Overview

Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP <797>.
Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. ...
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Compounding Sterile Preparations

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NOOK Book (eBook - Third Edition)
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Overview

Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP <797>.
Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on:
  • Gap analysis and action plans
  • Safe use of automatic compounding devices
  • Cleaning and disinfecting
  • Radiopharmaceuticals as CSPs
  • Allergen extracts as CSPs.
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Editorial Reviews

Doody's Review Service
Reviewer: Nancy M Makem, Pharm D(Nazareth Hospital)
Description: This third edition of a reference detailing all of the requirements for compounding includes important updates to the USP 797 guidelines.
Purpose: It is intended to be used in order to help improve compliance and understanding of the USP 797 guidelines. The guidelines have been revised (and finalized) and many states are now requiring that these guidelines be followed.
Audience: According to the author, the book is intended for use in colleges of pharmacy, pharmacy departments, and pharmacy technician training programs. It is a valuable resource, especially for any director of pharmacy or IV room coordinator who is preparing to open a new clean room.
Features: This book covers all of the 797 requirements, as well as how to comply with the requirements and resources available for doing so. I found the section on hand hygiene and garbing particularly helpful as our IV room has been open less than two months. This was a great review to ensure that we are, indeed, compliant. The reference section is excellent and contains all of the needed guidelines for hazardous drugs and CETA certifications. I would have liked to have seen the USP 797 final revision included in the reference section.
Assessment: This an excellent book to have on hand in any operational IV room and a definite must have for any pharmacy that is preparing to open a USP 797 compliant IV room. This third edition is needed now that the final revision of USP 797 guidelines has been published.
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Product Details

  • ISBN-13: 9781585283316
  • Publisher: ASHP
  • Publication date: 2/1/2009
  • Sold by: Barnes & Noble
  • Format: eBook
  • Edition description: Third Edition
  • Edition number: 3
  • Pages: 481
  • File size: 7 MB

Meet the Author


E. Clyde Buchanan, M.S., R.Ph. FASHP
 
Clyde Buchanan is a pharmacy consultant and recognized expert on compounding sterile preparations and pharmacy planning, budgeting and operations. He is retired from Emory Healthcare in Atlanta where he was Senior Director of Pharmaceutical Services. Mr. Buchanan received his B.S. in Pharmacy from the University of North Carolina and M.S. and residency training from The Ohio State University. Prior to Emory, he held pharmacy leadership positions at Duke University Medical Center and St. John’s Hospital in Springfield IL. Mr. Buchanan has served the American Society of Health-System Pharmacists (ASHP) as Chairman of SIG on Administrative Practice; Vice Chair of the Council on Legal and Public Affairs; member of the House of Delegates, several committees, and task forces. Mr. Buchanan has edited and authored four books on sterile compounding and numerous manuscripts and book chapters. He has been a frequent speaker for state and national conferences on USP Chapter <797>.
 
Philip J. Schneider, M.S., F.A.S.H.P.
 
 
Philip J. Schneider is Clinical Professor and Associate Dean for Academic and Professional Affairs for the University of Arizona, College of Pharmacy at the Phoenix Biomedical campus. In this position, he provides oversight, development, and administration of educational initiatives including teaching, service and scholarship activities at the newly created Phoenix Biomedical Campus. 
 
He received a B.S. in Pharmacy from the University of Wisconsin, and M.S. in Hospital Pharmacy from The Ohio State University and received a Certificate of Residency from The Ohio State University Hospitals. During his 38 years of professional and academic service, he has published more than 170 articles and abstracts in professional and scientific journals, 38 book chapters, edited seven books and given more than 500 contributed or invited presentations in 22 countries and the US.
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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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