Pharmacovigilance
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. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. (Reference: WHO)
Department of Pharmacovigilance of Radiant Pharmaceuticals Limited performs all Pharmacovigilance related activities of Radiant Pharmaceuticals Limited, Radiant Nutraceuticals Limited, Radiant Business Consortium Limited, Radiant Export Import Enterprise, Radiant Distributions Limited, Pharmacil Limited, and Jenphar Bangladesh Limited. The pharmacovigilance system of Radiant was set up in 2013. A group of pharmacists is presently working in this department.
Department of Pharmacovigilance maintains separate PV QMS (Pharmacovigilance Quality Management System) to carry out all PV functions including processing ICSRs, monitoring local literature, providing PV awareness training to all employees, communicating & reporting to local Regulatory Authority as well as our Business Partners (F. Hoffmann-La Roche, Boehringer Ingelheim, Cheplapharm, Ferring, Fresenius Kabi, Pfizer, Wockhardt).
What to Report
All Serious & Non-serious Adverse Event (AE) or Adverse Drug Reaction (ADR) related to the use of Radiant’s Products (manufactured, imported and/or distributed) should be reported to the Department of Pharmacovigilance.
An adverse event report should contain the four essential information:
Patient’s Details
Name/ Initials
Gender, age
Contact number
Pregnancy status
Reporter’s Details
Name
Occupation
Address
Contact number
Adverse Event
Date of onset
Symptoms
Outcome
Seriousness
Medical history
Suspected Product(s)
Brand name
Dose, frequency
Route
Batch number
Other medications
All consumers or patients are advised to contact their doctor for advice on medicines or any health problems/ medical emergencies. Pharmacovigilance enhance safer use of medicine by monitoring the safety and efficacy of medicines and by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Confidentiality Note: Any information related to the identities of the patient and reporter will be kept confidential unless it is subject to disclose due to regulatory obligation.
