The History of Pharmacovigilance

The following is a brief overview of some of the major historical events that led to the need for Pharmacovigilance and forever changed patient safety oversight in the pharmaceutical industry. Pharmacovigilance began in 1898, following the death of a young girl from Northern England who was administered a chloroform anesthetic before the surgical removal of an infected toenail. Some speculated that the chloroform anesthetic might have caused a cardiac arrhythmia or pulmonary aspiration that led to her death, but the actual cause of death was not determined. Subsequently, on June 30, 1906, the United States Federal Food and Drug Act was formed and it was mandated that drugs must be pure and free of any adulteration. During the months of September–October 1937, the first major public case of drug-related deaths in the United States occurred. A drug called Sulfanilamide, used to treat streptococcal infections at that time, was responsible for the deaths of 107 people. In early 1937, Sulfanilamide was used in powder and tablet form. Due to increased demand for a liquid form of the medication, the manufacturer, S.E. Massengill Company, decided to develop a liquid form of Sulfanilamide. As a result of these sulfanilamide elixir-related deaths, the Food, Drug, and Cosmetic Act, which increased the FDA's authority to regulate drugs, was passed in 1938.