merrell lim, pharm.d. investigational drug services pharmacist mlim1@clarian.org 317-944-1900

Merrell Lim, Pharm.D.Investigational Drug Services Pharmacist

mlim1@clarian.org317-944-1900

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. (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)