MedDRA Management Board Statement on SPL Mapping (21 February 2007) In May 2005, the US Department of Health and Human Services (HHS) announced that SNOMED CT would be used in the building of an electronic health information infrastructure in the USA. On April 19, 2006, to further advance this federal effort, the FDA announced that the “Problem List” subset of SNOMED would be used to electronically code important terms in the Highlights section of Structured Product Labeling (SPL), such as adverse reactions, and indications for use for prescription drug products. Consequently, during the recent MedDRA Management Board meeting in Chicago in October, 2006, the Board requested further clarification from FDA regarding the intended use of the Problem List in order to evaluate the potential need for development of a MedDRA to SNOMED- CT Problem List mapping. The Board had the opportunity to discuss the topic directly with an FDA expert who attended the meeting, and reached the following conclusions: Based on clarifications provided by the FDA, the Board did not see a need to support a mapping of MedDRA to the “Problem List” of SNOMED. The Board requested FDA to develop a statement that would provide clarity to MedDRA subscribers for distribution to the MedDRA community. Please review the FDA statement (below) for additional details supporting the Board’s determination that a MedDRA to SNOMED-CT Problem List mapping is not considered necessary. FDA Statement for the MedDRA User Community Regarding Mapping Between the SNOMED Problem List Subset and MedDRA 1/31/2007 During the recent MedDRA Management Board meetings in Chicago (October 21-22, 2006), FDA staff responded to questions about the limited role of SNOMED in Structured Product Labeling (SPL). To facilitate sharing the details of these discussions with the wider community of MedDRA users, this Statement summarizes the key points. First and foremost, as FDA officials have stressed previously, the Agency remains committed to its international agreements, including in particular the continued use of MedDRA for coding adverse events in postmarketing safety reports. However, the U.S. government terminology standards for the electronic health record include SNOMED but not MedDRA. FDA is using the Veterans Health Administration and Kaiser Permanente (VA/KP) Problem List, a subset of SNOMED, for certain data elements in SPL. One benefit of using the VA/KP Problem List is to facilitate access to key product information in computerized medical decision support systems. The VA/KP Problem List is used in coding medical conditions in the Highlights data elements in Structured Product Labeling. For example, the data element <indicationObservationCriterion>.code would come from the VA/KP Problem List. But this code would not appear in the text of the Highlights section. Only the natural language description of the medical condition would appear there. Some have proposed that the MSSO might develop and maintain a mapping from MedDRA to SNOMED CT. However, because the primary text in labeling is created from natural language to capture nuances of safety information, a mapping is not necessary for the purpose of selecting terms from the VA/KP Problem List for SPL. With the small numbers of terms likely to be needed for each label, firms can look them up directly in the VA/KP Problem List and talk with their FDA contacts if they have any difficulty in finding a code for a particular concept. (The VA/KP Problem List is a working file that will be expanded as needed.) In addition, direct translations from natural language to SNOMED CT will avoid risks of inaccuracies that might accumulate with successive code conversions or mappings. The FDA web site provides a variety of additional information about SPL: http://www.fda.gov/oc/datacouncil/spl.html The following section* describes how to obtain the VA/KP Problem List files. Medical Condition Source: Veterans Health Administration and Kaiser Permanente (VA/KP) Problem List subset of SNOMED OID: 2.16.840.1.113883.6.96 The VA/KP Problem list subset is available for download from NCI Enterprise Vocabulary Services in three different formats (text file, Excel spreadsheet and zip file) through the following links: Problem List ReadMe File ftp://ftp1.nci.nih.gov/pub/cacore/EVS/FDA/ProblemList/ProblemListSubset. txt ftp://ftp1.nci.nih.gov/pub/cacore/EVS/FDA/ProblemList/ProblemListSubset. xls ftp://ftp1.nci.nih.gov/pub/cacore/EVS/FDA/ProblemList/ProblemListSubset. zip Yatbu is a free browser from Kaiser Permanente used for searching the VA/KP Problem List ftp://ftp1.nci.nih.gov/pub/cacore/EVS/FDA/ProblemList/Browser/ * from http://www.fda.gov/oc/datacouncil/term.html#med MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). SNOMED CT is a registered trademark of the International Health Terminology Standards Development Organisation.
Pages to are hidden for
"MedDRA Management Board Statement on SPL Mapping - DOC"Please download to view full document