(91) Global Extent of The Valsartan Drug Recall and Its Effect on Antihypertensive Drug Use: A Multi-National Study

Publication Number: 1136

Background: Increasing and highly persistent drug shortages are a global problem that harms patient care and strains healthcare system. Globalization of manufacturing has resulted in centralization of supply chains that is vulnerable to disruptions. A recall of valsartan, an angiotensin receptor blocker (ARB), in July 2018 due to the contamination with a probable carcinogen illustrates the global nature of supply chains. Yet, the global impact of the valsartan shortage on the overall use of antihypertensives has not been studied.

Objectives: To examine the effects of the global valsartan recall and shortage on the utilization trends of antihypertensive medication in 83 countries.

Methods: A cross-sectional, time-series analysis of the global sales of antihypertensive medications across 83 countries from Jan 2017 to July 2020 was conducted using the IQVIA MIDAS Database. The total retail and hospital-based wholesale purchases of valsartan, non-valsartan ARBS and angiotensin-converting-enzyme (ACE) inhibitors were studied in a global context and by economic development status. The 1-, 3-, 6-month percent changes in monthly valsartan purchases for each country from July-December 2017 to the same period in 2018 were also quantified and analyzed.

Results: Overall, total monthly global purchases of valsartan significantly decreased by 17.9% from July to August 2018 and 13.2% between August 2017 and 2018 following the recall. The purchases of non-valsartan ARBs increased by 12.2% from July to August 2018 and 28.9% between August 2017 to 2018. Of the 32 developed countries, 20 (62.5%) showed a decline in 1 month (July-Aug) percent change in valsartan sales between 2017 and 2018, whereas only 10 out of 33 developing countries (30.3%) had decreased valsartan purchases after the valsartan recall. Average percent changes in 1, 3, and 6 months for developed countries were -1.2%, -9.3%, and -12.2%, respectively, while the changes for developing countries were 25.0%, 7.3%, and -1.2%.

Conclusions: Global purchases of valsartan decreased in the month of the valsartan recall, highlighting the impact of the recall across continents. The opposing trends depending on economies raise concerns: immediate reductions in valsartan purchases mostly in developed countries suggest the distribution of substandard medications to developing countries. Developed countries that showed reductions appear to have responded to the recall faster. Concerted actions to address equitable global access to quality medicines are needed.