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(digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks (digital.ashp.org)Purchased by [email protected], Anna CunninghamFrom: ASHP eBooks 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Because of ongoing research and improvements in technology, the information and its applications contained in this text are constantly evolving and are subject to the professional judgment and interpretation of the practitioner due to the uniqueness of a clinical situation. The editors and ASHP have made reasonable efforts to ensure the accuracy and appropriateness of the information presented in this document. However, any user of this information is advised that the editors and ASHP are not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information in the document in any and all practice settings. Any reader of this document is cautioned that ASHP makes no representation, guarantee, or warranty, express or implied, as to the accuracy and appropriateness of the information contained in this document and specifically disclaims any liability to any party for the accuracy and/or completeness of the material or for any damages arising out of the use or non-use of any of the information contained in this document.

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Library of Congress Cataloging-in-Publication Data

Names: Bing, Caryn M., editor. | Nowobilski-Vasilios, Anna, editor. | American Society of Health-System Pharmacists, issuing body.Title: Extended stability for parenteral drugs / [edited by] Caryn Dellamorte Bing, Anna Nowobilski-Vasilios.Description: Sixth edition. | Bethesda, MD : American Society of Health-System Pharmacists, [2017] | Includes bibliographical references and index.Identifiers: LCCN 2017001433 | ISBN 9781585285273Subjects: | MESH: Drug Stability | Drug Storage | Time Factors | Home Infusion Therapy | Parenteral Nutrition | HandbooksClassification: LCC RS424 | NLM QV 735 | DDC 615.8/55--dc23 LC record available at https://lccn.loc.gov/2017001433

© 2017, American Society of Health-System Pharmacists, Inc. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, includ-ing photocopying, microfilming, and recording, or by any information storage and retrieval system, without written permis-sion from the American Society of Health-System Pharmacists.

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iii

E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

Dedication To the ever-growing network of colleagues who inspire and encourage us:

It is impossible to recognize and thank you all appropriately for your continued support of this ongoing drug information project.

AcknowledgmentsThe preparation of this updated reference was a team effort that would not have been possible without the exceptional group of capable writers and reviewers. They spent many hours on what some might consider minutia but this team considers essential. The editors appre-ciate the dedication and focus that these extremely talented and very busy professionals applied to this edition, and are grateful to others who contributed extensively to prior editions.


iv

E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SContents

Preface ...................................................................................... viiAbout the Editors ....................................................................... ixWriters’ Affiliations .................................................................... xHow to Use This Reference ....................................................... xi

Part IApplying Stability Data in Patient Care ...................................... 1

Introduction ............................................................................ 3Factors Affecting Extended Drug Stability ................................ 3Preparation Sterility and Quality Assurance ............................. 4Professional, Regulatory, and Accreditation Expectations ......... 5Commercial Products and Extemporaneous

Compounding ...................................................................... 6Infusate Properties .................................................................. 7Vascular Access Devices and Catheters Used

in Medication Administration ............................................... 8Labeling Instructions ............................................................. 11Assigning Beyond-Use Dates ................................................. 11Patient and Site-Specific Considerations ................................ 12Considerations in Selecting Administration Methods

and Infusion Devices .......................................................... 14External Factors Affecting Stability ......................................... 18Ethanol and Antibiotic Locks ................................................. 19Summary .............................................................................. 19References ............................................................................ 20

Parenteral Nutrition ................................................................. 23Beyond-Use Dating of Parenteral Nutrition

Formulations ...................................................................... 23Non-Formulation Factors Affecting PN Stability ..................... 23Formulation Factors Affecting PN Stability ............................. 25Commercial Products and Extemporaneous

Compounding .................................................................... 29Professional, Regulatory, and Accreditation

Expectations and Guidance ................................................ 30Summary .............................................................................. 31

Parenteral Nutrition Monographs ............................................ 32Carnitine ............................................................................... 32Chromium ........................................................................... 32Copper ................................................................................. 33Famotidine ........................................................................... 34Folic Acid ............................................................................. 35Heparin ................................................................................ 36Iron ...................................................................................... 36Manganese ........................................................................... 37Ranitidine ............................................................................. 37

Selenium .............................................................................. 38Trace Elements ..................................................................... 38Vitamin A ............................................................................. 39Vitamin B1 ............................................................................ 40Vitamin B2 ............................................................................ 41Vitamin B3 ............................................................................ 42Vitamin B5 ............................................................................ 42Vitamin B6 ............................................................................ 43Vitamin B12 .......................................................................... 43Vitamin C ............................................................................. 44Vitamin D ............................................................................. 45Vitamin E .............................................................................. 46Vitamin K .............................................................................. 47Zinc ...................................................................................... 47References ............................................................................ 47

Part IIDrug Monographs .................................................................... 53

Acetaminophen .................................................................... 55Acyclovir sodium .................................................................. 56ADO-Trastuzumab Emtansine ............................................... 58Aldesleukin ........................................................................... 59Amikacin Sulfate ................................................................... 60Amiodarone Hydrochloride .................................................. 62Amphotericin B..................................................................... 63Amphotericin B Lipid Complex ............................................. 64Amphotericin B Liposome ..................................................... 65Ampicillin Sodium ................................................................ 66Ampicillin Sodium–Sulbactam Sodium .................................. 68Azithromycin ........................................................................ 70Aztreonam ............................................................................ 71Baclofen ............................................................................... 73Bevacizumab ........................................................................ 75Bleomycin Sulfate ................................................................. 76Blinatumomab ..................................................................... 77Bortezomib ........................................................................... 78Bumetanide .......................................................................... 79Bupivacaine Hydrochloride................................................... 80Calcitriol ............................................................................... 83Carboplatin ........................................................................... 84Caspofungin Acetate ............................................................. 86Cefazolin Sodium ................................................................. 88Cefepime Hydrochloride ...................................................... 91Cefotaxime Sodium .............................................................. 94


