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Version1.2 SUSPECTED ADVERSE DRUG REACTION REPORTING FORM For VOLUNTARY reporting of Adverse Drug Reactions by Healthcare Professionals INDIAN PHARMACOPOEIA COMMISSION (National Coordination CentrePharmacovigilance
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01
Begin by gathering all relevant information about the suspected adverse drug reaction, including the patient's medical history, current medications, and any relevant test results.
02
Complete a suspected adverse drug reaction form, which may vary depending on your country or healthcare system. Ensure that you provide accurate and detailed information about the reaction, including the onset, duration, and severity of symptoms.
03
Include any known allergies or intolerances to medications, as well as any previous adverse drug reactions experienced by the patient.
04
If available, attach any supporting documents or lab reports that could help in assessing the suspected adverse drug reaction.
05
Submit the completed form to the designated regulatory authority or healthcare organization responsible for collecting and monitoring adverse drug reactions. Follow their specific instructions for submission, whether it is through an online portal, by fax, or by mail.
06
Keep a copy of the submitted form for your own records and ensure that it is securely stored.
07
If necessary, follow up with the regulatory authority or healthcare organization to inquire about the progress of the suspected adverse drug reaction report.

Who needs suspected adverse drug reaction?

01
Healthcare professionals, including physicians, nurses, pharmacists, and other healthcare providers, need suspected adverse drug reaction reports to monitor and evaluate medication safety.
02
Patients who have experienced an adverse drug reaction should also report it to their healthcare providers, as this information can contribute to improved patient safety and help prevent similar reactions in the future.
03
Regulatory authorities, such as drug regulatory agencies or pharmacovigilance centers, need suspected adverse drug reaction reports to perform pharmacovigilance activities, including monitoring the safety profiles of medications and taking appropriate regulatory actions if necessary.
04
Pharmaceutical companies use suspected adverse drug reaction reports to monitor the safety of their products and comply with regulatory requirements.
05
Researchers and academics may also utilize suspected adverse drug reaction reports to study the prevalence, characteristics, and outcomes of adverse drug reactions, ultimately contributing to the advancement of medical knowledge and patient care.
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Suspected adverse drug reaction refers to any harmful or unintended response to a medication or drug that occurs at doses normally used for treatment or prevention of a disease.
Healthcare professionals, pharmaceutical companies, and patients are required to report suspected adverse drug reactions.
Suspected adverse drug reactions can be reported through official channels such as the FDA's MedWatch program or the WHO's VigiBase database.
The purpose of reporting suspected adverse drug reactions is to monitor the safety and efficacy of medications, inform healthcare decisions, and improve patient outcomes.
Information such as patient demographics, description of the adverse event, timeline of drug use, concomitant medications, and outcomes must be reported on suspected adverse drug reactions.
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