Pharmacy Training Documents

Transcription

1 Pharmacy Training Documents PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 1 of 12

2 Top of pack gives instructions and information about the intervention Security tab (top) Package identifier Identifiers are located on the side of the pack Security tab (bottom) Expiry date Inside are 91 sachets individually labelled Package identifier Expiry date PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 2 of 12

3 How to access the randomisation program You will need access to the internet! The randomisation program is located at: Add a shortcut to this website in your favourites or on your desktop. Pharmacy login details will be provided during site training visit and can be found on the inside cover of the Pharmacy File. The presentation given during the site training visit can be found on the PiPS website ( under the Pharmacy Staff section Select your hospital from the drop down box 2. Enter your username 3. Enter your password 4. Click login PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 3 of 12

4 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 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 PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 4 of 12

5 Current status of packages at site and those due for delivery 2. Click here to complete receipt of the shipment 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 PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 5 of 12

6 Select all packs 2. Click on available for use Confirm by clicking Yes PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 6 of 12

7 Total number of packs available at site 2. Total number of packs available in the pharmacy 3. Number of packages assigned to the NICU 4. 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 notifying them to restock the NICU The ID numbers of the assigned packages will be listed in the and on the randomisation program Only when the assigned packages have be delivered to the NICU should they be checked-in as available using the randomisation program Update the Pharmacy Stock Balance Log (details of how to do this are given on pages 11 and 12) PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 7 of 12

8 Current status of packages at site and those assigned to the NICU 2. Click here to see ID numbers of assigned packages Select the packages that were stocked on the NICU 2. Click here to login packages PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 8 of 12

9 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 PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 9 of 12

10 These links will only be available when a shipment is sent to the pharmacy or packages are assigned to the NICU If there is a problem with the randomisation program or website If in office hours contact the PiPS Trial Office on 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 (see Guidance Sheet 9 for details of how to use). PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 10 of 12

11 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 E E1011, E E etc do not exist, hence you can record the delivery as E 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. An example of how to complete the Pharmacy Stock Balance Log is given overleaf. N.B. 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!). 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 PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 11 of 12

12 PiPS_EudraCT No: _REC REF: 09/H0604/30 Pharmacy Training Documents _Version 3.0 dated 30Jul10 Page 12 of 12