http://digital.ashp.org/docgoto/pjer9d/20http://digital.ashp.org/docgoto/pjer9d/20http://digital.ashp.org/docgoto/pjer9d/26http://digital.ashp.org/docgoto/pjer9d/26http://digital.ashp.org/docgoto/pjer9d/42http://digital.ashp.org/docgoto/pjer9d/42http://digital.ashp.org/docgoto/pjer9d/17http://digital.ashp.org/docgoto/pjer9d/35http://digital.ashp.org/docgoto/pjer9d/35http://digital.ashp.org/docgoto/pjer9d/18http://digital.ashp.org/docgoto/pjer9d/18http://digital.ashp.org/docgoto/pjer9d/41http://digital.ashp.org/docgoto/pjer9d/41http://digital.ashp.org/docgoto/pjer9d/13http://digital.ashp.org/docgoto/pjer9d/13http://digital.ashp.org/docgoto/pjer9d/35http://digital.ashp.org/docgoto/pjer9d/16http://digital.ashp.org/docgoto/pjer9d/37http://digital.ashp.org/docgoto/pjer9d/15http://digital.ashp.org/docgoto/pjer9d/24http://digital.ashp.org/docgoto/pjer9d/30http://digital.ashp.org/docgoto/pjer9d/80http://digital.ashp.org/docgoto/pjer9d/44http://digital.ashp.org/docgoto/pjer9d/31http://digital.ashp.org/docgoto/pjer9d/76http://digital.ashp.org/docgoto/pjer9d/23http://digital.ashp.org/docgoto/pjer9d/70http://digital.ashp.org/docgoto/pjer9d/92http://digital.ashp.org/docgoto/pjer9d/74http://digital.ashp.org/docgoto/pjer9d/65http://digital.ashp.org/docgoto/pjer9d/65http://digital.ashp.org/docgoto/pjer9d/77http://digital.ashp.org/docgoto/pjer9d/103http://digital.ashp.org/docgoto/pjer9d/23http://digital.ashp.org/docgoto/pjer9d/35http://digital.ashp.org/docgoto/pjer9d/19http://digital.ashp.org/docgoto/pjer9d/98http://digital.ashp.org/docgoto/pjer9d/78http://digital.ashp.org/docgoto/pjer9d/88http://digital.ashp.org/docgoto/pjer9d/106http://digital.ashp.org/docgoto/pjer9d/68http://digital.ashp.org/docgoto/pjer9d/72http://digital.ashp.org/docgoto/pjer9d/100http://digital.ashp.org/docgoto/pjer9d/50http://digital.ashp.org/docgoto/pjer9d/75http://digital.ashp.org/docgoto/pjer9d/67http://digital.ashp.org/docgoto/pjer9d/15http://digital.ashp.org/docgoto/pjer9d/82http://digital.ashp.org/docgoto/pjer9d/89http://digital.ashp.org/docgoto/pjer9d/55http://digital.ashp.org/docgoto/pjer9d/71http://digital.ashp.org/docgoto/pjer9d/87http://digital.ashp.org/docgoto/pjer9d/96http://digital.ashp.org/docgoto/pjer9d/32http://digital.ashp.org/docgoto/pjer9d/46http://digital.ashp.org/docgoto/pjer9d/47http://digital.ashp.org/docgoto/pjer9d/49http://digital.ashp.org/docgoto/pjer9d/52http://digital.ashp.org/docgoto/pjer9d/53http://digital.ashp.org/docgoto/pjer9d/54http://digital.ashp.org/docgoto/pjer9d/54http://digital.ashp.org/docgoto/pjer9d/55http://digital.ashp.org/docgoto/pjer9d/59http://digital.ashp.org/docgoto/pjer9d/90http://digital.ashp.org/docgoto/pjer9d/91http://digital.ashp.org/docgoto/pjer9d/95http://digital.ashp.org/docgoto/pjer9d/44http://digital.ashp.org/docgoto/pjer9d/49http://digital.ashp.org/docgoto/pjer9d/51http://digital.ashp.org/docgoto/pjer9d/56http://digital.ashp.org/docgoto/pjer9d/57http://digital.ashp.org/docgoto/pjer9d/58http://digital.ashp.org/docgoto/pjer9d/59http://digital.ashp.org/docgoto/pjer9d/83http://digital.ashp.org/docgoto/pjer9d/44http://digital.ashp.org/docgoto/pjer9d/50http://digital.ashp.org/docgoto/pjer9d/85http://digital.ashp.org/docgoto/pjer9d/31http://digital.ashp.org/docgoto/pjer9d/43http://digital.ashp.org/docgoto/pjer9d/48http://digital.ashp.org/docgoto/pjer9d/45http://digital.ashp.org/docgoto/pjer9d/48http://digital.ashp.org/docgoto/pjer9d/59http://digital.ashp.org/docgoto/pjer9d/7http://digital.ashp.org/docgoto/pjer9d/9http://digital.ashp.org/docgoto/pjer9d/10http://digital.ashp.org/docgoto/pjer9d/11

