Supply, Management

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Supply, Management accountabilityJanuary 26,
2016Linda Sailor, PharmdRania Sadaka, Pharmd

• Investigational Drug Service

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Objectives

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

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History of IDS

• 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

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MISSION STATEMENT

• 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

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ABOUT IDS

• 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

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IDS SCOPE OF SERVICE

• 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

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SERVICES AVAILABLE

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

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SERVICES AVAILABLE

• 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

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SERVICES AVAILABLE

• 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

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SERVICES AVAILABLE

• 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

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SERVICES AVAILABLE

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

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SPECIALIZED SERVICES

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

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ADDED BENEFITS

• IRB MEMBERS
• SAE REVIEWERS

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TRICKS OF THE TRADE
Bridging The Gap Between Investigator And Sponsor
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Drug Accountability- Basic Services

• 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

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Examples of Investigational Drug Storage
andControl 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

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Examples of Investigational Drug Storage
andControl Accountabilities cont

• 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

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Examples of Investigational Drug Storage
andControl Accountabilities cont

• 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

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Examples of Investigational Drug Storage
andControl Accountabilities cont

• 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

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Examples of Investigational Drug Storage
andControl Accountabilities cont

• The DARF has been designed for use at each
  location where agents are stored, eg, main
  pharmacy, satellite pharmacy, physicians 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)

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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)

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Drug Accountability Record Forms- Examples

• Sponsor forms
• - Sponsors should provide at SIV
• NCI forms
• - Oral accountability forms vs. Investigational
  accountability record

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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/

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IDS Service Contact Information

• Cell 267-240-4731
• Phone [phone]
• Fax [phone]
• Resident Pager Hours Weekdays 430pm -10pm and
• Weekends 8am to 8pm
• 1-877-656-7797
• Night Pharmacy Hours 10pm to 7am
• 215-955-7147

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References

• 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 Pharmacys Role in
  Investigational Studies? Presentation. April
  2008. University of CONN Health Center.

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Questions