JANUARY 26, 2016
LINDA SAILOR, PHARMD
RANIA SADAKA, PHARMD

1. Discuss history of Investigational Drug Service
2. Discuss services provided
3. Discuss how pharmacists can impact clinical research
4. Discuss proper accountability documentation
5. Discuss techniques to employ during auditing visits

• Pharmacy has always provided assistance in research
• 1990 Formal Service was initiated with 1 pharmacist
• Current service expanded with 2 pharmacists providing variety of services

• To provide safe, effective and responsible handling of investigational medications
• To provide assistance and support to the investigator and study research team
• To assure compliance with all federal, state, JCAHO/HSPO regulations concerning investigational medication

* Continuous coverage 24 hr/ day; 7 days / week
- Night Call
- Pharmacy Residents
• 76 Sponsored Trials
• 25 Cooperative Group Trials
• 108 Pending Protocols; 22 Awaiting Official Closure

• TJUH Center City Campus
– Mandatory Inpatient
– Outpatient (Bodine Infusion Center, Jefferson Infusion Center, Physician offices)
• Jefferson Hospital of the NeuroSciences
– Inpatient
– Outpatient (Physician offices)
• Methodist Campus
• Network Affiliates
– Depot Pharmacy for medication

• Initial review of Protocol
-Feasibility
-Preparation of Pharmacy Budget

• Procurement of investigational supplies
- proper storage of medication (room temp vs. refrigeration vs. freezing )
- maintenance of par levels
- storage in limited access area
• Preparation of Drug Data Sheet
- includes step-by-step directions for drug preparation and dispensing of medication

• Randomization (if required) along with maintenance of blind
(if needed)
• Prior to dispensing, verification of:
- patient study enrollment
- accuracy of dose prescribed
-doses prescribed (Inpt- JeffChart, Outpt-Rx)
• Completion of accountability records along with other protocol specific forms

• Labeling of medication
• Staff education and assistance
- Drug Information
• Meeting with sponsor representatives for pre-site, initiation, periodic audits and termination visits
- FDA audits
- Cooperative group audits
- Internal audits

• Return or destruction of investigational supplies
• Accuracy of records upon completion prior to archiving
• Maintenance of archived records
- storage indefinite

• Preparation of Randomization Schema
• Blinding of Medication
- Pharmacists as “unblinded staff”

• IRB MEMBERS
• SAE REVIEWERS

• Maintain drug accountability logs
• Medication computer order entry
- CPOE, OnCare- Future – EPIC (Willow, Beacon)
• Prepare dispensing procedures
- Protocol is reviewed and summarized; step-by-step procedures outlined
• Maintain specific logs wherever the drug is stored

Examples of Investigational Drug Storage and
Control Accountabilities
• IP(Investigational Product) stored in secure location, accessible to only authorized personnel, preferably in the pharmacy
-Our Physical location has 3 secured entries
• Maintain careful record of the receipt, use, and final disposition of all IP received
-100% accountability from moment drug arrives at site until study closure; documentation of receipt, dispensing, drug destruction/ return to sponsor

Examples of Investigational Drug Storage and
Control Accountabilities con’t
• Maintain appropriate storage to ensure stability and integrity of IP
-secure area, back up generator, continuous temperature monitoring
• Maintenance of temperature records (room temperature, refrigerator, freezer)
• Each IP should be stored separately by protocol and labeled
-maintenance of separate Drug Accountability Record
Form (DARF) for each protocol

Examples of Investigational Drug Storage and
Control Accountabilities con’t
• There should be a separate DARF for each patient specific drug supply if indicated in protocol (double blind study)
• Agents received from PMB(Pharmaceutical Management Branch, DCTD
(Division of Cancer Treatment and Diagnosis)- are used only for patients entered onto an approved DCTD-sponsored protocol
• There should be a separate DARF for each agent in a multi agent protocol

Examples of Investigational Drug Storage and
Control Accountabilities con’t
• Separate accountability logs should be maintained for each different strength or dosage form of a particular agent (eg, an
IP with 5mg capsules and 20 mg capsules would require different DARFs for the 5mg and 20mg capsules)
• Appropriate documentation of drug dispensing to multiple patients of multi-dose medication on separate line of the
DARF

Examples of Investigational Drug Storage and
Control Accountabilities con’t
• The DARF has been designed for use at each location where agents are stored, eg, main pharmacy, satellite pharmacy, physician’s office, or other dispensing areas
• The DARF is also designed to accommodate both dispensing records and other agent transaction documentation (eg, receipt of agent, returns, broken vials)

Guidelines for DARF Completion
• Black Pen Only
• No White Out
• Capture information in real time
• Complete all fields
• Error with line through, date, initials (no scribble)

Drug Accountability
Record Forms- Examples
• Sponsor forms
- Sponsors should provide at SIV
• NCI forms
- Oral accountability forms vs. Investigational accountability record

Websites to Visit for General Information
NCI –Cancer Therapy Evaluation Program (CTEP) http://ctep.cancer.gov/
NSABP (National Surgical Adjuvant Breast and Bowel Project) http://www.nsabp.org/
NIH (National Institutes of Health) http://www.nih.gov/
RTOG (Radiation Therapy Oncology Group) http://www.rtog.org/
ECOG (Eastern Cooperative Oncology Group) http://www.ecog.org/

IDS Service Contact Information
Cell: 267-240-4731
Phone: 215-955-6923
Fax: 215-955-7946
Resident Pager Hours Weekdays: 430pm -10pm and
Weekends 8am to 8pm
1-877-656-7797
Night Pharmacy Hours 10pm to 7am
215-955-7147

1. 2006 CTMB guidelines
2. Mark, SM, Weber, RJ. Advanced Practice Programs in Hospital Pharmacy-Investigational Drug
Services. Hospital Pharmacy. Volume 43, Number 2, pp 143-148. 2008 Wolters Kluwer Health,
Inc.
3. Lacasse, R. What is a Pharmacy’s Role in Investigational Studies? Presentation. April 2008.
University of CONN Health Center.