The following scenario illustrates the supply, receipting and movement of ANODE packs. Allocation and shipment of IMP

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1 Guidance Sheet 11 IMP Management and Stock Control Participants in the ANODE Trial will receive an intravenous (IV) dose of either co-amoxiclav or an unmatched inactive placebo (0.9% saline). This is an Investigational Medicinal Product (IMP) and should be stored below 25 C (temperature monitoring and storage should be as per local trust procedures). The ANODE IMP has a shelf life of 2 years. ANODE IMP is manufactured and supplied by Guy s and St Thomas Pharmacy Manufacturing Unit (GSTPMU). The IMP will be supplied in dispensing boxes which contain 5 packs, these boxes have a flap at the bottom which allows only the next sequentially numbered pack to be removed at randomisation. It will be possible to view the labels of all IP packs in the boxes though a window without opening the boxes. All shipments of trial packs will be received by the hospital pharmacy and stored until they are required on the Maternity Unit. Upon receipt of a shipment, pharmacy should check the delivery for any damage or inconsistencies against the accompanying inventory sent by GSTPMU and the sent by the randomisation program. The ANODE packs should be receipted at the first opportunity using the ANODE website randomisation program and using the GSTMU shipment receipt confirmation. ANODE website randomisation program: Stock levels will be monitored by the Coordinating Centre using the randomisation program and pharmacy will be resupplied when required. It is essential that the receipt and movement of ANODE packs are carried out in an accurate and timely fashion and recorded using the randomisation program. The Clinical Trials pharmacist s address will automatically receive s informing them which packs have been sent, when boxes are assigned and logged into the Maternity Unit. The following scenario illustrates the supply, receipting and movement of ANODE packs. The ANODE Coordinating Centre will assign packs to the site GSTPMU will send packs to pharmacy. Allocation and shipment of IMP Packs will show as in transit, and an is generated to the pharmacy department similar to the message (right). Subject: ANODE [Packs to be sent] Message to: centre_pharmacy@npeu.ox.ac.uk From: ANODE <donotreply@npeu.ox.ac.uk> The following packs are to be sent to your centre: Name of centre (10 packs)

2 Receipting IMP- Randomisation program When the delivery is received, pharmacy staff should log in to the website using their username and password. Click Login packs at pharmacy. In this example there are 20 packs in transit and require logging in. 18 packs are available (12 in pharmacy, 6 in pharmacy assigned to Maternity Unit) and 20 packs in transit to your centre Click on Login packs at pharmacy to view pack ID contained within shipment and to log in stock. Immediately after opening contents, take out the WarmMark Temperature indicator and record the relevant information. If indicator reads PROLONGED, please quarantine stock according to Trust procedures and immediately contact the Trial Team or Trial Coordinating Centre ( ). If indicator reads NONE, BRIEF, or MODERATE, supplies can be used.

3 Check integrity of boxes before log in. Do not open boxes to inspect individual packs, if damage is noted on a dispensing box mark all packs listed in the box as damaged. On the website select the individual pack numbers and click damaged. An example of packs highlighted in blue shows how damaged or missing packs might be identified. If none are highlighted, then ALL packs will be logged in. Select all 5 packs in a damaged box and click damaged Confirm Available for use and then confirm by clicking Yes. Receipting IMP- Guy s and St Thomas Pharmacy Manufacturing Unit In addition to the above, pharmacy staff should also receipt IMP with GSTPMU using the documentation enclosed within the shipment. Immediately after opening contents, take out the WarmMarkTemperature and note shipment conditions and if shipment was intact on the receipt. Scan and completed document production.pharmacists@gstt.nhs.uk

4 Pharmacy Stock Log The Pharmacy Stock Log should be completed by a delegated member of pharmacy staff when a box of packs is received or dispensed to the Maternity Unit. Each individual pack should be accounted for. Logging packs on at the Maternity Unit If pharmacy staff are taking packs directly to the Maternity Unit please click on Login at Maternity Unit and take packs directly to allocated drug cupboard on the Maternity Unit. OR Packs can be taken and logged in by delegated trial staff using the unit login details. The ANODE IMP Accountability Log should be completed by the person delivering/releasing packs to the Maternity Unit. Complete Section A and the first 3 columns of Section B when a box is dispensed to the Maternity Unit log should remain with Dispensing Box until it is complete. Section B will be completed each time an intervention pack is removed from the Dispensing Box.

5 Storage monitoring There is no specific requirement for temperature monitoring for the ANODE IMP. The IMP should be stored as per Trust procedures for co-amoxiclav. If there are any concerns regarding the ANODE IMP contact the ANODE Trial Team immediately (by calling extension within office hours or ing outside office hours). The ANODE Trial team will contact a member of the pharmacy department as soon as becoming aware of the event. The affected IMP stock should be immediately quarantined according to Trust procedures. If possible, the IMP should be moved to the pharmacy, or another secure area where storage requirements can be met. The trial team and Coordinating Centre will take advice from a QP at the manufacturing site, GSTPMU. The QP will advise whether the IMP can still be used, or should be destroyed. Quarantined IMP should not be used until authorised. The trial team will report any IMP issues using the ANODE Incident and Deviation Reporting Form and document any further action in response to the reported issue. Destruction of IMP IMP will be allocated to each participant via taking the next sequentially numbered pack from the dispensing box. IMP will be given according to the ANODE protocol and documented using the Trial Intervention section of Form 2: Randomisation and Intervention. Once the IMP has been given to the participant, the empty vials should be disposed of in a yellow sharps bin along with syringe and packaging to ensure blinding is maintained. Any unused expired IMP will be returned to pharmacy for destruction. Please contact the Coordinating Centre for authorisation prior to destroying any IMP supplies. IMP should be destroyed as per Trust procedures and copies of all destruction documentation should be sent to the Coordinating Centre. All ANODE documentation should be stored in the ANODE pharmacy file.