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. Â 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 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 … 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
Severity and Seriousness Assessment Severity and Seriousness Assessment: Severity and seriousness are two critical but distinct concepts in the evaluation of adverse drug reactions (ADRs). Both are essential for determining the appropriate response to an ADR, such as continuing or discontinuing treatment, reporting to regulatory authorities, and managing patient outcomes. 1. Severity of Adverse Drug … Read more
Introduction: Causality assessment is a critical process in pharmacovigilance aimed at determining whether a specific drug is responsible for an observed adverse drug reaction (ADR). It helps in identifying the strength of the relationship between drug exposure and the adverse event. Causality assessment is complex, as multiple factors like the patient’s condition, co-administered drugs, or … Read more
The Naranjo Algorithm, developed in 1981 by Naranjo et al., is a structured, questionnaire-based tool used to assess the probability that a drug caused an adverse drug reaction (ADR). It is widely used in pharmacovigilance and clinical research to standardize causality assessment. Structure of the Naranjo Algorithm The Naranjo algorithm consists of 10 questions, each … Read more
Introduction to Causality assessment Causality assessment is a critical process in pharmacovigilance aimed at determining whether a specific drug is responsible for an observed adverse drug reaction (ADR). It helps in identifying the strength of the relationship between drug exposure and the adverse event. Causality assessment is complex, as multiple factors like the patient’s condition, … Read more
