Research from A. Scheuerle and colleagues provide new insights into pharmaceuticals
2009 JUL 28 - (NewsRx.com) -- Research findings, 'Measurements of birth defect prevalence: which is most useful as a comparator group for pharmaceutical pregnancy registries,' are discussed in a new report. According to a study from the United States, "Pharmaceutical pregnancy registries document birth defects and other complications reported in pregnancies exposed to specific medications or diseases. A baseline estimate of birth defect prevalence is necessary for comparison." "To identify potential teratogenic signals, the pregnancy registry must have a comparator that most closely matches the exposed population and data collection methodology, which are characteristics that vary among the multiplicity of birth defect surveillance systems. The system that yields the most accurate prevalence data may be different from that most closely matching the pregnancy registry methods. State public health programs have highly accurate and precise statistics, but their populations are broader than those of a pharmaceutical pregnancy registry. Large collaborative databases may have a more useful covered population, but there are secondary problems related to data precision. Health care databases enroll large numbers of patients and have good information about exposures and health problems, but the data can be difficult to access and lack useful detail. Exposure-related databases are closer in population definition and collection methods, though the presence of different diseases and exposures can be problematic. Internal comparators are likely to be most useful in formal statistical analysis, but added cost and management burden and may require significantly increased registry enrollment," wrote A. Scheuerle and colleagues, . The researchers concluded: "There is no ideal comparator, and this must be taken into account when planning a single-exposure or single-disease pregnancy registry." Scheuerle and colleagues published the results of their research in Birth Defects Research Part A, Clinical and Molecular Teratology (Measurements of birth defect prevalence: which is most useful as a comparator group for pharmaceutical pregnancy registries' Birth Defects Research Part A, Clinical and Molecular Teratology, 2009;85(7):611-20). For additional information, contact A. Scheuerle, Tesserae Genetics, 9702 Vinewood Drive, Dallas TX USA.. The publisher of the journal Birth Defects Research Part A, Clinical and Molecular Teratology can be contacted at: Blackwell Publishing Inc., 350 Main St., Malden, MA 02148, USA. Keywords: United States, Epidemiology, Pharmaceuticals, Public Health. This article was prepared by Drug Law Weekly editors from staff and other reports. Copyright 2009, Drug Law Weekly via NewsRx.com.
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