Pharmacovigilance (PV)
According to WHO, Pharmacovigilance (PV) is defined as the
science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
drug-related problem.
Objective of PV:
Patient Care :
|
To improve patient care & safety
|
Public Health :
|
Early detection of unknown safety problem
|
Risk Benefit Assessment :
|
To contribute to the identification, assessment of benefit, harm, effectiveness & risk of medicine
|
Radiant Policy on Pharmacovigilance (PV)
Radiant is committed to inculcate Good PV Practices & thus is
committed to improve patient care & safety by:
- The rational & safe use of Radiant products.
- To create awareness regarding PV.
What to Report
All serious & non-serious adverse events (AE) should be reported to the Department of Pharmacovigilance.
Minimum Information to Reporting
An adverse event report should contain the Four essential information
1. Patient’s Details
- Name/Initials
- Gender, Age
- Contact number
- Pregnancy status
|
2. Reporter’s Details
- Name
- Occupation
- Address
- Contact number
|
3. Adverse Event
- Date of onset
- Symptoms
- Outcome
- Seriousness
- Medical history
|
4. Suspected Product(s)
- Brand name
- Dose, frequency
- Route
- Batch number
- Other medication
|
How to Report
Any adverse event regarding Radiant Products (manufactured and imported) can be reported to the Department of Pharmacovigilance.
Contacts of Department of Pharmacovigilance
|
E-mail
pv@radiant.com.bd
|
Contact Number +88 01844018052
|
Adverse events(AE) Report Form
Click here to Download AE Report Form
|
Postal/Courier Address
Department of Pharmacovigilance
Radiant Pharmaceuticals Limited
22/1 Dhanmondi, Road 2, Dhaka 1205.
|
Confidentiality: Any information related to the identities of the
patient and reporter will be kept confidential if not otherwise have
regulatory obligation.