PGY-2 Investigational Drug Services | Department of Pharmacy Services | UC Davis Health

ASHP Residency Directory listing

University of California Davis Medical Center PGY2 Investigational Drugs and Research Pharmacy Residency Purpose

PGY2 residency programs build upon Doctor of Pharmacy (PharmD) education and PGY1 pharmacy residency training to develop pharmacist practitioners with knowledge, skills, and abilities as defined in the educational competency areas, goals, and objectives for advanced practice areas. Residents who successfully complete PGY2 residency programs are prepared for advanced patient care or other specialized positions, and board certification in the advanced practice area, if available.

Program Overview

The Investigational Drugs and Research Pharmacy Residency at the University of California, Davis Medical Center, is a one-year, PGY2 specialty residency in Investigational Drug Services and Research Pharmacy Residency. The residency is supported by the Department of Pharmacy.

The Investigational Drug Services (IDS) is a strong, well-established, and progressive center of excellence at the UC Davis Medical Center. The IDS manages investigational products for a robust portfolio of Phase I, II, and III studies which are conducted through the UC Davis Medical Center hospital, hospital-based clinics, Alpha Stem Cell Clinic, and UC Davis Comprehensive Cancer Center. UC Davis Medical Center is a Level 1 Trauma Center located on the main Sacramento health campus which also houses the CIRM awarded UC Davis Alpha Stem Cell Clinic, the Mind Institute, and the UC Davis Comprehensive Cancer Center. The UC Davis Comprehensive Cancer Center is a NCI-designated Comprehensive Cancer Center as well as a member of the National Comprehensive Cancer Network (NCCN). As an institution, UC Davis Medical Center is within the top recipients for NIH funding, with individual researchers within the top percentage of recipients. At UC Davis Medical Center, investigational products (also known as study drugs) are dispensed from various pharmacy locations to serve a highly diverse catchment area of 19 inland northern California counties, as well as patients coming elsewhere in California and many surrounding states. The Investigational Drugs and Research Pharmacy Residency will provide each resident with a comprehensive training and robust educational experience in research pharmacy services.

UC Davis Medical Center and Pharmacy Services

UC Davis Medical Center is a major academic health center located in Sacramento, California. The Department of Pharmacy Services recruits, hires, and trains caregivers to provide progressive pharmacy services as collaborative team members to support optimal patient outcomes.
More about the Department of Pharmacy Services can be found on our Webpage

Program Design

The UC Davis Medical Center PGY2 Investigational Drugs and Research Pharmacy Residency is designed to meet the educational goals and objectives as outlined by the ASHP PGY2 Investigational Drugs and Research Pharmacy Residency Accreditation Standards.

Educational Outcomes Required by the Accreditation Standard:

R1. Patient Care
R2. Advancing Practice and Improving Patient Care
R3. Research Protocols and Regulations
R4. Leadership and Management
R5. Teaching, Education, and Dissemination of Knowledge
Electives may be added based on available resources and resident interest

Program Structure

The PGY2 Investigational Drugs and Research Pharmacy Residency is a full-time, one-year commitment, typically beginning on July 1st and ending on June 30th. Clearance to start work by UC Davis Health Employee Health and a Human Resources orientation meeting must be completed prior to the established residency start date.

Example Resident Schedule (subject to change):

