacy controlled substance wasting requirements </li></ul></ul></ul>
    9. 9. Project Challenges <ul><li>Examples for consideration </li></ul><ul><ul><li>Keeping waste collection container lids closed </li></ul></ul><ul><ul><li>Placement of containers at point of use </li></ul></ul><ul><ul><ul><li>Under constant control of the generator </li></ul></ul></ul><ul><ul><li>No regulatory standard for many toxic drugs </li></ul></ul><ul><ul><ul><li>Paclitaxel versus cychlophosphamide </li></ul></ul></ul><ul><ul><li>Storage volumes of containers </li></ul></ul><ul><ul><ul><li>P wastes =1 quart maximum allowed at an SAA </li></ul></ul></ul><ul><ul><ul><ul><li>Based upon container volume not material quantity </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Complicates collection of multiple wastes in one container </li></ul></ul></ul></ul><ul><ul><li>Availability of containers </li></ul></ul><ul><ul><li>Processes force education of all staff in waste assessment process </li></ul></ul><ul><ul><li>Adequate staff to support/manage the program </li></ul></ul>
    10. 10. DHMC Approach
    11. 11. Anticipation <ul><li>No collection of waste pharmaceuticals with exception of: </li></ul><ul><ul><li>Trace chemo wastes </li></ul></ul><ul><ul><li>Reverse distribution (EXP) </li></ul></ul><ul><li>Partnership with H2E, EPA, NH DES, PharmEcology </li></ul><ul><li>Awareness of EPA Region I Hospital Compliance Focus </li></ul><ul><li>Conducted a multimedia environmental audit </li></ul><ul><li>Initiated an executive oversight group </li></ul><ul><ul><li>Estimated increased costs </li></ul></ul><ul><ul><li>Sensitivities associated with increased staff awareness </li></ul></ul><ul><ul><li>How to store increased waste volumes </li></ul></ul><ul><li>Reviewed contractor services and capabilities </li></ul>
    12. 12. Identification <ul><li>No existing models identified to emulate </li></ul><ul><li>Through the Pharmacy project, defined the program scope and general approach </li></ul><ul><li>Established a project plan of action </li></ul><ul><ul><li>Very aggressive, and exceeded our ability to complete all aspects of the project </li></ul></ul><ul><li>Focused on the Institution’s Formulary and Pharmacy staff knowledge </li></ul><ul><li>Regulatory knowledge obtained from DHMC and contractor staff </li></ul><ul><ul><li>Consultation with NH DES </li></ul></ul>
    13. 13. Evaluation <ul><li>Used PharmEcology Wizard to assess potentially hazardous waste pharmaceuticals contained in DHMC formulary </li></ul><ul><li>Very difficult to define locations of use and use volumes </li></ul><ul><ul><li>Conducted a frequency analysis using pharmacy purchasing records over a 3 month/1 year period (Cerner System) </li></ul></ul><ul><ul><ul><li>Helped define high use locations and medications </li></ul></ul></ul><ul><li>Conducted assessments of units use and wasting practices </li></ul><ul><li>Considered but did not employ the use of logs to determine disposal activities </li></ul><ul><li>Incorporated unit (Nursing) champions </li></ul><ul><ul><li>Briefed project plan/approach to the DHMC Nursing Council </li></ul></ul><ul><li>Assessed pharmacy production and distribution process </li></ul><ul><ul><li>Options for labeling and communication to the user </li></ul></ul>
    14. 14. Control <ul><li>Validated our regulatory assumptions </li></ul><ul><ul><li>Internal team and regulators </li></ul></ul><ul><li>Validated formulation, use and wasting procedures </li></ul><ul><ul><li>Worked with nursing staff/pharmacy to understand procedures for medication formulation, medicating patients and wasting </li></ul></ul><ul><li>Considered deployment options </li></ul><ul><ul><li>Focused on specific medication types </li></ul></ul><ul><ul><ul><li>Antineoplastic agents </li></ul></ul></ul><ul><ul><ul><li>Epinephrine </li></ul></ul></ul><ul><ul><ul><li>Warfarin </li></ul></ul></ul><ul><ul><li>Other Considerations </li></ul></ul><ul><ul><ul><li>Staff knowledge and interest (Heme Onc Nurses) </li></ul></ul></ul><ul><ul><ul><li>Waste quantity and toxicity </li></ul></ul></ul><ul><ul><ul><li>Existing labeling procedures </li></ul></ul></ul>
    15. 15. Control <ul><li>Developed and initiated staff education programs </li></ul><ul><ul><li>Expanded or adapted by some units for internal use </li></ul></ul><ul><li>Included health and safety expectations along with environmental concerns </li></ul><ul><li>Identified waste accumulation points (SAAs) </li></ul><ul><ul><li>Identified SAA managers </li></ul></ul><ul><ul><li>Unit staff helped identify storage and collection areas </li></ul></ul><ul><li>Identified and tested waste collection containers </li></ul><ul><ul><li>Kendal and Hospitec </li></ul></ul><ul><li>Continued use of reverse distribution Systems </li></ul><ul><li>Established information/communication tools </li></ul>
    16. 16. Control <ul><li>Public Health and Community Awareness </li></ul><ul><ul><li>Collaboration with the City of Lebanon, NH </li></ul></ul><ul><ul><ul><li>Solid Waste and Waste-water departments </li></ul></ul></ul><ul><ul><li>U.S. Fish and Wildlife Service SMARxT Disposal </li></ul></ul><ul><ul><ul><li>Out Patent Disposal Guidelines provided with each prescription </li></ul></ul></ul><ul><ul><li>Institutional focus on non-hazardous waste pharmaceuticals </li></ul></ul><ul><ul><ul><li>“ One Stop Drop” </li></ul></ul></ul><ul><ul><ul><ul><li>Focus on destruction through incineration </li></ul></ul></ul></ul>
    17. 17. Parting Thoughts and Considerations <ul><li>Reference the H2E 10-Step Blueprint </li></ul><ul><li>Thoroughly assess each material considered for collection </li></ul><ul><li>Integrate your Pharmaceutical waste program with your “Industrial” Waste program </li></ul><ul><li>Control at the front end of our system is the critical challenge </li></ul><ul><ul><li>Identification </li></ul></ul><ul><ul><li>Labeling </li></ul></ul><ul><li>Working with the affected staff and depts. is the key to success </li></ul><ul><li>Need for better regulation and integrated guidance </li></ul><ul><li>Capitalize on professional organization guidance </li></ul><ul><ul><li>ONS </li></ul></ul><ul><li>Awareness of waste concerns prompts occupational exposure concerns </li></ul><ul><li>Need for better support from and regulation of suppliers </li></ul><ul><ul><li>Pre-assessment and quantification by EPA ID Code </li></ul></ul><ul><ul><li>National labeling strategy </li></ul></ul><ul><li>Need for state/municipal funded public collection programs </li></ul><ul><li>KISS was never more important! </li></ul>
    18. 18. Thank You