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This form is used to report suspected adverse drug reactions. It captures essential patient particulars, details of the adverse reaction, suspected medicines, management of the adverse reaction, concomitant medical products, and reporter details. The information collected is used for pharmacovigilance purposes to ensure drug safety.
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How to fill out suspected adverse drug reaction

01
Identify the suspected adverse reaction experienced by the patient.
02
Gather relevant patient information, including demographics and medical history.
03
Collect details about the medication involved, including dosage, route of administration, and duration of use.
04
Document the specifics of the adverse reaction, including onset, severity, and duration.
05
Note any other medications or treatments the patient is receiving that may contribute to the reaction.
06
Ensure that any relevant laboratory or diagnostic results are included.
07
Report the suspected adverse reaction to the appropriate regulatory authority or institution.
08
Follow any additional protocols specific to your institution regarding adverse drug reactions.

Who needs suspected adverse drug reaction?

01
Healthcare professionals including doctors, nurses, and pharmacists.
02
Patients experiencing adverse drug reactions to their medications.
03
Pharmaceutical companies for safety monitoring of their products.
04
Regulatory agencies for drug safety surveillance and public health protection.
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A suspected adverse drug reaction is an unwanted or harmful reaction experienced by a patient after taking a medication, which is believed to be related to the drug.
Healthcare professionals, including doctors, nurses, and pharmacists, as well as patients and their caregivers, are required to file a suspected adverse drug reaction.
To fill out a suspected adverse drug reaction, provide details about the patient, the medication involved, the nature of the adverse reaction, the onset date, and any other relevant clinical information.
The purpose of reporting suspected adverse drug reactions is to monitor drug safety, identify potential risks, improve patient care, and facilitate regulatory actions if necessary.
Information that must be reported includes patient demographics, details of the reaction, the suspected drug, dosage, duration of use, and any prior history of adverse reactions.
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