1. Audit Pharmacy Review Rosalyn D. Williams
Alliance for Clinical Trials in Oncology, Chicago Office
Audit Workshop, November 1st , 2018
Do we have any pharmacist in the audience

2. Presentation Objectives
Pharmacy security is important. What are the expectation at the time of the audit?
Is storage of drug appropriate?
Are supplied drug stored under proper conditions?
DARFs ~ Drug Accountability Record Form
Are the NCI DARFs being used and correctly maintained?
Standard DARF
Oral DARF
eDARF
So during this presentation the objectives
September 6th, 2017 CTMB came out w/ new guidelines, for Pharmacy it would be section 5.3.4

3. So let’s try to help sort this out…

4. We want to give you audit relief.
CTMB section 5.3

5. Is the pharmacy SECURE ?

6. Security Access to Pharmacy Who has access? Pharmacy Staff
Research Staff
Is the unit locked?
Badge Access
Key
A bell to get into the Pharmacy
1. Anybody walking down hall should not have access to the pharmacy. You should know who has access to your Pharmacy.

7. Is this secure?
Is their anything wrong w/ this picture.

8. Authorized Prescribers
Who are the authorized Prescribers?
Are all Investigators CTEP registered?
Is there a process in place to be sure each investigator remains compliant?
Only Physicians that are CTEP registered can order and dispense investigational drug. Nurse Practitioners and Physician Assistant cannot prescribe supplied drug unless the order is cosigned by a CTEP registered Physician.
If a Investigator is still treating a patient, they cannot let their compliance lapse
CTEP = Cancer Therapy Evaluation Program

9. Storage Is there temperature monitoring? Is there an Alarm?
Shelf storage
Is the study drug stored separately from commercial drug?
Is the returned drug stored separately?
How are patient drugs returned?
Are procedures in place to know if the temperature goes outside safety window who is notified ? Pharmacy staff ?
Patient returned drug should be stored separately from the study drug to be dispensed.
The site cannot take returned drug and put it back on the shelf

11. DARFs Drug Accountability Record Form Standard DARF Oral DARF eDARF
These DARF’s are used to track the disposition of investigational agents used for NCI clinical trials
DARF forms can be found on CTEP website:
So what is a DARF
You can also find the DARF’s on PMB training video, that website is at the end of these slides
CTEP = Cancer Therapy Evaluation Program

12. Standard DARF
We want to make sure that the header is complete and we are not using DARF is not expired.

13. Oral DARFs

14. Oral DARFs Must be used for all NCI studies using an oral agent
All headers must be completed
You must use the correct dispensing row to document patient drug return by completing the date returns and the quantity returns

15. Oral DARF
Oral DARF has 4 extra columns they are the expiration date if available, the date the patient returned the drug, the patient returned quantity and the recorders initials

16. Common DARF Errors
Example

17. DARF - Headers Common audit errors or Missing information
Protocol title
Dispensing Area
Control/Satellite check box
Page number(s)
Dose form and strength
Example

18. DARF Entry Errors Common audit entry errors
Entry of the drug received from the NCI
Patient initials not listed
Balance totals not completed
Correct patient dose
More common audit errors

19. Example Incomplete DARF
Who can tell me what is wrong with this DARF ? Audience participation

20. Example of an Incomplete DARF
Initial receipt of agent is not documented.
In the header page number is not completed. The check box whether it is the control vs satellite pharmacy. The agent dose form and strength not completed. Remember the entire header section should be complete.
Satellite might be the out patient
They may not have assigned it a local protocol no.
For line number 1 you can see that there was distribution before receipt of the agent from the supplier.
2 is not in done in real time.

