pharmacovigilance program in india.pptx

Detail informative presentation on pharmacovigilance program in India.
along with ADR reporting process in India

1. PHARMACOVIGILANCE PROGRAMME IN INDIA By: Bibi Khuteja A J Bpharm KLE College of Pharmacy. Hubli, Karnataka.

2. Instruction BACKGROUNG CHECK: 1989 – ADR monitoring system for India was proposed [12 regions] 1997 – India joined WHO-ADR monitoring programme [3 centers-AIIMS,KEM.JLN] 2004-2008 – National pharmacovigilance programme 2010 – Pharmacovigilance programme of India[PvPI] As per WHO: Pharmacovigilance is a system relating to the detection,assessment,understanding and prevention of adverse effect and any other drug related problems. PvPI is a programme initiated with AIIMS New Delhi as National Coordination centre(NCC) for monitoring ADR in the country 14 th July 2010 shifted to India pharmacopoeia commission (IPC) ,Ghaziabad, Uttar Pradesh on 15 th April 2011. 2

3. V ision: To improve patient safety and welfare in Indian population by monitoring the drug safety and there by reducing the risk of associated with use of medicine Mission: Safeguard the health of Indian population by ensuring that the benefits of use of medicine outweigh the risk associated with its use. Objectives: To create a nation wide system for patient safety reporting. To identify and analyze the new signal (ADR) from the reported cases. To analyze the benefit-risk ratio of marketed medication. To generate the evidence based information on safety of medicine. To support regulatory agencies in the decision making process on use of medicine. To emerge as a national center of excellence for pharmacovigilance activity. 3

4. IMPLEMENTATION OF PvPI IPC assumes the need for establishing local hospital based centers across the nation for better patient safety.It was significant to monitor both the known and previously unknown side effects of medicines in order to determine any new information available in relation to their safety profile.For a coumtry like India with a population over 1.2 billion and vast ethnic variability, different disease,practice of different system of medicine ,it was important to have a standardized pharmacovigilance and drug safety monitoring programme for the nation. 4

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6. S hort term goals To develop and implement pharmacovigilance system in India To enroll,initially,allMCI approved medical colleges in the programme covering north,south,east,and west of india To encourage healthcare professionals in reporting of ADR of drugs ,vaccines, medical devices and biological products Collection of case reports and data 6

7. To expand the pharmacovigilance programme to all hospitals(govt. & pvt.)and centers of public health programs located across India. To develop and implement electronic reporting system (e-reporting) Long term goals 7 To develop reporting culture amongst healthcare professionals. To make ADR reporting mandatory for healthcare professionals.

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9. Causes of failure of implementation of PvPI Pharmacovigilance systems are not well funded and systematized for a vast country like India to serve patients and public. The data obtained to the data in zonal centers from various peripheral centers is often poor and not well-analyzed. There is inadequate research on ADRs in India, so the exact incidence of specific ADR is unknown. Involvement of healthcare professionals and knowledge and motivation for pharmacovigilance is negligible. In India, there are several consumers groups who encourage patients to report any adverse reactions encountered by them, although there is no information for patients to report ADRs directly to the regulatory authorities. 9

10. P harmacovigilance methods: Spontaneous reporting : immediate ADR reporting by healthcare professional and consumers to company, regulatory authorities or organization. Targeted spontaneous reporting : To learn more about the ADR profile of specific medicines in population. Cohort event monitoring : A prospective, longitudinal, observational , cohort study of adverse events with one or more monitored medicines. it is related to class of medicine that has previously caused ADR. Observed during post-marketing surveilance. Organization committees under NCC STEERING COMMITTEE PvPI working group Quality review panel Signal review panel Core training panel 10

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13. R egional centers of PvPI Let’s start with the first set of slides 1

14. Maps 14

15. ADR monitoring center functions 15

16. VIGIFLOW 16 Vigiflow is an individual case report (ICSR) management system developed and hosted by UPPSALA MONITORING CENTRE (UMC) The main information to enter non spontaneous report for it to be considered complete by vigiflow is the following six mandatory fields : Report title Patient initial Patient age Onset date of reaction Reaction term Drug name

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20. 20 Current status of NCC-PvPI ADR reporting status 64.66% of ICSRs reported by clinicians 14.75% by pharmacists 18.83% by nurses and dentists

21. INDIAS CONTRIBUTION TO WHO-UMC 2013 117 Countries participating in the WHO programme for international drug monitoring India stood at 7 th position in contributing to ICSRs safety database for the year 2013. 21

22. Mobile project ADR-PvPI mobile project was developed by NCC-PvPI within 6 moths in the year 2017 with aims of immediate reporting of ADR by any healthcare providers or consumers. T ill date more than 5500 users downloaded the app 262 reports recieved B y 2018 96.45% of ADRs were reported using ADR-PvPI app. 22

23. 24 Thanks!

24. R eferance Google Article by –innovations in pharmacy 25 http://z.umn.edu/INNOVATIONS PPT by chandan kumar [Mpharm-NIPER] PPT by Jamshed Ahmad –Sr.technical data associate at CDISCO