The whole ethos of drug safety monitoring or ‘pharmacovigilance’ as it is known today, came into being through the tragedy of thalidomide.
"Between 1959 and 1962, the thalidomide disaster produced an estimated 10,000 deformed children born in those countries in which the drug was taken by women in the early stages of pregnancy". (Modern Drug Use, Ronald D.Mann, 1984).
There is a particular irony in that the building the Drug Safety Research Unit (DSRU) inhabits today, was once a children’s hospital where some of the worst cases of thalidomide were cared for in order to provide parental respite.
Following the thalidomide tragedy, a Committee on Safety of Drugs was established, later renamed and still known today as the Committee on Safety of Medicines (CSM). Its task was to identify problems relating to pharmaceutical substances, to assess their toxicity and report the findings to prescribers and patients. The CSM today monitors adverse drug reactions (ADR’s) by way of a spontaneous reporting mechanism known as the ‘Yellow Card’ scheme managed by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK licensing authority.
Formerly known as the Drug Surveillance Research Unit, the Drug Safety Research Unit was founded in 1980 by Professor William Inman, one of the earliest contributors to post marketing surveillance. Dr. Inman devised a method for the early detection of potential drug hazards known as Prescription-Event Monitoring (PEM) which he based on ‘Event Monitoring’ (Finney D.J. The design and logic of a monitor of drug use. J. Chron. Dis.18:77).
In the early years, the DSRU was part of the University of Southampton, having received an initial grant from the Office of the Chief Scientist together with unconditional pledges from the pharmaceutical industry. In 1986, it was reconstituted as a registered independent charity (No. 327206), changing its name to Drug Safety Research Unit because of the emotive connotation of the word ‘surveillance’.
The DSRU operates in association with the University of Portsmouth.