Unit-1

Basic Terminologies in Pharmacovigilance

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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 the WHO as “the … Read more

Management of Adverse Drug Reactions (ADRs)

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Management of Adverse Drug Reactions

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 in Adverse Drug Reactions (ADRs)

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Predictability & Preventability Assessment

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 in Adverse Drug Reactions (ADRs)

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Screenshot 2025 04 03 120321 Severity and Seriousness Assessment in Adverse Drug Reactions (ADRs)

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

Methods in Causality Assessment

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Screenshot 2025 04 03 115315 Methods in Causality Assessment

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

Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions (ADR)

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Screenshot 2025 03 22 165732 Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions (ADR)

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

Methods in Causality Assessment

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Screenshot 2025 03 22 164954 Methods in Causality Assessment

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

Detection and Reporting of Adverse Drug Reactions (ADR)

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Screenshot 2025 03 22 164145 Detection and Reporting of Adverse Drug Reactions (ADR)

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)

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Adverse Drug Reactions (ADRs)

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

Pharmacovigilance Program of India (PvPI)

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Pharmacovigilance Program of India

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