IDS coordinated studies can be Phase I-IV drug studies and may involve investigational new drugs or commercially available drugs for new indications. All inpatient studies and all chemotherapy studies must be dispensed by pharmacy and are coordinated through IDS. However, not all outpatient studies being conducted through clinics involve pharmacy dispensing or coordination.
Purchasing Investigational Drugs
IDS does not purchase investigational drugs. All purchasing of drugs goes through the pharmacy buyer or IUPUI Purchasing.
Once contacted about a study, IDS will prepare specific procedures for ordering, preparing, dispensing, record-keeping, and destroying study drugs. IDS will also prepare a budget that identifies what will be billed to the study grant for the IDS/Pharmacy activities. Unfortunately, not all studies are funded by a sponsor, an IDS budget is not always available.
Investigational Study Approval Process Summary/Documents
All studies involving patients at any of the IU Health Hospitals must go through one of six IUPUI/IU Health Institutional Review Boards.
Protocol and Amendments
The complete study design is contained in protocol and must be submitted to the IRB for approval. Any changes are submitted as amendments to the original protocol.
This is a multipage document that summarized some protocol information but also include site locations (specific hospitals and clinics, etc.), subject recruitment, names of all co-investigators and other detail.
Informed Consent Statement (ICS)
This is the consent form that details all the study information, risks, and benefits, for the subject. The IRB approves the final wording, which should be at an 8th grade level. For children, an "Assent" form is included which is a very short summary that they can review since the parents will actually sign the Informed Consent Statement.
This is provided for any drug that is not currently FDA approved. It contains the currently available information about the drug, animal study results, human study results (if any).
All the above information is considered confidential and not for general distributions.
The IRB assigns a number to each study that is reviewed. The numbers all begin with the last 2 digits of the year, then the 2 digits of the month, and the last numbers represent the sequence received at the IRB for that month. For example, IRB Number 0605-11 means the study was reviewed in 2006, month 05 (May), as the 11th study.
The IRB #3 that only covers Methodist Hospital studies does not include the "month" in their numbering but continues sequentially for the year (e.g. 06-035)
IDS Study Files
The pharmacy staff can access a folder on the Pharmacy J Drive: "INVESTIGATIONAL STUDIES". This folder contains the general information and an Excel Spreadsheet (Investigational Studies List) with all the IDS coordinated studies throughout the IU Health system. The study list is in order by the IRB Number. It contains the study drug name, sponsor's protocol number, sponsor, disease state, primary investigator, start date and can be sorted by these categories.
IDS maintains a master protocol file for each study. Each study is filed by its IRB Number starting with the first two digits (year). The file folders for each study contain the protocol, IDS budget, and Investigators' Brochures.
Each pharmacy area will have a binder for the study drugs dispensed from that location. This binder contains a set of procedures and the log sheets that are required for record keeping. When multiple dispensing areas are available, one area will be the designated primary location and the other areas will be satellite locations. The procedures will also contain a short background/drug information section.
Location of Study Drugs
This represents the main supply of drug for a study. Currently, IDS (IUSCC-C2102) is the primary location for most studies. Depending on the type of study, primary locations can be: UH inpatient, RI inpatient, RI outpatient, MH inpatient, MH ICU satellite.
A satellite location exists when more than one area can dispense the drug. The primary location will have the majority of the inventory. In some cases, the primary location will have the entire inventory and only transfer enough to the satellite location for a specific patient's treatment.
Each dispensing area should have designated space where study binders are kept and drugs are stored (room temperature storage, refrigerator storage, freezer storage). In addition, there is a special (- 70°C) freezer in IDS.
Orders for Investigational Drugs
All inpatient orders for study drugs follow the same requirements as regular inpatient orders. The new physician order sets (POG approved) can be used for extensive studies but these may or may not be posted due to study confidentiality agreements. IDS must request a review of all order sets prior to study initiation so that the study drug information is clear and matches the Cerner product build sent by IDS. The actual drug names will begin with "Study...". The inpatient areas will get the orders transmitted via Pyxis Connect. IDS will receive a copy from the study coordinator/nurse for all drugs prepared by IDS.
