STUDY REFERENCE MANUAL. Appendix 6: Quick Reference Guides

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1 STUDY REFERENCE MANUAL Appendix 6: Quick Reference Guides January 7, 2009

QUICK REFERENCE GUIDE A: COATS Pre-screening Inclusion criteria: Yes No Diagnosis of schizophrenia or schizoaffective disorder? Been treated with antipsychotic medication for LESS than 5 years?

2 QUICK REFERENCE GUIDE A: COATS Pre-screening Inclusion criteria: Yes No Diagnosis of schizophrenia or schizoaffective disorder? Been treated with antipsychotic medication for LESS than 5 years? Have had a recent psychotic exacerbation within the month prior to study entry that required psychiatric hospitalization or an increased level of care? years old? Willing and able to provide informed consent? For women who can become pregnant: using birth control? Exclusion criteria: Yes No BMI 35 kg/m 2 or 18 kg/m 2? Hemoglobin A1c is 7 %? Hematocrit < 31 %? Non-HDL cholesterol 190 mg/dl? Triglycerides 500 mg/dl? Documented failure (inefficacy or intolerability) with an adequate trial of olanzapine, perphenazine or aripiprazole (Note: Adequate trials last at least four weeks at a minimum dose. Minimum doses: Aripiprazole 15 mg/day, Olanzapine 15 mg/day, Perphenazine 16 mg/day)? Current treatment with olanzapine, perphenazine or aripiprazole for more than one month? Known hypersensitivity to metformin, simvastatin, or benztropine? Other serious or unstable medical condition? Treatment with a medication prescribed for weight loss? Diagnosis of diabetes mellitus or treatment with insulin or other diabetes medication? Contraindications to metformin use: congestive heart failure, renal impairment, hepatic disease, metabolic acidosis, recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material, Alcohol abuse or dependence as determined by SCID within the past month Concurrent Tx with: furosemide, nifedipine, and cationic drugs including cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, and vancomycin. (discuss with Project Medical Officer) Women who are pregnant or breastfeeding? DSM-IV-TR diagnosis of mental retardation or delirium?

3 QUICK REFERENCE GUIDE B: COATS Lab Procedures IMPORTANT NOTES: Specimen Collection: Specimen collection varies by visit. Please follow the table below: Visit 1 Visit 5 Visit 7 Visit 11/DC Simvastatin Follow-up Visits 6, 8, 9 or 10 Screening Week 4 Week 12 Week 28 Week 8, 26, 20 or 24 3 RED 2 RED 2 RED 2 RED 1 RED 1 LAV 1 LAV 1 LAV 1 LAV URINE x x x Processing: The red top tube must be allowed to clot at room temperature for minutes before spinning. Do not freeze the whole blood purple top specimen at any time! The whole blood tube should be refrigerated at 2-8 o C. The urine container should not be more than one-third full---mix well and discard excess urine before freezing. Processed transport vials (red cap) and urine container must be: o o placed into the freezer within 90 minutes of specimen collection. Do not allow the specimens to thaw at any time. placed in a -70 o freezer for a minimum of 60 minutes prior to packaging. Do not package specimens that are not frozen completely. (see FAQs for instructions when using a -20 o freezer). Acceptable Temperature Range Refrigerator 2 o - 8 o C -20 o Freezer -15 o o C -70 o Freezer -60 o o C Packaging and Shipment: Specimens must be shipped to the Core Lab on the same day as collection. If necessary, schedule a FedE pickup. Shipments may be sent Monday through Friday only. Please remove any identifiers other than COATS Patient ID Labels. 1

4 CHECK LIST: Specimen Preparation Completed The lab kit must correspond with the correct visit number. Please check to make sure that none of the collection tubes have expired. The small foam box with the refrigerant pack (lid removed) should be stored in the 2-8 o C refrigerator (NOT the -20 o freezer) the day before specimen collection so that the pack will be ready for shipment the next day. Measure the temperature of the refrigerator in which you plan to store the hematology specimens (purple top EDTA tubes) to ensure optimal specimen condition prior to shipment to the Core Laboratory. Acceptable temperature range is 2-8 o C. Prior to the study visit, the visit number, sequence number, and date should be recorded in permanent marker on the bar-coded labels provided by the Core Lab and attach them to each tube, transport vial, and urine container. Prior to the visit, the header information should be recorded and bar-coded label attached to the BSF (Biospecimen Shipping/Receiving Form). Please make sure that you have access to a freezer for specimen storage. Please make sure that you have enough dry ice on hand for shipment. Please make sure that you have all the proper labels for shipment (dry ice label, Exempt Human Specimen label, pre-printed FedE air bill, and any other label that your institution might require). 2