Required Learning Experiences	Type of Experience	Overview
Orientation and IDS Training	Block (4 weeks)	Orientation to UC Davis Medical Center, pharmacy residency program policies and the specific residency program. Training for IDS Pharmacy Coverage and Department of Pharmacy Service (DPS) Evening Support will occur during this time. Duration may be adjusted based on the resident’s previous experience and knowledge of UC Davis Medical Center.
Investigational Drug Service I	Block (4 weeks)	Provides introduction to processes related to dispensing and managing investigational drugs, ERX development, and clinical trials in the non-oncology IDS Pharmacy.
Investigational Drug Service Cancer Center I	Block (4 weeks)	Provides introduction to processes related to dispensing and managing investigational drugs, ERX development, and clinical trials in the IDS Cancer Center Pharmacy. The resident will also attend at least one half-day of a medical oncology clinic (e.g. lung cancer clinic) with a PI to provide an overview of the ambulatory workflow in oncology and clinical trial patient care and observe the relationship to IDSCC operations.
Protocol Management	Block (4 weeks)	This rotation immerses the resident in the day-to-day management of the clinical trials portfolio, from feasibility assessment to fee schedule development to study start-up to study document and workflow modifications.
Cancer Center Infusion	Block (4 weeks)	Cancer Center Infusion will focus on the fundamentals of the Infusion Pharmacy workflow, with an emphasis on oversight of preparation and dispensing of chemotherapy and investigational drugs. The resident will be introduced to the process of reviewing and processing of chemotherapy orders; management and prevention of chemotherapy-related toxicities; medication safety/preventing chemotherapy errors; patient counseling.
Pediatric Oncology	Block (4 weeks)	Clinical rotation with the pediatric oncology outpatient clinic and infusion pharmacy services. The focus of this rotation will be the management of care for pediatric patients enrolled on clinical trials and patients treated per trial.
Ambulatory Care Clinic (non-Oncology)	Block (4 weeks)	Ambulatory clinic rotation in a setting with robust pharmacy services and clinical trial study teams. Clinic experiences will be assigned based on the current clinical trial portfolio and ambulatory care service pharmacists to provide exposure to patient populations, clinic workflow, clinical pharmacist services, recruitment, retention, and treatment workflows, study team member roles, and clinical trials treatment. Clinic options may include, but are not limited to: Infectious Disease, Pulmonary Critical Care, or Transplant.
Scholarship and Precepting	Block (4 weeks) (To run concurrently with another learning experience)	This rotation provides the resident the opportunity to engage in precepting with other learners (students or residents) and to develop their precepting skills.
Investigational Drug Service II or IDS Cancer Center II	Block (4 weeks)	The rotation will focus on the coordination and synthesis of activities in the IDS Pharmacy. The emphasis will be focused on review, implementation, modification, and feasibility of clinical trials and pharmacy workflow management. This rotation is the capstone of the residency integrating all information learned throughout the year, allowing the resident to showcase their independence and practice autonomously as an IDS pharmacist.

Required Longitudinal Learning Experiences

• Research/QI Project (including two 5 day research weeks + 3 floating project days)
• Grand Rounds
• RPS Performance Improvement Project
• Research Quality and Safety
• IDS Pharmacy Practice Management
• Protocol Development
• IDS BEACON
• Research Compliance and Business Practice
• Institutional Review Board (IRB)/Regulatory Affairs
• Dept of Pharmacy Services Staffing (including DPS Evening/Block Staffing: TOC and IDS Pharmacy Coverage on weekends)

Elective Experiences

• Alpha Stem Cell Clinic
• Cellular Therapy Service
• Inpatient Medical Oncology
• Protocol Development
• Drug Development
• Oncology Specialty Pharmacy

Additional elective rotations can be developed based on the clinical trial portfolio available at the time and the interests of the resident. Any such modification will be noted in the customized development plan.

Additional Opportunities

Based on interest, the clinical trial portfolio, and current therapeutic and trial management advancements, the resident may choose to attend the quarterly Molecular Tumor Board, attend Clinical and Translational Science Center (CTSC) education courses as applicable, and shadow at the Clinical Research Center (CCRC) and the Office of Clinical Research (OCR). Other opportunities identified can be attended with approval from the RPD. These are optional experiences that may be incorporated into the residency year based on resident interest to increase their foundational knowledge and augment their self-driven, independent, professional development.

Assignment of Education Goals and Objectives to Specific Learning Experiences – see learning experiences and objectives outlined in PharmAcademic.

The UC Davis Medical Center PGY2 Investigational Drugs and Research Pharmacy Residency is designed to provide the resident with a broad range of experiences in a variety of practice settings. Required learning experiences have been designed to meet the content requirements, as outlined in the ASHP PGY2 Investigational Drugs and Research Pharmacy Residency required competency areas, goals and objectives and to provide exposure to the key investigational drugs and research pharmacy residency topic references.

UC Davis Medical Center PGY2 Investigational Drugs and Research Resident’s Role in Teaching:
UC Davis Medical Center offers many opportunities for both clinical and didactic teaching. The resident will be responsible for assisting preceptors with clerkship teaching for University of California, San Francisco pharmacy students and UC Davis Medical Center PGY1 pharmacy residents. Should the rotations overlap, the resident will assume the primary preceptor role for any UCSF pharmacy students during their last IDS or IDSCC learning experience. The resident will otherwise have the opportunity to engage in precepting and learning activities during the Scholarship and Precepting Learning Experience.

