Drug Supply Management + Accountability
The record keeping associated with the receipt, storage, and dispensation of an investigational product is known as study drug accountability. While the study sponsor is responsible with packaging and distributing the product to the study sites, it is the responsibility of the site to maintain adequate records of the products handling and dispensation.
Often sponsors will provide tools such as tracking logs to assist in the maintenance of such records. However, if no tools are offered by the sponsor, the site should plan to develop their own tracking method. For all hospital-based drug studies, Investigational Drug Services is responsible for managing the research study drug supply and drug accountability records.
Packaging
Study drug will often be packaged to protect the product, ease dispensation, and to preserve blinding when necessary. Typically the packaging will offer a place to record the study participant ID.
Receipt
When study drug is received at the study site, it is important to inspect the shipment in its entirety. The packing slip should be compared to both the order form and the contents of the shipment. Often study sponsors will require that the packing slip be signed, dated, and returned in order to acknowledge receipt of the shipment. If it appears that the shipment is incomplete or was damaged in transit, contact the sponsor immediately.
Storage
Storage instructions should be included with the shipment, including specifications for temperature ranges. Study drug should always be stored in a secure location, either at the study pharmacy or in a locked cabinet within a separate locked room. Temperature logs should be maintained in the storage area to ensure that the product remains viable.
If study drug requires storage in a refrigerator, the refrigerator should have a lock on it and should remain free of food. This means that study drug cannot be kept in the break room refrigerator. Likewise, lunch cannot be kept in the study drug refrigerator.
Dispensation
The tracking of study drug dispensation can become complicated with many study participants over the course of a lengthy trial. Meticulous records are required in order to be compliant with accountability. Study drug received from the sponsor should be tracked, as well as drug dispensed to study participants. So there is a constant flow of drug in and drug out.
Example 1:
Study drug received is tracked on the same log as study drug dispensed.
Received/
Dispensed
Date
Participant ID
Lot #
Quantity
Total Remaining
Received
06/01/2010
NA
L0124
12 bottles
12 bottles
Dispensed
06/03/2010
101
L0124
2 bottles
10 bottles
Dispensed
06/04/2010
102
L0124
1 bottle
9 bottles
Dispensed
06/06/2010
103
L0124
2 bottles
7 bottles
Received
06/07/2010
NA
L0216
12 bottles
19 bottles
Dispensed
06/10/2010
101
L0124
1 bottle
18 bottles
Example 2:
Study drug received is tracked on one log and study drug dispensed is tracked on a separate log.
Received/
Dispensed
Date
Participant ID
Lot #
Quantity
Total
Received
06/01/2010
NA
L0124
12 bottles
12 bottles
Received
06/07/2010
NA
L0216
12 bottles
24bottles
Received/
Dispensed
Date
Participant ID
Lot #
Quantity
Total
Dispensed
06/03/2010
101
L0124
2 bottles
2 bottles
Dispensed
06/04/2010
102
L0124
1 bottle
3 bottles
Dispensed
06/06/2010
103
L0124
2 bottles
5 bottles
Dispensed
06/10/2010
101
L0124
1 bottle
6 bottles
Example 3:
Study drug received is tracked on one log and study drug dispensed is tracked on a separate log per subject.
Received/
Dispensed
Date
Participant ID
Lot #
Quantity
Total
Received
06/01/2010
NA
L0124
12 bottles
12 bottles
Received
06/07/2010
NA
L0216
12 bottles
24 bottles
Received/
Dispensed
Date
Participant ID
Lot #
Quantity
Total
Dispensed
06/03/2010
101
L0124
2 bottles
2 bottles
Dispensed
06/10/2010
101
L0124
1 bottle
3 bottles
Unblinding
In rare cases, the unblinding of study drug is required. This may occur as a result of an adverse event where it is necessary to know the type of study treatment that was being received in order to determine how to treat the event. Unblinding procedures vary from study to study and should be covered during protocol training, such as the Site Initiation Visit or Investigator Meeting.
Disposition
The sponsor will determine if remaining study drug will be returned or destroyed on site at study completion. Thus drug reconciliation often occurs as part of the Close-Out Visit. It is important to keep all empty containers until a reconciliation has occurred and permission was granted by the sponsor to return or destroy drug. This includes keeping any empty pill bottles, vials, etc. Study participants should always be informed that they should return their empty containers rather than discarding them. Adequate records should be maintained whether study drug is returned or destroyed on site. Any discrepancies should be clearly noted in a memo-to-file.