At the present time, there are no standard clinic orders for all outpatient infusions (e.g. chemotherapy) since it depends on the clinic location, pharmacy services to the clini, etc. However, investigational drugs should be clearly designated on all orders and the study/IRB number noted. The clinic orders should follow the same process as the inpatient orders if Cerner is used for order entry (see section above). If Sunrise Disease Manager (SDM) is used, IDS will still review all orders prior to starting a study.
IDS prepares special outpatient prescriptions prepared for each study that will have outpatient or "take home" meds dispensed. These prescriptions are faxed to IDS to be filled.
Cerner Computer Entry
The area that receives the order and dispenses the initial doses, should enter the order. This could be IDS or inpatient pharmacy depending on the specific study. Cerner PharmNet designations:
- INV-: Investigational study drugs can be found by searching the mnemonic "inv-". For example, an amiodarone study drug can be found by searching "inv-amio".
- Study Drug: All study drugs will be built with the name (description) that starts "Study-" This is how it will appear on the label, pharmacy profile, and eMAR.
- TNF-: If a study begins before the study drugs can be built into the Cerner system, the orders are entered as "non-formulary"(TNF). The name of the drug should be "Study..." for all these entries.
For studies with multiple study drugs, order sets are built so that the specific drugs may be selected from the list. The specific study procedures will indicate how this is listed [example: INV-Inos/Placebo (IRB#0911-06)].
The billing code for all investigational drugs built in Cerner will default to "INVNC". This code will not bill the patient for the drug/dispensing fee. Study drugs that were not prebuilt but entered as TNF-INV-... must have the billing code changed to NC. If these TNF-INV-... orders are "copied", the code must again be changed to NC.
The study's IRB Number will be listed in this section. Other protocol names/numbers may be included in this section
Outpatient Clinic Orders
Orders for outpatient infusions may be entered in Cerner if open accounts are available. Oral medications are not entered since they are usually filled as outpatient prescriptions (bulk vials).
Outpatient IDS Requirements
IDS has a special Cerner Retail package that is used to enter outpatient prescriptions. These labels look just like a retail pharmacy label but contain all the IDS information, protocol and IRB number listed. This Cerner Retail is only available in IDS so it is not confused with IU Health Retail Pharmacy dispensing.
Each study sponsor specifies the records that will be required for their study. All sponsors require some form of drug accountability and may allow the site to use their own accountability logs.
Drug Accountability Logs
Each study requires a complete record of all transactions for investigational drug supplies. The "Drug Accountability Logs" are specific for the drug and strength supplied for the study. These are completed at the time of drug receipt or dispensing.
Patient Specific Logs
These records are used to record all the doses for a given patient on their individual record. These records are not required on all studies and are in addition to the "Drug Accountability Logs".
Tear off Labels
Some drug products are supplied with tear-off labels that must be removed prior to dispensing. The study procedures will identify what is to be done with these labels.
Record Retention at Study Conclusion
At the end of the study, all records are given to the principle investigator or their study coordinator. This are then filed and stored with all other study records and regulatory documents.
Double Blind Studies
Some studies have drug shipped that are blinded to pharmacy. They are generally labeled with the drug name/placebo and a bottle/vial code number. Most of these studies require calling an IVRS (Interactive Voice Response System) to obtain the bottle/vial number to dispense for a patient. For these studies, it is not possible to replace a bottle/vial that is lost, broken or misplaced. The IVRS or sponsor may authorize a replacement but this is not an easily accomplished task and generally requires the study coordinator to initiate the process.
Some studies ship active drug and placebo drug so that the pharmacy personnel are un-blinded to the drug product. These studies may require a randomization chart or IVRS to obtain the appropriate treatment and is usually done by the IDS or dispensing area. Even though the pharmacy has access to the blinding, this should not be revealed.
Breaking the Blind
The IDS procedures for the study will indicate if the blind can be broken for a specific study and who has the authority to approve this. In most cases only the investigator can break the blind. The goal is to avoid breaking the blind, if at all possible. For immediate concerns, such as adverse reactions, it may be necessary to treat the subject as if they are on active drug until the "un-blinding issue" is resolved.