The PGY2 Investigational Drug and Research Resident can also participate in didactic teaching for clinical research coordinators, study teams, nurses, and pharmacist. In addition, the PGY2 Investigational Drugs and Research Pharmacy Resident may choose to participate in academic teaching, as requested by regional schools of pharmacy, with the approval of the PGY2 Investigational Drugs and Pharmacy Research Residency Program Director.

Residency Research Project:
All UC Davis Medical Center PGY2 residents are required to complete a research project during their residency and present their research at a regional, state, or national conference. In preparation for conducting their research project, the resident will be complete UC Davis Health IRB-required training and certification. The resident will prepare a project proposal, which will be reviewed and approved by the Pharmacy Research Oversight Committee. The resident will also submit their project to the Pharmacy and Therapeutics Committee and the IRB for approval before embarking on their research. The resident will also be provided opportunities to present their research at one or more regional pharmacy residency conferences. Upon completion of the project, the resident will be required to summarize their research project in a manuscript and submit for publication. This will occur during the Research/QI Project Learning Experience.

Grand Rounds: The resident will be required to prepare an ACPE accredited pharmacy grand rounds (or equivalent) presentation on a topic pertaining to emerging therapies, clinical trials, or investigational drugs, based on the resident’s interests and per department needs assessment. A presentation, to an external department or entity, that is deemed to be equivalent may be permitted as an alternative. This will occur during the Grand Rounds Learning Experience.

Committee Assignments:
The PGY2 Investigational Drug and Research residents will rotate in quarterly assignments through at least four (4) of the following UC Davis Health Committees: 1) Data Safety Monitoring Committee (DSMC); 2) Medication Error Reduction Committee (MERC); 3) UC IDS Pharmacy Collaborative Team; 4) Hematology Oncology Pharmacist Association (HOPA) IDS Special Interest Group (SIG); 5) BEACON Clinical Trials Workgroup. The resident will be assigned various activities and projects during each committee rotation. Activities may include specific projects, coordinating agendas and minutes, and reviewing documents. The purpose of the resident’s committee involvement is to ensure the resident gains exposure to the IDS pharmacist’s role in activities related to quality-improvement, study management on a site level, practice standardization, understanding the impact of clinical trials in standard of care practice, medication safety, safe handling of hazardous drugs, guideline development, and assessment/implementation of technology and automation within the institution and pharmacy department. This is part of the Longitudinal IDS Pharmacy Practice Management learning experience.

Professional Development:
The PGY2 Investigational Drug and Research resident is encouraged to maintain an active role in pharmacy professional organizations. The resident is required to attend the Pharmacy Research Summit and is strongly encouraged to join a professional organization with a mission, initiative, or concerted effort to further research pharmacy services (RPS) or Investigational Drug Services (IDS) practices. The resident is expected to complete the ASHP Investigational Drug Services Certificate program or attend a second professional conference to further develop their clinical interests and areas of research. The resident will be provided with some financial support from the institution and professional leave time to facilitate participation in professional development activities. This is captured in the Investigational Drug Service Cancer Center I and Longitudinal IDS Pharmacy Practice Management learning experiences.

Pharmacy Department Service:
The PGY2 Investigational Drug and Research resident will be expected to provide approximately 400 hours of pharmacy department service. This expectation will be met primarily by providing Investigational Drug Service pharmacist coverage (approximately 280 hours; every 3rd weekend) plus one major holiday (Thanksgiving, Christmas Eve, Christmas Day or New Year’s Day) and one minor holiday as well as providing 120 hours of evening Department of Pharmacy support. This is accomplished through the IDS Pharmacy Coverage and DPS Evening/Block Staffing Learning Experiences.

Required Competencies:
Residents function as licensed pharmacists in patient care activities. As such, minimum knowledge in a variety of areas must be assured. Within one month of starting the Residency, the resident must complete competencies required of all clinical pharmacists, including Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS). For residents who completed their PGY1 Pharmacy Residency at UC Davis Medical Center, renewal during the PGY2 year will be as outlined by the institution renewal cycles and requirements for competency.

