History of Pharmacovigilance

The history of Pharmacovigilance started 169?years ago, on Jan 29, 1848, when a young girl (Hannah Greener) from the north of England died after receiving chloroform anesthetic before removal of an infected toenail. Sir James Simpson had discovered that chloroform was a safer and powerful anesthetic, and he had introduced it in clinical practice. The causes of Hannah’s death was investigated to understand what happened to Hannah, but it was impossible to identify what killed her. Probably she died of a lethal arrhythmia or pulmonary aspiration.

Pharmacovigilance (PV) is defined by the European Commission (EU) as the “Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines”.

The US Federal Food and Drug Act was formed on June 30, 1906, and it established that drugs must be pure and free of any contamination. In 1937, there were 107 deaths in the USA, because of the use of sulfanilamide elixir, containing diethyl glycol as the solvent. This solvent was considered the cause of deaths, but the manufactory companies were not aware about its toxicity at that time. Consequently, the Federal Food, Drug and Cosmetic Act was established in 1938; its aim was to renovate the public health system. Indeed, the new system foresaw that the safety of drugs should be demonstrated before their market approval, and introduced the possibility of conducting factory inspections. Factory inspection started by USFDA in 1938 first time in the world.

In 1961, a big change of European Pharmacovigilance happened following the tragedy of Thalidomide. Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children. In November 1961, thalidomide was taken off the market due to massive pressure from the press and public.

In USA (1962), the amendment, requiring safety and efficacy data of drugs before premarketing submission, was approved. In 1964, the “Yellow card” (YC) was structured in the UK. YC is a specific form to compile a spontaneous report of drug toxicity. In 1966, a pilot study of Boston Collaborative Drug Surveillance Program started. It was the first group to conduct epidemiologic researches to quantify the potential adverse effects of drugs utilizing in-hospital monitoring and had an essential role in the development and application of methods in drug epidemiology. In 1968, the WHO Programme for International Drug Monitoring was instituted and ten members participated in this program (Australia, UK, USA, Germany, Canada, Ireland, Sweden, Denmark, New Zealand, and Netherlands). Italy participated in this program in 1975. In 1995, the European Medicines Agency (EMA) was set up. In 2001, EudraVigilance was funded. It is the official European database for managing and analyzing information on suspected adverse reactions to medicines which have been authorized for the market or being studied in European clinical trials. In November 2017, the new EudraVigilance format was launched. Furthermore, the new legislation set-up measures to facilitate the performance of PV, called the Good Pharmacovigilance Practices (GVP).

Currently 150 countries have established National Pharmacovigilance Centers and everyday one and other countries are trying to establish National Pharmacovigilance Centers. National Pharmacovigilance Centers remains connected with International Center for Pharmacovigilance and down the line with regional pharmacovigilance centers and regional pharmacovigilance centers remains connected with marketing authorization holders whosoever adopted drug safety database.

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