About MedDRA
What is MedDRA terminology?
MedDRA is the acronym for Medical Dictionary for Regulatory Activities. It is an international terminology employed by the pharmaceutical industry, medical product industry and regulatory agencies throughout the entire drug development process and product postmarketing activities. The current version of MedDRA (version 11.0
effective as of May 2008) contains a total of 85,000 unique terms. MedDRA terminology was developed under the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use and is a registered trademark of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).
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What is the most recent version of MedDRA?
The current version of MedDRA terminology is version 11.1 released in September 2008. MedDRA version 12.0 is scheduled for release in March of 2009.
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What is new in MedDRA?
MedDRA versions which are a whole number (10.0, 11.0, etc) include both simple changes and complex changes. MedDRA versions 10.1, 11.1, etc, include only simple changes. For a complete summary of the changes introduced in version 11.1 you may refer to MedDRA Terminology Version 11.1 Review..
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When is MedDRA's next release scheduled?
New MedDRA versions are released in March and September each year. MedDRA version 12.0 is scheduled for release in March of 2009.
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What is ICH?
ICH is the acronym for The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH is a joint project between regulatory authorities from Europe, Japan and the United States, and the pharmaceutical and medical product industry to attain uniformity in the process of registration of medical products. The development and implementation of MedDRA resulted from ICH activities and recommendations. For more information visit:
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
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What is the MSSO?
The International Conference on Harmonisation (ICH) and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) designated MedDRA Maintenance and Support Services Organization (MSSO) as the organization responsible for the maintenance and distribution of the MedDRA terminology.
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How is MedDRA structured?
MedDRA coding terminology is hierarchical and multiaxial in nature. A data retrieval section of MedDRA is an associative grouping of terms.
The different levels of the terminology from highest (broadest concept) to lowest (most specific) are the following:
A PT may be grouped in more than one SOC, depending on the medical concept - this is MedDRA multiaxiality.
The SMQs (see below) are associative groupings of MedDRA terms used in data retrieval.
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What is a Special Search Category (SSC)?
SSCs used to be present in MedDRA. SSC were created by grouping PTs from the same or different SOCs which represent the same medical concept. Examples: SSC Bone Marrow Depression, SSC Cardiac Ischemia, SSC Haemorrhage, etc. However, the Standardised MedDRA Queries (SMQs) have come to replace SSCs. Consequently, SSCs have been retired as of MedDRA Version 10.0 release.
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What are the SMQ's?
Standardised MedDRA Queries (SMQs) are created by grouping relevant MedDRA terms to represent a particular medical concept. This grouping assists in the formulation of a "case definition" and in data exploration and retrieval.
Other than data presentation by SOCs, data retrieval was initially also addressed with 13 Special Search Categories (SSCs). These are simple groupings of associated PTs which pertain to the same medical concept. To better address the need for standardization of data retrieval queries, Council for International Organizations of Medical Sciences (CIOMS) and MSSO have been working together on developing an extensive set of SMQs. These are retrieval groupings with a more complex and thus useful structure, a narrow and broad scope, some with an inherent hierarchy, and some with an algorithm. MedDRA version 11.1 contains 67 SMQs in production, with more SMQs in development.
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What are MedDRA term modifiers?
Terms such as "Aggravated", "Worsening", "Worsened", "Exacerbation", "Recurrence", "Progression" and others are considered as modifiers. When used in conjunction with other MedDRA terms these modifiers alter the meaning of the "root" or base term. For example, LLT Bronchospasm aggravated and LLT Exacerbation of acne represent an increase in the severity of an already existing condition. Recent versions of MedDRA have demoted almost all terms containing these types of modifiers to the LLT level..
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What is the document "Points to Consider" about?
There are two ICH-endorsed "Points to Consider" documents regarding MedDRA. One is a guide document designed as a universal coding standard, to promote consistency in MedDRA coding. The other guide is for data output. Both of these are companion documents to the MedDRA dictionary and are endorsed by ICH.
See MedDRA® TERM SELECTION: POINTS TO CONSIDER Release 3.11 based on MedDRA version 11.1 at:
http://www.ich.org/LOB/media/MEDIA4826.pdf
See MedDRA® DATA RETRIEVAL AND PRESENTATION: POINTS TO CONSIDER Release 1.6 based on MedDRA version 11.1 at:
http://www.ich.org/LOB/media/MEDIA4822.pdf
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Is MedDRA coding required by the FDA?
See Department of Health and Human Services, Food and Drug Administration 21 CFR Parts 310, 312, 314, 320, 600,601, 606; Docket No.00N-1484 RIN 0910-AA97: Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.html
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What is the impact of the recent adoption in the USA of SNOMED-CT as a medical terminology standard on the use of MedDRA?
In 2003, SNOMED was selected as the standard terminology for electronic medical records in the United States. However, prior to that, ICH designated MedDRA as the standard terminology for the coding of adverse drug reactions. The FDA has published the following document in which they propose to require the use of MedDRA for postmarketing safety reports ( http://www.fda.gov/oc/initiatives/barcode-sadr/, http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.html ). There are plans to map MedDRA to SNOMED in the near future via the National Library of Medicine Unified Medical Language System (UMLS). Thus, everything indicates so far that postmarketing safety reports will continue to be coded in MedDRA.
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Can you explain what is meant by "... with MedDRA having achieved step 5 of the ICH process"?
There are 5 steps to the ICH process. Steps 1-4 ensure that the document, in this case MedDRA, has been approved by the Steering Committee, agreed to by the EU, USA, and Japan, sent out as a draft document for comments, and consensus has been reached between regulatory agencies and industry. Thus, at Step 5 the document is ready for regulatory implementation at the national/regional level according the various procedures and requirements. MedDRA has been implemented by the EMEA and the MHLW for post-marketing adverse event reporting.
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How are companies handling the conversion of their legacy data to MedDRA?
In order to achieve what an individual company would consider a "successful" conversion, the company must take into careful consideration the following:
What are the objectives of conversion?
- Do I simply want to "MedDRA-size" the legacy data?
- Is the intent to preserve the specificity of the original term?
- What is the intended future use for this data?
What is the source of the conversion?
- Will I be converting terms from a standardized dictionary such as COSTART, WHO-ART, J-ART or HARTS?
- Will I be converting terms from a standardized dictionary or an in-house dictionary where the terms may not be as "pure"?
- Is the basis of the conversion the verbatim?
- Is the basis the verbatim combined wih the old code?
How many terms are to be converted?
What is the expectation of the resulting data in terms of quality and accuracy?
Will the conversion process allow for modifications as necessary according to the most current version of MedDRA?
Depending on the answers to these questions, there are basically two industry wide accepted approaches to successfully converting legacy data. They are the "automated" and the "manual" approach. The "automated" approach usually involves the "normalization" of terms and applies multiple algorithms and runs the legacy data through multiple iterations to convert approximately 80% to 90% of the legacy data leaving the remaining 10% to 20% to be "manually" converted. The advantages and disadvantages of this method include:
Advantages:
- Quick processing
- Ideal for converting "large" dictionaries especially if the purpose is to simply MedDRA-size i.e. to have the terms converted into MedDRA without intent for future use of this data
Disadvantages:
- Applied algorithms may not result in a match with the most clinically accurate term at the LLT level
- Without a QA process performed by a MedDRA specialist, quality and accuracy are questionable
- Number of successful matches decreases significantly if the source is the verbatim or a homegrown dictionary and not a standardized dictionary
Despite what the name may imply, the "manual" method is not entirely performed manually, but is usually a hybrid. Ideally the legacy data is processed using an algorithm developed specifically to meet the particular idiosyncrasies of that data set. This initial process may successfully match 40% - 50 % of the data. The manual aspect of this method then takes place. The results of the match are reviewed by a MedDRA specialist to confirm that the matches are indeed accurate and appropriate. The remaining 50% to 60% of the terms are then matched manually by a coder who through the use of a browser makes a determination as to which MedDRA term best represents the concept conveyed by the original term. Once the matching/coding process is complete, ideally the data undergoes a QA process to ensure quality, consistency, and accuracy. The advantages and disadvantages to this method include:
Advantages:
- Quality, accuracy, consistency, and preservation of the integrity of converted data is ensured
- Usability of data in the future
- Complete data retrieval is possible
- Preserving specificity of the original term is better achieved via the manual method than through the automated method
Disadvantages:
- Resource intensive
Requires a true MedDRA specialist to be available in order for a "successful" conversion to take place. The MedDRA specialist must understand not only the clinical significance but also the implications of MedDRA coding.
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What type of MedDRA coding training is available? What is the best way to train our coding group?
MedDRA coding training is available but one must be cautious as to what the course is able to offer. Currently there are three types of courses being offered by various organizations:
Theory and Structure: These courses offer the student an overview and discussion of MedDRA in terms of its background, intent, and hierarchical structure. They may be of interest to the executive more so than the person who actually has to deal with MedDRA on a daily basis. These courses would not impart a practical, working knowledge upon the student. The course can be delivered by a trainer, or as a Computer Based Training (CBT)
Theory and Demonstration: These courses attempt to provide the student with both the theoretical discussion and partial "hands-on" experience. The "hands-on" portion offers the student an opportunity to view a browser and the process of MedDRA-coding a report. However, merely providing students with a demonstration of MedDRA coding should not be equated with practical training.
