DTC Update Volume 5 No 4 July 2015

Transcription

1 DTC Update Volume 5 No 4 July 2015 A publication of the Provincial Drugs and Therapeutics Committee (DTC) for use within Alberta Health Services Provincial Drugs & Therapeutics Committee (DTC) In this Issue AHS Correctional Facilities Drug Formulary Updates Acyclovir injection Alfentanil Amiodarone injection Bortezomib (Velcade ) CefaCLOR capsules Cetirizine (Reactine ) Desloratadine (Aerius ) Meeting date: 11 June 2015 guaifenesin Indigo Carmine Melatonin Methylene Blue Nitroglycerin Pantoprazole injection QUEtiapine XR Rivaroxaban Ticarcillin-clavulanate Formulary Terminology Definitions of formulary codes DC: Manufacturer Discontinued; DCTI: Manufacturer Discontinued with Therapeutic Interchange; F: Formulary; FG: Formulary with Usage Guidelines; FGSAP: Formulary with Usage Guidelines, Special Access Programme; FGTI: Formulary with Usage Guidelines & Therapeutic Interchange; FR: Formulary Restricted; FRG: Formulary Restricted with Usage Guidelines; FRGTI: Formulary Restricted with Usage Guidelines and Therapeutic Interchange; FRSAP: Formulary Restricted, Special Access Programme; FRTI: Formulary Restricted with Therapeutic Interchange; FSAP: Formulary, Special Access Programme; FTI: Formulary with Therapeutic Interchange; NF: Non-Formulary; NFG: Non-Formulary with Usage Guidelines; NFGTI: Non- Formulary with Usage Guidelines and Therapeutic Interchange; NFTI: Non-Formulary with Therapeutic Interchange; NPP: Not a Pharmacy Product (NPP). A C in any formulary status code in the AHS Correctional Facilities Drug Formulary denotes that the correctional facilities formulary status differs from the AHS Provincial Drug Formulary status. Exception: Formulary status code DC : Manufacturer discontinued DTC Update Page 1 of 9 Volume 5 No 4 July 2015

2 Provincial Formulary Additions Note: Brand names are listed for information only. Unless a specific brand name is specified (e.g. X brand only) the contracted or lowest cost alternative will be supplied. 08:00 - Anti-infective Agents acyclovir Zovirax 50 mg/ml vial (10 ml) F 20:00 - Blood Formation, Coagulation, and Thrombosis Agents rivaroxaban Xarelto 15 mg, 20 mg tablets FRG VTE treatment: rivaroxaban shown to be noninferior to standard treatment (enoxaparin followed by warfarin) in preventing recurrent VTE in patients with acute symptomatic DVT or PE at a dose of 15 mg twice a day for 3 weeks followed by 20 mg a day. The safety evidence shows an incidence of major bleed similar to or lower than rates of major or clinically relevant bleeding from standard treatment. In a pooled analysis of the DVT and PE trials, there was a statistically significant lower risk of major bleed, including intracranial hemorrhage, than standard care. Restriction A) Prevention of stroke and systemic embolism (SSE) Restricted to: 1. Patients on rivaroxaban for prevention of stroke and systemic embolism (SSE) prior to admission OR 2 Patients with a CHADS2 score of greater than or equal to 1 in whom warfarin is indicated AND are unable to achieve adequate anticoagulation with warfarin OR 3. Anticoagulation with warfarin is contraindicated or not possible due to inability to regularly monitor via International Normalized Ratio (INR) (i.e. no access to INR testing services at a laboratory, clinic, pharmacy or at home) AND 4. Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (GFR) is 30 ml/min or greater CHADS2 = clinical prediction rule in which stroke rate depends on following risk factors: (1 point): congestive heart failure, hypertension, age over 75 years, diabetes mellitus or (2 points) a history of stroke or TIA at least 35% of INR testing results outside the desired range following a minimum of two months of therapy B) Venous thromboembolism (VTE) treatment Restricted to: For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) in patients with an intended duration of therapy of less than 6 months AND with creatinine clearance (CrCl) is 30 ml/min or greater DTC Update Page 2 of 9 Volume 5 No 4 July 2015

3 Guidelines A) Stroke prophylaxis: 1. Clinicians should undertake an assessment of a patient's risk for bleeding before initiating anticoagulant therapy. The HAS-BLED score schema is recommended. (Hypertension [1 point], Abnormal Renal/Liver Function [1 point each], Stroke, Bleeding History or Predisposition, Labile INR, Elderly (>65 years), Drugs/Alcohol Concomitantly (antiplatelets/nsaids)[1 or 2 points]. A HAS-BLED score of 3 or higher should warrant caution and regular review. 2. There are no data to support that rivaroxaban provides adequate anticoagulation in patients with prosthetic heart valves, with or without atrial fibrillation so the use of rivaroxaban is not recommended in this setting. B) Treatment of deep vein thrombosis (DVT) or pulmonary embolus (PE): Clinicians should undertake an assessment of a patient s risk for bleeding before initiating anticoagulant therapy. For treatment of venous thromboembolism (VTE), the RIETE score schema can be used: Recent major bleed (less than 15 days prior to VTE) (2 points); Creatinine (serum) greater than 106 umol/l (1.5 points);anemia (Hgb under 130 g/l (men) or 120 g/l (women) (1.5 points); Cancer (1 point); Clinically overt pulmonary embolism (1 point); Age greater than 75 years (1 point) 0 points: low risk of major bleed (0.1%) 1 to 4 points: moderate risk of major bleed (1.4%-4.2%) 4.5 to over 6 points: high risk of major bleed (4.9 to 20%) 24:00 - Cardiovascular Drugs nitroglycerin Trinipatch 0.2; Trinipatch 0.4; Trinipatch mg/hour; 0.4 mg/hour; 0.6 mg/hour patch Nitro-Dur is no longer on contract effective June 1, Trinipatch is on contract and will be the nitroglycerin patch supplied by Pharmacy Services. 28:00 - Central Nervous System Agents QUEtiapine Restriction Seroquel XR 50 mg, 150 mg, 200 mg, 300 mg, 400 mg tablets, extended release 1. Patients stabilized/maintained prior to admission; 2. Patients who exhibit abuse/abuse potential or intolerable adverse events to quetiapine immediate-release (IR) formulation (i.e. excessive sedation). F FR DTC Update Page 3 of 9 Volume 5 No 4 July 2015

4 Provincial Formulary Changes/Updates 04:00 - Antihistamine Drugs cetirizine Reactine 10 mg tablet F The formulary status of this product has changed from NFTI to F based on contract pricing changes. desloratadine Aerius 5 mg tablet NFTI The formulary status of this product has changed from F to NFTI based on contract changes. Therapeutic Interchange Original Order Interchange Non-formulary antihistamines, non-sedating, single entity oral solid preparations. E.g.: desloratadine, fexofenadine, loratadine Children 2 to less than 6 years old: Cetirizine 5 mg PO daily Children 6 to less than 12 years old: Cetirizine 10 mg PO daily* Adults and children 12 years and older: Cetirizine 10 mg PO daily* Complexity Level* Level 2 *Patients with CrCL less than 50 ml/min - Cetirizine 5 mg daily Level 2: Mid Complexity - Additional patient specific information required/additional pharmacist assessment required. The therapeutic interchange (TI) for second generation antihistamines oral solid preparations has been changed to reflect the formulary status updates of cetirizine 10 mg tablet and desloratadine 5 mg tablet. The TI for second generation antihistamines oral liquid preparations remains unchanged. 10:00 - Antineoplastic Agents bortezomib (mannitol boronic ester) Velcade 3.5 mg/vial injection FR During the last 16 months, the Alberta Blood and Marrow Transplant Program have been using bortezomib as a component of induction prior to the ASCT with bortezomib given on days -5 and -2 in the outpatient setting. This has been followed with two doses given on day +1 and day +4 after high dose melphalan as an inpatient. The pretransplant doses have been covered under the current Outpatient Cancer Drug Benefit Program (OCDBP) criteria but use as part of the conditioning therapy (inpatient use) has never been through an approval process. DTC approved the updated wording and funding of of bortezomib for the following restricted indication: as a component of induction therapy prior to and/or as a component of the high dose therapy for autologous stem cell transplant (ASCT) for newly diagnosed patients with multiple myeloma who are eligible for ASCT. The updated wording is to ensure if the patient is an inpatient the two doses needed would be approved and budgeted by AHS. Previous and current criteria of use for bortezomib on the AHS Provincial Drug Formulary are now Formulary Restricted (FR). Restriction Hematology/Lymphoma Relapsed Multiple Myeloma DTC Update Page 4 of 9 Volume 5 No 4 July 2015

