1. Merrell Lim, Pharm.D. Investigational Drug Services Pharmacist mlim1@clarian.org 317-944-1900

2.  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

3.  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

4.  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

5.  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

6.  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

7.  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

8. IDS Pharmacy (Control Site) Riley Inpatient Pharmacy (Satellite Site) Eagle Highlands Medical Offices (Satellite Site) Methodist Inpatient Pharmacy (Satellite Site)

9.  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

10.  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

11.  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

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

13.  IDS Pharmacy labeling ◦ Drug name  Listed as “Study drug/placebo” ◦ IRB # ◦ Study Protocol # ◦ Drug formulation ◦ Quantity ◦ Hospital name and address

14.  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

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

16.  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

17.  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

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

19.  IDS website: www.clarian.org/investigationaldrugservices www.clarian.org/investigationaldrugservices  IDS Pharmacists: ◦ Bonnie Klank, Pharm.D. (bklank@clarian.org)bklank@clarian.org ◦ Edward Leung, Pharm.D. (leunge@clarian.org)leunge@clarian.org ◦ Merrell Lim, Pharm.D. (mlim1@clarian.org)mlim1@clarian.org  IDS Technicians: ◦ Denise Cox (dccox@clarian.org)dccox@clarian.org ◦ Ronda Murphy (rmurphy@clarian.org)rmurphy@clarian.org ◦ Jan Pfeiffer (jpfeiffe@clarian.org)jpfeiffe@clarian.org ◦ Jada Weger-Effinger (jwegere1@clarian.org)jwegere1@clarian.org