(009) Extent of the Ranitidine Shortage and its Impact on Acid Suppression Drug Utilization in Canada and the United States: an Interrupted Time Series Analysis
Assistant Professor University of Toronto University of Toronto Toronto, Canada
Background: Drug shortages are a complex global challenge. Shortages have been shown to negatively affect patient outcomes and drain health system resources, but few studies have analyzed quantitative data on their impacts. In September 2019, detection of a nitrosamine impurity in ranitidine led to recalls and shortages; this presented an opportunity to analyze the effects of a shortage of a commonly used drug in both Canada and the United States (US).
Objectives: Our aim was to determine the impact of the ranitidine shortage on the utilization of acid suppression drugs in Canada and the US.
Methods: We conducted a repeated cross-sectional study from January 2016 through December 2021 using monthly data for Canada and the US. We determined the utilization of acid suppression drugs by calculating the monthly number of purchased units of all histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) available in Canada or the US. Country-level purchasing data were obtained from IQVIA’s MIDAS database, which comprises all drug purchases through retail and hospital distribution channels. We performed interrupted time series analysis using autoregressive integrated moving average models to determine the impact of the shortage on purchasing rates for ranitidine, other (non-ranitidine) H2RAs, and PPIs.
Results: Prior to the recalls, 20,439,915 ranitidine units were purchased monthly in Canada and 189,038,496 in the US on average. After the recalls started in September 2019, purchasing rates decreased for ranitidine (Canada p = 0.0048, US p < 0.0001) and increased for non-ranitidine H2RAs (Canada p = 0.0192, US p = 0.0534). One month after the recalls started, ranitidine purchasing rates dropped from the pre-recall average of 54,652 units per 100,000 persons to 524 (99% decrease) in Canada and from 57,689 to 27,135 (53% decrease) in the US; non-ranitidine H2RA purchasing rates increased from 6743 to 15,398 (128.3% increase) in Canada and from 29,412 to 40,377 (37.3% increase) in the US. After twenty-four months, ranitidine purchasing rates were 6711 units per 100,000 persons (87.7% decrease) in Canada and 0 (100% decrease) in the US; non-ranitidine H2RA purchasing rates were 21,935 (225.3% increase) in Canada and 70,144 (138.5% increase) in the US. PPI purchasing rates did not change significantly in either country (Canada p = 0.7469, US p = 0.1888).
Conclusions: The ranitidine shortage led to immediate and sustained shifts in utilization of H2RAs in both countries, potentially affecting hundreds of thousands of patients. Our results emphasize the need for future studies of the clinical and financial implications of the shortage. More work is needed worldwide to mitigate and prevent drug shortages, and address this global problem.
