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    ADR Form

    Uploaded by

    Sachin Jadon
    This document contains a reporting form for suspected adverse reactions to Ayurveda, Siddha, and Unani (ASU) drugs. The form collects information about the patient, suspected adverse reaction, ASU and other drugs used, treatment provided, and outcome. It requests reporting of all suspected reactions and notes that columns 1, 2, 3, 4, 6, and 10 are compulsory. The form is to be sent to the National Pharmacovigilance Resource Centre for ASU Drugs to monitor suspected adverse reactions confidentially.

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

    ADR Form

    Uploaded by

    Sachin Jadon
    321 views2 pages
    This document contains a reporting form for suspected adverse reactions to Ayurveda, Siddha, and Unani (ASU) drugs. The form collects information about the patient, suspected adverse reaction, ASU and other drugs used, treatment provided, and outcome. It requests reporting of all suspected reactions and notes that columns 1, 2, 3, 4, 6, and 10 are compulsory. The form is to be sent to the National Pharmacovigilance Resource Centre for ASU Drugs to monitor suspected adverse reactions confidentially.

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    Adverse drug reaction form for pharmacovigilance

    Original Title

    ADR form

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    This document contains a reporting form for suspected adverse reactions to Ayurveda, Siddha, and Unani (ASU) drugs. The form collects information about the patient, suspected adverse reaction, ASU and other drugs used, treatment provided, and outcome. It requests reporting of all suspected reactions and notes that columns 1, 2, 3, 4, 6, and 10 are compulsory. The form is to be sent to the National Pharmacovigilance Resource Centre for ASU Drugs to monitor suspected adverse reactions confidentially.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    321 views2 pages

    ADR Form

    Uploaded by

    Sachin Jadon
    This document contains a reporting form for suspected adverse reactions to Ayurveda, Siddha, and Unani (ASU) drugs. The form collects information about the patient, suspected adverse reaction, ASU and other drugs used, treatment provided, and outcome. It requests reporting of all suspected reactions and notes that columns 1, 2, 3, 4, 6, and 10 are compulsory. The form is to be sent to the National Pharmacovigilance Resource Centre for ASU Drugs to monitor suspected adverse reactions confidentially.

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    of 2

    Number: Centre / Month / Year

    NATIONAL PHARMACOVIGILANCE PROGRAMME


    FOR AYURVEDA, SIDDHA & UNANI (ASU) DRUGS
    Reporting Form for Suspected Adverse Reactions to ASU Drugs
    Please note : (I) Information about the patients, prescribers and reporters will remain confidential.
    (II) It is requested to report ALL suspected reactions as soon as possible, even if complete
    information is not available. Please note however that column numbers 1,2,3,4, 6 & 10 are
    compulsory.
    1. Patient / consumer identification (please complete or tick boxes below as appropriate) :
    Name /Identifier Initials Patient’s Record Number
    (PRN):
    Ethnicity: IPD/OPD Age : Sex : Male / Female
    Address Weight: Prakriti/ Mizaj /
    Village/ Town
    Post/ Via Occupation:
    District/ State
    2. Description of the suspected Adverse Reactions (please complete boxes below) :
    Date and time of initial observations:
    Description of
    reactions

    3. List of all ASU drugs including drugs of other systems used by the patient during the
    reporting period :
    Manufacturer’s Date
    Dosage form and
    Name of the name/ Batch no./ Daily
    route of Reason for use
    medicine Manufacture/ dose Starting Stopping
    administration
    Expiry date

    4. Brief details of the suspected ASU Medicine :


    a. Composition of the formulation / Part and form of the raw material used
    b. Expiry date if any:
    c. Remaining part of drug / Product label
    d. Please tick : Ayurveda, Siddha, Unani, any other
    e. Adjuvant(Anupana):
    f. Dietary history(Intake/Restrictions) if any:
    g. Whether the drug is consumed under medical supervision or used as self medication.
    h. Any other relevant information.

    5. Treatment provided (if any) for suspected adverse reaction :


    6. Outcome of the suspected adverse reaction (please complete the boxes below) :
    Recovered / Unknown : If Fatal
    Not recovered Fatal :
    Recovering : Date of death:
    Severe: Yes/ No Reactions abated after drug stopped or dose reduced:

    Reaction reappeared after re introduction:

    Was the patient admitted to hospital?


    If yes, give name and address of hospital
    Is any follow up required:

    7. Laboratory investigations done, which provides suspicion of drug involvement :

    8. Please tick, if the patient is suffering with any chronic disorders :


    Hepatic Renal Cardiac Diabetes Malnutrition Any Others

    9.Whether history of allergy / Drug reactions exists:

    10. Identity of the reporter :


    Nurse / Doctor / Pharmacist / Health worker / Patient / Manufacturer /
    Type (please tick):
    Distributor / Supplier / Any others (please specify)
    Name :

    Address :
    Telephone / E – mail
    if any :

    Signature of the reporter: Date:

    Please send the completed form to:


    The centre from where the form is received or
    To The Coordinator
    Name & address of the
    National Pharmacovigilance Resource Centre For ASU Drugs
    RPC-ASU / PPC-ASU :
    I.P.G.T. & R.A., G.A.U., Jamnagar, Gujarat - 361 008, India
     (O) 0288 – 2553936 , Fax : 0288 – 2676856 / 2553936
    Website : www.ayurveduniversity.com, Email: [email protected]

    Who Can Report? :


     Any Health care professionals including, ASU Doctors / Dentists / Nurse / Pharmacists
    etc.
    What to Report? :
     All suspected adverse reactions, Lack of effects, Resistance, Drug interactions,
    Dependence and Abuse
    Where to Report ?
     Peripheral Pharmacovigilance Centre or Regional Pharmacovigilance Centre or
    National Pharmacovigilance Centre
    Confidentiality:
     The patient’s identity will be held in strict confidence and protected to the fullest extent.
    Programme staff will not disclose the reporter’s identity in response to a request from
    the public.
     Submission of report doesn’t constitute an admission that, medical personnel or
    manufacturers or the product caused or contributed to the reaction.

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