Objectives-As international scientific collaboration increases, there is a growing requirement for research data to be comparable among countries. Despite the importance of medication and dietary supplement data in research, there are no international standards for the collection and storage of these data. In the absence of such standards, we needed to adopt a strategy for classification and coding of medications and dietary supplements to meet demands of our multi-national study.Methods-Given the inter-country variations in nomenclature that characterize prescription, overthe-counter (OTC) medications, traditional herbal medicines, and dietary supplements, we adopted RxNorm as a data standard for medication data, and developed an independent system that extends this standard and allows for flexible and scalable data collection for dietary supplements.Results-RxNorm was implemented in May 2005 and as of July 2006, coverage has been 99%, at the level of active ingredients, of all the medications reported in our study. Development of a dietary supplement database began in August 2005, and has thus far coded some 1200 dietary supplements and 650 infant formula products and forms from the four countries in our study.
Conclusion-The methods we have used to collect, store, and manage medication and dietary supplement data serve as interim solutions until international standards are developed. It is hoped that such standards will ultimately emerge, and that our strategy and data model will be of value in other research environments in the immediate future. Keywords medications; dietary supplements; data standardization; data management; epidemiological methods; clinical research
Brief AccountWhat was known before the study?• Epidemiologic and other human research studies collect data on the use of pharmaceutical products and dietary supplements.• There is no standard international or global coding or classification scheme for these data.Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Author ManuscriptInt J Med Inform. Author manuscript; available in PMC 2009 January 1.
Published in final edited form as:Int J Med Inform. 2008 January ; 77(1): 58-67.
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NIH-PA Author Manuscript• There is no standard practice for collecting and storing these data, nor is there a standard data model to guide local efforts.What this study has added to the body of knowledge?• This work reviews current data standards and "best" practices (both in the USA and the EU) for the collection and storage of data related to the use of pharm...