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Physician reporting of adverse drug reactions: results of the Rhode Island adverse drug reaction reporting project

Article Abstract:

The United States Food and Drug Administration (FDA) collects reports of adverse drug reactions (ADRs) from pharmaceutical manufacturers and physicians nationwide. This system for collecting data is very important because it supplements the laboratory testing and brief clinical trials performed before a drug is marketed. The premarketing clinical trials are limited in their ability to detect the range of adverse reactions that may occur because they typically include only 3,000 or fewer middle-aged persons without complicated medical problems who are not using other drugs. The studies rarely last more than three years, so any long-term effects of a drug cannot be observed. Thus, the FDA's surveillance of ADRs is the only means of identifying many important adverse drug effects. The main source of ADR reports to the FDA is the pharmaceutical companies, who are required by law to submit such information when it is brought to their attention. FDA records for 1970 showed that physicians only filed 1 percent of the reports, but the information they provided identified 24 percent of the ADRs that led to changes drug labeling; therefore, this input was very valuable. A joint research project was conducted between the FDA and the Rhode Island Department of Health to educate physicians on the need to report suspected ADRs to the FDA. Two years after the educational efforts began, voluntary reporting by physicians in Rhode Island had increased more than 17-fold. Both the number of reports and the reports of severe reactions increased to a similar degree. When surveyed, physicians also showed improved awareness of and attitude toward the reporting system. The project demonstrated that physicians will respond to programs that encourage voluntary reporting of suspected ADRs, which can make the federal surveillance system more effective. (Consumer Summary produced by Reliance Medical Information, Inc.)

Drugs, Medicine, Reports, Complications and side effects, Telecommunications systems, Statistics, United States. Food and Drug Administration, Drug interactions, Adverse drug reactions, Pharmaceutical research

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Active and passive smoking and pathological indicators of lung cancer risk in an autopsy study

Article Abstract:

Individuals who are constantly exposed to cigarette smoke (passive smokers) may develop changes in their lung tissue that could be precancerous. At least 12 tissue samples were taken from various parts of the lungs during 283 autopsies on people who had died from a condition other than lung disease or cancer. They were assigned scores based on the number of epithelial, possibly precancerous lesions (EPPL) that were observed on examination. Relatives of 206 of the deceased were interviewed and asked about the individual's occupation, residential history and smoking status, as well as the spouse's smoking status. Individuals who had smoked while alive had higher EPPL scores than those who were former smokers. Deceased nonsmoking women who had been married to smokers had higher scores than women married to nonsmokers.

Health aspects, Risk factors, Lung cancer, Passive smoking

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Neonatal End-of-Life Decision Making: Physicians' Attitudes and Relationship With Self-reported Practices in 10 European Countries

Article Abstract:

Whether or not a doctor will pursue aggressive treatment for dying patients depends on what country he or she practices in. In a survey of 1,391 doctors in 10 European countries, those in Sweden, the Netherlands, and the UK were most likely to limit aggressive treatment if it would negatively impact the patient's life.

Terminal care

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