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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Summary:

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Summary:

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Summary:

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

... Read more »

Single Copies, Member Price: $300

ASA Applauds the DEA for its Proposed Rule on Issuance of Multiple Prescriptions for Schedule II Controlled Substances

Chicago — (September 7, 2006) 

In response to strong ASA lobbying, the Drug Enforcement Administration (DEA) published in the September 6 Federal Register a rule that would allow physicians to issue multiple “dated” prescriptions so patients undergoing long-term pain management can receive, over time, up to a 90 day supply of their Schedule II medications.

In March of 2005 and 2006, ASA submitted joint comment letters with the American Medical Association (AMA) to make the case for post-dating prescriptions. In the letters and our direct conversations with DEA officials, ASA and AMA indicated that the practice is often necessary to ensure the best pain management possible. We appreciate the DEA’s responsiveness to our concerns in addressing this issue, and we look forward to a continued dialogue with the Agency in the future on this and other matters of concern.

The DEA has also issued a policy statement, “Dispensing Controlled Substances for the Treatment of Pain,” to assure physicians that the Agency does not intend to interfere with the legitimate practice of pain medicine, or make physicians hesitant to provide legitimate pain treatment.

ASA expects to file official comments with DEA expressing support of the proposed rule, which will protect the legitimate practice of pain medicine, give long-term pain patients more convenient access to their medications, and put in place safeguards that will help prevent the abuse and diversion of Schedule II controlled substances.

Please use the links below for more information:

THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

Anesthesiologists: Physicians providing the lifeline of modern medicine. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 46,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists Web site at www.asahq.org. For patient information, visit LifeLineToModernMedicine.com

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Contact:

Jennifer Gremmels
j.gremmels@asahq.org
847-268-9128