Blumenthal Urges FDA to Address Crisis-Level Shortages of Critical Pain Medications

(Hartford, CT)—Today. U.S. Senator Richard Blumenthal (D-Conn.) released a letter to U.S. Food and Drug Administration (FDA) commissioner Scott Gottlieb urging the FDA to address the shortage of several narcotic products used in hospitals to manage pain and sedate patients.

“Drug shortages continue to plague hospitals around the country, with some of these shortages lasting for years on end and fluctuating in intensity,” Senator Blumenthal writes. “This inevitably burdens hospitals with the tall task of finding workarounds, emergency solutions, and less than ideal plans to be implemented, occasionally for an extended period of time. However, in the end, it is patient care that suffers and patients themselves who bear the full brunt of these drug shortages. Whether it be sodium bicarbonate, saline, or injectable narcotics, drug shortages are unacceptable and action must be taken to mitigate current shortages and prevent future shortages to ensure that hospitals can focus on providing excellent care without undue barriers caused by this recurring issue.

This letter follows a notice from several Connecticut healthcare providers concerned with an ongoing shortage of injectable forms of Morphine Sulfate and Hydromorphone Hydrochloride, which are used regularly in hospitals across the country to sedate patients on ventilators, as well as treat intra-operative and post-surgical pain, acute injury, and palliative therapy pain control. 

“While I fully, and unequivocally support efforts to combat the substance use epidemic by increasing access to alternative pain management practices that deter reliance on opioids, there is still a need for well-managed medicinal use. Shortages of these drugs can have disastrous and life-threatening consequences if surgeries are cancelled or delayed because clinically necessary injectable opioids are unavailable,” the letter continues.

The full text of the letter can be found below.

 

 

April 5, 2018

 

The Honorable Scott Gottlieb

Commissioner

U.S. Food and Drug Administration

 

Dear Commissioner Gottlieb,

I write to bring to your attention an urgent shortage of several narcotic products used in hospitals to manage pain and sedate patients. These drug shortages have become so unmanageable that one Connecticut hospital described it as reaching “crisis level.” In light of the ongoing shortages, I request that the Food and Drug Administration (FDA) immediately take additional steps to increase market supply of these controlled products at approved manufacturing facilities.

Drug shortages continue to plague hospitals around the country, with some of these shortages lasting for years on end and fluctuating in intensity. This inevitably burdens hospitals with the tall task of finding workarounds, emergency solutions, and less than ideal plans to be implemented, occasionally for an extended period of time. However, in the end, it is patient care that suffers and patients themselves who bear the full brunt of these drug shortages. Whether it be sodium bicarbonate, saline, or injectable narcotics, drug shortages are unacceptable and action must be taken to mitigate current shortages and prevent future shortages to ensure that hospitals can focus on providing excellent care without undue barriers caused by this recurring issue.

Most recently, my office received notice from Connecticut healthcare providers related to an ongoing shortage of injectable forms of Morphine Sulfate and Hydromorphone Hydrochloride, which are used regularly in hospitals across the country to sedate patients on ventilators, as well as treat intra-operative and post-surgical pain, acute injury, and palliative therapy pain control.  These medications are frequently used in their most medically fragile patients, and are one of the basic underpinnings of humane treatment. While I fully, and unequivocally support efforts to combat the substance use epidemic by increasing access to alternative pain management practices that deter reliance on opioids, there is still a need for well-managed medicinal use. Shortages of these drugs can have disastrous and life-threatening consequences if surgeries are cancelled or delayed because clinically necessary injectable opioids are unavailable.

As such, I urge FDA to work quickly in using all tools at its disposal to remedy this shortage and work with manufacturers and other interested parties, like hospitals, to prevent or lessen the impact of future drug shortages.