Research Pharmacy

Research Pharmacy

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The ACTRI Research Pharmacy is a fully operational pharmacy staffed by three fulltime pharmacists and three technicians through our collaboration with the UC San Diego Pharmacy Department. This investigational drug pharmacy is a temperature-controlled space that includes four refrigerators, a -20° C freezer, a -70° C freezer, two rooms for ambient temperature storage, a licensed ante room and a world-class clean room for sterile compounding. It has a general pharmacy license and a sterile compounding license. In June 2017, the pharmacy moved into the Altman Clinical and Translational Research Institute Building, inhabiting 1,000 square feet of the Center for Clinical Research (CCR).The addition of the pharmacy to our CCR makes our clinical research operations more efficient, effective, and comprehensive, giving ACTRI 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.

Representatives from the CTRI and the UC San Diego Pharmacy Services

The pharmacy team at the newly opened ACTRI Research Pharmacy includes (from left): Brendan Costello, CPhT, pharmacy technician; Thaine Ross, CPhT, pharmacy technician; Alex Yee, CPhT, pharmacy technician; Thuan Le, PharmD, Investigational Drug Service pharmacist; Ji Sun, PharmD, PhD, Investigational Drug Service manager; and Carolyn Nguyen, PharmD, Investigational Drug Service pharmacist.

Pharmacy services are critical to the success of clinical trials involving experimental drugs. 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 ACTRI pharmacist is an active member of the research team, helping with the design of the study and participating in protocol review. Our pharmacist ensures 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 vital member of the pharmacy team who 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 saves time and removes drug stability issues that could arise during transport. 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 ACTRI CCR presently supports more than 150 clinical trials – and the number is growing.  On-site formulation and administering of experimental medications improve clinical trial safety. The ACTRI pharmacy helps 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.

The ACTRI pharmacy is capable of supporting hundreds of clinical trials.

For more information, e-mail Ji Sun, PharmD, PhD, Investigational Drug Service Manager.

Service requests must come through the ACTRI website request form in order to receive the approved recharge rates.

Recharge Rates are below.

Research PharmacyUsers
Protocol Set-Up – Inpatient/Outpatient TrialsOne time non-refundable fee includes but is not limited to: reviewing the protocol; developing specific dispensing procedures set by the study protocol; creating randomization scheme (if needed); building inpatient order sets in Epic (mandatory); and developing pre-printed orders sets for 7/24 inpatient studies (must be approved by the PI prior to use). In addition, but is not limited to: Investigational Drug Service (IDS) to meet with the sponsor at Site Initiation Visit and during scheduled quarterly monitoring visits; study drug inventory will be accurately maintained and documented; and IDS staff will provide in-service training to nursing and impatient pharmacy studies
Renewal Fee – AnnualFor multi-year studies, an annual maintenance fee will be applied on the anniversary of the date that the initial Set-Up Fee was applied. The maintenance fee covers, but is not limited to: scheduled quarterly monitoring visits and continuing investigational product management (temperature-controlled storage, regular inventory and documentation, and query responses that occur regardless of medication dispensation). $1,250
Closure FeeClosing Task includes, but is not limited to: conducting close-out visit with the sponsor; performing final drug accountability and drug destruction on site (if needed); completing any inquiries; providing supporting documents such as temperature logs, drug receipts, etc.; completing final billing (if not finalized prior); and storing protocol-specific pharmacy binder (on site up to 12 months, then long-term storage [Iron Mountain] for additional 22 years). $500
Fee per Rx Dispensed/Compounded per hour for weekdays$125
Fee per RX Dispensed/Compounded per hour for evenings
Fee per RX Dispensed/Compounded first two hours for weekends, holidays $376
Fee per RX Dispensed/Compounded hour 3+ for weekends, holidays
Fee for Simple Encapsulation (costs of drug and labor are not included): $1/capsule
Randomization Assignment (flat fee)          $100
Additional Monitoring Visit beyond the quarterly visits  $100/visit