Author: Ms. Shikha Singh
Volume: 01
First Online: 31 August 2024
Pages: 87-102
DOI:

Establishing a pharmacovigilance program is a critical step in ensuring the safe and effective use of medications within a healthcare system. The program aims to systematically monitor, detect, assess, understand, and prevent adverse drug reactions (ADRs) and other drug-related problems. Key components include setting up a robust reporting system for healthcare professionals and patients to report ADRs, creating a centralized database to collect and analyze safety data, and developing standard operating procedures (SOPs) for the timely assessment and management of risks. Training healthcare providers on the importance of pharmacovigilance and how to recognize and report ADRs is essential for the program’s success. Collaboration with regulatory authorities and adherence to international guidelines, such as those provided by the World Health Organization (WHO) and the International Council for Harmonisation (ICH), ensure the program’s alignment with global standards. Continuous monitoring, regular audits, and periodic reviews help to maintain and improve the program’s effectiveness. Ultimately, a well-established pharmacovigilance program enhances patient safety, supports informed regulatory decisions, and contributes to the overall quality of healthcare.