Compounding Sterile Preparations / Edition 3

Compounding Sterile Preparations / Edition 3

by E. Clyde Buchanan, Philip J. Schneider
     
 

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ISBN-10: 1585281794

ISBN-13: 9781585281794

Pub. Date: 02/01/2009

Publisher: Ashp

Ensure patient safety with this comprehensive review of the fundamentals of preparing sterile products in hospital, home care, and community pharmacy settings. The third edition is a complete revision and update of this popular reference/textbook and incorporates the latest revisions to USP 797. You'll review the compounding process step-by-step, learn quality

Overview

Ensure patient safety with this comprehensive review of the fundamentals of preparing sterile products in hospital, home care, and community pharmacy settings. The third edition is a complete revision and update of this popular reference/textbook and incorporates the latest revisions to USP 797. You'll review the compounding process step-by-step, learn quality assurance methods for process validation and end-product evaluation, and fine-tune your knowledge on all aspects of the dispensing process. New chapters to this edition include: - Gap analysis and action plans - Safe use of automatic compounding devices - Cleaning and disinfecting - Radiopharmaceuticals as compounded sterile preparations - Allergen extracts as compounded sterile preparations

Product Details

ISBN-13:
9781585281794
Publisher:
Ashp
Publication date:
02/01/2009
Edition description:
New Edition
Pages:
450
Product dimensions:
8.30(w) x 10.80(h) x 1.00(d)

Table of Contents

Table of Contents
Dedication.............................................................................................................................iii
Preface..................................................................................................................................v
Contributors...........................................................................................................................xi

Section I: Sterile Preparation
1. Standards for Sterile Preparations................................................................................... 1
E. Clyde Buchanan
2. Sterile Preparation Formulation.......................................................................................19
E. Clyde Buchanan
3. Ancillary Equipment and Supplies................................................................................. 33
E. Clyde Buchanan
4. Primary Engineering Controls.........................................................................................43
James T. Wagner
5. Personnel Cleansing and Garbing..................................................................................61
E. Clyde Buchanan
6. Aseptic Technique..........................................................................................................69
Philip J. Schneider
7. Hazardous Drugs as Compounded Sterile Preparations...............................................79
Luci A. Power
8. Radiopharmaceuticals as Compounded Sterile Preparations.....................................  99
George H. Hinkle
9. Allergen Extracts as Compounded Sterile Preparations..............................................109
Lina Lattouf
10. Storage and Beyond-Use Dating.................................................................................115
Caryn M. Bing
11. Labeling Sterile Preparations.......................................................................................129
Patricia J. Kuban
12. Documentation of Compounded Sterile Preparations................................................ 143
E. Clyde Buchanan
13. Verification of Compounding Accuracy and Sterility................................................... 149
Eric S. Kastango
14. Finished Preparation Release Checks and Tests........................................................159
Eric S. Kastango
15. Handling Sterile Commercial Products and Compounded Sterile Preparations Within
the Pharmacy................................................................................................................   171
E. Clyde Buchanan
16. Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs......... 183
Caryn M. Bing
17. Batch Compounding.................................................................................................. 191
E. Clyde Buchanan

Section II: Quality Management
18. Gap Analyses and Action Plans................................................................................. 201
E. Clyde Buchanan
19. Pharmacist Education..................................................................................................241
Philip J. Schneider
20. Pharmacy Technician Education, Certification, Training, Evaluation,
and Regulation..............................................................................................................    249
E. Clyde Buchanan
21. Secondary Engineering Controls.................................................................................259
E. Clyde Buchanan
22. Safe Use of Automated Compounding Devices..........................................................281
Jay M. Mirtallo and Philip J. Schneider
23. Cleaning and Disinfecting.............................................................................................289
E. Clyde Buchanan
24. Environmental Quality and Control...............................................................................303
Eric S. Kastango
25. Dealing with Latex Allergies..........................................................................................317
Stephen K. Hetey
26. Personnel Training and Competency Evaluation of Garbing and
Aseptic Work Practices.................................................................................................     325
Eric S. Kastango
27. Policies, Procedures, and Quality Assurance Programs............................................. 337
E. Clyde Buchanan
28. Outsourcing the Compounding of Sterile Preparations............................................... 355
E. Clyde Buchanan

Section III: Appendixes
A. ASHP Guidelines on Pharmacy-Prepared Ophthalmic Products....................................367
B. ASHP Guidelines on the Safe Use of Automated Compounding Devices for the
Preparation of Parenteral Nutrition Admixtures................................................................   371
C. ASHP Guidelines on Handling Hazardous Drugs........................................................   379
D. CETA Applications Guide for the Use of Compounding Aseptic Isolators in
Compounding Sterile Preparations in Healthcare Facilities
CAG-001-2005 (12/8/2008)................................................................................................ 409
E. CETA Compounding Isolator Testing Guide CAG-002-2006 (12/8/2008)..................... 419
F. CETA Certification Guide for Sterile Compounding Facilities
CAG-003-2006 (12/8/2008)................................................................................................ 437
G. FDA Compliance Policy Guide...................................................................................... 443
H. Guidance for FDA Staff and Industry Compliance Policy Guides Manual Sec. 460.200
Pharmacy Compounding...................................................................................................  447
I. Model Rules for Sterile Pharmaceuticals......................................................................... 453
J. The National Institute for Occupational Safety and Health (NIOSH) Alert—
Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs
in Health Care Settings........................................................................................................ 459
K. The American Society for Parenteral and Enteral Nutrition document Safe Practices
for Parenteral Nutrition......................................................................................................... 461
Glossary............................................................................................................................... 463
Index .................................................................................................................................... 477
 
 

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