International Aspects of Spontaneous Reporting of Adverse Drug Reactions

Abstract

Spontaneous reporting of possible adverse effects of drugs can make an important contribution to their early detection, but is of limited value for estimation of incidence. At present, the enormous differences between countries in the organization and functioning of spontaneous reporting systems limit their potential. International standardization and coordination of procedures would be easy and highly beneficial. Health professionals in all countries should be encouraged and appropriately motivated to report important adverse drug experiences to the appropriate recipient in their country. The pharmaceutical manufacturer in the reporting country should be charged with the investigation of all ADR reports concerning their drugs, regardless of who is the initial recipient of the report. The reporting of investigated ADRs by pharmaceutical manufacturers to their national drug authorities should be strengthened and standardized internationally. Free exchange of information concerning ADRs should be established between pharmaceutical manufacturers and drug regulatory agencies on national and international levels.