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    ADR Reporting Form - Single Page

    Uploaded by

    Armel Samselvanathan

    Copyright:

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

    ADR Reporting Form - Single Page

    Uploaded by

    Armel Samselvanathan
    6 views1 page

    Original Title

    ADR reporting form - single page

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    PDF, TXT or read online from Scribd

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    Copyright:

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    6 views1 page

    ADR Reporting Form - Single Page

    Uploaded by

    Armel Samselvanathan

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Version 1.

    SUSPECTED ADVERSE DRUG REACTION REPORTING FORM


    For VOLUNTARY reporting of ADRs by Healthcare Professionals
    INDIAN PHARMACOPOEIA COMMISSION (National Coordination Centre-Pharmacovigilance Programme of India)
    Ministry of Health & Family Welfare, Government of India, Sector-23, Raj Nagar, Ghaziabad-201002
    PvPI Helpline (Toll Free) :1800-180-3024 (9:00 AM to 5:30 PM, Monday-Friday)

    Initial Case  Follow-up Case  FOR AMC / NCC USE ONLY


    A. PATIENT INFORMATION * Reg. No. / IPD No. / OPD No. / CR No. :
    1. Patient Initials: 2. Age or date of birth: AMC Report No. :
    3. Gender: M  F  Other  4.Weight (in Kg.) Worldwide Unique No. :
    12. Relevant investigations with dates :
    B. SUSPECTED ADVERSE REACTION *
    5. Event / Reaction start date (dd/mm/yyyy)
    6. Event / Reaction stop date (dd/mm/yyyy)
    7. Describe Event/Reaction management with details , if any

    13. Relevant medical / medication history (e.g. allergies,


    pregnancy, addiction, hepatic, renal dysfunction etc.)

    14. Seriousness of the reaction : No  if Yes  (please tick anyone)


     Death (dd/mm/yyyy)  Congenital-anomaly
     Life threatening  Disability
     Hospitalization-Initial/Prolonged  Other Medically important
    15. Outcome:
     Recovered  Recovering  Not Recovered
     Fatal  Recovered with sequelae  Unknown
    C. SUSPECTED MEDICATION(S) *
    S. 8. Manufactu Batch No. Expiry Dose Route Frequency Therapy Dates Indication Causality
    No. Name rer / Date Date Date Assessment
    (Brand/ (if known) Lot (if Started Stopped
    Generic) No. known)
    i
    ii
    iii
    iv #
    10. Reaction reappeared after reintroduction of
    9. Action taken after reaction (please tick)
    suspected medication (please tick)
    S. Drug Dose Dose Dose not Not Unknown Yes No Effect Dose
    No. withdrawn increased reduced changed applicable unknown (if re-
    as introduced)
    per C
    i
    ii
    iii
    iv
    11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
    Name Dose Route Frequency (OD, Therapy Dates Indication
    S. No. (Brand / Generic) BD, etc.)
    Date Started Date Stopped

    i
    ii
    iii #
    Additional Information : D. REPORTER DETAILS *
    16. Name & Address : __________________ __________________________
    ______________________________________ __________________________
    Pin : __________ Email : ___________________________________________
    Contact No- : _______________________________
    Occupation : _______________________Signature : ___________________
    17. Date of this report (dd/mm/yyyy) :
    Signature and Name of Receiving Personnel :
    Confidentiality : The patient’s identity is held in strict confidence and protected to the fullest extent. Submission of a report does not
    constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction. Submiss ion of an
    ADR report does not have any legal implication on the reporter.
    # Use separate page for more information
    * Mandatory Fields for suspected ADR Reporting Form

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