MedDRA Management Board Statement on SPL Mapping - DOC by NeilOlder

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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.

								
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