Transcript Investigational Drug Services & VA Research

Merrell Lim, Pharm.D.
Investigational Drug Services Pharmacist
[email protected]
317-944-1900
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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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IDS Pharmacy:
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IDS hours
◦ Coordinate Phase I to Phase IV studies
◦ Commercially available and investigational agents
◦ Drug accountability, record keeping, study
procedures
◦ 8:00 a.m. ~ 4:30 p.m.
◦ Monday to Friday
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IDS Location:
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IDS Staff:
◦ IU Simon Cancer Center Room C2102
◦ Three full-time pharmacists
◦ Four pharmacy technicians
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Responsibilities of IDS Pharmacists:
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Responsibilities of IDS technicians:
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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
◦ Drug preparation
◦ Drug procurement (ordering, returns, inventory
management)
◦ Study monitor guidance
◦ Study billing
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Drug accountability involves:
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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 drugs can be obtained from:
◦ Research organization
◦ Study company
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Methods
◦ Company order sheets
◦ Phone calls
◦ Interactive Voice Response System (IVRS)
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Study drugs not ordered in bulk
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Drug accountability logs
◦ Completed with each study drug transaction
◦ Completed at time of study drug receipt or
dispensing
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Patient specific logs
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Tear off labels
◦ Used in addition to the ‘Drug Accountability Logs’
◦ Affixed to specific patient log to track study drug
dispensing
IDS Pharmacy
(Control Site)
Riley
Inpatient
Pharmacy
(Satellite Site)
Eagle
Highlands
Medical Offices
(Satellite Site)
Methodist
Inpatient
Pharmacy
(Satellite Site)
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IDS storage area for:
◦ Study binders
◦ Study drugs
◦ Study drug returns
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Study drugs stored specific to drug product:
◦ Room temperature/Refrigerator/Freezer
◦ Light Sensitivity
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Items arranged by IRB# assigned
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Pharmacy blinded
◦ Study drug name/placebo
◦ Bottle/vial number
◦ IVRS needed to assign drug/placebo to patient
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Pharmacy unblinded
◦ Active drug and placebo shipped separately
◦ IVRS or randomization chart needed to assign study
drug/placebo to patient
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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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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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IDS Pharmacy labeling
◦ Drug name
 Listed as “Study drug/placebo”
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IRB #
Study Protocol #
Drug formulation
Quantity
Hospital name and address
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Patient specific log filled out
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Research RN picks up study medications
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No counseling from IDS about study
medications
Returning containers
◦ Educate patients on adherence issues
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Visits by study monitor
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Reviewing of accountability logs
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Destroying study medications on site
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Returning supply to study sponsor
◦ Check and see what sponsor requires
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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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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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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 website:
www.clarian.org/investigationaldrugservices
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IDS Pharmacists:
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IDS Technicians:
◦ Bonnie Klank, Pharm.D. ([email protected])
◦ Edward Leung, Pharm.D. ([email protected])
◦ Merrell Lim, Pharm.D. ([email protected])
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Denise Cox ([email protected])
Ronda Murphy ([email protected])
Jan Pfeiffer ([email protected])
Jada Weger-Effinger ([email protected])