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Version1.3SUSPECTED ADVERSE DRUG REACTION REPORTING FORM For VOLUNTARY reporting of Adverse Drug Reactions by Healthcare ProfessionalsINDIAN PHARMACOPOEIA COMMISSION (National Coordination CentrePharmacovigilance
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How to fill out suspected adverse drug reaction

How to fill out suspected adverse drug reaction
01
To fill out a suspected adverse drug reaction, follow these steps:
02
- Collect all necessary information about the patient, such as their age, gender, and medical history.
03
- Document the details of the suspected adverse drug reaction, including the name of the drug, dosage, start and end date of treatment, and symptoms experienced.
04
- Include any additional relevant information, such as concomitant medications or pre-existing conditions.
05
- Use a standardized format or reporting system, if available, to ensure consistency and compatibility with regulatory agencies.
06
- Submit the completed suspected adverse drug reaction form to the appropriate authority or pharmacovigilance program.
Who needs suspected adverse drug reaction?
01
Suspected adverse drug reaction reports are necessary for healthcare professionals, including doctors, nurses, and pharmacists.
02
Regulatory authorities also require these reports to monitor the safety and efficacy of medications.
03
Pharmaceutical companies may need suspected adverse drug reaction reports to update drug labels or conduct further investigations.
04
Patients and their caregivers play a crucial role in reporting suspected adverse drug reactions, as they can provide valuable firsthand information.
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What is suspected adverse drug reaction?
Suspected adverse drug reaction refers to an undesirable reaction or side effect that occurs after taking a medication, even if it is not proven to be caused by the drug.
Who is required to file suspected adverse drug reaction?
Healthcare professionals, manufacturers, and consumers are required to report suspected adverse drug reactions.
How to fill out suspected adverse drug reaction?
Suspected adverse drug reactions can be reported through official reporting systems provided by regulatory authorities or health organizations.
What is the purpose of suspected adverse drug reaction?
The purpose of reporting suspected adverse drug reactions is to monitor the safety and effectiveness of medications, and to take appropriate actions to protect public health.
What information must be reported on suspected adverse drug reaction?
Information such as the name of the drug, the adverse reaction observed, the patient's details, and the circumstances surrounding the reaction must be reported on suspected adverse drug reactions.
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