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Anesthesia Industry and Market News: eAlerts

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January 29, 2018

Summary

Drug shortages remain a serious problem, and anesthesia providers are particularly vulnerable, with anesthesia drugs often among those in short supply.  We offer a glimpse of current trends, advocacy initiatives by the American Society of Anesthesiologists and others, research on causes and potential solutions, and programs at individual institutions.

As anesthesia practitioners know, drug shortages can cause a variety of complex adjustments to medical treatment that can jeopardize patient safety and interfere with the quality of care. And they remain a serious public health problem.  A 2016 study by the Government Accountability Office (GAO) showed that, while the number of new drug shortages has trended downward since 2011, the number of ongoing drug shortages has remained high.  The American Society of Health-System Pharmacists (ASHP), which maintains a database, currently lists 147 drugs that are in short supply.

The severe shortage of sodium chloride 0.9% IV bags and other saline bags due in large part to the devastation wrought by Hurricane Maria on pharmaceutical plants in Puerto Rico offers one of the more unsettling recent examples.  (The commonwealth manufactures more pharmaceuticals for the United States than any of the 50 states or any foreign country.)

To help address the shortage, on January 24, the Food and Drug Administration (FDA) extended the shelf life of certain IV solutions made by Baxter Healthcare beyond the manufacturer’s labeled expiration date.  In a statement, the FDA said it expects the shortage will improve in the coming weeks and months and is working with manufacturers to import product into the U.S. from their foreign facilities.  (A comprehensive fact sheet on strategies for dealing with shortages of small-volume parenteral solutions is available from the ASHP.)

Drug shortages tend to hit anesthesia especially hard. In October 2017, the FDA announced a nationwide shortage of many injectable forms of fentanyl citrate, a shortage that persists.  A 2014 GAO study found that central nervous system drugs accounted for 17 percent of all drug shortages and that the shortages of these drugs were routine.  A 2012 survey by the American Society of Anesthesiologists (ASA) found that 97.6 percent of responding anesthesiologists were experiencing at least one anesthesia-related drug shortage. 

Organizations are joining forces to find long-term solutions to the crisis.  A 2017 report by the Pew Charitable Trusts and the International Society for Pharmaceutical Engineering based on interviews with 10 drug manufacturers points to manufacturing quality issues as a driving force behind many shortages.  These issues often lead to lower-than-expected yields.  The report recommends, among other things, that manufacturers develop systems to proactively identify and resolve quality issues across their supply chains.

At the same time, the ASA, ASHP, the American Hospital Association, American Medical Association and other healthcare groups have called on Congress to take immediate action to address the crisis and to support the development of a strategy to examine and remedy the underlying causes of drug shortages.

Strategies That Work

Providers have used some innovative approaches to help prevent or reduce the impact of drug shortages on their institutions.  Duke University Hospital (Durham, NC) formed a multidisciplinary perioperative drug shortage response team to address shortages of neuromuscular blocking agents such as succinylcholine in their operating rooms.

When a shortage is deemed critical, the coordinator of the Center for Medication Policy convenes a task force to discuss whether the shortage can be managed best by pharmacy alone or by a multidisciplinary group that includes anesthesiologists, nurse anesthetists, surgeons and OR nurses.

The team also uses data from its anesthesia information management system (AIMS) to identify trends and patterns in medication usage in the perioperative setting and develop strategies to repackage bulk medications into smaller unit doses whenever possible.  The approach allows the hospital to conserve inventory, reduce waste and extend the availability of difficult to obtain medications.

Anesthesia providers might also take a cue from pharmacist Trac Pham, RPh, of Advocate Health Care, who outlined strategies that have worked at his health system:

  • Use inventory control specialists whose responsibilities revolve around identifying red flags such as back orders and partial fulfillments. Empower frontline employees to identify these potential shortages.
  • Assess current inventory when a potential shortage has been identified—a step many hospitals fail to take. How much is sitting on the shelf today?  What is the hospital’s utilization rate?  How long is the current supply going to last?
  • Collaborate with supply chain and pharmacy to evaluate potential shortages, identify alternative therapies, prioritize patients who should receive the affected drug and modify clinical plans.
  • Develop a process that allows executives, clinicians and employees to communicate in a timely manner with each other to navigate drug shortages.
  • To ensure uninterrupted care, update the health information management system promptly to reflect alternative drugs when there is a shortage. 
  • Harness predictive analytics to identify market variables historically associated with drug shortages.

For more information, also see the ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems, American Journal of Health-System Pharmacy, 2009; 66:1399-405.

With best wishes,

Tony Mira
President and CEO