Pharmacovigilance

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)
The Department of Pharmacovigilance of Popular Pharmaceuticals Limited PLC performs all Pharmacovigilance-related activities of Popular Pharmaceuticals Limited PLC.The Department of Pharmacovigilance maintains a 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 the local Regulatory Authority as well as our Business Partners

How to report

Please refer to the  adverse event report and provide the previously mentioned 4 essential informations

Download Adverse Event Report Form

What to Report

All Serious & Non-serious Adverse Event (AE) or Adverse Drug Reaction (ADR) related to the use of Popular's Products (manufactured, imported and/or distributed) should be reported to the Department of Pharmacovigilance.

Minimum Information to Report

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 medications