September 2020 | Denise Klinker, PharmD, MBA

McCreadie Group is excited to collaborate with Yale New Haven Hospital to offer a research pharmacy learning experience to residents enrolled in their PGY2 Investigational Drugs and Research residency program. Rachael Aletti, Vestigo’s Senior Account Manager and experienced IDS pharmacist, is developing the learning experience and will serve as the primary preceptor. “The IDS landscape is constantly evolving and there has never been a time more crucial for curating the necessary tools to treat research patients and impact future therapies. I am excited to collaborate with residents from Yale New Haven Hospital to focus on the role of technology and automation within research.”

Not only do our research pharmacists serve as residency preceptors, McCreadie Group offers two innovative software solutions: PharmAcademic to facilitate pharmacy residency training, and Vestigo to support investigational drug services (IDS). This puts us in a unique position to take a close look at the current state of IDS residency training where our two areas of expertise, pharmacy education and IDS practice, intersect.

IDS teams are responsible for the management of drugs used in clinical trials. As of July 31, 2020, there were a total of 347,442 research studies on ClinicalTrials.gov, a large increase from 301,497[1] on March 28, 2019. Many IDS teams are currently under added pressure due to the number of COVID-19 clinical trials being implemented across the country in addition to their normal workload. Of the 347,442 studies, 2844 are clinical studies relating to COVID-19. Many facilities are now initiating COVID-19 studies at their institution and establishing an IDS service for the first time.

As the Director of Educational Products, I try to keep up-to-date with trends and opportunities in pharmacy education.  Looking at the increased need for clinical trails, it made me wonder about the current opportunities for pharmacy residents. So, I did a little digging into PharmAcademic to see how many IDS residency programs currently exist, the types of residency programs currently requiring IDS learning experiences (LEs), and what the LEs entail relating to assigned objectives and activities.

Now Emerging: PGY2 – Investigational Drugs and Research Residency Programs

Currently three hospitals offer PGY2 – Investigational Drugs and Research Residency programs; two are combined PGY1/PGY2* programs: 1) The Johns Hopkins Hospital* (JHH), 2) University of Michigan Health System* (UMHS) and 3) Yale New Haven Hospital (YNHH). The JHH team published an article in 2019 describing their journey in the evaluation and creation of the first IDS residency program.[1]  I highly recommend reading this article if you have interest in or are considering initiating an IDS residency program. The group at JHH formed a residency development committee to evaluate the need for an IDS residency program at their institution and determined an IDS residency would be of great benefit. They went on to develop the initial set of Competency Areas, Goals and Objectives for an IDS residency program.

According to ASHP’s PGY2 Investigational Drugs and Research competency areas document, residents will have expertise in “clinical trial design and conduct, pharmacy operations and clinical services for the research enterprise, and investigational drug service pharmacy leadership within an interprofessional environment” upon completion of the program.

PGY2 – Investigational Drugs and Research Residency Competency Areas

The goal of an IDS residency program is to develop and train pharmacists to meet the increasing need for pharmacists in this area of practice. The current ASHP approved Competency Areas, Goals and Objectives for PGY2 Investigational Drugs and Research programs are available on-line on the ASHP website. ASHP provides a list of required and elective competency areas for PGY2 – Investigational Drugs and Research Residency programs as shown in the table below.

Current Learning Experiences in PharmAcademic for Investigational and Research Residency Programs

Of the three residency programs, JHH and UMHS have enrolled and graduated at least one resident; YNHH has enrolled their first resident this year. All three programs have LEs relating to operations, drug/clinical trial development, human subjects protection/Institutional Review Board (IRB) and IDS leadership with several elective LEs residents can choose from. Overall, the programs provide a comprehensive experience with a robust schedule for those interested in IDS pharmacy. Please see the table below for a list of learning experiences offered for each program.

