DMU Research Highlights Risk of Prescription Drug Shortages

Study by DMU Professor, Fellow Researchers, Points to Need for More “Agile” Health Systems 

Many health risks — like sitting too much, eating unhealthy foods and smoking — can be avoided. Other health threats — like not being able to get certain prescription medicines — are out of our control and can wreak havoc. 

A study published recently in the Journal of the American Heart Association sheds light on the dire consequences of drug recalls and shortages. “A retrospective cohort study of the 2018 angiotensin receptor blocker recalls and subsequent drug shortages in patients with hypertension” explores the significant effects of a 2018 shortage of the blood pressure medication valsartan. The shortage began in July 2018, following a recall ordered by the U.S. Food and Drug Administration due to the discovery of cancer-causing impurities in the drug. Lead author Joshua Devine, Pharm.D., Ph.D., assistant professor of public health at Des Moines University, joined researchers from the University of Toronto, University of California-San Diego and University of Pittsburgh to investigate the impact of this shortage on hypertension patients. 

Joshua Devine, Pharm.D., Ph.D.
Joshua Devine, Pharm.D., Ph.D.

The study authors compared health outcomes among 76,934 patients taking valsartan with 509,472 patients on alternative hypertension drugs. The findings were telling. Patients who took valsartan had a greater risk of hospitalization, emergency department visits or use of urgent care services than those taking nonrecalled drugs. Valsartan users also faced an increased risk of cardiac events in the six months following the recall. 

“This study has far-reaching implications,” the authors stated in the study. “Shortages of noninjectables are becoming more common, now comprising more than 50% of drug shortage reports annually. Substituting drugs on shortage for alternative medications may be more complicated in the fragmented outpatient health care system.” 

Other implications, which the authors say warrant further study, include the “cost of additional health care resources required to prescribe an alternate medication, pharmacist time to communicate with prescribers and procure alternate medications, and increased medication costs.” 

Devine points to the need to better coordinate health care systems and improve the quality of U.S. retail drug supply chains to ensure patient access to alternative medications. 

“Hypertension is a condition that affects nearly half of the nation’s adult population. In addition, other recent drug shortages, such as oncology drugs that have been staples of cancer treatment for decades or pain relief medications to treat high fevers among children, have raised national attention on the need to better understand these supply chain issues so we’re not as susceptible,” he says.  

While the authors note limitations in their results — for example, the administrative claims data they used can be subject to measurement error — Devine says it provides “further evidence that outpatient drug shortages can disrupt supply chains and affect clinical outcomes.” 

“As these shortages become increasingly common, we have to determine how our fragmented health care system can act collectively and become more agile to reduce poor patient outcomes and prevent avoidable and costly health care use,” he says. 

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