Hi and welcome to this video tutorial on Local Destruction in the PMB Investigational Drug
Accountability series.
This video will review when and how to perform local destruction of PMB-supplied agents.
During the course of a clinical trial, it may become necessary to return PMB-supplied
agents.
There are special circumstances when the PMB directs sites to request local destruction.
These special circumstances involve Dangerous Goods or infectious agents, clinical trial
sites located outside the United States or when otherwise directed by the PMB.
Refer to the Agent Returns video for the returns process for agents that are not DGs and for
sites that are located within the US.
A DG is a compound requiring special labelling and packaging for shipping.
The **DG** notation is located on the Shipment Record under the agent name.
Any stock notifications issued for a DG will have specific instructions for requesting
local destruction.
If your institution does not have the capability for shipping DGs or infectious agents, approval
is required from the PMB for local destruction.
This approval must be received prior to the destruction.
Local destruction is performed according to your institution�s standard operating procedures.
International sites should request local destruction for all PMB-supplied agents.
To begin the process, obtain the Request for Authorization for Local Destruction form.
If you do not have this form, contact the Local Destruction Coordinator at PMBafterhours@mail.nih.gov.
Complete each field in the form.
The Investigator on the form should be the same investigator on whose behalf agent was
ordered or transferred.
This is also the same investigator who is listed on the DARF.
Notice in the example provided here that local destruction is being requested on behalf of
Dr. John Smith for pazopanib 200 mg tablets used on NCI study 1234.
The form must be signed by the investigator, shipping designee, or an authorized ordering
designee prior to emailing to the PMB.
If approved, the PMB will send a signed authorization letter that contains the details of the request
and authorizes you to destroy the approved quantity.
Proceed with destruction according to institutional policy and applicable regulations and record
destruction of the supply on the appropriate DARF.
Documentation should be made for the proper lot, quantity and date of destruction.
If more than one lot was destroyed, use more than one line.
In our example DARF, destruction of pazopanib 200 mg tablets occurred on November 4, 2014
and is documented on line 17 as having been authorized by the PMB.
After destruction has occurred, certify by signing the form and then email it to the
PMB with a copy of the appropriate page of the DARF documenting the destruction.
Only the page of the DARF reflecting the destruction should be submitted.
If this documentation is not received by the PMB within 30 days, the local destruction
authorization is rescinded.
Once the PMB reviews and approves the submitted documents, the completed destruction authorization
form will be emailed to you with a return number.
If authorization is rescinded, this will be documented as the final disposition instead
of a return number.
Regardless of the final disposition, the authorization form must be retained with your accountability
records to have available for auditing purposes.
If authorization for destruction has been granted and the required documentation has
not been provided 2 weeks of the date of authorization, the local destruction coordinator will email
a warning letter to the requestor.
The authorization will be rescinded after 30 days if required documentation is not received.
In this example warning letter, the PMB is reminding John Doe that he has not yet adequately
documented destruction of expired pazopanib 200 mg tablets for Dr. Smith�s protocol
after authorization was granted on October 28.
The most common reasons for rescission of local destruction authorization include date
of destruction occurs before the date of authorization and destruction is not reported within 30
days of authorization
In our example, destruction authorization was rescinded because the required documents
were not provided within 30 days of authorization.
Keep in mind there are several reasons why your initial request for local destruction
may be denied.
1.
Agent was not supplied by PMB. 2.
The Agent is a DG or infectious agent and the lot has not expired and can be transferred
to another protocol, and 3.
Agent is not a DG or infectious agent.
If your local destruction request is denied, follow the directions specified by the study
sponsor.
The Policy and Guidelines for Investigational Agent Local Destruction and other topics mentioned
in this video can be found on the PMB website under Agent Management.
Our FAQs also provide information on related topics.
Thank you for watching this video tutorial.
Additional PMB Investigational Drug Accountability videos are available through our YouTube Playlist.
Please note that the video and any items displayed within the videos are subject to change.
Check back periodically for updates.
Questions can be directed to the Pharmaceutical Management Branch, CTEP, NCI by phone at 240-276-6575,
Monday through Friday from 8:30am to 4:30pm Eastern Time or by email at PMBAfterhours@mail.nih.gov
any time.