Control of Pharmaceuticals Control of Pharmaceuticals at DHMCat DHMC

Control of Pharmaceuticals Control of Pharmaceuticals at DHMCat DHMC

Lindsey C. WaterhouseManager, Safety and Environmental Programs

603.650.6180

lindsey.c.waterhouse@hitchcock.org

Total Employees = 7200Total Employees = 72003800 Direct Patient Care3800 Direct Patient Care

Dartmouth Medical School

DHMC

Mary Hitchcock Hospital

Dartmouth Hitchcock Clinic

Dartmouth-Hitchcock Medical Center

396 Inpatient beds Tertiary Care Center,

New Hampshire

600 Students 16 Departments

Physicians throughout NH & VT

Pioneering Pharmaceutical Waste Pioneering Pharmaceutical Waste Minimization & Management in HospitalsMinimization & Management in Hospitals

Pioneering Pharmaceutical Waste Pioneering Pharmaceutical Waste Minimization & Management in HospitalsMinimization & 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:

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

2. Identify and implement waste minimization techniques;3. Develop a blueprint for implementation that can be

replicated in healthcare organizations nationwide; 4. Share information and help educate state regulators;5. Provide training for healthcare organizations nationwide

and JCAHO surveyors;6. Create measurable results.

Project Challenges and ConsiderationsProject Challenges and ConsiderationsProject Challenges and ConsiderationsProject Challenges and Considerations

Project ChallengesProject ChallengesProject ChallengesProject 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

Project ChallengesProject ChallengesProject ChallengesProject 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

Project ChallengesProject ChallengesProject ChallengesProject 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

Project ChallengesProject ChallengesProject ChallengesProject 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

Project ChallengesProject ChallengesProject ChallengesProject 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

DHMC ApproachDHMC ApproachDHMC ApproachDHMC Approach

AnticipationAnticipationAnticipationAnticipation• 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

IdentificationIdentificationIdentificationIdentification

• 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

EvaluationEvaluationEvaluationEvaluation• 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

ControlControlControlControl• 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

ControlControlControlControl

• 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

ControlControlControlControl

• 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 ConsiderationsParting Thoughts and ConsiderationsParting Thoughts and ConsiderationsParting 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!

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