Drug Safety Monitoring: Objective and Importance:
Systematic drug safety monitoring, or pharmacovigilance, involves continual monitoring of unwanted effects and other safety-related aspects of drugs that are already available on the market. This strives to promote rational use of drugs with minimum risk to consumers.
Eisai is firmly committed to fulfilling its pharmacovigilance responsibilities, and Eisai encourages the reporting by the concerned parties of complaints associated with the intake or administration of any Eisai drug product. This activity helps in the continuous assessment of the benefit-risk ratio of Eisai drug products.
WHAT CAN BE REPORTED (I.E., EVENT) |
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Any Adverse Experience/Side Effect that occurred after taking an Eisai drug product. |
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Lack of expected clinical response after taking an Eisai drug product. |
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Overdosing, abuse, misuse of a drug, off-label use with or without adverse experience / side effects, medication errors with or without adverse experience / side effects, interactions, occupational exposure with an Eisai drug product. |
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Eisai drug product in original package found damaged, discoloured, misshaped, or tampered with, or any product quality-related complaint. |
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Having taken an Eisai drug product while being pregnant, breast feeding or lactating with or without adverse events/Paternal exposure of drug. |
WHO CAN REPORT (I.E., REPORTER) |
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A healthcare professional/person who experienced it or his/her relative, friend, lawyer, acquaintance/anyone who has sufficient knowledge of the event. |
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A healthcare professional/ person who experienced it or his/her relative, friend, lawyer, acquaintance/anyone who has sufficient knowledge of the event. |
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A healthcare professional / person who experienced it or his/her relative, friend, lawyer, acquaintance / anyone who has sufficient knowledge of the event. |
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A healthcare professional/ person who experienced it or his/her relative, friend, lawyer,acquaintance/anyone who has sufficient knowledge of the event. |
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A healthcare professional/ person who experienced it or his/her relative, friend, lawyer, acquaintance/anyone who has sufficient knowledge of the event. |
To report an adverse event in South Africa, please follow the below-mentioned steps.
Download the Printable Version of EISAI Suspected ADR Report Form, fill-up its print copy and post it to the following address:
Eisai Pharmaceuticals Africa (Pty) Ltd.
2nd Floor, Golden Oak House, Ballyoaks Office Park,35 Ballyclare Drive, Bryanston, Johannesburg – 2191, Gauteng, South Africa
or
You can also send the AE report via email to EPA-vigilance@eisai.co.za
or
You can also call the office number number to report an adverse event+27-10-590-4325
From Monday to Friday, between 09:00AM and 04:00PM.
*Note: Please do not leave any fields blank. STRIKE OUT WHERE INFORMATION IS ‘NOT AVAILABLE’ OR ‘NOT APPLICABLE.
*In case of a medical emergency, please visit the nearest emergency room or hospital.
*Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. The pharmacovigilance staff at Eisai is not expected to and will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel, the manufacturer, or the product caused or contributed to the reaction.
MEDICINES SIDE EFFECT REPORTING FORM