5 CHECK LIST: Specimen Collection and Processing Check List Please refer to Appendix D of the Lab Manual: Collection and Processing, for diagrams outlining the collection and processing procedures for all specimens at each visit. Completed Step1 Step 2 Immediate Processing (Purple Tops) Immediately place the whole blood purple top tube upright into a rack in a refrigerator at 2-8 o C for holding until shipment Minutes Post Venipuncture (Red Tops) Allow the red top tube to clot at room temperature for at least 30 minutes, but no longer than 45 minutes. Remove the red top tube from the room temperature rack and centrifuge at 2000 G for 15 minutes. Post-centrifugation, match the bar-coded Patient ID label on the tube with that on the transport vial and, using a plastic pipette from the kit, transfer all of the serum into one transport vial. If a second SST tube was collected at this visit, using the same pipette, transfer all of the serum from that tube into a second transport vial. (HINT: Do not allow the pipette tip to touch the gel. Do not overfill the vial---allow some space at the top for expansion when freezing.) Fasten red screw cap(s) on the transport vial(s) and place into the same 5 x 8 plastic bag as the green cap transport vial processed in Step 1. Place the 5 x 8 bag (with red cap transport vials) in the -70 o C freezer until ready for shipment. Re-stopper the empty blood collection tube(s) and discard. Step 3 Urine (only at Visit 1) After collection, mix the urine well and discard any excess volume if the container is more than one-third full. Screw the lid on tightly and check to make sure you have a bar-coded label (with the date) on the container before adding it to the 5 x 8 plastic bag in the freezer. If you cannot freeze the urine sample immediately, place it in the refrigerator until you can put it in the freezer in the 5 x 8 bag. 3

6 CHECK LIST: Specimen Packaging and Shipment to Core Lab Check List Please refer to Appendix E of the Lab Manual: Packaging Specimens for Shipment, for diagrams outlining the packaging instructions for specimens. Completed Step 1 Step 2 Step 3 Packaging Purple Top Tube Wrap the paper towel from the lab kit around the whole blood purple top tube and place the tube and absorbent pad in the 3 x 5 (small) plastic bag that came with the kit. Place the small plastic bag containing the wrapped purple top tube on top of the refrigerant pack inside the small foam box and place the lid on the foam box. Insert the small foam box into the cardboard sleeve (carton), close the tabs, and place this foam box assembly into the large (13 x 15 ) plastic bag and seal the bag after expelling the air inside. Packaging Frozen Specimens (Red Caps and Urine) Once you remove the 5 x 8 plastic bag (containing the frozen specimens) from the freezer, check to make sure that the absorbent pad is in the bag before sealing the bag. Put a significant amount of dry ice (especially during warmer months) in the large foam box before and after you place the 5 x 8 bag into the large foam box. If you are packaging 2 or more 5 x 8 plastic bags in one large foam box, make sure to put a layer of dry ice between the bags. Seal the larger foam box with one strip of packaging tape over the top that extends approximately 6 inches down each side of the box (making sure to not encircle the box with strapping tape or to apply tape along the seam where the lid meets the box). Packaging Entire Shipment Place both the large foam box and small foam box assembly (inside its 13 x 15 plastic bag) into the largest cardboard box. Include a completed copy of the BSF (Biospecimen Shipping/Receiving Form) on top of the large foam box inside the large cardboard box. Pad the remaining space in the box with filler packing material. Seal the large cardboard box tightly with strapping tape and attach all the proper labels for shipment (dry ice label, Exempt Human Specimen label, pre-printed FedE air bill, and any other label that your institution might require) to the large cardboard box so that they can be easily seen. the Core Lab [Maren Nowicki (mnowick1@fairview.org), Naomi Thompson (nthomps2@fairview.org), and Mike Emerson (memerso1@fairview.org)] with the following information on the day of shipment: FedE tracking number, visit number, site number and site name. If necessary, schedule a FedE pickup for the same day as collection. 4

Quick Reference Guide C: BLISTER PACK GUIDE Building the Blister Pack 1.) Get one sheet of plastic blister pack cells and one 3 panel folding blister pack frame. 2.

) From the Right hand side, Peel away the adhesive paper to reveal the sticky side of the far right panel. 4.

