Research Implementation Office (RIO) Solid Tumor/Heme/Heme Malignancy Protocol Specific Pre printed Order (PPO) Guidelines

Transcription

1 Research Implementation Office Solid Tumor/Heme/Heme Malignancy Protocol Specific Pre printed Order (PPO) Guidelines Note: As of February 11, 2015, the only preprinted orders which remain on paper for Solid Tumor/Heme/Heme Malignancy protocols are medication orders dispensed by Investigational Drug Services (IDS) Pharmacy, and if applicable, cell collection and infusion orders. The IDS related orders include chemotherapy orders, supportive therapy orders and prescriptions. All paper orders need to be used in conjunction with Computerized Provider Order Entry (CPOE) PowerPlans for the ordering of labs, procedures, nursing supportive care, consults, and scheduling. Orders placed within ORCA can be done by using protocol specific PowerPlans or generic research PowerPlans. The RIO facilitates the electronic review (e review) process of paper preprinted orders (PPO). The following document has been created to assist study staff with creating protocol specific PPOs. It is recommended to review SCCA Policies: Prescribing and Ordering of Ambulatory Chemotherapy (Appendix A), Unacceptable Abbreviations (Appendix B) and SCCA Infusion IDS Order Guidelines (Appendix C) before preparing protocol specific pre printed orders. It is always assumed that the Principal Investigator (PI) has approved the content of draft orders that are submitted for review. Contact information: Paper Order Templates (New Drafts) Copies of Approved Orders (Modifications) Review Requests (New or Modified Orders) General Questions Archival Chemotherapy Order Content Questions/Consultation Research Implementation Office (RIO) Infusion Services Investigational Drug Services (IDS) Prescription Content Questions/Consultation Investigational Drug Services (IDS) PowerPlan Development/CPOE Build Request (OP) Dorsee Zaballero (CIS) PowerPlan Development/CPOE Build Request (IP) Laura Armes (CIS) Preprinted Order Supply/Print Requests Materials Management Appendix: I. Chemotherapy Orders Instructions (w/ Format Example) II. Oral Chemotherapy Prescription Instructions (w/ Format Example) III. Reference Material: A. Prescribing & Ordering of Ambulatory Chemotherapy Policy B. Link to SCCA Policies: C. Unacceptable Abbreviations or Dose Designations D. SCCA SLU Paper/CPOE Order Guidelines E. RIO Submission Form

2 I. CHEMOTHERAPY ORDER INSTRUCTIONS: All cancer treatment should be prescribed on chemotherapy order with appropriate pharmacy review and nursing review signature lines. If a study team is requesting that oral medications be administered by an infusion RN and documented in ORCA emar, then BOTH Chemotherapy orders and a Prescription should be used. Note: Supportive therapy should be prescribed on a separate order. Some items that are included in the IDS regimen involving supportive therapy should be included on concurrent chemotherapy order. Header: Include the Consortium (UW/CC/FH) protocol number, full protocol title and PI first and last name Footer: Line 1, Page Number: the template should default to Page 1 of X Line 2, Footer File name: The file name in the footer should match the electronic file name. Line 2, Revision Date: this date should reflect the date of your current draft order, the final draft, or the latest revision. The date is written in the format: MM DD YY Example: Page 1 of 2 UW10111_Chemo_Cycles_1_2.doc A: Day 1 This box is used to provide a window of DAY 1 of the order only. Other administration windows (e.g.: +/ 3 days) for belong in the FREQUENCY OR DAY # box (J) B: Regimen Name If a protocol has multiple ARMs or COHORTS the specific ARM/COHORT for the order would be listed here. C: Venous Access Prefill central line if central line is required per protocol. D: Weight & Body Surface Area (BSA) Please put N/A in boxes that will not be used. For example if a drug is dosed as mg/kg place N/A in the BSA box. **If BASELINE weight is to be used for calculations instead of Actual Weight please place an asterisk (*) in the box and make a note in Section (M) E: Chemotherapy Drugs E 1: IV, IM, SQ Chemotherapy Drugs If applicable (when IDS is dispensing drug), drug info must include the note From IDS Supply, RGXXXXXXXR with all IDS drugs and research billable therapy (commercial supply billing to the research account). For combination therapy, please list the drugs in the dosing sequence required per protocol. Please also include a note in Section (M) regarding the drug dosing sequence and any observation or wait time required between therapies as needed. E 2: For oral medication administered in the infusion room: Please specify if patient will self administer or if infusion nursing will administer. The infusion RN must administer in order to document in the emar (if documentation of administration is required per protocol). Please also specify if patient will use OWN supply previously dispensed by IDS as outpatient prescription or if IDS will dispense individual doses to infusion room in (Section L). F: Rec. Dose Please put protocol specified doses here. If dose reductions are allowed, those options may be included on the order. G: BSA/kg If study drug dose is calculated by weight or BSA leave this blank as the provider will need to enter the individual patient weight or BSA here. Place N/A in this box, if the study drug is a flat dose (i.e. every subject gets the same dose regardless of size). H: Dose to be given Please show dose calculation if dose is based on height, weight, or BSA. If flat dose is used this number should match the Rec. Dose (F). I: Route Indicate the administration route and include any protocol required filters. J: Rate Indicate the rate of IV infusion including any windows (e.g. +/ 6 mins) or N/A if not applicable. For those drugs which require titration or checkboxes should be made for prescriber to select various rate titration schema depending on patient's tolerance. If protocol uses approximately as a time point indication, this must be further defined by Sponsor or PI. e.g. Infuse approximately over 1 hour. It should appear as Infuse over 1 hour (+/ 6 min).

