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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/12/01 11:25:17」(JST)

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MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary (and thesaurus) used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Originally available in English and Japanese, MedDRA is now also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Portuguese and Spanish. ^[1] MedDRA is widely used internationally, including in the United States, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

Organization of the dictionary

The MedDRA dictionary is organized by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lowest Level Terms (LLT).^[2] In addition, the MedDRA dictionary includes Standardized MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest.

Individual cases are usually coded for data entry at the most specific (LLT) level, and outputs of counts or cases are usually provided at the PT level. The higher levels (HLT, HLGT and SOC) as well as SMQ are used for searching and for organisation and subtotalling of outputs.

Maintenance of MedDRA

MedDRA is managed by the MSSO (Maintenance and Support Services Organization). The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is the Trustee of the International Conference on Harmonisation (ICH) Steering Committee and holds the intellectual property rights (ownership) of MedDRA. The ICH has contracted Northrop Grumman to act as the MSSO. MedDRA is free for regulators and priced according to company revenue for industry. The Japanese counterpart for MSSO is called JMO. ^[3]

The MSSO updates MedDRA according to subscriber change requests, for example to add a new medical concept that is yet to be in MedDRA or to change an existing concept. The decisions are made by international medical officers on how to map the terminology within the grouping categories according to a general consensus based on language considerations internationally.

The MSSO releases updated MedDRA versions twice a year - in March and September. The March release is the main annual release and contains changes at the HLT level and above along with LLT and PT changes. The September release typically contains changes only at the LLT and PT level. The September 2015 Version 18.1 release is the current version.

References

^ "Welcome to MedDRA".
^ "What are the structural elements of the terminology in MedDRA?". MedDRA FAQ. Retrieved 25 January 2012.
^ "About MSSO".

External links

MedDRA and the MSSO

English Journal

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

Goedecke T1, Ord K2, Newbould V3, Brosch S3, Arlett P3.
Drug safety.Drug Saf.2016 Jun;39(6):491-500. doi: 10.1007/s40264-016-0410-4.
A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at a
PMID 26940903

Cardiovascular disorders associated with naloxone monotherapy and in fixed-dose combination with opioids: Data from international safety surveillance.

Sandhu A1, Kao D2, Mehler PS3, Haigney MC4, Krantz MJ5.
International journal of cardiology.Int J Cardiol.2016 Jun 1;212:360-3. doi: 10.1016/j.ijcard.2016.03.079. Epub 2016 Mar 24.
BACKGROUND: The widespread use of opioids has resulted in sharp rise of associated complications, particularly opioid-induced constipation (OIC). Opioid receptor antagonists have been proposed to treat OIC, but could precipitate rapid opioid withdrawal. As cardiovascular safety data are lacking, we
PMID 27060723

Drug-Induced Liver Injury Associated With Antidepressive Psychopharmacotherapy: An Explorative Assessment Based on Quantitative Signal Detection Using Different MedDRA Terms.

Gahr M1, Zeiss R1, Lang D2, Connemann BJ1, Hiemke C3, Schönfeldt-Lecuona C1.
Journal of clinical pharmacology.J Clin Pharmacol.2016 Jun;56(6):769-78. doi: 10.1002/jcph.662. Epub 2015 Dec 14.
Drug-induced liver injury is a major problem of pharmacotherapy and is also frequent with antidepressive psychopharmacotherapy. However, there are only few studies using a consistent methodologic approach to study hepatotoxicity of a larger group of antidepress ants. We performed a quantitative sign
PMID 26470856