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Pharmacovigilance programme of india
The Pharmacovigilance Programme of India (PVPI) aims to enhance patient safety by monitoring drug safety and assessing adverse drug reactions (ADRs) across the country. Established in 2010, it emphasizes reporting by healthcare professionals and pharmaceutical companies to mitigate risks associated with medications while supporting regulatory decision-making. The program includes various reporting methods and is structured to facilitate training, support, and consultation to promote a culture of safety in medicinal use.
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Pharmacovigilance programme of india
- 1. Pharmacovigilance Programme of India(PvPI) Chandan Kumar M. Pharm, Clinical Research NIPER, S.A.S Nagar
- 2. Introduction Pharmacovigilance is asystem to monitor the safety and effectiveness of medicines and other pharmaceutical products. As per WHO: Pharmacovigilance as “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”.
- 3. Background 1989 - ADRmonitoring system for India proposed (12 regional centres) 1997 - India joined WHO-ADR monitoring programme (3 centres: AIIMS, KEM, JLN) 2004 – 2008 - National Pharmacovigilance Programme 2010 – Pharmacovigilance Programme of India
- 4. Initiated withAIIMS, New Delhi as National Coordination Centre (NCC) for monitoring ADRs in the country July 2010, shifted to Indian Pharmacopoeia Commission (IPC), Ghaziabad on 15th April 2011 Vision: To improve patient safety and welfare of Indian population by monitoring the drug safety and thereby reducing the risk associated with use of medicines Mission: Safeguard the health of the Indian population by ensuring that the benefits of use of medicine outweigh the risks associated with its use
- 5. PERFORMANCE & EFFECTIVENESSOF THE PHARMACOVIGILANCE SYSTEM Who can Report What to Report Whom to Report Healthcare professionals (clinician, dentist pharmacist ,nurses and others) can report suspected adverse drug reaction. Pharmaceutical companies can also send ICSRs specific for their product to NCC. All types of suspected ADRs- irrespective of whether they are known or unknown, serious and non-serious, frequent or rare. Although pharmacovigilance is primarily concerned with pharmaceutical medicines, adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies) should also be considered. Use the ‘Suspected Adverse Drug Reaction Reporting Form’ which is available on the official website of IPC (www.ipc.gov.in) as well as CDSCO (www.cdsco.nic.in) to report any ADR. A reporter who is not a part of AMC can submit the ICSR to the nearest AMC or directly to the NCC.
- 6. Scope and Objectives *To create a nation-wide system for patient safety reporting * To identify and analyze new signal from the reported cases * To analyze the benefit - risk ratio of marketed medications * To support regulatory agencies in the decision-making process on use of medications * To communicate the safety information on use of medicines to various stakeholders to minimize the risk * To provide training and consultancy support to other national pharmacovigilance centers across globe * To promote rational use of medicine
- 7. Short Term Goals To develop and implement pharmaco-vigilance system in India To enroll, initially, all MCI approved medical colleges in the program covering north, south, east and west of India To encourage healthcare professionals in reporting of adverse reaction to drugs, vaccines, medical devices and biological products Collection of case reports and data
- 8. Long Term Goal To expand the pharmacovigilance programme to all hospitals (govt. & private) and centres of public health programs located across India To develop and implement electronic reporting system (e-reporting) To develop reporting culture amongst healthcare professionals To make ADR reporting mandatory for healthcare professionals
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- 10. 1. Spontaneous Reporting Aspontaneous report is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organisation (e.g., WHO, CDSCO etc) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection scheme
- 11. Spontaneous reporting systemunder PvPI Electronic reporting: Electronic transmission of ICSRs from ADR Monitoring Centers to National Coordination Centre through VigiFlow (WHO Global Safety Database). Voluntary reporting: Submission of ICSRs to the National Coordination Centre by Pharmaceutical companies or health care professionals. Peripheral reporting: Submission of ICSRs by hospitals, healthcare clinics, health care professionals, patient to the nearest ADR Monitoring Centre.