7 Quick Reference Guide C: BLISTER PACK GUIDE Building the Blister Pack 1.) Get one sheet of plastic blister pack cells and one 3 panel folding blister pack frame. 2.) Take the 3 panel folding blister pack frame and lay it open so that you see the wording: place prescription labels below at the top of the far left panel. (See image below) 3.) From the Right hand side, Peel away the adhesive paper to reveal the sticky side of the far right panel. 4.) Place the sheet of plastic blister pack cells into this portion of the blister pack frame. 5.) Fill the blister pack cells with medication using the date and time of day guidelines visible in the margins of this panel. The blister pack is designed so that these labels will correspond with the labels the patient will see on the reverse side. 6.) Once medication is filled, peel away the rest of the paper to reveal the middle panel of the blister pack frame. 7.) Fold the blister pack frame by bringing the middle panel down to meet the far right panel. Press around edges to ensure that these two sides are stuck together. 8.) Fold the far left panel over the blister pack cells like a book cover. (See image below)

9.) On the yellow cover of the blister pack, write in the patient s name and visit number. If multiple blister packs are distributed to a patient, number them so the patient can keep track.

Filling the Blister pack The blister pack is designed so that one pack is used per week.

8 9.) On the yellow cover of the blister pack, write in the patient s name and visit number. If multiple blister packs are distributed to a patient, number them so the patient can keep track. For example, 1/3 for pack one out of three total. 10.) On the inside of the cover where it says Place Prescription Labels Below, note the patient s prescription(s). Filling the Blister pack The blister pack is designed so that one pack is used per week. The day of the week is read from top to bottom starting with Sunday, and each day has 4 blister pack cells that allow for 4 different dosing times. These times are morning, noon, evening and bedtime. Note: Depending on how you are looking at the blister pack these go from left to right or right to left. BE CAREFUL! Front (medication visible) Back (tear-able side) L to R: Morning, Noon, Evening, Bedtime L to R: Bedtime, Evening, Noon, Morning Below are general guidelines that will help you fill blister packs for your patients. 1.) Plan out your blister pack using the form on the last page of this appendix. This will reduce errors and you can keep this form with your patient visit CRFs for future reference. 2.) Find out what medications the patient is on. Some doses of medication will be taken all at once while others will be taken multiple times a day. Here are common abbreviations: QD: Once a day BID: 2 times a day TID: 3 times a day QID: 4 times a day 3.) Group medication. It is easier for patients to have to remember to take medication 2 times a day instead of 3 times a day. This in mind, if a patient is on 850mg BID dose of Glucophage along with 10mg QD of Olanzapine, this will be three total pills. However, the first dose of Glucophage can be taken at the same time as the dose of Olanzapine therefore these two medications will occupy a single cell of the

blister pack. Also, since Glucophage is best tolerated with meals, the coordinator in this example should schedule doses at meal times; morning, noon and evening, and not at bedtime.

9 blister pack. Also, since Glucophage is best tolerated with meals, the coordinator in this example should schedule doses at meal times; morning, noon and evening, and not at bedtime. (See a worked out example of this scenario in the blister pack plan example on page.) 4.) Fill medication in the Blister pack using your plan sheet as a guide. Seal the blister pack. Make as many blister packs as you need to last the patient until their next study visit. 5.) Mark s over unused cells using a black marker. It is unlikely that every cell in the blister pack will be filled. To avoid confusion, mark s on the tear-able side of the blister pack (back side of the folded blister pack book) so the patient knows there is no medication in these cells. Do this also for blister packs that start midweek. For example, if you see the patient on Tuesday, their first blister pack will begin on Wednesday and all cells for Sunday, Monday and Tuesday of that week can be d out. Note: If patients take their medications at night, you will fill the blister pack for the night of their visit. 6.) Mark dates along the side of the blister pack with a black marker. This will be helpful for patients and coordinators alike. Once you have assembled all the blister packs you need, flip assembled blister packs over to reveal the tear-able side, and along the right margin, mark the calendar dates (mm/dd) corresponding to when the patient should be taking this medication. This will help minimize confusion and assist with adherence. (See below) Alternative ways of filling the Blister pack: One cell = One day In the COATS study, it is possible that patients are assigned to medication that can be taken once a day. If this is the case and the patient s next visit is a month away (ie when you are dispensing at visits 5, 6, 7, 8, 9, 10), it is wasteful to hand out blister packs which only have one cell filled per week.. Thus, blister packs can be filled with the same dose per cell so that each cell corresponds to one day of medication for a total of 28 days. To follow this method, please do the following:

