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Pharmascript October 2016: Residency Spotlight - Creating an Investigational Drug Services Residency

Thursday, October 20, 2016   (0 Comments)
Posted by: Alysa Craig
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Molly Wascher, PharmD
PGY2 Health-System Pharmacy Administration Resident at Johns Hopkins Hospital

Background

The Investigational Drug Services (IDS) are responsible for supporting clinical trial research and contributing to the institutional strategic priority to provide high quality care to patients enrolled in clinical trials. Pharmacists and pharmacy technicians play a vital role in clinical research; roles include assistance with protocol development, management and preparation of investigational products, monitoring clinical parameters for both standard of care and research, patient education and medication adherence monitoring, facilitation of electronic order set development and maintenance, and Institutional Review Board (IRB) membership and regulatory compliance.1,2 As described in the Food and Drug Administration’s (FDA) statement on the 21st Century Cures Act3, clinical trials continue to increase in complexity and diversity. This presents an opportunity for the advancement of pharmacy practice in the area of Investigational Drug Services (IDS). IDS pharmacy practitioners have increasing direct patient care responsibilities to meet the needs of the patients and to assure that all patients receive the same high quality standards of care.

Currently, there are no specialty residency training programs focused in IDS. Only a small proportion of pharmacy students have access to training in IDS via limited classroom instruction and the elective nature of an IDS advanced practice experience. The goal of the IDS residency is to meet the increasing need for expertise in this specialty area of practice akin to that seen with other newly developed residency training programs such as informatics and pain and palliative care. This new residency-training program will meet the needs of an evolving area of the profession of pharmacy.

Development Process: Utilization of an Expert Panel

As part of the residency development process, a multi-disciplinary expert panel was recruited consisting of 22 members both internal and external to the institution. Internal representation consisted of research leadership, pharmacy leadership, principal investigators, and regulatory expertise, in addition to IDS pharmacists. External representation included key stakeholders in clinical research; the National Institutes of Health (NIH) including the National Cancer Institute (NCI), FDA, a life-sciences company, and IDS leadership from an outside institution. The panel met for a one day meeting on January 11th,, 2016. The majority of the day’s discussion concentrated on four proposed residency competency areas; (1) patient care, (2) research protocols and regulations, (3) leadership and management, and (4) teaching, education, and dissemination of knowledge.

The overall outcome of the meeting was an overwhelming support for the development of an IDS focused residency program. There was also strong support for developing a resident with the knowledge and skills necessary for expanding IDS roles and responsibilities. The discussion at the meeting provided valuable information to support the development of the PGY2 IDS Competency Areas, Goals, and Objectives.

Residency Program Structure

The IDS Residency will be a combined PGY1 and PGY2 program where the resident will receive a PGY1 Pharmacy certificate and a PGY2 IDS certificate. Below are the PGY2 Investigational Drug Services Rotations Offered:

Core rotations

- IDS Operations Rotations (2)
- Clinical Research Office
- Johns Hopkins Office of Human Subjects Research
- Drug Development (2)
- Longitudinal Outpatient clinic
- Patient Care Team (ex: Hematologic Malignancy service, HIV Service, or Pediatric Oncology)
- IDS Leadership and Management
- Research Medication Safety and Clinical Decision Support

Elective rotations

- FDA: Office of Clinical Pharmacology
- NIH: National Cancer Institute, Pharmaceutical Management Branch
- Drug manufacturer: Pharmaceutical Industry, Drug Discovery and Development

Application Process:

Upon completion, the resident will be prepared for a position as an IDS pharmacist or other opportunities within clinical research. For interested candidates, participation in Personnel Placement Service at the Midyear Clinical Meeting is recommended. Candidates interested in the program should apply online through the Pharmacy Online Residency Centralized Application Services (PhORCAS), deadline is January 1st, 2017. For additional information about our pharmacy residency programs, please visit our website at http://www.hopkinsmedicine.org/pharmacy/residents/.

References:
1. ASHP guidelines on clinical drug research. Am J Health-Syst Pharm. 1998; 55: 369-76.
2. Amin SA, Lee JS, Avila JG, et al. HOPA investigational drug service best practice standards. 2014.
3. Woodcock J. 21st century cures: modernizing clinical trials and incorporating the patient perspective. FDA. July 2014.