3 K: Frequency or Day # Indicate how often or on what day(s) the drug should be administered. If dosing window is allowed please include with dosing frequency. L: # of Doses Consider maximum dose quantity and if recurring order is clinically appropriate. Current policy allows for recurrence up to a 13 weeks maximum. For ORAL chemotherapy, please also specify if patient will use OWN supply previously dispensed by IDS as outpatient prescription or if IDS will dispense individual doses to infusion room. M: Notes Please list additional concise information pertinent to the administration of the drugs listed. Types of items to list here include: Indicate if a generic research PowerPlan template will be used along with this order OR if a protocol specific PowerPlan will be generated. Indicate here if the BASELINE weight should be used instead of the Actual Weight for dose calculations. For combination therapy, the order of drugs listed on the order is the dosing sequence. Please include any note regarding observation or wait time between therapies as needed. If protocol uses approximately as a time point indication, this needs to be further defined by Sponsor or PO. E.g. Wait approximately 1 hour between the end of infusion for X drug to start Y drug. In this example, it is not clear what approximately means. Instead include specific instruction with window identified e.g. Wait 1 hour (+/ 6 min) between end of infusion of X drug to start Y drug. For oral medications, please include fasting or food requirements when appropriate. N: Parameter(s) on day of administration Include only quantifiable lab or vital sign parameters are also acceptable (e.g. Temperature, blood pressure, etc.) consistent with protocol specified dose HOLD or Modification parameters. If protocol specified parameters are not clinically appropriate, more stringent parameters may be used at PI s discretion. Express lab parameters in measuring units consistent with reporting values at each institution. If the protocol states Hold study medication X for any > Grade 3 AE, the PI must choose a limited set of parameter to list on the order. If combination therapies have differing parameters listed for each drug, PI must choose one value for the order. If there are different thresholds for different days of dosing (e.g. day 1 parameters, Day 8 and 15 parameters), please specify. O: Instructions Indicate who should be notified if a value is out of parameter and/or whether or not to HOLD the drug. P: Page 2 Indicate by PRE checking boxes, if PI wishes to use any of the hydration, pre med or anti emetics consistently for ALL patients.

