Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pathophysiol. Apr 12, 2020; 11(2): 32-42
Published online Apr 12, 2020. doi: 10.4291/wjgp.v11.i2.32
Outcomes of a drug shortage requiring switching in patients with ulcerative colitis
Daniel R van Langenberg, Richard Kai-Yuan Cheng, Mayur Garg
Daniel R van Langenberg, Richard Kai-Yuan Cheng, Mayur Garg, Department of Gastroenterology, Eastern Health, Box Hill, Victoria 3128, Australia
Daniel R van Langenberg, Mayur Garg, Eastern Health Clinical School, Monash University, Box Hill, Victoria 3128, Australia
Richard Kai-Yuan Cheng, Department of Gastroenterology, Redcliffe Hospital, Redcliffe, Queensland 4020, Australia
Mayur Garg, Department of Gastroenterology, Royal Melbourne Hospital, Parkville, Victoria 3052, Australia
Author contributions: van Langenberg DR conceived and designed the work, plus contributed to the collection, analysis and interpretation of data and drafting of the manuscript; Cheng RKY contributed to the collection of data and to drafting the manuscript; Garg M contributed to the design and contributed to analysis and interpretation of data, plus drafting the manuscript; all authors approved the final version of the manuscript.
Institutional review board statement: This study was approved as a low-risk application by the Eastern Health Office for Human Research & Ethics.
Informed consent statement: Patient consent was not deemed to be required for this non-interventional observational study using deidentified data.
Conflict-of-interest statement: All authors have no conflicts of interest to declare in relation to this work.
Data sharing statement: Not applicable.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Daniel R van Langenberg, FRACP, MBBS, PhD, Associate Professor, Head of IBD, Gastroenterologist, Department of Gastroenterology, Eastern Health, 8 Arnold Street, Box Hill, Victoria 3128, Australia. daniel.van-langenberg@monash.edu
Received: November 12, 2019
Peer-review started: November 12, 2019
First decision: December 23, 2019
Revised: March 4, 2020
Accepted: March 12, 2020
Article in press: March 12, 2020
Published online: April 12, 2020
Processing time: 148 Days and 7.3 Hours
Core Tip

Core tip: As a chronic disease, this study of a drug shortage in ulcerative colitis provides an excellent, novel insight into the short and long term effects of an sudden, unexpected nationwide drug shortage (in this case balsalazide) in patients previously in stable remission. The study highlights the importance of maintaining a seamless drug supply for both patients (given significant rates of disease worsening occurred, directly attributable to shortage), and drug manufacturers given the loss of market share engendered by even a short term drug shortage.