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Pharmacovigilance and Ensuring Drug Safety

Krasen Tonev, Evgeni Grigorov, Konstantin Kalaidjiev


Introduction: Nowadays medication therapy plays a crucial role in modern medicine. Consequently, drug molecules and pharmaceutical preparations must fulfil the requirements for quality, efficacy and safety. Since ensuring patient safety is embedded in the underlying maxim of medicine – “Primum non nocere.”, understanding and preventing adverse drug reactions and drug-related problems is pivotal to the clinical outcome of the therapy.

The aim of the present work is to present a brief history of pharmacovigilance, its evolution over the years, the challenges it faces and new opportunities for future development.

Materials and Methods: A search of up-to-date scientific research on the problem was carried out in several web databases (Science Direct, PubMed and Google Scholar).

Results: Through various drug-related tragedies ranging from chloroform during the 19th century, passing through the thalidomide crisis in the late 1950s, the oral biguanide phenformin during the 1980s and even rofecoxib and valdecoxib in the new millennium, it has become clear that pharmaceutical companies should provide a clear proof of safety for new investigational drugs. Furthermore, drug molecules should be subject to rigorous post-authorization monitoring. Data in the form of signals about suspected adverse drug reactions is being gathered daily through “yellow cards” filled out by healthcare professionals worldwide. It is then analysed to assess if there is a causal relationship between drug intake and the development of unknown or undocumented adverse drug reactions. In recent years, however, there has been an increasing interest in finding new ways for generating signals including, for instance, the use of user posts in social media user posts.

Conclusions: The emergence and development of pharmacovigilance and the acceptance of drug safety regulations are among the milestones of modern medicine. Furthermore, generation, monitoring and assessment of various reports of adverse drug reactions greatly contribute to providing the public with safer yet effective medications.


pharmacovigilance, drug safety, adverse drug reactions


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