4 Day 1 to be administered on specified day [ ] Day 1 to be administered + 24 hours [ ] Day 1 to be administered within days Insert Protocol #, Title, (PI: ) Day 1 of this order: Patient diagnosis: Reference citation: N/A Regimen Name: Cycle # [ ] Central Line [ ]Peripheral Line Actual Weight: Ideal Weight: Adjusted Weight: Height: Body Surface Area: kg kg kg cm m 2 CHEMOTHERAPY ORDERS: For each drug ordered below, fill in all boxes on the corresponding line or indicate n/a if not applicable. Chemotherapy Drug Rec. Dose BSA / kg Dose to be given Drug A * (from IDS supply, RGXXXXXXXR) Drug B * (from IDS supply, RGXXXXXXXR) Drug C # (from IDS supply, RGXXXXXXXR, ROUTE RATE FREQUENCY OR DAY # IV 0.2 micron filter IM Oral Infuse over 60 min (+ 6 mins) N/A N/A # OF DOSES Patient s OWN supply administered by RN) *Give Drug A first then wait 30 min before giving Drug B # Take at least 2 hours after previous meal and at least 1 hour before next meal. If vomiting occurs dose should NOT be repeated [ ] Use separate generic CPOE PowerPlan to order additional nursing care requirements. [ ] Use separate CPOE (name) AMB Protocol (protocol #) IDS (PowerPlan title) PowerPlan to order additional nursing care requirements PARAMETER(s) on day of administration INSTRUCTIONS (Check all that apply) Research Staff Name/Pager: Call Clinical Research Coordinator [ ] Call Provider [ ] Call either [ ] [ ] [ ] [ ] [ ] [ ] [ ] Other: [ ] [ ] Other: [ ] [ ] Preparer Signature (MD/PA-C/ARNP): Date: Time: 2 nd Attending MD Signature (required for non-standard dose when no resource document is available) Date: Time: Two RNs must verify dose of chemotherapy prior to administration of initial dose HOLD Attending MD Signature (required prior to order submission IF prescriber is not an attending level MD); Date: Time: Pharmacist Review Signature (required prior to forwarding to Pharmacy for verification & dispensing) Date: Time: Two RPh s must verify the dose of chemotherapy prior to dispensing initial dose Original-CHART Copy-PHARMACY Page 1 of 2 (Insert protocol number)_chemo_ids_(insert details).doc - MM-DD-YY CHEMOTHERAPY ORDERS

5 Insert Protocol #, Title, (PI: ) [ ] HYDRATION [ ] HYDRATION NOT REQUIRED SOLUTION VOLUME ADDITIVES RATE DURATION INSTRUCTIONS PRE MEDS: [ ] Dexamethasone mg PO/IV 30 minutes before chemo usual range = 4-20 mg [ ] Acetaminophen 650 mg PO 30 minute before chemo [ ] Diphenhydramine mg PO/IV 20 minutes before chemo usual range = mg [ ] Ranitidine 150 mg PO 30 minutes before chemo [ ] Ranitidine 50 mg IV over minutes before chemo [ ] Other [ ] Other Emetogenicity MINIMAL [ ] No antiemetic premedication required LOW [ ] Prochlorperazine 10 mg PO X 1 [ ] Lorazepam mg PO X 1 usual range 1-2 mg MODERATE [ ] Ondansetron 16 mg PO DAILY minutes pre-chemotherapy OR [ ] Ondansetron 8 mg IV DAILY minutes pre-chemotherapy PLUS [ ] Dexamethasone mg PO/IV X 1 pre-chemotherapy usual range = 4 20 mg [ ] Lorazepam mg PO/IV X 1 pre-chemotherapy usual range = 1 2 mg HIGH-VERY HIGH [ ] Palonosetron 0.25mg IVP daily minutes X 1 pre-chemotherapy PLUS [ ] Dexamethasone 10mg PO/IV DAILY minutes X 1 pre-chemotherapy usual range = 4-20 mg [ ] Lorazepam 1 mg PO X 1 usual range = 1 2 mg AS NEEDED: for nausea and/or vomiting [ ] Prochlorperazine 10 mg PO/IV Q 4 hours PRN [ ] Lorazepam mg PO/IV Q 4 hours PRN [ ] Diphenhydramine mg PO/IV Q 4 hours PRN [ ] Metoclopramide 10 mg PO/IV Q 6 hours PRN HYPERSENSITIVITY REACTIONS: For chemotherapy-related hypersensitivity reactions, institute "SCCA Protocol for Management of Hypersensitivity-Type Reactions in Adult General Oncology Patients [ ] Do not institute the SCCA Hypersensitivity Protocol OTHERS: [ ] [ ] Prescriber Signature (MD/PA-C/ARNP): NPI # / Code: Date: Time: WHITE-CHART YELLOW-PHARMACY PINK-NURSING Page 2 of 2 (Insert protocol number)_chemo_ids_(insert details).doc - MM-DD-YY CHEMOTHERAPY ANTIEMETICS & HYDRATION ORDERS

