Due attention to the problem of treatment safety and to monitoring the adverse effects of medicinal products began to be paid in the late 19th and early 20th centuries.
The latter is due to a number of global tragedies that occurred in connection with the use of medicinal products. The first of these was the death of 107 Americans from an "elixir" of a sulfanilamide medicinal product that contained the solvent ethylene glycol.
The largest medicinal tragedy in human history was the so-called “thalidomide tragedy.” Over the period of 1957-1961, about 11000 children were born in European countries with congenital limb malformations (phocomelia), whose arms and legs were deformed and resembled seal flippers. The cause was the use of thalidomide by pregnant women as an antiemetic and sedative.
The next tragedy that shocked humanity occurred in 1971. It was then discovered that the use of diethylstilbestrol by pregnant women had caused malignant neoplasms of the vagina in pubertal girls.
Since then, the global medical community has concluded that comprehensive, rigorous studies are needed at the stage of medicinal product development, as well as safety monitoring during their widespread medical use.
in European countries and the United States of America (USA), agencies began to be established that were tasked with controlling medicinal products. For example, in the USA, since the 30s, the central link of the state system of medicinal product control has been the US Food and Drug Administration (FDA). Among the main institutions of the European Union (EU) in the field of medicinal product control, a specialized independent EU body was established in 1993 – the European Medicines Agency (EMA). EMA evaluates medicinal products intended for human use or for veterinary use and monitors them in the post-registration period.
Safety monitoring of medicinal products during their medical use is one of the main areas in implementing national medicines policy in all countries of the world. The international and national regulatory mechanism for monitoring the safety of medicinal products is called pharmacovigilance.
Pharmacovigilance is both a system and a process. According to the definition of the World Health Organization (WHO), pharmacovigilance is a scientific field and a practical activity related to the detection, assessment, understanding, and prevention of adverse effects or any other problems related to medicinal products (WHO, 2004).
In the 80s, a view of the problem of drug safety took shape and became established, which allowed WHO experts to develop approaches to assessing the use of medicinal products and ways of detecting new or rare adverse reactions (ARs). In 1964, the first WHO program for monitoring ARs of medicinal products came into force. Currently, 104 countries participate in the international WHO Programme for International Drug Monitoring. In 2002, Ukraine became a full member of this Programme.
Pharmacovigilance makes it possible to ensure effective and safe treatment of patients through timely regulation of the pharmaceutical market by restricting or discontinuing the use of dangerous or ineffective medicines.
The main directions of implementing the pharmacovigilance system at the global and national levels are:
- introduction into health care (HC) practice of a system for monitoring the safety of medicines;
- development of a modern methodology for organizing medicinal product safety monitoring;
- development and implementation of modern methodology for studying adverse reactions to medicinal products;
- participation in the development and implementation of regulatory documents on the organization and conduct of oversight of adverse reactions to medicinal products;
- providing advisory, methodological and educational activities in the field of medicinal product safety surveillance among the medical community and the public;
- conducting ongoing analysis and consolidation of information on adverse reactions to medicinal products in order to provide substantiated recommendations for safe pharmacotherapy and pharmacoprophylaxis in patients and to make appropriate regulatory decisions;
- exchange of information among all stakeholders about ARs of medicinal products;
- declaring a policy of transparency on medicinal product safety.
The main outcome of the activities of national pharmacovigilance systems in any country of the world is the withdrawal from the pharmaceutical market of products whose risk from use outweighs the benefit. It should be emphasized that in all countries, the adoption of various progressive additions to existing legislation is a process fraught with numerous obstacles. However, in the last century, especially in its second half, views began to prevail that convincingly argued that without a clear legal framework and oversight of the safety of medicinal products, control over medicinal products would be far from complete, and the consequences for the population would be irreversibly fatal. This understanding became the basis for the creation of a new field of activity – pharmacovigilance. Today, oversight of the safety of medicinal products is a component of state policy in the field of healthcare, which underscores the importance of this activity for the healthcare system and the safety of society.
