Pharmacovigilance ppt.pptx

Small Group Discussion (SGD)
CBME based curriculum

1. Pharmacovigilance By Nishant Raj

2. Introduction Emergence of newer discipline that widens the area of drug safety

3. According To WHO 2002, Pharmacovigilance is the science and activities related to : Detection Assessment Understanding Prevention of Adverse effects or any other possible drug related problem ..

4. What’s the Need..

5. Dying from a disease may be inevitable , dying from a medicine is unacceptable Insufficient evidence of safety Animal experiments Clinical trials prior to marketing ( however , some adverse reactions (ADRs) are often detected ONLY after marketing ADRs are expensive/ can be life threatening

6. PRE Authorization : Analysis of safety information ( usually obtained from preclinical and clinical studies ) collected before the marketing authorization of the drug Preclinical phase Phase I,II,III POST Authorization : Analysis of safety information (usually obtained from spontaneous case reports , literature publications, safety studies ) collected after the marketing authorization of the drug Phase IV PRE AUTHORTISATION AND POST AUTHOISATION PHARMACOVIGILANCE

7. A Lesson from History…….

8. AIM OF PHARMACOVIGILANCE

9. Framework of Pharmacovigilance

10. Functions of Pharmacovigilance

11. Causality Assessment It is the assessment of relationship between a drug treatment and the occurrence of an Adverse event Basically the practical tool for assessment of case reports Grading – Definite : clearly caused by the exposure Probable : likely to be related to the exposure Possible : may be relate to exposure Unlikely : doubtfully related to the exposure Unrelated : clearly not related to the exposure

12. ORGANISATIONS INVOLVED WHO – collaborating center for international drug monitoring is Uppsala monitoring center ,sweden,1978, provides activities and events CIOMS (council for international organizations of medical sciences) – ensuring the communication between regulators and industries ICH ( International conference on harmonization )

13. India joined WHO programme of international drug monitoring in 1997 It started as the National pharmacovigilance programme (NCC) officially in 2004 The Pharmacovigilance programme was initiated in the year 2010, by the government of India at AIIMS as National Coordinating center (NCC) but shifted to Indian Pharmacopoeia commission (IPC) , Ghaziabad (U.P) in the year 2011 Pharmacovigilance is conducted by CDSCO ( center for drug standard and control organisation, Delhi and coordinating by IPC

14. Key stockholders in Pharmacovigilance …..

15. REPORT

16. ADR Monitoring Centers Report ADR at AMCs or NCC Toll free number. 1800-180-3024 ( 9 am to 5.30 pm ) Monday to Friday Email at: [email protected] or [email protected] ADR mobile app As of today , in India there are more than 300 AMCs ( March ,2021)

17. our college has obtained recognition as AMC center in 2017 JUNE by Ministry of Health and family welfare , Government Of India under pharmacovigilance programme of India SHKM GMC , NALHAR ,NUH HARYANA

18. Mobile Application e- PvPI

19. Procedure for Reporting ADR

20. Some withdrawn drugs…. Rofecoxib Rosiglitazone Phenylpropanolamine Astemizole Terfenadine Thalidomide Gatifloxacin Trovafloxacin Nimesulide

21. … Thank You …