Total Parenteral Nutrition (TPN) drugs play an integral role in the growth and immune system health of newborns and children who cannot digest nutrients on their own. Unfortunately, TPN drugs have been in critical shortage for several months. Since 2010, there have been 300 drug, vitamin, and trace element shortages in the United States, the highest number ever recorded by the University of Utah Drug Information Service.
Prompted by an article entitled, “Children Are Dying”, in the Washingtonian magazine, several Delawareans first brought this issue to Senator Coons’ attention in May. The Senator’s staff subsequently met with representatives of Nemours, a non-profit health organization that operates A.I. duPont Children’s Hospital in Wilmington, Delaware. Nemours representatives confirmed that TPN drug shortages are a life-threatening problem for many newborns and are directly affecting the quality of care in neonatal intensive care units in Delaware and across the country.
The shortage began after American Regent, the leading provider of TPN drugs, temporarily halted operations in late 2012 when U.S. Food and Drug Administration (FDA) investigators found particulate matter in the company’s injectable products. Though the company was set to reopen after 30 days, it is still not fully operational. The FDA is working to import drugs from trusted foreign manufacturers, but has faced challenges due to the strenuous approval process and strict FDA requirements.
Thankfully, in late May, the FDA had a breakthrough with the importation of trace elements and phosphate injections from a Norwegian plant. The agency has also begun importing critical nutrients like calcium chloride and intra-lipids. Although zinc shortages remain an issue, the FDA is continuing to look for new importers and to assist suspended manufacturers in resuming production. While there is no clear indication of when and to what level domestic production will resume, the FDA has made resolving the TPN shortage a top priority. Additionally, various legislative and executive efforts, such as President Obama’s 2011 Executive Order requiring drug manufacturers to notify the FDA when a shortage appeared imminent, have proven successful in enabling the FDA to recognize shortages early and proactively identify alternate drug suppliers and manufacturers.
This is good news for hospitals, like A.I. duPont Children’s Hospital, that treat vulnerable patients like newborns and chronically ill children who rely on TPN drugs for survival. The FDA is continuing to work with domestic drug manufacturers to get operations back online as quickly as possible and ensure that the necessary drugs, vitamins, and trace-elements get to our nation’s hospitals. Our staff will continue to monitor the TPN drug shortage situation and keep Delawareans informed of its progress.