Scribd Logo
Upload

Welcome to Scribd!

  • 112 views

    Adverse Drug Reaction Reporting System in Pakistan

    Uploaded by

    sara raees
    This document provides an overview of the adverse drug reaction (ADR) reporting system in Pakistan. It describes the purpose of ADR reporting, which is to monitor the risk-benefit balance of drugs and encourage reporting of suspected ADRs. It outlines the regulatory bodies responsible, including the Drug Regulatory Authority of Pakistan and the Pakistan National Pharmacovigilance Centre. It details the procedure for reporting ADRs, including who can report, the reporting form, and where to submit reports. It also discusses what should be reported and potential outcomes of the reporting system.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd

    Adverse Drug Reaction Reporting System in Pakistan

    Uploaded by

    sara raees
    112 views31 pages
    This document provides an overview of the adverse drug reaction (ADR) reporting system in Pakistan. It describes the purpose of ADR reporting, which is to monitor the risk-benefit balance of drugs and encourage reporting of suspected ADRs. It outlines the regulatory bodies responsible, including the Drug Regulatory Authority of Pakistan and the Pakistan National Pharmacovigilance Centre. It details the procedure for reporting ADRs, including who can report, the reporting form, and where to submit reports. It also discusses what should be reported and potential outcomes of the reporting system.

    Original Description:

    Presentation on reporting on adverse drug reactions of medicines

    Original Title

    ADR

    Copyright

    © © All Rights Reserved

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides an overview of the adverse drug reaction (ADR) reporting system in Pakistan. It describes the purpose of ADR reporting, which is to monitor the risk-benefit balance of drugs and encourage reporting of suspected ADRs. It outlines the regulatory bodies responsible, including the Drug Regulatory Authority of Pakistan and the Pakistan National Pharmacovigilance Centre. It details the procedure for reporting ADRs, including who can report, the reporting form, and where to submit reports. It also discusses what should be reported and potential outcomes of the reporting system.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    112 views31 pages

    Adverse Drug Reaction Reporting System in Pakistan

    Uploaded by

    sara raees
    This document provides an overview of the adverse drug reaction (ADR) reporting system in Pakistan. It describes the purpose of ADR reporting, which is to monitor the risk-benefit balance of drugs and encourage reporting of suspected ADRs. It outlines the regulatory bodies responsible, including the Drug Regulatory Authority of Pakistan and the Pakistan National Pharmacovigilance Centre. It details the procedure for reporting ADRs, including who can report, the reporting form, and where to submit reports. It also discusses what should be reported and potential outcomes of the reporting system.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 31

    Adverse Drug Reaction

    Reporting System in Pakistan


    Contents
     Basic Concepts
     Purpose of ADRs reporting system
     Need of ADRs reporting system
     Regulatory Bodies responsible for ADR reporting system
     Procedure for ADR reporting system
     Outcomes
     Conclusion
    Adverse Drug Reaction
    What is Pharmacovigilance
    (PV)?
    World Health Organization
    The World Health Organization is a specialized agency of the United
    Nations that is concerned with international public health. It was
    established on 7 April 1948.
    World Health Organization,
    Uppsala Monitoring System
    World Health Organization Programme for International Drug Monitoring
    (WHO-PIDM) that was started in 1968 in the aftermath of thalidomide
    tragedy.
    Uppsala Monitoring Centre (UMC), Sweden is responsible to provide
    operational support to WHO-PIDM.
    In Pakistan, PNPC-DRAP is responsible to coordinate with WHO on the
    matter of Pharmacovigilance.
    Drug Regulatory Authority
    of Pakistan
    The Drug Regulatory Authority of Pakistan (DRAP) has been
    established under the DRAP Act 2012 to provide effective coordination
    and enforcement of the Drugs Act, 1976 and to bring harmony in inter-
    provincial trade and commerce of therapeutic goods.
    Purpose
     To operationalize the pharmacovigilance programme of Pakistan
     Monitoring the risk-benefit balance of therapeutic goods
     To encourage reporting of suspected ADRs
     Training
     Recommend regulatory actions
     Coordination
    Regulatory Bodies responsible
    for ADRs reporting system
    Drug Regulatory Authority of
    Pakistan

    Division of Pharmacy Services

    Pakistan National
    Pharmacovigilance Centre (PNPC)

    Provincial Pharmacovigilance
    Centers (PPCs)
    Organogram
    Head of PNPC/ Chairman
    PRAEC

    In charge PNPC/ Focal Person


    PV & Secretary PRAEC

    Pharmacovigilance Officers
    (Deputy Directors, Division of
    Pharmacy services

    Pharmacovigilance Officers
    (Assistant Directors, Division
    of
    Pharmacy services
    Responsibilities of Regulatory Bodies

    DRAP PNPC PPC


    Supervising PNPC Coordinate with WHO-
    UMC Collection of
    reports
    Allocation of Budget
    Coordinate with PPCs

    Hiring/ Appointments
    Submission of
    reports to PNPC
    Recommend regulatory
    Implementation of actions to DRAP
    policies
    Awareness
    Sharing of data to
    Approval of guidelines vigibase campaign
    Who can report?

    Patient

    Health care professionals

    Public health programs

    Registration holder of therapeutic


    goods
    Suspected ADR reporting Form

    Patient

    Medicine/ Vaccine/ Alternative


    medicines

    Reaction

    Reporter Details
    Where and How to report?
    Health care
    Patients can Registration
    professional
    report to holders
    s
    Health care
    PPC PPC
    professionals

    Registration holders PNPC PNPC

    Online submission Online submission Online submission


    What to report?

    Serious/ Non-serious ADRs

    ADRs with medication errors

    ADRs with quality problems


    When to report?

    Serious ADRs within 15 days of


    reporting

    Non-serious ADRs within 30 days of


    reporting
    Address of PNPC
    In charge Pakistan National Pharmacovigilance Centre
    Division of Pharmacy Services
    Drug Regulatory Authority of Pakistan
    3rd Floor, TF Complex,
    7-Mauve Area
    Islamabad.
    Phone No: +92519107413, +92-51-9262182
    Email Address: [email protected], [email protected]
    Website : www.dra.gov.pk
    What happened to report?
    Hospitals

    PHP

    PPCs

    PNPC
    Assessment of ICSRs

    Quality of documentation

    Coding

    Relevance

    Identification of duplicate reports


    OUTCOME
    Communication of
    Outcomes
     Direct Healthcare professionals communication
     Documents in lay language
     Websites
     Press communication
    Failure to report ADR

    Uncertain association

    Awareness

    Unavailability of report forms

    Legal liability concerns


    Use of Pharmacovigilance data
     Early detection of signal and strengthening
     Risk Management followed by coordinated and economical application
    of resources
     Drug Regulation
     Risk communication and Information
    “You can reduce the suffering and
    save thousands of patients lives by
    doing one thing”

    You might also like