Medicines and risk

Drug safety – important to us all!

“…The main focus of control of medicines’ quality and properties has been markedly changed during the development which has taken place during the latter half of the 20th century. In 1976 Waldenström wrote an editorial on ‘Toxicology in clinical medicine’ [1], later editorials in this journal have dealt with ‘Adverse drug reactions – a plea for a realistic attitude’ [2], ‘Post‐marketing surveillance’ [3] and ‘Medicines and risk’ [4]. The titles point to the shift which has taken place, from questions of pure toxicity to an acceptance of negative drug reactions as a realistic phenomenon, the need for control of drugs even after their introduction on the market and, by the same token, the need for an informed balancing of advantages against disadvantages, a risk evaluation.…”

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“…Hazard is, after all, 'the situation that in particular circumstances could lead to harm' (Royal Society Study Group, 1983). There is, for example, the danger of being accused of plagiarism, a risk enhanced by the number of recent publications on risk (Anonymous, 1990;Black, 1991;Bottiger, 1990;British Medical Association, 1987;Cooper, 1985;Lave, 1987;. Risk here means 'the probability that a particular adverse outcome occurs during a given quantum of exposure to hazard', for example during a given time interval, per lifetime, or per editorial written ( Figure 1).…”