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

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

So let’s try to help sort this out…

We want to give you audit relief. CTMB section 5.3

Is the pharmacy SECURE ?

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.

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

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

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

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: http://ctep.cancer.gov/forms 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

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

Oral DARFs

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

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

Common DARF Errors Example

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

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

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

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.

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

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

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

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.

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.

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 5.3.4 & 5.3.5 defines what a Critical deficiency.

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

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.

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.

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

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

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

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

http://ctep.cancer.gov/branche s/pmb Newsletters PMB information http://ctep.cancer.gov/branche s/pmb Newsletters Pharmacy training Videos CTMB guidelines Section 5.3 ctep.cancer.gov/branches/ctmb /clinicalTrials/monitoring https://www.allianceforclinicalt rialsinoncology.org/main Alliance P & P Section 2.8.7.3 PMB = Pharmaceutical monitoring branch CTMB = Clinical trials Monitoring Branch

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

Questions

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