v


Cefotetan Disodium .............................................................. 97Cefoxitin Sodium .................................................................. 99Ceftaroline Fosamil ............................................................. 101Ceftazidime ........................................................................ 102Ceftolozane–Tazobactam .................................................... 105Ceftriaxone Sodium ............................................................ 106Cefuroxime Sodium ............................................................ 109Chlorpromazine Hydrochloride .......................................... 112Cidofovir ............................................................................ 113Ciprofloxacin ...................................................................... 114CISplatin ............................................................................. 116Cladribine ........................................................................... 118Clindamycin Phosphate ...................................................... 119Clonidine Hydrochloride .................................................... 121Coagulation Factor VIIa Recombinant ................................ 124Coagulation Factor VIII ....................................................... 125Coagulation Factor IX ............................................................129Coagulation Factor X ......................................................... 131Coagulation Factor XIII ...................................................... 132Colistimethate Sodium ....................................................... 133Co-Trimoxazole (Trimethoprim–Sulfamethoxazole) ............. 135Cyclophosphamide ............................................................ 136Cyclosporine ....................................................................... 138Cytarabine .......................................................................... 139Dacarbazine ....................................................................... 141Dalbavancin ....................................................................... 142Daptomycin ........................................................................ 143DAUNOrubicin Hydrochloride (Daunomycin) .................... 145Deferoxamine Mesylate ...................................................... 146Dexamethasone Sodium Phosphate .................................... 149DimenHYDRINATE ............................................................. 151DIphenhydrAMINE Hydrochloride ...................................... 152DOBUTamine Hydrochloride ............................................. 153Docetaxel .......................................................................... 154Dolasetron Mesylate ........................................................... 155DOPamine Hydrochloride ................................................. 156Doripenem ......................................................................... 158DOXOrubicin Hydrochloride ............................................. 161Doxycycline Hyclate ........................................................... 164Enoxaparin Sodium ............................................................. 166Epirubicin Hydrochloride ................................................... 167Epoetin Alfa ........................................................................ 169

Epoprostenol Sodium ........................................................ 170Ertapenem Sodium ............................................................. 172Erythromycin Lactobionate ................................................. 174Ethanol (Catheter Lock) ....................................................... 175Etoposide ............................................................................ 176Etoposide Phosphate ........................................................... 179Famotidine ........................................................................ 181Fentanyl Citrate .................................................................. 182Ferric Carboxymaltose ........................................................ 185Filgrastim ............................................................................ 186Floxuridine ......................................................................... 187Fluconazole ........................................................................ 188Fludarabine Phosphate ....................................................... 190Fluorouracil ........................................................................ 191Foscarnet Sodium ............................................................... 194Fosphenytoin Sodium ......................................................... 196Furosemide ......................................................................... 197Ganciclovir Sodium............................................................. 199Gemcitabine Hydrochloride ................................................ 201Gentamicin Sulfate ............................................................. 202Glycopyrrolate .................................................................... 204Granisetron Hydrochloride ................................................. 205Haloperidol Lactate ............................................................ 207Heparin Sodium ................................................................. 209Hydralazine Hydrochloride ................................................. 212Hydrocortisone Sodium Succinate ..................................... 213Hydromorphone Hydrochloride ......................................... 214Hydroxyzine Hydrochloride ................................................ 216Ibuprofen .......................................................................... 217Ibuprofen LYSINATE ........................................................... 218Ifosfamide ........................................................................... 219Imipenem–Cilastatin Sodium .............................................. 221Immune Globulin (Human) ................................................. 223Infliximab ........................................................................... 226Interferon alfa-2b ................................................................ 227Irinotecan Hydrochloride .................................................... 228Iron Sucrose ........................................................................ 229Ketamine Hydrochloride ..................................................... 230Ketorolac Tromethamine .................................................... 232Leucovorin Calcium ............................................................ 234Levofloxacin ....................................................................... 236Linezolid ........................................................................... 237

Drug Monographs, continued


http://digital.ashp.org/docgoto/pjer9d/147http://digital.ashp.org/docgoto/pjer9d/157http://digital.ashp.org/docgoto/pjer9d/136http://digital.ashp.org/docgoto/pjer9d/225http://digital.ashp.org/docgoto/pjer9d/161http://digital.ashp.org/docgoto/pjer9d/164http://digital.ashp.org/docgoto/pjer9d/124http://digital.ashp.org/docgoto/pjer9d/226http://digital.ashp.org/docgoto/pjer9d/233http://digital.ashp.org/docgoto/pjer9d/173http://digital.ashp.org/docgoto/pjer9d/186http://digital.ashp.org/docgoto/pjer9d/213http://digital.ashp.org/docgoto/pjer9d/217http://digital.ashp.org/docgoto/pjer9d/224http://digital.ashp.org/docgoto/pjer9d/228http://digital.ashp.org/docgoto/pjer9d/165http://digital.ashp.org/docgoto/pjer9d/179http://digital.ashp.org/docgoto/pjer9d/240http://digital.ashp.org/docgoto/pjer9d/133http://digital.ashp.org/docgoto/pjer9d/137http://digital.ashp.org/docgoto/pjer9d/144http://digital.ashp.org/docgoto/pjer9d/187http://digital.ashp.org/docgoto/pjer9d/235http://digital.ashp.org/docgoto/pjer9d/117http://digital.ashp.org/docgoto/pjer9d/168http://digital.ashp.org/docgoto/pjer9d/242http://digital.ashp.org/docgoto/pjer9d/244http://digital.ashp.org/docgoto/pjer9d/131http://digital.ashp.org/docgoto/pjer9d/141http://digital.ashp.org/docgoto/pjer9d/145http://digital.ashp.org/docgoto/pjer9d/158http://digital.ashp.org/docgoto/pjer9d/197http://digital.ashp.org/docgoto/pjer9d/202http://digital.ashp.org/docgoto/pjer9d/143http://digital.ashp.org/docgoto/pjer9d/113http://digital.ashp.org/docgoto/pjer9d/167http://digital.ashp.org/docgoto/pjer9d/176http://digital.ashp.org/docgoto/pjer9d/182http://digital.ashp.org/docgoto/pjer9d/191http://digital.ashp.org/docgoto/pjer9d/208http://digital.ashp.org/docgoto/pjer9d/219http://digital.ashp.org/docgoto/pjer9d/109http://digital.ashp.org/docgoto/pjer9d/118http://digital.ashp.org/docgoto/pjer9d/211http://digital.ashp.org/docgoto/pjer9d/214http://digital.ashp.org/docgoto/pjer9d/230http://digital.ashp.org/docgoto/pjer9d/239http://digital.ashp.org/docgoto/pjer9d/246http://digital.ashp.org/docgoto/pjer9d/121http://digital.ashp.org/docgoto/pjer9d/178http://digital.ashp.org/docgoto/pjer9d/111http://digital.ashp.org/docgoto/pjer9d/148http://digital.ashp.org/docgoto/pjer9d/184http://digital.ashp.org/docgoto/pjer9d/194http://digital.ashp.org/docgoto/pjer9d/206http://digital.ashp.org/docgoto/pjer9d/163http://digital.ashp.org/docgoto/pjer9d/216http://digital.ashp.org/docgoto/pjer9d/221http://digital.ashp.org/docgoto/pjer9d/126http://digital.ashp.org/docgoto/pjer9d/150http://digital.ashp.org/docgoto/pjer9d/181http://digital.ashp.org/docgoto/pjer9d/203http://digital.ashp.org/docgoto/pjer9d/241http://digital.ashp.org/docgoto/pjer9d/248http://digital.ashp.org/docgoto/pjer9d/114http://digital.ashp.org/docgoto/pjer9d/153http://digital.ashp.org/docgoto/pjer9d/154http://digital.ashp.org/docgoto/pjer9d/199http://digital.ashp.org/docgoto/pjer9d/200http://digital.ashp.org/docgoto/pjer9d/130http://digital.ashp.org/docgoto/pjer9d/151http://digital.ashp.org/docgoto/pjer9d/155http://digital.ashp.org/docgoto/pjer9d/193http://digital.ashp.org/docgoto/pjer9d/198http://digital.ashp.org/docgoto/pjer9d/209http://digital.ashp.org/docgoto/pjer9d/231http://digital.ashp.org/docgoto/pjer9d/238http://digital.ashp.org/docgoto/pjer9d/125http://digital.ashp.org/docgoto/pjer9d/128http://digital.ashp.org/docgoto/pjer9d/166http://digital.ashp.org/docgoto/pjer9d/170http://digital.ashp.org/docgoto/pjer9d/188http://digital.ashp.org/docgoto/pjer9d/229http://digital.ashp.org/docgoto/pjer9d/249

