ASA addresses drug shortages to ensure patient safety

A guest column by the American Society of Anesthesiologists, exclusive to

by Arnold J. Berry, MD, MPH

Drug shortages continue to impact patients across the nation. Over the past year, anesthesiologists have been faced with the challenge of finding alternatives for several unique drugs needed to safely provide anesthesia for patients having surgical, diagnostic or therapeutic procedures.

Anesthesiologists have the knowledge and training to work around the severe shortages of some drugs by using alternatives, but for other extremely critical medications that do not have a comparable alternative, they must consider whether it would be safer to postpone elective procedures.

In contrast, there have been some successes with alleviating drug shortages. In late 2009, when there were widespread reports of propofol shortages, the American Society of Anesthesiologists (ASA) worked with the Food and Drug Administration (FDA) to permit importation of a European formulation of propofol. This temporarily eased the shortage and permitted anesthesiologists to have a supply of the drug until greater production could resume in the United States.

To develop more long-term solutions to the drug shortage problem, anesthesiologists have turned to their medical specialty organization. In November 2010, ASA participated in a Drug Shortages Summit to coordinate efforts with other key health care organizations, pharmaceutical manufacturers and supply chain entities. Several recommendations came from the Summit, including the need for:

  • Improved communications among stakeholders in the pharmaceutical supply chain and patient care providers.
  • Required manufacturing redundancies to develop plans for vulnerable drugs.
  • Increased collaboration between industry, the Drug Enforcement Administration and the FDA to better modify quotas in response to shortages.

Unfortunately, a few months after the Summit, Hospira announced its plans to stop manufacturing sodium thiopental, a drug that anesthesiologists had used for decades to induce general anesthesia.  Although it has recently been replaced in many cases with propofol, sodium thiopental remained the drug of choice for use in geriatric patients as well as patients having neurologic, cardiovascular or obstetric procedures. The company’s decision further underscored the need to continue to develop solutions to ensure patients have the best drugs available to meet their clinical needs.

As part of an effort to implement recommendations from the Summit and to address the absence of sodium thiopental and the ongoing shortages of other drugs, Senators Amy Klobuchar (D-Minn) and Bob Casey (D-Pa) introduced legislation in February 2011 that would require drug makers to  promptly notify FDA when an issue arises that could result in a shortage. ASA looks forward to working with the senators on this critical patient safety issue.

My own institution, as well as others across the country, is currently facing shortages of neostigmine, a drug necessary for reversing the effects of potent muscle relaxants, and norepinephrine, a medication used to treat severe low blood pressure in critically ill patients. While the causes of these drug shortages and others are complex and multifactorial, ASA will continue to work to ensure that patients remain safe and receive the highest quality of care.

Arnold J. Berry is Vice President for Scientific Affairs of the American Society of Anesthesiologists.

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