Resident Portfolio:
Each resident must maintain a portfolio containing all information from the residency year including but not limited to: copies of papers and projects done during rotations, lectures given, and other miscellaneous deliverables. The portfolio shall be maintained in PharmAcademic and/or in the resident’s folder on the Pharmacy Department shared drive.

Benefits:
Health, Dental and Vision insurance for resident and dependents; 15 days of Paid Time Off (PTO), 14 holidays, 12 days Sick Leave, and 4 days for Professional Development.  Professional development/travel funds (~$2500) are included in the base salary. There is a stipend for Pharmacy Department scrubs. Use of PTO must be arranged in advance with the RPD. Preceptors must be notified in advance of the learning experience.

Resident Personnel Policies:
The following policies can be located in the Pharmacy Resident Personnel Manual

• Resident Qualifications
• Early Commitment Policy
• Pre-employment drug testing
• Health insurance and Benefits
• California pharmacist licensure requirement
• Moonlighting
• Duty hours/tracking of duty hours
• Professional, family, and extended leave policies
• Dismissal policy and consequences of failure to progress

Criteria for Successful Completion of the PGY2 Investigational Drugs & Research Pharmacy Residency

Requirements

• California Pharmacist Licensure per Pharmacy Resident Manual Policy
• A minimum of 52 weeks training inclusive of vacation, professional, and sick leave
• Completion of assigned competencies, including BLS
• Completion of CITI and GCP training during Orientation and IDS Training
• Completion of all required rotations/learning experiences
• Completion of staffing contributions as outlined by the program description
• Presentation of Research/QI Project at a regional, state, or national conference
• “Achievement for the Residency” of at least 80% of program objectives. No objectives may have a final assessment of “Needs Improvement.” (Program objectives may be ACHR by the RPD throughout the year and/or at resident closeout.)
• Completion of staffing requirements as outlined by the residency program description
• Active participation in committee meetings and projects as assigned
• Active participation in the annual program QI meeting
• Attendance at the Research Pharmacy Summit
• Completion of ASHP IDS certificate program
• Resident closeout completed in PharmAcademic, confirming all tasks are completed
• Deliverables
  • Design or redesign safe and effective patient-centered therapeutic regimens and monitoring plans (care plans) fo research participants—complete at least three times over 52 weeks
    • Adjust supportive care medications or treatment and monitoring plans based on patient feedback, clinical response, treatment-related toxicities, and patient experience (Pediatric Oncology)
    • Determine necessary changes/adjustments to the regimen based on patient-specific factors (Cancer Center Outpatient Infusion)
  • For research participants, document direct patient care activities—complete at least three times over 52 weeks
    
    • Use the protocol to determine appropriate monitoring parameters and verify the patient meets parameters (Pediatric Oncology)
    • Assess patient response to therapy and reported toxicities and determine if the regimen is appropriate based on the protocol (Cancer Center Outpatient Infusion) 
  • Prepare or revise a drug class review, monograph, treatment guideline, or protocol related to care of research patients, including proposals for medication-safety technology improvements (R 2.1.1)—complete at least once in each learning experience.
    