vi


Lorazepam .......................................................................... 238Meperidine Hydrochloride ................................................. 240Meropenem ...................................................................... 242Mesna................................................................................. 245Methadone Hydrochloride.................................................. 247Methotrexate Sodium ......................................................... 248Methylprednisolone Sodium Succinate ............................... 250Metoclopramide Hydrochloride .......................................... 252Metronidazole .................................................................... 254Micafungin Sodium ........................................................... 256Midazolam Hydrochloride .................................................. 258Milrinone Lactate ................................................................ 260Mitomycin .......................................................................... 261Mitoxantrone Hydrochloride ............................................. 263Morphine Sulfate ................................................................ 264Nafcillin Sodium ................................................................. 269Octreotide Acetate ............................................................. 272Ondansetron Hydrochloride ............................................... 273Oprelvekin (Interleukin-11) ................................................. 275Oritavancin Diphosphate .................................................... 276Oxacillin Sodium ................................................................ 277Oxaliplatin .......................................................................... 279Oxytocin ............................................................................. 280Paclitaxel ............................................................................ 281Pantoprazole Sodium .......................................................... 283Pemetrexed Disodium ........................................................ 285Penicillin G Potassium ......................................................... 286Penicillin G Sodium ............................................................ 288Pentamidine Isethionate ..................................................... 290Pertuzumab ........................................................................ 292

Piperacillin Sodium–Tazobactam Sodium ............................ 293Quinupristin–Dalfopristin .................................................... 295Ranitidine Hydrochloride .................................................... 296Rituximab ........................................................................... 298Ropivacaine Hydrochloride................................................. 299Sargramostim ...................................................................... 301Sufentanil Citrate ................................................................ 302Tedizolid Phosphate ........................................................... 304Telavancin Hydrochloride ................................................... 305Thiotepa ............................................................................. 306Tigecycline ........................................................................ 307Tobramycin Sulfate ............................................................. 308Tocilizumab ........................................................................ 310Topotecan Hydrochloride ................................................... 311Trastuzumab ....................................................................... 312Treprostinil Sodium ............................................................. 313Valproate Sodium ............................................................... 315Vancomycin Hydrochloride ................................................ 316VinBLAStine Sulfate ............................................................ 318VinCRIStine Sulfate ............................................................. 320Vinorelbine Tartrate ............................................................ 322Voriconazole ...................................................................... 323Ziconotide Acetate ............................................................. 324Zidovudine ......................................................................... 327Zoledronic Acid .................................................................. 328

Part IIIAppendix A: Manufacturer and Compendium

Abbreviations ........................................................................ 331Appendix B: Glossary of Terms ............................................ 335Index ..................................................................................... 337

