
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.
At the end of May 2016, 153 countries were part of the WHO PV Program.
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. Biocyte Healthcare Ltd is committed to inculcating Good PV Practices to improve patient care & safety by the rational & safe use of our products to create awareness regarding PV. Our Pharmacovigilance activities are carried out by a group of qualified pharmacists.
What to Report
All serious & non-serious adverse events (AE) or adverse drug reactions (ADR) have to be reported to the Pharmacovigilance team.
How to Report
Any adverse event regarding Biocyte Healthcare Ltd products can be reported by Phone call or SMS to the PV team or filling up Adverse Events (AE) Form and sending it through Email
Minimum Information for Reporting
An adverse event report should contain four essential information
Patient’s Details
- Name/Initials
- Gender, Age
- Contact number
- Pregnancy statu
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 medication