The P&T 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 Subcommittee must review a research protocol if it 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 P&T Subcommittee must review research studies using drugs as described above 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 the IRB and the P&T Subcommittee. Release of the study by the UI IRB is contingent upon receipt and review of P&T Subcommittee deliberations. If the study is going to WIRB, please review the other committee procedures here.
If the P&T Subcommittee review is completed after the UI IRB review, the IRB chair reviews any P&T Subcommittee 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.
P&T Subcommittee approval is not required prior to emergency use of an investigational drug. However, UIHC policies require that the appropriate consent document and the G-12 Form be inserted in the subject's electronic medical record. A copy of the information submitted to the IRB is forwarded to the P&T Subcommittee for its review and records.
In compliance with Joint Commission regulations, the P&T Subcommittee 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. And, 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. Questions about this policy should be directed to Janet Schlechte, MD.
Investigators must discuss their study with an Investigational Drug Pharmacist (356-2577) 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/or completing the Investigational Drug Study Standard Charge Worksheet.
P&T Subcommittee collaborates with the Investigational Drug Service to ensure appropriate dispensing procedures have been planned for prior to approving the study. 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, s/he 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 and submitting it to the Investigational Drug Service (c/o Pharmacy, CC101 GH)
The G-12 Form is designed to provide healthcare providers who are not involved in the research study, and do not have ready access to the Investigator's Brochure, with succinct information regarding the study medication.
A G-12 Form should be submitted under the following circumstances:
- The medication is not currently approved by the FDA for marketing in the US;
- The dosage form or route of administration is not included in the medication's current prescribing information;
- The dose to be used in the study falls outside the current prescribing information, including the use of the medication in patient populations not included in the current prescribing information (e.g., use in pediatric subjects);
- The study medication is an herbal or other natural product (these products do not have FDA-approved prescribing information); or
- The intended use of the study medication is dissimilar from the medication's FDA-labeled indication. (For example, if a medication is FDA-labeled to treat colon cancer, a G-12 Form would not be required if it is being studied for lung cancer, if the dosage regimens are similar.)
Additional information can be found in the UIHC Formulary Handbook.
Direct questions to:
Jason Wilbur, MD
Chair Pharmacy and Therapeutics Sub-Committee
Ron Herman, PhD
Clinical Pharmacy Specialist
P&T Liaison to IRB-01