Merrell Lim, Pharm.D. Investigational Drug Services Pharmacist

 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 Inpatient Pharmacy (Satellite Site) Eagle Highlands Medical Offices (Satellite Site) Methodist Inpatient Pharmacy (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:  IDS Pharmacists: ◦ Bonnie Klank, Pharm.D. ◦ Edward Leung, Pharm.D. ◦ Merrell Lim, Pharm.D.  IDS Technicians: ◦ Denise Cox ◦ Ronda Murphy ◦ Jan Pfeiffer ◦ Jada Weger-Effinger