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  • workshop-PV Training

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    Hala Mohamed
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    This document discusses pharmacovigilance and the collection of individual case safety reports (ICSRs). It defines ICSRs and outlines what types of adverse drug reactions should be reported, including serious and non-serious cases. The document explains how to submit an ICSR using the CIOMS form, including collecting patient information, drug details, and adverse reaction. Reporting cases helps monitor new or known risks, signals, and regulatory actions. Submitting valid and complete ICSRs aids in signal detection and regulatory decision making. Follow-up may be required to track outcomes of reported cases like pregnancies or hospitalizations.

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    Pharmacovigilance training workshop to non PV personnel

    Original Title

    workshop-PV training

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    This document discusses pharmacovigilance and the collection of individual case safety reports (ICSRs). It defines ICSRs and outlines what types of adverse drug reactions should be reported, including serious and non-serious cases. The document explains how to submit an ICSR using the CIOMS form, including collecting patient information, drug details, and adverse reaction. Reporting cases helps monitor new or known risks, signals, and regulatory actions. Submitting valid and complete ICSRs aids in signal detection and regulatory decision making. Follow-up may be required to track outcomes of reported cases like pregnancies or hospitalizations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    23 views36 pages

    workshop-PV Training

    Uploaded by

    Hala Mohamed
    This document discusses pharmacovigilance and the collection of individual case safety reports (ICSRs). It defines ICSRs and outlines what types of adverse drug reactions should be reported, including serious and non-serious cases. The document explains how to submit an ICSR using the CIOMS form, including collecting patient information, drug details, and adverse reaction. Reporting cases helps monitor new or known risks, signals, and regulatory actions. Submitting valid and complete ICSRs aids in signal detection and regulatory decision making. Follow-up may be required to track outcomes of reported cases like pregnancies or hospitalizations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 36

    Pharmacovigilance

    (PV)

    PRESENTED BY:
    QPPV: Hala Mohamed
    LSR: Yara Samir
    Queen Pharm International 1
    Workshop for ICSR
    collection

    Queen Pharm International 2


    What is the ICSR ?!

    Queen Pharm International 3


    ADR reporting form

    Queen Pharm International 4


    Types of ADRs

    Queen Pharm International 5


    Type1: serious ADR (6 cases)
    1.Death

    Queen Pharm International 6


    2. Life threating event

    Queen Pharm International 7


    3. Permanent Disability

    Queen Pharm International 8


    4. Hospitalization(Initial/Prolonged)

    Queen Pharm International 9


    5. Congenital Anomaly or Birth Defect

    Queen Pharm International 10


    6. Medical Intervention

    Queen Pharm International 11


    Type 2: Non-Serious ADR

    Any other case will be considered as non-


    serious case

    Queen Pharm International 12


    What to be reported
    as an ICSR?

    Queen Pharm International 13


    1. New Risk /Side Effect/ADR

    Queen Pharm International 14


    2. Already Known Risks

    Queen Pharm International 15


    Why to report already known ADR?!

    Queen Pharm International 16


    Signal detection Regulatory Action

    Queen Pharm International 17


    3. Pregnancy and Breastfeeding

    Queen Pharm International 18


    4. Drug Interactions

    Queen Pharm International 19


    5. Medication Errors

    Queen Pharm International 20


    6. Over Dose + Misuse + Off Label Use

    Queen Pharm International 21


    7. Lack of Efficacy

    Queen Pharm International 22


    8. Quality Defects

    Queen Pharm International 23


    9. counterfeits

    Queen Pharm International 24


    CIOMS form

    Queen Pharm International 25


    Follow – up report

    • Some of the reported cases are invalid (due to


    missing information)
    • Follow-up on the progress and outcome of the case
    (if needed) as (pregnancy and hospitalized).

    Queen Pharm International 26


    Queen Pharm International 27
    How to make an ICSR?

    Queen Pharm International 28


    Step 1: Always keep the form ready

    Queen Pharm International 29


    Step 2: fill the form

    Queen Pharm International 30


    PATIENT

    DRUG REACTION

    REPORTER
    Queen Pharm International 31
    Step 3: Report

    Report this form to PV department at Queen


    Pharm International

    • E-mail: pharmacovigilance.queen@gmail.com
    • Address: Head office 56, Helwan Agri. road – Badr tower –
    Maddi – floor (15) flat (8)
    • Mobile : 01023366732 – 01224458057
    • Tel & Fax : (02) 23785536

    Queen Pharm International 32


    Reporting cases (WHO newsletters)

    • Domperidone.
    • Diclofenac.

    Queen Pharm International 33


    Newsletter 2013 No.4

    Queen Pharm International 34


    DHPC of Diclofenac

    Queen Pharm International 35


    Queen Pharm International 36

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