investigational drugs
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Investigational Drugs. DUMC STERILE PREPARATIONS CLEANROOM TRAINING MODULE:. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS. PHARMACIST DUTIES : Identify protocol (IDS or ONC) by drug name and IRB number . - PowerPoint PPT PresentationTRANSCRIPT
Investigational DrugsInvestigational Drugs
DUMCDUMCSTERILE PREPARATIONS CLEANROOMSTERILE PREPARATIONS CLEANROOM
TRAINING MODULE:TRAINING MODULE:
11DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
PHARMACIST DUTIES:
Identify protocol (IDS or ONC) by drug name and IRB number.
Retrieve protocol notebook located in the supply cabinet in the anteroom.
Read information for compounding (SPA Procedures in IDS or ONC notebook).
2DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
PHARMACIST DUTIES:
Complete study drug accountability log.
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
3DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
PHARMACIST DUTIES:
Complete study drug accountability log.
Be sure to sign out for each supply – drug, diluent, and vial size.
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
4DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
PHARMACIST DUTIES:
Complete study drug accountability log.
Be sure to sign out for each supply – drug, diluent, and vial size.
Obtain drug supply from the supply cabinet in the anteroom or the investigational drug section of the refrigerator.
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
5DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
PHARMACIST DUTIES:
Complete study drug accountability log.
Be sure to sign out for each supply – drug, diluent, and vial size.
Obtain drug supply from the supply cabinet in the anteroom or the investigational drug section of the refrigerator.
Reconcile log balance matches the actual drug supply each time study drug is signed out.
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
6DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
PHARMACIST DUTIES:
Verify that DRUG NAME and IRB/IDS NUMBER match Verify that DRUG NAME and IRB/IDS NUMBER match everywhereeverywhere - Study notebook, study drug supply (bin), and - Study notebook, study drug supply (bin), and dose label.dose label.
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
7DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
PHARMACIST DUTIES:
Pharmacist writes compounding instructions from the study notebook on the work label. These instructions should include:
Any necessary volume or concentration calculation Auxiliary labels Expiration date Special instructions for preparation Handling instructions
Investigational Drugs:Investigational Drugs:PRODUCT PROCUREMENT AND PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONSCOMPOUNDING INSTRUCTIONS
8DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
TECHNICIAN DUTIES:
The technician provides all necessary documentation on the work label.
Investigational Drugs:Investigational Drugs:
DOSE PREPARATIONDOSE PREPARATION
9DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
TECHNICIAN DUTIES:
The technician provides all necessary documentation on the work label.
Only auxiliary labels indicated in study notebook are placed on the dose label.
Investigational Drugs:Investigational Drugs:
DOSE PREPARATIONDOSE PREPARATION
10DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
TECHNICIAN DUTIES:
The technician provides all necessary documentation on the work label.
Only auxiliary labels indicated in study notebook are placed on the dose label.
Prepare the dose per established guidelines and according to the instructions specific to the study involved.
Investigational Drugs:Investigational Drugs:
DOSE PREPARATIONDOSE PREPARATION
11DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
TECHNICIAN DUTIES:
The technician provides all necessary documentation on the work label.
Only auxiliary labels indicated in study notebook are placed on the dose label.
Prepare the dose per established guidelines and according to the instructions specific to the study involved.
Refer to the instructions given by the pharmacist.
Investigational Drugs:Investigational Drugs:
DOSE PREPARATIONDOSE PREPARATION
12DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
The pharmacist verifies the identity and amounts of the ingredients in the dose before the product is dispensed.
Refer to the PHARMACIST VERIFICATION OF CSPs SOP for more information on end-product verification.
Investigational Drugs:Investigational Drugs:
VERIFICATION AND RELEASE OF THE DOSEVERIFICATION AND RELEASE OF THE DOSE
13DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009
End of Presentation:End of Presentation:
Take the Test!Take the Test!
14DUMC STERILE PREPARATIONS CLEANROOMDUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009