- 12. Spontaneous Reporting Pros Cons Coversthe whole population Inherent under-reporting Includes all marketed medicines Captures only suspected ADRs Continual monitoring throughout life cycle of medicine Reporting bias e.g. Seriousness, severity New medicine Publicity of specific ADR Detects signals of new, rare or serious ADRs Denominator unknown Most commonly used method Difficult to detect - delayed ADRs &
- 13. 2. Targeted SpontaneousReporting Objective: To learn more about the ADR profile of specific medicine(s) in your population Or To estimate the incidence of a known ADR to a specific medicine in your population
- 14. 3. Cohort EventMonitoring Objective: A prospective, longitudinal, observational, cohort study of adverse events associated with one or more monitored medicines. It is related to class of medicine that has previously caused ADRs Potentially significant adverse event observed during post-marketing surveillance
- 15. Cohort Event Monitoring ProsCons Early detection of signals of unsuspected ADRs More labor intensive than SR or TSR Denominator information allows incidence rates of ADRs to be calculated More costly Much data collected most of which represents ‘Background noise’ Assessment of risk; identification of risk factor; between drug comparisons Training required Death record LTFU may be substantial and needs to be actively managed Cohort event monitoring
- 16. Comparing the Pvmethods Method Medicines Population Reports Spontaneous Reporting All medicines All exposed individuals but denominator unknown All ADRs Targeted Spontaneous Reporting Specific medicines All exposed individuals but denominator known Specific ADRs Cohort Event Monitoring Specific medicines Defined cohort All AEs
- 17. Organization Committees under NCC SteeringCommittee PvPI Working Group Quality Review Panel Signal Review Panel Core training panel
- 18. NCC Working Module Letterof intent from AMCs Coordinator NCC-PvPI Examine the Suitability Approved by NCC Vigi-Flow login details provided by NCC to AMCs AMCs- To perform the causality assessment of the ADRs and furnish the mandatory fields in the suspected ADRs form AMCs – upload the ADRs in Vigi-Flow NCC-PvPI Send to
- 19. Quality assessment byNCC-PvPI CDSCO (HQ)WHO-UMC (Sweden) NCC_PvPI
- 20. Responsibilities of Stakeholder Personnelat AMC • Collection of ADR reports • Perform follow up with the complainant to check completeness as per SOPs • Data entry into Vigiflow • Reporting to PvPI National Coordinating Centre (PvPI NCC) throughVigiflow with the source data (original) attached with each ADR case • Training/ sensitization/ feedback to physicians through newsletters circulated by the PvPI NCC
- 21. Personnel atNCC • Preparation of SOPs, guidance documents & training manuals • Data collation, Cross-check completeness, Causality Assessment etc as per SOPs • Conduct Training workshops of all enrolled centers • Publication of Medicines Safety Newsletter • Reporting to CDSCO Headquarters • Analysis of the PMS, PSUR, AEFI data received from CDSCO HQ
- 22. Personnel atZonal/ Sub-zonal CDSCO • Provide procurement, financial and administrative support to ADR monitoring centers • Report to CDSCO HQ Personnel at CDSCO HQ • Take appropriate regulatory decision & actions on the basis of recommendations of PvPI NCC at IPC Ghaziabad. • Propagation of medicine safety related decisions to stakeholders • Collaboration with WHO-Uppsala Monitoring Center - Sweden • Provide for budgetary provisions & administrative support to run PvPI
- 24. 90 PvPI AMCs NationalCoordinating Center, IPC, Ghaziabad 4 Zonal CDSCO Offices (provide operational and logistical support) Ghaziabad Mumbai Kolkata Chennai PvPI Headquarters, CDSCO Pharmacovigilance Programme of India (PVPI) PHASE 1
- 25. Phases or RoadMap of PvPI Initiation phase (2010-2011) Expansion and consolidation phase (2011-2012) Expansion and maintenance phase (2012-2013) Expansion and optimization (2013-2014) Excellence phase (2014-2015)
- 27. VIGIFLOW Vigiflow is anIndividual Case Safety Report (ICSR) management system developed and hosted by Uppsala monitoring centre (UMC). How to access Vigiflow Web address: https://adr.who-umc.org Log in is done with a personal user name and password from the secure web-page
- 28. The minimum informationyou have to enter on a spontaneous report for it to be considered ‘complete’ by VigiFlow is the following six mandatory fields: 1) Report title 2) Patient initial 3) Patient age (either date of birth, age at time of onset or age group) 4) Onset date of reaction (year only) 5) Reaction term 6) Drug name
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- 32. Information on PrimarySource
- 33. Death related information Resultof test and procedure
- 34. Relevant medical history RelevantPast Drug Therapy
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- 36. VigiFlow Demo Chart Loginwith User Id and password Quick start REPORT INFO PAGE a) Report information section b) Information on sender c) Information on Primary source PATIENT PAGE a) Patient Characteristics b) Death related information TEST AND PROCEDURES PAGE a) Result from test and procedure b) test RELEVANT MEDICAL HISTORY PAGE Free Text Information Structured Information Free text information Structured Information 1 2 3 4
- 37. RELEVANT PAST DRUG THERAPY REACTIONPAGE a) Reactions/ Events- Free text b) Relatedness of Drugs to reactions DRUG PAGE a) Suspected Drugs b) Concomitant drug 5 6 7 1 2 76543 The CAUSALITY ASSESSMENT Save Report Send to NCC Quality Review at NCC Submit Report to UMC