Pharmacy and Therapeutics (P&T) Committee

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

  1. 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,
  2. review policies and procedures related to proper medication administration to assure medications are administered safely and appropriately,
  3. facilitate education of healthcare providers and students regarding medication-related issues,
  4. assure that medications are prescribed appropriately safely, and effectively through medication use evaluation processes,
  5. assure compliance with the Joint Commission, FDA, and other regulatory guidelines related to medication use,
  6. review and support investigational medication studies to ensure patient safety and adherence to UI Health Care policies, and
  7. 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 safety deliberations.  If the study is going to WIRB, 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 Safety 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 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.  Questions about this policy should be directed to the Chair of P&T Committee. 

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. 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.

Investigator-Dispensed Drugs

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 and submitting it to the Investigational Drug Service (c/o Pharmacy, CC101 GH).

Investigator-Dispensed Drug Study Form

G-12 Form

Purpose of the G-12 Form

Medications prescribed in EPIC, have a button (link) to MicroMedex so healthcare workers can find out more about the medication if they are not familiar with it.  If the medications is a new investigational agent then it will not be in MicroMedex; EPIC cannot link to this information.  The G-12 Form is used in these instances to link to the study medication when there is no MicroMedex information to provide healthcare workers with essential information about how the drug works, its potential interactions, side effects and what to do if too much is given.  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 or study protocol, with succinct information regarding the study medication. The principal investigator is responsible for extracting the information from the investigator’s brochure and placing in the G-12 Form.

A G-12 Form should be submitted under the following circumstances:

  • The study medication is an herbal or other natural product because these products do not have FDA-approved prescribing information.
  • The medication is not currently approved by the FDA for marketing in the U.S.
  • 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 patients).
  • 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. 
  • A G-12 form  would be required if the FDA-labeled use is to treat cancer, but the study drug is being used  to see if the drug can stimulate the production of insulin in the pancreas.
  • If the substance being used in the research study will never be prescribed in EPIC and it is being used on a single occasion in a research lab, then a G-12 is not required for that substance.

Tips for Preparing a G-12 Form

  • The G-12 from is for healthcare workers, so it does not need to be simplified language. If possible, keep it to one page.
  • Generic name vs Trade:  The trade name is also called the brand and it is capitalized.  The generic name is not capitalized.
  • Other names: numbers or code names
  • Drug class: brief phrase
  • Use: the use in the protocol being submitted
  • Dosage, Onset of Action, Duration, and Mechanism of Action:   Healthcare workers will not be interested in the animal or laboratory data.  Include only what is relevant from the human studies.
  • Interacting drugs: describe the nature of the interaction, such as increased serum levels of the test drug, increased toxicity, etc.  If no studies have been done yet, mention that.  If the drug has a certain CYP450 elimination and the investigator’s brochure (IB) mentions possible inhibitors or enhancers be sure to mention that.
  • Adverse Effects:  Be brief. Use medical terminology. Avoid duplication. Do not refer to the investigator’s brochure, since that is not available to the caregiver.  In addition to the most frequent adverse effects, the uncommon but serious adverse effects should be included. It is best found in the section of the IB entitled Guidance for the Investigator.
  • Toxicity Management:   Indicate whether there is a specific antidote.  Most of the time there will not be one.  In that case, mention what standard supportive care will be necessary if an accidental excessive dose is given.  Do not indicate what dosage adjustments should be made for various levels (grades) of adverse events.  You do not want healthcare workers who are not part of the research team adjusting the dose of study medications without consulting you.
  • References:  Should be journal articles or abstracts that can be accessed by the caregiver (available in the library or on line). Include the title of the article. Do not list the investigator’s brochure or the protocol itself as a reference, as these documents are not accessible to non-study caregivers.

G-12 Form 

Additional information can be found in the UIHC Formulary Handbook.

Direct questions to:

Jason Wilbur, MD 
Chair Pharmacy and Therapeutics Sub-Committee 
01291-A PFP 
(319) 384-7222 
Jason-Wilbur@uiowa.edu 

Jolene Furr, RPh
Pharmacy Practice Specialist
Investigational Drug Service 
01284 PFP
(319) 356-2577

rxinvestdrug@healthcare.uiowa.edu