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    PvPI Edited

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    neeraj devarinti
    The document discusses India's Pharmacovigilance Programme (PvPI). It was initiated in 2010 to monitor adverse drug reactions nationwide. The program's goals are to create a patient safety reporting system, identify new safety signals from reported cases, and communicate safety information to stakeholders. PvPI collects reports from healthcare facilities across India and sends them to the National Coordination Centre for analysis. Stakeholders like doctors, hospitals, and drug companies are responsible for reporting any adverse drug reactions to the monitoring centers.

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    PvPI Edited

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    neeraj devarinti
    39 views29 pages
    The document discusses India's Pharmacovigilance Programme (PvPI). It was initiated in 2010 to monitor adverse drug reactions nationwide. The program's goals are to create a patient safety reporting system, identify new safety signals from reported cases, and communicate safety information to stakeholders. PvPI collects reports from healthcare facilities across India and sends them to the National Coordination Centre for analysis. Stakeholders like doctors, hospitals, and drug companies are responsible for reporting any adverse drug reactions to the monitoring centers.

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    The document discusses India's Pharmacovigilance Programme (PvPI). It was initiated in 2010 to monitor adverse drug reactions nationwide. The program's goals are to create a patient safety reporting system, identify new safety signals from reported cases, and communicate safety information to stakeholders. PvPI collects reports from healthcare facilities across India and sends them to the National Coordination Centre for analysis. Stakeholders like doctors, hospitals, and drug companies are responsible for reporting any adverse drug reactions to the monitoring centers.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    39 views29 pages

    PvPI Edited

    Uploaded by

    neeraj devarinti
    The document discusses India's Pharmacovigilance Programme (PvPI). It was initiated in 2010 to monitor adverse drug reactions nationwide. The program's goals are to create a patient safety reporting system, identify new safety signals from reported cases, and communicate safety information to stakeholders. PvPI collects reports from healthcare facilities across India and sends them to the National Coordination Centre for analysis. Stakeholders like doctors, hospitals, and drug companies are responsible for reporting any adverse drug reactions to the monitoring centers.

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    Download as pdf or txt
    of 29

    PHARMACOVIGILANCE

    PROGRAMME OF
    INDIA
    INTRODUCTION

    The Pharmacovigilance Programme of India (PvPI) was initiated by CDSCO under the aegis of Ministry
    of Health Family and Welfare.

    On 14th July 2010 with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National
    Coordination Centre for monitoring Adverse Drug Reactions (ADRs) in the country.

    In the year 2010, 22 ADR monitoring centres including AIIMS, New Delhi was set up under this
    Programme.

    The National Coordination Centre was shifted from All India Institute of Medical Sciences (AIIMS),
    New Delhi to the Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh on 15th April 2011.
    OBJECTIVES
    To create a nation-wide
    To emerge as a national centre of system for patient safety
    excellence for Pharmacovigilance reporting
    activities
    To collaborate with other national To identify and
    centres analyze the new
    signal (ADR) from the
    for the exchange of information and reported cases
    data management

    To communicate the
    To analyze the
    safety information on
    benefit - risk ratio of
    use of medicines to
    marketed
    various stakeholders
    medications
    to minimize the risk

    To support regulatory
    agencies in the To generate the
    decision-making evidence based
    process on use of information on safety
    medications of medicines
    GOALS OF PvPI

    SHORT TERM GOALS

    To develop and implement Pharmacovigilance 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 of drugs,
    vaccines, medical devices and biological products.

    Collection of case reports and data.


    LONG TERM GOALS

    To expand the Pharmacovigilance programme to all hospitals (govt. & private) and

    centers 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.


    Programme Communications
    Pharmaceutical
    CDSCO- Headquarter, industries in India
    New Delhi National Immunization
    Programme
    Professional bodies like
    IDMA, OPPI etc
    National Coordination Centre
    IPC, Ghaziabad
    Signal Review Panel

    Steering Working Group Core Training Panel


    Committee
    Quality Review Panel

    CDSCO Zonal Offices


    ADRs Monitoring North Zone, Ghaziabad
    Centers
    South Zone, Chennai

    West Zone, Mumbai

    East Zone, Kolkata

    Healthcare Professionals and Patients


    WHO - UMC & INDIA

    The Uppsala Monitoring Centre is responsible for the collection of data about adverse
    drug reactions from around the world, especially from countries that are members of
    the WHO including India.
    Member countries send their reports to the Uppsala Monitoring Centre where they are
    processed, evaluated and entered into the WHO International Database.
    When there are several reports of adverse reactions to a particular drug this process
    may lead to the detection of a signal — an alert about a possible hazard and will be
    communicated to member countries.
    This happens only after detailed evaluation & expert review. These ADR reports are
    assessed locally and may lead to action within the country.

    Through membership of The WHO International Drug Monitoring Program, a country


    can know if similar reports are being made elsewhere.
    RESPONSIBILITIES OF STAKEHOLDERS
    ADR MONITORING CENTRES NATIONAL COORDINATING CENTRES

    – Collection of ADR reports – Preparation of SOPs, guidance documents


    – Perform follow up with the complainant to &training manuals.
    check completeness as per SOPs. – Data collation, Cross-check completeness&
    – Data entry into Vigiflow Causality Assessment as per SOPs.

    – Reporting to PvPI National Coordinating – Conduct Training workshops of all enrolled


    Centre (PvPI NCC) through Vigiflow with the centers.
    source data (original) attached with each – Publication of Medicines Safety Newsletters.
    case(ADR). – Reporting to CDSCO Headquarters.
    – Training/ sensitization/ feedback to – Analysis of the PMS, PSUR, AEFI data received
    physicians through newsletters circulated by from CDSCO HQ.
    the PvPI NCC.
    SOURCES FOR THE COLLECTION OF ADRs REPORTS

    MCI approved medical


    Private hospital
    colleges and hospitals

    Public health Autonomous Institutions


    programmes (ICMR )
    PHARMACOVIGILANCE METHODS

    Spontaneous
    Reporting

    PV Methods in
    PvPI

    Targeted
    Cohort Event
    Spontaneous
    Monitoring
    Reporting
    1. SPONTANEOUS REPORTING
    A spontaneous report is an unsolicited communication by healthcare professionals or consumers to a
    company, regulatory authority or other organization (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 organized data collection scheme
    SPONTANEOUS REPORTING SYSTEM UNDER 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.
    2. TARGETED SPONTANEOUS REPORTING
    Objective:

    To learn more about the ADR profile of specific medicine(s) in a targeted population

    Or

    To estimate the incidence of a known ADR to a specific medicine in the targeted population.
    3. COHORT EVENT MONITORING

    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.
    MANDATORY
    FIELDS OF ADR
    FORMS
    THE IMPORTANT FIELDS THAT HAS TO BE FILLED IN THE
    ADR FORM TO CONSIDER IT AS A VALID REPORT.

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