Learn more about the duties, practice settings, typical workdays, and educational opportunities, as well as personal advice from pharmacists in this practice area.
What is investigational pharmacy?
Investigational pharmacy is a practice area with the experience of working in multiple types of pharmacy settings. Investigational pharmacists can resemble community, hospital, and compounding pharmacy settings all in one day. They provide therapies under investigation for study participants who may not have any other therapeutic options. Drug accountability is very important in their field. They need to be able to tell the story of what happens by studying medication when the product arrives at the pharmacy to dispense to the patient.
Where does an investigational pharmacist work?
Investigational pharmacy staff work in an academic medical center system. They support oncology and non-oncology studies. They also train pharmacy staff on dispensing study medication for studies that are conducted at satellite sites, which are locations outside of the main hospital campus. A study must be conducted at the main campus in order for it to be conducted at a satellite location.
Here is a link to a video tour of an investigational pharmacy location. This video highlights the various places for study medication storage.
What does a typical day look like?
For investigational pharmacists, a typical workday includes switching positions regularly to help with resiliency and fatigue for any one task. Their roles include a blend of operational tasks (e.g., verifying orders, dispensing and checking study medications) and clinical tasks (e.g., reviewing study protocol, performing concomitant medication checks, counseling on new oral therapy). They also communicate and attend meetings with study teams and sponsors regarding the logistics of conducting the study in the hospital system. The investigational pharmacists also work closely with pharmacists in the central pharmacies and the different hospital units and clinics. This collaboration is key to ensure that investigational pharmacists are following institution policies and study protocol.
What educational opportunities are available for pharmacists in this area?
- In addition to residency training, ASHP has a dedicated ASHP Connect Investigational Drug Service (IDS) and IRB Practitioners Community for student pharmacists and practitioners to learn more about the unique needs and practices in this specialty area.
- Additionally, ASHP has guidelines for more information about investigational pharmacy and tools to help you understand the practice: ASHP Guidelines for the Management of Investigational Drug Products (Am J Health-Syst Pharm.2018; 75: 561-73).
How can I learn more about this career path?
- The best way to learn about this pharmacy career path is to speak with an individual who works in an investigational pharmacy.
- Also, reading the ASHP guidelines (Am J Health-Syst Pharm 2018;75(8):561-573) will help you understand the various tasks and skills required in this area of pharmacy.
Member Career Profiles
Elyse A. MacDonald, Pharm.D., MS, BCPS
Pharmacy Manager, Investigational Drug Service
University of Utah Health / Huntsman Cancer Institute – Salt Lake City, Utah
What interested you in pharmacy and this career path?
“My original training was as an analytical chemist, and I worked in research and development (R&D) for a major pharmaceutical company. I worked in a laboratory, and I developed and validated methods to assess dissolution, impurities, content uniformity, etc. for the compounds we had in development. After a few years in the lab, I transitioned to clinical supplies as a project leader. I worked with our packaging group, clinical development, regulatory affairs, and the research group to prepare the study medications for shipment to the study centers. I liked working in this role, but I felt my clinical knowledge was lacking, which is why I pursued a career in pharmacy. My current role in the investigational pharmacy brings me full circle for my career overall. I enjoy bringing hope to study participants, when sometimes a clinical trial is the last resort to help treat their disease.”
What advice do you have for someone interested in this career field?
“Investigational pharmacy gives you the experience to work in multiple pharmacy settings. We resemble community, hospital, and compounding pharmacy settings. So many different skill sets are valuable for this field. It takes a village for an investigational pharmacy to operate properly. Generally, pharmacists are exposed to various types of study designs and phases of studies (I-IV), so it is interesting to read the protocol and learn how it was designed and will be conducted. There is a lot of attention to detail that is required to dispense a study medication, so the pharmacist and technicians have to be ‘on their game’ every day so errors do not occur. The investigational pharmacy staff really enjoy learning about the up-and-coming therapies for cancer, rare genetic disorders, gastrointestinal disorders, and more! You will always be learning in this pharmacy environment.”
Member Spotlight
Jeff Purcell
Credentials: Pharm.D.
Position/Title: Lead Pharmacist, Investigational Drug Services
Organization: Harborview Medical Center
Primary Specialty: Investigational Drug Services
Specialties: Critical Care, Home Health and Infusion
