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US and EU pharmacovigilance compared: contemporary approach for spontaneous consumer report

This article was originally published in RAJ Devices

Executive Summary

Traditionally, reports on marketed product experiences are referred to as spontaneous reports, also commonly called voluntary, unsolicited or anecdotal reports. They are different from reports arising from clinical trials with regard to expedited and periodic reporting procedures. There are several influences complicating the classification and handling. For example, it is believed that the regulatory authorities of only two countries, the US and Canada, require the collection and reporting of direct reports from consumers. Conversely, there is a significant debate internationally about the role of such cases in pharmacovigilance. Some argue that the valid reports require “medical confirmation” while others regard patient-direct reports as potentially valuable.1 Nevertheless, the current system of pharmacovigilance in other regions, such as Europe, encourages reporting of adverse drug reactions (ADRs), mainly from healthcare professionals. Underreporting is a major problem, more so in the developing world than in the developed world. Less than 3% of reports added to the WHO database in the year 2000 originated from the developing countries, although around 80% of the global population lives in the developing world. 2




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