When there is sufficient evidence of a hazard to warrant further investigation, detailed consideration is given to causality, possible mechanisms, frequency and preventability. Assessment of these issues may require new epidemiological studies, but the hypothesis may be strengthened or weakened using immediately available sources of retrospective information such as worldwide spontaneous reporting, published literature and epidemiological databases.
The broad principles relating to post-authorisation studies have been set out in guidelines for pharmaceutical companies (European Commission, 2001, Part I, Chapter 1). When new data become available from purpose-designed studies it is important that they are reviewed in the context of the existing data. An assessment is made of whether and how the new evidence changes the previous evaluation, focusing particularly on the strength of the evidence for a drug-related association and possible approaches to prevention. In the latter respect, detailed analysis of the data to identify possible risk factors for the hazard is important.
The output of an evaluation is an assessment report that brings together the key information on the hazards and facilitates discussion of the risks and benefits of the medicine and possible measures which may facilitate safe use. Experts in pharmaco-epidemiology and relevant therapeutic areas are consulted and involved in such discussions both at national and EU level.
Was this article helpful?