Drug Promotion - What We Know, What We Have Yet to Learn - Reviews of Materials in the WHO/HAI Database on Drug Promotion - EDM Research Series No. 032
(2004; 102 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentExecutive summary
Open this folder and view contentsIntroduction
Open this folder and view contentsReview 1. What attitudes do professional and lay people have to promotion?
Open this folder and view contentsReview 2. What impact does pharmaceutical promotion have on attitudes and knowledge?
Open this folder and view contentsReview 3. What impact does pharmaceutical promotion have on behaviour?
Close this folderReview 4. What interventions have been tried to counter promotional activities, and with what results?
View the document4.1 Guidelines, codes and regulations for printed and broadcast material
View the document4.2. The ‘Fair Balance’ requirement
View the document4.3 Guidelines for sales representatives
View the document4.4 Guidelines for post-marketing surveillance
View the document4.5 Guidelines on conflict of interest in research
View the document4.6 Guidelines for package inserts and compendia
View the document4.7 Guidelines about gifts
View the document4.8 Guidelines for trainee doctors and for hospitals
View the document4.9 Knowledge of these guidelines and their effect on attitudes
View the document4.10 Education about promotion
View the document4.11 Monitoring/countering promotion
View the document4.12 Research as an intervention
View the documentSummary of conclusions
View the documentDirections for future research
View the documentFinal conclusions
View the documentReferences
 

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.

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