Student Voices: Breannah Keys
Second year student, Breannah Keys, shares her summer experience
Story by Breannah Keys | Published August 15, 2023
Student Voices gives first-person perspectives written by the students of the UNC Eshelman School of Pharmacy. For this piece, we hear from Breannah Keys, PharmD candidate ’26 about her summer immersion and internship.
My summer after PY1 year has been eventful, yet filled with great learning opportunities. Following finals, I had my first immersion experience at Duke University Main Hospital doing my health systems immersion in May and June. My immersion was split into two parts: clinical and operations.
In my clinical month, we were given patient cases and presented our findings and assessment and plan to different preceptors. Additionally, we performed medication requisitions and learned about different disease states, pertinent lab values, and the medications to treat them through writing i-vents.
During my operations month, I was able to visit the different specialty pharmacies throughout the hospital like pediatrics/OB, cancer inpatient pharmacy and the operating room pharmacy to learn about their specialized workflows and the medications they use the most. Additionally, I rotated through the storeroom, IV room, and central pharmacy that supports the hospital at large and their importance for the operation of the hospital.
After my immersion, I started an internship at the Food and Drug Administration as an Oak Ridge Institute for Science and Education (ORISE) fellow in the Center for Drug Evaluation Research (CDER) Office of New Drug (OND) Pharmacy Compounding Review Team (PCRT) under my mentor Dr. Edna Albuquerque. In this role, I evaluate nonclinical information of compounds nominated by 503B outsourcing facilities to be included on the FDA bulks drug list for safety. Specifically, I review pharmacology, pharmacokinetic/toxicokinetics, acute and repeat dose toxicity, carcinogenicity, genotoxicity, and reproductive toxicity for the nominated substances.
In this role, I have learned about the importance of nonclinical information to inform the safety of compounds and its role in determining doses to be used in first in-human studies. Moreover, I have learned about the regulatory process at the FDA and the different guidelines used to determine if substances should be compounded.
As a part of the ORISE program at the FDA, I have had the chance to network with other fellows of different backgrounds who support the mission of the FDA and learn about their work. My experience at the FDA has been great so far and I hope to continue building great connections with those who work there.