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November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur


FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled


Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator


FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall



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GAO Releases Drug Shortages Report; Finds Anesthetic Drugs Comprise Highest Percent of Shortages

Tuesday, February 11, 2014

On February 10, the Government Accountability Office (GAO) released a long-anticipated report on drug shortages, "Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability." 

In 2012, Congress directed GAO to study drug shortages through the Food and Drug Administration Safety and Innovation Act (FDASIA), a legislative package of important FDA provisions that includes Title X, a section dedicated solely to preventing and mitigating national drug shortages.  ASA's advocacy, in collaboration with other key stakeholders, resulted in the inclusion of Title X into FDASIA. 

The GAO report reviewed drug shortage trends, examined the causes of shortages, and evaluated the FDA's progress in combating shortages. 

The GAO report found anesthetic and central nervous system drugs are among the class of drugs experiencing the highest frequently of shortages at 17 percent of all shortages.

The GAO report recognized that the FDA has improved its response to drug shortages and has effectively worked to prevent more potential shortages.  However, "challenges remain" according to the GAO.   

The GAO highlighted deficiencies related to the manner in which the FDA currently collects and utilizes drug shortage data.  To enhance the FDA's work, the GAO recommended:

"FDA should strengthen its internal controls over its drug shortage data and conduct periodic analyses to routinely and systematically assess drug shortage information, using this information to proactively identify drug shortage risk factors."

In November of 2013, the Food and Drug Administration (FDA) released their "Strategic Plan for Preventing and Mitigating Drug Shortages."  The FDA plan recognized ASA's ongoing work with the FDA on drug shortages and stated that the FDA would "join with other stakeholder groups, such as groups convened by the American Society of Anesthesiologists…" to develop long-term prevention strategies on shortages.

ASA staff is currently reviewing the report and its recommendations.  ASA will continue to work with the FDA and stakeholders to combat drug shortages.

Review the report.
Learn more about ASA’s Advocacy on FDASIA and Title X. 
Learn more about the FDA Recognizing ASA’s Ongoing Work to Combat Shortages.

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