PHARMACOVIGILANCE IN AND EMERGING MARKETS: AN INDUSTRY PERSPECTIVE. Shashidhar Swamy (Head, Pharmacovigilance) Wockhardt limited, Mumbai

Transcription

1 PHARMACOVIGILANCE IN AND EMERGING MARKETS: AN INDUSTRY PERSPECTIVE Shashidhar Swamy (Head, Pharmacovigilance) Wockhardt limited, Mumbai 1

2 Disclaimer The content expressed in this presentation is solely my experience and practice in Pharmacovigilance. This presentation and views stated are not necessarily that of Wockhardt Limited. 2

3 Contents Why? Emerging markets Role of Pharmaceutical Industry Stake holders Pharmacovigilance Models 3

4 In recognizing the drug adverse effects at the earliest possible stage so that the risk never becomes disproportionate to benefit. Benefit Risk Why Pharmacovigilance??? 4

5 Russia Middle East and North Africa (MENA) India South East Asia Latin America (LatAm) These emerging markets have their own PV systems 5

6 AERS Med watch Program (voluntary and Mandatory)/ electronic reporting Consumer reporting Eudravigilance Mandatory electronic reporting Yellow card system Manual/Vigiflow via PVPI (ADR monitoring centre) Manual reporting HCP reporting/consumer reporting PSUR Requirement: 1) Quarterly during the first 3 years 2) Annual reports thereafter. PSUR Requirement: 1) Every 6 months for 2 years 2) Annually for the 3 years 3) Every 5 years PSUR Requirement: 1) Every 6 months for 2 years 2) Annually for the 2 following years 3) Every 5 years. 6

7 Role of Pharmaceutical Industry Collection of adverse events Monitoring drug safety trends PSUR (periodic safety update report) Adequate training and communication Creating awareness about drug safety Reporting system for all type of cases (ex: serious ADR,SUSARs etc) Synchronization between Pharmaceutical company and regulatory authorities 7

8 Pharmacovigilance model: Stake holders Patients Physician and medical associations Media Pharma Industry and associations Regulatory authorities 8

9 IN HOUSE PV model: Part In- house Part Outsourced PV model: PV model: IN HOUSE Fully Outsourced end to end Fully In- house end to end OUTSOURCED OUTSOURCED PHARMACOVIGILANCE MODEL 9

10 Pharmacovigilance model: An industry perspective DATA DISTRIBUTION MEDICAL REVIEW DATA COLLECTION DATA PROCESSING DATA ANALYSIS 10

11 Pharmacovigilance model: An industry perspective DATA DISTRIBUTION MEDICAL REVIEW DATA COLLECTION DATA PROCESSING DATA ANALYSIS 11

12 Clinical trials Health care professionals Non- Health care professionals Spontaneous reporting CMS Literature searches Electronic medical records Post marketing surveillance DATA COLLECTION 12

13 FORM 13

14 14

15 Signal generation HCPs Non- HCPs Spontaneous reporting Clinical trials Electronic medical records Post marketing surveillance Literature searches Signal strengthening Signal detection Signal quantification Signal confirmation Medical Evaluation Regulatory authorities 15

16 Authorized vendor In house translation system Data in regional languages Data in English language Translation of data/ adverse event forms is a part of data collection system which is carried out to translate data from regional language to English language. 16

17 Safety data exchange agreements (SDEA) License partners Third party manufacturers Safety data Safety data exchange agreements (SDEA) Khattri et al. Clin Res Reg Aff,

18 Pharmacovigilance model: An industry perspective DATA DISTRIBUTION MEDICAL REVIEW DATA COLLECTION DATA PROCESSING DATA ANALYSIS 18

19 Data collected from eligible sources Revalidation DATA ANALYSIS Discrepancy Verified 19

20 Pharmacovigilance model: An industry perspective DATA DISTRIBUTION MEDICAL REVIEW DATA COLLECTION DATA PROCESSING DATA ANALYSIS 20

21 Pharmacovigilance model: Data processing system ARGUS MedDRA ARISG WHO drug dictionary Local regulatory AE form Company drug repository 21

22 Pharmacovigilance Model: An industry perspective DATA COLLECTION DATA DISTRIBUTION MEDICAL REVIEW DATA PROCESSING DATA ANALYSIS 22

23 Pharmacovigilance Model: Medical review Causal relationship Medicinal product Adverse drug reaction Medical review is carried out to determine the causal relationship between medicinal product and ADR. 23

24 Pharmacovigilance Model: An industry perspective DATA DISTRIBUTION MEDICAL REVIEW DATA COLLECTION DATA PROCESSING DATA ANALYSIS 24

25 Pharmacovigilance Model: Data distribution system National & International regulatory authorities Regional centers Local centers 25

26 Need of the hour in Pharmacovigilance in India and Emerging Markets Need for adequate data capturing systems Under and inaccurate reporting Need for training Collaboration with different Stake holders Biswas P. J Pharmacol Pharmacother, Kumar A. Sys Rev Pharm, Pan GJD. Drug Saf,

27 A robust approach to Pharmacovigilance Public health focused Regulatory compliant approach Thank you Evidence based system Electronic databases 27