What s New MedDRA Version 13.1

Transcription

1 What s New MedDRA Version 13.1

2 Acknowledgements ACKNOWLEDGEMENTS MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Adobe is a registered trademark of Adobe Systems Incorporated. Copyright 2010 International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). All Rights Reserved. ii

3 Table of Contents TABLE OF CONTENTS 1. DOCUMENT OVERVIEW VERSION 13.1 CHANGE REQUESTS TERMINOLOGY CHANGES TRANSLATION CHANGES NEW DEVELOPMENTS IN VERSION ASHT TERMS STANDARDISED MedDRA QUERIES (SMQS) CORRECTING TRANSLATED MedDRA TERMS SUMMARY OF CHANGES SUMMARY OF IMPACT ON THE TERMINOLOGY SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES MedDRA TERM COUNTS MODIFIED PT AND LLT NAMES LLT CURRENCY STATUS CHANGES LIST OF TABLES Table 4-1. Summary of Impact on SOCs, HLGTs, HLTs... 5 Table 4-2. Summary of Impact on PTs... 6 Table 4-3. Summary of Impact on LLTs... 6 Table 4-4. Summary of Impact on SMQs... 6 Table 4-5. Summary of Impact on Records in MedDRA Files... 8 Table 4-6. MedDRA Term Counts Table 4-7. Modified PT/LLT Names Table 4-8. LLT Currency Changes iii

4 Document Overview 1. DOCUMENT OVERVIEW This What s New document contains information on the source and types of changes made to the Medical Dictionary for Regulatory Activities (MedDRA) terminology between Version 13.0 and Version Section 2, Version 13.1 Change Requests, provides information on the number of change requests processed for the version. Section 3, New Developments in Version 13.1, highlights changes in v13.1 related to change request submissions, new initiatives, and information on Standardised MedDRA Queries (SMQs). Section 4, Summary of Changes, contains details on: Tables to show the impact of this version on the terminology Impact on the records in MedDRA files MedDRA term counts Modified Preferred Terms (PT) and Lowest Level Terms (LLT) names All LLTs in MedDRA that had a currency status change. All updated documentation associated with this version is located in the distribution file in Adobe Portable Document Format (PDF). Please refer to the!!readme.txt file for a complete listing. The Maintenance and Support Services Organization (MSSO) Help Desk can be reached at International AT&T Toll Free at or mssohelp@ngc.com 1

5 Version 13.1 Change Requests 2. VERSION 13.1 CHANGE REQUESTS 2.1 TERMINOLOGY CHANGES Changes to the MedDRA terminology result both from subscriber change requests and from internal change requests. Internal change requests result from internal maintenance activities as well as special working group activities in which the MSSO participates. MedDRA v13.1 is a simple change version which means changes were made only at the PT and LLT level. Change requests involve both MedDRA terminology updates as well as SMQ changes. There were a total of 1051 change requests processed for this version; 734 change requests were approved and implemented, and 241 change requests were rejected. There are, in addition, 76 change requests suspended for further consideration and resolution beyond this version. The electronic version of these changes is accessible both as a cumulative Detail Report (all change requests and actions taken for v13.1) which is included in the MedDRA English version download as well as a weekly supplemental update file (for v13.1). In addition, subscribers may review all change requests from MedDRA v5.1 to the present in WebCR. Please see Section 4 for a summary of the changes in MedDRA v TRANSLATION CHANGES In addition to terminology changes, there were 402 changes made to replace misspelled or mistranslated terms in the non-english versions of MedDRA. Below is a summary of the number of changes made and the language affected. 46 Chinese 2 Czech 3 German 347 Italian 4 Spanish The large number of changes to Italian MedDRA is due to efforts by the MSSO and the Italian regulatory authority, Agenzia Italiana del Farmaco (AIFA), to identify and correct a set of issues with the Italian translation. The MSSO is in the process of coordinating reviews of other European language translations for similar issues. A formal translation correction change request process has been instituted to allow MedDRA users to submit corrections to translated MedDRA terms. Please see section 3.3 for more details. 2

