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Awareness - NY1 "Week in Review" Show
At Twin Cities Hospitals, Doing More With Less Blood
Anemia therapy under recall over hypersensitivity, one death.
The Wall Street Journal (5/22, Jones, Subscription Publication, 2.29M) reports Amag Pharmaceuticals Inc. announced that its marketing partner, Osaka, Japan-based Takeda Pharmaceutical Company, issued a recall for its iron-deficiency treatment Rienso (ferumoxytol), based on the receipt of four reports of hypersensitivity occurring after the drug was administered to patients, one who subsequently died. Although Takeda distributes the anemia treatment in US, Canada and the EU, the recall is limited to a specific lot that was sold in Switzerland, Amag said, adding that the two pharmaceutical firms are reviewing the specific batch of the therapy under recall to determine what might have caused the adverse reactions.
According to Reuters (5/22, Ail), Amag announced the recalled batch of Rienso, which is marketed under the brand name Feraheme in the US and Canada, in an SEC filing yesterday. The Lexington, Massachusetts-based drug maker said it intends to seek approval from Switzerland's regulatory body, Swissmedic, to produce new batches of the therapy to replace the recalled product. Reuters adds that last August, Swissmedic approved Rienso as treatment for iron deficiency anemia in chronic kidney disease patients undergoing dialysis, and the company was hoping to get an extended approval for Rienso to treat anemia in all patients.
CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.
Administrative and Clinical Standards for Patient Blood Management Programs
SABM is presenting for public review and comment a draft of the second edition of the Administrative and Clinical Standards for Patient Blood Management. These Standards provide a framework of those elements SABM feels are essential to development and maintenance of a high-quality Patient Blood Management Program. For those familiar with the first edition of these Standards, we have provided a brief overview of the major differences between the first edition and this second edition.
Please forward comments to Varlerie Getchell at [email protected]
Administrative and Clinical Standards for Patient Blood Management are copyrighted.
Considered by many to be the ultimate expression of community participation in healthcare, voluntary blood donation has enabled medicine to make use of this unique and complex liquid organ. Hailed as a life-saving measure since WWII, blood transfusion is one of the most common medical interventions performed worldwide. Nonetheless, emerging scientific evidence is pointing to it being a questionable therapy of unproven benefit.
Amazingly, blood products have escaped the rigors of testing that would measure their safety and efficacy. Furthermore, the gap between science and medical practice is alarming, but not unprecedented. Like in other areas of human endeavor, old habits die hard. The Semmelweis reflex—the knee-jerk rejection of new knowledge that contradicts strong-held beliefs and entrenched norms—helps explain this divide.
Primum non Nocere – First, Do No Harm—examines this concept in the setting of global transfusion practice, and reveals the costly efforts to reduce patient exposure to infectious complications. The film discovers the heartening results achieved by surgeons and blood bankers alike who are guided by this immutable oath, thus bridging the gap between science and widespread belief.
PBM: A hot topic at the Patient Safety Summit
The Inaugural Patient Safety Science and Technology Summit held in Laguna Niguel California on January 13 and 14, 2013 was a success. Joe Kiani, President and CEO of Masimo hosted the meeting which was attended by international healthcare leaders. President Bill Clinton gave the keynote address.
SABM’s President, Aryeh Shander, MD was the moderator of Challenge #3: Overuse of red cell transfusions. Seven physicians joined Dr Shander in the panel discussion as well as the break out session on red cell overuse: Wael Nabil Fahmey Awada, MD, Keith J. Ruskin, MD, David C. Classen, MD, Howard Shapiro, MD, Charles R. Denham, MD, L.T. Goodnough, MD and John A. Ulatowski, MD. Of the three challenges, red cell overuse was undoubtedly the least recognized by most attendees. This was great opportunity for many health care leaders from all over the world to become informed about PBM.
To see videos from this important summit click the link below.
Red cell Overuse Panel Discussion video: