Introduction to Pharmacovigilance sem 8 hand written notes pdf

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Pharmacovigilance is the process of identifying, assessing, and preventing adverse effects or any other drug-related problems that may occur in patients taking pharmaceutical products. This practice ensures the safety and efficacy of medications through the collection, analysis, and reporting of adverse drug reactions (ADRs) and other safety-related information.

Pharmacovigilance plays an important role in public health by closely monitoring and evaluating the safety of drugs. This helps to identify potential safety concerns before they become major issues and allows for early detection and management of adverse events. It also helps to inform healthcare professionals and patients about the potential risks associated with the use of certain medications.

The key activities involved in pharmacovigilance include:

1. Detection and reporting of adverse drug reactions (ADRs) by healthcare professionals and patients.

2. Collection, analysis, and evaluation of ADRs and other safety-related data from various sources, including clinical trials, post-marketing surveillance, and medical literature.

3. Risk management activities, including identification of risks associated with drug products, risk assessment and mitigation measures to minimize the potential for harm.

4. Regulatory activities, including safety monitoring, signal detection, and risk management planning for new and existing drugs.

Pharmacovigilance is a continuously evolving field and requires the participation of various stakeholders such as pharmaceutical companies, regulatory bodies, healthcare professionals, patients, and the general public. The ultimate goal of pharmacovigilance is to ensure that the benefits of drug therapy outweigh its potential risks, thereby ensuring the safety and well-being of patients.