Drug Monographs, continued


http://digital.ashp.org/docgoto/pjer9d/341http://digital.ashp.org/docgoto/pjer9d/343http://digital.ashp.org/docgoto/pjer9d/343http://digital.ashp.org/docgoto/pjer9d/305http://digital.ashp.org/docgoto/pjer9d/262http://digital.ashp.org/docgoto/pjer9d/347http://digital.ashp.org/docgoto/pjer9d/264http://digital.ashp.org/docgoto/pjer9d/287http://digital.ashp.org/docgoto/pjer9d/275http://digital.ashp.org/docgoto/pjer9d/285http://digital.ashp.org/docgoto/pjer9d/307http://digital.ashp.org/docgoto/pjer9d/311http://digital.ashp.org/docgoto/pjer9d/252http://digital.ashp.org/docgoto/pjer9d/308http://digital.ashp.org/docgoto/pjer9d/317http://digital.ashp.org/docgoto/pjer9d/328http://digital.ashp.org/docgoto/pjer9d/259http://digital.ashp.org/docgoto/pjer9d/270http://digital.ashp.org/docgoto/pjer9d/288http://digital.ashp.org/docgoto/pjer9d/302http://digital.ashp.org/docgoto/pjer9d/323http://digital.ashp.org/docgoto/pjer9d/298http://digital.ashp.org/docgoto/pjer9d/334http://digital.ashp.org/docgoto/pjer9d/260http://digital.ashp.org/docgoto/pjer9d/295http://digital.ashp.org/docgoto/pjer9d/297http://digital.ashp.org/docgoto/pjer9d/300http://digital.ashp.org/docgoto/pjer9d/316http://digital.ashp.org/docgoto/pjer9d/325http://digital.ashp.org/docgoto/pjer9d/330http://digital.ashp.org/docgoto/pjer9d/332http://digital.ashp.org/docgoto/pjer9d/284http://digital.ashp.org/docgoto/pjer9d/314http://digital.ashp.org/docgoto/pjer9d/320http://digital.ashp.org/docgoto/pjer9d/336http://digital.ashp.org/docgoto/pjer9d/268http://digital.ashp.org/docgoto/pjer9d/272http://digital.ashp.org/docgoto/pjer9d/276http://digital.ashp.org/docgoto/pjer9d/281http://digital.ashp.org/docgoto/pjer9d/289http://digital.ashp.org/docgoto/pjer9d/327http://digital.ashp.org/docgoto/pjer9d/340http://digital.ashp.org/docgoto/pjer9d/266http://digital.ashp.org/docgoto/pjer9d/313http://digital.ashp.org/docgoto/pjer9d/335http://digital.ashp.org/docgoto/pjer9d/291http://digital.ashp.org/docgoto/pjer9d/319http://digital.ashp.org/docgoto/pjer9d/322http://digital.ashp.org/docgoto/pjer9d/324http://digital.ashp.org/docgoto/pjer9d/293http://digital.ashp.org/docgoto/pjer9d/304http://digital.ashp.org/docgoto/pjer9d/339http://digital.ashp.org/docgoto/pjer9d/250http://digital.ashp.org/docgoto/pjer9d/254http://digital.ashp.org/docgoto/pjer9d/273http://digital.ashp.org/docgoto/pjer9d/310http://digital.ashp.org/docgoto/pjer9d/292http://digital.ashp.org/docgoto/pjer9d/318http://digital.ashp.org/docgoto/pjer9d/257http://digital.ashp.org/docgoto/pjer9d/349

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E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SPreface

The scarcity of published and/or labeled stability data beyond 24 hours at any temperature has been a historically compli-cating factor in the care of patients in alternate care sites. When home infusion practice emerged and grew in the 1980–90s, accurate information on extended parenteral stability was very limited. Independent and hospital-based home care pharma-cists were challenged to find drug stability data that supported realistic and cost-effective compounding and patient delivery schedules. Some national infusion companies put considerable resources to the task of compiling drug stability information to support their operational and patient care processes and maintained full-time drug information specialists supporting clinicians at their many national locations. The highly competitive nature of the home infusion industry also led to the devel-opment of unpublished, proprietary drug stability data based on independent studies contracted by large home infusion companies and drug product manufacturers.

The home infusion industry experienced tremendous change in the later part of the 1990s. Industry leaders merged or were acquired, resulting in fewer but larger national companies. A continuing trend includes acquisitions of home and spe-cialty infusion providers by chain pharmacy corporations, pharmacy benefit managers, and pharmacy-by-mail companies. Hospital and health-system infusion programs expanded in number, scope, and size in many areas. Growth in the subacute care component of long-term care pharmacy continues to contribute to the increased use of infusion products outside the hospital setting. The number and scope of services of free-standing, hospital-based, and physician-office-based ambulatory infusion programs have also increased. Reduced reimbursement, increased case management, and changes in technology decreased the typical length of service for alternate site home infusion services from primarily long-term (months to years) parenteral nutrition therapy to include more short-term (days to weeks) drug therapies such as anti-infectives. Many newer drug therapies for chronic diseases are infused in the home and outpatient infusion settings. Inpatient pharmacy services increasingly rely on extended beyond-use dating to minimize the wastage of high cost parenteral medication via appropriate recycling of unused compounded sterile parenterals. Implementation of sterile compounding practices under USP and other strict standards help to support extending beyond-use dating for many medications past the more traditional 24-hour post-admixture expiration date. Drug shortages also have forced practitioners to consider the need for extendedstability data in order to limit the wasting of limited supply medications where feasible.

The extended stability monographs and parenteral nutrition monographs in this edition represent a continuing drug information project focused on identifying, reviewing, and compiling relevant available information in a concise format. Monographs selected include most of the anti-infective medications and other parenteral drugs with useful extended sta-bility dating. They cite the majority of extended stability data available at the time of the edition. Many of the monographs reference well-known sources, such as the Handbook on Injectable Drugs (a “must-have” reference for every pharmacy that compounds sterile preparations). Additional references and sources include previously unpublished data for specific types of infusion devices and containers, direct communications from drug and device manufacturers, and a focused review of previously published data from the perspective of practitioners who use this information in their home and ambulatory infusion practice settings. The third edition included a comprehensive chapter on total parenteral nutrition; this chapter was reformatted for the fourth edition with stability and compatibility data summarized in parenteral nutrition monographs for some of the most common additives to parenteral nutrition preparations, and information on calcium/phosphate solubility was added to the fifth edition. In the fifth edition, Applying Stability Data in Patient Care added a nursing perspective, with a primer on the types of vascular access devices used in medication administration and important considerations for pH, osmolality, concentration, and administration devices.

