Pharmacovigilance is the science and set of activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with pharmaceutical products. It is also known as drug safety and represents a critical component of pharmaceutical science that ensures patient safety throughout the entire lifecycle of a medicine.
According to the World Health Organization (WHO), pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. An adverse drug reaction (ADR) in the post-marketing setting is defined as a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiology function.
The Pharmacovigilance Process
Pharmacovigilance follows a structured, multi-stage process to ensure comprehensive safety Monitoring.
Data Collection.
Data Processing.
Signal Detection.
Assessment and Evaluation.
Risk Management.
Quality Control.
Importance and Benefits of Pharmacovigilance
Pharmacovigilance plays several critical roles in modern medicine. It recognizes, observes, assesses, and documents drug-based problems and helps understand factors producing adverse effects.Early diagnosis and prompt treatment of pharmacological side effects are essential, and pharmacovigilance programs help compile data on both preventable and non-preventable adverse drug events through vigilant monitoring.
Pharmacovigilance !
Where it is started ?
Pharmacovigilance emerged from tragedic events like Thalidomide disaster and sulphanilamide tragedy,which lead WHO to start its global monitoring program and establishing Uppsala Monitoring Center in 1978.
Aim?
â—ŹImprove public health and safety.
â—ŹTimely detection of hazards caused by medications.
â—ŹPromote Rational use of Medicines.
Pharmacovigilance is basically about making sure medicines are safe to use, even after they are approved and available in the market. Many people think drug safety ends once a drug is approved, but in reality, monitoring continues throughout the drug’s life cycle.
The main goal of pharmacovigilance is to identify, assess, and prevent adverse drug reactions (ADRs). Sometimes, side effects only appear when a drug is used by a large number of people or for a long period of time. That’s why reporting and monitoring these reactions is so important.
Pharmacovigilance also helps in detecting rare or unexpected side effects that may not have been noticed during clinical trials. Based on safety data, regulatory authorities can update warning labels, restrict drug use, or even withdraw a drug if needed.
A clear and concise overview of pharmacovigilance. Drug safety doesn’t end at approval—continuous monitoring through robust pharmacovigilance systems is essential to detect ADRs early, minimize risks, and ensure patient safety throughout a medicine’s lifecycle.
Pharmacovigilance ensures drug safety by identifying and preventing adverse reactions. It plays a key role in protecting patients during real-world medicine use.
pharmacovigilance is crucial in a time with ever- emerging diseases and an equally rapid turnover of drugs to counter them. It enforces strict quality measures to ensure safety and promote health.
pharmacovigilance improves patient safety by observation and drug monitoring after market approval and detects long term side effects and improve quality of life.
Pharmacovigilance uses specialized databases to manage adverse event reports which includes WHO’s Vigibase, FDA’s FAERS and EMA’s Eudravigilance.