21. Completed Oral DARF Initial receipt
Everything is the header is complete there are no write overs and every transaction is done in chronological order and everything is done in real time
You can see there is agent receipt of agent from the supplier prior to distribution

22. eDARF’s NCI = National Cancer Institute
PMB = Pharmaceutical Management Branch

23. eDARF’s
If a Pharmacy accountability software is used, a paper copy must be printed for the audit that is identical to an NCI DARF
The NCI/PMB does not endorse any pharmacy software package
NCI = National Cancer Institute
PMB = Pharmaceutical Management Branch

24. Pharmacy Audit Results
A full re-audit will be for patient case, IRB and Pharmacy
Section 5.3.4
New CTMB guidelines dated 9/6/2017.

25. Pharmacy Audit Results
Pharmacy are either Critical, Non-Compliant, Compliant or Not reviewed.
If the Pharmacy section has too many non- compliant issues an unacceptable rating will be assigned.
An unacceptable will require a re-audit within 12 months
Re-audit can be for the pharmacy section only or a full re-audit.
A full re-audit will be for patient case, IRB and Pharmacy
Section 5.3.4
New CTMB guidelines dated 9/6/2017.

27. These are examples for assigning an Unacceptable rating
Inability to track the disposition of NCI-supplied study drug.
Multiple non-compliant categories identified.
A single Critical Non-compliance finding.
Any Finding identified before or during an audit that is suspected to be fraudulent activity should be cited as Critical deficiency.
Section & defines what a Critical deficiency.

28. Example of a Non - compliant issue
A shipping receipt for 13 bottles of study agent on 7/27/16 is not entered on the DARF. Dispensing of agent on 8/8/16 is documented on the DARF. No other entries were made on the DARF. In addition, there is a shipping receipt for 13 bottles on 11/2/16. The site staff present at the audit state that there are patients still on active treatment receiving supplied study agent.
Real case one of the auditors recently encountered.
Pharmacy 5.3

29. Critical example
Patient returns were added back into stock and subsequently dispensed to a different patient.
Return drug should not be returned into stock and should be shipped per protocol.

30. Which one of these is a Critical issue
Corrections are not lined out, initialed and dated on paper DARF
Study – supplied agent dispensed to a registered patient/study participant and not recorded on the appropriate DARF
Dispensing of study supplied agent to a non – registered patient/study participant
Would one of these drop downs / examples would be considered a critical non compliant issue.

31. Critical issue
Corrections are not lined out, initialed and dated on paper DARF
Study – supplied agent dispensed to a registered patient/study participant and not recorded on the appropriate DARF.
Dispensing of study supplied agent to a non – registered patient/study participant

32. Not reviewed
Off – site Pharmacy review where there is no IND (Investigation Drug) involved for the study participant.

33. DARF’s shipping receipts Study specific vs. Patient specific
How is drug supplied ?
Is the DARF study specific (open label) ?
Is the DARF patient specific (double- blinded) ?
If the receipt shows pt ID then you need a patient specific DARF the top one is open label study specific.
The bottom one is patient specific what is circled in blue tells you the pt. id, pt initials.
That is a easy way to tell you if the darf is study specific or pt. specific
The key is to check the drug receipt

34. DARF Drug Returns Returns Follow protocol for return or destruction
If possible transfer drug to another study, they will need to follow PMB guidelines.
Returns should be done within 90 days per CTMB guidelines (this is not pharma)
All documentation of return or destruction of drug should be maintained
1. PMB = Pharmacy Monitoring provides a receipt of drug return
3. Some pharmaceuticals companies require you to keep the drug on site until they come out to monitor you
CTMB guidelines website can be found at the end of this of these slides

35. http://ctep.cancer.gov/branche s/pmb Newsletters
PMB information
s/pmb
Newsletters
Pharmacy training Videos
CTMB guidelines
Section 5.3
ctep.cancer.gov/branches/ctmb /clinicalTrials/monitoring
rialsinoncology.org/main
Alliance P & P Section
PMB = Pharmaceutical monitoring branch
CTMB = Clinical trials Monitoring Branch

36. Now after this presentation when we come to audit you, we will be able to say good job

37. Questions

39. 2018 Fall Group Meeting November 1 – 3 / Chicago, IL