6 II. ORAL CHEMOTHERAPY PRESCRIPTION INSTRUCTIONS: All oral cancer treatment should be prescribed on a chemotherapy prescription with required diagnosis, pharmacy review and attending signature lines. Protocol-specific pre-printed prescriptions may also be prepared for standard of care dispensing but should be separated from prescription for Investigational Drug Services (IDS) dispensed drugs. Header: Include the Consortium (UW/CC/FH) protocol number, full protocol title and PI first and last name Footer: Footer File name: The file name in the footer should match the electronic file name. Revision Date: this date should reflect the date of your current draft order, the final draft, or the latest revision. The date is written in the format: MM-DD-YY. Example: UW10111_Rx_IDS_Oral_Chemotherapy.doc A: Height/Weight/BSA: If dose is based on kg or BSA, dose calculation must be shown. B: Drug Name: If applicable (when IDS is dispensing drug), drug info must include the note From IDS Supply, RGXXXXXXXR for IDS dispensed drugs and research billable therapy (commercial supply which is billing to a research account). C: Dose - Accurately describe a dose by including: Dose strength of each tablet or capsule; Dose in units consistent to dose strength, e.g. mg, mcg, international units; Number of tablets or capsules per dose, and; If dose-reductions are allowed, dose-reduction options may be included on the prescription. D: Dosing directions - must have the administration instructions, route, dosing frequency and schedule. E: Fill quantity - Should dispensing be in full bottle or repackage to specific quantity? What is tablet or capsule count per bottle? F: Consider maximum order quantity and if refill is clinically appropriate: If oral anticancer therapy, refills are allowed for up to a 13 weeks maximum supply including initial fill; If controlled substance (other than schedule II), up to 6 months maximum supply; No refill for Schedule II substance, and; Please put N/A in boxes that will not be used.

7 SCCA ORAL CHEMOTHERAPY PRESCRIPTION (protocol number/title) (PI: Name) Page 1 of 1 HEIGHT: cm WEIGHT kg Date weight obtained* BSA: m2 Diagnosis/Indication *if chemotherapy is dosed per meter squared, weight must be obtained within 4 weeks prior to administration RX INDICATE WHICH MEDICATIONS TO FILL BY CHECKING BOX TO LEFT OF DRUG NAME/DOSE Medication Dose (mg/m2) Dosing Directions Quantity to Dispense: (sig to include dose, frequency, route & schedule) (from IDS supply, RGXXXXXXXR) Start Date / / Refill (up to 13 weeks max) NPI # / CODE /PHYSICIAN NO DEA NO PRINT PRESCRIBER NAME HERE PRESCRIBER SIGNATURE (substitution permitted) Date: ATTENDING MD SIGNATURE (required for initial dose) Time: PRESCRIBER SIGNATURE (dispense as written) Date: Time: CLINICAL PHARMACIST VERIFICATION SIGNATURE (required for initial dose or dose increase) PT NO NAME DOB Date: Time: ALLERGIES: [ ] NKDA Date: Time: SEATTLE CANCER CARE ALLIANCE 825 Eastlake Avenue East Seattle, WA (206) XXXX_Rx_IDS_Oral_Chemotherapy.doc

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14 ATTACHMENT 1: Unacceptable Abbreviations or Dose Designations Effective immediately these do not use abbreviations, acronyms, and symbols must NOT be used on any documentation. Pharmacists, Nurses, and other authorized patient care staff shall contact prescribers to clarify the intended meaning of any handwritten order (not just medication orders) that contains an unacceptable abbreviation. Clarification of the order is to be appropriately documented as per verbal/telephone order policy & procedure and must be conducted prior to the order being carried out. Abbreviation/Dose Expression Intended Meaning Misinterpretation Recommendation ug Microgram Mistaken for mg when handwritten IU International Mistaken as IV or 10 Unit U or u Unit Read as zero (0) or a (4) causing a 10 fold overdose or greater Q.D. Q.O.D. MS MSO 4 MgSO 4 Once Daily Every Other Day Morphine Magnesium Mistaken for each other. The period after the Q can be mistaken for an I and the O can be mistaken for I. Confused for one another. Can mean morphine sulfate or magnesium sulfate Write mcg Write International Unit Always spell out units. Write daily and every other day Write morphine or magnesium Zero after decimal point (1.0) 1mg Misread as 10mg if the decimal point is not seen. Do not use terminal zeros for doses expressed in whole # s. No zero before decimal point (.5mg) Epi 0.5mg Misread as 5mg. Always use a zero before a decimal when the dose is less than a whole unit. Epidural or Epinephrine Could be confused for one another Write Epidural or Epinephrine MTX Methotrexate Mitoxantrone Always spell out drug name

