Влияние недавних изменений в GVP ЕАЭС
January 21, 2025
Enhancing Drug Safety: The Importance of Pharmacovigilance for Public Health
Pharmacovigilance plays a crucial role in maintaining public health by monitoring and evaluating the safety of medications after they reach the market, ensuring ongoing patient protection. This field is essential for the early identification of adverse drug reactions (ADRs), which can range from mild side effects to severe health risks, thereby preventing widespread health issues.
Pharmacovigilance contributes significantly to improving drug safety and efficacy by continuously assessing drug performance, leading to more informed therapeutic decisions.
Historical incidents like the Thalidomide tragedy of the 1950s and 60s underscore the importance of pharmacovigilance in detecting the harmful effects of drugs and have also contributed to stricter requirements for clinical trials and the establishment of drug regulatory authorities.
Real-Life Impact: Case Studies
Thalidomide Tragedy (1956-1962)
During the late 1950s and early 1960s, thalidomide was marketed as a safe remedy for morning sickness in pregnant women. However, it led to devastating outcomes, causing thousands of babies to be born with severe birth defects.
This tragedy, spanning from 1956 to 1962, affected 46 countries and resulted in 8,000-12,000 victims, becoming a pivotal moment in pharmaceutical history, and prompting the implementation of stringent drug testing and approval processes worldwide.
Uzbekistan Syrup Incident
In a more recent case, a medical crisis unfolded in Uzbekistan when a cough syrup containing ethylene glycol led to acute kidney failure, tragically resulting in the deaths of over 20 children. This incident underscores the essential role of pharmacovigilance in early detection of safety issues with medications, initiating investigations, and understanding the underlying causes to prevent serious outcomes.
Pharmacovigilance in the COVID-19 Era
The COVID-19 pandemic has highlighted the role of pharmacovigilance in rapidly identifying and addressing potential vaccine and treatment-related issues, demonstrating its critical role in managing public health crises. Through the collection and analysis of data, pharmacovigilance fosters a culture of continuous improvement in healthcare, leading to the development of safer and more effective treatments. Ultimately, effective pharmacovigilance builds public trust in the healthcare system, reassuring patients that their well-being is continuously monitored and protected.
Risk Minimization and Rapid Response
Inpharmatis assists pharmaceutical companies in minimizing risks by implementing comprehensive pharmacovigilance systems. These systems are crucial for the early identification and evaluation of ADRs, thereby preventing widespread health issues.
Additionally, Inpharmatis provides contact persons in various countries responsible for collecting data on ADRs and communicating them to regulatory authorities. This global network ensures a rapid and effective response to potential drug safety issues, enhancing patient protection.
In the countries such as Georgia, Turkmenistan, and Tajikistan, there are no requirements or regulations for pharmacovigilance. In Azerbaijan, Kyrgyzstan, Moldova, Mongolia, and Uzbekistan pharmacovigilance regulation is weak and just beginning to develop. Inpharmatis specialists use global experience and can apply successful practices from countries with more developed pharmacovigilance systems to support clients in these regions.
Inpharmatis experts stay abreast of actual updates in the rapidly evolving pharmacovigilance arena and ensure that clients receive the most effective drug safety monitoring services.
Article author
Hanna Balyka,
Pharmacovigilance Manager
Inpharmatis


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