Podcast
Questions and Answers
Which of the following is NOT a reason for the necessity of pharmacovigilance?
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?
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?
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?
Which of these is NOT a method used in pharmacovigilance?
What does the term 'pharmacovigilance' refer to?
What does the term 'pharmacovigilance' refer to?
Flashcards
Pharmacovigilance
Pharmacovigilance
The monitoring of drug safety to prevent adverse effects.
Adverse Drug Reactions (ADRs)
Adverse Drug Reactions (ADRs)
Negative effects or reactions caused by medications.
Thalidomide disaster
Thalidomide disaster
A critical event in the 1960s that highlighted drug safety issues.
Methods of pharmacovigilance
Methods of pharmacovigilance
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Pharmacovigilance Program of India
Pharmacovigilance Program of India
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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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