Overview of Investigational Drug Services and Study Drug Accountability

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Overview of Investigational Drug Services and
Study Drug Accountability

• Merrell Lim, Pharm.D.
• Investigational Drug Services Pharmacist
• mlim1_at_clarian.org
• 317-944-1900

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Learning Objectives

• Learn about services provided by investigational
  drug services (IDS) pharmacy
• Understand the role of IDS staff
• Learn about importance of drug accountability
• Gain further understanding of operations within
  the IDS pharmacy

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Investigational Drug Services (IDS)

• IDS Pharmacy
• Coordinate Phase I to Phase IV studies
• Commercially available and investigational agents
• Drug accountability, record keeping, study
  procedures
• IDS hours
• 800 a.m. 430 p.m.
• Monday to Friday
• IDS Location
• IU Simon Cancer Center Room C2102
• IDS Staff
• Three full-time pharmacists
• Four pharmacy technicians

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Investigational Drug Services (IDS)

• Responsibilities of IDS Pharmacists
• Review study protocols
• Participate in study start-up activities
• Write study procedures
• Verify study drugs prepared by IDS technicians
• Participate as reviewer for IRB Committee
• Responsibilities of IDS technicians
• Drug preparation
• Drug procurement (ordering, returns, inventory
  management)
• Study monitor guidance
• Study billing

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Investigational Drug Services (IDS)

• Drug accountability involves
• Drug procurement
• Drug and patient specific logs
• Control site VS. Satellite site
• Storage
• Drug packaging/Blinding
• Randomization
• Labeling
• Drug dispensing
• Drug returns

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Study Drug Procurement

• Study drugs can be obtained from
• Research organization
• Study company
• Methods
• Company order sheets
• Phone calls
• Interactive Voice Response System (IVRS)
• Study drugs not ordered in bulk

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Study Drug Accountability Logs

• Drug accountability logs
• Completed with each study drug transaction
• Completed at time of study drug receipt or
  dispensing
• Patient specific logs
• Used in addition to the Drug Accountability
  Logs
• Tear off labels
• Affixed to specific patient log to track study
  drug dispensing

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Transferring Study Medications
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Study Drug Storage

• IDS storage area for
• Study binders
• Study drugs
• Study drug returns
• Study drugs stored specific to drug product
• Room temperature/Refrigerator/Freezer
• Light Sensitivity
• Items arranged by IRB assigned

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Study Drug Packaging/Blinding

• Pharmacy blinded
• Study drug name/placebo
• Bottle/vial number
• IVRS needed to assign drug/placebo to patient
• Pharmacy unblinded
• Active drug and placebo shipped separately
• IVRS or randomization chart needed to assign
  study drug/placebo to patient

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Study Drug Packaging/Blinding

• Breaking the blind
• Principle investigator is the only person to
  break blind
• AVOID breaking blind if possible
• If treating adverse reactions, treat subject as
  if on active drug

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Study Drug Randomization

• Methods of randomizing patients
• Randomized by research RN (at screening)
• Pre-printed randomization lists
• Sealed envelopes
• Interactive Voice Response System (IVRS)

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Study Drug Labeling

• IDS Pharmacy labeling
• Drug name
• Listed as Study drug/placebo
• IRB
• Study Protocol
• Drug formulation
• Quantity
• Hospital name and address

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Study Drug Dispensing

• Patient specific log filled out
• Research RN picks up study medications
• No counseling from IDS about study medications
• Returning containers
• Educate patients on adherence issues

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Return of Drug Supply

• Visits by study monitor
• Reviewing of accountability logs
• Destroying study medications on site
• Returning supply to study sponsor
• Check and see what sponsor requires

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Overview of IDS Procedures

• Prepare budget for study (pharmacy portion)
• Attend IRB meeting to have study approved
• Build study product in Cerner
• Attend start up meeting
• Write study procedures

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Overview of IDS Procedures

• Create and build order sets
• Have order sets approved
• Print copies of procedures and study logs and
  have technician create study binder
• Document all shipping and correspondence in file
  cabinet

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Overview of IDS Procedures

• Checking study drug product
• Documenting study drug usage in accountability
  logs
• Accommodating monitor visits
• Close out studies that are completed
• Billing issues

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IDS Pharmacy Staff Contact information

• IDS website www.clarian.org/investigationaldrugse
  rvices
• IDS Pharmacists
• Bonnie Klank, Pharm.D. (bklank_at_clarian.org)
• Edward Leung, Pharm.D. (leunge_at_clarian.org)
• Merrell Lim, Pharm.D. (mlim1_at_clarian.org)
• IDS Technicians
• Denise Cox (dccox_at_clarian.org)
• Ronda Murphy (rmurphy_at_clarian.org)
• Jan Pfeiffer (jpfeiffe_at_clarian.org)
• Jada Weger-Effinger (jwegere1_at_clarian.org)

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Questions?