10 1.) Take a black marker and mark out all weekdays and time of day labels in the margins of the blister pack. Note: You will do this both in the inside and the back of the blister pack. 2.) On the back of the blister pack where there are the tear-able cells, mark the date the patient will be taking the medication on the cell with a black marker. Be careful not to poke a hole in the paper. 3.) Fill a second blister pack in the same manner if patient s next visit is more than 28 days away. There is no need to fill an entire second blister pack, just make sure the patient has enough medication until you see them again. Filling the Blister Pack for Cross-Titration (Visits 2/Baseline and 3) For the first 2 weeks the patient is on the study, they will be cross titrating from their old medication to their new randomly assigned anti-psychotic. This means, that you will be filling their blister pack with their old medication as well as their new medication. Cross titration should be completed within 2 weeks of the randomization, ie by Visit 4. Since we do not provide the medication the patient is originally on when entering the study, you will have to remind the patient to bring their old medication with them to visits 2/baseline and 3. Discuss titrating doses with your study doctor and fill the blister pack accordingly. Explain Blister Packs to the Patient No matter how the blister pack is filled, it is important that the patient understands how to take their medication. Make sure that patients understand that the side of the blister pack that they will see when accessing the medication is labeled with the morning dose on the right and the bedtime dose on the left. This is counterintuitive and must be pointed out to avoid error. Blister packs may be filled differently at later visits for the same patient depending on dose changes so it is important for study coordinators to explain and ensure understanding of the blister pack at each visit.

11 Blister Pack Plan Patient ID #: (Place ID sticker here) Visit #: Date: Medications: Number of packs given: Note: This view corresponds to what you see when you are filling the blister pack as well as what the patient will see when they are tearing the cells to access medication. Bedtime Evening Noon Morning SAT FRI THUR WED TUE MON SUN

12 Blister Pack Plan: EAMPLE Patient #: B Visit #: 6 Date: 10/21/08 Medications: Glucophage 850 BID, Olanzapine 10mg QD Number of packs given: _4_ Note: This view corresponds to what you see when you are filling the blister pack as well as what the patient will see when they are tearing the cells to access medication. Bedtime Evening Noon Morning SUN MON TUE 1 x Olanzapine 10 mg WED 1 x Olanzapine 10 mg THUR 1 x Olanzapine 10 mg FRI 1 x Olanzapine 10 mg SAT 1 x Olanzapine 10 mg

13 Blister Pack Plan: EAMPLE 2 Titration Patient #: B Visit #: 2 Date: 10/31/08 Medications: Number of packs given: _2_ Note: This view corresponds to what you see when you are filling the blister pack as well as what the patient will see when they are tearing the cells to access medication. Bedtime Evening Noon Morning SAT FRI THUR WED TUE MON SUN

14 Drug Inventory Log Site PI: Site ID: Drug Monitor: Location of Drugs: Page 1 example: Aripiprazole 10mg DATE Reason for Entry (Refer to Key) # Bottles on Hand # Pills on Hand (100 per Bottle) # Pills Dispensed to Pt OR Returned to Aptuit Total # of Pills Left MM/DD/YYYY 9/11/2008 IO / 300 9/13/2008 PV /15/2008 PV /16/2008 PV /30/2008 E /2/2008 RS / /30/2008 DR Page Reason for Entry Codes Drug in: RS = Resupply, IO = Initial Order Drug Out: E = Expired Drug, PV = Patient Visit, DR = Drug Return Directions: There are six drug inventory logs used for COATS, one for each of the six medications used on the study. For each drug inventory log, there are two pages: the first page is used to keep a running log of medication in stock while the second page is used to keep track of pill bottle labels and the dates which bottles were received and returned to Aptuit. First Page: The purpose of the first page of the drug inventory log is to keep track of all medication in stock that is received from the distributor and dispensed at patient visits. Change in the amount of drug in stock can be attributed to five different reasons. Drug supply will increase with the Initial Drug Order (IO) and Resupply order (RS). Drug supply will decrease with dispensing at Patient Visits (PV), initiation of a study wide Drug Return (DR) or when Drugs Expire (E). Page

