Director’s Message - Summer 2014

Dr. Firestein

I am extremely pleased to announce the July 1 opening of an investigational drug pharmacy at CTRI's Center for Clinical Research (CCR) in our East Campus Office Building. Pharmacy services are critical to the success of clinical trials involving experimental drugs. This fully operational pharmacy will be staffed by a fulltime pharmacist and a fulltime technician through our collaboration with the UC San Diego Pharmacy Department. We are grateful to the Pharmacy Department's Pharmacist-in-chief, Charles Daniels, RPh, PhD, and Investigational Drug Service manager Ji Sun, PharmD, PhD, for setting up and managing this service at CTRI. Through the effort of the pharmacy team, our CTRI pharmacy facilities successfully passed inspections by the California Board of Pharmacy, and were issued a general pharmacy license and a sterile compounding license on June 18.

The CTRI CCR presently supports 70 clinical trials – and the number is growing.  Our new pharmacy makes our clinical research operations more efficient, effective, and comprehensive. In addition, on-site formulation and administering of experimental medications improve clinical trial safety. The CTRI pharmacy will help us better support all phases of clinical trials, including Phase I, the early phase trials that test a drug's safety during the development of novel treatments.

Our pharmacy is a 150-square-foot, temperature-controlled space that includes a refrigerator, a freezer, storage, compounding areas, and a glove box for handling sterile material. Pharmacists are responsible for procuring and storing drugs; maintaining all records regarding their purchase, regulation, and dispensing; compounding and dispensing study drugs; providing consultations to subjects enrolled in clinical trials; monitoring potential drug side effects in subjects enrolled in the studies; and assuring quality control and compliancy. The CTRI pharmacist will be an active member of the research team, helping with the design of the study and participating in protocol review. He or she will ensure that labeling, drug storage, dispensing, and accountability records of all investigational new drugs comply with federal, state, and institutional guidelines. The pharmacy technician is also a critical member of the pharmacy team because he or she works with drug sponsors and auditors, and performs day-to-day compounding, dispensing, record keeping, and billing.

All UC San Diego pharmacies use Epic, an electronic medical record keeping system that minimizes the medication errors normally seen in paper-based records. Also, UC San Diego pharmacy services require all actions to be double checked, including the protocol, dispensing, and treatment time billed. These combined actions heighten safety and ensure quality.

Our on-site pharmacy will save time and remove drug stability issues that could arise during transport. Prior to establishing the pharmacy, the clinic staff would order and pick up investigational medication at a nearby UC San Diego pharmacy after the subject entered the clinic. Many investigational drugs are expensive; some need to be thawed and can't be re-frozen. The on-site pharmacy better serves our investigators, clinic staff, and subjects by eliminating drug stability concerns and transport responsibilities, and decreasing wait time.

The addition of the pharmacy gives CTRI a full slate of clinical trial services under one roof, from nursing and clinical coordination, to biostatistics and labs, to physician oversight and investigational drug compounding. The pharmacy, which can support up to 150 clinical trials, primes us for stage two – a 1,000 square-foot pharmacy in the Altman CTRI. The ACTRI, scheduled to open in 2016, will house a pharmacy capable of supporting hundreds of clinical trials.

We welcome the pharmacy team in helping us enhance clinical and translational research as we advance the science that improves human health.

Gary S. Firestein, MD, Director of CTRI
Professor of Medicine, Dean and Associate Vice Chancellor of Translational Medicine

transmed@ucsd.edu
Phone: (858) 822-3824