Key Drug Shortages Threaten Patients in the US

Drug shortages in the United States are negatively affecting our ability to care for our own. Hard to believe that in this great nation in 2011, enough medicines cannot be produced and distributed to serve the needs of our population, but it’s true: In a January 2011 report from a November 2010 summit held on U.S. drug shortages, it was noted that “Problems caused by drug shortages…have caused significant disruptions in patient care. These disruptions include canceled or delayed medical treatments and procedures, as well as adverse events caused by medications that may have the potential for greater harm than the first line therapy that is unavailable due to a shortage.”

According to a May 1, 2011, article in The Washington Post, Rob Stein reports that 211 medications became scarce in 2010.

These drug shortages are especially difficult to comprehend noting the former largesse of the U.S. pharmaceutical corporations’ market share, world-wide distribution, innovative manufacturing technology, sales expertise and tremendous profitability over a period of many years. One can only think that this could be partially attributed to the surge of mergers and buy-outs of U.S. pharmaceutical giants in the past few years resulting in a big "woops" at home. (Another glitch in the global economy?)

“Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.” And pharmaceutical companies are now relying on other countries to produce the raw materials for medicines—which may come from India, Italy and, in some cases, China. Gordon Johnston, President of the Generic Pharmaceutical Association, says that if there’s a problem in India or Italy, it may disrupt the drug supply in the U.S.

Allen J. Vaida, executive director of the non-profit Institute for Safe Medicine Practices, said, “It just reached a point where the number of shortages was slowly going up and up, and now we have a national crisis with this huge shortage of critical medications.” The scarcities may be affecting hospital emergency rooms’ abilities to keep people alive, not to mention affecting the care of patients in oncology wards and intensive care units throughout the United States.

Not a temporary rice or milk shortage—where consumers may be able to find substitutes for needed staples—this is medicine. Many of the shortages are of older, cheaper generic medications, often those that are less profitable so that many firms have stopped producing them, reducing the number of sources for them. Most of the shortages involve “sterile injectable” medications that are complicated to manufacture and which often incur manufacturing problems in the process.

While federal regulators have been trying to help ease shortages allowing emergency imports from overseas and permitting firms to resume production more quickly,a manager of the Drug Information Service at the University of Utah recently commented that “This is a crisis.” Valerie Jensen, head of FDA’s Drug Shortages Program, says the FDA is doing everything it can “under [its] current authority to try to deal with this situation.” In turn, some industries blame the increased inspections and oversight by the FDA which has made drug safety a high priority.

The shortage situation has also generated concern in Congress. Senate bill S. 296, the “Preserving Access to Life-Saving Medications Act” was introduced in February, co-sponsored by Amy Klobuchar (D-MN) and Bob Casey (D-PA), that would require companies to notify the FDA in advance when they anticipate a shortage in the production of a certain drug. While this is a good effort, the horse is already out of the barn. And while the legislation, if passed, may help to prevent further deterioration of the current situation, it won’t give us back our formerly healthy manufacturing capabilities. Again, it appears to be one more case of no one minding the company store.