MedDRA 13.0 Review. General Remarks. Version 13.0 Changes Overview. Changes in a Nutshell. Changes Highlights. MedDRA Version Changes

Transcription

1 MedDRA 13.0 Review MedDRA Version Changes General Remarks MedDRA Version 13.0 Specific Changes Version 13.0 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 13.0 Terminology Frequency Distribution MedDRA Version What's coming ahead?

2 MedDRA Changes - General Remarks There are two possible types of changes in the MedDRA terminology: simple changes and complex changes. Simple changes are changes to the existing terminology that involve terms at the PT and LLT levels. There are two types of Simple changes: (1) changes introduced by subscribers request and (2) Maintenance changes (also referred to as Associate changes). Maintenance changes are generated as a by-product of other changes requested by subscribers, or changes introduced by the MedDRA Management Board to preserve consistency within the dictionary. Complex changes involve modifications within the entire hierarchy, including the HLT, HLGT, and SOC terminology. Currently, the initial MedDRA terminology version release in one specific year (12.0, 13.0) includes both simple and complex changes, and the subsequent release in the same year (12.1, 13.1) represents a simple change of terminology. These changes are based on MedDRA subscribers' terminology change requests and on MedDRA terminology maintenance needs identified by MedDRA's maintenance organization reviewers. Please note that as a consequence of implementing some of these changes (e.g. demoting a multiaxial PT, adding a new HLT, etc.) it may be necessary to break the multiaxial links, to re-link the replacement terms, and/or to enable additional terms to be included within a particular SOC. All these changes may require modifications to your existing MedDRA coding, guideline development, and data retrieval practices. Keep in mind that changes involve both MedDRA terminology updates as well as Standardized MedDRA Queries (SMQ). Back to MedDRA 13.0 Review

3 MedDRA 13.0 Changes: Overview Changes In a Nutshell Complex Changes New Device related and Microorganism terms Standardized MedDRA Queries (SMQs) Changes Highlights Featured PT Changes New PTs Promoted LLTs Featured LLT Changes New LLTs Demoted PTs Currency changes Back to MedDRA 13.0 Review

4 Changes In a Nutshell Complex Changes The complex changes implemented in Version 13.0 are summarized below. At the SOC level: No changes were made to existing SOC terms and no new SOCs were added in Version 13.0 At the HLGT level: There were 3 HLGT s added and 1HLGT merged as a result of the complex changes in Version They are as follows: New HLGT s Complications associated with device to SOC General disorders and administration site conditions Device issues to SOC General disorders and administration site conditions Procedural related injuries and complications NEC to SOC Injury, poisoning and procedural complications Merged HLGT s Procedural and device related injuries and complications NEC to HLGT Procedural related injuries and complications NEC Modified HLGT Names There were no modified HLGTs in Version 13.0 At the HLT level: There were 17 new High Level Terms (HLTs) added and 7 HLTs merged as a result of the complex changes in Version They are as follows: New HLT s Breast complications associated with device to HLGT Complications associated with device Cardiac complications associated with device to HLGT Complications associated with device Cerebrospinal fluid therapeutic procedures to HLGT Nervous system, skull and spine therapeutic procedures Complications associated with device NEC to HLGT Complications associated with device Device computer issues to HLGT Device issues Device electrical issues to HLGT Device issues Device incompatibility issues to HLGT Device issues Device information output issues to HLGT Device issues Device issues NEC to HLGT Device issue Device malfunction events NEC to HLGT Device issues Device operational issues NEC to HLGT Device issues Device physical property and chemical issues to HLGT Device issues Eye complications associated with device to HLGT Complications associated with device Reproductive complications associated with device to HLGT Complications associated with device Respiratory complications associated with device to HLGT Complications associated with device Thrombocytoses to HLGT Platelet disorders Vascular complications associated with device to HLGT Complications associated with device Merged HLT s

5 Calymmatobacteria infections to HLT Klebsiella infections Cerebrospinal fluid shunt therapeutic procedures to HLT Cerebrospinal fluid therapeutic procedures Device component findings to HLT Device issues NEC Device malfunction events to HLT Device malfunction events NEC Device related complications to HLT Complications associated with device NEC Paracolon bacillus infections to HLT Bacterial infections NEC Secondary thrombocythaemias to HLT Thrombocytoses Back NEW DEVICE RELATED AND MICROORGANISM TERMS NEW DEVICE RELATED TERMS New device related HLGTs and HLTs were added to SOC General disorders and administration site conditions where HLGT Product quality issues is linked. Existing device related HLTs under SOC Injury, poisoning and procedural complications were merged under corresponding new HLTs added to SOC General disorders and administration site conditions. Existing device related PT/LLT terms were moved from SOC Injury, poisoning and procedural complications to the appropriate new device HLTs and new approved device PT/ LLT terms were added. Of the 300 device related term changes proposed, 279 changes were approved, including the addition of 58 new terms, and 21 changes were rejected. The remainder of the approved changes consisted of movement of existing terms, changes in hierarchy (e.g., demotions of PTs) and changes to the currency status of LLTs. Some examples of new PT s added under HLGT Device issues are: Device alarm issue Device capturing issue Device chemical property issue Device colour issue Device component issue Device computer issue NEW MICROORGANISM TERMS A regulatory authority that uses MedDRA proposed a set of microorganism terms to capture identification (by a test) of an organism when there is no documented infection. As a result, a total of 371 new PT and LLT terms were added and 194 existing terms were moved (e.g., demoted PTs, promoted LLTs, LLTs moving from one PT to another, etc.) Terms added have the organism name with a test positive modifier at the end of the term (e.g. PT Brucella test positive). To avoid having two very close concepts represented at the PT level, existing identified/test positive PT terms were demoted under corresponding new PTs and are now LLTs. Similarly, existing serology / test positive PT terms have been demoted to LLTs under corresponding new microorganism test positive PTs. Below are several examples.

6 Existing PT in MedDRA v12.1 New PT added in MedDRA v13.0 LLTs in MedDRA v13.0 Chlamydia identification test positive Chlamydia test positive Chlamydia identification test positive Brucella serology positive Brucella test positive Brucella serology positive Legionella serology positive Legionella test positive Legionella serology positive The modifier test positive implies that an organism had been identified, but what is often performed especially for clinical viral disease is a measurement of a titer, viral load, etc. To capture various measurements, broad concept terms such as PT Viral titre increased, PT Viral titre decreased, and PT Viral titre were added for MedDRA v13.0. For consistency with the new test positive terms, new PTs were added for existing negative and unqualified test/serology terms which were demoted under these new PTs. Below are some examples. Existing PT in MedDRA v12.1 New PT added in MedDRA v13.0 LLTs in MedDRA v13.0 Borrelia burgdorferi serology negative Brucella serology negative Borrelia test negative Brucella test negative Borrelia burgdorferi serology negative Brucella serology negative Brucella serology Brucella test Brucella serology Microorganism Test Negative/Unqualified Terms Back Standardized MedDRA Queries (SMQs) A total of 3 new level 1 SMQs were released into production in MedDRA Version There are now 82 level 1 SMQs in production as of this version. The new SMQs are listed below. SMQ Name Osteonecrosis (SMQ) Renovascular disorders (SMQ) Scleral disorders (SMQ) In addition to three new SMQs, the scope of PTs in Gastrointestinal perforation, ulceration, haemorrhage or obstruction (SMQ) (except those under sub-smq

7 Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (SMQ)) and Oropharyngeal disorders (SMQ) changed from broad to narrow after a review by the CIOMS Working Group and the MSSO. The table below lists the sub-search SMQs affected. Level 1 SMQ Oropharyngeal disorders (SMQ) Scope Changes to PTs in Sub-Search SMQs Gingival disorders (SMQ) Oropharyngeal allergic conditions (SMQ) Gastrointestinal perforation, ulceration, haemorrhage or obstruction (SMQ) Oropharyngeal infections (SMQ) Oropharyngeal lesions, non-neoplastic, non-infectious and non-allergic (SMQ) Oropharyngeal neoplasms (SMQ) Gastrointestinal haemorrhage (SMQ) Gastrointestinal obstruction (SMQ) Gastrointestinal perforation (SMQ) Gastrointestinal ulceration (SMQ) Back Back to MedDRA 13.0 Review

8 MedDRA Version 13.0 Specific Changes Changes Highlights Featured PT Changes PT Changes: new PTs - 20 Promoted LLTs demoted PTs - Net new 145 PTs Net change of PTs equals the number of new PTs plus the number of promoted LLTs minus the number of demoted PTs. VERSION 13.0 Following are several examples: Hydrolipoclasy Internal fixation of spine Intestinal stent removal Laryngeal dilation procedure Low carbohydrate diet Lung wedge resection Vitreal cells Vitreous floaters Submaxillary gland enlargement Device expulsion Device extrusion New PT New PT New PT New PT New PT New PT Promoted LLT Promoted LLT Promoted LLT Promoted LLT Promoted LLT Back

9 Featured LLT Changes New LLTs there was a net change of 755 new LLTs Demoted PTs 246 PTs were demoted to LLT level in version 13.0 Currency changes 16 LLTs had a currency change in version 13.0 from current to non-current Modified LLTs- 25 LLTs were modified No LLTs changed from non-current to current status LLT Version 13.0 Currency Non-current Brahma forest enterovirus antibody test Non-current Cold Non-current Drug implant rejection Non-current Extrapyramidal disorder aggravate Non-current HTLV-I Mechanical complication due to coronary bypass Non-current graft Non-current Intrauterine device disorder LLT Currency Changes (partial) The following table partially lists LLTs that were modified (renamed) to correct for misspelling, double spacing, capitalization or other valid 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 PT / LLTs. Level Code Term name in v12.1 Term name in v13.0 LLT Echo virus serology Echovirus serology LLT LLT Group A betahaemolytic streptococcal positive Group A betahemolytic streptococcal positive Group A beta haemolytic Streptococcus positive Group A beta hemolytic Streptococcus positive

10 LLT LLT LLT LLT LLT LLT LLT LLT LLT Group B betahaemolytic streptococcal negative Group B betahaemolytic streptococcal positive Group B betahaemolytic streptococcal test Group B betahemolytic streptococcal negative Group B betahemolytic streptococcal positive Group B betahemolytic streptococcal test Methicillin-resistant staphylococcal aureus test Methicillin-resistant staphylococcal aureus test negative Methicillin-resistant staphylococcal aureus test positive Group B beta haemolytic Streptococcus negative Group B beta haemolytic Streptococcus positive Group B beta haemolytic Streptococcus test Group B beta hemolytic Streptococcus negative Group B beta hemolytic Streptococcus positive Group B beta hemolytic Streptococcus test Methicillin-resistant Staphylococcus aureus test Methicillin-resistant Staphylococcus aureus test negative Methicillin-resistant Staphylococcus aureus test positive LLT Ramsey-Hunt syndrome Ramsay-Hunt syndrome LLT Staphylococcal identification test Staphylococcus identification test LLT Staphylococcal identification test negative Modified LLTs (partial list) Staphylococcus identification test negative Back Back to MedDRA 13.0 Review

11 MedDRA Version 13.0 Terminology Frequency Distribution by MedDRA Version Level Version Version Version Version Version Version Version Version Version SOC HLGT HLT 1,682 1,682 1,682 1,682 1,688 1,688 1,699 1,699 1,709 PT 17,320 17,505 17,719 17,867 18,075 18,209 18,483 18,641 18,786 LLT 63,817 64,620 65,147 65,605 66,135 66,587 67,159 67,503 68,258 Current LLT's 54,834 55,621 56,125 56,580 57,104 57,556 58,124 58,451 59,190 Non-current LLT's 8,983 8,999 9,022 9,025 9,031 9,031 9,035 9,052 9,068 : For complete downloads please check on the following MSSO link: Back to MedDRA 13.0 Review

12 MedDRA Version What's Coming Ahead? The next MedDRA terminology release, version 13.1, is scheduled for September Back to MedDRA 13.0 Review