Extract from Editorial

While mankind moves into the third millennium, the Drug Safety Research Unit (DSRU) in Southampton, UK will enter its third decade during the year 2000.  The difference in scale reflects the history of pharmacovigilance.  Although the origins of monitoring the safety of medicines can be traced to the Babylonians and the laws of Hammorabi, modern pharmacovigilance emerged as a discipline after the thalidomide disaster in 1961.  The spontaneous reporting system in the UK started in 1964.  The need for other methods to monitor the safety of medicines in large populations were identified as early as 1965.  The Committee on the Safety of Drugs, which subsequently became the Committee on Safety of Medicines, recognised the need for post-marketing monitoring 30 years ago.  In the 1969-1970 annual report, the Committee stated that 'not all hazards can be known before the drug is marketed; neither tests in animals nor clinical trials in patients will always reveal all the possible side effects of the drug.  These may only be known when the drug has been administered to a large number of patients over considerable periods of time'.  The 1970s and 1980s saw the establishment of units specialising in monitoring and studying drug safety.  The Drug Epidemiology Unit (now the Slone Epidemiology Unit), which extended the hospital based Boston Collaborative Drug Surveillance Program, was established in the USA in 1970 and the Drug Surveillance Research Unit in Southampton (now the Drug Safety Research Unit) was established by Bill Inman in 1980.  Other units have been formed in other parts of the world since then, and there has been increasing utilisation of record linkage in databases such as the general practice research database (GPRD) in the UK for research in this field.