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JNTU B.Pharmacy IV PHARMACOVIGILANCE Previous Question Paper (December 2023 / January 2024 - R17)

B.Pharmacy | IV | I | R17 | December 2023 / January 2024

Answer PaperPaper Code: 247AGMaximum Marks: 75Time: 3 Hours

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

1a

What is relative risk?

2 marks

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.

RR = [a / (a + b)] / [c / (c + d)]

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.

1b

What is rational use of drugs means.

3 marks

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.
1c

Define defined daily dose.

2 marks

Answer

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1d

Name the basic drug information resources.

3 marks

Answer

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1e

Define adverse event.

2 marks

Answer

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1f

What is active Surveillance means?

3 marks

Answer

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1g

List the statistical tests used in clinical phase.

2 marks

Answer

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1h

What is expedited reporting?

3 marks

Answer

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1i

Define pharmacogenomics in ADRs.

2 marks

Answer

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1j

Compare avoidable and unavoidable ADRs.

3 marks

Answer

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Part B

210 marks
a

Explain methods in causality assessment.

5 marks

Answer

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b

Write the development of Pharmacovigilence.

5 marks

Answer

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OR
3

Discuss WHO international drug monitoring program.

10 marks

Answer

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410 marks
a

Discuss about standadized MedDra queries.

5 marks

Answer

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b

Explain basic drug information resources.

5 marks

Answer

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OR
5

Discuss establishment and operation of drug safety centre at Industry.

10 marks

Answer

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6

Discuss cross sectional studies and cohort studies.

10 marks

Answer

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OR
7

Explain passive surveillance methods.

10 marks

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8

Discuss statistical methods used in post approval phase for evaluating medication safety.

10 marks

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OR
9

Explain good clinical practice in pharmacovigilence.

10 marks

Answer

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10

Discuss drug safety evaluation in lactation.

10 marks

Answer

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OR
11

Discuss drug safety evaluation in geriatrics.

10 marks

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About this paper

This page contains the solved question paper with answers of PHARMACOVIGILANCE from JNTU for B.Pharmacy IV I, December 2023 / January 2024, R17.

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