JNTU
JNTU B.Pharmacy IV PHARMACOVIGILANCE Previous Question Paper (December 2023 / January 2024 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
What is relative risk?
Answer
Relative risk (RR) is a measure of the association between an exposure and an outcome, defined as the ratio of the probability of an event occurring in an exposed group to the probability of the event occurring in a non-exposed group.
In this formula, a represents exposed individuals with the outcome, b represents exposed individuals without the outcome, c represents unexposed individuals with the outcome, and d represents unexposed individuals without the outcome.
What is rational use of drugs means.
Answer
Rational use of drugs (RUD) is defined as a situation where patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community. It ensures that the right drug is selected based on efficacy, safety, suitability, and cost-effectiveness for the specific patient.
Key components of rational drug use include:
- Correct diagnosis and assessment of the patient's condition.
- Selection of the most appropriate therapeutic intervention.
- Consideration of the patient's medical history, potential drug interactions, and contraindications.
- Provision of clear information and instructions to the patient regarding the medication regimen.
- Regular monitoring of the treatment outcome and adherence.
Define defined daily dose.
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Name the basic drug information resources.
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Define adverse event.
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What is active Surveillance means?
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List the statistical tests used in clinical phase.
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What is expedited reporting?
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Define pharmacogenomics in ADRs.
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Compare avoidable and unavoidable ADRs.
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Part B
Explain methods in causality assessment.
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Write the development of Pharmacovigilence.
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Discuss WHO international drug monitoring program.
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Discuss about standadized MedDra queries.
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Explain basic drug information resources.
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Discuss establishment and operation of drug safety centre at Industry.
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Discuss cross sectional studies and cohort studies.
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Explain passive surveillance methods.
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Discuss statistical methods used in post approval phase for evaluating medication safety.
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Explain good clinical practice in pharmacovigilence.
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Discuss drug safety evaluation in lactation.
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Discuss drug safety evaluation in geriatrics.
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