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 which are already available in the market. This strives to promote rational use of drugs with minimum risk to the consumers. Eisai is firmly committed to fulfilling its pharmacovigilance responsibilities and Eisai encourages reporting by the concerned parties of complaints associated with intake or administration of any Eisai drug product. This activity helps in continuous assessment of the benefit-risk ratio of Eisai drug products.
| WHAT CAN BE REPORTED (I.E., EVENT) | WHO CAN REPORT (I.E., REPORTER) |
|---|---|
| Any Adverse Experience/Side Effect that occurred after taking an Eisai drug product | A healthcare professional/person who experienced it or his/her relative, friend, lawyer, acquaintance/anyone who has sufficient knowledge of the event |
| Lack of expected clinical response after taking an Eisai drug product | A healthcare professional/ person who experienced it or his/her relative, friend, lawyer, acquaintance/anyone who has sufficient knowledge of the event |
| 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 | A healthcare professional / person who experienced it or his/her relative, friend, lawyer, acquaintance / anyone who has sufficient knowledge of the event |
| 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 | A healthcare professional / person who experienced it or his/her relative, friend, lawyer, acquaintance / anyone who has sufficient knowledge of the event |
| Eisai drug product in original package found damaged, discoloured, misshaped, or tampered with, or any product quality-related complaint | A healthcare professional / person who experienced it or his/her relative, friend, lawyer, acquaintance / anyone who has sufficient knowledge of the event |
| Having taken an Eisai drug product while being pregnant, breast feeding or lactating with or without adverse events | A healthcare professional / person who experienced it or his/her relative, friend, lawyer, acquaintance / anyone who has sufficient knowledge of the event |
Eisai Pharmaceuticals India Pvt. Ltd.
To report an adverse event in India, 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:
*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.
From Monday to Friday, between 09:00AM and 05:00PM.