5 In the first line treatment of previously untreated multiple myeloma who are not candidates for autologous stem cell transplantation (HDT-ASCT) As a component of induction therapy prior to and/or as a component of the high dose therapy for autologous stem cell transplant (ASCT) for newly diagnosed patients with multiple myeloma who are eligible for ASCT. (Note: The Alberta Blood and Marrow Transplant Program have been using bortezomib as a component of induction prior to the ASCT with bortezomib given on days -5 and -2 in the outpatient setting. This has been followed with two doses given on day +1 and day +4 after high dose melphalan as an inpatient. The pre- transplant doses have been covered under the current Outpatient Cancer Drug Benefit Program (OCDBP) criteria and the two doses given on day +1 and day +4 after high dose melphalan may be given inpatient) Initial prescribing limited to written authorization by named oncology physicians (as recommended by the hematology/lymphoma tumour program) Criteria of use to align with AHS Outpatient Cancer Drug Benefit Program 48:00 Respiratory Tract Agents guaifenesin Robitussin 20 mg/ml syrup (100 ml) F The formulary status of guaifenesin is unchanged. Tall Man lettering is now required for guaifenesin. 56:00 - Gastrointestinal Drugs pantoprazole sodium Panto IV 40 mg powder FRGTI The guidelines for use of pantoprazole injection in Non-Variceal Upper Gastrointestinal bleeding (Adults) have been updated to include intermittent BID pantoprazole IV dosing for 72 hours post endoscopy as an alternative to the standard dosing regimen of pantoprazole IV bolus plus continuous infusion to prevent recurrent bleeding of high-risk bleeding ulcers. DTC Update Page 5 of 9 Volume 5 No 4 July 2015

6 Guidelines B) Guidelines for use in Non-variceal Upper Gastrointestinal bleeding (Adults) Alternatives treatment options: 1. Pantoprazole sodium injection 80 mg bolus followed by an 8 mg/hour continuous infusion for a maximum of 72 hours post-endoscopy. Continuous infusion should be reassessed following endoscopy. OR 2. Intermittent BID administration of pantoprazole sodium injection for 72 hours post-endoscopy (e.g. pantoprazole sodium injection 40 mg IV BID). - Pantoprazole injection should be switched to a formulary oral proton pump inhibitor (PPI) once hemostasis is achieved with therapeutic endoscopy (usually within 24 hours). - Patients hemodynamically stable within 24 hours, who will not undergo diagnostic or therapeutic endoscopy may be converted to once daily IV/PO PPI dosing (e.g., pantoprazole 40 mg IV/PO daily) depending on the patient's NPO status. - Due to the comparable pharmacodynamic effects of equivalent doses of oral and IV PPIs, route of administration is determined by the patient's NPO status. 92:00 - Miscellaneous Therapeutic Agents methylene blue 1% vial (1 ml & 5 ml) F Was formulary restricted to the treatment of drug-induced methemoglobinemia. Now open-listed, note: safety risk if used in tube feeds for detecting aspiration. Provincial Formulary Exclusions/Deletions 08:00 - Anti-infective Agents acyclovir Zovirax, Hospira Brand 25 mg/ml vial (20 ml) NF Significant price increase; use 50 mg/ml strength (10 or 20 ml vial) instead. cefaclor Ceclor 250 mg & 500 mg capsules DCTI Was non-formulary with therapeutic interchange; now discontinued by the manufacturer. ticarcillin - clavulanic acid Timentin 3 g mg injection DC Discontinued by the manufacturer. DTC Update Page 6 of 9 Volume 5 No 4 July 2015

