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FDA MEDWATCH ALERTS

December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

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FDA MedWatch Recall - Particulate Matter

November 21, 2014

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

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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

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

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American Society of Anesthesiologists (ASA®) applauds GAO drug shortages report, urges continued vigilance on important public health issue

Chicago — (February 13, 2014) 

ASA applauds the release of the Government Accountability Office (GAO) report, “Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability,” which makes recommendations to help combat drug shortages.  The Society is pleased that GAO recognizes the need for continued attention and action on this issue as it gravely impacts patient safety and physician anesthesiologists’ ability to provide care.

The report identifies the trends and causes of drug shortages over the past several years, as well as recommendations for the U.S. Food and Drug Administration (FDA) going forward.

GAO found that “in 2012, for the first time since 2006, there was a decrease in the number of drug shortages reported.”  However, the number of drug shortages remains high, and anesthetic and central nervous system drugs are still the therapeutic class of drugs most frequently found in short supply.

“ASA commends the FDA for preventing more potential shortages and improving its ability to resolve existing shortages,” said ASA President Jane C. K. Fitch, M.D. “While there has been improvement in reducing drug shortages, it is still a major concern. ASA is proud to be a leader in efforts to address these shortages and we look forward to providing insight in the future."

ASA has actively led efforts to combat drug shortages on both legislative and regulatory fronts. ASA, along with key stakeholders, actively lobbied for passage of Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA), a section dedicated to addressing drug shortages.  This past November, in the FDA’s “Strategic Plan for Preventing and Mitigating Drug Shortages,”  the FDA recognized ASA’s ongoing work 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.

The FDA started the Drug Shortage Program in 1999 in order to address potential and actual shortages in the U.S. Shortly thereafter, ASA, along with the FDA and the American Society of Health-System Pharmacists (ASHP) held the first meeting on drug shortages.

ASA looks forward to continue working with the FDA and stakeholders on efforts to prevent and mitigate drug shortages.

 

THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

Founded in 1905, the American Society of Anesthesiologists (ASA) is an educational, research and scientific society with more than 52,000 members organized to raise and maintain the standards of the medical practice of anesthesiology. ASA is committed to ensuring physician anesthesiologists evaluate and supervise the medical care of patients before, during and after surgery to provide the highest quality and safest care every patient deserves.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org . To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/WhenSecondsCount. Like ASA on Facebook , follow ASALifeline on Twitter and follow ASA on LinkedIn .

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Contact:

American Society of Anesthesiologists
pr@asahq.org
847-825-5586