JNTU
JNTU B.Pharmacy IV PHARMACOVIGILANCE Previous Question Paper (January / February - 2023 - 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
Define Pharmacovigilance.
Answer
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. Its primary objective is to enhance patient care and safety in relation to the use of medicines and all medical and paramedical interventions.
Outline the role of WHO collaborating centre.
Answer
The WHO Collaborating Centre for International Drug Monitoring, known as the Uppsala Monitoring Centre (UMC), plays a central role in global pharmacovigilance by managing the international database of adverse drug reactions (ADRs). Its primary functions include:
- Data Collection and Management: It receives, processes, and maintains individual case safety reports (ICSRs) submitted by national pharmacovigilance centers worldwide into the VigiBase database.
- Signal Detection: It utilizes sophisticated statistical tools and data mining techniques to identify potential new safety signals or previously unknown associations between drugs and adverse events.
- Technical Support and Standardization: It provides guidance, training, and standardized tools (such as the WHO Drug Dictionary and MedDRA coding) to member countries to ensure the quality, consistency, and interoperability of safety data globally.
Define WHO drug dictionary.
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Show the types of services provided by CROs.
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List the role of NRA in Immunization Safety Surveillance.
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Define surveillance according to Langmuir.
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Name the specific guidance that contains related text: i) E1A ii) E3
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Define Potency.
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Compare personalized medicine and pharmacogenomics.
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Summarize the genomic approaches to serious adverse drug reactions.
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Part B
Explain in detail about history and development of Pharmacovigilance with special reference to Pharmacovigilance Program of India (PvPI).
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Identify the following abbreviations: a) ADR b) CD c) AIMDD d) CRO e) GCP f) IND g) OTC h) PSUR i) SMF j) SSRI.
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Elaborate the importance of safety monitoring of medicine.
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Develop ADR monitoring form.
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Explain the Anatomical, Therapeutic and Chemical Classification of drugs.
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Enumerate the different types of information resources available in Pharmacovigilance with Drug Dictionaries and coding used in Pharmacovigilance.
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Explain the International classification of diseases.
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Explain MedDRA and Standardized MedDRA queries.
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Explain briefly about vaccine pharmacovigilance
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Explain the role and responsibility of immunization Programme in immunization safety surveillance.
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Explain briefly about vaccination failure.
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Explain about passive surveillance.
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Discuss briefly about post approval expedited reports.
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Explain briefly about clinical phase.
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Explain about expedited reporting.
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Explain about post approval phase.
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Explain the criteria for Drug safety evaluation in Pediatric population.
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Briefly discuss about pharmacogenomics.
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Explain the guidelines involved in pregnancy and lactation.
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Explain the criteria for Drug safety evaluation in Geriatrics.
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