Medicines and side-effects

The information delivered by pre-registration studies rarely forms an accurate reflection of the risks posed by a drug after its market authorisation. This is not only true for drugs that are currently on the market, but possibly even more so for those that will be conditionally authorised in the future in the fast-track procedure. This implies that monitoring safety problems will demand even greater attention. Drug safety requires continuous vigilance among all those involved: prescribers, patients, supervisory bodies, registration holders, the Dutch Medicine Evaluation Board (MEB) and the Netherlands Pharmacovigilance Centre (Lareb). Although observations from the field provide the first step towards greater insights, causal relations are often still unclear, as are the incidences of particular side-effects. Hence, these early warning signals should be supplemented, where necessary, with data from post-marketing studies by the pharmaceutical industry or studies by research institutions, or from practice. This does not, however, make observations from the field less valuable. On the contrary, without such observations, targeted research into new side-effects would be impossible.

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  • Prof dr E.P. van Puijenbroek