merrell lim, pharm.d. investigational drug services pharmacist [email protected] 317-944-1900
TRANSCRIPT
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
IDS Pharmacy:◦ Coordinate Phase I to Phase IV studies◦ Commercially available and investigational
agents◦ Drug accountability, record keeping, study
procedures IDS hours
◦ 8:00 a.m. ~ 4:30 p.m. ◦ Monday to Friday
IDS Location:◦ IU Simon Cancer Center Room C2102
IDS Staff:◦ Three full-time pharmacists◦ Four pharmacy technicians
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
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
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
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
IDS Pharmacy(Control Site)
Riley InpatientPharmacy
(Satellite Site)
EagleHighlands
Medical Offices(Satellite Site)
MethodistInpatientPharmacy
(Satellite Site)
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
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
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
Methods of randomizing patients
◦ Randomized by research RN (at screening)
◦ Pre-printed randomization lists
◦ Sealed envelopes
◦ Interactive Voice Response System (IVRS)
IDS Pharmacy labeling◦ Drug name
Listed as “Study drug/placebo”◦ IRB #◦ Study Protocol #◦ Drug formulation◦ Quantity◦ Hospital name and address
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
Visits by study monitor
Reviewing of accountability logs
Destroying study medications on site
Returning supply to study sponsor◦ Check and see what sponsor requires
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
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
Checking study drug product Documenting study drug usage in
accountability logs Accommodating monitor visits Close out studies that are completed Billing issues
IDS website: www.clarian.org/investigationaldrugservices
IDS Pharmacists:◦ Bonnie Klank, Pharm.D. ([email protected])◦ Edward Leung, Pharm.D. ([email protected])◦ Merrell Lim, Pharm.D. ([email protected])
IDS Technicians:◦ Denise Cox ([email protected])◦ Ronda Murphy ([email protected])◦ Jan Pfeiffer ([email protected])◦ Jada Weger-Effinger ([email protected])
