Risk-benefit decisions in licensing changes

Abstract

It is at this point that the fallibility of human judgement enters in, for as a clinician I start with patients, where the regulatory body leaves off. Mike Rawlins described it as a relatively crude mechanism for sifting and sorting the process of defining benefits and risks, but it is nevertheless important. As a practising clinician, I take information from the regulatory body and from other sources in seeking practical and up-to-date guidance on such matters as quality, efficacy and, in particular, safety. As a family doctor I spend a large part of my time prescribing. I work at two different levels; firstly by tradition at the personal level with individual patients, who are, or think they are, ill, and secondly with those patients who are well but want a service which may include giving a drug, for example vaccination, or antenatal care. A third dimension has entered into my field of work only relatively recently, that is anticipatory care where I or my team go out to search for vulnerable groups in the population who may be at risk, for example from suspected blood pressure or diabetes. This adds a new dimension to the risk-benefit question.