The WHO Drug Dictionary (WHO-DD) is an internationally recognized database of medicinal products and their related information, developed and maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization’s Collaborating Centre for International Drug Monitoring. It is primarily used in pharmacovigilance, clinical trials, and drug safety monitoring for identifying and coding medications across various … Read more
MedDRA and SMQs MedDRA and SMQs: MedDRA (Medical Dictionary for Regulatory Activities) is a globally standardized medical terminology developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is used in regulatory submissions, clinical trials, and post-marketing surveillance to describe adverse drug reactions (ADRs), medical conditions, and therapeutic … Read more
In pharmacovigilance, drug dictionaries and coding systems play a crucial role in ensuring accurate and consistent documentation, reporting, and analysis of drug-related information, especially in the context of adverse drug reactions (ADRs). These standardized systems help in the collection, classification, and analysis of drug safety data, ensuring uniformity across regions and institutions. Coding systems facilitate … Read more
International Nonproprietary Names (INN) are unique names given to pharmaceutical substances or active ingredients, as standardized by the World Health Organization (WHO). These names are recognized globally and are intended to provide a universal standard for the identification of drugs, free from the limitations and confusion of brand names and regional trade names. The INN … Read more
The Defined Daily Dose (DDD) is an internationally recognized statistical unit developed by the World Health Organization (WHO) through its Collaborating Centre for Drug Statistics Methodology. It represents the assumed average maintenance dose per day for a drug when used for its principal indication in adult populations. This standardized metric facilitates meaningful comparisons of drug … Read more
The International Classification of Diseases (ICD) is a standardized system used globally for the classification of diseases, health conditions, and related health problems. Maintained by the World Health Organization (WHO), the ICD provides a comprehensive framework for identifying and documenting diseases and various health conditions in a universally accepted format. 1. Overview of the International … Read more
Drug and Disease Classification: Anatomical, Therapeutic, and Chemical Classification of Drugs Drug and disease classification systems are essential frameworks in healthcare and pharmacology. They provide a standardized approach for organizing and categorizing drugs based on their anatomical site of action, therapeutic use, chemical structure, and mechanism of action. These classifications aid in drug discovery, clinical … Read more
Basic Terminologies in Pharmacovigilance: Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Effective pharmacovigilance relies on a well-understood terminology that ensures clarity and accuracy in communication. 1. Basic Terminologies in Pharmacovigilance 1. Pharmacovigilance (PV): Defined by the WHO as “the … Read more
Management of Adverse Drug Reactions Management of Adverse Drug Reactions: Adverse Drug Reactions (ADRs) are undesirable effects associated with the use of drugs. They can range from mild to life-threatening and are a significant concern in healthcare due to their impact on patient safety, treatment efficacy, and healthcare costs. Proper management of ADRs is crucial … Read more
Predictability & Preventability Assessment Predictability & Preventability Assessment: In the evaluation of Adverse Drug Reactions (ADRs), predictability and preventability are important concepts that help assess whether a reaction could have been foreseen or avoided. These assessments guide clinicians in reducing the risk of future ADRs and improve patient safety by minimizing preventable drug-related harm. 1. … Read more
