Overview of Investigational Drug Services and Study Drug Accountability

1. Overview of Investigational Drug Services and Study Drug Accountability Merrell Lim, Pharm.D. Investigational Drug Services Pharmacist mlim1@clarian.org 317-944-1900

2. 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

3. 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 • 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. 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

5. 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

6. 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

7. 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

8. Transferring Study Medications

9. 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

10. 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

11. 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

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

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

14. 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

15. 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

16. 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

17. 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

18. 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

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

20. Questions?