After 5 years of declines in the number of new drug shortages in the U.S., they jumped to 39 last year from 26 in the two preceding years. And while that is a far cry from the peak of more than 250 registered in 2011, the FDA acknowledges that many of the current shortages have been for critical drug products and “are having a tangible impact on patients.”
Those critical shortages spanned the spectrum from Mylan’s EpiPen, to injectable painkillers used in hospitals, to mundane but essential IV fluids.
“These shortages greatly impact patient treatment options and require practitioners to make difficult decisions that can compromise care, such as rationing supplies or using less desirable, but more readily available, alternative therapies,” the FDA said in a statement this week.
Manufacturing problems at one of the largest U.S. drugmakers, Pfizer, are at the heart of some of the most troubling shortages for the the FDA and the healthcare system. Its Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.
The FDA pointed out in a report that shortages of these particular drugs were caused by production delays tied to changes and upgrades made at a Pfizer facility in Kansas after the agency slapped it with a warning letter. It was then “exacerbated by recent issues related to manufacturing quality at the same facility.”
The FDA has been working with Pfizer and other drugmakers to deal with the shortage, but for its part, Pfizer expects the supply problem to continue into 2019.
On top of that, quality issues at another Pfizer plant that also provoked the FDA to issue a warning letter disrupted supplies of Mylan’s ubiquitous EpiPen, an autoinjector for lifesaving epinephrine. The devices are made by Pfizer’s Meridian Medical Technologies at a plant near St. Louis, Missouri.
In the warning letter issued last year, the FDA reported that the plant continued to manufacture the devices even in the face of mounting evidence that many were failing during emergencies. The warning letter said the unit had received hundreds of complaints that its “EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.”
The FDA is working with Mylan and other manufacturers of epinephrine injectors to monitor supplies and increase production and says that it expects the regional shortages to be short-lived. The FDA acknowledges, however, that they are a serious concern to patients or parents of anyone that could have a fatal reaction to a bee sting or allergy.
“We recognize the anxiety that is felt when access to these products are not guaranteed, and we want to assure the public that we are doing everything we can to address supply issues with the brand product,” the agency said.
While manufacturing problems are manmade causes of drug shortages, the FDA has also found itself dealing with so-called acts of God when hurricanes ripped through the Carribean last year, leaving plants in Puerto Rico of the biggest supplier of IV fluids without power to produce. The interruptions forced some hospitals to ration their saline solution and amino acid products and to make tough decisions about who would get what when.
Many presentations of saline were already in short supply before the hurricanes took Baxter’s three saline and amino acid plants out of meaningful production. The power issues on the island have now been mostly resolved, but it will take some time before stockpiles will be fully restored.
All of this has left some members of Congress wondering whether the FDA is doing all it can to resolve the perpetual shortage problem. Thirty-one senators from both parties sent a letter (PDF) to Commissioner Scott Gottlieb, M.D., acknowledging the strides that have been made but urging him to address "our nation's ongoing and worsening drug shortage crisis."