6 New Developments in Version NEW DEVELOPMENTS IN VERSION ASHT TERMS MedDRA was selected by the Alerting System for Chemical Health Threats (ASHT II) project, funded by the European Union Public Health Programme, for use in the Rapid Alert System for Chemical Incidence (RAS-CHEM). One of the ASHT II project goals is to incorporate a harmonized terminology of symptoms and syndromes to signal the possible release or exposure to toxic chemicals. MedDRA will be used to improve information sharing, analysis and reporting of events between health professionals from poison centers and national public health officials. The majority of concepts needed by the ASHT II project were already in MedDRA. The ASHT II project members requested the addition of a set terms that were not in MedDRA. After a review by the MSSO, a total of 95 changes were made for MedDRA v13.1 which includes 20 new PTs, 69 new LLTs, 5 moved terms and an additional link for an existing PT. Please see the subscriber section of the MSSO Web site for a detailed list of these changes. 3.2 STANDARDISED MedDRA QUERIES (SMQS) A total of 2 new level 1 SMQs were released into production in MedDRA v13.1 SMQ Ocular infections and SMQ Ocular motility. There are now 84 level 1 SMQs in production as of this version. In addition to new SMQs, there has been one major change made to SMQs this version. In consultation with the CIOMS Working Group, the MSSO reassigned the scope of 18 PTs in the SMQ Dementia based from broad to narrow. Additionally, 2 PTs were flagged inactive in the SMQ Dementia: PT Cerebral atrophy congenital and PT Delusional disorder, jealous type. Please see the Introductory Guide for Standardised MedDRA Queries (SMQs) v13.1 for details on these changes. 3.3 CORRECTING TRANSLATED MedDRA TERMS MedDRA is currently available in ten languages including English. The MSSO frequently receives requests from MedDRA users to correct misspellings or replace translated terms with an improved translation. The number of available languages is expected to increase and as a result, the MSSO anticipates receiving more of these requests. To better manage these changes, a formal translation correction change request process has been instituted. There are two methods available to request translation corrections: WebCR (capability - currently under development) and the Translation Correction Change Request form 3

7 New Developments in Version 13.1 located on the change request section of the MSSO Web site. Using either method, the following information is required when submitting a translation correction. English Term Text MedDRA Code Language Current translated term Replacement translated term Justification of request Once submitted, the MSSO will review the request with our translation vendors and communicate the disposition of the request as soon as possible. All other changes to the terminology (e.g., adding new terms, moving existing terms, SMQ related requests, etc.) must be requested using the established change request methods. Please see the change request section of the MSSO Web site for more information. For questions about the Japanese translation, please contact the Japanese Maintenance Organization. 4

8 4. SUMMARY OF CHANGES 4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY The tables below summarize the impact on the MedDRA terminology in v13.1. These tables are intended only as a reference. For detailed information on the changes to v13.1, please see the MedDRA Version Report located within the English language download. SOC, HLGT, HLT Changes Level Change Request Action Net Change Version 13.0 Version 13.1 SOC Total SOCs New HLGTs HLGT Merged HLGTs Total HLGTs New HLTs HLT Merged HLTs Total HLTs Table 4-1. Summary of Impact on SOCs, HLGTs, HLTs 1 Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minus the number of merged HLGTs or HLTs. PT Changes Level Change Request Action Version 13.0 Version 13.1 PT New PTs Promoted LLTs

9 Level Change Request Action Version 13.0 Version 13.1 Demoted PTs Net Change Total PTs Table 4-2. Summary of Impact on PTs 1 Net change of PTs equals the number of new PTs plus the number of promoted LLTs minus the number of demoted PTs. LLT Changes Level Change Request Action Net Change Version 13.0 Version 13.1 LLT Total LLTs Table 4-3. Summary of Impact on LLTs 1 Total LLTs include PTs because every PT in MedDRA is also an LLT. SMQ Changes Level Change Request Action Net Change Version 13.0 Version 13.1 SMQs New SMQs Table 4-4. Summary of Impact on SMQs 1 The number of SMQs shown only includes level 1 SMQs. 6

10 4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES The table below summarizes the impact on the MedDRA terminology in v13.1. The table is intended only as reference. ASCII File INTL_ORD.ASC SOC.ASC SOC_HLGT.ASC HLGT.ASC HLGT_HLT.ASC HLT.ASC Added, Removed, Modified Added 0 Modified 0 Added 0 Modified 0 Added 0 Modified 0 Added 0 Modified 0 Added 0 Modified 0 Added 0 Modified 0 No. Records Added 318 Removed 88 HLT_PT.ASC MDHIER.ASC PT.ASC Modified 0 Added 343 Removed 108 Modified 0 Added 181 Removed 48 Modified 9 7

11 ASCII File LLT.ASC SMQ_LIST.ASC 1 SMQ_CONTENT.ASC Added, Removed, Modified Added 403 Modified 246 Added 1 2 Modified 178 No. Records Added 1085 Modified 201 Table 4-5. Summary of Impact on Records in MedDRA Files 1 The number of SMQs added includes both level 1 and sub-smqs. 8

