Introduction to Pharmacovigilance| B- PHARM| PHARMACOVIGILANCE

This presentation includes the basic overview for the pharmacovigilance.
This presentation covers topic such as:
1) What is Pharmacovigilance ?
2) Basic Terminologies for Pharmacovigilance ?
3) Needs and Aim of Pharmacovigilance.
4) Adverse Drug Reaction.
5) Severe Adverse Drug Reaction.
6) Classification of ADRs
7) Adverse Drug Event.
8) What is causality ?
9) ADR vs ADE.
10) Sources of Adverse Event Reports.

1. Pharmacovigilance By World Of Pharmacy

2. Pharmacovigilance Pharmacovigilance: It is comprises of etymology Pharmakon (Greek Word) Vigilia (Latin Word) Medical Substances To Keep Watch Over

3. Basic Terminologies for Pharmacovigilance Co-Suspect Drug Drug taken along with suspected drug and results in an adverse event. Concomitant Drug Drug taken along with suspected drug. Past Drug Drug stopped before starting of the suspected drug. Suspect Drug A drug which is associated with adverse drug reaction

4. What is Pharmacovigilance ? As per the WHO, Pharmacovigilance is defined as the “ Science and activities relating to the assessment, detection, understanding and prevention of adverse effects or any other possible drug-related problem”.

5. Needs & Aim of Pharmacovigilance Lack of Evidence for safety from Clinical Trials To understand the risk and effectiveness of drug To enhance public health and safety Assist the rational use of medicines To enhance patient care and Safety

6. Adverse Drug Reaction Any unintended and noxious response to a active pharmaceutical ingredient or a drug at any particular or a specified dose is termed as Adverse Drug Reaction.

7. Severe Adverse Drug Reaction Severe Adverse Drug Reactions (ADRs) are a huge wellbeing trouble as characterized as responses to any portion of a medication that outcome in death, are dangerous, require hospitalization or prolongation of existing hospitalization and may lead to death

8. Classification of ADRs Type A - Augmented Type B - Bizzare Type C - Chemical Type D - Delayed Type E – Exit/End of Treatment Type F - Familial Type G - Genotoxicity Type H - Hypersensitivity Type U - Unclassified

9. Adverse Drug Event Any untoward medical occurrence which happens to either a patient or subject in a clinical investigation when an active pharmaceutical ingredient is been administered by a patient.

10. What is Causality ? It can be termed as a relationship between suspected drug and its adverse drug event.

11. ADR vs ADE One who finds the causality for adverse occurrence is adverse drug reaction. One who fails to find the causality for adverse occurrence is adverse drug event.

12. Sources of Adverse Event Reports Solicited Reports Market Surveys Medical Chart Reviews Continuous Reporting Patient Registries

13. Thank You