The whole ethos of drug safety monitoring or ‘pharmacovigilance’ as it is known today, came into being through the tragedy of thalidomide.

This disaster of the early 1960s produced an estimated 10,000 deformed babies in the countries in which the drug was widely used in early pregnancy. This disaster led directly to the establishment in Europe of the modern drug regulatory mechanisms. In the UK these mechanisms were first enacted into law by the Medicines Act, 1968. Even before this Act was implemented it was officially recognised that no drug which is pharmacologically effective is entirely without hazard and not all hazards can be known before a drug is marketed.

Following the thalidomide tragedy, a Committee on Safety of Drugs was established, later renamed the Commission on Human Medicines (CHM). 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.

Post-marketing surveillance (PMS) of new drugs is imperative to quantify common adverse drug reactions and to identify rare adverse reactions. In the UK the only form of PMS which prompts all doctors using new drugs to report the events which follow their use is Prescription-Event Monitoring (PEM). This method of pharmacovigilance is undertaken by the Drug Safety Research Unit (DSRU) at Southampton to examine the safety of new drugs intended for widespread use in primary care. There is a particular irony in that the building the 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.

Formerly known as the Drug Surveillance Research Unit, the Drug Safety Research Unit (DSRU) was founded in 1980 by Professor William Inman, one of the earliest contributors to post marketing surveillance and the person responsible for developing the yellow card system. Although spontaneous reporting systems have many real advantages, he recognised their limitations and as a result Dr. Inman established the DSRU and 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). Initially, having received an initial grant from the Office of the Chief Scientist together with unconditional pledges from the pharmaceutical industry, the DSRU was part of the Faculty of Medicine at the University of Southampton. However 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 now operates in association with the University of Portsmouth.

Founder, Professor William Inman FRCP, FFCM.

The grounds of the DSRU provide a safe habitat for many birds