Scientists and the Regulation of Risk
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Scientists and the Regulation of Risk

Standardising Control

David Demortain

Risks are increasingly regulated by international standards, and scientists play a key role in standardisation. This fascinating book exposes the action of ‘invisible colleges’ of scientists – loose groups of prominent scientific experts who combine practical experience of risk and control with advisory responsibility – in the formulation of international standards.
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Chapter 4: Drawing Lessons: Medical Professionals and the Introduction of Pharmacovigilance Planning

David Demortain


In 2004, the International Conference on Harmonisation (ICH)1 adopted a guideline for ‘pharmacovigilance planning’ (PVP) that responds to the failure of the pharmacovigilance system to act on the discovery of unexpected, serious and sometimes frequent adverse effects associated with volume-selling drugs, and leading to a growing number of cases of worldwide withdrawals since the end of the 1990s. Pharmacovigilance planning is one of the latest innovations introduced globally in response to the shortcomings of the monitoring of drugs and their adverse effects in the market. Controlling the risks posed by medicines is a never-ending task. In spite of methodological sophistication, clinical trials are always insufficient to uncover all potential adverse effects. The same applies to the monitoring of adverse drug reactions that were unknown at the time when the drug was authorised. Over several decades, various ways of collecting data directly from physicians, pharmacists and patients have been devised. Large sets of data are now accumulated about the number of products prescribed to a patient, when and how they were taken, and which effects appeared. Statistical analyses are made on these data sets to try to find warning signals of a drug directly causing a negative health event. This information is always limited in some way, notably because businesses and physicians fail to report a lot of the cases they see. Given these limits, pharmacovigilance is prone to failure – and to constant improvements. The idea of pharmacovigilance planning crystallised soon after 2000 and a series of abrupt withdrawals of...

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