The practices and integrity of pharmacists and others who compound sterile preparations have been under great scrutiny in recent years. Increased awareness by health care consumers, boards of pharmacy, and federal regulators further presses us to employ the diligence and professionalism with which we are entrusted to protect the public. We strongly emphasize the importance of using the extended stability data in this compilation responsibly and as part of the overall quality and stan-dards-focused process of preparing sterile compounds.

The monographs and chapters are compiled as an easy-to-use reference on extended stability of the parenteral drugs and biologicals most common to alternate site infusion practice, including data in container types commonly used outside the acute care setting. The user should always consult the newest literature, and manufacturer labeling, prior to establishing the beyond-use date for a compounded sterile preparation.


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E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SPreface

What's New in This EditionThe 165 stability monographs in this sixth edition include updates to all but five of the monographs from the fifth edition, and 11 new stability monographs: ado-trastuzumab emtansine, blinatumomab, ceftolozane-tazobactam, coagulation factor X, dalbavancin, ferric carboxymaltose, ibuprofen lysinate, iron sucrose, oritavancin diphosphate, pertuzumab, and tedizolid phosphate. Monograph updates include revisions for a number of container types, as well as information for new elasto-meric infusion device brands. The Parenteral Nutrition chapter cites fifteen new references; the Applying Stability Data in Patient Care chapter also cites fifteen new or revised references, and summarizes the implications of nursing, pharmacy, and compounding standards of practice revisions for extended beyond-use dating. Also noteworthy is our decision to retain stability data on some devices that were previously widely used and are now no longer marketed in the United States, but are still available internationally and in Puerto Rico; monograph footnotes clarify this status. My long time friend and col-league, Anna Nowobilski-Vasilios, has been a monograph writer/reviewer since the first edition of this book at the turn of the millennium; Anna willingly continued for her second ‘term’ as the invaluable co-editor for this edition. As with prior editions, the publisher, editors, and writers welcome your feedback and suggestions.

Caryn Dellamorte Bing, RPh, MS, FASHP

May 2017, Las Vegas, NV


ix

E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SAbout the Editors

Caryn Dellamorte Bing, RPh, MS, FASHP, is Principal at CB Healthcare Consulting. Caryn mostly retired in 2014 after a diverse career in home and specialty infusion. She is a contract surveyor for the Center for Pharmacy Practice Accreditation (CPPA). Caryn was Senior Manager Clinical Services and PGY1 Residency Program Director for Critical Care Systems, Inc., a national home and specialty infusion provider, with responsibilities for developing and supporting clinical standards of practice, clinician training and professional development, and leadership and management of PGY1 Pharmacy Residency programs. Caryn’s career spanning more than 30 years has included corporate leadership, general management, operations, clinical management, accreditation surveyor, consulting, training, and pharmacy practice roles in national and regional home/specialty infusion and other alternate site and acute care practice settings. Caryn holds a BS from University of Illinois College of Pharmacy and MS in Health Systems Management from Rush University. She completed her pharmacy residency at Rush Medical Center. She is a Rho Chi Scholar and Fellow of the American Society of Health-System Pharmacists. Caryn has been active in professional association leadership throughout her career, including terms as a presidential officer for the Illinois and Nevada ASHP state affiliates, and numerous times as an ASHP Delegate and Alternate Delegate. She served on and chaired the NHIA Education Committee; still serves as a reviewer for articles, practice standards, accreditation stan-dards, and other publications; and has mentored practitioners and students in a variety of settings. She served on the ASHP Home Care Section Executive Committee and was Chairperson for the ASHP Continuity of Care Task Force. Caryn received the first Distinguished Service Award from the ASHP Home Care Section, and is the 2017 ASHP Board of Directors Distin-guished Leadership Award recipient. She served on several editorial boards for national professional journals; has published a number of articles and book chapters; and has presented at many state and national meetings. Caryn has been Editor of Extended Stability for Parenteral Drugs since its inception.

Anna Nowobilski-Vasilios, PharmD, MBA, FASHP, BCNSP, CNSC, is Principal at Anovation, Inc., a practice specializing in the consultative support of home infusion, specialty pharmacy, ambulatory care, accrediting organizations, and other industries related to outpatient clinical services. Prior to establishing her consulting practice, she served Option Care, Inc. for 14 years in roles of increasing responsibility, culminating as Senior Vice President of Care Management Services. Previously, she held various management and clinical positions at home infusion companies, home health agencies, and hospitals. Anna received a BS (Pharmacy) from the University of Illinois (1979), MBA from the Keller Graduate School of Management (1993), and PharmD from Midwestern University (2). She is a Fellow of the American Society of Heath-System Pharmacists (FASHP), and has been board certified in nutrition support pharmacy (BCNSP) for over 20 years. Anna is an active member of ASHP, NHIA, ASPEN, INS, ICHP, and the Polish American Pharmacists’ Association (PAPA). She has lectured and directed courses related to home infusion therapy and sterile preparation at Midwestern University, Chicago State University, Uni-versity of Illinois, and Roosevelt University. She served on the Practice Analysis Task Force in Sterile Compounding for the Board of Pharmacy Specialties (BPS), and she has been appointed as content matter expert for the APhA/ASHP petition to BPS for specialty recognition of sterile compounding. Anna is a contract surveyor and consultant for the Center for Pharmacy Practice Accreditation (CPPA). She has spoken and published on topics related to home infusion therapy, specialty phar-macy, new drug approvals, accreditation, sterile preparation, nutrition support, and interdisciplinary collaboration.


x

E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SWriters’ Affiliations

Co-Editors

Caryn Dellamorte Bing, RPh, MS, FASHPPrincipal ConsultantCB Healthcare ConsultingLas Vegas, Nevada