12 4.3 MedDRA TERM COUNTS The table below shows term counts by SOC for HLGTs, HLTs, primary and secondary PTs and LLTs, and primary PTs and LLTs. SOC LLTs* (Primary) 1 PTs (Primary) 1 LLTs* (Primary and Secondary) 2 PTs (Primary and Secondary) 2 HLTs 3 HLGTs 3 Blood and lymphatic system Cardiac Congenital, familial and genetic Ear and labyrinth Endocrine Eye Gastrointestinal General and administration site conditions Hepatobiliary

13 SOC LLTs* (Primary) 1 PTs (Primary) 1 LLTs* (Primary and Secondary) 2 PTs (Primary and Secondary) 2 HLTs 3 HLGTs 3 Immune system Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition Musculoskeletal and connective tissue Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system Pregnancy, puerperium and perinatal conditions Psychiatric Renal and urinary

14 SOC LLTs* (Primary) 1 PTs (Primary) 1 LLTs* (Primary and Secondary) 2 PTs (Primary and Secondary) 2 HLTs 3 HLGTs 3 Reproductive system and breast Respiratory, thoracic and mediastinal Skin and subcutaneous tissue Social circumstances Surgical and medical procedures Vascular Total Table 4-6. MedDRA Term Counts 1 Primary count only includes the number of terms that are primarily linked to the designated SOC at either the LLT level or the PT level. The sums of primary LLTs and PTs match those in Tables 4-3 and Primary and secondary PT counts include the number of terms that are both primarily and secondarily linked to the designated SOC at either the LLT level or the PT level. Therefore, the sums of total LLTs and PTs are greater than those in Tables 4-3 and The HLT and HLGT counts are not necessarily unique values given MedDRA s multiaxiality (see Section 2.2 of the Introductory Guide for a discussion of multi-axiality). There are some HLTs that are counted in more than one SOC. For example, HLT Connective tissue congenital and HLGT Musculoskeletal and connective tissue congenital are counted in SOC Congenital, familial and genetic and SOC Musculoskeletal and connective tissue. The sums of HLTs and HLGTs are greater than those found in Table

15 4.4 RENAMED TERMS As part of ongoing MedDRA maintenance activities, existing PTs and LLTs can be renamed to correct for misspelling, double spacing, capitalization or other errors that meet the renaming criteria in MedDRA. This rename provision retains the original MedDRA code of the term and preserves its original meaning. This facilitates the reuse of the same MedDRA code for the renamed PTs or LLTs. The table below lists the LLTs renamed in MedDRA v13.1. No PTs were renamed in MedDRA v13.1. Level Code Name in v13.0 Name in v13.1 Calymmattobacterium granulomatis Calymmatobacterium LLT infection granulomatis infection LLT Lead microdislodgment Lead microdislodgement Table 4-7. Modified PT/LLT Names 4.5 LLT CURRENCY STATUS CHANGES The following table reflects terms at the LLT level in v13.1 that have a change in their currency status along with the rationale for that change. This includes terms made either current or non-current during this version. Lowest Level Term Cold Allergy to plants Carcinoma uterine cerix recurrent Currency Status Changed to Current Non- Current Non- Current Rationale LLT Cold was made non-current in MedDRA v13.0 per change request The status of LLT Cold was changed back to current for MedDRA v13.1 following a secondary review and the potential negative effect on legacy data. Allergy to plants was a PT in MedDRA v13.0 and was demoted to an LLT under PT Seasonal allergy. Allergy to plants is an ambiguous concept and does not indicate to which kind of allergy it refers (contact dermatitis vs. seasonal allergy);as a result, such a term may disperse safety signals. LLT Carcinoma uterine cerix recurrent was made noncurrent because the word cervix is misspelled. The correctly spelled term LLT Carcinoma uterine cervix recurrent is available. 12

16 Lowest Level Term Cardiac varices O/A OA Currency Status Changed to Non- Current Non- Current Non- Current Rationale Cardiac varices is an ambiguous term that can be interpreted as relating to the heart or the cardia, a specific anatomic area of the stomach. Additionally, the use of cardiac varices in literature is inconsistent. O/A does not appear to have a universally accepted meaning. Individuals tend to interpret its connotation on the basis of geographic or national location, medical specialty, etc. Therefore, the status of LLT O/A will be changed to non-current. OA does not appear to have a universally accepted meaning. Individuals tend to interpret its connotation on the basis of geographic or national location, medical specialty, etc. Therefore, the status of LLT OA will be changed to noncurrent. Table 4-8. LLT Currency Changes 13