Pharmacovigilance – Need for Society.pptx

Pharmacovigilance – Need for Society

1. Pharmacovigilance – Need for Society By Dr. K . Manohar Babu Professor GIET School of Pharmacy

2. Introduction- Definition of PV – D, A, U, P History, Examples of failure in PV Need for Pharmacovigilence Types of ADRs Drug discovery process Limitations of clinical studies Reporting and Governing stricture

3. Introduction

4. Achyuth - Very popular character artist died of heart attack at the age of 41.

5. Taraka Ratna suffers from heart attack

6. Adverse Drug Reactions 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.

7. Scope of Pharmacovigilance ADRs event Medication errors Substandard medication Lack of efficacy of medicine Misuse and abuse of drugs Interaction between medications

8. Types of ADRs

9. Type A: Predictable, related to mechanism of action Type B: Unpredictable, not related to known mechanism Type A Type B Dose dependency Yes No Predictable from known pharmacology Yes No Predisposing factor Co-morbidities Genetic, Immunological, Frequency Common Uncommon Seriousness Variable Serous

10. Mechanisms of action of ADRs Pharmacodynamics- PD • Mechanism of action • Targets • Specificity Pharmacokinetics- PK • Drug absorption • Drug distribution • Drug metabolism • Drug excretion

11. Reasons for Type A reactions PK variability • Bioavailability • Excretion • Interactions with drug/food • Genetic Concentration abnormal! PD variability • Individual susceptibility due to altered target organ sensitivity • Interactions • Additive • Synergistic • Genetic

12. Type B – Immunologic reactions Drug allergies – 4 pathophysiological types Anaphylaxis II . Antibody-mediated cytotoxic reactions III . Immune complex-mediated reactions IV . Delayed type hypersensitivity

13. Drug factors associated with ADRs Narrow therapeutic index • anticoagulants • immuno suppressants Effects at multiple targets (“dirty drugs”) • antipsychotics • Corticosteroids Toxic effects in one organ • Aminoglycoside ototoxicity • Chloroquine retinopathy

14. Examples of failure in PV

15. Need for Pharmacovigilence ???

16. Drug Drug used for Side Effect Year of ban Avandia Type-2 Diabetes Increased risk of heart attacks 2010 Chantix Quit smoking tobacco products Serious hypersensitivity 2021 Vioxx rofecoxib NSAID Risk of heart attacks and strokes 2007 Baycol Blocks LDL cholesterol  Muscle tissue breaks down 2001 Tysabri Multiple sclerosis Multifocal leukoencephalopathy 2005

17. Drug Development process

18. Reporting and Governing stricture

19. Thank you