Anna Nowobilski-Vasilios, PharmD, MBA, FASHP, BCNSP, CNSC

PrincipalAnovation, Care Management InnovationChicago, Illinois

Writers

Gene Bernieri, PharmD, CNSCStaff PharmacistUCLA Medical CenterLos Angeles, California

Stanley N. Chamallas, RPh, FASHPArea Clinical Director—NortheastOption CareNewmarket, New Hampshire

Donald J. Filibeck, PharmD, MBA, CSP, FASHPVice President, PharmacyOption CareDublin, Ohio

Crystin Gloude, PharmDArlington Heights, Illinois

Brenda L. Gray, PharmD, CNSC, BCNSPOwner and Senior Pharmacy and Accreditation ConsultantClinical Pharmacy PartnersTampa, Florida

Annemarie Hocking, PharmDClinical Pharmacist & Lead Preceptor PGY1 ResidencyOption CareWood Dale, Illinois

Barbara Limburg-Mancini, PharmD, BCNSPBurr Ridge, Illinois

Kevn M. McNamara, PharmD, CNSCOwner and Senior Pharmacy and Accreditation ConsultantClinical Pharmacy PartnersTampa, Florida

Diane Nitzki-George, PharmD, MBAClinical PharmacistPhysicians Regional HospitalNaples, Florida

and

Clinical Assistant ProfessorWorking Professional Doctor of Pharmacy ProgramUniversity of Florida College of Pharmacy

and

Freelance Medical Writer/Clinical ConsultantDNG Consulting, Inc.

Shamir K. Patel, PharmDPharmacy Supervisor, Coram CVS/Specialty Infusion

ServicesNorwood, Massachusetts

Kevin L. Ross, BSN, RNVice President, Nursing OperationsSoleo HealthSharon Hill, Pennsylvania

Lisa L. Siefert, RPh, FASHP, ASQ-CMQ/OESenior Director of Specialty ServicesKloudscriptOakbrook Terrace, Illinois

Paula Zelle, PharmD, FASHPPharmacy and Accreditation ConsultantInfusion Consultant ServicesCanton, Ohio


xi

E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SHow to Use This Reference

Stability MonographsEach monograph in this reference represents a drug for which some extended parenteral chemical stability information is available from peer reviewed publications and/or drug and/or device/container manufacturers. Practitioners who are unfa-miliar with this reference and the principles of extended stability should review the “Applying Stability Data in Patient Care” chapter. Selected monographs include shorter stability data that may be useful in alternate site practice. Stability mono-graphs are alphabetical by generic drug name. Each monograph includes a compilation of drug stability data for various con-tainer systems, solutions, concentrations, and temperature storage and administration conditions. The parenteral nutrition additive monographs are only applicable to parenteral nutrition formulations.

The following temperature ranges were adapted from the USP to evaluate reported stability study conditions1:

Refrigerated 2°C to 8°C

Frozen –25°C to –10°C

Room Temperature* 15°C to 30°C

Body Temperature 37°C

*See the USP definition of Controlled Room Temperature in Appendix B, Glossary of Terms.

When studied storage conditions fall outside these ranges, a monograph note will indicate the variation.

To use a stability monograph, find the desired container or material type in the first column. When a container type is not listed, then clinically useful or extended stability data were not available for the drug in that container type. Next, check the concentration, diluent, and manufacturer of the drug studied in that container type. The next column indicates the osmolality of the sample studied if it was assayed or calculated by the authors of the cited study. The pH column either includes the actual or range of pH for the specific concentration, or a note that ties to more general pH data for the drug product. Additional columns list the extended stability data that have been documented for the drug in the container and specified conditions. If frozen stability information is available, check the post-thaw stability data; this may differ from the room temperature and refrigerated stability data for the same drug in a never-frozen state. The final column indicates the reference(s) used for the particular line in the monograph. When n/a is noted in any field, no information is available for that item.

Within the stability monograph, footnotes highlight important information. Each footnote corresponds to information in the Notes section of the monograph that is crucial to interpretation of the data. These include comments on variations from USP temperature ranges, detailed descriptions of storage conditions, and more. A Special Considerations section includes special information on drug storage and preparation.

Flush compatibility refers to the chemical compatibility of the drug with common solutions used to flush vascular access devices. Practitioners should be aware of nursing practice guidelines (such as those of the Intravenous Nurses Society), access device specifications, and drug-solution compatibility when determining the type and volume of solution(s) used for line maintenance. When a drug is incompatible with heparinized saline (i.e., heparin lock flush), it may be necessary to flush with saline before and after administration. (Commonly referred to as SASH, this stands for Saline-Administration- Saline-Heparin.) A few drugs are not compatible with saline or heparinized saline; in these cases, flushing with an alterna-tive compatible solution, such as D5W, may be necessary. If the line flush procedures for a specific therapy vary from the organization's standard approach, the pharmacist should provide written directions to clarify the flush method used. Hepa-rinization may not always be required to maintain line patency for some access devices (e.g., Groshong catheters) or when positive displacement catheter caps are used.

Some references and notes from previous editions have been removed from this edition. The reference numbers and/or notes are not sequential on monographs where this is applicable.


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E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G SHow to Use This Reference

Use of Additional ResourcesThe information contained in these monographs is a compilation of extended stability data from multiple sources. This infor-mation is not a substitute for the official product literature. Practitioners should consult the primary literature and the prod-uct manufacturer to determine the applicability of stability data to a particular patient and practice scenario. Practitioners should maintain current drug reference resources as well as the most current edition of a comprehensive reference on drug stability and compatibility. Every pharmacy that compounds or provides sterile preparations should maintain resource files, including the phone numbers and all correspondence with the medical or clinical affairs departments of pharmaceutical manufacturers. The pharmacy should also have access to a drug information center or the expertise and ability to conduct a literature search for the most up-to-date clinical and pharmaceutical information on parenteral drugs.

