Published online Apr 12, 2020. doi: 10.4291/wjgp.v11.i2.32
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
Drug shortages are common yet their impact on patient care and their commercial ramifications has not been adequately researched. In Australia a shortage of balsalazide (2012-2013) necessitated substitution with alternative 5-aminosalicylate (5-ASA) formulations for ulcerative colitis (UC).
To assess and compare the clinical and commercial sequelae of non-medical switching from balsalazide to another 5-ASA and/or return to balsalazide once supply resumed.
A prospective cohort study of patients on balsalazide for mild-moderate UC was conducted where, strictly due to the national shortage (November 2012- January 2013), were switched to alternative 5-ASA and/or then returned to balsalazide once supply resumed. Clinical (Partial Mayo), endoscopic (Mayo score) activity, adverse effects (to alternative 5-ASA) and percentage market share (of continuous 5-ASA users) from baseline (i.e., time of switching due to shortage) through to five years were assessed.
Of 31 patients switched due to the shortage, 12 (38.7%) resumed balsalazide immediately once supply resumed, 8 (25.8%) prompted by adverse effects to the alternative 5-ASA used. Three patients (9.7%) had documented symptomatic improvement, 15 (48.4%) were unchanged and 13 (41.9%) had symptomatic worsening vs baseline (P < 0.01), after switching to an alternative 5-ASA. At 3 and 5y post switch, overall 26/31 (83.9%) and 23/31 (74.2%) had remained continuously on any 5-ASA therapy respectively. Twelve (38.7%) and 11 (35.5%) patients remained on balsalazide continuously at three and five years respectively after drug supply returned, equating to a loss of market share (within 5-ASA class) of 45.2% and 38.7% respectively.
This study of a balsalazide shortage in UC patients exemplifies the detrimental impact of a drug shortage on long term patient, disease and commercial outcomes.
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.