Download PiPS Intervention Stock Control Presentation

Trial of probiotic to prevent necrotising
entrocolitis and infection
PiPS Pharmacy Training
Randomisation Program and Intervention
Stock Control
Fiona Stacey
PiPS Research Nurse
Top of pack gives
instructions and
information about
the intervention
Security
tab (top)
Identifiers are
located on the
side of the pack
Package
identifier
Security tab
(bottom)
Expiry
date
Inside are 91 sachets
individually labelled
Package
identifier
Expiry
date
• The supplier is Bilcare GCS
• Delivery will be in set batches of 30
or 20 packages
• Opposite is a sample of the batch
delivery label
• Deliveries will come with receipts
detailing the consignment contents
(sign-off receipts and store in the
back of the PiPS Pharmacy File)
How to access the randomisation program
• You will need access to the internet!
• The randomisation program is located at:
https://rct.npeu.ox.ac.uk/pips/login.php
• We can add a shortcut to this website in your favourites or on your
desktop, please just ask.
• Pharmacy login details will be provided during site training visit and can be
found on the inside cover of the Pharmacy File.
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2.
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4.
Select your hospital from the
drop down box
Enter your username
Enter your password
Click login
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Randomisation program homepage
1. Click for help
2. Status of packages at the site
3. Main menu
4. Emergency contact page (see
Guidance Sheet 9)
How to login an IMP shipment
upon receipt
• The PiPS Trial Office will initiate a shipment when the pharmacy stock
level drops below 12 packs
• The pharmacy will receive an email notifying them that a delivery has
been dispatched
• The first delivery to a site will contain 30 packages, thereafter restocking
deliveries will only consist of 20 packages
• Upon delivery check shipment for damage and inconsistencies (if you
receive any damaged packages please retain for the PiPS Research Nurse)
• Check-in the delivered packages using the Randomisation Program and
update the Pharmacy Stock Balance Log
• Sign-off the delivery receipt and store in the back of the pharmacy file
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Current status of packages at site
and those due for delivery
Click here to complete receipt of
the shipment
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•
The initial shipment IMP
will contain 30 packages
Subsequent restocking
deliveries will contain 20
packages
Check for any damage or
inconsistencies by
comparing the ‘package
ID numbers’ on the
packages with the
delivery note and the
randomisation program
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2.
Select all packs
Click on available for use
Confirm by clicking ‘Yes’
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Total number of packs available
at site
Total number of packs available
in the pharmacy
Number of packages assigned to
the NICU
Total number of packs available
on the NICU
Stocking the NICU with assigned packages
• The first stocking of the NICU will be with 12 packages, thereafter
restocking of the NICU will be with 6 packages
• The PiPS Trial Office will assign packages to the NICU for restocking when
the NICU stock level drops below 6 packages
• The pharmacy will receive an email notifying them to restock the NICU
• The ID numbers of the assigned packages will be listed in the email and
on the randomisation program
• Only when the assigned packages have be stocked on the NICU should
they be checked-in as available using the randomisation program
• Update the Pharmacy Stock Balance Log
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2.
Current status of packages at site
and those assigned to the NICU
Click here to see ID numbers of
assigned packages
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2.
Select the packages that were
stocked on the NICU
Click here to login packages
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•
Select ‘Yes’ to confirm the packages
have been delivered to the NICU
Doing so will allocate packages as
available for randomisation
The package status summary is updated
and shows the number of packages now
available in the pharmacy and on the NICU
These links will only be available when a
shipment is sent to the pharmacy or
packages are assigned to the NICU
Add site name
Complete these columns for deliveries from the supplier
Complete these columns
when the NICU is stocked
Always complete these columns
Add sheet number
Completing the Stock Balance Log
• Each batch of packages sent from the supplier to the pharmacy will have
package ID numbers in sequential order e.g.
E1000, E1012, E1023, E1038, E1041, E1059, E1064, E1076, E1085, E1097
E1106, E1118, E1124, E1130, E1145, E1153, E1161, E1177, E1189, E1192
E1205, E1213, E1222, E1239, E1246, E1258, E1267, E1271, E1280, E1294
• Package ID numbers E1001 - E1011, E1013 - E1022...etc do not exist,
hence you can record the delivery as E1000 - E1294.
• When recording stocking of the NICU the assigned packages will not be in
sequential order so you will have to write down each individual package ID
number in the log.
• If you make a mistake recording this information in the log, strike through
once and sign and date the correction (do not use Tipp-ex!).
Initial delivery
of IMP
Restocking
delivery of IMP
Initial stocking
of NICU
Restocking
of NICU
Site Randomisation Information
How to access details of all the
packages at your site
If there is a problem with the
randomisation program or website
• If in office hours contact the PiPS Trial Office.
• If out of hours then refer to Guidance Sheet 9: Procedures for emergency
queries.
• A link to the emergency pager can be found on all pages of the
randomisation program.
Click on log out, please do not leave
the browser open once completed
Trial of probiotic to prevent necrotising
entrocolitis and infection
Professor Kate Costeloe
Ms Fiona Stacey
PiPS Chief Investigator
PiPS Research Nurse
Tel: 020 8510 7225
Tel: 020 8510 7168
[email protected]
[email protected]
Dr Paul Heal
PiPS Trial Co-ordinator
Tel: 01865 617924
[email protected]