15 Each time one of these events occur Reason for entry is filled out using Reason for Entry Codes noted in a key below the log. Also recorded in this entry is the date the change occurred, the number of bottles/pills that you started with, number of pills dispensed or returned, and the number of total pills left. When dispensing, the number of pills left value will correspond to the number of pills on hand for the next entry into the inventory log. If you are recording a drug supply increase due to the Initial Drug Order or Resupply Order, the number of pills dispensed or returned column will be blank. Each bottle of medication is equal to 100 pills. Since medication is received by bottle and dispensed by pill, it is important to note both number of bottles on hand and number of pills available. If you have 1 to 100 pills, you have 1 bottle on hand. If you have 101 to 200 pills you have 2 bottles on hand. Above is a worked out example for Aripiprazole that shows how the drug inventory log works. Notice there is not a column to note how many drugs are received from the distributor as a resupply (RS). When you get a resupply of drug, you must add the number of bottles you received to the number you have on hand and report this number in the # bottles on hand column. This is demonstrated in the example. Before the resupply, there were only 50 pills (1 bottle) left in inventory. 2 more bottles were supplied and so the # of bottles on hand is now 1+2 = 3. # of pills on hand is now 250. Unlike CAMP, automatic drug orders will not be triggered at any point in the study. If you see that your inventory is running low and are in need of more medication, please contact Erika Libero erika_libero@med.unc.edu. We recommend that sites order more medication when they have only one bottle of medication left. Please note that medication will never be returned to UNC nor shipped from site to site. Second Page: The second page of the drug inventory log is used to keep track of pill bottle labels that come with the medication. When bottles are shipped to your site from Aptuit, note the date you received the medication in the left column and affix the pill bottle label to the right. Drug may be returned to Aptuit for a variety of reasons such as a site wide drug return, or a return of expired drug. When medication is returned to Aptuit, please fill in the return date in the left column adjacent to the label of the specific bottle you are returning. Notice it is possible that the return date will be left blank if all the pills in the bottle are dispensed. In this event, sites may line through the return date box to show that this field is not waiting to be populated. Page

QUICK REFERENCE GUIDE E: Special medication instructions If a patient is on a medication known to effect metformin blood levels, the Project Medical Officer must be contacted and approval to include

16 QUICK REFERENCE GUIDE E: Special medication instructions If a patient is on a medication known to effect metformin blood levels, the Project Medical Officer must be contacted and approval to include the participant in the study must be established. A listing of such possible medications is below: CONCURRENT DRUGS KNOWN TO EFFECT METFORMIN BLOOD LEVELS--REQUIRING PMO APPROVAL Generic Name Brand Name furosemide Lasix nifedipine Adalat, Nifedical, Procardia cimetidine Tagamet amiloride hydrochloride Amiloride, Midamor digoxin Lanoxin morphine Roxanol, MS Contin, Avinza, Oramorph SR, Kadian procainamide Pronestyl quinidine Quinaglute, Quinidex, Quinora, Quinine ranitidine Zantac triamterene Dyrenium, *Maxzide, *Dyazide (*in combination w/hydrochlorothiazide [HCTZ]) trimethoprim Trimpex, Proloprim, Primsol, Bactrim, Septra vancomycin hydrochloride Vancomycin Additional antipsychotic medications, antiparkinson medications and lipid-lowering agents not specified by protocol are not allowed. The exception is lipid-lowering agents used at a stable dose for one month prior to study randomization, which may be continued. Common antiparkinson medications are listed below. COMMON ANTIPARKINSON MEDICATIONS NOT ALLOWED DURING THE STUDY Generic Name Brand Name Generic Name Brand Name larodopa Levodopa biperiden Akineton lodosyn Carbidopa amantadine hydrochloride Symmetrel trihexyphenidyl hydrochloride Artane bromocriptine Parlodel diephenhydramine hydrochloride Benadryl entacapone Comtan selegiline hydrochloride/selegeline/l-deprenyl Eldepryl, Carbex, Zelapar, Emsam tolcapone Tasmar bromocriptine mesylate Parlodel pramipexole Mirapex carbidopa-levodopa sustained release Sinemet CR ropinirole Requip procyclidine Kemadrin COATS SRM Appendix 6 Quick Reference Guide E 01/16/2009

How to safely collect blood samples from persons suspected to be infected with highly infectious blood-borne pathogens (e.g.

How to safely collect blood samples from persons suspected to be infected with highly infectious blood-borne pathogens (e.g. Ebola) Step 1: Before entering patient room, assemble all equipment (1 st part)