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
Introduction to Adverse Drug Reactions Adverse Drug Reactions (ADRs) are an essential aspect of drug safety monitoring and are critical for ensuring the safe use of medicines. According to the World Health Organization (WHO), an ADR is defined as any unintended, harmful reaction to a drug administered at normal doses for prevention, diagnosis, or treatment. … Read more
Adverse Drug Reactions (ADRs) refer to unintended and harmful reactions that occur in response to the administration of medications at normal therapeutic doses. These reactions can manifest in various forms, ranging from mild discomfort to severe adverse effects, and they can occur immediately after drug intake or after prolonged use. ADRs are distinct from the … Read more
The Pharmacovigilance Program of India (PvPI) is a national initiative launched by the Government of India to ensure the safety of medicines used by the Indian population. It aims to monitor, detect, assess, and prevent adverse drug reactions (ADRs) and ensure that medicines available in the market are safe and effective for public use. PvPI … Read more
The WHO International Drug Monitoring Programme, Programme for International Drug Monitoring (PIDM) is a global initiative established by the World Health Organization (WHO) to improve patient safety by monitoring the safety of medicinal products worldwide. Launched in 1968 in response to the thalidomide disaster, the program seeks to detect, assess, understand, and prevent adverse effects … Read more
Safety monitoring of medicines, often referred to as pharmacovigilance, is a critical process that ensures the safe and effective use of pharmaceutical products throughout their lifecycle. While clinical trials provide valuable insights into a drug’s efficacy and safety, these trials are limited in terms of the number of patients, the duration of the study, and … Read more
The World Health Organization (WHO) took a leading role in global pharmacovigilance efforts. In 1968, WHO established its International Drug Monitoring Programme, which initially involved ten countries (Australia, Canada, Denmark, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, United States, West Germany (now part of Germany)). This program aimed to improve drug safety by encouraging countries … Read more
