In 1996, MedDRA (Medical Dictionary for Regulatory Activities) was created to facilitate the international exchange of medical regulatory information and has since become the global industry standard. It contains specific standardised medical terminology, to enable sharing of regulatory information for medical products used by humans.
WHODrug is the international classification of medicines developed by the World Health Organization (WHO) which is used in about 150 countries. Created in 1968, WHODrug has been through many upgrades and is currently available in a single subscription service called WHODrug Global. Its aim is to facilitate the coding of medications in adverse event reports, allowing for more efficient data analysis.
These dictionaries (and others including IMDRF, IDF Japan, etc.) are valuable tools for pharmacovigilance, helping to identify trends and patterns related to adverse reactions. They have helped unify PV efforts around the world and facilitated compliance across the industry. However, central management of dictionaries including multiple languages, multiple versions and the impact assessment and update processes twice a year, represent a major overhead for many companies to manage effectively and efficiently. Often companies have multiple systems that need access to up to date and historical dictionary information, making the coordination of dictionary management even more problematic.
What can the HALOPV module do for you?
The HALOPV Dictionaries and Terms module facilitates central access, browsing and management of all relevant dictionaries and the downstream dissemination of updated data to your PV systems. In addition, you can create tailored term collections to support your business needs in signaling, reporting, safety surveillance, etc.
Key features of the module:
Central management of all dictionaries including multiple versions and languages
Dictionary browse and search functions
Term Collection Management
Product Labelling Management
Integration with downstream systems such as your safety database, signal detection system, reporting systems, clinical systems, etc. via API (standard out of the box integrations include Argus Safety and Commonwealth Vigilance Workbench (CVW))
Dictionary upgrades twice a year including impact assessment reports
MedDRA Functions:
MedDRA Hierarchy Search & Browser (any version & language)
MedDRA Tree Structure Search & Browse (any version & language)
MedDRA Standard MedDRA Queries (SMQ) and Custom MedDRA Queries (CMQ)
Associate a product with a CMQ to create product labels
Management of Term Collections: Request, Review, Approve process
WHO Functions:
WHO Search & Browse (Drug Search)
WHO Search & Browse (Drug by ATC)
WHO Search & Browse (Drug by SDG)
WHO ATC Search & Browse
IDF Japan Search & Browse
Reporting & Oversight:
Impact assessment report including automated changes and those that require manual review & confirmation
Worklist management reports
User specific configurable dashboards
These global dictionaries are an essential tool in identifying patterns in adverse reactions and helping unify PV compliance across the world. It can be a time consuming and complex task keeping up to date with their continuous updates, so why not let HALOPV do it for you?
The Dictionaries and Terms module is available now and already being used by one of the Top 10 Global Pharma companies for central dictionary management. Do not hesitate to contact us if you’d like to hear more, just email hello@insife.com