Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Root Cause Analysis, Part 2: Sterile Compounding

Author(s):  Cabaleiro Joe, Jackson Kathleen

Issue:  Mar/Apr 2016 - Volume 20, Number 2
View All Articles in Issue

Page(s):  99-104

Root Cause Analysis, Part 2: Sterile Compounding Page 1
Root Cause Analysis, Part 2: Sterile Compounding Page 2
Root Cause Analysis, Part 2: Sterile Compounding Page 3
Root Cause Analysis, Part 2: Sterile Compounding Page 4
Root Cause Analysis, Part 2: Sterile Compounding Page 5
Root Cause Analysis, Part 2: Sterile Compounding Page 6

Download in electronic PDF format for $75

Abstract:  When an adverse event or near miss occurs in a pharmacy, eliminating the root cause to prevent recurrence is critically important. Addressing the root cause of the problem reduces the recurrence of putting patients and the pharmacy at risk. This article proposes a method for performing Root Cause Analysis applicable to sterile compounding.

Related Keywords: compounded sterile preparations, environmental contamination, drug safety, root cause analysis, adverse events, sterility testing, pharmacy staff training, United States Pharmacopeia, USP, pharmacy standards, case study, standard operating procedures, product recall

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Root Cause Analysis, Part 2: Sterile Compounding
Cabaleiro Joe
, Jackson Kathleen
Mar/Apr 2016
Pg. 99-104

Root Cause Analysis, Part 1: Nonsterile Compounding
Cabaleiro Joe
, Jackson Kathleen
Nov/Dec 2015
Pg. 465-469

Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
Nov/Dec 2021
Pg. 491-496

Microbiologic Testing for 503A Sterile-Compounding Pharmacies
Mixon William
, Roth Abby
May/Jun 2017
Pg. 193-203

Establishing a Structured Pharmacy Training Program in Sterile Compounding
Dirbas Muhannad
, AbuSara Aseel K, Whiyabi Shatha, Harb Rema, Telfah Shorouq
Nov/Dec 2020
Pg. 460-465

Quality Control and Basics of Sterile Compounding: Attempting to Avoid Out-of-Specification Results and Patient Harm in Sterile Compounding
Martin Matt
Jan/Feb 2019
Pg. 47-49

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 14: Environmental Quality and Control (Continued)
Okeke Claudia C
, Allen Loyd V Jr
Jul/Aug 2009
Pg. 322-329

Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations
Dawson Michael F
Jan/Feb 2006
Pg. 36-39

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

Basics of Compounding: Considerations for Implementing USP Chapter <797> Pharmacy Compounding -- Sterile Preparations, Part 20: Patient or Caregiver Training, Patient Monitoring and Adverse Events Reporting, and Quality-Assurance Program
Okeke Claudia C
, Allen Loyd V Jr
Jul/Aug 2010
Pg. 328-331

Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
McElhiney Linda F
Jul/Aug 2013
Pg. 307-311

Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2007
Pg. 404-410

Quality Control Analytical Methods: Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 2: USP Waters: Experts at the United States Pharmacopeia Answer Compounders' Questions
Schnatz Rick
, Hernandex-Cardoso Antonio
May/Jun 2011
Pg. 224-232

Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations
Ashe Krystina
, Baskett Dustin
Sep/Oct 2018
Pg. 387-398

Adventures in the Environmental World and Environmental Microbiology Sampling of Air for Pharmaceutical Sterile Compounding
Ligugnana Roberto
May/Jun 2017
Pg. 182-190

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 5: Verification of Accuracy, Sterility, and Sterilization of Compounded Preparations
Allen Loyd V Jr
, Okeke Claudia C
Jan/Feb 2008
Pg. 54-60

Advanced Compounding; How to Investigate Microbiological Excursions at a Sterile Compounding Facility
Summers Amy
Mar/Apr 2023
Pg. 114-121

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
Martin Matt
Sep/Oct 2018
Pg. 401-404

Return to Top