chapter  13
10 Pages

Overcoming Limitations of Routine Surveillance of Drug Overdose

WithNewell E. McElwee, Joseph C. Veltri, Mary Catherine Schumacher

Drug overdose, either accidental or intentional, is inevitable in today’s society and represents a serious public health problem. Yet the problem of drug overdose is studied much less rigorously than drug toxicity at therapeutic dosage levels. For newly marketed drugs, the overdose knowledge base often consists of at most a few isolated case reports and extrapolations from animal studies, usually done with rodents. There are several potential sources of data for detailed descriptive studies of drug overdose. Because the effects are usually acute and dose-related and must be described in detail, clinical trials would probably afford the most ideal study design for evaluating the effects of drug overdose. Ibuprofen is a nonsteroidal antiinflammatory agent and analgesic which changed in 1984 from prescription to over-the-counter status in the United States. The health care personnel record objective clinical findings at designated time intervals on a study flow sheet and obtain an electrocardiogram in patients meeting specific criteria.