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Severity and seriousness assessment: BP805T Pharmacovigilance Notes

Definitions 

Adverse Drug Reaction:

According to WHO Adverse drug reaction is defined as ”A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.” 

Adverse Event:

Adverse event is defined as ” Any medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.”

Severity:

It describes the extent to which the ADRs influence the everyday life of patients.

Seriousness:

It is of an ADR is related to its life-threatening nature and is defined as any untoward reaction to the medicinal product that may result in death and requires patient hospitalization


Severity Assessment:

 1. Karch and Lasagna classify severity into minor, moderate, severe and lethal.

• Mild(Minor)

• Moderate

• Severe

• lethal 

2. Hartwig et al categorized ADRs into seven levels as per their severity.

Level 1 & 2 fall under mild category,

Level 3 & 4 under moderate and

level 5, 6 & 7 fall under severe category.


Seriousness assessment

The seriousness of the reaction is categorized according to FDA criteria on the basis of their life-threatening nature. 

• Death

• Life-threatening

• Hospitalization (initial or prolonged)

• Disability or Permanent Damage

• Congenital Anomaly/Birth Defect

• Required Intervention to Prevent Permanent Impairment or Damage (Devices)

• Naranjo Algorithm: It is used to determine adverse drug reaction probability


Suggested readings:

  • BP101T Human Anatomy and Physiology I Theory
  • Methods in Causality assessment: BP805T Pharmacovigilance Notes
  • Importance of safety monitoring of Medicine
  • Detection and reporting of adverse drug reactions
  • Definitions and classification of ADRs

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

B Pharmacy Notes (Subjectwise/Topicwise)

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  • T Y B Pharmacy Notes
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  • 1st Year D Pharmacy
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