Pharmacovigilance Systems and Strategies: Importance of Post-Marketing
Surveillance for Ensuring Drug Safety and Patient Health in Europe,
United States, and India
Abstract
After a drug is granted a marketing license, its post-marketing
surveillance is evaluated to ensure that it is continuously monitored
for undesirable effects. This monitoring is achieved through an
effective Pharmacovigilance system. In our review, we discuss the
Pharmacovigilance systems of Europe, the United States, and India, along
with several examples of effective Pharmacovigilance strategies, such as
the Tracleer® Access Programme and Tracleer® Excellence programs for
Bosentan, Merck’s Worldwide Adverse Experience System, the European and
United States Varicella Zoster Virus Identification Programs for
Varivax, the Siddha Initiative for Documentation of Drug Adverse
Reaction, an android mobile app for AYUSH Pharmacovigilance, and the
Global Pharmacovigilance Database by Sanofi Pasteur. This report
demonstrates the importance of post-marketing surveillance in detecting
rare adverse experiences that may go unnoticed during clinical trials.
It also emphasizes the significance of highlighting the field of
Pharmacovigilance to improve patient safety and offer them the best
possible quality of life.