Department of Pharmacy

Investigational Drug Service (IDS)

Objectives

  • Assist in execution of the scientific, clinical and administrative functions of drug research.
  • Assure that drug studies are conducted in a safe, effective and efficient manner.
  • Assure compliance with all federal, state and JCAHO regulations concerning investigational drugs.

IDS Staff

The service consists of an IDS Coordinator, a part-time Pharmacist, and a Pharmacy Technologist. The service is covered by a member of the IDS 24 hours a day. The IDS is currently involved with the drug management of approximately 140 drug studies at UTMB. The service interacts closely with UTMB physicians, nurses, study coordinators, pharmacists, and various drug sponsors involved with clinical drug trials.

Initiation of IDS Involvement with A Clinical Drug Study

The IDS requests a copy of the Sponsor’s protocol and Investigator’s Drug Brochure. The Coordinator will review the protocol; meet with sponsor representatives, the principal investigator, and other study personnel to assess the potential IDS requirement. An IDS budget will be developed for the investigator and the study staff to adequately plan for all necessary pharmacy costs in the study budget. Unless the IDS is presented with proposed changes, the IDS budget is assumed to be accepted as the pharmacy budget for the study protocol.

Patient Enrollment

  • IDS will communicate with the investigator or study coordinator to ensure that patient enrollment, drug dispensing, and drug administration are consistent with the protocol.
  • Randomization of the patient to determine the correct drug and treatment regimen will occur promptly. The IDS can develop a patient randomization schedule if one is not provided in the study protocol.
  • Preparation of doses as described in the protocol. All study drugs are packaged to maintain blinding when required and to promote safe administration.
  • Patient counseling about the study drug’s mechanism of action, side effects, food and drug interactions, and dosing regimen will be provided to all patients as needed.
  • Patients will be recorded at entry onto an enrollment log to track each patient’s entry date and randomization.

Inventory Control

  • Completion of the investigational drug accountability records to document all dispensings.
  • Storage of study drugs separately from general stock in appropriate temperature conditions, (i.e. refrigerator, freezer, ultra-cold freezer, room temperature).
  • Maintenance of adequate levels of study drugs to keep up with enrollment and return study visits.
  • Database of all study drugs inventory expiration dating.

Study Returns and Close-Out

  • Conduct correspondence and meet with sponsor monitors regularly.
  • Assist in the investigation and reporting of adverse drug reactions.
  • Collection of all patient drug returns and reconciliation.
  • Participation in final close-out of the study protocol with the sponsor by providing copies of all drug disposition and inventory control records.
  • Drug destruction policies in place to destroy expired or returned drug on site.
  • Successful participation in FDA, NCI, pharmaceutical manufacturer, and NIH audits.
  • Storage of all terminated clinical drug study records for up to 15 years after closure.

Storage

Investigational drugs are stored in the IDS storeroom and/or pharmacy satellite depending on the nature of the drug study. All study drug inventory is labeled with IRB identification and stored separately from other commercial drug products under appropriate security and stability conditions. Refrigerator and freezer storage is available. Temperatures are monitored by an alarm system (except for ambient temperature recording device).

Database

The IDS has developed an internal database to track participation in drug studies, inventory control, and sponsor information. Queries can be made concerning investigators, HIV related research, cancer research, various medical departments, investigational agents, sponsor information, approval and termination dates, drug expiration dates, etc. 

Audit

All study protocols that involve the use of a study drug in human subjects and are not controlled by IDS will be audited periodically by a member of the IDS staff to ensure that drug labeling, storage, dispensing, and accountability meet the regulatory guidelines and requirements.

Billing

All IDS fees will be billed electronically through PeopleSoft at least on a quarterly basis using the FRS number provided by the investigator. Materials and medication not provided by the investigator or sponsor may be obtained by special order at an additional cost. Any questions about a bill should be addressed to the Coordinator of the Investigational Drug Service.

Fees for Service

For information regarding the IDS Fee Schedule please contact the Coordinator of the Investigational Drug Service.

Initial Protocol Setup Fee includes:

  • Protocol Review and assessment of pharmacy involvement
  • Preparation of IDS protocol budget
  • Preparation of drug accountability forms
  • Development of dispensing guidelines
  • Attend start-up meeting with investigator and study sponsor
  • Preparation of pre-printed orders or Rx’s
  • In-service of pharmacy staff, if necessary

Inventory Maintenance Fee includes:

  • Ordering study medication
  • Receiving study medication
  • Storage
  • Inventory record maintenance
  • Meetings with research monitors
  • Quality assurance checks
  • Collection, reconciliation & storage of returns
  • Destruction of used or expired drug
  • Study close-out

Low Intensity: Limited stock; small number of subjects; no compounding required; simple randomization; limited dispensing

Moderate Intensity: Multiple stock; compounding; no special preparation or equipment needed; procedural randomization

High Intensity: Chemotherapy; controlled substances; special preparation, equipment or storage required; extensive staff in-servicing; pharmacokinetic monitoring, requires 24 hour enrollment coverage

Annual Renewal: Fee - All inventory maintenance services listed above for an additional year.