Pharmacovigilance AKTU THEORY EXAMINATION 2021-22 PDF | PPT
Description: This resource provides comprehensive answers and explanations for the Pharmacovigilance AKTU Theory Examination 2021-22. It covers key topics such as drug event monitoring, contraindications in pregnancy, CIOMS forms, EudraVigilance, teratogenicity, post-marketing safety, clinical trials, and more. Downloadable PDFs and PowerPoint presentations are available for academic and professional use.
Keywords: Pharmacovigilance, AKTU Exam, Drug Event Monitoring, Teratogenicity, Post-Marketing Safety, CIOMS Form, EudraVigilance, Clinical Trials, PDF Download, PPT Slides
Pharmacovigilance AKTU THEORY EXAMINATION 2021-22 PDF | PPT
Introduction:
The AKTU Theory Examination 2021-22 on Pharmacovigilance tests students' understanding of critical concepts related to drug safety and adverse drug reaction (ADR) monitoring. This guide provides detailed explanations for all the questions in the exam, ensuring clarity and depth of knowledge. Whether you're preparing for exams or seeking practical insights into pharmacovigilance, this resource is an invaluable tool.
a. What is Drug Event Monitoring?
Drug event monitoring involves the systematic collection and analysis of data related to adverse drug reactions (ADRs) and other drug-related events. It helps identify potential safety concerns, assess risk-benefit ratios, and ensure the safe use of medications. Examples include spontaneous reporting systems and cohort event monitoring.
b. List Four Drugs Contraindicated in Pregnant and Lactating Women:
- Isotretinoin: Known for its teratogenic effects, causing severe birth defects.
- Warfarin: Can cause fetal bleeding and developmental abnormalities.
- Methotrexate: Associated with miscarriage and congenital malformations.
- ACE Inhibitors: Linked to kidney damage and growth retardation in fetuses.
c. Suggest the Requirements for CIOMS Form:
The Council for International Organizations of Medical Sciences (CIOMS) form is used for standardized reporting of individual case safety reports (ICSRs). Key requirements include:
- Patient demographics (age, gender).
- Details of the suspected drug(s).
- Adverse event description and severity.
- Causality assessment and outcome.
d. What is EudraVigilance?
EudraVigilance is the European Union's system for managing and analyzing information on suspected adverse reactions to medicines. It supports regulatory authorities and pharmaceutical companies in monitoring drug safety and ensuring compliance with EU regulations.
e. What is Teratogenicity? Give Examples:
Teratogenicity refers to the ability of a substance to cause developmental abnormalities in a fetus. Examples include:
- Thalidomide: Causes limb deformities.
- Valproic Acid: Linked to neural tube defects.
f. What is Post-Marketing Safety?
Post-marketing safety involves monitoring the safety of drugs after they have been approved and marketed. It includes activities like Phase IV clinical trials, spontaneous reporting, and signal detection to identify rare or long-term adverse effects.
g. Narrate the Minimum Criteria Required for a Valid Report:
A valid pharmacovigilance report must include:
- An identifiable patient.
- An identifiable reporter.
- A suspect drug.
- An adverse event.
h. What is Phase IV of Clinical Trials?
Phase IV, also known as post-marketing surveillance, occurs after a drug has been approved for public use. Its purpose is to monitor the drug's safety and efficacy in larger populations and over longer durations.
i. What Are the Basic Objectives of Pharmacovigilance Planning?
- To detect, assess, and prevent adverse drug reactions.
- To ensure the safe and effective use of medicines.
- To comply with regulatory requirements.
- To improve public health outcomes.
j. Mention Few Examples of Predictable Adverse Drug Reactions:
- Nausea caused by chemotherapy drugs.
- Hypoglycemia from insulin therapy.
- Drowsiness from antihistamines.
Benefits of Downloadable Resources:
This resource includes downloadable PDFs and PowerPoint presentations, which enhance learning and teaching experiences. These materials are particularly useful for educators preparing lectures, students revising for exams, and professionals conducting training sessions.
Conclusion:
The Pharmacovigilance AKTU Theory Examination 2021-22 is a comprehensive test of essential pharmacovigilance concepts. By exploring topics such as drug event monitoring, teratogenicity, post-marketing safety, and clinical trials, this guide equips readers with the knowledge needed to excel in their studies and contribute effectively to drug safety. Whether you're downloading the PDF or utilizing the PPT slides, you'll find valuable educational content tailored to your needs.
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