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James M. Roswold is licensed in Missouri Only. Heather A. Lottmann is licensed in Kansas and Missouri. Victor B. Finkelstein is licensed in Kansas and Missouri.
Digital Records May Increase Reporting of Dangerous Drug Side Effects
A report published in 2006 in the the Journal of the American Medical Association estimated that 700,000 people a year, especially the elderly, experience adverse drug events that lead to emergency room visits. However, many times serious drug side-effects go unreported which gives patients and doctors a false reassurance that adverse drug reactions to certain medications are rare.
A new study recently published in Pharmacoepidemiology and Drug Safety suggests that computerized patient records could be used to improve the reporting of serious drug side effects.
The study was conducted at Massachusetts General Hospital and Brigham & Women's hospitals in Boston over five months in 2008 and 2009. During this time, 26 doctors at the two hospitals reported 217 side effects to regulators at the Food and Drug Administration. They were using an automated computerized system to generate the reports.
The computer system generated an alert whenever one of the doctors in the study recorded discontinuing a medicine because a patient experienced a negative reaction. The computer program asked the doctor whether the side effect was serious and automatically submitted a report to the FDA.
Twenty percent of the reports involved a serious side effects; some of these required hospitalization.
Types of Adverse Drug Reactions
• Allergic reactions • Contact dermatitis • Drug side-effects • Dangerous drug interactions • Overdose and incorrect dosing • Drug intolerance
Reporting of medication side effects is voluntary; however, drug recalls and the FDA's drug-safety efforts are based on these voluntary reports. If the reporting of drug side-effects is automated, the FDA may be better able to identify potentially dangerous drugs.
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