(2004; 102 pages)
4.4 Guidelines for post-marketing surveillance
In the UK, in 1988 the Committee on Safety of Medicines, the Association of the British Pharmaceutical Industry, the British Medical Association, and the Royal College of General Practitioners agreed voluntary guidelines on post-marketing surveillance. These relate to observational cohort studies, in which doctors prescribe drugs under normal conditions. Under the guidelines, information about these studies, and the results, must be submitted to the Medicines Control Agency. Waller et al.219 reviewed the studies that had been carried out under these guidelines. They found that studies were characterised by weak designs and had considerable difficulties in recruiting participants, and suggest that they could make only a limited contribution to assessing the safety of new medicines. Others have suggested that in reality these studies are a promotional tool 220,221.
CONCLUSION: The only reported regulatory system for post-marketing surveillance that has been studied has not been successful.