Spontaneous Reporting of Adverse Reactions to Drugs

In spontaneous reporting, as a rule, suspected unusual and severe adverse effects of newly marketed drugs are given priority. In this situation, the number of patients exposed to the suspected drug is usually unknown or can only be estimated (Dunne 1978 Finney 1974 Kohler and Kimbel 1978 Maronde et al. 1978 WHO 1969). 

Studies of drug utilisation may be interesting for comparisons of various centres on a national and even international level (Dukes 1978 James et al. 1978 Law-son and Jick 1976). Computer studies should help to compare changing drug utilisation with changing patterns of complications and causes (Bottiger and Westerholm 1973). 

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Stem, R.S. and Bigby M., An expanded profile of cutaneous reactions to nonsteroidal antiinflammatory dmgs reports to a specialty-based system for spontaneous reporting of adverse reactions to drugs, JAMA, 252,1433-1437,1984. 

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