Pharmacy Training Protocol Version: 31 August 2015

Investigational Product Active: NutreStore™ (L-glutamine) Control: Maltrin® M100 (maltodextrin)  IP will be shipped to you in pre-blinded individual 5g packets  Lot numbers on the back of the packets will be exposed for identification Back of packet with Lot # exposed Sample blinded packet Actual IP may look different

INVESTIGATIONAL PRODUCT Blinding Label Products will arrive with this label applied to the front of each packet.

cool, dry area, 25  C (77  F) excursions allowed  C (59-86  F) cool, dry area, below 32  C (90  F) MALTRIN® Maltodextrin Maintain Temperature logs/documentation Storage and Temperature Logs

Ordering Investigational Product Central Pharmacy Depot Kingston, ON Order via to: Chris Gray, CCRP Site ID will be provided by the PL closer to Site Activation

 Initial Shipment – will be arranged by the Project Leader  Subsequent shipments : your order to the Central Pharmacy Depot at: Orders will be processed on the next business day IP will ship on Mon., Tues., and Wed. of each week o (exceptions for statutory holidays) Allow 7 days for delivery of your shipment Ordering Investigational Product

After randomization, Research Coordinator will immediately notify the pharmacy and provide: 1.the 8 digit randomization # (automatically generated ) 2.the patient’s pre-burn weight 3.any other details required by the pharmacy i.e. patient medical record ID# 8 digit randomization # “Q” NOT randomized “R” Randomized R001 Site# Patient I.D. Central Randomization System

CRS Pharmacy Login Pharmacy Staff will access the CRS at the following web address:  CERU will assign access to Central Randomization System (CRS) after the signed Pharmacy CRS Access Log is received  User Name and Password – one or multiple, your choice You may choose to have only one User Name and Password that is shared among pharmacy staff OR Each pharmacy staff member may have her/his own Complete the Pharmacy CRS Access Log for each person requiring a User Name and Password

After you Login, you will see a list of all studies you have access to through this site. Click on “RE-ENERGIZE – Definitive” It may be the only study displayed for you. CRS Home Screen

Treatment assignment will be displayed as below:  Check the Randomization number against the number provider by the Research Coordinator.  Newly randomized patients will appear in the last row on the bottom of the table. CRS Treatment Assignment R001 Site# Patient I.D.

CRS Treatment - BMI and Dosing Weight  If the patient’s BMI is > 35 kg/m 2 the dosing weight will be adjusted based on a BMI of 25 kg/m 2 and (Adjusted) will appear in the Dosing Weight column Adjusted Body Weight (ABW) = IBW + [(pre-burn dry weight – IBW) x 0.25]

CRS Treatment Dosage The Treatment Dosage is based on the Dosing Weight, not actual weight of the patient and rounded to the nearest 5g dose  Treatment allocation and dose must be verified and signed by 2 pharmacists/delegates

Printing Single Patient Record To print the allocation for just one patient, check the box next to the randomization number When you print the form, only the patient you selected will print Sign and date the form x 2 File with your study documents

Pharmacy Procedures 0.5 g/kg/day Dosing Weight (kg) X 0.5 = g/day (rounded to the nearest 5g) Dosage and Dispensing: Daily study dose is calculated by the CRS as follows: Example: Wt. 75 kg X 0.5 = 37.5g/day rounded to the nearest 5g = 40g/day Wt. 74 kg X 0.5 = 37g per day rounded to the nearest 5g = 35g/day Dosing Weight Chart provides a quick reference and suggested dosing regimen based on q4h administration

Dosing Weight Chart Dose # q4h Body weight (kg) Number of 5g doses Total dosesg/day

 Blind each packet by covering the Lot # on the back  Avoid scheduling dose administration at midnight – dosing compliance is calculated daily from 00:00 to 23:59 Packet Labelling: Cover the Lot # Sample label template

IP Dispensing  IP is dispensed in 5g packets  IP will be reconstituted and administered bedside by the clinical staff  Each 5g packet should be mixed with 50 mL of water or other non-heated liquid or food  IP should NOT be mixed with soda or highly acidic juices (grapefruit, orange, lemonade) as it degrades or becomes unstable in an acidic medium  Dispense enough packets for one a week of treatment  Dispense packets weekly until the patient is off the study Weekly Dispensing Recommend

IP Dispensing Log Record the IP Dispensed on the IP Dispensing Log

IP Accountability Logs Maintain IP Accountability Logs for both products

Training and Delegation Log  Document Training of each pharmacy team member working on RE-ENERGIZE  List delegated tasks on the log  Send the Log to the Project Leader before start of the study  Update the log as personnel changes

Resources online