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    Suspected Adverse Drug Reactions

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    This document appears to be an adverse drug reaction (ADR) reporting form from the Health Sciences Authority of Singapore. It requests information about a patient who experienced an adverse reaction, including demographic details, description of the reaction, suspected drugs/medications taken, treatment received, and details of the reporting healthcare professional. The form notes that all serious ADRs should be reported, including those that are life-threatening, cause hospitalization or disability, or are related to newly marketed drugs. Reporters are assured confidentiality and encouraged to submit any follow-up reports or additional information.

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    Suspected Adverse Drug Reactions

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    BBB.AAA
    85 views2 pages
    This document appears to be an adverse drug reaction (ADR) reporting form from the Health Sciences Authority of Singapore. It requests information about a patient who experienced an adverse reaction, including demographic details, description of the reaction, suspected drugs/medications taken, treatment received, and details of the reporting healthcare professional. The form notes that all serious ADRs should be reported, including those that are life-threatening, cause hospitalization or disability, or are related to newly marketed drugs. Reporters are assured confidentiality and encouraged to submit any follow-up reports or additional information.

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    Suspected Adverse Drug Reactions

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    This document appears to be an adverse drug reaction (ADR) reporting form from the Health Sciences Authority of Singapore. It requests information about a patient who experienced an adverse reaction, including demographic details, description of the reaction, suspected drugs/medications taken, treatment received, and details of the reporting healthcare professional. The form notes that all serious ADRs should be reported, including those that are life-threatening, cause hospitalization or disability, or are related to newly marketed drugs. Reporters are assured confidentiality and encouraged to submit any follow-up reports or additional information.

    Copyright:

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

    Suspected Adverse Drug Reactions

    Uploaded by

    BBB.AAA
    This document appears to be an adverse drug reaction (ADR) reporting form from the Health Sciences Authority of Singapore. It requests information about a patient who experienced an adverse reaction, including demographic details, description of the reaction, suspected drugs/medications taken, treatment received, and details of the reporting healthcare professional. The form notes that all serious ADRs should be reported, including those that are life-threatening, cause hospitalization or disability, or are related to newly marketed drugs. Reporters are assured confidentiality and encouraged to submit any follow-up reports or additional information.

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    CONFIDENTIAL

    SUSPECTED ADVERSE DRUG REACTIONS !"#


    $%&'(
    Safer Medicines Through Reporting

    I-PARTICULARS OF PATIENT

    Patient’s initials: Record no./NRIC/Passport no.:

    Age: years Weight: kg Ethnic group: Chinese Indian Malay Eurasian

    Sex: Female Male Others (Please specify):

    II-DETAILS OF ADVERSE DRUG REACTION (ADR)


    Outcome: Recovered (Date): Not yet recovered

    Date of onset: Fatal (Date of death): Unknown


    ( d d / m m / y y )
    Sequelae (any permanent complications or injuries as a result of the ADR):
    Yes No Unknown
    Description of ADR(s):

    Suspected drug(s) Dosage Frequency Route Date Date Indication(s) for using drug
    (Please specify brand name if known. started stopped
    For vaccines, please indicate batch no.)

    1.
    2.
    3.
    Other drugs (including complementary medicines, consumed at the same time and/or 3 months before)
    1.
    2.
    3.
    4.
    5.
    Other relevant information: e.g. medical history, allergies, pregnancy, smoking, alcohol use, rechallenge (if performed). Please enclose any relevant laboratory results.

    III-MANAGEMENT OF ADVERSE REACTION

    Hospitalisation (following the ADR): Yes No Already hospitalised before ADR occurred
    Do you consider the reaction to be serious? Yes No
    If yes, please indicate why the reaction is considered to be serious (please tick ✓ all that apply):
    Patient died due to reaction Involved or prolonged in-patient hospitalisation
    Life threatening Involved persistent or significant disability or incapacity
    Congenital anomaly Medically significant, please give details:
    Treatment given: Yes No (If yes, please specify):

    IV-PARTICULARS OF REPORTER Name and address of place of practice

    Name: Signature:
    Profession: Date:
    Contact no: Email address: Ref No. (for official use)
    EXPLANATORY NOTES

    CONFIDENTIALITY HOW TO REPORT


    Any information related to the identities of the reporter and patient will be kept
    confidential.
    Mail to:
    WHAT TO REPORT Adverse Event Management Unit
    Vigilance Branch
    An Adverse Drug Reaction (ADR) is defined as a reaction which is noxious (harmful) and
    Health Products Regulation Group
    unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, Health Sciences Authority
    or treatment of a disease, or for the modification of a physiological function. 11 Biopolis Way
    #11-03, Helios
    Singapore 138667
    HSA encourages the reporting of all suspected adverse reactions to drugs and other
    medicinal substances (including herbal, traditional or alternative remedies). In particular,
    please report the following:
    Fax: (65) 6478 9069
    1. All serious adverse drug reactions which
    a. are life threatening or fatal,
    b. require in-patient hospitalisation or prolong existing hospitalisation,
    c. cause persistent incapacity or disability,
    Phone: (65)
    d. cause birth defect,
    e. are medically significant.

    2. All adverse drug reactions to recently marketed drugs that have been introduced Email: HSA_productsafety@hsa.gov.sg
    into Singapore in the recent 5 years, regardless of their nature and severity.

    Please do not be deterred from reporting because some details are not known. You may send
    the completed ADR Report Form (through your respective hospital pharmacies, if applicable) Online Reporting:
    to the Vigilance Branch, Health Products Regulation Group (see below for full address). http://www.hsa.gov.sg/adr_online
    Additional pages may be attached if required.

    The form can be downloaded from


    SUBMISSION OF FOLLOW-UP REPORTS http://www.hsa.gov.sg/adr_form
    Any follow-up information for an ADR that has already been reported can be sent to us in
    another form or via any other modes of reporting. Please indicate that it is a follow-up
    report. It is very important that follow-up reports are identified and linked to the original
    report.
    HSA ADR reporting form/Apr 2010

    Adverse Event Management Unit Vigilance Branch Health Products Regulation Group
    Health Sciences Authority 11 Biopolis Way, #11-03, Helios, Singapore 138667
    http://www.hsa.gov.sg

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