General Abbreviationsd day(s)h hour(s)iso iso-osmoticm month(s)min minute(s)n/a not availableRTU ready to use from manufacturerunspec. unspecifiedw week(s)y year(s)

Solution AbbreviationsBWFI Bacteriostatic water for injectionD Dextrose solution (percentage unspecified)D2.5 Dextrose 2.5% in waterD2.5½S Dextrose 2.5% in sodium chloride 0.45%D5LR Dextrose 5% in lactated Ringer’sD5¼S Dextrose 5% in sodium chloride 0.225%D5½S Dextrose 5% in sodium chloride 0.45%D5S Dextrose 5% in sodium chloride 0.9%D10S Dextrose 10% in sodium chloride 0.9%D5W Dextrose 5% in waterD7W Dextrose 7% in waterD10W Dextrose 10% in waterDXN-6 Dextran 6%LR Ringer's injection, lactatedM10 Mannitol 10%NMD5W Normosol M in dextrose 5%NRD5W Normosol R in dextrose 5%NS Sodium chloride 0.9%R Ringer's solution½S Sodium chloride 0.45%¼S Sodium chloride 0.22%W Sterile water for injection

Reference1. United States Pharmacopeial Convention. Chapter Pharmaceutical Compounding—Nonsterile Preparations. Official August 1,

2008.


E X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

PART I

Applying Stability Data in Patient CareIntroduction

Factors Affecting Extended Drug Stability

Preparation Sterility and Quality Assurance

Professional, Regulatory, and Accreditation Expectations

Commercial Products and Extemporaneous Compounding

Infusate Properties

Vascular Access Devices and Catheters Used in Medication Administration

Labeling Instructions

Assigning Beyond-Use Dates

Patient and Site-Specific Considerations

Considerations in Selecting Administration Methods and Infusion Devices

External Factors Affecting Stability

Ethanol and Antibiotic Locks

Summary

Parenteral NutritionBeyond-Use Dating of Parenteral Nutrition (PN) Formulations

Non-Formulation Factors Affecting PN Stability

Formulation Factors Affecting PN Stability

Commercial Products and Extemporaneous Compounding

Professional, Regulatory, and Accreditation Expectations and Guidance

Summary

PARENTERAL NUTRITION MONOGRAPHS


Applying Stability Data in Patient CareE X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

3

Applying Stability Data in Patient CareCaryn Dellamorte Bing, Kevin L. Ross

IntroductionAlternate site pharmacists must use extended stability data to assign beyond-use dating to facilitate the cost-effective dispensing and delivery of compounded sterile preparations for multiple days of ther-apy. Pharmacists, regardless of practice setting, should always assign beyond-use dates that accurately represent the stability of the medication, combination of medications, or other component ingredients under the intended preparation, packing, shipping, storage, and administration conditions. To do this, the pharmacist must be familiar with the chemical and physical factors that affect the sterility, integrity, and stability of the final preparation. Additionally, environmental, operational, and personnel factors that contribute to the quality of a compound cannot be discounted. In light of very visible examples and tragic patient outcomes from contaminated preparations,1 pharmacists and technicians must diligently ensure that their facility produces contaminant-free preparations, which can then be assigned reasonable extended stability dates that are valid for their organization. Nurses and other professionals who adminis-ter parenteral medications must understand the application of beyond-use dating and physical/chemical characteristics of compounded sterile preparations in the patient care and patient education process.

Parenteral drugs are usually compounded and/or packaged in something other than the original manufacturer's container. They are often diluted prior to administration and stored under different conditions than the bulk (source) ingredients. These factors have a direct and important impact on the stability of the final preparation.

Factors Affecting Extended Drug StabilityKey terminology, definitions, a discussion of factors affecting extended drug stability, and some consid-erations for alternate site practice are provided below. References 3 and 40 are additional resources on the topics of drug stability, compatibility, and beyond-use dating.3,40

The shelf life stability of a drug is the length of time that the preparation retains the labeled potency of the active ingredient(s) under the labeled storage conditions. The common types of stability include chemical, physical, microbiological, therapeutic, and toxicological.40

The extended stability expiration dating in the monographs contained in this reference is the maximum time in which 90% or greater of a labeled active ingredient is measurable in the solution and container specified, under the stated storage conditions. For coagulation factor products, the stability is defined as retaining at least 80% of baseline activity.

Instability refers to the chemical processes that result in drug degradation, including hydrolysis, oxidation, reduction, and photochemical decomposition reactions. Increased temperature and expo-sure to light can increase the likelihood of chemical instability for many drugs, particularly those that are affected by hydrolysis or oxidation reactions. Practitioners should always be aware of the basis for a preparation's instability, as the byproduct(s) of drug degradation can have therapeutic and/or toxicity implications for patient care.

Incompatibility refers to a physical or chemical phenomenon that reduces the concentration of the active ingredient. In some cases, the incompatibility is easily observed, as with a precipitate, haze, color


4

Applying Stability Data in Patient CareE X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

formation, or other obvious visual change. However, many incompatibilities are not readily observed. Factors that affect drug stability, such as the diluent, its pH, the concentration of the drug, the com-ponent makeup of the container, and the presence of other agents and buffers, are summarized in Table 1.4,40

Combination drugs. Practitioners must establish the beyond-use date based on the least stable moiety of a combination drug. For example, with ticarcillin disodium/clavulanate potassium or piperacillin sodium/tazobactam sodium, the ticarcillin and piperacillin are the least stable components of the com-binations and are the basis for determining the beyond-use dating of these combination drugs.

Concentration dependence or independence of chemical stability. Many drugs exhibit consistent chemical stabilities within the normally used clinical ra

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