Medication Dispensary Support for Clinical Trials

Implementation Date:

Date of Last Revision:

Next Review Due:

 

Reviewed by VTH Administrative Team:

Reviewed by VTH Board:

 

Reviewed by Legal Counsel: N/A

Reviewed by Biosecurity Subcommittee: N/A

Subject to modification by the VTH Director without approval.

Policy

The intent of this policy is to describe the process of charging for dispensary general services and compounding medications for those Principal Investigators involved in VTH clinical trials or campus research. This policy applies to any principal investigator utilizing the VTH dispensary services. Principal investigators that utilize dispensary services for VTH clinical trials or campus research are charged utilizing the tier system described below. A pharmacist should be consulted early in the study design to determine feasibility and the appropriate amount for inclusion in the study budget. The dispensary must be given sufficient notification to prepare compounded medications or repackage medications.

Guidelines

If a project involves medication use, a pharmacist should be engaged as early in the process as possible to discuss study planning considerations. All clinical trials that involve / utilize dispensary services must have completed a research assistance request form prior to the ordering and preparation of medications. That form will be provided after the initial discussion with a pharmacist regarding the study.

Clinical trials will be assessed a one-time fee based on the amount of time and effort that is involved in preparation on the part of the dispensary. These fees are in addition to any drug or supply charges that may be incurred.

Tier 1: Repackaging of products (treatment and control)

• Dispensary staff will work with the PI to find suitable products for their study, develop a system to maintain blinding, repackage products (if needed), and develop a randomization chart.
• Fee for Tier 1 studies will be a one-time fee per study of $150.

Tier 2: Development of compounded placebo

• Dispensary staff will work with the PI to find suitable products for their study, develop a system to maintain blinding, develop and compound a placebo medication, and develop a randomization chart.
• Fee for Tier 2 studies will be a one-time fee per study of $300.

Tier 3: Compounded treatment and compounded placebo

• Dispensary staff will work with the PI to find suitable products for their study, develop a system to maintain blinding, develop and compound a placebo medication and medication for the treatment arm, and develop a randomization chart.
• Fee for Tier 3 studies will be a one-time fee per study of $450.

If the PI plans to utilize non-sterile hazardous medication (e.g., Mycophenolate, Chloramphenicol, Chemotherapy, etc.) then they must provide an appropriate BSC if one is required per USP 800.

Procedure (if applicable)

All clinical trials that involve/utilize dispensary services must have completed a research assistance request form prior to the ordering and preparation of medications. That form will be provided after the initial discussion with a pharmacist regarding the study.

Those interested in purchasing medications for research must provide dispensary staff with the medication(s) they are looking for and confirm the quantities, strength, and pricing prior to ordering.

All PIs must have a SANDI research account created in order for dispensary staff to charge out medication appropriately. Having only an FOP will not work, and dispensary staff will not order medications until provided with a SANDI account number. Directions for requesting a SANDI research account can be found on the Knowledge Base at https://appserv7.admin.uillinois.edu/FormBuilderSurvey/Survey/ef00ca39-1528-4fe6-b0ae-adb700ce7cf6/Survey.

Definitions (if applicable)

BSC – Biological Safety Cabinet

PI – Primary Investigator

Veterinary Teaching Hospital (VTH): The collective clinical services of the Large Animal Clinic, Midwest Equine, the Small Animal Clinic, and the Veterinary Medicine South Clinic.