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    Report On Suspected ADR

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    a183554
    This document provides a form and instructions for reporting suspected adverse drug reactions to the National Centre for Adverse Drug Reaction Monitoring in Malaysia. The form collects patient information, a description of the adverse reaction, details on the suspected drug, concomitant medications, investigations and medical history, and reporter details. Instructions emphasize providing complete information, defining key terms, and noting details to allow follow up if needed. Reporters are asked to submit additional details if the reaction was serious or involved the skin.

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    Report On Suspected ADR

    Uploaded by

    a183554
    33 views2 pages
    This document provides a form and instructions for reporting suspected adverse drug reactions to the National Centre for Adverse Drug Reaction Monitoring in Malaysia. The form collects patient information, a description of the adverse reaction, details on the suspected drug, concomitant medications, investigations and medical history, and reporter details. Instructions emphasize providing complete information, defining key terms, and noting details to allow follow up if needed. Reporters are asked to submit additional details if the reaction was serious or involved the skin.

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    Report on suspected ADR

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    This document provides a form and instructions for reporting suspected adverse drug reactions to the National Centre for Adverse Drug Reaction Monitoring in Malaysia. The form collects patient information, a description of the adverse reaction, details on the suspected drug, concomitant medications, investigations and medical history, and reporter details. Instructions emphasize providing complete information, defining key terms, and noting details to allow follow up if needed. Reporters are asked to submit additional details if the reaction was serious or involved the skin.

    Copyright:

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

    Report On Suspected ADR

    Uploaded by

    a183554
    This document provides a form and instructions for reporting suspected adverse drug reactions to the National Centre for Adverse Drug Reaction Monitoring in Malaysia. The form collects patient information, a description of the adverse reaction, details on the suspected drug, concomitant medications, investigations and medical history, and reporter details. Instructions emphasize providing complete information, defining key terms, and noting details to allow follow up if needed. Reporters are asked to submit additional details if the reaction was serious or involved the skin.

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    © All Rights Reserved
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    Download as docx, pdf, or txt
    of 2

    REPORT ON SUSPECTED ADVERSE DRUG REACTIONS

    NATIONAL CENTRE FOR ADVERSE DRUG REACTIONS MONITORING


    Email: fv@npra.gov.my Website: www.npra.gov.my
    (Please report all suspected adverse drug reactions including those for vaccines, health supplements and traditional products. Do not hesitate to
    report if some details are not known. Mandatory fields are marked with *, but please give as much other information as you can. Identities of
    Reporter, Patient and Institution will remain Confidential.)
    REPORT No. (for official use only): ………………………………………………………………………………..
    PATIENT INFORMATION
    Please tick (if applicable):
    I.C. No. / R/N / Initials *Age *Gender (please tick) Wt (kg) *Ethnic Group Initial Report
    Male Female
    Follow-up Report

    *ADVERSE REACTION DESCRIPTION (inc. sequence of adverse events, details of rechallenge, interactions)

    Time to onset Date start of Date end of DD / MM / YYYY


    of reaction : (please circle) reaction : reaction :
    Reaction subsided after stopping drug / reducing dose : Yes No Unknown N/A (drug continued)

    Reaction reappeared after reintroducing drug : Yes No Unknown N/A (not reintroduced)
    Extent of reaction : Mild Moderate Severe
    Seriousness Life Caused or prolonged Caused disability Caused birth N/A
    of reaction : threatening hospitalisation or incapacity defect (not serious)

    Treatment of adverse reaction & action taken :


    Recovered Not Date &
    Outcome : Recovering Unknown Fatal:
    fully recovered Cause of death:…………....................

    Drug-reaction relationship : Certain Probable Possible Unlikely Unclassifiable


    *Suspected Drug(s) : N/A: Not applicable
    Dose & Therapy Dates
    Batch / Lot
    Product / Generic Name Frequency MAL No. Indication
    No. Start Stop
    Given
    Ciprofloxacin 500mg BD 26/9/2018 Antibiotic

    For Vaccines Only: Vaccine dose (please circle) : Diluent Batch / Lot No. :

    Concomitant Drug(s) / Other Vaccine(s) given just prior to AEFI [adverse events following immunisation] (please state ‘NIL’ if none) :
    Dose & Therapy Dates
    Batch / Lot
    Product / Generic Name Frequency MAL No. Indication
    No. Start Stop
    Given

    (Please attach additional sheets if necessary)

    Relevant Medical History


    Relevant Investigations / Laboratory Data
    (e.g.: hepatic / renal dysfunction, allergies, pregnancy status, etc)
    WBC count: 12.1
    Temperature: 38 degree Celsius

    Reporter Details
    *Name : *Institution Name
    & Address :

    Designation : *Tel No :
    *Email Address : Date of Report : Signature : revision-01

    Submission of a report does not constitute an admission that medical personnel or the products caused or contributed to the reaction. Thank you for reporting.
    ADR Reporting Guide
    Before submitting your ADR report, do check if you have inserted the following information.
    *Please try to fill every section in the ADR form overleaf, stating ‘none / nil’ if applicable. A complete report is a useful report.

    NO. IMPORTANT POINTS TO NOTE

    1 Definitions:
    (i) Time to onset of reaction: time interval between first dose (initiation) of the drug until first sign of the ADR.
    (ii) Initial report: First submission of report to NPRA of a particular patient involving a particular ADR.
    (iii)Follow-up report: Submission of further reports related to the same case to inform of additional information not
    mentioned previously or which occurred after the initial report. Please mention the date of initial report for reference.
    2 Please specify any previous history of allergy (including drugs, food, etc.).

    3 Include information on any concomitant medications or underlying illnesses? (Please state ‘nil’ if none)
    Date started and stopped for each medication
    Please state ‘cont’ for any medication still continued after the ADR

    4 Please state the specific indication of the suspected drug


    (e.g.: ‘pneumonia due to S. Pneumoniae’ - not ‘infection’ or ‘antibiotic’).

    5 If the ADR reappeared after reintroducing drug (rechallenge), please describe the rechallenge fully (dose given, timing, brand
    used, etc.) under section ‘Adverse Reaction Description’.

    6 Please specify if any treatment was given for the ADR, or if the suspected drug was stopped, what alternative drug was started
    and how the patient responded.

    7 Please include the latest / current outcome of the patient (e.g. recovered fully, not recovered).
    If possible, follow-up the patient periodically until the final outcome is known. A
    follow-up report may be sent in to update on the final outcome of the patient.
    8 Skin reactions: Please describe the specific type and location of the skin reaction.
    (Use the Cutaneous ADR form and guide available on www.npra.gov.my)

    Lipat di sini
    9 Do keep your own record of details enabling you to contact the patient or trace the case notes later on if necessary
    (e.g. IC number, patient name and phone number).

    Please refer to our website for additional guidance on ADR Reporting, or contact us at fv@npra.gov.my if you have any queries.

    Lipat di sini
    Laporan Kesan Advers Ubat
    Bahagian Regulatori Farmasi Negara (NPRA)
    Kementerian Kesihatan Malaysia

    PUSAT PEMONITORAN KESAN ADVERS UBAT KEBANGSAAN


    BAHAGIAN REGULATORI FARMASI NEGARA
    LOT 36, JALAN UNIVERSITI
    46200 PETALING JAYA

    SELANGOR

    - Sila lipat dua, lekat, dan hantar. Tekan beberapa saat dan pastikan pelekatan adalah memuaskan -

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