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Pharmacovigilance: Drug Safety Monitoring

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Pharmacovigilance: Drug Safety Monitoring

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Questions and Answers

Which of the following is NOT a reason for the necessity of pharmacovigilance?

Limited preclinical safety data

Changing drug use patterns

Increased production of generic drugs (correct)

Lack of awareness regarding drug interactions

What is the primary goal of the Pharmacovigilance Program of India?

To develop new drugs for specific diseases

To promote the use of traditional medicine

To ensure the safety of drugs and their benefits outweigh risks (correct)

To evaluate the efficacy of new drugs

What significant event prompted major worldwide changes in drug safety systems?

The thalidomide disaster (correct)

The development of the polio vaccine

The discovery of penicillin

The outbreak of the Spanish flu

Which of these is NOT a method used in pharmacovigilance?

<p>Clinical trials (C)</p> Signup and view all the answers

What does the term 'pharmacovigilance' refer to?

<p>The monitoring of drug safety (B)</p> Signup and view all the answers

Study Notes

Pharmacovigilance: Drug Safety Monitoring

Pharmacovigilance is the process of monitoring drug safety.
The thalidomide tragedy in the 1960s highlighted the need for improved drug safety systems.
Inadequate preclinical safety data and shifts in drug use patterns necessitate pharmacovigilance.

Reasons for Pharmacovigilance

Limited preclinical safety data before drug launch.
Changing drug use patterns.

Aims and Methods of Pharmacovigilance

Aims to identify and understand adverse drug reactions (ADRs).
Uses methods like spontaneous reporting, case studies, and periodic safety reports.

Pharmacovigilance Program of India

Focuses on monitoring adverse drug reactions in India.
Ensures benefits of drugs outweigh risks.

Types of Adverse Drug Reactions (ADRs)

Different types of ADRs exist, not specified.

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Description

This quiz covers important aspects of pharmacovigilance, with a focus on drug safety monitoring and its significance following past tragedies. It discusses the aims, methods, and specific programs like the Pharmacovigilance Program of India, as well as the implications of adverse drug reactions. Test your knowledge on this essential field of healthcare.