4 Things to Know about Drug Shortages

The Healthcare Supply Chain Association of America has released an Avalere Health report on the role of group purchasing organizations in managing and alleviating drug shortages in the United States.

The report outlines the ongoing causes and ramifications of drug shortages, what GPOs can do to help the situation and policy recommendations to help address the problem.

Here are four things to know about drug shortages from the HSCA's report.

1. The number of active drug shortages has been relatively static over the past two years. At the end of the first quarter of 2014, there were 305 active drug shortages. The number of active shortages has remained relatively steady since the third quarter of 2012, with an average of 295 shortages. However, this is almost double the 152 active shortages at the end of the first quarter of 2010.

2. Drug shortages are multi-faceted problems caused by both economic and non-economic forces. The U.S. Food and Drug Administration estimates approximately 70 percent of drug shortages are caused by a breakdown in product quality and manufacturing. Other commonly discussed players in drug shortages include drug recalls, industry consolidation, regulatory enforcement, reduced manufacturing capacity and quality control at manufacturing plants. Additionally, the HSCA reports the sudden expansion of the generic drug industry has impacted existing shortages, as generic drug manufacturers experienced a boom in the scope and volume of products without expanding manufacturing capacity.

3. Patient care and healthcare costs are adversely impacted by drug shortages. A study of oncologists presented by the Abramson Cancer Center and the Perelman School of Medicine showed 83 percent of oncologists are experiencing drug shortages, 43 percent of which delayed their patients' treatments. As a result, 78 percent of oncologists experiencing a drug shortage reported treating patients with an alternate regimen, sometimes not knowing the risks to patient safety. In terms of cost, the prices of generic drugs have risen, and providers are increasingly having a difficult time accessing these drugs. The study also found physicians had to use brand-name drugs 60 percent of the time as a result of generic drug shortages.

4. The federal government is concentrating efforts to improve the FDA's ability to respond to and mitigate the drug shortages. President Obama signed Executive Order 13588 in November 2011, requiring increased reporting of shortages. Manufacturers are now required to notify the FDA at least six months prior to discontinuing manufacturing of a drug. President Obama also signed the Drug Supply Chain Security Act in November 2013, addressing drug safety concerns regarding compounded drugs.

More Articles on Drug Shortages:

Navigating the Saline Solution Shortage: 4 Things to Know
The More Things Change, the More They Stay the Same: Dealing With Drug Shortages
8 Statistics on Care Affected by Drug Shortages

 

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