DICTIONARIES USED IN PHARMACOVIGILANCE

March 16, 2023

DICTIONARIES USED IN PHARMACOVIGILANCE

Drug dictionaries:

The huge abundance of available medicines provides a challenge for those wishing to store accurate information on databases. When considering all the different formulations, dosage forms, routes of administration, therapeutic and pharmacological classes, approved and proprietary names for each of these, the work becomes daunting indeed. A number of standard classifications have been obtained.

The World Health Organization Drug Dictionary:

This contains of the order of 45,000 proprietary drug names, with about 2600 being added annually (Uppsala Monitoring Centre, 2002). It is an international classification, which gives the names used in different countries, together with all active ingredients with unique reference numbers. Drugs are classified according to ATC code. The dictionary was established in 1968 and it includes all drugs mentioned on adverse reaction reports submitted under the World Health Organization (WHO) Programme on International Drug Monitoring.

Medical dictionary for Regulatory Activities:

Med = Medical

D= Dictionary for

R= Regulatory

A =Activities

Definition: MedDRA is a clinically validated international medical terminology which is used by regulatory authorities and the biopharmaceutical industry. The MedDRA terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation.

MedDRA terms

Symptoms, signs, diseases, syndromes and diagnosis.
Medication errors
Medical, social and family history information
Sites (EX: Application, implant, injection sites)
Approved use for medications and medication devices
Types of investigations (EX: Liver function test)

STRUCTURE OF MedDRA:

What is the Purpose of using MedDRA?

To aggregate reported terms in medically meaningful groupings for the purpose of reviewing or analysing safety data.
To facilitate consistent retrieval of specific cases or medical conditions from databases.
It helps to improve consistency in comparing and understanding safety signals and aggregated clinical data.
To report adverse reaction /adverse event (ADR/ADE) terms via individual case report form.
To identify frequency of medically similar ADR/AE.

WHAT ARE THE APPLICATIONS OF MedDRA?

Numerous applications including:

Indications for treatment
Medical history
Adverse events, Serious adverse events
Investigations/ test results

ADVERSE DRUG REACTION DICTIONARIES

World Health Organization Adverse Reaction Terminology: WHO-ART

This WHO-ART is used by the WHO Uppsala Monitoring Centre for reporting suspected adverse reactions on their worldwide database, as well as by many regulatory authorities for their pharmacovigilance activities.
WHO-ART (Uppsala Monitoring Centre, 2000) has been significantly used in the past by pharmaceutical companies, but has often been modified by the addition of many new terms within individual organizations, so that these in-house versions are effectively have separate terminologies.
With regard to the ‘standard’ dictionary, this is updated at intervals by the addition of new terms and with the release of new versions.
Translations are possible in several languages, and there are both paper and electronic versions.
WHO-ART is a four-level hierarchical and multiaxial structure.
Preferred terms are used for data input and they represent the separate medical concepts.
Included terms are equivalent to the Preferred terms and are used for finding the most appropriate Preferred term for coding purposes.
However, included terms can also be used for data entry.
High level terms are used to classify qualitatively similar Preferred terms, but many Preferred terms have no corresponding High-level term.

At the top end of the WHO-ART System, there are 32 System-organ classes, which provide groupings for the High-level terms and Preferred terms. A Preferred term may be allocated up to three different System-organ classes. Preferred and Included terms in WHO-ART are assigned numerical codes that provide information about the level of the term and the System-organ classes to which it is allocated. Thus, in addition to a unique record number, each Preferred term is assigned the number 0100. Each System-organ class is affiliated with a four-digit code, for example, 0600 for Gastro-intestinal system disorders.

WHO-ART System – Organ classes

Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)

This was distributed by the US Food and Drugs Administration (FDA) and has been widely used by many companies for coding adverse events in clinical trials and post-marketing surveillance.
At the peak of the COSTART (Food and Drugs Administration, 1989) hierarchy, there are 12 body systems. At the next lowest level in COSTART, there is a mid-level classification which is mainly used for retrieval purposes based on pathophysiology.
Coding symbols are associated with one or more Glossary terms, which are used to aid in selection of the Coding symbol when it is used for coding.
For example, for the Coding symbol ANGINA PECTORIS, we have Glossary terms including Angina at rest Prinz metal’s; Angina attack; Angina of effort; Angina pectoris; Angina pectoris aggravated; Anginal pain; Anginal syndrome; Effort angina; etc.
The status of COSTART is insubstantial, in view of the adoption of MedDRA by the FDA. In time it is likely that it will be completely replaced by MedDRA.

COSTART BODY SYSTEM