Over the past six years, there have been a growing number of drugs in critically short supply due to a number of factors including lack of manufacturer regulations. More than 80% of these were generic injectable medications, and over 60% were drugs concentrated in five disease areas: oncology, anti-infectives, cardiovascular, central nervous system and pain management.
Unfortunately, injectables make up a large portion of pediatric care, placing a disproportionate burden on children’s hospitals becuase oral medication is more difficult for children to ingest. Some of the drugs that have been unattainable or on limited supply include methotrexate, a life-saving cancer drug, anti-nausea drugs, anesthetics using in surgery, and preventative and nutritive medicines used in neonates.
According to the FDA, the top three reasons for the shortages include product-quality issues, suppliers discontinuing production of a medication and capacity constraints. In some cases, these shortages have resulted in delays in patient treatment, increased prices in scarce drugs by as much as 650 percent and pediatric drug shortage setbacks.
At Children’s, we have worked closely with U.S. Senator Amy Klobuchar’s office on legislation that would broaden manufacturer reporting requirements for future supply chain disruptions. Thanks to the Senator's leadership, a bill that requires drug manufacturers to report all permanent and temporary interruptions in production at least six months in advance (or as soon as practicable upon awareness of a likely shortage) was passed into law in 2012. This bill will give the FDA the advance notice it needs to avert shortages. Find out more about drug shortages and pharmaceutical access.