    • Prepare or revise an institutional protocol, policy, or treatment guideline (IDS Pharmacy Practice Management (Longitudinal))
    • Create and/or revise paper/BEACON clinical trial order or study drug ERX (Protocol Management)
    • Create and/or revise paper/BEACON clinical trial order or study drug ERX (IDS or IDSCC II)
    • Participate in a medication-use evaluation related to care of research participants (R 2.1.3) 
      • Complete at least 5 times over 52 weeks
        • Utilize the event reporting system to review errors involving study drugs for a given period of time and analyze processes involved with improvement opportunities (Research Quality and Safety (longitudinal))
      • Complete at least 1 evaluation/project
        • Evaluate given workflow or medication use process as part of RPS PI project (RPS Process Improvement)
    • Identify opportunities for improvement of the medication-use system related to care of research participants (R2.1.5)—complete at least 1 in each learning experience
      • Identify a longitudinal project to improve the care of research participation in an area of quality or safety. Present finding to relevant enterprise service line(s). (Research Quality and Safety (longitudinal))
      • Work with preceptors to identify a need based on quality improvement need or patient safety concern (RPS Process Improvement)
    • Contribute to departmental planning (R4.2.1)—complete at least once in each learning experience
      • Contribute to departmental planning through attending leadership meetings (IDS Pharmacy Practice Management (Longitudinal)
      • Attend and participate in meetings that the preceptor attends (IDS Pharmacy Practice Management (Block))
      • Participate in preparation/planning for implementation and compliance with regulatory requirements in investigational drugs (IDS Pharmacy Practice Management (Block))
    • Contribute to investigational drug services departmental management (R4.2.3) —complete at least once in each learning experience
      • Participate in committee meetings and activities (IDS Pharmacy Practice Management (Longitudinal)
      • Participate in committee meetings and activities (IDS Pharmacy Practice Management (Block)
      • Use regulatory guidance related to handling and preparation of hazardous drugs to make informed decisions and influence workflows (IDS Pharmacy Practice Management (Block)
    • Participate in the clinical trial appraisal process and effectively design a budget for pharmacy services to support a clinical trial (R4.3.2)—complete at least 2 in each learning experience
      • Apply knowledge of trial budgets and IDS fees to create and/or adjust protocol specific fee schedules (Protocol Management)
      • Prepare a fee schedule for a study using information available (IDS Pharmacy Coverage)
      • Explain how IDS uses billing software to generate clinical trial invoices (IDS/IDSCC II)
      • Prepare IDS fee schedule for a new clinical trial protocol (IDS/IDSCC II)
    • Use effective presentation and teaching skills to deliver education related to care of research participants (R5.1.2)  
      • Complete at least once over 52 weeks
        • Utilize a PowerPoint format and active teaching and learning methods to deliver and defend the Grand Rounds (or equivalent presentation) material (Grand Rounds))
        • Construct and facilitate topic discussions that incorporate multiple learning strategies including active learning (Research Quality and Safety (longitudinal))
        • Make use of audio-visual aids and/or handouts to enhance topic discussions (Research Quality and Safety (longitudinal))
        • Integrate various educational strategies, such as interactive experiences, cases, knowledge checks, ad instructional information, into the 20-30 min presentation (IDSCC I)
      • Complete at least 4 times during the learning experience
        • Counsel patients and caregivers/family about the medications prescribed for the treatment (Pediatric Oncology)
        • Choose teaching methods that will clearly communicate information/points of interest to deliver education (Scholarship and Precepting)
    • Use effective written communication to disseminate knowledge related to care of research participants (R5.1.3)
      • Complete at least once for each learning experience during the 52 weeks
        • Presentation and dissemination of written summary of project at the relevant service line team meeting (RPS Process Improvement)
        • Completion of PowerPoint slides that will compile a useful written resource for audience (Grand Rounds)
      • Complete a the below in combination for total of four times during the 52 weeks
        • Use pharmacy expertise to write or rewrite any pharmacy related portions of the protocol (Protocol Development (Longitudinal))
        • Interpret protocol language as written and comment in writing with edits, suggestions, or modifications to protocol language (Protocol Development (Longitudinal))
    • Appropriately assess effectiveness of education related to care of research participants. (R5.1.4)
      • Complete at least once for each learning experience during the 52 weeks
        • Completion of Pharmacy Grand Rounds (or equivalent) presentation (Grand Rounds)
        • Completion of a Research/QI Project, including abstract, manuscript, and manuscript submission for publication (Research/QI Project)
      • Complete at least 4 times during the learning experience
        • Use the teach back method to assess patient understanding of medication regimen (Pediatric Oncology)
        • Utilize methods such as teach back or interactive questions to assess the learner’s understanding of education (Scholarship and Precepting)

Expectations

• Use of PTO must be arranged in advance with the RPD in advance of start of rotation (with exception of extenuating circumstances or illness). Preceptor notification of must be in advance of assigned learning experience for planned leave.
• Timely completion of PharmAcademic evaluations and evaluation co-signatures
• Resident attends at least 80% of assigned committee meetings
• Attendance at 80% of IDS and IDSCC Monthly Huddles
• Attendance at a second professional meeting, based on resident clinical area of interest and selection
• Join a professional organization with a mission, initiative, or concerted effort to further research pharmacy services (RPS) or Investigational Drug Services (IDS) practices

Pharmacy Residency training programs at UC Davis Health are conducted under the licensed entity within UC Davis Health which is UC Davis Medical Center.