15 SCCA SLU IDS PAPER/CPOE ORDER GUIDELINES Orders IDS Dispensed Drug PAPER ORDERS ONLY Description Regardless of route Combo regimens: IDS dispensed drug with non IDS dispensed drug for all cycles IDS Drug Related Orders Change in administration rate/time Stop and start time due to reaction Use the IDS telephone order stamp Premeds, Anti emetics & Hydration Changes Made to Premeds, Anti emetics & Hydration Orders Drug Given Same Day Immediately Following Therapy Second page of chemotherapy paper order RN to get an one time IDS telephone order on day of service Use the IDS telephone order stamp RN to communicate with research team to rewrite page 2 of chemotherapy order Part of IDS therapy regimen Neulasta X1 Vitamin B12 X1 Orders Growth Factors One Time Drug Supportive Care Drug ELECTRONIC ORDERS ONLY Description Day(s) after therapy i.e. Demerol due to reaction Day(s) after therapy Not part of IDS therapy regimen i.e. Denosumab, Lupron, Zometa 1

16 SCCA SLU IDS PAPER/CPOE ORDER GUIDELINES Orders Combination Regimen Hypersensitivity Order/Authorization BOTH PAPER AND ELECTRONIC ORDERS Description 1. Paper: Cycles that include both IDS dispensed drug and non IDS dispensed drug 2. Electronic: Cycles that no longer include IDS dispensed drug for the rest of protocol duration 1. Paper: On the second page of chemotherapy paper order, if the box is not check 2. Electronic: Initiate/Activation of CPOE Hypersensitivity Authorization PowerPlan 2

17 Research Implementation Office To: Subject: Research Implementation Office (Protocol Number) PPO Submission Directions (Delete after reading): Study Staff, please complete the below template when submitting pre printed order(s) for review and approval by service areas and your PI. The answers to the questions below must be yes. If any answers below are no, the RIO will consider this submission incomplete and it will be returned. Please attach the orders you would like reviewed to this message. Send to Dear RIO, Please find attached NEW/MODIFIED pre printed orders. Consortium Protocol Number: (Insert) Complete Study Title: (Insert) Full PI Name: (Insert) Study Contact for Orders: (Insert) Study Status: (Active/In Process) If In Process, what is the SIV date (must be within two weeks or have already occurred; if not, RIO will not accept submission): (Insert) Patients are scheduled and said order(s) should be expedited: Yes or No (Yes or No are acceptable here.) If Yes, when is the first patient scheduled? (Insert) Number of pre printed paper orders submitted for review: (Insert) I have/ have not done pre review with IDS prior to this submission. [If you have done pre review with IDS, you must attach clear documentation of this review in the submission. If you do not include clear documentation of IDS prereview, the RIO will need to obtain review from IDS again, which will delay the process.] Below is the information the RIO requires to process said order(s). Answer questions below: 1. New Order(s): Study Staff have ed the RIO and requested the most recent blank templates, which Study Staff used to create the attached new order(s): Yes or No; AND the new order(s) do NOT contain tracked changes: Yes or No 2. Modified Order(s): Study Staff have ed the RIO and requested the most recent approved order(s), from which Study Staff have created the attached modified order(s): Yes or No; AND the modified order(s) DO contain tracked changes: Yes or No 3. All Order(s): I have consulted with the PI and obtained PI review prior to submission to the RIO: Yes or No I have ensured the file name and footer name are the same: Yes or No The template(s) used reference PowerPlans (generic or protocol specific) per the most recent blank template language (if applicable N/A for Rx): Yes or No I have included the RG study code and appropriate modifier (R or RS) where applicable: Yes or No Additional comments/considerations for the RIO: (Insert) Thank you, 1