FEATURE chair for research at Cleveland Clinic ’ s Medicine Institute and director of its Center for Value-Based Care Research , and co-authors found that each service assessed different measures of structure , process , and outcomes and used inconsistent reporting periods and patient definitions . “ Consequently , they failed to agree on hospital rankings within any diagnosis , even when using the same metric ( such as mortality ),” the authors concluded .
The report offered suggestions for improving public reporting and ranking systems , such as a more active role for hospitals in designing “ measures that can be efficiently collected and that represent the true quality of care offered ,” citing the Hospital Quality Alliance ( which develops and implements the aforementioned CAHPS survey ) and the American College of Surgeons ’ National Surgical Quality Improvement Program as good
“ What ’ s interesting and valuable to patients may very well be lost in the aggregation .”
— CHARLES DINERSTEIN , MD examples of active participants . They also called on rating services to solve the problems of “ risk adjustment and random variation ” with standardized methodology and reporting periods to level the playing fields for providers .
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FEIBA [ Anti-Inhibitor Coagulant Complex ] Indications and Selected Important Risk Information for Healthcare Professionals
Indications for FEIBA [ Anti‐Inhibitor Coagulant Complex ]
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for :
• Control and prevention of bleeding episodes
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes .
FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX .
Selected Important Risk Information for FEIBA [ Anti‐Inhibitor Coagulant Complex ]
WARNING : THROMBOEMBOLIC EVENTS
• Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA , particularly following the administration of high doses and / or in patients with thrombotic risk factors .
• Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events .
The use of FEIBA is contraindicated in patients with :
• Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components , including factors of the kinin generating system
• Disseminated intravascular coagulation ( DIC )
• Acute thrombosis or embolism ( including myocardial infarction )
Thromboembolic events ( including venous thrombosis , pulmonary embolism , myocardial infarction , and stroke ) can occur with FEIBA , particularly following the administration of high doses ( above 200 units per kg per day ) and / or in patients with thrombotic risk factors .
Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg body weight . Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute . Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC , acute coronary ischemia , and signs and symptoms of other thromboembolic events . If clinical signs or symptoms occur , such as chest pain or pressure , shortness of breath , altered consciousness , vision , or speech , limb or abdomen swelling and / or pain , discontinue the infusion and initiate appropriate diagnostic and therapeutic measures .
Hypersensitivity and allergic reactions , including severe anaphylactoid reactions , can occur following the infusion of FEIBA . The symptoms include urticaria , angioedema , gastrointestinal manifestations , bronchospasm , and hypotension . These reactions can be severe and systemic ( e . g ., anaphylaxis with urticaria and angioedema , bronchospasm , and circulatory shock ). Other infusion reactions , such as chills , pyrexia , and hypertension have also been reported . If signs and symptoms of severe allergic reactions occur , immediately discontinue administration of FEIBA and provide appropriate supportive care .
Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents , e . g ., viruses , the variant Creutzfeldt‐Jakob disease ( vCJD ) agent and , theoretically , the Creutzfeldt-Jakob disease ( CJD ) agent .
The most frequently reported adverse reactions observed in > 5 % of subjects in the prophylaxis trial were anemia , diarrhea , hemarthrosis , hepatitis B surface antibody positive , nausea , and vomiting .
The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events , including stroke , pulmonary embolism , and deep vein thrombosis .
Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended .
Please see FEIBA Brief Summary of full Prescribing Information continued on the following page .