Theory and Practical "Formal" training : In addition to an in-depth discussion on theory and hierarchy, this course allows the student to not only code utilizing MedDRA but to also comprehend the implications of MedDRA's granularity and complexities on data retrieval, grouping in clinical trials, etc. Giving the student the opportunity to code and retrieve the data coupled with a detailed discussion of the results best demonstrates the implications of MedDRA.
Unlike COSTART, WHO-ART, or HARTS, attempting to memorize MedDRA is an impractical use of time and effort due to the on-going modifications, the complex hierarchical structure, and more importantly, the granularity of MedDRA. It is, therefore, strongly recommended that anyone who will have to deal with MedDRA as a coder, clinical data manager, reviewer, or IT support personnel should undergo "formal" training . Emphasis is placed on the term "formal" because there are a handful of organizations that, as self-proclaimed "MedDRA experts", offer MedDRA coding training courses. Most are competent in providing instruction on the theoretical and structural background of MedDRA. However, only organizations that have themselves had extensive experience utilizing MedDRA to code could be considered qualified to offer the practical training. Thus, in deciding which course to spend your budgeted resources on, the key questions to ask are:
What are my objectives in taking this course?
- Will this course provide me with the insight and skills needed so that I will not have to re-invent the wheel when it comes down to actually performing coding or data retrieval?
What makes this organization an expert?
- What are their credentials? What are their instructor's credentials?
- Where is their expertise derived from? Is their expertise based on theory or from actually having applied MedDRA and analyzed MedDRA coded data?
- Do they have real experience using MedDRA to code real life reports? How many MedDRA coded reports have they submitted and have had accepted by a regulatory authority as having met the regulatory standards?
Post-training, will I have the ability and opportunity to ask follow-up questions?
- Will there be support services provided once I have had an opportunity to use MedDRA in the real world?
The answers to these questions should point you to the organization that would best address your training needs.
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I know that MedDRA coding training is available, but what type of training is available for those of us who need to search ADE/ADR databases for signal generation and safety surveillance i.e. retrieving the data?
Although there are organizations that have opted to offer distinctly separate courses for those who enter the data (i.e. coders) and those who have to use or retrieve the data (i.e. clinical data managers, safety evaluators, statisticians), this approach to training may have been acceptable with COSTART or WHO-ART, but may not necessarily be the best team approach to MedDRA. It is important to remember that the purpose of coding is to allow for complete and accurate data retrieval - that these two groups are essentially two sides of the same coin. For this reason, an integrated approach to training has been proposed which would allow the user to maximize the benefits MedDRA has to offer. This approach would allow the student to leave with a more comprehensive perspective and understanding of MedDRA and appreciation for the complex implications.
Having a comprehensive perspective is more important in MedDRA than it ever was in COSTART or WHO-ART. Unlike COSTART and WHO-ART, MedDRA is multi-axial which complicates the data retrieval. Unless the users of the data know and understand why and how the coders code, the resulting data retrieval could depict an inaccurate and incomplete picture of a medication's safety profile. Thus, an emphasis on MedDRA structure and coding principles is an integral part of both the coding and the retrieval trainings. From there, retrieval training should cover the theory and provide examples of searches. Most comprehensive retrieval trainings may even include an AE dataset coded in a legacy dictionary as well as in MedDRA for hands-on exercises and comparison of results.
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How can I obtain a copy of MedDRA? Is it available to purchase on CD or paper? As a medical coder, I would like to receive a copy to familiarize myself with it.
An electronic copy of MedDRA is available by purchasing a licensing agreement from the MSSO. However, retaining a copy of MedDRA is not the most efficient method available to familiarize yourself with MedDRA. Unlike COSTART, WHO-ART, or HARTS, attempting to memorize MedDRA is an impractical use of time and effort due to the on-going modifications, the complex hierarchical structure, and more importantly, its granularity. It is, therefore, strongly recommended that anyone who will have to deal with MedDRA as a coder, clinical data manager, reviewer, or IT support personnel should undergo "formal" training .
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What is the process for having a new term accepted into the dictionary?
All proposed changes to MedDRA including the addition or deletion of "terms" must be submitted to the Maintenance and Support Services Organization (MSSO), which is responsible for updating the terminology on a regular basis. MSSO will only accept requests for changes from its core service subscribers.
Not all requests will be implemented. Once a change request is submitted, MSSO evaluates it and reserves the right to use professional discretion in determining whether the proposed change will be implemented or rejected. If rejected, MSSO will provide the person or party who made the submission with a reason.
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