Published by MedDRA MSSO for our Users March 2017

Transcription

1 Published by MedDRA MSSO for our Users March 2017 Quick Links: What s New for MedDRA Version 20.0 Reduced Subscription Rates Unqualified Test Name Term List U.S. Industry MedDRA User Group Meeting European MedDRA User Group Webinar: Update on Medication Errors New Self-Service Application for Users Coming in Spring 2017 Combined MedDRA and WHODrug User Group Meetings in India Follow us on MedDRA trademark is owned by IFPMA on behalf of ICH

2 What s New for MedDRA Version 20.0 By Brian J. O Hare Terminology Maintenance Manager MedDRA Version 20.0 was made available to MedDRA users on 1 March 2017 from the Downloads page on the MedDRA website. MedDRA Version 20.0 is a complex change version which means that changes may be made at all levels of the MedDRA hierarchy. There were a total of 3,405 change requests processed for this version; 3,066 change requests were approved and implemented, and 331 change requests were not approved. There are, in addition, 8 change requests suspended for further consideration and resolution beyond this version. See the table below for MedDRA Version 20.0 term counts. Number of Terms in MedDRA Level Version 19.1 Version 20.0 System Organ Classes (SOC) High Level Group Terms (HLGT) High Level Terms (HLT) 1,732 1,738 Preferred Terms (PT) 22,210 22,499 Lowest Level Terms (LLT) 76,468 77,248 Total terms in MedDRA* 78,562 79,350 *Total LLTs include PTs as they are included together in the LLT distribution file. The major change implemented for Version 20.0 was a revision of the medication error and product use issues hierarchy. The new hierarchy groups the medication errors and unspecified product use issues terms together under new HLGT Medication errors and other product use errors. This new grouping avoids a forced classification between these sometimes overlapping concepts that presented coding and analysis challenges in earlier versions of MedDRA. New HLTs have been added such as HLT Product dispensing errors and issues which correspond to the various stages in the medication/product use process (prescribing, storage, dispensing, preparation for administration, and administration). Concepts representing intentional product uses are grouped under new HLGT Off label uses, and intentional product misuses/use issues. Continued on page 2 1

3 Continued from page 1 What s New for MedDRA Version 20.0 (continued) The figure below shows the new hierarchy. Please see the What s New Version 20.0 document for full details. Other changes included the implementation of two proactivity requests. One request focused on adding a small set of terms to represent the gradation of chemical burns in MedDRA (e.g., PT First degree chemical burn of skin). The other request asked the MSSO to improve the differentiation between a reduction in visual acuity (sharpness of vision) and other reductions in vision. As a result of this review, 12 LLTs, such as LLT Vision decreased, were moved from PT Visual acuity reduced to PT Visual impairment and LLT Transient partial visual loss was moved from PT Visual acuity reduced transiently to PT Blindness transient for better conceptual term alignment. No new level 1 SMQs were added in MedDRA Version Structural changes were made to Malignancies (SMQ). Four level 4 sub-search SMQs (two each) were added to level 3 Malignant tumours (SMQ) and level 3 Tumours of unspecified malignancy (SMQ) which are under level 1 SMQ Malignancies. This was the result of work by the CIOMS SMQ Implementation Working Group to further enhance specificity options for case identification. The two sub-search SMQs added under Malignant tumours (SMQ) and Tumours of unspecified malignancy (SMQ) are shown in the diagram below with red arrows: The Full Hierarchy of Malignancies (SMQ) Continued on page 3 2

4 Reduced Subscription Rates in 2017 By Patrick Revelle Director, MedDRA MSSO The 2017 MSSO subscription rates for MedDRA have been reduced at least 9-10% for all subscription levels. The 2016 Commercial 2 subscription level (defined as organizations with annual revenue between $10-$500 Million USD) has been divided into two levels. The 2017 Commercial 2 subscription level is defined as organizations with annual revenue between $10-$20 Million USD and now has an annual subscription rate of $2,765 which is a 50% reduction from 2016 rates. This revision in the Commercial 2 subscription level is aimed at reducing the cost of MedDRA for a large group of organizations with revenue under $20 million USD. This reduction is a reflection of the continued success of MedDRA as a global standard; with over 4,800 subscribing organizations worldwide, the costs of maintaining and developing the terminology can be distributed over a wider base, while still providing the same high standard of tools and services to MedDRA users. Continued from page2 What s New for MedDRA Version 20.0 (continued) The PTs originally under Malignant tumours (SMQ) and Tumours of unspecified malignancy (SMQ) have been moved under the appropriate sub-search SMQs. Please see the MedDRA Version 20.0 SMQ Introductory Guide for details. For more detailed information on MedDRA term additions and changes, users may wish to use the MedDRA Version Analysis Tool (MVAT) which is an online tool that compares any two MedDRA versions including non-consecutive versions to identify changes. The output of MVAT is similar to the Version Report. MVAT is free to MedDRA users as part of their subscription. The MSSO encourages MedDRA users to consider submitting change requests to help us maintain MedDRA as a rigorous terminology that is responsive to your needs. Change requests can be submitted to the MSSO via the online change request application WebCR ( 3

5 Unqualified Test Name Term List By Judy Harrison, MD Chief Medical Officer The MSSO has developed an Unqualified Test Name Term List and an explanatory document, which are available for MedDRA users to download from the support documentation section of the MedDRA website (see right side of page under Related Links). The list is designed as an optional tool to improve data quality. Unqualified test name terms, e.g., PT Blood glucose, are intended for use only in the test name data element in data transmission standards and are not meant for use in other data fields capturing information such as adverse events/adverse reactions, or medical history. The Unqualified Test Name Term List was developed to help regulatory authority and industry users check data quality by identifying the inappropriate use of unqualified test name terms in data fields other than the test name data element. The list is a comprehensive list of all unqualified test name terms at the Preferred Term (PT) and Lowest Level Term (LLT) levels in SOC Investigations, and currently includes over 3,600 terms. It is maintained and updated by the MSSO with every MedDRA release in spreadsheet form. For questions about the Unqualified Test Name Term List, please contact the MSSO Help Desk. 1 4

6 U. S. Industry MedDRA User Group Meeting By Brian J. O Hare Terminology Maintenance Manager User Group meetings are a great way to interact with fellow MedDRA users, hear interesting speakers and topics, participate in interactive discussions, and ask questions. The U.S. Industry MedDRA User Group Meeting, hosted by AbbVie and held on 15 September 2016 in Mettawa, Illinois, USA, was no exception and was a great success. The meeting was attended by approximately 70 MedDRA users and featured topics on combination products, using MedDRA for purposes other than adverse event coding, medication error hierarchy changes anticipated in MedDRA Version 20.0, and practical applications of MedDRA. Additionally, there were plenty of interactive discussions and exchanges between the attendees. The MSSO thanks Dr. Sandy Fielder and the Abbvie team for including the MSSO in the meeting. The Abbvie teams s planning and execution on the day of the meeting ensured the success of the meeting. The MSSO also hosts user group meetings and attends meetings hosted by industry groups (like this one). We encourage new and veteran MedDRA users alike to attend User Group meetings. Please visit the User Group section on the MedDRA website for information on past and future user group meetings, or contact the MSSO Help Desk at mssohelp@meddra.org. The MSSO hopes to see you at the next User Group meeting! Participants at the 2016 U.S. Industry MedDRA User Group Meeting hosted by AbbVie Pictured from left to right: Dr. Sandy Fielder (AbbVie), Dr. William Gregory (Pfizer), Jody Trieloff (AbbVie), Melissa Truffa (AbbVie), Dr. Khaudeja Bano (AbbVie), Patrick Revelle (MSSO), Dr. Judy Harrison (MSSO), Susan O Hara-Smith (AbbVie), Brian O Hare (MSSO) 5

7 European MedDRA User Group Webinar: Update on Medication Errors By Judy Harrison, MD Chief Medical Officer The MSSO was pleased to collaborate with the European MedDRA User Group to conduct a webinar on 15 November The topic was Update on Medication Errors and it is an indication of the considerable interest in this evolving area of pharmacovigilance that the webinar was very well attended with over 300 MedDRA users participating worldwide. The speakers and discussion topics are listed below. Ms. Victoria Newbould from the European Medicines Agency (EMA) provided an introduction to the EMA guidance and regulatory expectations on medication errors. Mrs. Hilary Vass from Biogen reviewed updates to the MedDRA Term Selection: Points to Consider document related to medication errors. Dr. Tomás Moraleda (MedDRA MSSO) provided an overview of the upcoming changes to the medication error/product use issue hierarchy in MedDRA Version 20.0, and a description of the new SMQ Medication errors. Following the formal presentations, Dr. Sonja Brajovic (FDA) joined the panelists for a lively discussion of challenging real-world coding examples that had been previously submitted by MedDRA users. Don t worry if you missed this interesting and informative webinar; the presentation slides and a webinar recording for streaming or download are available under Past User Groups on the User Groups page on the MedDRA website. 6

8 New Self-Service Application for Users Coming in Spring 2017 By Shalini Gupta IT Manager Have you ever wanted to register for a MedDRA training class but you did not know your organization s MedDRA ID? Have you ever wanted to check the MedDRA subscription status of a business partner? Have you ever wanted to get a certificate (hardcopy or PDF version) for attending a MedDRA training class? If you answered Yes to any of these questions, the new Self Service Application is your solution. The MSSO is currently developing and testing the new web-based tool to provide support to frequently asked Help Desk questions. The functions for the new tool include:. Print or save to PDF training certificates for face-to-face classes attended Check the MedDRA subscription status of business partners The Primary Point of Contact will be able to retrieve their organization s MedDRA password and unzip passwords for MedDRA release files Retrieve your organization s MedDRA ID and the address for your organization s Primary Point of Contact. The screenshot below shows the home page for the Self-Service Application. MedDRA Self-Service Application 7

9 Combined MedDRA and WHODrug User Group Meetings in India By Jane Knight Clinical Associate In February of this year, the first ever MedDRA User Group meetings to take place in India were held in Bangalore and Mumbai. In a collaborative partnership, the MedDRA MSSO joined forces with the Uppsala Monitoring Centre (UMC) to host a joint one-day User Group meeting in each location for users of MedDRA and WHODrug. Bangalore User Group Participants Both meetings generated overwhelming interest from local users, reaching the maximum number of registrations well ahead of the meetings themselves, with around 80 attendees at each event. Participants came from a wide range of organisations and roles, including Coding, Medical Review and Management in the areas of Clinical Data Management and Pharmacovigilance. There were also Medical Writers and Software Developers, keen to interact with other users. Overall, the audience brought with them a wealth of industry experience with the clear majority of attendees having between five and ten years experience in using MedDRA. This range of organisation types, focus areas, and experience led to two full days of detailed and stimulating discussions. Continued on page 9 Mumbai User Group Participants 8

10 Continued from page 8 Combined User Group Meetings (continued) The MedDRA portion of the day started with an introduction to the MedDRA MSSO, its services and tools, outlining ways in which users can maximize their subscription. Many attendees had first-hand experience of both training and Help Desk services so could illustrate how beneficial these channels of communication were to their use of MedDRA. The session also offered an opportunity to exchange opinions on the browsers and MedDRA Version Analysis Tool, (MVAT). The next two sessions focused on the practical use of MedDRA for coding and coded data review. In a workshop format, the handling of some more challenging verbatim terms was discussed. The fourth session described the change request process and internal consensus discussions that are held among the MSSO International Medical Officers (IMOs), to consider whether changes to MedDRA as requested by users should be made to subsequent versions of the terminology. This engaging topic generated lengthy discussions as attendees shared their individual proposals and rationale in response to examples of some recent change requests received for MedDRA Version In both meetings, participants gained an understanding of how the IMOS use open discussion and apply term placement conventions to achieve consensus, as individual opinions can differ. Participants in the workshop took part in these discussions exactly as would have happened among the MSSO IMO team who reviewed the actual change requests. Together, the MSSO and UMC User Groups prompted a great deal of interest and discussion that filled a full day-long meeting in each city. Lunch, dinner, and networking sessions were invaluable opportunities for attendees to approach individual speakers with specific questions and connect with fellow terminology users. Holding a combined meeting was an efficient use of time for participants, especially those who had travelled considerable distance. It also allowed for discussions which drew parallels between MSSO and UMC tools such as the MedDRA Version Analysis Tool (MVAT) and the WHODrug Change Analysis Tool (CAT), and the standardised groupings for analysis, Standardised MedDRA Queries, SMQs, likened to the Standardised Drug Groupings, SDGs. The panel discussions and open forums addressed topics relevant to coding and analysis in general, including risk assessments, resourcing, regulatory requirements, etc. Feedback from attendees demonstrated how valuable and enjoyable the two meetings were. As one participant commented, Very well executed meeting and some great presentations and another, The presentations were very insightful. This meeting not only gives an opportunity to enhance one s knowledge and skills, but also to know people and build a professional network. We have conducted WHODrug User Group Meetings in India both 2015 and After both meetings, attendees approached us with requests for MedDRA User Group Meetings as well. Therefore, we presented the idea of having joint MedDRA&WHODrug User Group Meetings to the MedDRA MSSO and were delighted to learn that the interest was mutual. By providing two-in-one meetings we hope to make our User Group Meetings easily accessible for the end-users of both MedDRA&WHODrug, which in many cases are the same people. In retrospect, both meetings went really well and we are certainly looking forward to future joint efforts and collaborations. Damon Fahimi Product Specialist Uppsala Monitoring Centre Continued on page 10 9

11 Continued from page 9 Combined User Group Meetings (continued) Mumbai User Group Presentation Jane Knight, MSSO Meeting users across the global range of the MedDRA community is a key component of our annual MSSO User Group meeting programme. It is an opportunity to get to know our users individually and hear their experiences in using the terminology and related tools. Questions and comments raised to MSSO staff during networking breaks provide us with feedback and suggestions for future projects and meetings. Having made the links with the user base in India, we hope to have closer collaboration with our users there and to continue the communication through training events, s to the Help Desk, Change Requests, and future face-to-face meetings. 10

12 Please visit us at the Drug Information Association Annual Meetings 29th Annual EuroMeeting Glasgow, United Kingdom March rd US DIA Annual Meeting Chicago, Illinois USA June 2017 and the MedDRA User Group Meetings European MedDRA User Group Meeting Glasgow, United Kingdom 28 March 2017 US MedDRA User Group Meeting Chicago, Illinois USA 22 June 2017 Chinese MedDRA User Group Meeting Beijing, China 6 September 2017 US Industry MedDRA User Group Meeting Gaithersburg, Maryland 29 September 2017 We want your Feedback! Please contact us: mssohelp@meddra.org MedDRA website: Toll Free International: Direct: Fax: