E.g., only ampicillin given in injection form.ĭata is not directly mapped to a specific standard.This allows a requestor to be as granular as needed. Using the 3M Healthcare Data Dictionary (HDD), medications can be broken into their components and ingredients. Wildcard searches are inaccurate due to misspellings, abbreviations, and unwanted combination medications. Of the patients with a diagnosis of 123.45, I want to know who was on ampicillin.Ī request for a general category like the above is nearly impossible without hours spent sifting through the medication dictionary and choosing one by one the needed medications. To obtain a user account to access the quarterly updates, please contact the eIT PMO via DHA Global Service Center Help Desk (GSC) at (800) 600-9332 / or email eIT PMO Mailbox ( The WHO DD browser User Guide is located in the Public Folder in the eIT PMO EDMS at. WHO DD has a web based access option hosted and maintained by the UMC. The latest MedDRA Desktop Browser, ASCII files, and MedDRA User Guide are available in the Public Folder in the eIT PMO EDMS at. Once installed, the user will download the latest updates (ASCII files). The MedDRA Desktop Browser is a 'stand-alone' viewer that can be downloaded from the Public Folder in EDMS. The dictionaries can be viewed outside of the systems noted above: Updates to both dictionaries are imported to the EDC-CRDMS and the SAE system as they become available. These dictionaries can be imported into other USAMRMC systems in order to uniformly code clinical study data for submission to the FDA.Ĭurrently, the eIT PMO Serious Adverse Event (SAE) and the eIT PMO Electronic Data Capture Clinical Research Data Management System (EDC-CRDMS) products utilize these dictionaries. The eIT PMO manages the medical dictionary subscriptions and access to the latest updates for use by USAMRDC with no cost to the users. More information about WHO DD can be found on the UMC website. WHO DD updates are released Quarterly (March, June, September, and December) by the UMC. WHO DD is sponsored, licensed, and maintained by the Uppsala Monitoring Centre (UMC). Since the WHO Drug Dictionary contains a high percentage of product names that appear as co-medication, the need for manual investigations and fact-finding are reduced and the quality of coded data is increased. It translates a drug name into useful information, which is used for coding and analysis of drug safety data, for both pre- and post-marketing.

The World Health Organization's Drug Dictionary (WHO DD) is a comprehensive source of medicinal product information used to identify drug names, active ingredients, and therapeutic use in the course of drug safety surveillance.

More information about MedDRA and the MSSO can be found on their website: WHO Drug: MedDRA updates are released Bi-Annually (1 March and 1 September) by the MSSO. The MSSO is the source for the most up-to-date information regarding MedDRA and its application. The Maintenance and Support Services Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA.

MedDRA was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), acting as trustee for the ICH steering committee. The FDA currently uses MedDRA in several of its internal data systems. Coding this data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products. The Medical Dictionary for Regulatory Activities (MedDRA) contains medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines).

Medication dictionaries