Transcript Investigational Drugs

DUMC
STERILE PREPARATIONS CLEANROOM
TRAINING MODULE:
Investigational Drugs
DUMC STERILE PREPARATIONS CLEANROOM
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING 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).
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING INSTRUCTIONS
PHARMACIST DUTIES:
Complete study drug accountability log.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING INSTRUCTIONS
PHARMACIST DUTIES:
Complete study drug accountability log.
Be sure to sign out for each supply – drug,
diluent, and vial size.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING INSTRUCTIONS
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.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING INSTRUCTIONS
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.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING INSTRUCTIONS
PHARMACIST DUTIES:
Verify that DRUG NAME and IRB/IDS NUMBER match
everywhere - Study notebook, study drug supply (bin), and
dose label.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
PRODUCT PROCUREMENT AND
COMPOUNDING INSTRUCTIONS
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
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
DOSE PREPARATION
TECHNICIAN DUTIES:
The technician provides all necessary
documentation on the work label.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
DOSE PREPARATION
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.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
DOSE PREPARATION
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.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
DOSE PREPARATION
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.
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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Investigational Drugs:
VERIFICATION AND RELEASE OF THE DOSE
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.
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End of Presentation:
Take the Test!
DUMC STERILE PREPARATIONS CLEANROOM
JG/SA 2009
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