The P&T Safety Subcommittee has been established to provide the UI Health Care administration and its clinical leadership with information and advice concerning the proper use of drugs and related products.
The mission of this committee is to
- promote evidence-based, best practice standards in the formulary decision-making process to assure clinical efficacy, patient safety, and cost-effective prescribing within UI Health Care,
- review policies and procedures related to proper medication administration to assure medications are administered safely and appropriately,
- facilitate education of healthcare providers and students regarding medication-related issues,
- assure that medications are prescribed appropriately safely, and effectively through medication use evaluation processes,
- assure compliance with the Joint Commission, FDA, and other regulatory guidelines related to medication use,
- review and support investigational medication studies to ensure patient safety and adherence to UI Health Care policies, and
- evaluate and assess point-of-care and other technology systems and processes to effectuate safe, prompt, and efficient prescribing in both the inpatient and ambulatory care settings.
The P&T Safety Subcommittee has asked the Investigational Drug Service (IDS) of the Department of Pharmaceutical Care to carry out item 6 of its mission. IDS has two roles to fulfill -- 1) ensure safe handling, preparation and storage of investigational medications and, 2) a Safety Review where they must review a research protocol to ensure that all medications in the study are used safely and all research subjects are informed about the risks of all study medications.
A safety review must be done if the study involves
- the administration of investigational new drugs or drugs that are given "off-label",
- FDA approved drugs that are given as a component of a research protocol,
- any other substance that is ingested (with the exception of enteral feedings such as baby formulas, unless they contain a non-Generally Regarded As Safe [GRAS] ingredient), or
- any other substance that is injected, inhaled, or applied to the body.
The Investigational Drug Service must conduct both reviews (handling of study medications and a safety review) of research studies before final approval is granted by the UI IRB. To prevent delays in the total review process, the UI IRB usually allows concurrent review by IDS. Release of the study by the UI IRB is contingent upon receipt and review of IDS' P&T safety subcommittee deliberations. If the study is going to WCG, please review the other committee procedures here.
If the IDS Safety review is completed after the UI IRB review, the IRB chair reviews any IDS Safety comments. If the chair believes the suggested changes are appropriate and qualify as minor modifications, the IRB chair reviews these through an expedited process. If changes exceed minor modifications, the IRB chair refers the application back to the full board for review prior to final approval.
IDS’ P&T safety subcommittee approval is not required prior to emergency use of an investigational drug. The IRB forwards a copy of the information submitted to IDS for its review and records.
In compliance with Joint Commission regulations, the IDS Safety approval of UIHC inpatient medication studies is contingent on the utilization of the Department of Pharmaceutical Care's Investigational Drug Service to store, dispense, label, and distribute study medications. Additionally, studies involving investigational (non-FDA-approved) drugs conducted on an outpatient basis must also utilize the Investigational Drug Service to store, dispense, label, and distribute study medications. Outpatient studies involving FDA-approved drugs may be dispensed by the investigator or the Investigational Drug Service.
Investigators must discuss their study with an Investigational Drug Pharmacist (353-7077) to determine Pharmacy resources and funding required while the study is in the early planning stages. Estimates of the charges for Pharmacy Services can be obtained by contacting the Investigational Drug Pharmacist and completing the Investigational Drug Study Standard Charge Worksheet. To generate an IDS Charge Worksheet, first log into HawkIRB with your Hawk ID and password. Select "Other Review Attachments," and then click on the down arrow for the P&T IDS section. This opens an option to generate the Drug Charge Worksheet and Drug Study Form.
If an investigator chooses to dispense an outpatient study drug that uses an FDA-approved drug, they must notify the Investigational Drug Service at the time the study is submitted to the Biomedical Institutional Review Board (IRB-01). Notification includes completing the Investigator-Dispensed Drug Study Form 75A and submitting it to the Investigational Drug Service (c/o IDS Pharmacy, 01284PFP).
The G12 form is no longer required for UIHC research studies utilizing an investigational drug. The UI Health Care policy CM.P.24 Documentation of Patient Participation as a Subject in a Research Protocol or Use of an Investigational Medication, Study Medication, Investigational Device, or Biologic has been updated to remove the use of the G-12 document. A copy of the policy in its entirety can be found on The Point.
As a result of the policy update, Principal Investigators (PI)s no longer need to submit or update G-12 documentation as part of their IRB applications on associated human subjects research protocols. It is also no longer necessary to upload a copy of the G-12 documentation into the EPIC medical record. PIs may delete the G-12 from their research protocols at their convenience by submitting a modification to the IRB.
Record of Consent section of IRB application
The Record of Consent (ROC) section in the IRB application will serve as a replacement to the G-12 document. Any research protocols using an investigational medication, per the CM.P.24 policy, are required to select “does meet” on ROC.1 in the HawkIRB application. It is very important to fully complete this section to provide detailed information covering
- Key complications and adverse effects from the study drug(s) or study procedure(s)
- Other relevant information that may be important to clinical/emergency personnel, including drug interactions and toxicity management.
This is important so clinical care teams can be informed when providing clinical care to UIHC patients involved in this type of research. The information in the ROC section of the HawkIRB application is automatically imported on the study team behalf to the EPIC Research Study Description section of EPIC upon IRB approval and release of the study.
Additional information can be found in the UIHC Formulary Handbook.
Direct questions regarding P&T and IDS reviews to:
Jolene Furr, RPh
Pharmacy Practice Specialist
Investigational Drug Service
Wendi Slaughter, RPh
Pharmacy Practice Specialist
Investigational Drug Service