Learning Experience Activities

For IDS residency programs, residents can actively participate in the day-to-day operations of IDS pharmacy practice leadership and clinical care for research participants. The learning experiences center around the following activities:

1. Roles and responsibilities of those involved in clinical trials, i.e. principal investigator, trial monitors, clinical research coordinator, research nurse, IDS pharmacist, IDS technician
2. Regulatory requirements for the conduct of clinical trials
3. Responsibilities of the IRB and other committees that support clinical trials research
4. Protocol review and management, including how to evaluate proposed studies and implement them in a safe and effective manner
5. Drug information resource and educator relating to investigational products
6. Electronic health record and other electronic system or software support
7. Medication order review and verification for investigational products (IP)
8. Investigational product preparation and dispensing
9. Inventory management, including documentation of IP disposition and temperature monitoring
10. IDS financial performance review, quality assurance and strategic planning activities

Opportunities at Other PGY1 and PG2 Residency Programs Offering IDS Training

IDS Learning Experiences in PharmAcademic for Non-IDS Residency Programs

There are 170 sites currently offering 241 IDS LEs in non-IDS residency programs. Many of these sites have multiple programs offering an IDS LE. The top programs are PGY1 – Pharmacy with 105 programs representing 9% of PGY-1 Pharmacy programs and PGY-2 Oncology Pharmacy representing 75.4% of PGY-2 Oncology Programs. Many of the protocols often managed by IDS teams are oncology protocols so it makes sense to see such a high percentage of PGY-2 Oncology programs offering an IDS LE. In fact, of the 89 programs offering an IDS LE, 74 (83%) require residents to complete the IDS LE and only 15 offer it as an elective. The opposite is true for PGY-1 Pharmacy programs, only 11 (10.5%) require the resident to complete an IDS LE. The table below lists the types of residency programs currently offering an IDS learning experience (elective or required), the number of programs per type, and what percentage each type contributes to the total number of programs.

Top Ten Objectives Mapped to PGY1 – Pharmacy and PGY2 – Oncology IDS Learning Experiences

The ASHP approved set of required Competency Areas, Goals and Objectives for PGY2 – Oncology Pharmacy programs includes Competency Area R5: Oncology Investigational Drugs that has one goal and three objectives, R5.1.1, R5.1.2, and R5.1.3. As expected, the majority of IDS LEs offered in PGY2 – Oncology Pharmacy programs have mapped these required objectives to their IDS LE ensuring the resident is evaluated for competency. The other mapped objectives vary between Competency Area R1: Patient Care and Competency Area R3: Leadership and Management. For PGY1 – Pharmacy programs, the top objectives vary between Competency Area R1: Patient Care and Competency Area R4: Teaching, Education, and Dissemination of Knowledge. I have included a list of the Top Objectives for IDS Learning Experiences for both program types.

Learning Experience Activities

The purpose of IDS LEs in non-IDS programs is to expose the resident to IDS pharmacy practice and the important role of pharmacists in the care of patients enrolled in clinical trials. Residents may be limited in what they can independently perform during a traditional IDS LE due to regulatory requirements, sponsor specifications and protocol specific training or documentation requirements. Most resident experiences are focused on logistics including protocol set-up, EHR drug and protocol build, documentation management using Vestigo®, budget and billing processes, and meeting participation.

Learn More about Research Pharmacy and a Career Working as an IDS Pharmacist

IDS pharmacists continue to learn and be exposed to investigational products and advancements in new drug development. Although they have a major focus on operations, they also focus on the clinical care of the patient ensuring the safe and effective use of investigational products. There couldn’t be a better time to learn more about IDS pharmacy practice. Do a quick search for open IDS positions; you will be surprised at the number available across the country!

Interested in learning more? Join the McCreadie Group for the first ever Research Pharmacy Summit. Attendees will participate in compelling sessions, earn Continuing Education (ACPE) credits, and network with other research practitioners across the country. Session topics include best practices for the operation of investigational drug services, lessons learned while adapting to the pandemic, approaches to building strong relationships with sponsors, as well as reporting and billing issues and solutions. For more information, and to register for the summit, please visit the Research Pharmacy Summit page of our website.

[1] Wascher M, Mighty J, Brown V, et al. Establishing an investigational drugs and research residency at an academic medical center. American Journal of Health-System Pharmacy. 2019;76(22):1862-1867. doi: https://doi.org/10.1093/ajhp/zxz175.