ABSTRACT
Easy access to large quantities of accurate health data is required to understand medical and scientific information in real-time; evaluate public health measures before, during, and after times of crisis; and prevent medical errors. Introducing a system in the USA that allows for efficient access to such health data and ensures auditability of data facts, while avoiding data silos, will require fundamental changes in current practices. Here, we recommend the implementation of standardized data collection and transmission systems, universal identifiers for individual patients and end users, a reference standard infrastructure to support calibration and integration of laboratory results from equivalent tests, and modernized working practices. Requiring comprehensive and binding standards, rather than incentivizing voluntary and often piecemeal efforts for data exchange, will allow us to achieve the analytical information environment that patients need.
Subject(s)
Anti-Bacterial Agents/adverse effects , Chemical and Drug Induced Liver Injury , Clinical Trials as Topic , Drug Approval , Ketolides/adverse effects , United States Food and Drug Administration , Advisory Committees , Humans , Product Surveillance, Postmarketing , Scientific Misconduct , United StatesSubject(s)
Acetamides/therapeutic use , Anti-Bacterial Agents/therapeutic use , Anti-Infective Agents/therapeutic use , Cross Infection/drug therapy , Methicillin Resistance , Oxazolidinones/therapeutic use , Pneumonia, Staphylococcal/drug therapy , Vancomycin/therapeutic use , Cross Infection/mortality , Humans , Linezolid , Pneumonia, Staphylococcal/mortality , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE: Reports of cefotetan-associated haemolytic anaemia have prompted a US Food and Drug Administration (FDA) review of the overall number, severity, and causality of such cases. METHODS/RESULTS: A search of the FDA's Spontaneous Reporting System and the World Health Organization's database revealed 85 cases of haemolytic anaemia since the approval of cefotetan in 1985, 15 of them fatal. Moderate to severe haemolysis was reflected in a mean fall in haemoglobin levels by 6.65 mg/dl (n = 20) and a mean final haemoglobin concentration of 5.2 mg/dl (n = 52). Transfusion of packed red blood cells was required in 47 patients (55.3%). New onset renal dysfunction was noted in 7 patients (8.2%). The direct antiglobulin test was positive in 50 patients (59%), and serological studies revealed antibodies to cefotetan in 30 patients (35%). CONCLUSION: These data suggest that treatment with cefotetan may induce severe autoimmune haemolytic anaemia.