7 24:00 - Cardiovascular Drugs amiodarone Cordarone 50 mg/ml injection (6 ml) DC 6 ml size discontinued by the manufacturer. The 3 and 9 ml sizes are still available. nitroglycerin Minitran 0.2 mg/hour; 0.4 mg/hour; 0.6 mg/hour patch NF Trinipatch is on contract and will be the nitroglycerin patch supplied by Pharmacy Services. nitroglycerin Nitro-Dur 0.2; Nitro-Dur 0.4; Nitro-Dur mg/hour; 0.4 mg/hour; 0.6 mg/hour patch NF Nitro-Dur is no longer on contract effective June 1, Trinipatch is on contract and will be the nitroglycerin patch supplied by AHS Pharmacy Services. The nitroglycerin 0.8 mg/hour patch will remain on formulary; however the Mylan brand will be supplied as the generic equivalent for Nitro-Dur. 28:00 - Central Nervous System Agents alfentanil Alfenta 500 mcg/ml injection (2 ml) DC Discontinued by the manufacturer. melatonin 3 mg tablet, sublingual NF melatonin 1 mg & 3 mg capsules NF melatonin Vivitas Sleep Right 3 mg/ml oral solution NF Reviewed and excluded for the treatment of insomnia. There is a lack of evidence to support the use of melatonin for sleep disorders. Several insomnia guidelines do not support the use of melatonin. Further studies in the form of large randomized controlled trials with strong methodology and longer periods of follow up are required in order to determine the optimal dosage, type of melatonin formulation and to confirm efficacy and long-term safety before it can be used routinely for this indication. 36:00 - Diagnostic Agents indigotindisulfonate sodium Indigo Carmine Solution 8 mg/ml injection (5 ml) DC Discontinued by the manufacturer. DTC Update Page 7 of 9 Volume 5 No 4 July 2015

8 AHS Correctional Facilities Drug Formulary Updates The presence of a C in a drug s formulary status code indicates that the formulary status of this drug on the AHS Correctional Facilities Drug Formulary differs from what is listed on the AHS Provincial Drug Formulary. These differences exist to address specific needs of the inmate patient population. Only drugs with a C in their formulary status on the AHS Correctional Facilities Drug Formulary approved at the 11 June 2015 DTC meeting are listed in this section. Exception: Formulary status code DC : Manufacturer discontinued 28:00 - Central Nervous System Agents QUEtiapine Restriction 50 mg, 150 mg, Seroquel XR 200 mg, 300 mg, 400 mg 1. Treatment of schizophrenia and/or bipolar disorder; 2. Patients stabilized/maintained prior to admission. 48:00 Respiratory Tract Agents tablets, extended release FRC guaifenesin Robitussin 20 mg/ml syrup (100 ml) NFC The formulary status of guaifenesin is unchanged. Tall Man lettering is now required for guaifenesin. Insite Pharmacy Services Webpage The AHS Provincial Formulary is available on Insite at the following link under Clinical Tools: Links to current and archived issues of the DTC Update newsletter and supplements are available on Insite under Our Teams / Departments >> Pharmacy Services >> Drug Utilization >> Drugs and Therapeutics Committee ( For AHS physicians without login access to Insite, the current issue of the DTC Update newsletter can be accessed through an AHS external site at the following link: DTC Update Page 8 of 9 Volume 5 No 4 July 2015

9 This document has been prepared for informational purposes for employees of Alberta Health Services. All rights reserved in relation to this document. Without limiting the reservation of copyright, no person shall reproduce, store in a retrieval system or transmit in any form or by any means (electronic, mechanical, photocopying, recording or otherwise) part or the whole of this document without the prior written permission of Alberta Health Services. Requests or inquiries related to this document should be directed to: This newsletter is circulated broadly to AHS staff. Editor: AHS Pharmacy Therapeutics, Drug Utilization DTC Update Page 9 of 9 Volume 5 No 4 July 2015