Finding Potential Adverse Events in the Unstructured Text of Electronic Health Care Records: Development of the Shakespeare Method.

Background: Big data tools provide opportunities to monitor adverse events (patient harm associated with medical care) (AEs) in the unstructured text of electronic health care records (EHRs). Writers may explicitly state an apparent association between treatment and adverse outcome ("attributed") or state the simple treatment and outcome without an association ("unattributed"). Many methods for finding AEs in text rely on predefining possible AEs before searching for prespecified words and phrases or manual labeling (standardization) by investigators.

Treatment of animal toxicoses: a regulatory perspective.

This article focuses on the regulatory issues to consider when veterinarians are called upon to treat animal toxicoses, in particular those involving food-producing animals. The lack of Food and Drug Administration-approved drugs to treat animal toxicoses has been a long-standing problem. This article reviews extralabel drug use regulations, and the responsibilities of the treating veterinarian.

Safety of antibiotic drugs in food animals: comparison of findings from preapproval studies and postapproval experience in the United States with safety information in published literature.

Antibiotics are among the most widely prescribed drugs and are generally considered safe for the target species. However, their use has been associated with various adverse toxic effects in target animals, such as allergic reactions, gastrointestinal signs, cardiovascular effects, hypoglycemia, hepatic/renal toxicity, thrombocytopenia, and anaphylaxis. This article provides a qualitative summary of the adverse events observed in target animals during the evaluation of antibiotics by the Food and Drug Administration during both preapproval and postapproval periods.